Acadia Pharmaceuticals Reports Second Quarter 2023 Financial Results and Operating Overview
- Strong performances from both commercial franchises with DAYBUE net product sales of $23.2 million and NUPLAZID net product sales of $142.0 million
- Expanded licensing agreement for trofinetide includes ex-North American rights, indicating global growth potential
- Completed enrollment in Phase 3 study for pimavanserin, with results expected in the first quarter of 2024
- Initiation of Phase 3 trial of ACP-101 for Prader-Willi syndrome and seamless Phase 2 and 3 program for ACP-204 in Alzheimer’s disease psychosis demonstrate commitment to rare disease portfolio
- Positive pivotal results from the Phase 3 LAVENDER™ study published in Nature Medicine, showcasing DAYBUE’s efficacy in modifying core symptoms of Rett syndrome
- Decrease in research and development expenses compared to the same period in 2022 could raise concerns about the pace of innovation and new drug development
- Increase in selling, general and administrative expenses, particularly associated with the DAYBUE launch, may impact overall profitability
- 2Q23 DAYBUE™ (trofinetide) net product sales of
- 2Q23 NUPLAZID® (pimavanserin) net product sales of
- Expanded licensing agreement for trofinetide includes ex-North American rights
“Our second quarter 2023 results reflect strong performances from both commercial franchises. The DAYBUE launch is off to a highly successful start as evidenced by broad demand across the entire Rett community, and our NUPLAZID franchise is increasingly profitable while continuing to gain market share,” said Steve Davis, President and Chief Executive Officer. “In our late-stage portfolio, we have completed enrollment in our Phase 3 negative symptoms of schizophrenia clinical trial, with results on track for the first quarter of next year. In the fourth quarter of this year, we will initiate a Phase 3 trial of ACP-101 for Prader-Willi syndrome, and commence a seamless Phase 2 and 3 program to study ACP-204 in Alzheimer’s disease psychosis.”
Company Updates
- Acquired global rights to trofinetide (DAYBUE) through an expanded agreement with Neuren Pharmaceuticals. The expanded agreement follows the company’s April 2023 U.S. launch of DAYBUE as the first and only drug approved for the treatment of Rett syndrome.
- Completed enrollment in ADVANCE-2, a Phase 3 study evaluating pimavanserin for the treatment of the negative symptoms of schizophrenia, with top-line results expected in the first quarter of 2024.
- Announced the addition of ACP-101, a Phase 3 development candidate to its rare disease portfolio for the treatment of hyperphagia in Prader-Willi syndrome (PWS). The Company recently aligned on plans with the FDA to initiate a Phase 3 study in the fourth quarter of 2023.
- Completed Phase 1 development of ACP-204 which demonstrated a favorable safety and tolerability profile, and supports Acadia's target product profile as a potential treatment for Alzheimer’s disease psychosis. Acadia met with the FDA and aligned on dosing and plans to initiate a Phase 2/3 program in the fourth quarter of 2023.
- Pivotal results from the Phase 3 LAVENDER™ study evaluating DAYBUE (trofinetide) efficacy and safety in patients with Rett syndrome were published in Nature Medicine, demonstrating DAYBUE’s ability to modify the core symptoms of Rett syndrome, which provided the basis for its FDA approval.
- Initiated patient enrollment in the real world evidence Lotus study, a two-year, prospective, online observational study of participants prescribed DAYBUE.
- Announced the appointment of Dr. Kevin R. Oliver as Senior Vice President, Chief Business Officer to oversee all business development functions and partnering activities.
Financial Results
Revenue
Total net product sales, comprised of 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 three months ended June 30, 2023 were
Selling, General and Administrative
Selling, general and administrative expenses for the three months ended June 30, 2023 were
Net Income
For the three months ended June 30, 2023, Acadia reported net income of
Cash and Investments
At June 30, 2023, Acadia’s cash, cash equivalents and investment securities totaled
Financial Guidance
Third Quarter 2023
-
DAYBUE third quarter net sales in the range of
to$45 .$55 million
Full Year 2023
-
NUPLAZID full year net sales in the range of
to$530 .$545 million -
R&D expense in the range of
to$335 , which has been adjusted for the$355 million upfront payment to Neuren in July for the expanded licensing agreement.$100.0 million -
SG&A expense range increased to
to$380 due to higher operating costs as a result of favorable business performance, including employee retention costs as well as DAYBUE incentive compensation and investments in patient support services.$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 September 1, 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
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
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 June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Product sales, net |
|
$ |
165,235 |
|
|
$ |
134,563 |
|
|
$ |
283,697 |
|
|
$ |
250,031 |
|
Total revenues |
|
|
165,235 |
|
|
|
134,563 |
|
|
|
283,697 |
|
|
|
250,031 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of product sales (1)(2) |
|
|
7,459 |
|
|
|
2,667 |
|
|
|
9,126 |
|
|
|
5,617 |
|
Research and development (2) |
|
|
58,771 |
|
|
|
75,646 |
|
|
|
127,915 |
|
|
|
204,501 |
|
Selling, general and administrative (2) |
|
|
95,968 |
|
|
|
89,901 |
|
|
|
197,203 |
|
|
|
186,580 |
|
Total operating expenses |
|
|
162,198 |
|
|
|
168,214 |
|
|
|
334,244 |
|
|
|
396,698 |
|
Income (loss) from operations |
|
|
3,037 |
|
|
|
(33,651 |
) |
|
|
(50,547 |
) |
|
|
(146,667 |
) |
Interest income, net |
|
|
4,550 |
|
|
|
580 |
|
|
|
8,350 |
|
|
|
685 |
|
Other (loss) income |
|
|
(1,244 |
) |
|
|
(497 |
) |
|
|
3,601 |
|
|
|
(157 |
) |
Income (loss) before income taxes |
|
|
6,343 |
|
|
|
(33,568 |
) |
|
|
(38,596 |
) |
|
|
(146,139 |
) |
Income tax (benefit) expense |
|
|
5,229 |
|
|
|
443 |
|
|
|
3,311 |
|
|
|
928 |
|
Net income (loss) |
|
$ |
1,114 |
|
|
$ |
(34,011 |
) |
|
$ |
(41,907 |
) |
|
$ |
(147,067 |
) |
Earnings (net loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic |
|
$ |
0.01 |
|
|
$ |
(0.21 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.91 |
) |
Diluted |
|
$ |
0.01 |
|
|
$ |
(0.21 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.91 |
) |
Weighted average common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic |
|
|
163,458 |
|
|
|
161,654 |
|
|
|
163,109 |
|
|
|
161,443 |
|
Diluted |
|
|
165,046 |
|
|
|
161,654 |
|
|
|
163,109 |
|
|
|
161,443 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
(1) Includes license fees and royalties |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
(2) Includes the following stock-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of product sales, license fees and royalties |
|
$ |
200 |
|
|
$ |
346 |
|
|
$ |
368 |
|
|
$ |
669 |
|
Research and development |
|
$ |
3,666 |
|
|
$ |
7,232 |
|
|
$ |
7,638 |
|
|
$ |
12,696 |
|
Selling, general and administrative |
|
$ |
11,288 |
|
|
$ |
12,934 |
|
|
$ |
21,853 |
|
|
$ |
22,110 |
|
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) |
||||||||
|
|
June 30,
|
|
|
December 31,
|
|
||
|
|
(unaudited) |
|
|
|
|
||
Assets |
|
|
|
|
|
|
||
Cash, cash equivalents and investment securities |
|
$ |
375,378 |
|
|
$ |
416,823 |
|
Accounts receivable, net |
|
|
81,852 |
|
|
|
62,195 |
|
Interest and other receivables |
|
|
2,304 |
|
|
|
885 |
|
Inventory |
|
|
9,199 |
|
|
|
6,636 |
|
Prepaid expenses |
|
|
23,895 |
|
|
|
21,398 |
|
Total current assets |
|
|
492,628 |
|
|
|
507,937 |
|
Property and equipment, net |
|
|
5,193 |
|
|
|
6,021 |
|
Operating lease right-of-use assets |
|
|
52,382 |
|
|
|
55,573 |
|
Intangible assets, net |
|
|
68,219 |
|
|
|
— |
|
Restricted cash |
|
|
8,120 |
|
|
|
5,770 |
|
Long-term inventory |
|
|
4,924 |
|
|
|
4,924 |
|
Other assets |
|
|
11,303 |
|
|
|
7,587 |
|
Total assets |
|
$ |
642,769 |
|
|
$ |
587,812 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
18,811 |
|
|
$ |
12,746 |
|
Accrued liabilities |
|
|
169,131 |
|
|
|
112,884 |
|
Total current liabilities |
|
|
187,942 |
|
|
|
125,630 |
|
Operating lease liabilities |
|
|
49,778 |
|
|
|
52,695 |
|
Other long-term liabilities |
|
|
9,256 |
|
|
|
9,074 |
|
Total liabilities |
|
|
246,976 |
|
|
|
187,399 |
|
Total stockholders’ equity |
|
|
395,793 |
|
|
|
400,413 |
|
Total liabilities and stockholders’ equity |
|
$ |
642,769 |
|
|
$ |
587,812 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20230802606003/en/
Media Contact:
Acadia Pharmaceuticals Inc.
Deb Kazenelson
(818) 395-3043
media@acadia-pharm.com
Investor Contact:
Acadia Pharmaceuticals Inc.
Jessica Tieszen
(858) 261-2950
ir@acadia-pharm.com
Source: Acadia Pharmaceuticals Inc.
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