Quarter highlighted by approval and launch of NUPLAZID™(pimavanserin) in
“The second quarter of 2016 was highlighted by transformative events forACADIA, including the
Recent Highlights
- NUPLAZID (pimavanserin) approved by the
U.S. Food and DrugAdministration (FDA ) onApril 29, 2016 for the treatment ofhallucinations and delusions associated with Parkinson’s diseasepsychosis. - NUPLAZID (pimavanserin) made available for prescription on
May 31,2016 with 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 ofCNS sales experience and 15 years in the pharmaceutical industry.
- Enrollment completed in a 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.
- Executing on plans to initiate a Phase II study with pimavanserin inAlzheimer’s disease agitation in the second half of 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 six months ended
Cash and Investments
At
Conference Call and Webcast Information
ACADIA management will review its second 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 ability of ACADIA to work with payors tomake NUPLAZID available to eligible patients, ACADIA’s ability to expandawareness of NUPLAZID among physicians through a number of initiatives,timing regarding the commencement of clinical trials, including theplanned Alzheimer’s disease agitation study, and the expected timing ofthe announcement of top-line results from ACADIA’s Phase II Alzheimer’sdisease psychosis study. These statements are only predictions based oncurrent information and expectations and involve a number of risks anduncertainties. Actual events or results may differ materially from thoseprojected in any of such statements due to various factors, includingthe risks and uncertainties inherent in drug discovery, development, andcommercialization, whether NUPLAZID receives adequate reimbursement fromthird-party payors, ACADIA’s ability to establish and maintain anadequate specialty pharmacy network to distribute NUPLAZID, the degreeto which NUPLAZID receives acceptance from patients and physicians forits approved indication, and the fact that past results of clinicaltrials may not be indicative of future trial results. For a discussionof these and other factors, please refer to ACADIA’s annual report onForm 10-K for the year ended
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) | ||||||||||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||||||||||
| Revenues | ||||||||||||||||||||||||
| Product sales, net | $ | 97 | $ | — | $ | 97 | $ | — | ||||||||||||||||
| Collaborative revenues | — | 1 | 4 | 5 | ||||||||||||||||||||
| Total revenues | 97 | 1 | 101 | 5 | ||||||||||||||||||||
| Operating expenses | ||||||||||||||||||||||||
| 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 | $ | (71,322 | ) | $ | (39,378 | ) | $ | (121,084 | ) | $ | (79,753 | ) | ||||||||||||
| 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 (in thousands) | |||||||||||||||
| June 30, 2016 | December 31, 2015 | ||||||||||||||
| (unaudited) | |||||||||||||||
| Assets | |||||||||||||||
| 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 | |||||||||||||
| Inventory | 2,867 | — | |||||||||||||
| 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 | — | |||||||||||||
| Restricted cash | 2,375 | 375 | |||||||||||||
| Other assets | 1,111 | 329 | |||||||||||||
| Total assets | $ | 438,034 | $ | 221,896 | |||||||||||
| Liabilities and stockholders’ equity | |||||||||||||||
| Accounts payable | $ | 1,024 | $ | 1,672 | |||||||||||
| Accrued liabilities | 27,485 | 20,230 | |||||||||||||
| Deferred revenue | 513 | — | |||||||||||||
| Total current liabilities | 29,022 | 21,902 | |||||||||||||
| Long-term liabilities | 197 | 232 | |||||||||||||
| Total liabilities | 29,219 | 22,134 | |||||||||||||
| Total stockholders’ equity | 408,815 | 199,762 | |||||||||||||
| Total liabilities and stockholders’ equity | $ | 438,034 | $ | 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.
Source:
Investor Contact:
ACADIA Pharmaceuticals Inc.
LisaBarthelemy
(858) 558-2871
ir@acadia-pharm.com
or
MediaContact:
Taft and Partners
Ted Deutsch
(609)578-8765
ted@taftandpartners.com