ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical
company focused on the development and commercialization of
innovative medicines that address unmet medical needs in
neurological and related central nervous system disorders, today
announced its financial results for the fourth quarter and year
ended December 31, 2014.
ACADIA reported a net loss of $28.4 million, or $0.28 per common
share, for the fourth quarter of 2014, compared to a net loss of
$12.0 million, or $0.13 per common share, for the fourth quarter of
2013. The net losses for the fourth quarters of 2014 and 2013
included $4.6 million and $2.2 million, respectively, in non-cash,
stock-based compensation expense. For the year ended December 31,
2014, ACADIA reported a net loss of $92.5 million, or $0.95 per
common share, compared to a net loss of $37.9 million, or $0.44 per
common share, for 2013. The net losses for 2014 and 2013 included
$16.0 million and $5.7 million, respectively, in non-cash,
stock-based compensation expense.
At December 31, 2014, ACADIA’s cash, cash equivalents, and
investment securities totaled $322.5 million compared to $185.8
million at December 31, 2013. This increase was primarily due to
net proceeds from sales of equity securities, including $196.8
million raised in a public offering in March 2014, offset in part
by cash used to fund ACADIA’s operations.
“Our accomplishments in 2014, highlighted by NUPLAZIDTM
receiving Breakthrough Therapy designation from the FDA, our
strengthened balance sheet, and our commercial preparations, set
the stage for a promising 2015,” said Uli Hacksell, Ph.D., Chief
Executive Officer of ACADIA. “Importantly, we continue to advance
our Parkinson’s disease psychosis program towards registration and
remain on track to submit our New Drug Application to the FDA in
the first quarter of 2015.”
“We have an important year ahead of us as we continue to add to
our commercial capabilities and prepare for the planned launch of
NUPLAZID in the United States. We also plan to initiate studies
with pimavanserin where new therapies are greatly needed, including
schizophrenia and sleep disturbances in Parkinson’s patients, as
well as continuing our ongoing Phase II study with pimavanserin in
Alzheimer’s disease psychosis. Additionally, we will prepare a
Marketing Authorization Application for NUPLAZID for submission in
Europe. In all, 2015 will be a pivotal year for ACADIA as we
advance NUPLAZID towards commercialization in the United States and
broaden the program into additional neurological and psychiatric
indications for which there are large unmet medical needs.”
Research and development expenses increased to $18.2 million for
the fourth quarter of 2014, including $1.7 million in stock-based
compensation, from $7.9 million for the comparable quarter of 2013,
including $791,000 in stock-based compensation. This increase was
primarily due to an increase of $7.8 million in external service
costs associated with the development of pimavanserin. Increases in
costs associated with ACADIA’s expanded research and development
organization, including $1.5 million in increased personnel costs
and $948,000 in increased stock-based compensation expense, also
contributed to the quarter-over-quarter increase.
General and administrative expenses increased to $10.4 million
for the fourth quarter of 2014, including $2.9 million in
stock-based compensation, from $4.3 million for the comparable
quarter of 2013, including $1.4 million in stock-based
compensation. This increase was due to a $2.1 million increase in
external service costs largely related to ACADIA’s commercial
preparations for the planned launch of NUPLAZID. Also contributing
to the quarter-over-quarter increase in general and administrative
expenses was a $1.7 million increase in personnel expenses largely
related to ACADIA’s preparations for the planned launch of
NUPLAZID, as well as a $1.5 million increase in stock-based
compensation expense.
ACADIA anticipates that the level of cash used in its operations
will increase in future periods in order to fund its work related
to the New Drug Application (NDA) submission and review and
commercial activities for NUPLAZID, and its ongoing and planned
development activities for pimavanserin for other indications.
ACADIA currently expects that its cash, cash equivalents, and
investment securities will be sufficient to fund its planned
operations at least into the second half of 2016.
2014 Highlights
NUPLAZID (pimavanserin)
- FDA granted Breakthrough Therapy
designation to NUPLAZID for the treatment of Parkinson’s disease
psychosis (PDP).
- Conducted successful pre-NDA meetings
with the FDA for NUPLAZID.
- FDA provisionally accepted the trade
name “NUPLAZID”™ for pimavanserin.
- Presented caregiver burden data from
Phase III PDP program at the 10th Annual International Congress of
Non-Motor Dysfunctions in Parkinson’s Disease and Related
Disorders.
- Continued to enroll patients in the
ongoing Phase II study with pimavanserin in Alzheimer’s disease
psychosis.
- Advanced commercial preparations for
the planned launch of NUPLAZID, comprising extensive market
research, foundational access and reimbursement research, national
and regional scientific advisory boards, pricing analysis, sales
force sizing, and adding to the leadership of the commercial
team.
Business and Other
- Completed a public offering of common
stock raising net proceeds of $196.8 million.
- Appointed Steve Davis as Executive Vice
President, Chief Financial Officer and Chief Business Officer.
Conference Call and Webcast Information
ACADIA management will review its fourth quarter financial
results and development programs via conference call and webcast
later today at 5:00 p.m. Eastern Time. The conference call may be
accessed by dialing 866-825-1709 for participants in the U.S. or
Canada and 617-213-8060 for international callers (reference
passcode 61156625). A telephone replay of the conference call may
be accessed through March 12, 2015 by dialing 888-286-8010 for
callers in the U.S. or Canada and 617-801-6888 for international
callers (reference passcode 58941986). 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
12, 2015.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development
and commercialization of innovative medicines to address unmet
medical needs in neurological and related central nervous system
disorders. ACADIA has a pipeline of product candidates led by
NUPLAZID (pimavanserin), for which we have reported positive Phase
III trial results in Parkinson’s disease psychosis and which has
the potential to be the first drug approved in the United States
for this disorder. Pimavanserin is also in Phase II development for
Alzheimer’s disease psychosis and has successfully completed a
Phase II trial in schizophrenia. ACADIA also has clinical-stage
programs for chronic pain and glaucoma in collaboration with
Allergan, Inc. All product candidates are small molecules that
emanate from internal discoveries. 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
timing of the submission of an NDA for NUPLAZID (pimavanserin) for
the treatment of PDP; the potential for pimavanserin to be the
first drug approved in the United States for PDP and the potential
timing of such approval, if approved at all; the potential outlook
for 2015 and the activities planned to be undertaken in the next
year; ACADIA’s plans to explore NUPLAZID (pimavanserin) in
indications other than PDP and to file a Marketing Authorization
Application in Europe; ACADIA’s future cash usage, including the
areas of such usage, and the cash runway; ACADIA’s ongoing
pre-commercial activities and plans to commercially launch
NUPLAZID; and the progress, timing and results of ACADIA’s drug
discovery and development programs, either alone or with a partner,
including the progress and expected timing of clinical trials,
including planned trials for 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, approval,
and commercialization, and collaborations with others, 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 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 Years Ended
December 31, December 31, 2014
2013 2014 (1)
2013 (1) Collaborative
revenues $ 47 $ 37 $ 120 $ 1,145 Operating expenses Research
and development (includes stock-based compensation of $1,739, $791,
$5,191, and $2,208, respectively) 18,182 7,926 60,602 26,722
General and administrative (includes stock-based compensation of
$2,906, $1,383, $10,848, and $3,503, respectively)
10,420 4,276
32,748 12,720 Total
operating expenses
28,602
12,202 93,350
39,442 Loss from operations (28,555 ) (12,165 )
(93,230 ) (38,297 ) Interest income, net
189
116 755
349 Net loss
$
(28,366 ) $
(12,049 ) $
(92,475 ) $
(37,948 ) Net loss per common share,
basic and diluted
$ (0.28 )
$ (0.13 ) $
(0.95 ) $ (0.44
) Weighted average common shares outstanding, basic
and diluted
99,850
90,947 97,248
85,715 (1)
The condensed consolidated statements of
operations for the years ended December 31, 2014 and 2013 have been
derived from the financial statements but do not include all of the
information and footnotes required by accounting principles
generally accepted in the United States for complete financial
statements.
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED
BALANCE SHEETS (in thousands) (Unaudited)
December 31,
December 31, 2014 (1) 2013 (1)
Assets Cash, cash equivalents, and investment securities $
322,486 $ 185,790 Prepaid expenses, receivables and other current
assets
2,132 2,570 Total
current assets 324,618 188,360 Other non-current assets
840 758 Total assets
$ 325,458 $
189,118 Liabilities and stockholders’ equity
Total liabilities $ 15,969 $ 6,987 Stockholders’ equity
309,489 182,131 Total liabilities
and stockholders’ equity
$ 325,458
$ 189,118
(1)
The condensed consolidated balance sheets
at December 31, 2014 and 2013 have been derived from the financial
statements at such date but do not include all of the information
and footnotes required by accounting principles generally accepted
in the United States for complete financial statements.
ACADIA Pharmaceuticals Inc.Steve Davis, Executive Vice
President,Chief Financial Officer and Chief Business OfficerLisa
Barthelemy, Director of Investor Relations858-558-2871
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