- 3Q20 Net Sales of $120.6 Million, a 27%
Increase Over 3Q19
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, 2020.
“This quarter we drove strong performance through the continued
growth of new prescribers with more patients benefitting from
NUPLAZID® treatment for their Parkinson’s disease psychosis and
remain on-track with our supplemental NDA for the treatment of
dementia-related psychosis with a PDUFA date of April 3, 2021,”
said Steve Davis, Acadia’s Chief Executive Officer. “We continue to
advance our late-stage programs and invest in new opportunities
through business development, highlighted by our recent acquisition
of CerSci Therapeutics which expands our clinical pipeline with an
innovative first-in-class, non-opioid, acute and chronic pain
program.”
Company Updates
- New clinical analyses across multiple studies of pimavanserin
are being presented at this week’s 13th Clinical Trials on
Alzheimer’s Disease (CTAD) meeting, including:
- Oral presentation by Dr. Clive Ballard, University of Exeter
Medical School: “Impact of Pimavanserin on Cognitive Measures in
Patients with Neurodegenerative Disease: Results from 4
Placebo-Controlled Clinical Studies.”
- Poster presentation by Dr. Daniel Weintraub, Perelman School of
Medicine at the University of Pennsylvania: “Impact of Pimavanserin
Treatment on Motor Function in Patients with Neurodegenerative
Disease: Results from 3 Clinical Studies.”
- In October, Acadia announced a partnership with The Lewy Body
Dementia Association (LBDA) on the release of a disease education
adaptation of the new documentary Robin’s Wish©. The film is
titled, “SPARK - Robin Williams and his Battle with Lewy Body
Dementia©,” and will be available to academic research institutions
and universities as part of educational programming for healthcare
professionals.
- In October, Acadia presented a poster titled “Healthcare
Resource Utilization and Associated Costs for Dementia Patients
with Psychosis: A Medicare Database Study,” at the Academy of
Managed Care Pharmacy’s (AMCP) Nexus conference, and received a
Silver ribbon based on its relevance, originality, quality, bias
and clarity of results.
- In August, Acadia acquired CerSci Therapeutics, a
clinical-stage biotechnology company with worldwide rights to a
portfolio of novel compounds for neurological conditions, including
non-opioid therapies for acute and chronic pain. Acadia plans to
initiate a Phase 2 program with the lead compound, ACP-044, in the
first half of 2021.
- Appointed Dr. Gudarz Davar as Executive Vice President and Head
of Research and Development, reporting to Serge Stankovic, M.D.,
M.S.P.H., President of Acadia.
- Elizabeth (Betsy) Garofalo, M.D. was appointed to the Acadia
Board of Directors.
Financial Results
Revenue Net sales of NUPLAZID (pimavanserin) were $120.6 million
for the three months ended September 30, 2020, an increase of 27%
as compared to $94.6 million reported for the three months ended
September 30, 2019. For the nine months ended September 30, 2020
and 2019, Acadia reported net product sales of $320.7 million and
$240.8 million, respectively.
Research and Development Research and development expenses for
the three months ended September 30, 2020 were $120.1 million,
compared to $62.6 million for the same period of 2019. This
increase was primarily due to $52.8 million in upfront
consideration and transaction expenses related to the acquisition
of CerSci Therapeutics. For the nine months ended September 30,
2020 and 2019, research and development expenses were $257.0
million and $182.9 million, respectively. This increase was
primarily due to the acquisition of CerSci Therapeutics and the
upfront payment to Vanderbilt University for the M1 PAM
program.
Selling, General and Administrative Selling, general and
administrative expenses for the three months ended September 30,
2020 were $81.6 million, compared to $72.7 million for the same
period of 2019. For the nine months ended September 30, 2020 and
2019, selling, general and administrative expenses were $267.9
million and $233.8 million, respectively. This increase was
primarily due to increased advertising and promotional costs as
well as an increase in personnel and related costs.
Net Loss For the three months ended September 30, 2020, Acadia
reported a net loss of $84.7 million, or $0.54 per common share,
compared to a net loss of $42.0 million, or $0.29 per common share,
for the same period in 2019. The net losses for the three months
ended September 30, 2020 and 2019 included $21.4 million and $22.0
million, respectively, of non-cash stock-based compensation
expense. For the nine months ended September 30, 2020, Acadia
reported a net loss of $214.8 million, or $1.37 per common share,
compared to a net loss of $182.2 million, or $1.26 per common
share, for the same period in 2019. The net losses for the nine
months ended September 30, 2020 and 2019 included $63.2 million and
$62.5 million, respectively, of non-cash stock-based compensation
expense.
Cash and Investments At September 30, 2020, Acadia’s cash, cash
equivalents, and investment securities totaled $644.4 million,
compared to $697.4 million at December 31, 2019.
2020 Financial Guidance
- Acadia reiterates its NUPLAZID net sales guidance of $430 to
$450 million.
- GAAP R&D guidance is increased to $325 to $340 million from
the previous range of $265 to $280 million, primarily as a result
of the $52.8 million upfront and transaction expenses associated
with the acquisition of CerSci Therapeutics.
- GAAP SG&A guidance is decreased to $385 to $400 million
from the previous range of $400 to $420 million.
- Non-cash stock-based compensation expense guidance is decreased
to $80 to $90 million from the previous range of $90 to $100
million.
- 2020 year-end cash, cash equivalents, and investment securities
guidance of $570 to $590 million is unchanged.
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 United
States or Canada and 443-877-4067 for international callers
(reference passcode 6266016). A telephone replay of the conference
call may be accessed through November 18, 2020 by dialing
855-859-2056 for callers in the United States or Canada and
404-537-3406 for international callers (reference passcode
6266016). 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 December 2, 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 any other neuropsychiatric disorders. 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 trailblazing
breakthroughs in neuroscience to elevate life through science. For
more than 25 years we have been working at the forefront of
healthcare to bring vital solutions to people who need them most.
We developed and commercialized the first and only approved therapy
for hallucinations and delusions associated with Parkinson’s
disease psychosis. Our late-stage development efforts are focused
on dementia-related psychosis, negative symptoms of schizophrenia
and Rett syndrome, and in early-stage clinical research we are
exploring novel approaches to pain management, cognition and
neuropsychiatric symptoms in central nervous system disorders. For
more information, visit us at www.acadia-pharm.com and follow us on
LinkedIn.
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, ACP-044 and the M1 PAM program; 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.
Copyright 2020 by Tiburon Sunrise, LLC
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,
2020
2019
2020
2019
Revenues
Product sales, net
$
120,577
$
94,586
$
320,748
$
240,750
Total revenues
120,577
94,586
320,748
240,750
Operating expenses
Cost of product sales, license fees and
royalties (1)
4,801
4,689
15,249
14,264
Research and development (1)
120,083
62,622
257,014
182,865
Selling, general and administrative
(1)
81,592
72,696
267,909
233,767
Total operating expenses
206,476
140,007
540,172
430,896
Loss from operations
(85,899
)
(45,421
)
(219,424
)
(190,146
)
Interest income, net
1,242
2,432
6,056
7,893
Other (expense) income
(202
)
747
(1,262
)
506
Loss before income taxes
(84,859
)
(42,242
)
(214,630
)
(181,747
)
Income tax expense
(199
)
(264
)
194
476
Net loss
$
(84,660
)
$
(41,978
)
$
(214,824
)
$
(182,223
)
Net loss per common share, basic and
diluted
$
(0.54
)
$
(0.29
)
$
(1.37
)
$
(1.26
)
Weighted average common shares
outstanding, basic and diluted
158,129
145,906
156,683
144,741
(1) Includes the following stock-based
compensation expense
Cost of product sales, license fees and
royalties
$
495
$
372
$
2,087
$
2,344
Research and development
$
7,953
$
8,680
$
23,645
$
24,461
Selling, general and administrative
$
12,924
$
12,971
$
37,495
$
35,697
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
September 30, 2020
December 31, 2019
(unaudited)
Assets
Cash, cash equivalents and investment
securities
$
644,441
$
697,429
Accounts receivable, net
46,344
35,781
Interest and other receivables
1,440
2,093
Inventory
7,979
6,341
Prepaid expenses
30,009
18,606
Total current assets
730,213
760,250
Property and equipment, net
8,427
3,180
Operating lease right-of-use assets
48,232
9,524
Intangible assets, net
1,477
2,585
Restricted cash
5,770
4,787
Other assets
1,545
2,857
Total assets
$
795,664
$
783,183
Liabilities and stockholders’
equity
Accounts payable
$
3,471
$
7,222
Accrued liabilities
88,385
67,604
Total current liabilities
91,856
74,826
Operating lease liabilities
45,343
6,361
Other long-term liabilities
3,598
2,861
Total liabilities
140,797
84,048
Total stockholders’ equity
654,867
699,135
Total liabilities and stockholders’
equity
$
795,664
$
783,183
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201104005622/en/
Media Contact: Acadia Pharmaceuticals Inc. Eric Endicott (858)
914-7161 media@acadia-pharm.com Investor Contact: Acadia
Pharmaceuticals Inc. Mark Johnson, CFA (858) 261-2771
ir@acadia-pharm.com
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