NUPLAZID® Net Product Sales Grew to $5.3
Million in the First Full Quarter of Commercialization
Expanding Pimavanserin Clinical Program With
Initiation of Studies for Alzheimer’s Disease Agitation and
Adjunctive Treatment of Schizophrenia
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 third quarter ended September 30,
2016.
“We are very pleased with the launch and are gratified by the
positive feedback we have received from physicians, patients, and
caregivers on NUPLAZID (pimavanserin),” said Steve Davis, ACADIA’s
President and Chief Executive Officer. “We saw solid
month-over-month prescription growth, reported increased payor
coverage, and continued to expand awareness of NUPLAZID among
movement disorder specialists, neurologists, and
psychiatrists.”
“In addition, we continue to expand our clinical program with
pimavanserin. We recently announced the initiation of our SERENE
study for the treatment of Alzheimer’s disease agitation and our
ENHANCE-1 study for adjunctive treatment of schizophrenia in
patients who have an inadequate response to current antipsychotic
treatment. These studies, together with additional studies we will
commence later this year, underscore our commitment to improving
the lives of patients with CNS disorders.”
Recent Highlights
- U.S. launch of NUPLAZID commenced May
31, 2016. NUPLAZID is the first and only drug approved by the FDA
for the treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis.
- NUPLAZID now on Medicare formularies;
coverage of NUPLAZID by commercial insurance plans continues to
grow.
- In October 2016, announced the
initiation of the SERENE study, a Phase II study with pimavanserin
for patients with Alzheimer’s disease agitation.
- In November 2016, announced the
initiation of ENHANCE-1, a Phase III study with pimavanserin for
adjunctive treatment for patients with schizophrenia who are
experiencing inadequate response to their current antipsychotic
therapy.
- Completed enrollment of our Phase II
study exploring the utility of pimavanserin for the treatment of
Alzheimer’s disease psychosis. Announcement of top-line results
from the study expected by the end of 2016.
- Presented multiple scientific posters
and hosted booth exhibits for healthcare providers and disease
education at the World Parkinson Congress.
- Sponsored the National Parkinson’s
Foundation Caregiver Summit.
- Raised approximately $215.9 million in
a common stock offering in August 2016.
Financial Results
Revenue
ACADIA reported net product sales of $5.3 million for the three
months ended September 30, 2016. No similar net product sales were
reported for the comparable period of 2015. NUPLAZID was made
available for prescription starting May 31, 2016. Through ACADIA’s
NUPLAZIDconnect™ site, upon initiation of therapy, physicians are
able to prescribe patients a 30-day free trial of NUPLAZID for
which no revenue is recognized.
Research and Development
Research and development expenses increased to $25.8 million for
the three months ended September 30, 2016 from $18.7 million for
the comparable period of 2015. This increase was primarily due to
increased clinical costs related to the development of pimavanserin
in indications other than Parkinson’s disease psychosis and an
increase in personnel and related costs associated with ACADIA’s
expanded research and development organization.
Selling, General and Administrative
Selling, general and administrative expenses increased to $50.5
million for the three months ended September 30, 2016 from $20.3
million for the comparable period of 2015. This increase was
primarily due to costs related to the hiring of our specialty sales
force in April 2016 and costs incurred to support our commercial
activities for NUPLAZID.
Net Loss
For the three and nine months ended September 30, 2016, ACADIA
reported a net loss of $71.6 million and $192.7 million, or $0.61
and $1.69 per common share, respectively, compared to a net loss of
$38.9 million and $118.7 million, or $0.39 and $1.18 per common
share, for the comparable periods of 2015, respectively. The net
losses for the three and nine months ended September 30, 2016
included $14.0 million and $39.8 million, respectively, of non-cash
stock-based compensation expense compared to $9.3 million and $31.3
million for the comparable periods of 2015, respectively.
Cash and Investments
At September 30, 2016, ACADIA’s cash, cash equivalents and
investment securities totaled $588.9 million, compared to $215.1
million at December 31, 2015.
Conference Call and Webcast Information
ACADIA management will review its third 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
6571523). A telephone replay of the conference call may be accessed
through November 21, 2016 by dialing 855-859-2056 for callers in
the U.S. or Canada and 404-537-3406 for international callers
(reference passcode 6571523). 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 November 21,
2016.
About NUPLAZID® (pimavanserin)
NUPLAZID is the first and only FDA-approved treatment for
hallucinations and delusions associated with Parkinson’s disease
psychosis. NUPLAZID is a non-dopaminergic, selective serotonin
inverse agonist preferentially targeting 5-HT2A receptors that are
thought to play an important role in Parkinson’s disease 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 focus of
commercial initiatives, the ability to improve the lives of
patients with CNS disorders, and the expected timing of the
announcement of top-line results from ACADIA’s Phase II Alzheimer’s
disease psychosis study. 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, whether
NUPLAZID receives adequate reimbursement from third-party payors,
ACADIA’s ability to establish and maintain an adequate specialty
pharmacy network to distribute NUPLAZID, the degree to which
NUPLAZID receives acceptance from patients and physicians for its
approved indication, 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, 2015 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 EndedSeptember
30,
Nine Months EndedSeptember
30,
2016 2015 2016
2015 Revenues Product sales, net $ 5,268 $ — $
5,365 $ — Collaborative revenues — 39
4 44 Total revenues 5,268 39 5,369 44
Operating expenses Cost of product sales 845 — 1,371
— License fees and royalties 475 — 723 — Research and development
25,813 18,729 69,066 53,403 Selling, general and administrative
50,534 20,308 128,793
65,688 Total operating expenses 77,667
39,037 199,953 119,091
Loss from operations (72,399 ) (38,998 ) (194,584 ) (119,047 )
Interest income, net 786 92
1,887 388 Net loss $ (71,613 ) $ (38,906 ) $
(192,697 ) $ (118,659 ) Net loss per common share, basic and
diluted $ (0.61 ) $ (0.39 ) $ (1.69 ) $ (1.18 ) Weighted average
common shares outstanding, basic and diluted 117,497
100,756 114,063 100,436
ACADIA PHARMACEUTICALS INC. CONDENSED
CONSOLIDATED BALANCE SHEETS
(in thousands)
September 30,2016
December 31,2015
(unaudited)
Assets Cash, cash equivalents, and investment
securities $ 588,859 $ 215,132 Accounts receivable, net 3,839 —
Interest and other receivables 1,385 1,638 Inventory 4,301 —
Prepaid expenses and other current assets 5,106 2,219
Total current assets 603,490 218,989 Property and equipment, net
3,159 2,203 Intangible assets, net 7,385 — Restricted cash 2,375
375 Other assets 975 329 Total assets $ 617,384 $
221,896
Liabilities and stockholders’ equity Accounts
payable $ 2,828 $ 1,672 Accrued liabilities 34,445 20,230 Deferred
revenue 1,876 — Total current liabilities 39,149
21,902 Long-term liabilities 177 232 Total
liabilities 39,326 22,134 Total stockholders’ equity 578,058
199,762 Total liabilities and stockholders’ equity $ 617,384
$ 221,896
Important Safety Information and
Indication for NUPLAZID (pimavanserin) tablets
WARNING: 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.
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161107006374/en/
Investor Contact:ACADIA Pharmaceuticals Inc.Lisa Barthelemy,
858-558-2871ir@acadia-pharm.comorMedia Contact:Taft
CommunicationsTed Deutsch,
609-578-8765ted@taftcommunications.com
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