Third Quarter Net Sales Grew to
– Company Raises Annual 2017 Net Sales Guidance to Between
“Our results this quarter reflect strong growth for NUPLAZID forParkinson’s disease psychosis,” said
Recent Highlights
- Initiated pivotal Phase III HARMONY Study with pimavanserin indementia-related psychosis in
October 2017 . FDA granted Breakthrough Therapy Designation to pimavanserin for thetreatment of dementia-related psychosis inOctober 2017 . This is thesecond Breakthrough Therapy Designation for pimavanserin.- Presented Phase II data with pimavanserin in Alzheimer’s diseasepsychosis at the Symposium, “The Importance of Serotonin inAlzheimer’s Disease Psychosis and the Role of Pimavanserin,” at theClinical Trials on Alzheimer’s Disease (CTAD) meeting in
Boston inNovember 2017 . - In addition to dementia-related psychosis, ACADIA continues to advanceits broad clinical development program with ongoing studies inschizophrenia inadequate response, schizophrenia negative symptoms,and major depressive disorder.
Financial Results
Revenue
Net product sales of NUPLAZID, which was first made available forprescription starting in
Research and Development
Research and development expenses for the three months ended
Selling, General and Administrative
Selling, general and administrative expenses for the three months ended
Net Loss
For the three months ended
Cash and Investments
At
2017 Financial Guidance
ACADIA is increasing its revenue guidance and now expects that full-yearNUPLAZID net sales for 2017 will be between
Pro Forma Reconciliation of Sell-Through to Sell-In Method
In the second quarter of 2017 the company began to recognize revenue atthe point 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, commonlyreferred to as the “sell-through” revenue recognition method. As aresult of this change, ACADIA recorded a one-time adjustment of
| (in millions) | |||||||||||||||
| March 31, | June 30, | September 30, | |||||||||||||
| 2017 | 2017 | 2017 | |||||||||||||
| NUPLAZID net sales, as reported1 | $ | 15.3 | $ | 30.5 | $ | 35.6 | |||||||||
| Difference2 | 1.5 | (3.6 | ) | - | |||||||||||
| NUPLAZID net sales, sell-in method3 | $ | 16.8 | $ | 26.9 | $ | 35.6 | |||||||||
| 1 Represents the net sales, as reported, for the periodspresented, including the three months ended March 31, 2017 utilizingthe sell-through revenue recognition method and the three monthsended June 30, 2017 utilizing the sell-in revenue recognition methodtogether with one-time recognition of previously deferred revenue asa result of the impact of the transition to the sell-in methodduring the three months ended June 30, 2017. | |||||||||||||||
| 2 Represents the impact of recognizing the deferredrevenue at period-end, net of allowances for rebates andchargebacks, had the sales been recognized in the quarter which theproduct was delivered to the specialty pharmacies and distributors. | |||||||||||||||
3 Represents pro forma results for the three monthsended March 31 and June 30, 2017. Results for the three monthsended September 30, 2017 are as reported. | |||||||||||||||
Conference Call and Webcast Information
ACADIA management will review its third 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 guidance for full-year 2017NUPLAZID net sales; the benefits to be derived from NUPLAZID(pimavanserin); and whether NUPLAZID will provide an important benefitto patients with dementia-related psychosis. These statements are onlypredictions based on current information and expectations and involve anumber of risks and uncertainties. Actual events or results may differmaterially from those projected in any of such statements due to variousfactors, including the uncertainty of future commercial sales andrelated items that would impact net sales for 2017, 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 September 30, | Nine Months Ended September 30, | ||||||||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||||||||
| Revenues | |||||||||||||||||||||
| Product sales, net | $ | 35,578 | $ | 5,268 | $ | 81,339 | $ | 5,365 | |||||||||||||
| Collaborative revenue | — | — | — | 4 | |||||||||||||||||
| Total revenues | 35,578 | 5,268 | 81,339 | 5,369 | |||||||||||||||||
| Operating expenses | |||||||||||||||||||||
| Cost of product sales | 2,135 | 845 | 6,622 | 1,371 | |||||||||||||||||
| License fees and royalties | 1,078 | 475 | 2,735 | 723 | |||||||||||||||||
| Research and development | 36,421 | 25,813 | 106,010 | 69,066 | |||||||||||||||||
| Selling, general and administrative | 62,255 | 50,534 | 189,523 | 128,793 | |||||||||||||||||
| Total operating expenses | 101,889 | 77,667 | 304,890 | 199,953 | |||||||||||||||||
| Loss from operations | (66,311 | ) | (72,399 | ) | (223,551 | ) | (194,584 | ) | |||||||||||||
| Interest income, net | 1,063 | 786 | 3,019 | 1,887 | |||||||||||||||||
| Net loss | $ | (65,248 | ) | $ | (71,613 | ) | $ | (220,532 | ) | $ | (192,697 | ) | |||||||||
| Net loss per common share, basic and diluted | $ | (0.53 | ) | $ | (0.61 | ) | $ | (1.81 | ) | $ | (1.69 | ) | |||||||||
| Weighted average common shares outstanding, basic and diluted | 122,484 | 117,497 | 122,089 | 114,063 | |||||||||||||||||
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) | |||||||||||||||||
| September 30, 2017 | December 31, 2016 | ||||||||||||||||
| (unaudited) | |||||||||||||||||
| Assets | |||||||||||||||||
| Cash, cash equivalents and investment securities | $ | 366,625 | $ | 529,036 | |||||||||||||
| Accounts receivable, net | 14,221 | 5,903 | |||||||||||||||
| Interest and other receivables | 1,033 | 1,237 | |||||||||||||||
| Inventory | 5,536 | 4,175 | |||||||||||||||
| Prepaid expenses | 14,557 | 7,546 | |||||||||||||||
| Total current assets | 401,972 | 547,897 | |||||||||||||||
| Property and equipment, net | 2,991 | 3,081 | |||||||||||||||
| Intangible assets, net | 5,907 | 7,015 | |||||||||||||||
| Restricted cash | 2,475 | 2,375 | |||||||||||||||
| Other assets | 369 | 785 | |||||||||||||||
| Total assets | $ | 413,714 | $ | 561,153 | |||||||||||||
| Liabilities and stockholders’ equity | |||||||||||||||||
| Accounts payable | $ | 2,962 | $ | 3,912 | |||||||||||||
| Accrued liabilities | 33,181 | 36,029 | |||||||||||||||
| Deferred revenue | — | 2,644 | |||||||||||||||
| Total current liabilities | 36,143 | 42,585 | |||||||||||||||
| Long-term liabilities | 245 | 157 | |||||||||||||||
| Total liabilities | 36,388 | 42,742 | |||||||||||||||
| Total stockholders’ equity | 377,326 | 518,411 | |||||||||||||||
| Total liabilities and stockholders’ equity | $ | 413,714 | $ | 561,153 | |||||||||||||
Important Safety Information and Indication forNUPLAZID (pimavanserin) tablets
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITHDEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated withantipsychotic drugs are at an increased risk of death. NUPLAZID is notapproved for the treatment of patients with dementia-related psychosisunrelated to the hallucinations and delusions associated withParkinson’s disease psychosis.
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