- Company reports record revenues resulting
from strong DAYBUE launch and growth in NUPLAZID franchise
- 3Q23 DAYBUE™ (trofinetide) net product sales
of $66.9 million
- 3Q23 NUPLAZID® (pimavanserin) net product
sales of $144.8 million
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced its
financial results for the third quarter ended September 30,
2023.
“In the third quarter, Acadia delivered record product revenue,
underscoring the continued strong launch of DAYBUE for the
treatment of Rett syndrome, and market share growth for the very
successful NUPLAZID franchise,” said Steve Davis, President and
Chief Executive Officer. “In addition to our strong commercial
performance, we continue to add to our late stage pipeline with the
planned initiations in the fourth quarter of a Phase 3 study of
ACP-101 for Prader-Willi syndrome and a Phase 2 / Phase 3 program
of ACP-204 for the treatment of Alzheimer’s disease psychosis.”
Company Highlights
- Acquired global rights to trofinetide (DAYBUE) through an
expanded agreement with Neuren Pharmaceuticals.
- The Company expects to report top-line results from ADVANCE-2,
a Phase 3 study evaluating pimavanserin for the treatment of the
negative symptoms of schizophrenia in the first quarter of
2024.
- The Company plans to initiate a Phase 3 placebo-controlled
study of ACP-101 for the treatment of hyperphagia in Prader-Willi
syndrome in the fourth quarter of 2023.
- The Company plans to initiate a Phase 2 study of ACP-204 as a
potential treatment for Alzheimer’s disease psychosis in the fourth
quarter of 2023.
- Appointed Albert Kildani as Senior Vice President, Investor
Relations and Corporate Communications, and Stephanie Kim as Senior
Vice President, Regulatory Affairs. Albert and Stephanie both join
Acadia’s Executive Management Committee.
Financial Results
Revenues
Total revenues, comprised of net product sales from NUPLAZID and
DAYBUE were $211.7 million for the three months ended September 30,
2023, and were $495.4 million for the nine months ended September
30, 2023.
Net product sales of NUPLAZID were $144.8 million and $130.7
million for the three months ended September 30, 2023 and 2022,
respectively. The approximately $14 million dollar increase year
over year is comprised of a $7 million in-channel inventory
reduction in the prior year that did not recur this year, $4
million attributable to lower 340B volumes, and $3 million as a
result of 2% demand bottle growth. Net product sales of NUPLAZID
were $405.3 million and $380.7 million for the nine months ended
September 30, 2023 and 2022, respectively.
Net product sales of DAYBUE were $66.9 million for the quarter
ended September 30, 2023, the first full quarter of
commercialization of DAYBUE following the April 17, 2023
launch.
Research and Development
Research and development expenses for the three months ended
September 30, 2023 were $157.0 million, compared to $81.3 million
for the same period of 2022. The increase in research and
development expenses was mainly due to the July 2023 agreement with
Neuren to expand Acadia’s license to trofinetide (DAYBUE) from
North American to worldwide rights, offset in part by other
reductions in research and development. For the nine months ended
September 30, 2023 and 2022, research and development expenses were
$284.9 million and $285.8 million, respectively.
Selling, General and Administrative
Selling, general and administrative expenses for the three
months ended September 30, 2023 were $97.9 million, compared to
$78.1 million for the same period of 2022. For the nine months
ended September 30, 2023 and 2022, selling, general and
administrative expenses were $295.1 million and $264.7 million,
respectively. The increase in selling, general and administrative
expenses in both periods was primarily due to increased commercial
costs associated with the DAYBUE launch, partially offset by
reductions in expenses associated with NUPLAZID.
Net Loss
For the three months ended September 30, 2023, Acadia reported a
net loss of $65.2 million, or $0.40 per common share, compared to a
net loss of $27.2 million, or $0.17 per common share, for the same
period in 2022. Net loss for the three months ended September 30,
2023 included the $100 million upfront payment to expand Acadia's
license to trofinetide (DAYBUE) from North American to worldwide
rights. Net loss for the three months ended September 30, 2023 and
2022 included $18.5 million and $18.3 million, respectively, of
non-cash stock-based compensation expense. For the nine months
ended September 30, 2023, Acadia reported a net loss of $107.1
million, or $0.65 per common share, compared to a net loss of
$174.3 million, or $1.08 per common share, for the same period in
2022. The net losses for the nine months ended September 30, 2023
and 2022 included $48.4 million and $53.8 million, respectively, of
non-cash stock-based compensation expense.
Cash and Investments
At September 30, 2023, Acadia’s cash, cash equivalents and
investment securities totaled $345.9 million, compared to $416.8
million at December 31, 2022. The change in these balances is
primarily due to the July 2023 $100 million upfront payment for
worldwide rights to trofinetide (DAYBUE) referenced above.
Financial Guidance
Fourth Quarter 2023
- DAYBUE net sales in the range of $80 to $87.5 million.
Full Year 2023
- NUPLAZID net sales in the range of $537.5 to $545 million.
- R&D expense in the range of $340 to $350 million.
- SG&A expense in the range of $390 to $400 million.
Conference Call and Webcast Information
The conference call will be available on Acadia’s website,
www.acadia.com, under the investors section and will be archived
there until December 4, 2023. 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. In animal studies,
trofinetide has been shown to increase branching of dendrites and
synaptic plasticity signals.1,2
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 approved
therapies for hallucinations and delusions associated with
Parkinson’s disease psychosis and 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 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 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, 2022, 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 1Tropea D, Giacometti E, Wilson NR, et al. Partial
reversal of Rett Syndrome-like symptoms in MeCP2 mutant mice. Proc
Natl Acad Sci USA. 2009;106(6):2029-2034. 2Acadia Pharmaceuticals
Inc., Data on file. Study Report 2566-026. 2010.
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,
2023
2022
2023
2022
Revenues
Product sales, net
$
211,699
$
130,714
$
495,396
$
380,745
Total revenues
211,699
130,714
495,396
380,745
Operating expenses
Cost of product sales (1)(2)
14,622
2,136
23,747
7,753
Research and development (2)
156,963
81,336
284,878
285,837
Selling, general and administrative
(2)
97,890
78,108
295,094
264,688
Total operating expenses
269,475
161,580
603,719
558,278
Loss from operations
(57,776
)
(30,866
)
(108,323
)
(177,533
)
Interest income, net
4,125
2,295
12,475
2,980
Other income
1,508
2,156
5,109
1,999
Loss before income taxes
(52,143
)
(26,415
)
(90,739
)
(172,554
)
Income tax expense
13,033
768
16,344
1,696
Net loss
$
(65,176
)
$
(27,183
)
$
(107,083
)
$
(174,250
)
Net loss per common share, basic and
diluted
$
(0.40
)
$
(0.17
)
$
(0.65
)
$
(1.08
)
Weighted average common shares
outstanding, basic and diluted
164,234
161,852
163,488
161,580
(1) Includes license fees and
royalties
(2) Includes the following stock-based
compensation expense
Cost of product sales, license fees and
royalties
$
276
$
344
$
644
$
1,013
Research and development
$
5,063
$
6,452
$
12,701
$
19,148
Selling, general and administrative
$
13,200
$
11,516
$
35,053
$
33,626
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
September 30, 2023
December 31, 2022
(unaudited)
Assets
Cash, cash equivalents and investment
securities
$
345,920
$
416,823
Accounts receivable, net
92,802
62,195
Interest and other receivables
1,730
885
Inventory
20,768
6,636
Prepaid expenses
37,950
21,398
Total current assets
499,170
507,937
Property and equipment, net
4,884
6,021
Operating lease right-of-use assets
50,758
55,573
Intangible assets, net
66,855
—
Restricted cash
5,770
5,770
Long-term inventory
4,628
4,924
Other assets
475
7,587
Total assets
$
632,540
$
587,812
Liabilities and stockholders’
equity
Accounts payable
$
12,310
$
12,746
Accrued liabilities
197,293
112,884
Total current liabilities
209,603
125,630
Operating lease liabilities
48,103
52,695
Other long-term liabilities
12,660
9,074
Total liabilities
270,366
187,399
Total stockholders’ equity
362,174
400,413
Total liabilities and stockholders’
equity
$
632,540
$
587,812
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231102863530/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
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