ACADIA Pharmaceuticals Reports Third Quarter 2018 Financial Results

-Third Quarter Net Sales Grew to $58.3 Million

-Recently Announced Positive Top-line Results from the Phase 2CLARITY Trial of Pimavanserin for Adjunctive Treatment for MajorDepressive Disorder

-FDA Issued Statement Reaffirming the Positive Benefit-Risk Profileof NUPLAZID^® for Patients with Hallucinationsand Delusions Associated with Parkinson’s Disease Psychosis

-Launched New Dosing Formulation and Strength of NUPLAZID

SAN DIEGO—(BUSINESS WIRE)—Nov. 6, 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 third quarterended September 30, 2018.

“We made significant progress this quarter. On the heels of launchingour new 34 mg capsule for NUPLAZID, the FDA issued a public statementreaffirming NUPLAZID’s positive benefit-risk profile for treatingParkinson’s disease psychosis. These actions, combined with ourcommercial initiatives, position ACADIA to deliver on NUPLAZID’s growthpotential,” said Steve Davis, ACADIA’s President and Chief ExecutiveOfficer. “In addition, last week we were very excited to announce robustpositive data from our Phase 2 CLARITY study evaluating pimavanserin asan adjunctive therapy for patients with major depressive disorder. Thesedata confirm our confidence that pimavanserin could be a very importantnew medicine for those who continue to suffer from MDD despite availabletreatment options. We plan to discuss our results with the FDA andinitiate a Phase 3 program in the first half of 2019.”

Recent Highlights

• Announced positive top-line results from the Phase 2 CLARITY trial ofpimavanserin for adjunctive treatment in patients with majordepressive disorder (MDD).
  
  
  • Pimavanserin met the pre-specified primary endpoint of theequally-weighted average results of Stage 1 and Stage 2 bysignificantly reducing 17-item Hamilton Depression Rating Scale(HAMD-17) total score compared to placebo (p=0.039). In Stage 1,an all-comer parallel comparison to placebo treatment period,pimavanserin showed a highly significant improvement over placebo(p=0.0003; Effect size=0.626).
  • Pimavanserin also demonstrated statistically significantreductions compared to placebo in the pre-specified key secondaryendpoint, the Sheehan Disability Scale (SDS), a patientself-assessment of work, family, and social activities (p=0.004).
  • Positive results were also observed on seven additionalpre-specified secondary endpoints including responder rate,improvement in sexual function, and reduction in daytimesleepiness.
  • Additional details from the Phase 2 CLARITY results are includedin the press release issued by the Company on October 31, 2018.
  • The Company plans to meet with the FDA and initiate a Phase 3program for pimavanserin as an adjunctive treatment for MDD in thefirst half of 2019.
• FDA issued a public statement reaffirming the positive benefit-riskprofile of NUPLAZID for patients with hallucinations and delusionsassociated with Parkinson’s disease psychosis.
• Announced an exclusive license agreement with Neuren Pharmaceuticals(ASX: NEU) for the North American development and commercialization oftrofinetide for all indications, including Rett syndrome, a rareneurodevelopmental CNS disorder. The Company plans to initiate a Phase3 trial with trofinetide for Rett syndrome in the second half of 2019.
• Launched a new 34 mg single capsule formulation of NUPLAZID to treatpatients living with hallucinations and delusions associated withParkinson’s disease psychosis.
• Appointed Robert Kaper, M.D., as Senior Vice President, Global Head ofMedical Affairs, Eliseo Salinas, M.D. M.Sc., as Senior Vice President,Chief Scientific Officer and Head of External Innovation, and ElenaRidloff, CFA, Senior Vice President of Investor Relations, as InterimChief Financial Officer.

Financial Results

Revenue
Net sales of NUPLAZID were $58.3 million for thethree months ended September 30, 2018, an increase of 64% as compared to$35.6 million reported for the three months ended September 30, 2017.For the nine months ended September 30, 2018 and 2017, ACADIA reportednet product sales of $164.2 million and $81.3 million, respectively.

Research and Development
Research and development expensesfor the three months ended September 30, 2018 were $53.1 million,compared to $36.4 million for the same period of 2017. For the ninemonths ended September 30, 2018 and 2017, research and developmentexpenses were $139.0 million and $106.0 million, respectively. Theincrease in research and development expenses during the 2018 periods ascompared to 2017 was primarily due to additional clinical study costsincurred by the Company as it continues to invest in additional pipelineprograms for pimavanserin as well as an upfront payment of $10.0 millionto Neuren Pharmaceuticals for trofinetide.

Selling, General and Administrative
Selling, general andadministrative expenses for the three months ended September 30, 2018were $61.1 million, compared to $61.6 million for the same period of2017. For the nine months ended September 30, 2018 and 2017, sellinggeneral and administrative expenses were $191.5 million and $188.4million, respectively.

Net Loss
For the three months ended September 30, 2018,ACADIA reported a net loss of $62.1 million, or $0.50 per common share,compared to a net loss of $65.2 million, or $0.53 per common share, forthe same period in 2017. The net losses for the three months endedSeptember 30, 2018 and 2017 included $20.2 million and $19.7 million,respectively, of non-cash stock-based compensation expense. For the ninemonths ended September 30, 2018, ACADIA reported a net loss of $179.7million, or $1.44 per common share, compared to a net loss of $220.5million, or $1.81 per common share, for the same period in 2017. The netlosses for the nine months ended September 30, 2018 and 2017 included$61.2 million and $53.5 million, respectively, of non-cash stock-basedcompensation expense.

Cash and Investments
At September 30, 2018, ACADIA’s cash,cash equivalents and investment securities totaled $214.1 million,compared to $341.3 million at December 31, 2017.

Financial Guidance

ACADIA is updating its 2018 NUPLAZID net sales guidance to be between$220 million and $225 million from a previous range of $210 million to$225 million.

ACADIA is updating its guidance for year end 2018 cash, cash equivalentsand investment securities on its balance sheet to be between $160million to $170 million from a previous range of $155 million to $170million.

Conference Call and Webcast Information
ACADIA managementwill review its third quarter financial results and operations viaconference call and webcast today at 5:00 p.m. Eastern Time. Theconference call may be accessed by dialing 855-638-4820 for participantsin the U.S. or Canada and 443-877-4067 for international callers(reference passcode 3659459). A telephone replay of the conference callmay be accessed through November 20, 2018 by dialing 855-859-2056 forcallers in the U.S. or Canada and 404-537-3406 for international callers(reference passcode 3659459). 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 November20, 2018.

About NUPLAZID^® (pimavanserin)
NUPLAZIDis the first and only FDA-approved treatment for hallucinations anddelusions associated with Parkinson’s disease psychosis. NUPLAZID is anon-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 biopharmaceuticalcompany focused on the development and commercialization of innovativemedicines to address unmet medical needs in central nervous systemdisorders. ACADIA has developed and is commercializing the first andonly medicine approved for the treatment of hallucinations and delusionsassociated with Parkinson’s disease psychosis. In addition, ACADIA hasongoing clinical development efforts in additional areas withsignificant unmet need, including dementia-related psychosis,schizophrenia inadequate response, schizophrenia-negative symptoms,major depressive disorder, and Rett syndrome. This press release andfurther information about ACADIA can be found at: www.acadia-pharm.com.

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 potential opportunity for future growth in sales ofNUPLAZID, including through sales of new dosages and forms; the timingof ongoing and future clinical studies for pimavanserin; the developmentand commercialization of trofinetide; and guidance for fourth quarterNUPLAZID net sales and certain expense line items. 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 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.

Important Safety Information and Indication forNUPLAZID (pimavanserin)

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITHDEMENTIA-RELATED PSYCHOSIS
Elderly patients withdementia-related psychosis treated with antipsychotic drugs are at anincreased risk of death. NUPLAZID is not approved for the treatment ofpatients with dementia-related psychosis unrelated to the hallucinationsand delusions associated with Parkinson’s disease psychosis.

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: The most common adverse reactions (≥2% for NUPLAZIDand 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: Coadministration with strong CYP3A4 inhibitors (e.g.,ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mgtaken orally as one tablet once daily. Coadministration with strongCYP3A4 inducers may reduce NUPLAZID exposure. Monitor patients forreduced efficacy and an increase in NUPLAZID dosage may be needed.

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

Dosage and Administration: Recommended dose: 34 mg taken orally oncedaily, without titration.

NUPLAZID is available as 34 mg capsules, 17 mg tablets and 10 mg tablets.

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
(858) 558-2871
ir@acadia-pharm.com
or
MediaContact:
ACADIA Pharmaceuticals Inc.
Maurissa Messier
(858)768-6068
media@acadia-pharm.com