SAN DIEGO--(BUSINESS WIRE)--Feb. 26, 2015--
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)
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FDA granted Breakthrough Therapy designation to NUPLAZID for the
treatment of Parkinson’s disease psychosis (PDP).
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Conducted successful pre-NDA meetings with the FDA for NUPLAZID.
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FDA provisionally accepted the trade name “NUPLAZID”™ for pimavanserin.
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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.
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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.
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ACADIA PHARMACEUTICALS INC.
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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(in thousands, except per share amounts)
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(Unaudited)
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Three Months Ended
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Years Ended
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December 31,
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December 31,
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2014
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2013
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2014 (1)
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2013 (1)
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Collaborative revenues
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$
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47
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$
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37
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$
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120
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$
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1,145
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Operating expenses
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Research and development (includes stock-based compensation of
$1,739, $791, $5,191, and $2,208, respectively)
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18,182
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7,926
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60,602
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26,722
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General and administrative (includes stock-based compensation of
$2,906, $1,383, $10,848, and $3,503, respectively)
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10,420
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4,276
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32,748
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12,720
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Total operating expenses
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28,602
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12,202
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93,350
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39,442
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Loss from operations
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(28,555
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)
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(12,165
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)
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(93,230
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)
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(38,297
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)
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Interest income, net
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189
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116
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755
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349
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Net loss
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$
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(28,366
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)
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$
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(12,049
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)
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$
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(92,475
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)
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$
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(37,948
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Net loss per common share, basic and diluted
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$
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(0.28
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)
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$
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(0.13
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)
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$
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(0.95
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)
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$
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(0.44
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)
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Weighted average common shares outstanding, basic and diluted
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99,850
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90,947
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97,248
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85,715
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(1)
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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.
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ACADIA PHARMACEUTICALS INC.
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CONDENSED CONSOLIDATED BALANCE SHEETS
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(in thousands)
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(Unaudited)
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December 31,
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December 31,
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2014 (1)
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2013 (1)
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Assets
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Cash, cash equivalents, and investment securities
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$
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322,486
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$
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185,790
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Prepaid expenses, receivables and other current assets
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2,132
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2,570
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Total current assets
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324,618
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188,360
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Other non-current assets
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840
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758
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Total assets
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$
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325,458
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$
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189,118
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Liabilities and stockholders’ equity
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Total liabilities
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$
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15,969
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$
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6,987
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Stockholders’ equity
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309,489
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182,131
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Total liabilities and stockholders’ equity
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$
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325,458
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$
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189,118
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(1)
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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.
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Source: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Steve Davis, Executive Vice
President,
Chief Financial Officer and Chief Business Officer
Lisa
Barthelemy, Director of Investor Relations
858-558-2871