- 2023 total net product sales of $726.4
million, reflecting 40% revenue growth.
- Fourth quarter DAYBUE™ (trofinetide) net
product sales of $87.1 million and full year 2023 net product sales
of $177.2 million.
- Fourth quarter NUPLAZID® (pimavanserin) net
product sales of $143.9 million and full year 2023 net product
sales of $549.2 million.
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its
financial results for the fourth quarter and full year ended
December 31, 2023.
“2023 was a transformational year for Acadia that positioned us
for continued success in 2024 and beyond. We achieved 40% revenue
growth primarily driven by the launch of our second commercial
product, DAYBUE for the treatment of Rett syndrome, in addition to
6% growth in our established NUPLAZID franchise,” said Steve Davis,
Chief Executive Officer. “In the fourth quarter we significantly
advanced our pipeline with the initiation of a Phase 3 trial of
ACP-101 in Prader-Willi syndrome, as well as our seamless Phase 2 /
Phase 3 program for ACP-204 in Alzheimer’s disease psychosis. We
look forward to announcing top-line results from our ADVANCE-2
study of pimavanserin for the negative symptoms of schizophrenia by
the end of the first quarter.”
Company Updates
- Anticipated to report top-line results from ADVANCE-2, a Phase
3 study evaluating pimavanserin for the treatment of the negative
symptoms of schizophrenia, by the end of the first quarter.
- Initiated a pivotal Phase 3 COMPASS PWS study of ACP-101
(intranasal carbetocin) for the treatment of hyperphagia in
Prader-Willi syndrome in the fourth quarter of 2023.
- Initiated a Phase 2 clinical trial of ACP-204 for the treatment
of Alzheimer’s disease psychosis in the fourth quarter of
2023.
- Appointed Jennifer J. Rhodes as Executive Vice President, Chief
Legal Officer and Secretary and Kimberly J. Manhard as Senior Vice
President, Global Strategic Planning and Execution. Jennifer and
Kimberly both joined Acadia’s executive leadership team.
Financial Results
Revenues
Total revenues, comprised of net product sales from NUPLAZID and
DAYBUE, were $231.0 million for the fourth quarter of 2023 and
$726.4 million for the full year 2023.
Net product sales of NUPLAZID were $143.9 million for the fourth
quarter of 2023, an increase of 5% as compared to $136.5 million
for the fourth quarter of 2022. Net product sales of NUPLAZID were
$549.2 million for the full year 2023, an increase of 6% as
compared to $517.2 million for the full year 2022. The increase in
net product sales of NUPLAZID was due to growth in unit sales and a
higher average net selling price in 2023 compared to 2022.
Net product sales of DAYBUE were $87.1 million for the fourth
quarter of 2023 and $177.2 million for the full year 2023. During
2022, there were no net product sales of DAYBUE, which was launched
in April 2023.
Research and Development
Research and development expenses for the fourth quarter of 2023
were $66.7 million, compared to $75.7 million for the same period
of 2022. For the full years of 2023 and 2022, research and
development expenses were $351.6 million and $361.6 million,
respectively. The decrease in research and development expenses
during 2023 was mainly due to trofinetide commercial supply build
that was expensed prior to approval. There was a similar level of
clinical spend and business development investment year over
year.
Selling, General and Administrative
Selling, general and administrative expenses for the fourth
quarter of 2023 were $111.5 million, compared to $104.4 million for
the same period of 2022. For the full years of 2023 and 2022,
selling, general and administrative expenses were $406.6 million
and $369.1 million, respectively. The increase in selling, general
and administrative expenses was primarily due to increased
commercial costs associated with the DAYBUE launch, partially
offset by reductions in expenses associated with NUPLAZID.
Net Income (Loss)
For the fourth quarter of 2023, Acadia reported net income of
$45.8 million, or $0.28 per common share, compared to a net loss of
$41.7 million, or $0.26 per common share, for the same period in
2022. The net income and loss for the fourth quarters of 2023 and
2022 included $18.0 million and $14.4 million, respectively, of
non-cash stock-based compensation expense. For the full year 2023,
Acadia reported a net loss of $61.3 million, or $0.37 per common
share, compared to a net loss of $216.0 million, or $1.34 per
common share, for the same period in 2022. The net losses for the
full years of 2023 and 2022 included $66.4 million and $68.2
million, respectively, of non-cash stock-based compensation
expense.
Cash and Investments
At December 31, 2023, Acadia’s cash, cash equivalents, and
investment securities totaled $438.9 million, compared to $416.8
million at December 31, 2022.
Full Year 2024 Financial Guidance
- DAYBUE net product sales in the range of $370 to $420
million.
- NUPLAZID net product sales in the range of $560 to $590
million.
- GAAP R&D expense in the range of $305 to $325 million.
- GAAP SG&A expense in the range of $455 to $480
million.
Conference Call and Webcast Information
Acadia will host a conference call to discuss the fourth quarter
and full year December 31, 2023 results today, Tuesday, February
27, 2024 at 1:30 p.m. PT/4:30 p.m. ET. The conference call will be
available on Acadia’s website, Acadia.com, under the investors section and will be archived
there until March 26, 2024. The conference call may also 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.
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 DAYBUE™ (trofinetide)
Trofinetide is a synthetic version of a naturally occurring
molecule known as the tripeptide glycine-proline-glutamate (GPE).
The mechanism by which trofinetide exerts therapeutic effects in
patients with Rett syndrome is unknown. Trofinetide was approved
for the treatment of Rett syndrome in adults and pediatric patients
two years of age and older by the U.S. Food and Drug Administration
in March 2023 under the trade name DAYBUE.
About Acadia Pharmaceuticals
Acadia is advancing breakthroughs in neuroscience to elevate
life. For 30 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 FDA-approved
drug to treat hallucinations and delusions associated with
Parkinson’s disease psychosis and the first and only FDA-approved
drug for the treatment of Rett syndrome. Our clinical-stage
development efforts are focused on treating the negative symptoms
of schizophrenia, Prader-Willi syndrome, Alzheimer’s disease
psychosis and multiple other programs targeting neuropsychiatric
symptoms in central nervous system disorders. For more information,
visit us at Acadia.com and follow us on LinkedIn and Twitter.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements include all statements other than
statements of historical fact and can be identified by terms such
as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,”
“anticipates,” “believes,” “estimates,” “projects,” “predicts,”
“potential” and similar expressions (including the negative
thereof) intended to identify forward-looking statements.
Forward-looking statements contained in this press release,
include, but are not limited to, statements about: (i) our business
strategy, objectives and opportunities; (ii) plans for, including
timing, development and progress of commercialization or regulatory
timelines for, NUPLAZID, DAYBUE and our product candidates; (iii)
benefits to be derived from and efficacy of our products, including
the potential advantages of NUPLAZID and DAYBUE; and (iv) our
estimates regarding our future financial performance, profitability
or capital requirements. Forward-looking statements are subject to
known and unknown risks, uncertainties, assumptions and other
factors that may cause our actual results, performance or
achievements to differ materially and adversely from those
anticipated or implied by our forward-looking statements. Such
risks, uncertainties and other factors include, but are not limited
to: our dependency on the continued successful commercialization of
NUPLAZID and DAYBUE and our ability to maintain or increase sales
of NUPLAZID or DAYBUE; the costs of our commercialization plans and
development programs, and the financial impact or revenues from any
commercialization we undertake; our ability to obtain necessary
regulatory approvals for our product candidates and, if and when
approved, market acceptance of our products; our dependence on
third-party collaborators, clinical research organizations,
manufacturers, suppliers and distributors; the impact of
competitive products and therapies; our ability to generate or
obtain the necessary capital to fund our operations; our ability to
grow, equip and train our specialized sales forces; our ability to
manage the growth and complexity of our organization; our ability
to maintain, protect and enhance our intellectual property; and our
ability to continue to stay in compliance with applicable laws and
regulations. Given the risks and uncertainties, you should not
place undue reliance on these forward-looking statements. For a
discussion of these and other risks, uncertainties and other
factors that may cause our actual results, performance or
achievements to differ, please refer to our quarterly report on
Form 10-Q for the quarter ended September 30, 2023 as well as our
subsequent filings with the Securities and Exchange Commission from
time to time, including our annual report on Form 10-K for the year
ended December 31, 2023. The forward-looking statements contained
herein are made as of the date hereof, and we undertake no
obligation to update them after this date, except as required by
law.
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(in thousands, except per share
amounts)
(Unaudited)
Three Months Ended December
31,
Years Ended December
31,
2023
2022
2023
2022
Revenues
Product sales, net
$
231,041
$
136,490
$
726,437
$
517,235
Total revenues
231,041
136,490
726,437
517,235
Operating expenses
Cost of product sales (1)(2)
17,891
2,413
41,638
10,166
Research and development (2)
66,741
75,738
351,619
361,575
Selling, general and administrative
(2)
111,465
104,402
406,559
369,090
Total operating expenses
196,097
182,553
799,816
740,831
Income (loss) from operations
34,944
(46,063
)
(73,379
)
(223,596
)
Interest income, net
4,759
3,630
17,234
6,610
Other income
—
1,543
5,109
3,542
Income (loss) before income taxes
39,703
(40,890
)
(51,036
)
(213,444
)
Income tax expense (benefit)
(6,094
)
835
10,250
2,531
Net income (loss)
$
45,797
$
(41,725
)
$
(61,286
)
$
(215,975
)
Earnings (net loss) per share:
Basic
$
0.28
$
(0.26
)
$
(0.37
)
$
(1.34
)
Diluted
$
0.28
$
(0.26
)
$
(0.37
)
$
(1.34
)
Weighted average common shares
outstanding:
Basic
164,812
161,988
163,819
161,683
Diluted
166,510
161,988
163,819
161,683
(1) Includes license fees and
royalties
(2) Includes the following share-based
compensation expenses
Cost of product sales, license fees and
royalties
$
363
$
93
$
1,007
$
1,106
Research and development
$
4,707
$
3,432
$
17,408
$
22,580
Selling, general and administrative
$
12,953
$
10,889
$
48,006
$
44,515
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
December 31, 2023
December 31, 2022
Assets
Cash, cash equivalents and investment
securities
$
438,865
$
416,823
Accounts receivable, net
98,267
62,195
Interest and other receivables
4,083
885
Inventory
35,819
6,636
Prepaid expenses
39,091
21,398
Total current assets
616,125
507,937
Property and equipment, net
4,612
6,021
Operating lease right-of-use assets
51,855
55,573
Intangible assets, net
65,490
—
Restricted cash
5,770
5,770
Long-term inventory
4,628
4,924
Other assets
476
7,587
Total assets
$
748,956
$
587,812
Liabilities and stockholders’
equity
Accounts payable
$
17,543
$
12,746
Accrued liabilities
236,711
112,884
Total current liabilities
254,254
125,630
Operating lease liabilities
47,800
52,695
Other long-term liabilities
15,147
9,074
Total liabilities
317,201
187,399
Total stockholders’ equity
431,755
400,413
Total liabilities and stockholders’
equity
$
748,956
$
587,812
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240227648052/en/
Media Contact: Acadia Pharmaceuticals Inc. Deb Kazenelson (818)
395-3043 media@acadia-pharm.com
Investor Contact: Acadia Pharmaceuticals Inc. Al Kildani (858)
261-2872 ir@acadia-pharm.com
Acadia Pharmaceuticals Inc. Jessica Tieszen (858) 261-2950
ir@acadia-pharm.com
Acadia Pharmaceuticals (NASDAQ:ACAD)
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