ACADIA Pharmaceuticals Reports Third Quarter 2017 Financial Results
– Third Quarter Net Sales Grew to
– Company Raises Annual 2017 Net Sales Guidance to Between
“Our results this quarter reflect strong growth for NUPLAZID for
Parkinson’s disease psychosis,” said
Initiated pivotal Phase III HARMONY Study with pimavanserin in
dementia-related psychosis in
FDAgranted Breakthrough Therapy Designation to pimavanserin for the treatment of dementia-related psychosis in October 2017. This is the second Breakthrough Therapy Designation for pimavanserin.
Presented Phase II data with pimavanserin in Alzheimer’s disease
psychosis at the Symposium, “The Importance of Serotonin in
Alzheimer’s Disease Psychosis and the Role of Pimavanserin,” at the
Clinical Trials on Alzheimer’s Disease (CTAD) meeting in
Bostonin November 2017.
- In addition to dementia-related psychosis, ACADIA continues to advance its broad clinical development program with ongoing studies in schizophrenia inadequate response, schizophrenia negative symptoms, and major depressive disorder.
Net product sales of NUPLAZID, which was first made available for
prescription 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
For the three months ended
Cash and Investments
2017 Financial Guidance
ACADIA is increasing its revenue guidance and now expects that full-year
NUPLAZID 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 at
the point of sale to its specialty pharmacy and specialty distributor
partners, commonly referred to as the “sell-in” revenue recognition
method. Previously, ACADIA had deferred the recognition of revenue until
it obtained evidence that its specialty partners had dispensed the
product to a patient or had sold the product to a government facility,
long-term care pharmacy or in-patient hospital pharmacy, commonly
referred to as the “sell-through” revenue recognition method. As a
result of this change, ACADIA recorded a one-time adjustment of
|March 31,||June 30,||September 30,|
|NUPLAZID net sales, as reported1||$||15.3||$||30.5||$||35.6|
|NUPLAZID net sales, sell-in method3||$||16.8||$||26.9||$||35.6|
|1 Represents the net sales, as reported, for the periods presented, including the three months ended March 31, 2017 utilizing the sell-through revenue recognition method and the three months ended June 30, 2017 utilizing the sell-in revenue recognition method together with one-time recognition of previously deferred revenue as a result of the impact of the transition to the sell-in method during the three months ended June 30, 2017.|
|2 Represents the impact of recognizing the deferred revenue at period-end, net of allowances for rebates and chargebacks, had the sales been recognized in the quarter which the product was delivered to the specialty pharmacies and distributors.|
3 Represents pro forma results for the three months ended March 31 and June 30, 2017. Results for the three months ended September 30, 2017 are as reported.
Conference Call and Webcast Information
ACADIA management will review its third quarter financial results and
operations via conference call and webcast later today at
About NUPLAZID® (pimavanserin)
NUPLAZID is the first and only
ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA maintains a website at www.acadia-pharm.com to which we regularly post copies of our press releases as well as additional information and through which interested parties can subscribe to receive e-mail alerts.
Statements in this press release that are not strictly historical in
nature are forward-looking statements. These statements include but are
not limited to statements related to guidance for full-year 2017
NUPLAZID net sales; the benefits to be derived from NUPLAZID
(pimavanserin); and whether NUPLAZID will provide an important benefit
to patients with dementia-related psychosis. These statements are only
predictions based on current information and expectations and involve a
number of risks and uncertainties. Actual events or results may differ
materially from those projected in any of such statements due to various
factors, including the uncertainty of future commercial sales and
related items that would impact net sales for 2017, the risks and
uncertainties inherent in drug discovery, development, approval and
commercialization, and the fact that past results of clinical trials may
not be indicative of 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)
Three Months Ended
Nine Months Ended
|Product sales, net||$||35,578||$||5,268||$||81,339||$||5,365|
|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 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
|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|
|Total current assets||401,972||547,897|
|Property and equipment, net||2,991||3,081|
|Intangible assets, net||5,907||7,015|
|Liabilities and stockholders’ equity|
|Total current liabilities||36,143||42,585|
|Total stockholders’ equity||377,326||518,411|
|Total liabilities and stockholders’ equity||$||413,714||$||561,153|
Important Safety Information and Indication for NUPLAZID (pimavanserin) tablets
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.
NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics. NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation 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 reduced efficacy. Increase in NUPLAZID dosage may be needed.
Renal Impairment: No dosage adjustment for NUPLAZID is needed in patients with mild to moderate renal impairment. Use of NUPLAZID is not recommended in patients with severe renal impairment.
Hepatic Impairment: Use of NUPLAZID is not recommended in patients with hepatic impairment. NUPLAZID has not been evaluated in this patient population.
Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated and should therefore be used in pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
Pediatric Use: Safety and efficacy have not been established in pediatric patients.
Dosage and Administration: Recommended dose: 34 mg per day, taken orally as 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.