NUPLAZID® Net Product Sales Grew to
Expanding Pimavanserin Clinical Program With Initiation of Studiesfor Alzheimer’s Disease Agitation and Adjunctive Treatment ofSchizophrenia
“We are very pleased with the launch and are gratified by the positivefeedback we have received from physicians, patients, and caregivers onNUPLAZID (pimavanserin),” said
“In addition, we continue to expand our clinical program withpimavanserin. We recently announced the initiation of our SERENE studyfor the treatment of Alzheimer’s disease agitation and our ENHANCE-1study for adjunctive treatment of schizophrenia in patients who have aninadequate response to current antipsychotic treatment. These studies,together with additional studies we will commence later this year,underscore our commitment to improving the lives of patients with CNSdisorders.”
Recent Highlights
- U.S. launch of NUPLAZID commenced
May 31, 2016 . NUPLAZID is the firstand only drug approved by theFDA for the treatment of hallucinationsand delusions associated with Parkinson’s disease psychosis. - NUPLAZID now on
Medicare formularies; coverage of NUPLAZID bycommercial insurance plans continues to grow. - In
October 2016 , announced the initiation of the SERENE study, a PhaseII study with pimavanserin for patients with Alzheimer’s diseaseagitation. - In
November 2016 , announced the initiation of ENHANCE-1, a Phase IIIstudy with pimavanserin for adjunctive treatment for patients withschizophrenia who are experiencing inadequate response to theircurrent antipsychotic therapy. - Completed enrollment of our Phase II study exploring the utility ofpimavanserin for the treatment of Alzheimer’s disease psychosis.Announcement of top-line results from the study expected by the end of2016.
- Presented multiple scientific posters and hosted booth exhibits forhealthcare providers and disease education at the
World ParkinsonCongress . - Sponsored the National Parkinson’s Foundation Caregiver Summit.
- Raised approximately
$215.9 million in a common stock offering inAugust 2016 .
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 three and nine months ended
Cash and Investments
At
Conference Call and Webcast Information
ACADIA management will review its third 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 focus of commercial initiatives, theability to improve the lives of patients with CNS disorders, and theexpected timing of the announcement of top-line results from ACADIA’sPhase II Alzheimer’s disease psychosis study. 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, whether NUPLAZID receivesadequate reimbursement from third-party payors, ACADIA’s ability toestablish and maintain an adequate specialty pharmacy network todistribute NUPLAZID, the degree to which NUPLAZID receives acceptancefrom patients and physicians for its approved indication, and the factthat past results of clinical trials may not be indicative of futuretrial results. For a discussion of these and other factors, please referto 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) | ||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||||||
| Revenues | ||||||||||||||||||||
| Product sales, net | $ | 5,268 | $ | — | $ | 5,365 | $ | — | ||||||||||||
| Collaborative revenues | — | 39 | 4 | 44 | ||||||||||||||||
| Total revenues | 5,268 | 39 | 5,369 | 44 | ||||||||||||||||
| Operating expenses | ||||||||||||||||||||
| Cost of product sales | 845 | — | 1,371 | — | ||||||||||||||||
| License fees and royalties | 475 | — | 723 | — | ||||||||||||||||
| Research and development | 25,813 | 18,729 | 69,066 | 53,403 | ||||||||||||||||
| Selling, general and administrative | 50,534 | 20,308 | 128,793 | 65,688 | ||||||||||||||||
| Total operating expenses | 77,667 | 39,037 | 199,953 | 119,091 | ||||||||||||||||
| Loss from operations | (72,399 | ) | (38,998 | ) | (194,584 | ) | (119,047 | ) | ||||||||||||
| Interest income, net | 786 | 92 | 1,887 | 388 | ||||||||||||||||
| Net loss | $ | (71,613 | ) | $ | (38,906 | ) | $ | (192,697 | ) | $ | (118,659 | ) | ||||||||
| Net loss per common share, basic and diluted | $ | (0.61 | ) | $ | (0.39 | ) | $ | (1.69 | ) | $ | (1.18 | ) | ||||||||
| Weighted average common shares outstanding, basic and diluted | 117,497 | 100,756 | 114,063 | 100,436 | ||||||||||||||||
| ACADIA PHARMACEUTICALS INC. | ||||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||||
(in thousands) | ||||||||||
September 30, | December 31, | |||||||||
| (unaudited) | ||||||||||
| Assets | ||||||||||
| Cash, cash equivalents, and investment securities | $ | 588,859 | $ | 215,132 | ||||||
| Accounts receivable, net | 3,839 | — | ||||||||
| Interest and other receivables | 1,385 | 1,638 | ||||||||
| Inventory | 4,301 | — | ||||||||
| Prepaid expenses and other current assets | 5,106 | 2,219 | ||||||||
| Total current assets | 603,490 | 218,989 | ||||||||
| Property and equipment, net | 3,159 | 2,203 | ||||||||
| Intangible assets, net | 7,385 | — | ||||||||
| Restricted cash | 2,375 | 375 | ||||||||
| Other assets | 975 | 329 | ||||||||
| Total assets | $ | 617,384 | $ | 221,896 | ||||||
| Liabilities and stockholders’ equity | ||||||||||
| Accounts payable | $ | 2,828 | $ | 1,672 | ||||||
| Accrued liabilities | 34,445 | 20,230 | ||||||||
| Deferred revenue | 1,876 | — | ||||||||
| Total current liabilities | 39,149 | 21,902 | ||||||||
| Long-term liabilities | 177 | 232 | ||||||||
| Total liabilities | 39,326 | 22,134 | ||||||||
| Total stockholders’ equity | 578,058 | 199,762 | ||||||||
| Total liabilities and stockholders’ equity | $ | 617,384 | $ | 221,896 | ||||||
Important Safety Information and Indication forNUPLAZID (pimavanserin) tablets
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.
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
Ted Deutsch,609-578-8765
ted@taftcommunications.com