- 1Q22 net sales of $115.5 million, an 8%
increase over 1Q21
- Reiterating FY22 net sales guidance of $510
to $560 million
- FDA Advisory Committee meeting to review sNDA
for pimavanserin for the treatment of ADP scheduled for June 17,
2022
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its
financial results for the first quarter ended March 31, 2022.
“NUPLAZID continued to deliver year over year growth in the
first quarter of 2022,” said Steve Davis, Chief Executive Officer.
“In the near term, we are focused on preparing for the upcoming
Advisory Committee meeting in connection with our resubmitted sNDA
for pimavanserin in Alzheimer’s disease psychosis. In addition, we
have aligned with the FDA on the contents of our upcoming NDA
submission for trofinetide in Rett syndrome and continue to enroll
patients in our ongoing Phase 3 study evaluating pimavanserin for
the negative symptoms of schizophrenia.”
Company Highlights
- The U.S. Food and Drug Administration (FDA) Advisory Committee
meeting is scheduled for June 17, 2022 to review the resubmission
of the supplemental New Drug Application (sNDA) for pimavanserin
for the treatment of hallucinations and delusions associated with
Alzheimer’s disease psychosis (ADP).
- The FDA is targeting an August 4, 2022 action date for the
resubmitted sNDA for pimavanserin for the treatment of ADP.
- Trofinetide for the treatment of Rett syndrome remains on track
for an NDA submission around mid-year 2022.
- Late-breaker oral presentation on the efficacy and safety data
from the Phase 3 Lavender study of trofinetide was presented at the
2022 American Academy of Neurology Annual Meeting (AAN) on April 5,
2022.
- Parag Meswani joined Acadia as Senior Vice President,
Trofinetide - Rare Disease Franchise to lead the trofinetide
commercial effort. In addition, Holly Valdiviez joined Acadia as
Senior Vice President, Head of Sales for NUPLAZID. Parag and Holly
have joined Acadia’s Executive Management Committee.
Financial Results
Revenue
Net sales of NUPLAZID (pimavanserin) were $115.5 million for the
three months ended March 31, 2022, an increase of 8% as compared to
$106.6 million reported for the three months ended March 31,
2021.
Research and Development
Research and development expenses for the three months ended
March 31, 2022 were $128.9 million, compared to $57.0 million for
the same period of 2021. This increase was primarily due to
expensing of the $60.0 million upfront payment made to Stoke
Therapeutics under the license and collaboration agreement made in
January 2022.
Selling, General and Administrative
Selling, general and administrative expenses for the three
months ended March 31, 2022 were $96.7 million, compared to $111.7
million for the same period of 2021. This decrease was primarily
due to decreased advertising and promotional costs and decreased
personnel expenses.
Net Loss
For the three months ended March 31, 2022, Acadia reported a net
loss of $113.1 million, or $0.70 per common share, compared to a
net loss of $66.4 million, or $0.42 per common share, for the same
period in 2021. This increase in net loss was primarily due to
expensing of the $60.0 million upfront payment made to Stoke
Therapeutics under the license and collaboration agreement made in
January 2022. The net losses for the three months ended March 31,
2022 and 2021 included $15.0 million and $13.2 million,
respectively, of non-cash stock-based compensation expense.
Cash and Investments
At March 31, 2022, Acadia’s cash, cash equivalents, and
investment securities totaled $446.0 million, compared to $520.7
million at December 31, 2021.
2022 Financial Guidance
Acadia is reiterating its previously provided guidance
ranges:
- NUPLAZID net sales guidance of $510 to $560 million.
- GAAP R&D guidance of $355 to $375 million, which includes
approximately $25 million of stock-based compensation expense.
- GAAP SG&A guidance of $360 to $380 million, which includes
approximately $45 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
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 6989476). A telephone replay of the conference call may be
accessed through May 19, 2022 by dialing 855-859-2056 for callers
in the United States or Canada and 404-537-3406 for international
callers (reference passcode 6989476). 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 1,
2022.
About NUPLAZID® (pimavanserin)
Pimavanserin is a selective serotonin inverse agonist and
antagonist preferentially targeting 5-HT2A receptors. These
receptors are thought to play an important role in neuropsychiatric
disorders. In vitro, pimavanserin demonstrated no appreciable
binding affinity for dopamine (including D2), histamine,
muscarinic, or adrenergic receptors. Pimavanserin was approved for
the treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis by the U.S. Food and Drug
Administration in April 2016 under the trade name NUPLAZID.
NUPLAZID is not approved for Alzheimer’s disease psychosis. In
addition, Acadia is developing pimavanserin in other
neuropsychiatric conditions.
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. Trofinetide is
thought to stimulate synaptic maturation and overcome the synaptic
and neuronal immaturities that are characteristic of Rett syndrome
pathophysiology. 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 shown to
inhibit the production of inflammatory cytokines, inhibit the
overactivation of microglia and astrocytes, and increase the amount
of available IGF-1 that can bind to IGF-1 receptors. Trofinetide
has been granted Fast Track Status and Orphan Drug Designation for
Rett syndrome and has also been granted Rare Pediatric Disease
(RPD) designation by the FDA.
About Acadia Pharmaceuticals
Acadia is advancing 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 treating psychosis in patients with dementia, the
negative symptoms of schizophrenia and Rett syndrome. Our
early-stage development efforts are focused on 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 and Twitter.
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 2022 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 2022, 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, 2021 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,
2022
2021
Revenues
Product sales, net
$
115,468
$
106,554
Total revenues
115,468
106,554
Operating expenses
Cost of product sales, license fees and
royalties (1)
2,950
4,692
Research and development (1)
128,855
56,973
Selling, general and administrative
(1)
96,679
111,661
Total operating expenses
228,484
173,326
Loss from operations
(113,016
)
(66,772
)
Interest income, net
105
200
Other income
340
145
Loss before income taxes
(112,571
)
(66,427
)
Income tax expense
485
21
Net loss
$
(113,056
)
$
(66,448
)
Net loss per common share, basic and
diluted
$
(0.70
)
$
(0.42
)
Weighted average common shares
outstanding, basic and diluted
161,231
160,011
(1) Includes the following stock-based
compensation expense
Cost of product sales, license fees and
royalties
$
323
$
163
Research and development
$
5,464
$
4,830
Selling, general and administrative
$
9,176
$
8,191
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
March 31,
2022
December 31,
2021
(unaudited)
Assets
Cash, cash equivalents and investment
securities
$
445,977
$
520,706
Accounts receivable, net
62,713
64,366
Interest and other receivables
769
978
Inventory
7,009
7,881
Prepaid expenses
25,755
23,892
Total current assets
542,223
617,823
Property and equipment, net
7,531
8,047
Operating lease right-of-use assets
58,186
58,268
Restricted cash
5,770
5,770
Long-term inventory
6,205
6,217
Other assets
4,336
3,997
Total assets
$
624,251
$
700,122
Liabilities and stockholders’
equity
Accounts payable
$
10,768
$
6,876
Accrued liabilities
108,835
89,192
Total current liabilities
119,603
96,068
Operating lease liabilities
55,478
56,126
Other long-term liabilities
4,373
7,034
Total liabilities
179,454
159,228
Total stockholders’ equity
444,797
540,894
Total liabilities and stockholders’
equity
$
624,251
$
700,122
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220504005888/en/
Media Contact: Acadia Pharmaceuticals Inc. Deb Kazenelson (818)
395-3043 media@acadia-pharm.com
Investor Contact: Acadia Pharmaceuticals Inc. Mark Johnson, CFA
(858) 261-2771 ir@acadia-pharm.com
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