ACADIA Pharmaceuticals Reports Fourth Quarter and Full Year 2017 Financial Results
-Fourth Quarter and Full Year 2017 Net Sales Grew to
“Our 2017 results reflect the robust uptake of NUPLAZID (pimavanserin)
in the treatment of Parkinson’s disease psychosis,” said
“As we look to 2018, we anticipate continued strong volume growth for NUPLAZID. In addition, we look forward to advancing our late-stage clinical programs in dementia-related psychosis, schizophrenia inadequate response and schizophrenia negative symptoms, as well as sharing the top-line results of our CLARITY study in major depressive disorder in the second half of 2018.”
Initiated a national direct-to-consumer disease awareness TV ad
campaign to educate patients and caregivers about Parkinson’s disease
psychosis (PD Psychosis) in
Initiated pivotal Phase 3 HARMONY Study with pimavanserin in
dementia-related psychosis in
Received a second Breakthrough Therapy Designation from the
FDAfor pimavanserin in October 2017. This designation is for the treatment of dementia-related psychosis.
Presented Phase 2 data with pimavanserin in Alzheimer’s disease
psychosis at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting
Bostonin November 2017.
Damien McDevitt, Ph.D., Senior Vice President, Corporate Development.
Net product sales of NUPLAZID, which was first made available for prescription starting in
Research and Development
Research and development expenses for the fourth quarter of 2017 were
Selling, General and Administrative
Selling, general and administrative expenses for the fourth quarter of 2017 were
For the fourth quarter of 2017, ACADIA reported a net loss of
Cash and Investments
At December 31, 2017, ACADIA’s cash, cash equivalents and investment securities totaled
2018 Financial Guidance
ACADIA expects that full-year NUPLAZID net product sales for 2018 will be between
Conference Call and Webcast Information
ACADIA management will review its fourth quarter financial results and operations via conference call and webcast later 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 first quarter and full-year 2018 NUPLAZID net sales; future strong volume growth for NUPLAZID; the benefits to be derived from NUPLAZID; whether NUPLAZID will be useful in other indications; and 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 December 31,||Years Ended December 31,|
|Product sales, net||$||43,562||$||11,962||$||124,901||$||17,327|
|Cost of product sales||2,455||1,704||9,077||3,075|
|License fees and royalties||1,248||608||3,983||1,331|
|Research and development||43,179||30,218||149,189||99,284|
|Selling, general and administrative||66,689||57,663||255,062||186,456|
|Total operating expenses||113,571||90,193||417,311||290,146|
|Loss from operations||(70,009||)||(78,231||)||(292,410||)||(272,815||)|
|Interest income, net||1,107||876||4,126||2,763|
|Loss before income taxes||(68,902||)||(77,355||)||(288,284||)||(270,052||)|
|Income tax expense||(31||)||1,341||1,119||1,341|
|Net loss per common share, basic and diluted||$||(0.55||)||$||(0.65||)||$||(2.36||)||$||(2.34||)|
|Weighted average common shares outstanding, basic and diluted||124,117||121,202||122,600||115,858|
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash, cash equivalents and investment securities||$||341,342||$||529,036|
|Accounts receivable, net||17,343||5,903|
|Interest and other receivables||1,087||1,237|
|Total current assets||373,477||547,897|
|Property and equipment, net||2,662||3,081|
|Intangible assets, net||5,538||7,015|
|Liabilities and stockholders’ equity|
|Total current liabilities||49,030||42,585|
|Total stockholders’ equity||335,285||518,411|
|Total liabilities and stockholders’ equity||$||384,506||$||561,153|
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: 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 reduced efficacy. Increase in NUPLAZID dosage may be needed.
Renal Impairment: No dosage adjustment for NUPLAZID is needed in patients with mild to moderate renal impairment. Use of NUPLAZID is not recommended in patients with severe renal impairment.
Hepatic Impairment: Use of NUPLAZID is not recommended in patients with hepatic impairment. NUPLAZID has not been evaluated in this patient population.
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.