Quarter highlighted by approval and launch of NUPLAZID™
(pimavanserin) in the United States, the first and only FDA-approved
drug for the treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis
SAN DIEGO--(BUSINESS WIRE)--Aug. 4, 2016--
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
second quarter ended June 30, 2016.
“The second quarter of 2016 was highlighted by transformative events for
ACADIA, including the FDA approval and recent commercial launch of
NUPLAZID™,” said Steve Davis, ACADIA’s President and Chief Executive
Officer. “We are executing on our plans to bring NUPLAZID to patients in
need – our sales specialists have been trained and deployed; our patient
and physician support system, NUPLAZIDconnect™, became operational at
approval; we are expanding awareness of NUPLAZID among healthcare
professionals through a number of initiatives including speaker
programs, media and digital campaigns, and symposia at major medical
meetings; and we are working with payors to make NUPLAZID available to
eligible patients.”
Recent Highlights
-
NUPLAZID (pimavanserin) approved by the U.S. Food and Drug
Administration (FDA) on April 29, 2016 for the treatment of
hallucinations and delusions associated with Parkinson’s disease
psychosis.
-
NUPLAZID (pimavanserin) made available for prescription on May 31,
2016 with physicians able to prescribe patients a 30-day free trial.
-
Approximately 135 seasoned sales specialists were onboarded, trained,
and deployed at launch. They have an average of over eight years of
CNS sales experience and 15 years in the pharmaceutical industry.
-
Enrollment completed in a 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.
-
Executing on plans to initiate a Phase II study with pimavanserin in
Alzheimer’s disease agitation in the second half of 2016.
Financial Results
Revenue
ACADIA reported net product sales of $97,000 for the three months ended
June 30, 2016. No similar net product sales were reported for the
comparable period of 2015. NUPLAZID was made available for prescription
on May 31, 2016. Through ACADIA’s NUPLAZIDconnect site, physicians are
able to prescribe patients a 30-day free trial of NUPLAZID upon
initiation of therapy, for which no revenue is recognized.
Research and Development
Research and development expenses increased to $20.5 million for the
three months ended June 30, 2016 from $18.4 million for the comparable
period of 2015. This increase was primarily due to increased personnel
and related costs associated with ACADIA’s expanded research and
development organization, and increased clinical costs related to the
development of pimavanserin in indications other than Parkinson’s
disease psychosis. These increases were partially offset by decreased
manufacturing development costs.
Selling, General and Administrative
Selling, general and administrative expenses increased to $50.8 million
for the three months ended June 30, 2016 from $21.1 million for the
comparable period of 2015. This increase was primarily due to
preparations for, and support of, the launch of NUPLAZID, and the hiring
of our specialty sales force in April 2016, as well as additional
medical education programs.
Net Loss
For the three and six months ended June 30, 2016, ACADIA reported a net
loss of $71.3 million and $121.1 million, or $0.63 and $1.08 per common
share, respectively, compared to a net loss of $39.4 million and $79.8
million, or $0.39 and $0.80 per common share, for the comparable periods
of 2015, respectively. The net losses for the three and six months ended
June 30, 2016 included $13.9 million and $25.8 million, respectively, of
non-cash stock-based compensation expense compared to $7.5 million and
$22.0 million for the comparable periods of 2015, respectively.
Cash and Investments
At June 30, 2016, ACADIA’s cash, cash equivalents and investment
securities totaled $412.6 million, compared to $215.1 million at
December 31, 2015.
Conference Call and Webcast Information
ACADIA management will review its second 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 54186458). A telephone replay
of the conference call may be accessed through August 18, 2016 by
dialing 855-859-2056 for callers in the U.S. or Canada and 404-537-3406
for international callers (reference passcode 54186458). 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 August 18,
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 ability of ACADIA to work with payors to
make NUPLAZID available to eligible patients, ACADIA’s ability to expand
awareness of NUPLAZID among physicians through a number of initiatives,
timing regarding the commencement of clinical trials, including the
planned Alzheimer’s disease agitation study, 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.
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ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
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|
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|
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|
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Three Months Ended
June 30,
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Six Months Ended
June 30,
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2016
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2015
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2016
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2015
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Revenues
|
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|
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|
|
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Product sales, net
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$
|
97
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|
|
|
|
$
|
—
|
|
|
|
|
$
|
97
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|
|
|
|
$
|
—
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|
Collaborative revenues
|
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|
|
|
—
|
|
|
|
|
|
1
|
|
|
|
|
|
4
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|
|
|
|
|
5
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|
Total revenues
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|
97
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|
|
|
1
|
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|
|
101
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5
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Operating expenses
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|
|
|
|
|
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|
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|
|
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Cost of product sales
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|
|
526
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|
|
|
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|
—
|
|
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|
|
526
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|
|
|
|
|
—
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License fees and royalties
|
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|
|
|
248
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|
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|
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|
—
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|
|
|
|
|
248
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|
|
|
|
|
—
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Research and development
|
|
|
|
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20,478
|
|
|
|
|
|
18,379
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|
|
|
|
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43,253
|
|
|
|
|
|
34,674
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Selling, general and administrative
|
|
|
|
|
50,768
|
|
|
|
|
|
21,119
|
|
|
|
|
|
78,259
|
|
|
|
|
|
45,380
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|
Total operating expenses
|
|
|
|
|
72,020
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|
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|
39,498
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|
|
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|
122,286
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|
|
|
|
|
80,054
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Loss from operations
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|
(71,923
|
)
|
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|
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|
(39,497
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)
|
|
|
|
|
(122,185
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)
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|
|
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(80,049
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)
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Interest income, net
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|
|
|
|
601
|
|
|
|
|
|
119
|
|
|
|
|
|
1,101
|
|
|
|
|
|
296
|
|
Net loss
|
|
|
|
$
|
(71,322
|
)
|
|
|
|
$
|
(39,378
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)
|
|
|
|
$
|
(121,084
|
)
|
|
|
|
$
|
(79,753
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)
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Net loss per common share, basic and diluted
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|
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|
$
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(0.63
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)
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|
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|
$
|
(0.39
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)
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|
|
|
$
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(1.08
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)
|
|
|
|
$
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(0.80
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)
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Weighted average common shares outstanding, basic and diluted
|
|
|
|
|
113,308
|
|
|
|
|
|
100,349
|
|
|
|
|
|
112,327
|
|
|
|
|
|
100,273
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|
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|
|
|
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ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
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June 30,
2016
|
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December 31,
2015
|
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|
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(unaudited)
|
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Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
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Cash and cash equivalents
|
|
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|
$
|
131,774
|
|
|
|
|
|
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$
|
102,138
|
Investment securities, available-for-sale
|
|
|
|
|
280,781
|
|
|
|
|
|
|
|
|
|
112,994
|
Accounts receivable, net
|
|
|
|
|
293
|
|
|
|
|
|
|
|
|
|
—
|
Interest and other receivables
|
|
|
|
|
1,340
|
|
|
|
|
|
|
|
|
|
1,638
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Inventory
|
|
|
|
|
2,867
|
|
|
|
|
|
|
|
|
|
—
|
Prepaid expenses and other current assets
|
|
|
|
|
6,842
|
|
|
|
|
|
|
|
|
|
2,219
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Total current assets
|
|
|
|
|
423,897
|
|
|
|
|
|
|
|
|
|
218,989
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Property and equipment, net
|
|
|
|
|
2,897
|
|
|
|
|
|
|
|
|
|
2,203
|
Intangible assets, net
|
|
|
|
|
7,754
|
|
|
|
|
|
|
|
|
|
—
|
Restricted cash
|
|
|
|
|
2,375
|
|
|
|
|
|
|
|
|
|
375
|
Other assets
|
|
|
|
|
1,111
|
|
|
|
|
|
|
|
|
|
329
|
Total assets
|
|
|
|
$
|
438,034
|
|
|
|
|
|
|
|
|
$
|
221,896
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
|
$
|
1,024
|
|
|
|
|
|
|
|
|
$
|
1,672
|
Accrued liabilities
|
|
|
|
|
27,485
|
|
|
|
|
|
|
|
|
|
20,230
|
Deferred revenue
|
|
|
|
|
513
|
|
|
|
|
|
|
|
|
|
—
|
Total current liabilities
|
|
|
|
|
29,022
|
|
|
|
|
|
|
|
|
|
21,902
|
Long-term liabilities
|
|
|
|
|
197
|
|
|
|
|
|
|
|
|
|
232
|
Total liabilities
|
|
|
|
|
29,219
|
|
|
|
|
|
|
|
|
|
22,134
|
Total stockholders’ equity
|
|
|
|
|
408,815
|
|
|
|
|
|
|
|
|
|
199,762
|
Total liabilities and stockholders’ equity
|
|
|
|
$
|
438,034
|
|
|
|
|
|
|
|
|
$
|
221,896
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160804006434/en/
Source: ACADIA Pharmaceuticals Inc.
Investor Contact:
ACADIA Pharmaceuticals Inc.
Lisa
Barthelemy
(858) 558-2871
ir@acadia-pharm.com
or
Media
Contact:
Taft and Partners
Ted Deutsch
(609)
578-8765
ted@taftandpartners.com