Acadia Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Operating Overview
- 2023 total net product sales of
- Fourth quarter DAYBUE™ (trofinetide) net product sales of
- Fourth quarter NUPLAZID® (pimavanserin) net product sales of
“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
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 andKimberly 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
Net product sales of NUPLAZID were
Net product sales of DAYBUE were
Research and Development
Research and development expenses for the fourth quarter of 2023 were
Selling, General and Administrative
Selling, general and administrative expenses for the fourth quarter of 2023 were
Net Income (Loss)
For the fourth quarter of 2023, Acadia reported net income of
Cash and Investments
At
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
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
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
About
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
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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(in thousands, except per share amounts) |
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(Unaudited) |
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Three Months Ended |
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Years Ended |
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2023 |
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2022 |
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|
2023 |
|
|
2022 |
|
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Revenues |
|
|
|
|
|
|
|
|
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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 |
|
|
|
|
|
|
|
|
|
|
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(1) Includes license fees and royalties |
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
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(2) Includes the following share-based compensation expenses |
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
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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 |
|
|
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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(in thousands) |
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|
|
|
|
|
|
|
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|
|
|
|
|
|
|
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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:
Deb Kazenelson
(818) 395-3043
media@acadia-pharm.com
Investor Contact:
(858) 261-2872
ir@acadia-pharm.com
(858) 261-2950
ir@acadia-pharm.com
Source: