ACADIA Pharmaceuticals Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2016
NUPLAZID® Net Product Sales Grew to
Executing on Broad Clinical Development Program in Alzheimer’s Disease Psychosis, Alzheimer’s Disease Agitation, Schizophrenia Inadequate Response, Negative Symptoms of Schizophrenia, and Major Depressive Disorder
“2016 was a transformational year for ACADIA highlighted by the launch
of NUPLAZID (pimavanserin) as the first and only drug approved by the
“More recently, we announced positive results from our Phase II study with pimavanserin in Alzheimer’s disease psychosis. Pimavanserin has now shown antipsychotic effects in clinical studies in three major CNS disorders: Parkinson’s disease, schizophrenia, and Alzheimer’s disease. These results, combined with the initiation of four new clinical programs, underscore the potential of pimavanserin to improve the lives of patients across multiple CNS disease states and our commitment to explore this potential in broad and substantive clinical programs.”
NUPLAZID now available on
Medicareformularies for the treatment of Parkinson’s disease psychosis (PD Psychosis); commercial coverage decisions now made for over 60% of commercial lives and continue to grow.
Positive top-line results from our Phase II study exploring the
utility of pimavanserin for the treatment of Alzheimer’s disease
psychosis announced in
- Initiated the SERENE study, a 430-patient study evaluating pimavanserin for the treatment of Alzheimer’s disease agitation.
- Initiated the ENHANCE-1 study, a 380-patient study evaluating pimavanserin for adjunctive treatment of schizophrenia in patients with an inadequate response to their current antipsychotic therapy.
- Initiated the ADVANCE study, a 380-patient study evaluating pimavanserin for adjunctive treatment in patients with negative symptoms of schizophrenia.
- Initiated the CLARITY study, a 188-patient study evaluating pimavanserin for adjunctive treatment in patients with major depressive disorder who have an inadequate response to standard antidepressant therapy.
ACADIA reported net product sales of
Research and Development
Research and development expenses increased to
Selling, General and Administrative
Selling, general and administrative expenses increased to
For the fourth quarter of 2016, ACADIA reported a net loss of
Cash and Investments
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 the benefits to be derived from
NUPLAZID (pimavanserin); the potential of pimavanserin to improve the
lives of patients across multiple CNS disease states and our commitment
to explore this potential in broad and substantive clinical programs;
and the utility of pimavanserin in indications other than hallucinations
and delusions associated with PD Psychosis. 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 risks and uncertainties inherent in drug
discovery, development, 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
|Product sales, net||$||11,962||$||—||$||
|Cost of product sales||1,704||—||3,075||—|
|License fees and royalties||608||2,500||1,331||2,500|
|Research and development||30,218||20,466||99,284||73,869|
|Selling, general and administrative||57,663||22,616||186,456||88,304|
|Total operating expenses||90,193||45,582||290,146||164,673|
|Loss from operations||(78,231||)||(45,565||)||(272,815||)||(164,612||)|
|Interest income, net||876||111||2,763||499|
|Loss before income taxes||(77,355||)||(45,454||)||(270,052||)||(164,113||)|
|Income tax expense||1,341||330||1,341||330|
|Net loss per common share, basic and diluted||$||(0.65||)||$||(0.45||)||$||(2.34||)||$||(1.63||)|
|Weighted average common shares outstanding, basic and diluted||121,202||101,207||115,858||100,630|
|ACADIA PHARMACEUTICALS INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash, cash equivalents, and investment securities||$||529,036||$||215,132|
|Accounts receivable, net||5,903||—|
|Interest and other receivables||1,237||1,638|
|Prepaid expenses and other current assets||7,546||2,219|
|Total current assets||547,897||218,989|
|Property and equipment, net||3,081||2,203|
|Intangible assets, net||7,015||—|
|Liabilities and stockholders’ equity|
|Total current liabilities||42,585||21,902|
|Total stockholders’ equity||518,411||199,762|
|Total liabilities and stockholders’ equity||$||561,153||$||221,896|
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.
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.