Full Press Release Details
Pharmaceuticals Reports
Third Quarter 2017 Financial
Net Sales Grew to $35.6 Million
Annual 2017 Net Sales Guidance to Between $124 Million and $127
SAN DIEGO, CA, November 7, 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 unaudited financial results
for the third quarter ended September 30, 2017.
results this quarter reflect strong growth for NUPLAZID for
Parkinson's disease psychosis, said Steve Davis,
ACADIA's President and Chief Executive Officer. We
also recently advanced our clinical portfolio with the initiation
of our Phase III study of pimavanserin for dementia-related
psychosis and were pleased to receive FDA Breakthrough Therapy
Designation for this program. If this study is successful, we
believe pimavanserin will provide an important benefit to patients
with dementia-related psychosis who currently have no FDA-approved
treatments available to them.
Phase III HARMONY Study with pimavanserin in dementia-related
psychosis in October 2017.
Breakthrough Therapy Designation to pimavanserin for the treatment
of dementia-related psychosis in October 2017. This is the second
Breakthrough Therapy Designation for pimavanserin.
data with pimavanserin in Alzheimer's disease psychosis at
the Symposium, The Importance of Serotonin in
Alzheimer's Disease Psychosis and the Role of
Pimavanserin, at the Clinical Trials on Alzheimer's
Disease (CTAD) meeting in Boston in November 2017.
dementia-related psychosis, ACADIA continues to advance its broad
clinical development program with ongoing studies in schizophrenia
inadequate response, schizophrenia negative symptoms, and major
depressive disorder.
product sales of NUPLAZID, which was first made available for
prescription starting in May 2016, were $35.6 million for the three
months ended September 30, 2017 compared to $5.3 million for the
three months ended September 30, 2016. For the nine months ended
September 30, 2017 and 2016, ACADIA reported NUPLAZID net product
sales of $81.3 million and $5.4 million, respectively.
Research and Development
and development expenses for the three months ended September 30,
2017 were $36.4 million, compared to $25.8 million for the same
period of 2016. For the nine months ended September 30, 2017 and
2016, research and development expenses were $106.0 million and
$69.1 million, respectively. The increase in research and
development expenses during the 2017 periods as compared to 2016
was primarily due to increased clinical costs related to the
clinical studies initiated in the fourth quarter of each of 2016
and 2017. The company also incurred additional personnel and
related costs associated with its expanded research and development
organization during 2017 as compared to 2016.
Selling, General and Administrative
general and administrative expenses for the three months ended
September 30, 2017 were $62.3 million, compared to $50.5 million
for the same period of 2016. For the nine months ended September
30, 2017 and 2016, selling, general and administrative expenses
were $189.5 million and $128.8 million, respectively. The increase
in selling, general and administrative expenses during the 2017
periods as compared to 2016 was primarily due to costs incurred to
support ACADIA's commercial activities for NUPLAZID,
including additional personnel and related costs and due to
increased charitable contributions.
three months ended September 30, 2017, ACADIA reported a net loss
of $65.2 million, or $0.53 per common share, compared to a net loss
of $71.6 million, or $0.61 per common share, for the same period in
2016. The net losses for the three months ended September 30, 2017
and 2016 included $19.7 million and $14.0 million,
respectively, of non-cash stock-based compensation expense. For the
nine months ended September 30, 2017, ACADIA reported a net loss of
$220.5 million, or $1.81 per common share, compared to a net loss
of $192.7 million, or $1.69 per common share, for the same period
in 2016. The net losses for the nine months ended September 30,
2017 and 2016 included $53.5 million and $39.8
million, respectively, of non-cash stock-based compensation
Cash and Investments
September 30, 2017, ACADIA's cash, cash equivalents and
investment securities totaled $366.6 million, compared to $529.0
million at December 31, 2016.
2017 Financial Guidance
is increasing its revenue guidance and now expects that full-year
NUPLAZID net sales for 2017 will be between $124 million and $127
Pro Forma Reconciliation of Sell-Through to Sell-In
second quarter of 2017 the company began to recognize revenue at the point of sale to
its specialty pharmacy and specialty distributor partners, commonly
referred to as the sell-in revenue recognition
method. Previously, ACADIA had deferred the recognition of revenue
until it obtained evidence that its specialty partners had
dispensed the product to a patient or had sold the product to a
government facility, long-term care pharmacy or in-patient hospital
pharmacy, commonly referred to as the sell-through
revenue recognition method. As a result of this change, ACADIA
recorded a one-time adjustment of $3.6 million in the second
quarter of 2017 to record revenue that had previously been deferred
as of March 31, 2017. For comparison purposes, the following table
presents NUPLAZID's pro forma quarterly net product sales
under the sell-in method for the three months ended March 31 and
June 30, 2017, respectively, if ACADIA had been able to reasonably
estimate its allowances for rebates and chargebacks from the time
of launch in May 2016. Net sales for the three months ended