Second Quarter Net Sales Grew to
“Our commercial efforts continue to drive strong financial performancewith solid market uptake for NUPLAZID in patients with Parkinson’sdisease psychosis,” said
During the second quarter of 2017, ACADIA generated
Starting with the second quarter of 2017, based on its determination ithad sufficient volume of activity to reasonably estimate its allowancesfor rebates and chargebacks, ACADIA began to recognize revenue at thepoint of sale to its specialty pharmacy and specialty distributorpartners, commonly referred to as the “sell-in” revenue recognitionmethod. Previously, ACADIA had deferred the recognition of revenue untilit obtained evidence that its specialty partners had dispensed theproduct to a patient or had sold the product to a government facility,long-term care pharmacy or in-patient hospital pharmacy. The
For comparison purposes, the following table presents NUPLAZID’s proforma quarterly net product sales under the sell-in method, if ACADIAhad been able to reasonably estimate its allowances for rebates andchargebacks from the time of launch in
Pro Forma Reconciliation of Sell-Through to Sell-In Method | |||||||||||||||||
(in millions) | Three Months Ended | ||||||||||||||||
June 30, | September 30, | December 31, | March 31, | June 30, | |||||||||||||
2016 | 2016 | 2016 | 2017 | 2017 | |||||||||||||
NUPLAZID net sales, as reported1 | $ | 0.1 | $ | 5.3 | $ | 12.0 | $ | 15.3 | $ | 30.5 | |||||||
Difference2 | 0.4 | 1.2 | 0.5 | 1.5 | (3.6 | ) | |||||||||||
Pro forma NUPLAZID net sales, sell-in method | $ | 0.5 | $ | 6.5 | $ | 12.5 | $ | 16.8 | $ | 26.9 | |||||||
1 | Includes the net sales as previously reported for the quarterlyperiods through March 31, 2017 utilizing the sell-through revenuerecognition method. | ||
2 | Represents the impact of recognizing the deferred revenue atperiod-end, net of allowances for rebates and chargebacks, had thesales been recognized in the quarter which the product was deliveredto the specialty pharmacies and distributors. | ||
Recent Highlights
- Conducted End-of-Phase II meeting with the
FDA on the Alzheimer’sdisease psychosis (AD Psychosis) program. - Abstract of Phase II data with pimavanserin for AD Psychosis wasaccepted for presentation at the Clinical Trials on Alzheimer’sDisease meeting in early
November 2017 . - Expanded penetration into the long-term care market with thedeployment of an additional 25 long-term care specialists; ACADIAcurrently has approximately 155 total sales specialists.
- NUPLAZID nominated for the 11th Annual
Prix Galien Awardfor Best Pharmaceutical Agent. - ACADIA named to Forbes Magazine’s List of World’s Most InnovativeGrowth Companies.
- Continue to advance broad clinical development program with ongoingstudies in Alzheimer’s disease agitation, schizophrenia inadequateresponse, schizophrenia negative symptoms, and major depressivedisorder.
Financial Results
Revenue
Net product sales of NUPLAZID, which was first madeavailable for prescription starting in
Research and Development
Research and development expensesfor the three months ended
Selling, General and Administrative
Selling, general andadministrative expenses for the three months ended
Net Loss
For the three months ended
Cash and Investments
At
2017 Financial Guidance
ACADIA expects that full-yearNUPLAZID net sales for 2017 will be between
Conference Call and Webcast Information
ACADIA managementwill review its second 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 fiscal year 2017 NUPLAZID net sales; thebenefits to be derived from NUPLAZID (pimavanserin); the utility ofpimavanserin in indications other than hallucinations and delusionsassociated with PD Psychosis; and the timing or results of futurestudies involving pimavanserin. These statements are only predictionsbased on current information and expectations and involve a number ofrisks and uncertainties. Actual events or results may differ materiallyfrom those projected in any of such statements due to various factors,including the uncertainty of future commercial sales and related itemsthat would impact net sales for 2017, the risks and uncertaintiesinherent in drug discovery, development, approval and commercialization,and the fact that past results of clinical trials may not be indicativeof 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) (Unaudited) | |||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||||
Revenues | |||||||||||||||||
Product sales, net | $ | 30,475 | $ | 97 | $ | 45,761 | $ | 97 | |||||||||
Collaborative revenue | — | — | — | 4 | |||||||||||||
Total revenues | 30,475 | 97 | 45,761 | 101 | |||||||||||||
Operating expenses | |||||||||||||||||
Cost of product sales | 2,224 | 526 | 4,487 | 526 | |||||||||||||
License fees and royalties | 982 | 248 | 1,657 | 248 | |||||||||||||
Research and development | 34,180 | 20,478 | 69,589 | 43,253 | |||||||||||||
Selling, general and administrative | 61,523 | 50,768 | 127,268 | 78,259 | |||||||||||||
Total operating expenses | 98,909 | 72,020 | 203,001 | 122,286 | |||||||||||||
Loss from operations | (68,434 | ) | (71,923 | ) | (157,240 | ) | (122,185 | ) | |||||||||
Interest income, net | 993 | 601 | 1,956 | 1,101 | |||||||||||||
Net loss | $ | (67,441 | ) | $ | (71,322 | ) | $ | (155,284 | ) | $ | (121,084 | ) | |||||
Net loss per common share, basic and diluted | $ | (0.55 | ) | $ | (0.63 | ) | $ | (1.27 | ) | $ | (1.08 | ) | |||||
Weighted average common shares outstanding, basic and diluted | 122,122 | 113,308 | 121,888 | 112,327 | |||||||||||||
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) | ||||||||
June 30, 2017 | December 31, 2016 | |||||||
(unaudited) | ||||||||
Assets | ||||||||
Cash, cash equivalents and investments | $ | 417,320 | $ | 529,036 | ||||
Accounts receivable, net | 11,594 | 5,903 | ||||||
Interest and other receivables | 784 | 1,237 | ||||||
Inventory | 6,003 | 4,175 | ||||||
Prepaid expenses | 8,044 | 7,546 | ||||||
Total current assets | 443,745 | 547,897 | ||||||
Property and equipment, net | 3,296 | 3,081 | ||||||
Intangible assets, net | 6,277 | 7,015 | ||||||
Restricted cash | 2,475 | 2,375 | ||||||
Other assets | 522 | 785 | ||||||
Total assets | $ | 456,315 | $ | 561,153 | ||||
Liabilities and stockholders’ equity | ||||||||
Accounts payable | $ | 3,588 | $ | 3,912 | ||||
Accrued liabilities | 37,325 | 36,029 | ||||||
Deferred revenue | — | 2,644 | ||||||
Total current liabilities | 40,913 | 42,585 | ||||||
Long-term liabilities | 262 | 157 | ||||||
Total liabilities | 41,175 | 42,742 | ||||||
Total stockholders’ equity | 415,140 | 518,411 | ||||||
Total liabilities and stockholders’ equity | $ | 456,315 | $ | 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 hypersensitivity reaction to pimavanserin or any of its components.Reactions have included rash, urticaria, tongue swelling, circumoraledema, and throat tightness.
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