Full Press Release Details
ACADIA Pharmaceuticals Reports Financial Results for the Fourth
Quarter and Year Ended December 31, 2016
NUPLAZID Net Product
Sales Grew to $12.0 Million in Fourth Quarter 2016
Executing on Broad Clinical Development Program in
Alzheimer's Disease Psychosis, Alzheimer's Disease
Agitation, Schizophrenia Inadequate Response, Negative Symptoms of
Schizophrenia, and Major Depressive Disorder
SAN DIEGO, CA February 28, 2017
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 financial
results for the fourth quarter and year ended December 31,
was a transformational year for ACADIA highlighted by the launch of
NUPLAZID (pimavanserin) as the first and only drug approved by the
FDA for the treatment of hallucinations and delusions associated
with Parkinson's disease psychosis, said Steve Davis,
ACADIA's President and Chief Executive Officer. We are
pleased with the strong progress of the launch and our execution in
bringing this drug to Parkinson's
recently, we announced positive results from our Phase II study
with pimavanserin in Alzheimer's disease psychosis.
Pimavanserin has now shown antipsychotic effects in clinical
studies in three major CNS disorders: Parkinson's disease,
schizophrenia, and Alzheimer's disease. These results,
combined with the initiation of four new clinical programs,
underscore the potential of pimavanserin to improve the lives of
patients across multiple CNS disease states and our commitment to
explore this potential in broad and substantive clinical
available on Medicare formularies for the treatment of
Parkinson's disease psychosis (PD Psychosis); commercial
coverage decisions now made for over 60% of commercial lives and
results from our Phase II study exploring the utility of
pimavanserin for the treatment of Alzheimer's disease
psychosis announced in December 2016.
SERENE study, a 430-patient study evaluating pimavanserin for the
treatment of Alzheimer's disease agitation.
ENHANCE-1 study, a 380-patient study evaluating pimavanserin for
adjunctive treatment of schizophrenia in patients with an
inadequate response to their current antipsychotic
ADVANCE study, a 380-patient study evaluating pimavanserin for
adjunctive treatment in patients with negative symptoms of
CLARITY study, a 188-patient study evaluating pimavanserin for
adjunctive treatment in patients with major depressive disorder who
have an inadequate response to standard antidepressant
reported net product sales of $12.0 million for the fourth quarter
of 2016. NUPLAZID was launched commercially in May 2016, so there
were no similar product sales for the comparable quarter of 2015.
Through ACADIA's NUPLAZIDconnectTM site, upon
initiation of therapy, physicians have been able to prescribe
patients a 30-day free trial of NUPLAZID for which no revenue is
Research and Development
development expenses increased to $30.2 million for the fourth
quarter of 2016 from $20.5 million for the comparable quarter of
2015. This increase was primarily due to increased clinical costs
related to the development of pimavanserin in indications other
than PD Psychosis and an increase in personnel and related costs
associated with ACADIA's expanded research and development
Selling, General and Administrative
and administrative expenses increased to $57.7 million for the
fourth quarter of 2016 from $22.6 million for the comparable
quarter 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
fourth quarter of 2016, ACADIA reported a net loss of $78.7
million, or $0.65 per common share, compared to a net loss of $45.8
million, or $0.45 per common share, for the comparable quarter of
2015. The net losses for the fourth quarters of 2016 and 2015
included $15.4 million and $8.9 million, respectively, of non-cash
stock-based compensation expense. For the year ended December 31,
2016, ACADIA reported a net loss of $271.4 million, or $2.34 per
common share, compared to a net loss of $164.4 million, or $1.63
per common share, for 2015. The net losses for the years ended
December 31, 2016 and 2015 included $55.3 million and $40.2
million, respectively, of non-cash stock-based compensation
Cash and Investments
December 31, 2016, ACADIA's cash, cash equivalents and
investment securities totaled $529.0 million, compared to $215.1
million at December 31, 2015.
Conference Call and Webcast Information
management will review its fourth 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
74539512). A telephone replay of the conference call may be
accessed through March 14, 2017 by dialing 855-859-2056 for callers
in the U.S. or Canada and 404-537-3406 for international callers
(reference passcode 74539512). 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 March
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