ACADIA Pharmaceuticals Reports First Quarter 2018 Financial Results
– Strong Performance for NUPLAZID® in First Quarter 2018
– First Quarter Net Sales Grew to
– ACADIA Reiterates 2018 Net Sales Guidance of
“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 the
benefits of NUPLAZID in treating the symptoms of Parkinson’s disease
Announced poster presentations at the 2018
American Academy of Neurology(AAN) Annual Meeting of clinical experience data from two independent studies of NUPLAZID (pimavanserin), including a retrospective chart review conducted by researchers at Vanderbilt University Medical Centerand a survey of real-life experiences conducted by researchers from the Parkinson’s Disease and MovementDisorder Center at Henry Ford Hospital.
Reported results of a survey conducted with the
Parkinson and Movement Disorder Alliancerevealing the serious impact of non-movement symptoms like hallucinations and delusions on quality of life of patients with Parkinson’s disease and their caregivers.
- Advanced broad clinical development programs with ongoing studies in dementia-related psychosis, schizophrenia inadequate response, schizophrenia negative symptoms and major depressive disorder with plans to announce top-line results of a Phase 2 study of pimavanserin in major depressive disorder in the second half of 2018.
Elena Ridloff, CFA, as Senior Vice President, Investor Relations.
Net sales of NUPLAZID were
Research and Development
Research and development expenses for the first quarter of 2018 were
Selling, General and Administrative
Selling, general and administrative expenses for the first quarter of 2018 were
For the first quarter of 2018, ACADIA reported a net loss of
Cash and Investments
At March 31, 2018, ACADIA’s cash, cash equivalents and investment securities totaled
ACADIA reiterates its 2018 NUPLAZID net sales guidance to be between
For the second quarter of 2018, ACADIA expects NUPLAZID net sales to be
ACADIA reiterates its expectation to end 2018 with more than
Conference Call and Webcast Information
ACADIA management will review its first quarter financial results and operations via conference call and webcast today at
About NUPLAZID® (pimavanserin)
NUPLAZID is the first and only
ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA maintains a website at www.acadia-pharm.com to which we regularly post copies of our press releases as well as additional information and through which interested parties can subscribe to receive e-mail alerts.
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements related to guidance for second quarter and full-year 2018 NUPLAZID net sales; potential opportunity for and future growth of NUPLAZID; the timing of ongoing clinical studies; and the timing of reporting of results from our study in major depressive disorder. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the uncertainty of future commercial sales and related items that would impact net sales during 2018, the risks and uncertainties inherent in drug discovery, development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA’s annual report on Form 10-K for the year ended
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
|Three Months Ended March 31,|
|Product sales, net||$||48,868||$||15,286|
|Cost of product sales||2,153||2,263|
|License fees and royalties||1,332||675|
|Research and development||39,276||35,409|
|Selling, general and administrative||60,926||65,660|
|Total operating expenses||103,687||104,007|
|Loss from operations||(54,819||)||(88,721||)|
|Interest income, net||1,170||963|
|Loss before income taxes||(53,649||)||(87,758||)|
|Income tax expense||647||85|
|Net loss per common share, basic and diluted||$||(0.44||)||$||(0.72||)|
|Weighted average common shares outstanding, basic and diluted||124,727||121,651|
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash, cash equivalents and investment securities||$||298,063||$||341,342|
|Accounts receivable, net||22,445||17,343|
|Interest and other receivables||903||1,087|
|Total current assets||340,014||373,477|
|Property and equipment, net||2,709||2,662|
|Intangible assets, net||5,169||5,538|
|Liabilities and stockholders’ equity|
|Total current liabilities||46,089||49,030|
|Total stockholders’ equity||304,169||335,285|
|Total liabilities and stockholders’ equity||$||351,040||$||384,506|
Important Safety Information and Indication for
NUPLAZID (pimavanserin) tablets
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.
NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics. NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation 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 reduced efficacy. Increase in NUPLAZID dosage may be needed.
Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated and should therefore be used in pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
Pediatric Use: Safety and efficacy have not been established in pediatric patients.
Dosage and Administration: Recommended dose: 34 mg per day, taken orally as 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.