[May 09, 2017] |
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ACADIA Pharmaceuticals Reports First Quarter 2017 Financial Results
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company
focused on the development and commercialization of innovative medicines
to address unmet medical needs in central nervous system (CNS)
disorders, today announced its unaudited financial results for the first
quarter ended March 31, 2017.
"We're very pleased with our strong start to 2017," said Steve Davis (News - Alert),
ACADIA's President and Chief Executive Officer. "The use of NUPLAZID®
in Parkinson's disease psychosis continues to expand as brand
awareness among neurologists, psychiatrists, and other healthcare
providers grows. We also continue to advance our ongoing clinical
studies in Alzheimer's disease agitation, schizophrenia inadequate
response, schizophrenia negative symptoms, and major depressive
disorder, and we look forward to moving our Alzheimer's disease
psychosis program into Phase III in the second half of 2017."
Recent Highlights
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Net revenue for the first quarter of 2017 of $15.3 million, an
increase of 28% from the fourth quarter of 2016.
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NUPLAZID (pimavanserin) available on Medicare formularies for the
treatment of Parkinson's disease psychosis (PD Psychosis); commercial
coverage decisions grew to over 90% of commercial lives.
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Expanded penetration into the long-term care market with 25 additional
long-term care sales specialists; ACADIA currently has approximately
155 total sales specialists.
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Continued to execute on broad clinical development program with
ongoing studies in Alzheimer's disease agitation, schizophrenia
inadequate response, schizophrenia negative symptoms, and major
depressive disorder.
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Plan to advance Alzheimer's disease psychosis (AD Psychosis) program
into Phase III in second half of 2017.
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Presented data on NUPLAZID in PD Psychosis at the American Association
for Geriatric Psychiatry Annual Meeting.
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Appointed Michael J. Yang as Executive Vice President, Chief
Commercial Officer.
Financial Results
Revenue ACADIA reported NUPLAZID net product sales of $15.3
million for the three months ended March 31, 2017. NUPLAZID was first
made available for prescription starting in May 2016 and there were no
similar net product sales for the comparable period of 2016. ACADIA
reports product sales when its specialty pharmacy partners dispense
NUPLAZID to a patient based on the fulfillment of a prescription or its
specialty distributor partners sell NUPLAZID to a government facility,
long-term care pharmacy or in-patient hospital pharmacy. As of March 31,
2017, the company had $4.1 million of deferred product revenue, net of
distribution fees, for product it had shipped to its distribution
partners that had not yet sold-through the distribution channel. At
December 31, 2016, the company had $2.6 million of deferred product
revenue, net of distribution fees.
Research and Development Research and development expenses
increased to $35.4 million for the three months ended March 31, 2017
from $22.8 million for the comparable period of 2016. This increase was
primarily due to increased clinical costs related to studies the company
initiated in the fourth quarter of 2016 for indications other than PD
Psychosis. The company also incurred additional personnel and related
costs associated with its expanded research and development organization
during the three months ended March 31, 2017 compared to the same period
in 2016.
Selling, General and Administrative Selling, general and
administrative expenses increased to $65.7 million for the three months
ended March 31, 2017 from $27.5 million for the comparable period of
2016. This increase was primarily due to costs incurred to support
ACADIA's commercial activities for NUPLAZID and costs related to its
specialty sales force that did not exist for the comparable period of
2016 prior to the launch of NUPLAZID.
Net Loss For the three months ended March 31, 2017, ACADIA
reported a net loss of $87.8 million, or $0.72 per common share,
compared to a net loss of $49.8 million, or $0.45 per common share, for
the comparable period of 2016. The net loss for the three months ended
March 31, 2017 included $15.6 million of non-cash stock-based
compensation expense compared to $12.0 million for the comparable period
of 2016.
Cash and Investments At March 31, 2017, ACADIA's cash, cash
equivalents, and investment securities totaled $469.5 million, compared
to $529.0 million at December 31, 2016.
Conference Call and Webcast Information ACADIA management
will review its first quarter financial results and operations via
conference call and webcast later today at 5:00 p.m. Eastern Time. The
conference call may be accessed by dialing 844-821-1109 for participants
in the U.S. or Canada and 830-865-2550 for international callers
(reference passcode 12435244). A telephone replay of the conference call
may be accessed through May 23, 2017 by dialing 855-859-2056 for callers
in the U.S. or Canada and 404-537-3406 for international callers
(reference passcode 12435244). The conference call also will be webcast
live on ACADIA's website, www.acadia-pharm.com,
under the investors section and will be archived there until May 23,
2017.
About NUPLAZID® (pimavanserin) NUPLAZID
is the first and only FDA-approved treatment for hallucinations and
delusions associated with PD Psychosis. NUPLAZID is a non-dopaminergic,
selective serotonin inverse agonist preferentially targeting 5-HT2A receptors
that are thought to play an important role in PD Psychosis. NUPLAZID is
an oral medicine taken once a day with a recommended dose of 34 mg (two
17-mg tablets). ACADIA discovered this new chemical entity and holds
worldwide rights to develop and commercialize NUPLAZID.
About ACADIA Pharmaceuticals 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 the benefits to be derived from NUPLAZID (pimavanserin); the
utility of pimavanserin in indications other than hallucinations and
delusions associated with PD Psychosis; and 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 risks and uncertainties inherent in drug discovery, development, 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 December 31, 2016 as well as ACADIA's subsequent filings
with the Securities and Exchange Commission. You are cautioned not to
place undue reliance on these forward-looking statements, which speak
only as of the date hereof. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. All
forward-looking statements are qualified in their entirety by this
cautionary statement and ACADIA undertakes no obligation to revise or
update this press release to reflect events or circumstances after the
date hereof, except as required by law.
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ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
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Three Months Ended
March 31,
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2017
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2016
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Revenues
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Product sales, net
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$
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15,286
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$
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-
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Collaborative revenue
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-
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4
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Total revenues
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15,286
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4
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Operating expenses
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Cost of product sales
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2,263
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-
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License fees and royalties
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675
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-
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Research and development
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35,409
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22,775
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Selling, general and administrative
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65,745
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27,491
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Total operating expenses
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104,092
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50,266
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Loss from operations
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(88,806
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)
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(50,262
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)
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Interest income, net
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963
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500
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Net loss
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$
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(87,843
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)
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$
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(49,762
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)
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Net loss per common share, basic and diluted
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$
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(0.72
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)
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$
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(0.45
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)
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Weighted average common shares outstanding, basic and diluted
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121,651
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111,346
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ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
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March 31,
2017
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December 31,
2016
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(unaudited)
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Assets
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Cash, cash equivalents, and investment securities
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$
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469,481
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$
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529,036
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Accounts receivable, net
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7,660
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5,903
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Interest and other receivables
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1,859
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1,237
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Inventory
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3,881
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4,175
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Prepaid expenses
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6,872
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7,546
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Total current assets
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489,753
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547,897
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Property and equipment, net
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3,471
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3,081
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Intangible assets, net
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6,646
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7,015
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Restricted cash
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2,475
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2,375
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Other assets
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668
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785
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Total assets
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$
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503,013
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$
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561,153
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Liabilities and stockholders' equity
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Accounts payable
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$
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2,166
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$
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3,912
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Accrued liabilities
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38,967
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36,029
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Deferred revenue
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4,132
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2,644
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Total current liabilities
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45,265
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42,585
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Long-term liabilities
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224
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157
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Total liabilities
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45,489
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42,742
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Total stockholders' equity
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457,524
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518,411
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Total liabilities and stockholders' equity
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$
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503,013
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|
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$
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561,153
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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 (News - Alert): 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170509006525/en/
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