- 3Q21 net sales of $131.6 million, a 9%
increase over 3Q20
- FDA meeting scheduled to discuss next steps
towards a resubmission of the pimavanserin sNDA
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its
financial results for the third quarter ended September 30,
2021.
“Our third-quarter results reflect volume growth across all
channels and our strong relative performance underscores our
commercial team’s ability to drive sales of NUPLAZID in a
challenging environment,” said Steve Davis, Chief Executive
Officer. “As we close out the year, we will meet with the FDA to
discuss additional analyses supporting a potential resubmission of
our sNDA for pimavanserin focused on specific subgroups of
dementia. In addition, we look forward to announcing results from
our ongoing Phase 3 LAVENDER study of trofinetide for the treatment
of Rett syndrome.”
Company Updates
- Scheduled meeting with the FDA to discuss additional analyses
supporting a potential resubmission of the pimavanserin sNDA
focused on specific subgroups of dementia. Acadia plans to provide
an update following this meeting around year-end.
- 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.
- Top-line results from the Phase 2 study of ACP-044 for the
treatment of postoperative pain following bunionectomy surgery are
expected in the first quarter of 2022.
- Three data presentations featuring new analyses of Medicare
claims data on dementia-related psychosis outcomes were presented
at the Psych Congress 2021 demonstrating the high unmet need in
dementia-related psychosis and providing further evidence of the
sub-optimal outcomes associated with the use of dopaminergic
atypical antipsychotic treatments in managing dementia-related
hallucinations and delusions, along with the related cost
burdens.
- A scientific presentation on pimavanserin for the treatment of
hallucinations and delusions in patients with Parkinson’s disease
dementia will be shared at the 14th Clinical Trials on Alzheimer’s
Disease (CTAD) conference.
- Brendan Teehan has been promoted to Executive Vice President,
Chief Operating Officer, Head of Commercial.
- Julie Fisher has been promoted to Senior Vice President,
Marketing & Commercial Strategy. Ms. Fisher will report to Mr.
Teehan and join the company’s Executive Management Committee.
Financial Results
Revenue
Net sales of NUPLAZID® (pimavanserin) were $131.6 million for
the three months ended September 30, 2021, an increase of 9% as
compared to $120.6 million reported for the three months ended
September 30, 2020. For the nine months ended September 30, 2021
and 2020, Acadia reported net product sales of $353.4 million and
$320.7 million, respectively.
Research and Development
Research and development expenses for the three months ended
September 30, 2021 were $58.6 million, compared to $120.1 million
for the same period of 2020. The decrease was largely due to
decreased costs associated with the upfront consideration and
transaction costs related to the acquisition of CerSci
Therapeutics. For the nine months ended September 30, 2021 and
2020, research and development expenses were $172.5 million and
$257.0 million. The decrease was largely due to the acquisition of
CerSci Therapeutics and reduced development costs for trofinetide
and the cessation of development of pimavanserin for major
depressive disorder, partially offset by increased costs of our
development activities for ACP-044.
Selling, General and Administrative
Selling, general and administrative expenses for the three
months ended September 30, 2021 were $81.7 million, compared to
$81.6 million for the same period of 2020. For the nine months
ended September 30, 2021 and 2020, selling, general and
administrative expenses were $290.1 million and $267.9 million,
respectively. The 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, 2021, Acadia reported a
net loss of $14.5 million, or $0.09 per common share, compared to a
net loss of $84.7 million, or $0.54 per common share, for the same
period in 2020. The net losses for the three months ended September
30, 2021 and 2020 included $15.5 million and $21.4 million,
respectively, of non-cash stock-based compensation expense. For the
nine months ended September 30, 2021, Acadia reported a net loss of
$124.8 million, or $0.78 per common share, compared to a net loss
of $214.8 million, or $1.37 per common share, for the same period
in 2020. The net losses for the nine months ended September 30,
2021 and 2020 included $50.7 million and $63.2 million,
respectively, of non-cash stock-based compensation expense.
Cash and Investments
At September 30, 2021, Acadia’s cash, cash equivalents, and
investment securities totaled $540.3 million, compared to $632.0
million at December 31, 2020.
2021 Financial Guidance
- NUPLAZID net sales guidance is narrowed to $480 to $500 million
from the previous range of $480 to $515 million.
- GAAP R&D is decreased to $230 to $245 million from the
previous range of $250 to $270 million. Current R&D guidance
includes approximately $25 million of stock-based compensation
expense.
- GAAP SG&A guidance is narrowed to $385 to $405 million from
the previous range of $385 to $415 million. Current SG&A
guidance includes approximately $45 million of stock-based
compensation expense.
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 9213599). A telephone replay of the conference call may be
accessed through November 22, 2021 by dialing 855-859-2056 for
callers in the United States or Canada and 404-537-3406 for
international callers (reference passcode 9213599). 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 6, 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 September
30,
Nine Months Ended September
30,
2021
2020
2021
2020
Revenues
Product sales, net
$
131,612
$
120,577
$
353,387
$
320,748
Total revenues
131,612
120,577
353,387
320,748
Operating expenses
Cost of product sales, license fees and
royalties (1)
6,682
4,801
16,580
15,249
Research and development (1)
58,565
120,083
172,473
257,014
Selling, general and administrative
(1)
81,666
81,592
290,116
267,909
Total operating expenses
146,913
206,476
479,169
540,172
Loss from operations
(15,301
)
(85,899
)
(125,782
)
(219,424
)
Interest income, net
129
1,242
462
6,056
Other income (expense)
383
(202
)
706
(1,262
)
Loss before income taxes
(14,789
)
(84,859
)
(124,614
)
(214,630
)
Income tax expense
(332
)
(199
)
162
194
Net loss
$
(14,457
)
$
(84,660
)
$
(124,776
)
$
(214,824
)
Net loss per common share, basic and
diluted
$
(0.09
)
$
(0.54
)
$
(0.78
)
$
(1.37
)
Weighted average common shares
outstanding, basic and diluted
160,663
158,129
159,651
156,683
(1) Includes the following stock-based
compensation expense
Cost of product sales, license fees and
royalties
$
439
$
495
$
1,025
$
2,087
Research and development
$
5,176
$
7,953
$
17,325
$
23,645
Selling, general and administrative
$
9,931
$
12,924
$
32,385
$
37,495
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
September 30,
2021
December 31,
2020
(unaudited)
Assets
Cash, cash equivalents and investment
securities
$
540,291
$
631,958
Accounts receivable, net
60,696
48,247
Interest and other receivables
972
2,035
Inventory
14,336
9,682
Prepaid expenses
24,622
25,694
Total current assets
640,917
717,616
Property and equipment, net
8,581
9,161
Operating lease right-of-use assets
60,032
47,283
Restricted cash
5,770
5,770
Other assets
2,373
2,786
Total assets
$
717,673
$
782,616
Liabilities and stockholders’
equity
Accounts payable
$
7,722
$
8,493
Accrued liabilities
80,496
97,474
Total current liabilities
88,218
105,967
Operating lease liabilities
57,677
44,460
Other long-term liabilities
4,823
5,180
Total liabilities
150,718
155,607
Total stockholders’ equity
566,955
627,009
Total liabilities and stockholders’
equity
$
717,673
$
782,616
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211108006012/en/
Media Contact: Acadia Pharmaceuticals Inc. Stephanie Fagan (858)
212-0534 media@acadia-pharm.com
Investor Contact: Acadia Pharmaceuticals Inc. Mark Johnson, CFA
(858) 261-2771 ir@acadia-pharm.com
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