- 2Q19 Net Sales Grew to $83.2 Million, a 46%
Increase Over 2Q18
- 2019 Net Sales Guidance Increased to $320
Million to $330 Million
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 disorders, today announced its financial results for
the second quarter ended June 30, 2019.
“Continued execution of our commercial initiatives led to strong
quarterly performance for NUPLAZID and a significant increase in
our sales guidance for the full year,” said Steve Davis, ACADIA’s
Chief Executive Officer. “This quarter we initiated a Phase 3
program for pimavanserin in major depressive disorder and in the
fourth quarter we plan to initiate a Phase 3 program for
trofinetide in Rett syndrome. Additionally for pimavanserin, we
expect to announce top-line results from our schizophrenia negative
symptoms ADVANCE study around year-end and we expect to announce
top-line results from our dementia-related psychosis HARMONY study
in the second half of 2020, with an interim read in the second half
of this year.”
Recent Highlights
- Announced top-line results from the Phase 3 ENHANCE study of
pimavanserin for adjunctive treatment in patients with
schizophrenia. In the study, adding pimavanserin to existing
antipsychotic treatment showed a consistent trend in improvement of
psychotic symptoms, however the results did not achieve statistical
significance on the primary endpoint, the Positive and Negative
Syndrome Scale (PANSS) total score (p=0.0940). Significant
improvements were observed on the secondary endpoint of PANSS
negative symptoms scale sub-score (unadjusted p=0.0474). Additional
details from the study are included in the press release issued by
the Company on July 22, 2019.
- Presented positive Phase 2 CLARITY results for pimavanserin as
an adjunctive treatment in major depressive disorder at the 2019
American Psychiatric Association Annual Meeting in May 2019.
- Initiated the international Phase 3 CLARITY-3 study with
pimavanserin for adjunctive treatment in patients with major
depressive disorder in July 2019.
- Announced in June 2019, alongside the Michael J. Fox Foundation
for Parkinson’s Research, the launch of “Parkinson’s IQ + You”, a
series of local events across the United States to educate and
empower patients with Parkinson’s disease and their care
partners.
Financial Results
Revenue Net sales of NUPLAZID® (pimavanserin) were $83.2 million
for the three months ended June 30, 2019, an increase of 46% as
compared to $57.1 million reported for the three months ended June
30, 2018. For the six months ended June 30, 2019 and 2018, ACADIA
reported net product sales of $146.2 million and $105.9 million,
respectively.
Research and Development Research and development expenses for
the three months ended June 30, 2019 were $67.3 million, compared
to $46.6 million for the same period of 2018. For the six months
ended June 30, 2019 and 2018, research and development expenses
were $120.2 million and $85.9 million, respectively. The increase
during the 2019 periods as compared to 2018 was primarily due to
development costs associated with trofinetide and additional
clinical study costs for pimavanserin.
Selling, General and Administrative Selling, general and
administrative expenses for the three months ended June 30, 2019
were $68.0 million, compared to $69.5 million for the same period
of 2018. This decrease was due to lower direct-to-consumer
advertising expense partially offset by an increase in personnel
costs. For the six months ended June 30, 2019 and 2018, selling,
general and administrative expenses were $161.1 million and $130.4
million, respectively. This increase was largely due to an increase
in marketing expense related to our direct-to-consumer advertising
campaign as well as increased charitable contributions and
personnel costs.
Net Loss For the three months ended June 30, 2019, ACADIA
reported a net loss of $54.9 million, or $0.38 per common share,
compared to a net loss of $63.3 million, or $0.51 per common share,
for the same period in 2018. The net losses for the three months
ended June 30, 2019 and 2018 included $20.4 million and $20.6
million, respectively, of non-cash stock-based compensation
expense. For the six months ended June 30, 2019, ACADIA reported a
net loss of $140.2 million, or $0.97 per common share, compared to
a net loss of $117.6 million, or $0.94 per common share, for the
same period in 2018. The net losses for the six months ended June
30, 2019 and 2018 included $40.3 million and $41.0 million,
respectively, of non-cash stock-based compensation expense.
Cash and Investments At June 30, 2019, ACADIA’s cash, cash
equivalents, and investment securities totaled $381.9 million,
compared to $473.5 million at December 31, 2018.
2019 Financial Guidance
- 2019 NUPLAZID net sales guidance is increased to $320 million
to $330 million from the previous range of $280 million to $300
million.
- 2019 GAAP R&D guidance of $250 million to $265 million is
unchanged compared to prior guidance.
- 2019 GAAP SG&A guidance is increased to $300 million to
$315 million from the previous range of $280 million to $295
million.
- Non-cash stock-based compensation expense guidance of $80
million to $90 million is unchanged compared to prior
guidance.
Conference Call and Webcast
Information ACADIA management will review its second quarter
financial results and operations via conference call and webcast
today at 4:30 p.m. Eastern Time. The conference call may be
accessed by dialing 855-638-4820 for participants in the U.S. or
Canada and 443-877-4067 for international callers (reference
passcode 1288895). A telephone replay of the conference call may be
accessed through August 14, 2019 by dialing 855-859-2056 for
callers in the U.S. or Canada and 404-537-3406 for international
callers (reference passcode 1288895). 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 through August 28,
2019.
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 selective
serotonin inverse agonist/antagonist 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. ACADIA discovered and
developed 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 has developed and commercialized
the first and only medicine approved for the treatment of
hallucinations and delusions associated with Parkinson’s disease
psychosis. ACADIA also has ongoing clinical development efforts in
additional areas with significant unmet need, including
dementia-related psychosis, schizophrenia, major depressive
disorder, and Rett syndrome. This press release and further
information about ACADIA can be found at: www.acadia-pharm.com.
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 potential opportunity for future growth
in sales of NUPLAZID, including through sales of new dosages and
forms; the timing of ongoing and future clinical studies for
pimavanserin; the development and commercialization of trofinetide;
and guidance for full-year 2019 NUPLAZID net sales and certain
expense line items. 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 uncertainty of future commercial sales and
related items that would impact net sales during 2019, the risks
and uncertainties inherent in drug development, approval and
commercialization, 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, 2018 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.
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(in thousands, except per share
amounts)
(Unaudited)
Three Months Ended June
30,
Six Months Ended June
30,
2019
2018
2019
2018
Revenues
Product sales, net
$
83,205
$
57,063
$
146,164
$
105,931
Total revenues
83,205
57,063
146,164
105,931
Operating expenses
Cost of product sales, license fees and
royalties (1)
4,995
5,078
9,575
8,563
Research and development (1)
67,320
46,592
120,243
85,868
Selling, general and administrative
(1)
67,981
69,472
161,071
130,398
Total operating expenses
140,296
121,142
290,889
224,829
Loss from operations
(57,091
)
(64,079
)
(144,725
)
(118,898
)
Interest income, net
2,527
1,279
5,461
2,449
Other expense
(12
)
(247
)
(241
)
(247
)
Loss before income taxes
(54,576
)
(63,047
)
(139,505
)
(116,696
)
Income tax expense
365
219
740
866
Net loss
$
(54,941
)
$
(63,266
)
$
(140,245
)
$
(117,562
)
Net loss per common share, basic and
diluted
$
(0.38
)
$
(0.51
)
$
(0.97
)
$
(0.94
)
Weighted average common shares
outstanding, basic and diluted
144,314
124,910
144,148
124,819
(1) Includes the following stock-based
compensation expense
Cost of product sales, license fees and
royalties
$
803
$
1,137
$
1,798
$
2,187
Research and development
$
7,901
$
7,894
$
15,781
$
15,551
Selling, general and administrative
$
11,718
$
11,521
$
22,726
$
23,256
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
June 30, 2019
December 31, 2018
(unaudited)
Assets
Cash, cash equivalents and investment
securities
$
381,887
$
473,520
Accounts receivable, net
31,781
26,090
Interest and other receivables
941
1,699
Inventory
3,824
4,070
Prepaid expenses
18,507
20,727
Total current assets
436,940
526,106
Property and equipment, net
3,427
3,309
Operating lease right-of-use assets
10,818
—
Intangible assets, net
3,323
4,062
Restricted cash
4,787
4,826
Other assets
1,588
1,899
Total assets
$
460,883
$
540,202
Liabilities and stockholders’
equity
Accounts payable
$
4,650
$
3,167
Accrued liabilities
59,164
56,398
Total current liabilities
63,814
59,565
Operating lease liabilities
6,742
—
Other long-term liabilities
1,413
1,558
Total liabilities
71,969
61,123
Total stockholders’ equity
388,914
479,079
Total liabilities and stockholders’
equity
$
460,883
$
540,202
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190731005929/en/
Investor Contact: ACADIA Pharmaceuticals Inc. Mark Johnson, CFA
(858) 261-2771 ir@acadia-pharm.com
Media Contact: ACADIA Pharmaceuticals Inc. Maurissa Messier
(858) 768-6068 media@acadia-pharm.com
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