Acadia Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Operating Overview
- Strong revenue growth of 40% in 2023 driven by DAYBUE and NUPLAZID sales.
- Initiation of Phase 3 trials for ACP-101 and ACP-204 in Prader-Willi syndrome and Alzheimer's disease psychosis.
- Positive outlook for future growth and top-line results from the ADVANCE-2 study.
- Financial results show net income for the fourth quarter and a net loss for the full year 2023.
- Cash, cash equivalents, and investment securities totaled $438.9 million at the end of 2023.
- Full year 2024 financial guidance includes expected net product sales for DAYBUE and NUPLAZID.
- Net loss reported for the full year 2023 despite revenue growth.
- Increase in selling, general, and administrative expenses in 2023.
- Non-cash stock-based compensation expenses impacting net income for both quarters in 2023.
- Research and development expenses slightly decreased in 2023 compared to 2022.
Insights
The reported 40% revenue growth for Acadia Pharmaceuticals Inc. is a significant figure, notably higher than the average pharmaceutical industry growth rate, which typically hovers in the single-digit percentage range. This surge is primarily attributed to the successful launch of DAYBUE, a new treatment for Rett syndrome, which has contributed $177.2 million in net sales. This suggests a strong market demand and effective market penetration strategies by Acadia.
Moreover, the 6% growth in the NUPLAZID franchise, although modest, indicates sustained performance in an established product line. The financial results also show a net income for Q4 2023, contrasting with a net loss in the same period the previous year. This turnaround could be indicative of a strategic shift that has begun to yield profitability. However, the full-year net loss suggests that there are still challenges to overcome for sustained financial health.
Investors should note the forward-looking guidance for 2024, which projects continued growth in DAYBUE sales and a steady increase for NUPLAZID. These projections are critical for evaluating the company's potential future performance and the sustainability of its growth trajectory.
Acadia's strategic investment in R&D, despite a slight decrease in expenses, reflects a commitment to innovation, particularly in areas of unmet medical needs such as Rett syndrome and Alzheimer’s disease psychosis. The initiation of Phase 3 trials for ACP-101 and ACP-204 signifies progress in the company's pipeline, which could have implications for future revenue streams and market positioning.
The biopharmaceutical market is highly competitive and Acadia's ability to advance its pipeline while managing R&D costs will be crucial in maintaining investor confidence. The anticipated top-line results from the ADVANCE-2 study could serve as a catalyst for the stock, depending on the outcome. Positive results could enhance the company's reputation for innovation and potentially lead to an increased market share.
The introduction of DAYBUE (trofinetide) represents a noteworthy advancement in the treatment of Rett syndrome, a rare neurological disorder with limited therapeutic options. The robust sales figures suggest that DAYBUE is meeting a significant unmet medical need. Additionally, the ongoing clinical trials for ACP-204 in Alzheimer's disease psychosis and ACP-101 in Prader-Willi syndrome highlight Acadia's focus on addressing complex psychiatric and neurological conditions.
Investors and stakeholders should monitor the progress of these trials closely, as they have the potential to disrupt existing treatment paradigms and contribute substantially to Acadia's future growth. The company's investment in these areas, despite the overall net loss, indicates a strategic prioritization of long-term value creation over immediate profitability.
- 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
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
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 December 31, 2023, Acadia’s cash, cash equivalents, and investment securities totaled
Full Year 2024 Financial Guidance
-
DAYBUE net product sales in the range of
$370 $420 million -
NUPLAZID net product sales in the range of
$560 $590 million -
GAAP R&D expense in the range of
$305 $325 million -
GAAP SG&A expense in the range of
$455 $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
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 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. |
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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 December 31, |
|
Years Ended December 31, |
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|
|
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 |
|
|
|
|
|
|
|
|
||||||||
|
|
|
|
|
|
|
|
|
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(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,
|
|
|
December 31,
|
|
||
|
|
|
|
|
|
|
||
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
Source: Acadia Pharmaceuticals Inc.
FAQ
What were Acadia Pharmaceuticals' total net product sales for the full year 2023?
What were the net product sales of NUPLAZID for the full year 2023?
What Phase 3 trials did Acadia initiate in 2023?
When will Acadia announce top-line results from the ADVANCE-2 study?
What was Acadia's net income for the fourth quarter of 2023?
How much cash and investments did Acadia have at the end of 2023?
What is Acadia Pharmaceuticals' financial guidance for full year 2024?
