ACADIA Pharmaceuticals Reports Third Quarter 2016 Financial Results
NUPLAZID® Net Product Sales Grew to
Expanding Pimavanserin Clinical Program With Initiation of Studies for Alzheimer’s Disease Agitation and Adjunctive Treatment of Schizophrenia
“We are very pleased with the launch and are gratified by the positive
feedback we have received from physicians, patients, and caregivers on
NUPLAZID (pimavanserin),” said
“In addition, we continue to expand our clinical program with pimavanserin. We recently announced the initiation of our SERENE study for the treatment of Alzheimer’s disease agitation and our ENHANCE-1 study for adjunctive treatment of schizophrenia in patients who have an inadequate 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 CNS disorders.”
U.S. launch of NUPLAZID commenced
May 31, 2016. NUPLAZID is the first and only drug approved by the FDAfor the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
NUPLAZID now on
Medicareformularies; coverage of NUPLAZID by commercial insurance plans continues to grow.
October 2016, announced the initiation of the SERENE study, a Phase II study with pimavanserin for patients with Alzheimer’s disease agitation.
November 2016, announced the initiation of ENHANCE-1, a Phase III study with pimavanserin for adjunctive treatment for patients with schizophrenia who are experiencing inadequate response to their current antipsychotic therapy.
- Completed enrollment of our Phase II study exploring the utility of pimavanserin for the treatment of Alzheimer’s disease psychosis. Announcement of top-line results from the study expected by the end of 2016.
Presented multiple scientific posters and hosted booth exhibits for
healthcare providers and disease education at the
World Parkinson Congress.
- Sponsored the National Parkinson’s Foundation Caregiver Summit.
$215.9 millionin a common stock offering in August 2016.
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 three and nine months ended
Cash and Investments
Conference Call and Webcast Information
ACADIA management will review its third 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 focus of commercial initiatives, the
ability to improve the lives of patients with CNS disorders, and the
expected timing of the announcement of top-line results from ACADIA’s
Phase II Alzheimer’s disease psychosis study. 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, whether NUPLAZID receives
adequate reimbursement from third-party payors, ACADIA’s ability to
establish and maintain an adequate specialty pharmacy network to
distribute NUPLAZID, the degree to which NUPLAZID receives acceptance
from patients and physicians for its approved indication, 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
Nine Months Ended
|Product sales, net||$||5,268||$||—||$||5,365||$||—|
|Cost of product sales||845||—||1,371||—|
|License fees and royalties||475||—||723||—|
|Research and development||25,813||18,729||69,066||53,403|
|Selling, general and administrative||50,534||20,308||128,793||65,688|
|Total operating expenses||77,667||39,037||199,953||119,091|
|Loss from operations||(72,399||)||(38,998||)||(194,584||)||(119,047||)|
|Interest income, net||786||92||1,887||388|
|Net loss per common share, basic and diluted||$||(0.61||)||$||(0.39||)||$||(1.69||)||$||(1.18||)|
|Weighted average common shares outstanding, basic and diluted||117,497||100,756||114,063||100,436|
|ACADIA PHARMACEUTICALS INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash, cash equivalents, and investment securities||$||588,859||$||215,132|
|Accounts receivable, net||3,839||—|
|Interest and other receivables||1,385||1,638|
|Prepaid expenses and other current assets||5,106||2,219|
|Total current assets||603,490||218,989|
|Property and equipment, net||3,159||2,203|
|Intangible assets, net||7,385||—|
|Liabilities and stockholders’ equity|
|Total current liabilities||39,149||21,902|
|Total stockholders’ equity||578,058||199,762|
|Total liabilities and stockholders’ equity||$||617,384||$||221,896|
Important Safety Information and Indication for NUPLAZID (pimavanserin) tablets
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
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.