- 3Q19 Net Sales Grew to $94.6 Million, a 62%
Increase Over 3Q18
- 2019 Net Sales Guidance Increased to $330 to
$340 Million
- Initiated Phase 3 LAVENDER Study of
Trofinetide in Rett Syndrome, a Rare Neurodevelopmental Congenital
CNS Disorder
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 third quarter ended September 30, 2019.
“We took a major step forward in fulfilling our mission to
improve the lives of patients and their caregivers living with CNS
disorders this quarter,” said Steve Davis, ACADIA’s Chief Executive
Officer. “More patients are receiving NUPLAZID treatment for their
Parkinson’s disease psychosis than ever before and I am proud to
report that our commercial efforts drove strong financial
performance with net sales of $94.6 million in the quarter,
representing a 62% increase year-over-year. For patients and their
families struggling with dementia-related psychosis (DRP), we
believe, based on the robustly positive HARMONY Phase 3 data, that
pimavanserin has the potential to be one of the first new
treatments approved for people with dementia in over fifteen years
and the first ever FDA-approved treatment for DRP.”
Recent Highlights
- Achieved the primary endpoint in the pivotal Phase 3 HARMONY
study, demonstrating a highly statistically significant longer time
to relapse of psychosis with pimavanserin compared to placebo in a
planned interim efficacy analysis. Additional details from the
study are included in the press release issued by the Company on
September 9, 2019. Data from this study will be presented in a
late-breaking oral presentation at the Clinical Trials on
Alzheimer's Disease (CTAD) meeting on December 4, 2019.
- Announced that The Journal of Clinical Psychiatry published
positive Phase 2 CLARITY study results for pimavanserin as
adjunctive treatment for patients with major depressive disorder in
September 2019. Presented additional positive secondary endpoint
data from CLARITY showing pimavanserin significantly improved
symptoms of sexual dysfunction compared to placebo in patients with
major depressive disorder at the 2019 Psych Congress.
- Presented positive exploratory data from an open-label Phase 2
study in Parkinson’s disease patients treated with pimavanserin
monotherapy or adjunctively with SSRI/SNRI for depressive symptoms
at the 2019 International Congress of Parkinson’s Disease and
Movement Disorders and at the 2019 Psych Congress.
- Initiated the Phase 3 LAVENDER 12-week placebo-controlled study
to evaluate the efficacy and safety of trofinetide for girls and
young women with Rett syndrome in October 2019.
Financial Results
Revenue Net sales of NUPLAZID® (pimavanserin) were $94.6 million
for the three months ended September 30, 2019, an increase of 62%
as compared to $58.3 million reported for the three months ended
September 30, 2018. Third quarter 2019 gross-to-net decreased to
11.0%, as compared to 13.3% in the third quarter 2018, primarily
due to a favorable adjustment to our Medicare accrual. This
adjustment resulted in a $2.2 million increase in third quarter
2019 net sales. For the nine months ended September 30, 2019 and
2018, ACADIA reported net product sales of $240.8 million and
$164.2 million, respectively.
Research and Development Research and development expenses for
the three months ended September 30, 2019 were $62.6 million,
compared to $53.1 million for the same period of 2018. For the nine
months ended September 30, 2019 and 2018, research and development
expenses were $182.9 million and $139.0 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 September 30,
2019 were $72.7 million, compared to $61.1 million for the same
period of 2018. For the nine months ended September 30, 2019 and
2018, selling, general and administrative expenses were $233.8
million and $191.5 million, respectively. This increase during the
2019 periods as compared to 2018 was largely due to increased
charitable contributions as well as an increase in marketing
expense related to our direct-to-consumer advertising campaign and
personnel costs.
Net Loss For the three months ended September 30, 2019, ACADIA
reported a net loss of $42.0 million, or $0.29 per common share,
compared to a net loss of $62.1 million, or $0.50 per common share,
for the same period in 2018. The net losses for the three months
ended September 30, 2019 and 2018 included $22.0 million and $20.2
million, respectively, of non-cash stock-based compensation
expense. For the nine months ended September 30, 2019, ACADIA
reported a net loss of $182.2 million, or $1.26 per common share,
compared to a net loss of $179.7 million, or $1.44 per common
share, for the same period in 2018. The net losses for the nine
months ended September 30, 2019 and 2018 included $62.5 million and
$61.2 million, respectively, of non-cash stock-based compensation
expense.
Cash and Investments At September 30, 2019, ACADIA’s cash, cash
equivalents, and investment securities totaled $683.8 million,
compared to $473.5 million at December 31, 2018. The increase was
primarily due to net proceeds of $271.5 million from ACADIA's
public offering of common stock completed in September 2019 as well
as additional cash proceeds from employee option exercises of $55.1
million.
2019 Financial Guidance
- 2019 NUPLAZID net sales guidance is increased to $330 to $340
million from the previous range of $320 to $330 million.
- 2019 GAAP R&D guidance is decreased to $240 to $250 million
from the previous range of $250 to $265 million.
- 2019 GAAP SG&A guidance is increased to $315 to $325
million from the previous range of $300 to $315 million.
- Non-cash stock-based compensation expense guidance of $80 to
$90 million is unchanged compared to prior guidance.
Conference Call and Webcast
Information ACADIA management will review its third 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 2264578). A telephone replay of the conference call may be
accessed through November 13, 2019 by dialing 855-859-2056 for
callers in the U.S. or Canada and 404-537-3406 for international
callers (reference passcode 2264578). 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 November
27, 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. NUPLAZID is not
FDA-approved for dementia-related psychosis, schizophrenia, major
depressive disorder, or depressive symptoms in patients with
Parkinson’s disease. ACADIA discovered and developed this new
chemical entity and holds worldwide rights to develop and
commercialize NUPLAZID.
About Trofinetide Trofinetide is an investigational drug. It is
a novel synthetic analog of the amino‐terminal tripeptide of IGF-1
designed to treat the core symptoms of Rett syndrome by potentially
reducing neuroinflammation and supporting synaptic function. In the
central nervous system, IGF-1 is produced by both of the major
types of brain cells – neurons and glia. IGF-1 in the brain is
critical for both normal development and for response to injury and
disease. Trofinetide has been granted Fast Track Status and Orphan
Drug Designation in the U.S. and Orphan Drug Designation in Europe
for both Rett syndrome and Fragile X syndrome.
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; 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
September 30,
Nine Months Ended
September 30,
2019
2018
2019
2018
Revenues
Product sales, net
$
94,586
$
58,305
$
240,750
$
164,236
Total revenues
94,586
58,305
240,750
164,236
Operating expenses
Cost of product sales, license fees and
royalties (1)
4,689
5,375
14,264
13,938
Research and development (1)
62,622
53,112
182,865
138,980
Selling, general and administrative
(1)
72,696
61,089
233,767
191,487
Total operating expenses
140,007
119,576
430,896
344,405
Loss from operations
(45,421
)
(61,271
)
(190,146
)
(180,169
)
Interest income, net
2,432
1,229
7,893
3,678
Other expense
747
(1,720
)
506
(1,967
)
Loss before income taxes
(42,242
)
(61,762
)
(181,747
)
(178,458
)
Income tax (benefit) expense
(264
)
376
476
1,242
Net loss
$
(41,978
)
$
(62,138
)
$
(182,223
)
$
(179,700
)
Net loss per common share, basic and
diluted
$
(0.29
)
$
(0.50
)
$
(1.26
)
$
(1.44
)
Weighted average common shares
outstanding, basic and diluted
145,906
125,009
144,741
124,883
(1) Includes the following stock-based
compensation expense
Cost of product sales, license fees and
royalties
$
372
$
838
$
2,344
$
3,025
Research and development
$
8,680
$
8,066
$
24,461
$
23,617
Selling, general and administrative
$
12,971
$
11,265
$
35,697
$
34,521
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
September 30,
2019
December 31,
2018
(unaudited)
Assets
Cash, cash equivalents and investment
securities
$
683,847
$
473,520
Accounts receivable, net
30,804
26,090
Interest and other receivables
1,465
1,699
Inventory
4,846
4,070
Prepaid expenses
21,368
20,727
Total current assets
742,330
526,106
Property and equipment, net
3,249
3,309
Operating lease right-of-use assets
9,959
—
Intangible assets, net
2,954
4,062
Restricted cash
4,787
4,826
Other assets
2,307
1,899
Total assets
$
765,586
$
540,202
Liabilities and stockholders’
equity
Accounts payable
$
3,444
$
3,167
Accrued liabilities
64,300
56,398
Total current liabilities
67,744
59,565
Operating lease liabilities
6,379
—
Other long-term liabilities
2,174
1,558
Total liabilities
76,297
61,123
Total stockholders’ equity
689,289
479,079
Total liabilities and stockholders’
equity
$
765,586
$
540,202
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191030005933/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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