-Fourth Quarter and Full Year 2017 Net Sales Grew to
“Our 2017 results reflect the robust uptake of NUPLAZID (pimavanserin)in the treatment of Parkinson’s disease psychosis,” said
“As we look to 2018, we anticipate continued strong volume growth forNUPLAZID. In addition, we look forward to advancing our late-stageclinical programs in dementia-related psychosis, schizophreniainadequate response and schizophrenia negative symptoms, as well assharing the top-line results of our CLARITY study in major depressivedisorder in the second half of 2018.”
Recent Highlights
- Initiated a national direct-to-consumer disease awareness TV adcampaign to educate patients and caregivers about Parkinson’s diseasepsychosis (PD Psychosis) in
November 2017 . - Initiated pivotal Phase 3 HARMONY Study with pimavanserin indementia-related psychosis in
October 2017 . - Received a second Breakthrough Therapy Designation from the
FDA forpimavanserin inOctober 2017 . This designation is for the treatment ofdementia-related psychosis. - Presented Phase 2 data with pimavanserin in Alzheimer’s diseasepsychosis at the Clinical Trials on Alzheimer’s Disease (CTAD) meetingin
Boston inNovember 2017 . - Appointed
Damien McDevitt , Ph.D., Senior Vice President, CorporateDevelopment.
Financial Results
Revenue
Net product sales of NUPLAZID, which was first madeavailable for prescription starting in
Research and Development
Research and development expensesfor the fourth quarter of 2017 were
Selling, General and Administrative
Selling, general andadministrative expenses for the fourth quarter of 2017 were
Net Loss
For the fourth quarter of 2017, ACADIA reported anet loss of
Cash and Investments
At December 31, 2017, ACADIA’s cash,cash equivalents and investment securities totaled
2018 Financial Guidance
ACADIA expects that full-yearNUPLAZID net product sales for 2018 will be between
Conference Call and Webcast Information
ACADIA managementwill review its fourth quarter financial results and operations viaconference call and webcast later 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 first quarter and full-year 2018 NUPLAZID netsales; future strong volume growth for NUPLAZID; the benefits to bederived from NUPLAZID; whether NUPLAZID will be useful in otherindications; and the timing of ongoing clinical studies and the timingof reporting of results from our study in major depressive disorder.These statements are only predictions based on current information andexpectations and involve a number of risks and uncertainties. Actualevents or results may differ materially from those projected in any ofsuch statements due to various factors, including the uncertainty offuture commercial sales and related items that would impact net salesduring 2018, the risks and uncertainties inherent in drug discovery,development, approval and commercialization, and the fact that pastresults of clinical trials may not be indicative of future trialresults. For a discussion of these and other factors, please refer toACADIA’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 December 31, | Years Ended December 31, | ||||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||||
| Revenues | |||||||||||||||||
| Product sales, net | $ | 43,562 | $ | 11,962 | $ | 124,901 | $ | 17,327 | |||||||||
| Collaborative revenue | — | — | — | 4 | |||||||||||||
| Total revenues | 43,562 | 11,962 | 124,901 | 17,331 | |||||||||||||
| Operating expenses | |||||||||||||||||
| Cost of product sales | 2,455 | 1,704 | 9,077 | 3,075 | |||||||||||||
| License fees and royalties | 1,248 | 608 | 3,983 | 1,331 | |||||||||||||
| Research and development | 43,179 | 30,218 | 149,189 | 99,284 | |||||||||||||
| Selling, general and administrative | 66,689 | 57,663 | 255,062 | 186,456 | |||||||||||||
| Total operating expenses | 113,571 | 90,193 | 417,311 | 290,146 | |||||||||||||
| Loss from operations | (70,009 | ) | (78,231 | ) | (292,410 | ) | (272,815 | ) | |||||||||
| Interest income, net | 1,107 | 876 | 4,126 | 2,763 | |||||||||||||
| Loss before income taxes | (68,902 | ) | (77,355 | ) | (288,284 | ) | (270,052 | ) | |||||||||
| Income tax expense | (31 | ) | 1,341 | 1,119 | 1,341 | ||||||||||||
| Net loss | $ | (68,871 | ) | $ | (78,696 | ) | $ | (289,403 | ) | $ | (271,393 | ) | |||||
| Net loss per common share, basic and diluted | $ | (0.55 | ) | $ | (0.65 | ) | $ | (2.36 | ) | $ | (2.34 | ) | |||||
| Weighted average common shares outstanding, basic and diluted | 124,117 | 121,202 | 122,600 | 115,858 | |||||||||||||
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) | ||||||||
| December 31, 2017 | December 31, 2016 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Cash, cash equivalents and investment securities | $ | 341,342 | $ | 529,036 | ||||
| Accounts receivable, net | 17,343 | 5,903 | ||||||
| Interest and other receivables | 1,087 | 1,237 | ||||||
| Inventory | 5,248 | 4,175 | ||||||
| Prepaid expenses | 8,457 | 7,546 | ||||||
| Total current assets | 373,477 | 547,897 | ||||||
| Property and equipment, net | 2,662 | 3,081 | ||||||
| Intangible assets, net | 5,538 | 7,015 | ||||||
| Restricted cash | 2,475 | 2,375 | ||||||
| Other assets | 354 | 785 | ||||||
| Total assets | $ | 384,506 | $ | 561,153 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Accounts payable | $ | 8,786 | $ | 3,912 | ||||
| Accrued liabilities | 40,244 | 36,029 | ||||||
| Deferred revenue | — | 2,644 | ||||||
| Total current liabilities | 49,030 | 42,585 | ||||||
| Long-term liabilities | 191 | 157 | ||||||
| Total liabilities | 49,221 | 42,742 | ||||||
| Total stockholders’ equity | 335,285 | 518,411 | ||||||
| Total liabilities and stockholders’ equity | $ | 384,506 | $ | 561,153 | ||||
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: 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
Bob Laverty, (609) 558-5570
bob@taftcommunications.com