- 1Q21 net sales of $106.6 million, an 18%
increase over 1Q20
- Reiterating FY21 net sales guidance of $510
to $550 million
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its
financial results for the first quarter ended March 31, 2021.
“NUPLAZID delivered strong year-over-year performance in the
first quarter of 2021. Looking ahead, we see positive signs in the
Parkinson’s disease psychosis market supporting revenue growth for
the remainder of the year as we anticipate continued improvements
in the conditions related to the pandemic,” said Steve Davis, Chief
Executive Officer. “Furthermore, we look forward to a Type A
meeting with the FDA to discuss an approval path for pimavanserin
in dementia-related psychosis and we continue to advance our two
Phase 3 programs for Rett syndrome and the negative symptoms of
schizophrenia, as well as our Phase 2 pain program and earlier
pipeline opportunities.”
Company Updates
- The Company received a Complete Response Letter (CRL) from the
U.S. Food and Drug Administration (FDA) regarding its supplemental
New Drug Application (sNDA) for NUPLAZID® (pimavanserin) for the
treatment of hallucinations and delusions associated with
dementia-related psychosis (DRP). The Company plans to conduct a
Type A meeting with the FDA to discuss the CRL and potential next
steps to support an approval.
- Top-line results from the Phase 3 LAVENDER study evaluating
trofinetide for the treatment of Rett syndrome are expected in the
fourth quarter of 2021.
- A Phase 2 study was initiated evaluating ACP-044, a novel,
first-in-class, orally administered, non-opioid analgesic for the
treatment of postoperative pain following bunionectomy surgery in
March 2021.
- A Phase 2 study evaluating ACP-044 for the treatment of pain
associated with osteoarthritis is expected to commence in the
second quarter of 2021.
Financial Results
Revenue
Net sales of NUPLAZID (pimavanserin) were $106.6 million for the
three months ended March 31, 2021, an increase of 18% as compared
to $90.1 million reported for the three months ended March 31,
2020.
Research and Development
Research and development expenses for the three months ended
March 31, 2021 were $57.0 million, compared to $72.6 million for
the same period of 2020. This decrease was primarily due to the
$10.0 million upfront payment to Vanderbilt University for the M1
PAM program incurred during the three months ended March 31, 2020
and decreased development costs associated with pimavanserin for
major depressive disorder.
Selling, General and Administrative
Selling, general and administrative expenses for the three
months ended March 31, 2021 were $111.7 million, compared to $102.0
million for the same period of 2020. This increase was primarily
due to increased costs associated with preparations for the
potential DRP launch, partially offset by a decrease in stock-based
compensation expense.
Net Loss
For the three months ended March 31, 2021, Acadia reported a net
loss of $66.4 million, or $0.42 per common share, compared to a net
loss of $88.0 million, or $0.57 per common share, for the same
period in 2020. The net losses for the three months ended March 31,
2021 and 2020 included $13.2 million and $22.3 million,
respectively, of non-cash stock-based compensation expense.
Cash and Investments
At March 31, 2021, Acadia’s cash, cash equivalents, and
investment securities totaled $577.8 million, compared to $632.0
million at December 31, 2020.
2021 Financial Guidance
- Acadia is reiterating its NUPLAZID net sales guidance of $510
to $550 million.
- GAAP R&D guidance is decreased to $280 to $300 million from
the previous range of $300 to $320 million. Current R&D
guidance includes approximately $25 million of stock-based
compensation expense.
- GAAP SG&A guidance is decreased to $385 to $415 million
from the previous range of $560 to $590 million. Previous guidance
included additional investments associated with the potential DRP
launch in 2021 and updated guidance reflects a reduction in these
expenses. Current SG&A guidance includes approximately $50
million of stock-based compensation expense.
Conference Call and Webcast
Information
Acadia management will review its first quarter financial
results and operations via conference call and webcast today at
5:00 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 4568937). A telephone replay of the conference call may be
accessed through May 19, 2021 by dialing 855-859-2056 for callers
in the United States or Canada and 404-537-3406 for international
callers (reference passcode 4568937). 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 2,
2021.
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 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. 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, and
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; and guidance
for full-year 2021 NUPLAZID net sales for Parkinson’s disease
psychosis only 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 2021, 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, 2020 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,
2021
2020
Revenues
Product sales, net
$
106,554
$
90,068
Total revenues
106,554
90,068
Operating expenses
Cost of product sales, license fees and
royalties (1)
4,692
4,974
Research and development (1)
56,973
72,636
Selling, general and administrative
(1)
111,661
101,973
Total operating expenses
173,326
179,583
Loss from operations
(66,772
)
(89,515
)
Interest income, net
200
2,989
Other income (expense)
145
(1,497
)
Loss before income taxes
(66,427
)
(88,023
)
Income tax expense
21
—
Net loss
$
(66,448
)
$
(88,023
)
Net loss per common share, basic and
diluted
$
(0.42
)
$
(0.57
)
Weighted average common shares
outstanding, basic and diluted
160,011
155,368
(1) Includes the following stock-based
compensation expense
Cost of product sales, license fees and
royalties
$
163
$
849
Research and development
$
4,830
$
8,457
Selling, general and administrative
$
8,191
$
13,042
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
March 31, 2021
December 31,
2020
(unaudited)
Assets
Cash, cash equivalents and investment
securities
$
577,768
$
631,958
Accounts receivable, net
56,832
48,247
Interest and other receivables
558
2,035
Inventory
10,311
9,682
Prepaid expenses
28,515
25,694
Total current assets
673,984
717,616
Property and equipment, net
9,757
9,161
Operating lease right-of-use assets
63,111
47,283
Intangible assets, net
738
1,108
Restricted cash
5,770
5,770
Other assets
1,813
1,678
Total assets
$
755,173
$
782,616
Liabilities and stockholders’
equity
Accounts payable
$
8,849
$
8,493
Accrued liabilities
100,524
97,474
Total current liabilities
109,373
105,967
Operating lease liabilities
60,581
44,460
Other long-term liabilities
3,613
5,180
Total liabilities
173,567
155,607
Total stockholders’ equity
581,606
627,009
Total liabilities and stockholders’
equity
$
755,173
$
782,616
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210505006004/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
Acadia Pharmaceuticals (NASDAQ:ACAD)
Historical Stock Chart
From Mar 2024 to Apr 2024
Acadia Pharmaceuticals (NASDAQ:ACAD)
Historical Stock Chart
From Apr 2023 to Apr 2024