Strong Performance for NUPLAZID® in First Quarter2018
– First Quarter Net Sales Grew to
– ACADIA Reiterates 2018 Net Sales Guidance of
“NUPLAZID delivered strong performance in the first quarter of 2018.Sequential volume growth of 13.5% drove sequential revenue growth of 12%as health care providers and patients continue to experience thebenefits of NUPLAZID in treating the symptoms of Parkinson’s diseasepsychosis,” said
Recent Highlights
- Announced poster presentations at the 2018
American Academy ofNeurology (AAN) Annual Meeting of clinical experience data from twoindependent studies of NUPLAZID (pimavanserin), including aretrospective chart review conducted by researchers atVanderbiltUniversity Medical Center and a survey of real-life experiencesconducted by researchers from the Parkinson’sDisease and Movement Disorder Center atHenry Ford Hospital .
- Reported results of a survey conducted with the
Parkinson and MovementDisorder Alliance revealing the serious impact of non-movementsymptoms like hallucinations and delusions on quality of life ofpatients with Parkinson’s disease and their caregivers. - Advanced broad clinical development programs with ongoing studies indementia-related psychosis, schizophrenia inadequate response,schizophrenia negative symptoms and major depressive disorder withplans to announce top-line results of a Phase 2 study of pimavanserinin major depressive disorder in the second half of 2018.
- Appointed
Elena Ridloff , CFA, as Senior Vice President, InvestorRelations.
Financial Results
Revenue
Net sales of NUPLAZID were
Research and Development
Research and development expensesfor the first quarter of 2018 were
Selling, General and Administrative
Selling, general andadministrative expenses for the first quarter of 2018 were
Net Loss
For the first quarter of 2018, ACADIA reported anet loss of
Cash and Investments
At March 31, 2018, ACADIA’s cash, cashequivalents and investment securities totaled
Financial Guidance
ACADIA reiterates its 2018 NUPLAZID net sales guidance to be between
For the second quarter of 2018, ACADIA expects NUPLAZID net sales to bebetween
ACADIA reiterates its expectation to end 2018 with more than
Conference Call and Webcast Information
ACADIA managementwill review its first quarter financial results and operations viaconference call and webcast today at
About NUPLAZID® (pimavanserin)
NUPLAZIDis the first and only
About
ACADIA is a biopharmaceuticalcompany focused on the development and commercialization of innovativemedicines to address unmet medical needs in central nervous systemdisorders. 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 releasethat are not strictly historical in nature are forward-lookingstatements. These statements include but are not limited to statementsrelated to guidance for second quarter and full-year 2018 NUPLAZID netsales; potential opportunity for and future growth of NUPLAZID; thetiming of ongoing clinical studies; and the timing of reporting ofresults from our study in major depressive disorder. These statementsare only predictions based on current information and expectations andinvolve a number of risks and uncertainties. Actual events or resultsmay differ materially from those projected in any of such statements dueto various factors, including the uncertainty of future commercial salesand related items that would impact net sales during 2018, the risks anduncertainties inherent in drug discovery, development, approval andcommercialization, and the fact that past results of clinical trials maynot be indicative of future trial results. For a discussion of these andother factors, please refer to ACADIA’s annual report on Form 10-K forthe year ended
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) | ||||||||||||||||||
Three Months Ended March 31, | ||||||||||||||||||
2018 | 2017 | |||||||||||||||||
Revenues | ||||||||||||||||||
Product sales, net | $ | 48,868 | $ | 15,286 | ||||||||||||||
Total revenues | 48,868 | 15,286 | ||||||||||||||||
Operating expenses | ||||||||||||||||||
Cost of product sales | 2,153 | 2,263 | ||||||||||||||||
License fees and royalties | 1,332 | 675 | ||||||||||||||||
Research and development | 39,276 | 35,409 | ||||||||||||||||
Selling, general and administrative | 60,926 | 65,660 | ||||||||||||||||
Total operating expenses | 103,687 | 104,007 | ||||||||||||||||
Loss from operations | (54,819 | ) | (88,721 | ) | ||||||||||||||
Interest income, net | 1,170 | 963 | ||||||||||||||||
Loss before income taxes | (53,649 | ) | (87,758 | ) | ||||||||||||||
Income tax expense | 647 | 85 | ||||||||||||||||
Net loss | $ | (54,296 | ) | $ | (87,843 | ) | ||||||||||||
Net loss per common share, basic and diluted | $ | (0.44 | ) | $ | (0.72 | ) | ||||||||||||
Weighted average common shares outstanding, basic and diluted | 124,727 | 121,651 | ||||||||||||||||
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) | |||||||||||||||||
March 31, 2018 | December 31, 2017 | ||||||||||||||||
(unaudited) | |||||||||||||||||
Assets | |||||||||||||||||
Cash, cash equivalents and investment securities | $ | 298,063 | $ | 341,342 | |||||||||||||
Accounts receivable, net | 22,445 | 17,343 | |||||||||||||||
Interest and other receivables | 903 | 1,087 | |||||||||||||||
Inventory | 5,583 | 5,248 | |||||||||||||||
Prepaid expenses | 13,020 | 8,457 | |||||||||||||||
Total current assets | 340,014 | 373,477 | |||||||||||||||
Property and equipment, net | 2,709 | 2,662 | |||||||||||||||
Intangible assets, net | 5,169 | 5,538 | |||||||||||||||
Restricted cash | 2,825 | 2,475 | |||||||||||||||
Other assets | 323 | 354 | |||||||||||||||
Total assets | $ | 351,040 | $ | 384,506 | |||||||||||||
Liabilities and stockholders’ equity | |||||||||||||||||
Accounts payable | $ | 2,996 | $ | 8,786 | |||||||||||||
Accrued liabilities | 43,093 | 40,244 | |||||||||||||||
Total current liabilities | 46,089 | 49,030 | |||||||||||||||
Long-term liabilities | 782 | 191 | |||||||||||||||
Total liabilities | 46,871 | 49,221 | |||||||||||||||
Total stockholders’ equity | 304,169 | 335,285 | |||||||||||||||
Total liabilities and stockholders’ equity | $ | 351,040 | $ | 384,506 | |||||||||||||
Important Safety Information and Indication forNUPLAZID (pimavanserin) tablets
WARNING: INCREASEDMORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderlypatients with dementia-related psychosis treated with antipsychoticdrugs are at an increased risk of death. NUPLAZID is not approved forthe treatment of patients with dementia-related psychosis unrelated tothe hallucinations and delusions associated with Parkinson’s diseasepsychosis.
NUPLAZID is an atypical antipsychotic indicated for the treatment ofhallucinations and delusions associated with Parkinson’s diseasepsychosis.
Contraindication: NUPLAZID is contraindicated in patients with a historyof a hypersensitivity reaction to pimavanserin or any of its components.Rash, urticaria, and reactions consistent with angioedema (e.g., tongueswelling, circumoral edema, throat tightness, and dyspnea) have beenreported.
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:Themost common adverse reactions(≥2%for NUPLAZID and greater than placebo) wereperipheral 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.
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.
ElenaRidloff, CFA
or
Lisa Barthelemy
(858) 558-2871
ir@acadia-pharm.com
or
MediaContact:
Taft Communications
Bob Laverty
(609)558-5570
bob@taftcommunications.com