ACADIA Pharmaceuticals Reports Second Quarter 2017 Financial Results
Second Quarter Net Sales Grew to
“Our commercial efforts continue to drive strong financial performance
with solid market uptake for NUPLAZID in patients with Parkinson’s
disease psychosis,” said
During the second quarter of 2017, ACADIA generated
Starting with the second quarter of 2017, based on its determination it
had sufficient volume of activity to reasonably estimate its allowances
for rebates and chargebacks, ACADIA 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. The
For comparison purposes, the following table presents NUPLAZID’s pro
forma quarterly net product sales under the sell-in method, if ACADIA
had been able to reasonably estimate its allowances for rebates and
chargebacks 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 quarterly periods through March 31, 2017 utilizing the sell-through revenue recognition method. | ||
|
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. | ||
Recent Highlights
-
Conducted End-of-Phase II meeting with the
FDA on the Alzheimer’s disease psychosis (AD Psychosis) program. -
Abstract of Phase II data with pimavanserin for AD Psychosis was
accepted for presentation at the Clinical Trials on Alzheimer’s
Disease meeting in early
November 2017 . - Expanded penetration into the long-term care market with the deployment of an additional 25 long-term care specialists; ACADIA currently has approximately 155 total sales specialists.
-
NUPLAZID nominated for the 11th Annual
Prix Galien Award for Best Pharmaceutical Agent. - ACADIA named to Forbes Magazine’s List of World’s Most Innovative Growth Companies.
- Continue to advance broad clinical development program with ongoing studies in Alzheimer’s disease agitation, schizophrenia inadequate response, schizophrenia negative symptoms, and major depressive disorder.
Financial Results
Revenue
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
Net Loss
For the three months ended
Cash and Investments
At
2017 Financial Guidance
ACADIA expects that full-year
NUPLAZID net sales for 2017 will be between
Conference Call and Webcast Information
ACADIA management
will review its second quarter financial results and operations via
conference call and webcast later today at
About NUPLAZID® (pimavanserin)
NUPLAZID
is the first and only
About
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.
Forward-Looking Statements
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 fiscal year 2017 NUPLAZID net sales; the
benefits to be derived from NUPLAZID (pimavanserin); the utility of
pimavanserin in indications other than hallucinations and delusions
associated with PD Psychosis; and the timing or results of future
studies involving pimavanserin. 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) (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 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 hypersensitivity reaction to pimavanserin or any of its components. Reactions have included rash, urticaria, tongue swelling, circumoral edema, and throat tightness.
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.
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Source:
Investor Contact:
ACADIA Pharmaceuticals Inc.
Lisa
Barthelemy, 858-558-2871
ir@acadia-pharm.com
or
Media
Contact:
Taft Communications
Bob Laverty,
609-558-5570
bob@taftcommunications.com