- 1Q20 Net Sales of $90.1 Million, a 43%
Increase Over 1Q19
- On-track to submit supplemental NDA for
pimavanserin for the treatment of dementia-related psychosis (DRP)
this summer
- Announced worldwide license agreement and
collaboration with Vanderbilt University for new central nervous
system (CNS) therapeutic program
- 2020 revenue guidance reduced by
approximately 5% due to currently anticipated COVID-19 impact
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 quarter ended March 31, 2020.
“ACADIA entered 2020 with positive momentum. Successful
execution of our commercial efforts led to continued strong
performance of NUPLAZID® for Parkinson’s disease psychosis and our
plans remain on track for delivering a potential second indication
with pimavanserin for the treatment of DRP. We also continue to
invest in our late-stage pipeline and business development
opportunities to shape our mid and long-term growth strategy,” said
Steve Davis, ACADIA’s Chief Executive Officer. “Our results this
quarter reflect the dedication of our employees and I am proud of
our team’s commitment to the patients we serve while adapting to
the challenges of the global COVID-19 pandemic.”
Company Updates
- ACADIA completed a pre-sNDA meeting with the U.S. Food and Drug
Administration and is on-track to submit a supplemental NDA this
summer for pimavanserin as a potential breakthrough therapy for
DRP.
- The FDA granted Rare Pediatric Disease designation to
trofinetide for the treatment of Rett syndrome, a serious and rare
neurological disorder.
- ACADIA entered into an exclusive worldwide license agreement
and research collaboration with Vanderbilt University, adding an
early clinical stage program focused on positive allosteric
modulators (PAMs) of the M1 receptor to potentially treat a range
of CNS disorders.
Financial Results
Revenue
Net sales of NUPLAZID (pimavanserin) were $90.1 million for the
three months ended March 31, 2020, an increase of 43% as compared
to $63.0 million reported for the three months ended March 31,
2019.
Research and Development
Research and development expenses for the three months ended
March 31, 2020 were $72.6 million, compared to $52.9 million for
the same period of 2019. The increase was primarily due to an
upfront payment of $10.0 million to Vanderbilt University for the
M1 PAM program and increased development costs associated with
trofinetide.
Selling, General and Administrative
Selling, general and administrative expenses for the three
months ended March 31, 2020 were $102.0 million, compared to $93.1
million for the same period of 2019. The increase was largely due
to increased personnel and medical affairs costs.
Net Loss
For the three months ended March 31, 2020, ACADIA reported a net
loss of $88.0 million, or $0.57 per common share, compared to a net
loss of $85.3 million, or $0.59 per common share, for the same
period in 2019. The net losses for the three months ended March 31,
2020 and 2019 included $22.3 million and $19.9 million,
respectively, of non-cash stock-based compensation expense.
Cash and Investments
At March 31, 2020, ACADIA’s cash, cash equivalents, and
investment securities totaled $651.4 million, compared to $697.4
million at December 31, 2019.
2020 Financial Guidance
ACADIA is revising 2020 net sales and expense guidance to
reflect the currently anticipated impact of the COVID-19 pandemic.
ACADIA’s 2020 net sales guidance reflects annual revenue growth of
approximately 28% for NUPLAZID, at the mid-point of the range.
- NUPLAZID net sales guidance is decreased to $420 to $450
million from the previous range of $440 to $470 million.
- GAAP R&D guidance of $270 to $285 million is unchanged from
prior guidance.
- GAAP SG&A guidance is decreased to $425 to $445 million
from the previous range of $440 to $460 million.
- Non-cash stock-based compensation expense guidance of $90 to
$100 million is unchanged compared to prior guidance.
- 2020 year-end cash, cash equivalents, and investment securities
of $470 to $500 million is unchanged compared to prior
guidance.
Conference Call and Webcast
Information
ACADIA management will review its
first 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
United States or Canada and 443-877-4067 for international callers
(reference passcode 1974276). A telephone replay of the conference
call may be accessed through May 21, 2020 by dialing 855-859-2056
for callers in the United States or Canada and 404-537-3406 for
international callers (reference passcode 1974276). 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 June 4, 2020.
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, major depressive
disorder, the negative symptoms of schizophrenia, 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; unanticipated
impacts of COVID-19 on ACADIA’s business, including its commercial
sales operations, current and planned clinical trials, supply
chain, and guidance for full-year 2020 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 2020,
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, 2019 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 March
31,
2020
2019
Revenues
Product sales, net
$
90,068
$
62,959
Total revenues
90,068
62,959
Operating expenses
Cost of product sales, license fees and
royalties (1)
4,974
4,580
Research and development (1)
72,636
52,923
Selling, general and administrative
(1)
101,973
93,090
Total operating expenses
179,583
150,593
Loss from operations
(89,515
)
(87,634
)
Interest income, net
2,989
2,934
Other expense
(1,497
)
(229
)
Loss before income taxes
(88,023
)
(84,929
)
Income tax expense
—
375
Net loss
$
(88,023
)
$
(85,304
)
Net loss per common share, basic and
diluted
$
(0.57
)
$
(0.59
)
Weighted average common shares
outstanding, basic and diluted
155,368
143,981
(1) Includes the following stock-based
compensation expense
Cost of product sales, license fees and
royalties
$
849
$
995
Research and development
$
8,457
$
7,880
Selling, general and administrative
$
13,042
$
11,008
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands)
March 31, 2020
December 31, 2019
(unaudited)
Assets
Cash, cash equivalents and investment
securities
$
651,406
$
697,429
Accounts receivable, net
41,636
35,781
Interest and other receivables
2,935
2,093
Inventory
6,318
6,341
Prepaid expenses
22,126
18,606
Total current assets
724,421
760,250
Property and equipment, net
5,089
3,180
Operating lease right-of-use assets
8,613
9,524
Intangible assets, net
2,215
2,585
Restricted cash
5,770
4,787
Other assets
1,342
2,857
Total assets
$
747,450
$
783,183
Liabilities and stockholders’
equity
Accounts payable
$
6,623
$
7,222
Accrued liabilities
93,118
67,604
Total current liabilities
99,741
74,826
Operating lease liabilities
6,090
6,361
Other long-term liabilities
3,237
2,861
Total liabilities
109,068
84,048
Total stockholders’ equity
638,382
699,135
Total liabilities and stockholders’
equity
$
747,450
$
783,183
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200507005977/en/
Media Contact: ACADIA Pharmaceuticals Inc. Stephanie Fagan (858)
212-0534 media@acadia-pharm.com
Investor Contact: ACADIA Pharmaceuticals Inc. Mark Johnson, CFA
(858) 261-2771 ir@acadia-pharm.com
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