- 2Q22 net sales of $134.6 million, a 17%
increase over 2Q21
- NDA submitted for trofinetide for the
treatment of Rett syndrome
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its
financial results for the second quarter ended June 30, 2022.
“In the second quarter of 2022, NUPLAZID net sales increased 17%
year-over-year,” said Steve Davis, Chief Executive Officer. “Last
month, we submitted an NDA for our second potential commercial
product, trofinetide which would be the first FDA-approved
treatment for Rett syndrome. Together with a strong balance sheet,
our late and early-stage portfolio, including our Phase 3 program
for pimavanserin for the treatment of the negative symptoms of
schizophrenia, and a continued focus on strategic business
development, we are well-positioned for long-term growth.”
Company Updates
- Submitted a New Drug Application (NDA) to the FDA for
trofinetide as a potential treatment for Rett syndrome in adults
and pediatric patients two years of age and older. Trofinetide
could be Acadia’s second commercial product and the first and only
approved treatment in the U.S. for Rett syndrome.
- Received a Complete Response Letter from the FDA for the
resubmitted supplemental NDA for pimavanserin for the treatment of
hallucinations and delusions associated with Alzheimer’s disease
psychosis (ADP).
- Presented two late-breaker posters at the American Society of
Clinical Psychopharmacology (ASCP) Annual Meeting in June 2022,
adding to the growing body of evidence of safety of pimavanserin in
the treatment of Parkinson’s disease psychosis.
- Acadia is developing an internally discovered new molecule,
ACP-204, currently in Phase 1. ACP-204 builds upon the learnings of
pimavanserin in the treatment of neuropsychiatric symptoms.
- Acadia is discontinuing the development of ACP-044 in acute and
chronic pain, based on evaluation of the final data set from a
previously completed Phase 2 bunionectomy study, and ACP-319 an M1
PAM modulator, based on a profile that does not support advancement
to Phase 2.
Financial Results
Revenue Net sales of NUPLAZID® (pimavanserin) were $134.6
million for the three months ended June 30, 2022, an increase of
17% as compared to $115.2 million reported for the three months
ended June 30, 2021. For the six months ended June 30, 2022 and
2021, Acadia reported net product sales of $250.0 million and
$221.8 million, respectively.
Research and Development Research and development expenses for
the three months ended June 30, 2022 were $75.6 million, compared
to $56.9 million for the same period of 2021. The increase was
primarily due to increased costs of our development activities for
ACP-044, ACP-319 and other early stage programs. For the six months
ended June 30, 2022 and 2021, research and development expenses
were $204.5 million and $113.9 million. The increase was mainly due
to the $60 million upfront payment made to Stoke Therapeutics for
the license and collaboration agreement in 2022.
Selling, General and Administrative Selling, general and
administrative expenses for the three months ended June 30, 2022
were $89.9 million, compared to $96.8 million for the same period
of 2021. For the six months ended June 30, 2022 and 2021, selling,
general and administrative expenses were $186.6 million and $208.5
million, respectively. The decrease in both periods was primarily
due to decreased advertising and promotional costs and personnel
expenses.
Net Loss For the three months ended June 30, 2022, Acadia
reported a net loss of $34.0 million, or $0.21 per common share,
compared to a net loss of $43.9 million, or $0.27 per common share,
for the same period in 2021. The net losses for the three months
ended June 30, 2022 and 2021 included $20.5 million and $22.0
million, respectively, of non-cash stock-based compensation
expense. For the six months ended June 30, 2022, Acadia reported a
net loss of $147.1 million, or $0.91 per common share, compared to
a net loss of $110.3 million, or $0.69 per common share, for the
same period in 2021. The increase was mainly due to the $60 million
upfront payment made to Stoke Therapeutics for the license and
collaboration agreement in 2022. The net losses for the six months
ended June 30, 2022 and 2021 included $35.5 million and $35.2
million, respectively, of non-cash stock-based compensation
expense.
Cash and Investments At June 30, 2022, Acadia’s cash, cash
equivalents, and investment securities totaled $436.4 million,
compared to $520.7 million at December 31, 2021.
2022 Financial Guidance
- NUPLAZID net sales guidance is updated to $510 to $540 million
from the previous range of $510 to $560 million.
- GAAP R&D guidance is updated to $340 to $360 million from
$355 to $375 million, which includes approximately $25 million of
stock-based compensation expense.
- GAAP SG&A guidance of $360 to $380 million is reiterated,
which includes approximately $45 million of stock-based
compensation expense.
Conference Call and Webcast Information The conference call may
be accessed by registering for the call here. Once registered,
participants will receive an email with the dial-in number and
unique PIN number to use for accessing the call. The registration
link will also be available on Acadia’s website, www.acadia.com
under the investors section and will be archived there until
September 5, 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. 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 clinical-stage development efforts are focused on
treating the negative symptoms of schizophrenia, Rett syndrome and
neuropsychiatric symptoms in central nervous system disorders. For
more information, visit us at www.acadia.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 June
30,
Six Months Ended June
30,
2022
2021
2022
2021
Revenues
Product sales, net
$
134,563
$
115,221
$
250,031
$
221,775
Total revenues
134,563
115,221
250,031
221,775
Operating expenses
Cost of product sales, license fees and
royalties (1)
2,667
5,206
5,617
9,898
Research and development (1)
75,646
56,935
204,501
113,908
Selling, general and administrative
(1)
89,901
96,789
186,580
208,450
Total operating expenses
168,214
158,930
396,698
332,256
Loss from operations
(33,651
)
(43,709
)
(146,667
)
(110,481
)
Interest income, net
580
133
685
333
Other (loss) income
(497
)
178
(157
)
323
Loss before income taxes
(33,568
)
(43,398
)
(146,139
)
(109,825
)
Income tax expense
443
473
928
494
Net loss
$
(34,011
)
$
(43,871
)
$
(147,067
)
$
(110,319
)
Net loss per common share, basic and
diluted
$
(0.21
)
$
(0.27
)
$
(0.91
)
$
(0.69
)
Weighted average common shares
outstanding, basic and diluted
161,654
160,421
161,443
160,217
(1) Includes the following stock-based
compensation expense
Cost of product sales, license fees and
royalties
$
346
$
423
$
669
$
586
Research and development
$
7,232
$
7,319
$
12,696
$
12,149
Selling, general and administrative
$
12,934
$
14,263
$
22,110
$
22,454
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
June 30, 2022
December 31, 2021
(unaudited)
Assets
Cash, cash equivalents and investment
securities
$
436,351
$
520,706
Accounts receivable, net
67,953
64,366
Interest and other receivables
936
978
Inventory
6,327
7,881
Prepaid expenses
20,952
23,892
Total current assets
532,519
617,823
Property and equipment, net
7,016
8,047
Operating lease right-of-use assets
57,417
58,268
Restricted cash
5,770
5,770
Long-term inventory
6,205
6,217
Other assets
3,839
3,997
Total assets
$
612,766
$
700,122
Liabilities and stockholders’
equity
Accounts payable
$
11,854
$
6,876
Accrued liabilities
105,827
89,192
Total current liabilities
117,681
96,068
Operating lease liabilities
54,693
56,126
Other long-term liabilities
5,544
7,034
Total liabilities
177,918
159,228
Total stockholders’ equity
434,848
540,894
Total liabilities and stockholders’
equity
$
612,766
$
700,122
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version on businesswire.com: https://www.businesswire.com/news/home/20220808005587/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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