ACADIA Pharmaceuticals Reports Second Quarter 2016 Financial Results
Quarter highlighted by approval and launch of NUPLAZID™
“The second quarter of 2016 was highlighted by transformative events for
ACADIA, including the
NUPLAZID (pimavanserin) approved by the
U.S. Food and Drug Administration( FDA) on April 29, 2016for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
NUPLAZID (pimavanserin) made available for prescription on
May 31, 2016with physicians able to prescribe patients a 30-day free trial.
- Approximately 135 seasoned sales specialists were onboarded, trained, and deployed at launch. They have an average of over eight years of CNS sales experience and 15 years in the pharmaceutical industry.
- Enrollment completed in a 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.
- Executing on plans to initiate a Phase II study with pimavanserin in Alzheimer’s disease agitation in the second half of 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 six months ended
Cash and Investments
Conference Call and Webcast Information
ACADIA management will review its second 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 ability of ACADIA to work with payors to
make NUPLAZID available to eligible patients, ACADIA’s ability to expand
awareness of NUPLAZID among physicians through a number of initiatives,
timing regarding the commencement of clinical trials, including the
planned Alzheimer’s disease agitation study, 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
Six Months Ended
|Product sales, net||$||97||$||—||$||97||$||—|
|Cost of product sales||526||—||526||—|
|License fees and royalties||248||—||248||—|
|Research and development||20,478||18,379||43,253||34,674|
|Selling, general and administrative||50,768||21,119||78,259||45,380|
|Total operating expenses||72,020||39,498||122,286||80,054|
|Loss from operations||(71,923||)||(39,497||)||(122,185||)||(80,049||)|
|Interest income, net||601||119||1,101||296|
|Net loss per common share, basic and diluted||$||(0.63||)||$||(0.39||)||$||(1.08||)||$||(0.80||)|
|Weighted average common shares outstanding, basic and diluted||113,308||100,349||112,327||100,273|
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||131,774||$||102,138|
|Investment securities, available-for-sale||280,781||112,994|
|Accounts receivable, net||293||—|
|Interest and other receivables||1,340||1,638|
|Prepaid expenses and other current assets||6,842||2,219|
|Total current assets||423,897||218,989|
|Property and equipment, net||2,897||2,203|
|Intangible assets, net||7,754||—|
|Liabilities and stockholders’ equity|
|Total current liabilities||29,022||21,902|
|Total stockholders’ equity||408,815||199,762|
|Total liabilities and stockholders’ equity||$||438,034||$||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.