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, 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
- Net revenue for the first quarter of
2017 of $15.3 million, an increase of 28% from the fourth quarter
of 2016.
- 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.
- Expanded penetration into the long-term
care market with 25 additional long-term care sales specialists;
ACADIA currently has approximately 155 total sales
specialists.
- 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.
- Plan to advance Alzheimer’s disease
psychosis (AD Psychosis) program into Phase III in second half of
2017.
- Presented data on NUPLAZID in PD
Psychosis at the American Association for Geriatric Psychiatry
Annual Meeting.
- Appointed Michael J. Yang as Executive
Vice President, Chief Commercial Officer.
Financial Results
RevenueACADIA 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 DevelopmentResearch 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 AdministrativeSelling, 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 LossFor 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 InvestmentsAt 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 InformationACADIA 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 PharmaceuticalsACADIA 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 StatementsStatements 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.
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(in thousands, except per share
amounts)
(Unaudited)
Three Months Ended
March 31,
2017 2016 Revenues Product
sales, net $ 15,286 $ — Collaborative revenue — 4
Total revenues 15,286 4
Operating expenses Cost of
product sales 2,263 — License fees and royalties 675 — Research and
development 35,409 22,775 Selling, general and administrative
65,745 27,491 Total operating expenses 104,092
50,266 Loss from operations (88,806 ) (50,262 ) Interest
income, net 963 500 Net loss $ (87,843 ) $ (49,762 )
Net loss per common share, basic and diluted $ (0.72 ) $ (0.45 )
Weighted average common shares outstanding, basic and diluted
121,651 111,346
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
March 31,
2017
December 31,
2016
(unaudited)
Assets Cash, cash equivalents, and investment
securities $ 469,481 $ 529,036 Accounts receivable, net 7,660 5,903
Interest and other receivables 1,859 1,237 Inventory 3,881 4,175
Prepaid expenses 6,872 7,546 Total current assets
489,753 547,897 Property and equipment, net 3,471 3,081 Intangible
assets, net 6,646 7,015 Restricted cash 2,475 2,375 Other assets
668 785 Total assets $ 503,013 $ 561,153
Liabilities and stockholders’ equity Accounts payable $
2,166 $ 3,912 Accrued liabilities 38,967 36,029 Deferred revenue
4,132 2,644 Total current liabilities 45,265 42,585
Long-term liabilities 224 157 Total liabilities
45,489 42,742 Total stockholders’ equity 457,524
518,411 Total liabilities and stockholders’ equity $ 503,013 $
561,153
Important Safety Information and
Indication for NUPLAZID (pimavanserin)
tabletsWARNING: INCREASED MORTALITY IN ELDERLY
PATIENTS WITH DEMENTIA-RELATED PSYCHOSISElderly 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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version on businesswire.com: http://www.businesswire.com/news/home/20170509006525/en/
ACADIA Pharmaceuticals Inc.Investor Contact:Lisa Barthelemy,
858-558-2871ir@acadia-pharm.comorMedia Contact:Taft
CommunicationsBob Laverty,
609-558-5570bob@taftcommunications.com
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