- 2Q21 net sales of $115.2 million, a 5%
increase over 2Q20
- Fiscal year 2021 revenue guidance reduced to
$480 to $515 million
- Type A meeting held with FDA regarding DRP;
Acadia will continue discussion with FDA in another meeting later
this year
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its
financial results for the second quarter ended June 30, 2021.
“NUPLAZID performed well in the second quarter of 2021,
highlighted by our ability to drive growth while still navigating
the continued impact from the pandemic,” said Steve Davis, Chief
Executive Officer. “We recently completed a Type A meeting with the
FDA regarding pimavanserin for dementia-related psychosis and plan
to continue our engagement in another meeting with the FDA later
this year to further discuss potential paths to approval. Looking
ahead, we plan to announce top-line results by the end of the year
from our Phase 3 study in Rett syndrome and our proof-of-concept
Phase 2 study in postoperative pain.”
Company Updates
- Completed a Type A End of Review meeting regarding the FDA’s
complete response letter (CRL) for the sNDA for pimavanserin for
the treatment of hallucinations and delusions associated with
dementia-related psychosis (DRP). At the meeting, the FDA
reiterated their stated position in the CRL, that pimavanserin
should be studied by individual subgroups of dementia, and advised
that the best path forward is to conduct an additional clinical
study in each of the subgroups for which we seek approval. However,
the FDA also indicated that they are open to having another meeting
to discuss additional analyses from the HARMONY and -019 studies in
support of a potential resubmission without an additional clinical
study.
- The New England Journal of Medicine published the positive
results from the Phase 3 HARMONY study evaluating pimavanserin in
patients with dementia-related psychosis in July 2021.
- Results from an open-label extension safety study with
pimavanserin supporting sustained response in Parkinson’s disease
psychosis patients was published online in the June 2021 issue of
Parkinsonism and Related Disorders.
- Completed enrollment of the Phase 3 LAVENDER study evaluating
trofinetide for the treatment of Rett syndrome, with top-line
results expected in the fourth quarter of 2021.
- Initiated a Phase 2 study of ACP-044 for pain associated with
osteoarthritis in the second quarter of 2021.
- Top-line results from the Phase 2 study of ACP-044 for the
treatment of postoperative pain following bunionectomy surgery are
expected in the fourth quarter of 2021.
Financial Results
Revenue
Net sales of NUPLAZID® (pimavanserin) were $115.2 million for
the three months ended June 30, 2021, an increase of 5% as compared
to $110.1 million reported for the three months ended June 30,
2020. For the six months ended June 30, 2021 and 2020, Acadia
reported net product sales of $221.8 million and $200.2 million,
respectively.
Research and Development
Research and development expenses for the three months ended
June 30, 2021 were $56.9 million, compared to $64.3 million for the
same period of 2020. The decrease in the three month period ending
June 2021 compared to June 2020 was largely due to the cessation of
development costs of pimavanserin for major depressive disorder and
lower development costs for DRP. For the six months ended June 30,
2021 and 2020, research and development expenses were $113.9
million and $136.9 million. The decrease for the six month period
ending June 2021 compared to June 2020 was largely due to lower
development costs of pimavanserin and trofinetide, partially offset
by increased development costs for ACP-044.
Selling, General and Administrative
Selling, general and administrative expenses for the three
months ended June 30, 2021 were $96.8 million, compared to $84.3
million for the same period of 2020. The increase for the three
month period ending June 2021 compared to June 2020 was primarily
due to increased costs associated with advertising and promotion,
corporate support functions and stock-based compensation. For the
six months ended June 30, 2021 and 2020, selling, general and
administrative expenses were $208.5 million and $186.3 million,
respectively. The increase for the six month period ending June
2021 compared to June 2020 was primarily due to increased costs
associated with advertising, promotion and preparations for the
potential DRP launch.
Net Loss
For the three months ended June 30, 2021, Acadia reported a net
loss of $43.9 million, or $0.27 per common share, compared to a net
loss of $42.1 million, or $0.27 per common share, for the same
period in 2020. The net losses for the three months ended June 30,
2021 and 2020 included $22.0 million and $19.5 million,
respectively, of non-cash stock-based compensation expense. For the
six months ended June 30, 2021, Acadia reported a net loss of
$110.3 million, or $0.69 per common share, compared to a net loss
of $130.2 million, or $0.83 per common share, for the same period
in 2020. The net losses for the six months ended June 30, 2021 and
2020 included $35.2 million and $41.9 million, respectively, of
non-cash stock-based compensation expense.
Cash and Investments
At June 30, 2021, Acadia’s cash, cash equivalents, and
investment securities totaled $556.9 million, compared to $632.0
million at December 31, 2020.
2021 Financial Guidance
- NUPLAZID net sales guidance is decreased to $480 to $515
million from the previous range of $510 to $550 million as a result
of the continued impact of the pandemic with fewer Parkinson’s
disease patient office visits and lower occupancy rates at
long-term care facilities, as well as a revised gross-to-net
expectation of approximately 20% compared to prior expectation of
high teens.
- GAAP R&D is decreased to $250 to $270 million from the
previous range of $280 to $300 million. Current R&D guidance
includes approximately $25 million of stock-based compensation
expense.
- GAAP SG&A guidance is reiterated at $385 to $415 million.
Current SG&A guidance includes approximately $50 million of
stock-based compensation expense.
Conference Call and Webcast
Information
Acadia management will review its second 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 8065926). A telephone replay of the conference call may be
accessed through August 18, 2021 by dialing 855-859-2056 for
callers in the United States or Canada and 404-537-3406 for
international callers (reference passcode 8065926). 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 September 1, 2021.
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 dementia-related 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. 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 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 2021 NUPLAZID net sales for Parkinson’s disease
psychosis 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 June
30,
Six Months Ended June
30,
2021
2020
2021
2020
Revenues
Product sales, net
$
115,221
$
110,103
$
221,775
$
200,171
Total revenues
115,221
110,103
221,775
200,171
Operating expenses
Cost of product sales, license fees and
royalties (1)
5,206
5,474
9,898
10,448
Research and development (1)
56,935
64,295
113,908
136,931
Selling, general and administrative
(1)
96,789
84,344
208,450
186,317
Total operating expenses
158,930
154,113
332,256
333,696
Loss from operations
(43,709
)
(44,010
)
(110,481
)
(133,525
)
Interest income, net
133
1,825
333
4,814
Other income (expense)
178
437
323
(1,060
)
Loss before income taxes
(43,398
)
(41,748
)
(109,825
)
(129,771
)
Income tax expense
473
393
494
393
Net loss
$
(43,871
)
$
(42,141
)
$
(110,319
)
$
(130,164
)
Net loss per common share, basic and
diluted
$
(0.27
)
$
(0.27
)
$
(0.69
)
$
(0.83
)
Weighted average common shares
outstanding, basic and diluted
160,421
156,535
160,217
155,951
(1) Includes the following stock-based
compensation expense
Cost of product sales, license fees and
royalties
$
423
$
743
$
586
$
1,592
Research and development
$
7,319
$
7,235
$
12,149
$
15,692
Selling, general and administrative
$
14,263
$
11,529
$
22,454
$
24,571
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
June 30,
2021
December 31,
2020
(unaudited)
Assets
Cash, cash equivalents and investment
securities
$
556,918
$
631,958
Accounts receivable, net
51,367
48,247
Interest and other receivables
453
2,035
Inventory
10,786
9,682
Prepaid expenses
26,206
25,694
Total current assets
645,730
717,616
Property and equipment, net
9,197
9,161
Operating lease right-of-use assets
61,371
47,283
Intangible assets, net
369
1,108
Restricted cash
5,770
5,770
Other assets
1,992
1,678
Total assets
$
724,429
$
782,616
Liabilities and stockholders’
equity
Accounts payable
$
9,065
$
8,493
Accrued liabilities
86,263
97,474
Total current liabilities
95,328
105,967
Operating lease liabilities
59,134
44,460
Other long-term liabilities
5,129
5,180
Total liabilities
159,591
155,607
Total stockholders’ equity
564,838
627,009
Total liabilities and stockholders’
equity
$
724,429
$
782,616
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210804006002/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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