NUPLAZID® Net Product Sales Grew to
Executing on Broad Clinical Development Program in Alzheimer’sDisease Psychosis, Alzheimer’s Disease Agitation, SchizophreniaInadequate Response, Negative Symptoms of Schizophrenia, and MajorDepressive Disorder
“2016 was a transformational year for ACADIA highlighted by the launchof NUPLAZID (pimavanserin) as the first and only drug approved by the
“More recently, we announced positive results from our Phase II studywith pimavanserin in Alzheimer’s disease psychosis. Pimavanserin has nowshown antipsychotic effects in clinical studies in three major CNSdisorders: Parkinson’s disease, schizophrenia, and Alzheimer’s disease.These results, combined with the initiation of four new clinicalprograms, underscore the potential of pimavanserin to improve the livesof patients across multiple CNS disease states and our commitment toexplore this potential in broad and substantive clinical programs.”
Recent Highlights
- NUPLAZID now available on
Medicare formularies for the treatment ofParkinson’s disease psychosis (PD Psychosis); commercial coveragedecisions now made for over 60% of commercial lives and continue togrow. - Positive top-line results from our Phase II study exploring theutility of pimavanserin for the treatment of Alzheimer’s diseasepsychosis announced in
December 2016 . - Initiated the SERENE study, a 430-patient study evaluatingpimavanserin for the treatment of Alzheimer’s disease agitation.
- Initiated the ENHANCE-1 study, a 380-patient study evaluatingpimavanserin for adjunctive treatment of schizophrenia in patientswith an inadequate response to their current antipsychotic therapy.
- Initiated the ADVANCE study, a 380-patient study evaluatingpimavanserin for adjunctive treatment in patients with negativesymptoms of schizophrenia.
- Initiated the CLARITY study, a 188-patient study evaluatingpimavanserin for adjunctive treatment in patients with majordepressive disorder who have an inadequate response to standardantidepressant therapy.
Financial Results
Revenue
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
Net Loss
For the fourth quarter of 2016, ACADIA reported a net loss of
Cash and Investments
At
Conference Call and Webcast Information
ACADIA management will review its fourth quarter financial results andoperations via conference call and webcast later today at
About NUPLAZID® (pimavanserin)
NUPLAZID is the first and only
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 maintains a website at www.acadia-pharm.comto which we regularly post copies of our press releases as well asadditional information and through which interested parties cansubscribe to receive e-mail alerts.
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 benefits to be derived fromNUPLAZID (pimavanserin); the potential of pimavanserin to improve thelives of patients across multiple CNS disease states and our commitmentto explore this potential in broad and substantive clinical programs;and the utility of pimavanserin in indications other than hallucinationsand delusions associated with PD Psychosis. These statements are onlypredictions based on current information and expectations and involve anumber of risks and uncertainties. Actual events or results may differmaterially from those projected in any of such statements due to variousfactors, including the risks and uncertainties inherent in drugdiscovery, development, 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
| ACADIA PHARMACEUTICALS INC. | ||||||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||||||
(in thousands, except per share amounts) | ||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||
Three Months Ended | Years Ended | |||||||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||||||
| Revenues | ||||||||||||||||||||
| Product sales, net | $ | 11,962 | $ | — | $ | 17,327 | $ | — | ||||||||||||
| Collaborative revenues | — | 17 | 4 | 61 | ||||||||||||||||
| Total revenues | 11,962 | 17 | 17,331 | 61 | ||||||||||||||||
| Operating expenses | ||||||||||||||||||||
| 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 | $ | (78,696 | ) | $ | (45,784 | ) | $ | (271,393 | ) | $ | (164,443 | ) | ||||||||
| 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 | ||||||||
(in thousands) | ||||||||
(Unaudited) | ||||||||
| December 31, | ||||||||
| 2016 | 2015 | |||||||
| Assets | ||||||||
| Cash, cash equivalents, and investment securities | $ | 529,036 | $ | 215,132 | ||||
| Accounts receivable, net | 5,903 | — | ||||||
| Interest and other receivables | 1,237 | 1,638 | ||||||
| Inventory | 4,175 | — | ||||||
| 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 | — | ||||||
| Restricted cash | 2,375 | 375 | ||||||
| Other assets | 785 | 329 | ||||||
| Total assets | $ | 561,153 | $ | 221,896 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Accounts payable | $ | 3,912 | $ | 1,672 | ||||
| Accrued liabilities | 36,029 | 20,230 | ||||||
| Deferred revenue | 2,644 | — | ||||||
| Total current liabilities | 42,585 | 21,902 | ||||||
| Long-term liabilities | 157 | 232 | ||||||
| Total liabilities | 42,742 | 22,134 | ||||||
| Total stockholders’ equity | 518,411 | 199,762 | ||||||
| Total liabilities and stockholders’ equity | $ | 561,153 | $ | 221,896 | ||||
Important Safety Information and Indication forNUPLAZID (pimavanserin) tablets
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITHDEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated withantipsychotic drugs are at an increased risk of death. NUPLAZID is notapproved for the treatment of patients with dementia-related psychosisunrelated to the hallucinations and delusions associated withParkinson’s disease psychosis.
NUPLAZID is an atypical antipsychotic indicated for the treatment ofhallucinations and delusions associated with Parkinson’s diseasepsychosis.
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 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 reducedefficacy. Increase in NUPLAZID dosage may be needed.
Renal Impairment: No dosage adjustment for NUPLAZID is needed inpatients with mild to moderate renal impairment. Use of NUPLAZID is notrecommended in patients with severe renal impairment.
Hepatic Impairment: Use of NUPLAZID is not recommended in patients withhepatic impairment. NUPLAZID has not been evaluated in this patientpopulation.
Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated andshould therefore be used in pregnancy only if the potential benefitjustifies the potential risk to the mother and fetus.
Pediatric Use: Safety and efficacy have not been established inpediatric patients.
Dosage and Administration: Recommended dose: 34 mg per day, taken orallyas 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.
Source:
Investor Contact:
ACADIA Pharmaceuticals Inc.
LisaBarthelemy
(858) 558-2871
ir@acadia-pharm.com
or
MediaContact:
Taft Communications
Bob Laverty
(609)558-5570
bob@taftcommunications.com