- Full year 2022 net sales of $517.2 million,
an increase of 7% over 2021
- Prescription Drug User Fee Act (PDUFA) action
date set for March 12, 2023, for trofinetide for the treatment of
Rett syndrome
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its
financial results for the fourth quarter and full year ended
December 31, 2022.
NUPLAZID® delivered net sales of $136.5 million in the fourth
quarter of 2022 and $517.2 million for the full year. The
improvement was mainly driven by an increase in demand in the
long-term care channel and retention of continuing patients across
all channels. Overall demand in 2022 was relatively steady compared
to the previous year.
“We are poised for a transformative year in 2023. Our
increasingly profitable NUPLAZID franchise supports future growth
opportunities, including trofinetide - which has the potential to
become our second marketed product - as well as the development of
our pipeline,” said Steve Davis, Chief Executive Officer. “Last
year we submitted our New Drug Application for trofinetide for the
treatment of Rett syndrome and we are eager to get to our PDUFA
action date of March 12, 2023. Importantly, we also advanced our
Phase 3 negative symptoms of schizophrenia program and introduced
ACP-204, a new molecule that we plan to evaluate in patients with
Alzheimer’s disease psychosis later this year.”
Company Operational, Scientific, and Regulatory
Updates
- Trofinetide New Drug Application (NDA) for the treatment of
Rett syndrome has an assigned PDUFA action date of March 12,
2023.
- Two large, retrospective analyses of Medicare patients were
published in 2022, the first in the American Journal of Psychiatry1
and the second in the journal, Drug Safety2. Both of these analyses
found a lower mortality risk in patients with Parkinson’s disease
psychosis (PDP) treated with NUPLAZID (pimavanserin) when compared
to other atypical antipsychotics over the first 180 days and first
12 months, respectively.
- Another large, retrospective analysis of Medicare patients
recently published in The Journal of Medical Economics3 found
health care resource utilization patterns, such as hospitalizations
and ER visits, were lower among patients with PDP treated with
NUPLAZID (pimavanserin) when compared to other atypical
antipsychotics over 12 months.
- Enrollment is expected to be completed for ADVANCE-2, a Phase 3
study evaluating pimavanserin for the negative symptoms of
schizophrenia, around mid-year 2023.
- Doug Williamson, M.D., was appointed as Executive Vice
President, Head of Research and Development in January 2023. Dr.
Williamson succeeded Dr. Srdjan (Serge) Stankovic who retired at
the end of 2022.
Financial Results
Revenue
Net sales of NUPLAZID® (pimavanserin) were $136.5 million for
the three months ended December 31, 2022, an increase of 4% as
compared to $130.8 million reported for the three months ended
December 31, 2021. For the years ended December 31, 2022 and 2021,
Acadia reported net product sales of $517.2 million and $484.1
million, respectively, an increase of 7% year-over-year.
Research and Development
Research and development expenses for the three months ended
December 31, 2022 were $75.7 million, compared to $67.1 million for
the same period of 2021. For the years ended December 31, 2022 and
2021, research and development expenses were $361.6 million and
$239.4 million, respectively. The increase in research and
development expenses during 2022 was primarily related to a $60
million upfront payment for a collaboration with Stoke
Therapeutics, a $10 million milestone payment to our partner,
Neuren Pharmaceuticals, upon acceptance of the trofinetide NDA
filing, as well as increased costs of manufacturing activities for
trofinetide, and the development of early-stage programs, including
additional business development activity.
Selling, General and Administrative
Selling, general and administrative expenses for the three
months ended December 31, 2022 were $104.4 million, compared to
$105.8 million for the same period of 2021. For the years ended
December 31, 2022 and 2021, selling, general and administrative
expenses were $369.1 million and $396.0 million, respectively. The
decrease was related to the continued reduction and optimization of
commercial spend related to NUPLAZID, leading to a reduction in
overall advertising and promotional costs, offset by investments in
preparing for the launch of trofinetide.
Net Loss
For the fourth quarter of 2022, Acadia reported a net loss of
$41.7 million, or $0.26 per common share, compared to a net loss of
$43.1 million, or $0.27 per common share, for the same period in
2021. The net losses for the fourth quarters of 2022 and 2021
included $14.4 million and $12.9 million, respectively, of non-cash
stock-based compensation expense. For the year ended December 31,
2022, Acadia reported a net loss of $216.0 million, or $1.34 per
common share, compared to a net loss of $167.9 million, or $1.05
per common share, for the same period in 2021. The net losses for
the years ended December 31, 2022 and 2021 included $68.2 million
and $63.6 million, respectively, of non-cash stock-based
compensation expense.
Cash and Investments
At December 31, 2022, Acadia’s cash, cash equivalents, and
investment securities totaled $416.8 million, compared to $520.7
million at December 31, 2021.
2023 Financial Guidance
For the full year 2023, the Company expects:
- Net NUPLAZID sales in the range of $520 to $550 million.
- On a GAAP basis, R&D expense in the range of $235 to $255
million, which includes approximately $20 million of stock-based
compensation expense.
- On a GAAP basis, SG&A expense in the range of $360 to $380
million, 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 April 3, 2023.
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 as a potential
treatment for the negative symptoms of schizophrenia.
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, Alzheimer’s disease psychosis and
neuropsychiatric symptoms in central nervous system disorders. For
more information, visit us at www.acadia.com and follow us on
LinkedIn and Twitter.
About Trofinetide
Trofinetide is an investigational drug. It is a synthetic analog
of the tripeptide glycine-proline-glutamate (GPE), a product of the
naturally occurring cleavage of insulin-like growth factor 1.
Trofinetide is thought to enhance neuronal synaptic function and
morphology, supporting its potential role in treating Rett
syndrome. This hypothesis is supported by findings from studies of
GPE and trofinetide in a Mecp2 mouse model of Rett syndrome, in
which increased branching of the dendrites that form synapses and
synaptic plasticity signals were observed.
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 regarding the
timing of future events. 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 risks and uncertainties inherent in
drug development, approval and commercialization. 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.
References
1Mosholder AD, Ma Y, Akhtar S, et al. Mortality among
Parkinson’s disease patients treated with pimavanserin or atypical
antipsychotics: an observational study in Medicare beneficiaries.
Am J Psychiatry. 2022;179(8):553‐561.
2Layton JB, Forns J, McQuay LJ, et al. Mortality in patients
with Parkinson’s disease‐related psychosis treated with
pimavanserin compared with other atypical antipsychotics: a cohort
study. Drug Safety. 2023;46(2):195-208.
3Rajagopalan K, Rashid N, Kumar S, and Doshi D. Health care
resource utilization patterns among patients with Parkinson’s
disease psychosis: analysis of Medicare beneficiaries treated with
Pimavanserin or other-atypical antipsychotics. J Med Econ.
2023;26(1):34-42.
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(in thousands, except per share
amounts)
(Unaudited)
Three Months Ended December
31,
Years Ended December
31,
2022
2021
2022
2021
Revenues
Product sales, net
$
136,490
$
130,758
$
517,235
$
484,145
Total revenues
136,490
130,758
517,235
484,145
Operating expenses
Cost of product sales, license fees and
royalties (1)
2,413
2,561
10,166
19,141
Research and development (1)
75,738
67,084
361,575
239,415
Selling, general and administrative
(1)
104,402
105,770
369,090
396,028
Total operating expenses
182,553
175,415
740,831
654,584
Loss from operations
(46,063
)
(44,657
)
(223,596
)
(170,439
)
Interest income, net
3,630
129
6,610
591
Other income
1,543
1,623
3,542
2,329
Loss before income taxes
(40,890
)
(42,905
)
(213,444
)
(167,519
)
Income tax expense
835
189
2,531
351
Net loss
$
(41,725
)
$
(43,094
)
$
(215,975
)
$
(167,870
)
Net loss per common share, basic and
diluted
$
(0.26
)
$
(0.27
)
$
(1.34
)
$
(1.05
)
Weighted average common shares
outstanding, basic and diluted
161,988
160,866
161,683
160,493
(1) Includes the following share-based
compensation expenses
Cost of product sales, license fees and
royalties
$
93
$
261
$
1,106
$
1,286
Research and development
$
3,432
$
4,644
$
22,580
$
21,969
Selling, general and administrative
$
10,889
$
7,975
$
44,515
$
40,360
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
December 31, 2022
December 31, 2021
(unaudited)
Assets
Cash, cash equivalents and investment
securities
$
416,823
$
520,706
Accounts receivable, net
62,195
64,366
Interest and other receivables
885
978
Inventory
6,636
7,881
Prepaid expenses
21,398
23,892
Total current assets
507,937
617,823
Property and equipment, net
6,021
8,047
Operating lease right-of-use assets
55,573
58,268
Restricted cash
5,770
5,770
Long-term inventory
4,924
6,217
Other assets
7,587
3,997
Total assets
$
587,812
$
700,122
Liabilities and stockholders’
equity
Accounts payable
$
12,746
$
6,876
Accrued liabilities
112,884
89,192
Total current liabilities
125,630
96,068
Operating lease liabilities
52,695
56,126
Long-term liabilities
9,074
7,034
Total liabilities
187,399
159,228
Total stockholders’ equity
400,413
540,894
Total liabilities and stockholders’
equity
$
587,812
$
700,122
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230227005643/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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