UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 8, 2024, Acadia Pharmaceuticals Inc. issued a press release announcing its financial results for the three months ended March 31, 2024. A copy of this press release is furnished herewith as Exhibit 99.1. Pursuant to the rules and regulations of the Securities and Exchange Commission, such exhibit and the information set forth therein and in this Item 2.02 have been furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under that section nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing regardless of any general incorporation language.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
|
Description |
99.1 |
|
|
|
|
|
104 |
|
Cover page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
Acadia Pharmaceuticals Inc. |
|
|
|
|
Date: |
May 8, 2024 |
By: |
/s/ Jennifer J. Rhodes |
|
|
|
Jennifer J. Rhodes |
Exhibit 99.1
Acadia Pharmaceuticals Reports First Quarter 2024 Financial Results and Operating Overview
- First quarter NUPLAZID® (pimavanserin) net product sales of $129.9 million
- First quarter DAYBUE™ (trofinetide) net product sales of $75.9 million
SAN DIEGO, CA, May 8, 2024 – Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced its financial results for the first quarter ended March 31, 2024.
“In the first quarter of 2024, Acadia delivered net product sales of $205.8 million, representing 74% revenue growth year over year, primarily due to the addition of our second commercial product, DAYBUE for the treatment of Rett syndrome, combined with growth in market share of NUPLAZID for the treatment of Parkinson’s disease psychosis,” said Steve Davis, Chief Executive Officer. “In addition, we are executing on our plans to bring DAYBUE to markets outside the U.S., continuing to enroll our late-stage trials in Prader-Willi syndrome and Alzheimer’s disease psychosis, and utilizing our financial strength to support our early-stage pipeline and business development opportunities.”
Company Updates
Financial Results
Revenues
Total revenues, comprised of net product sales from NUPLAZID and DAYBUE were $205.8 million for the three months ended March 31, 2024.
Net product sales of NUPLAZID were $129.9 million for the first quarter of 2024, an increase of 10% as compared to $118.5 million for the first quarter of 2023. The increase in net product sales of NUPLAZID was due to 6% sell in growth and a 4% net price benefit in 2024 compared to 2023.
Net product sales of DAYBUE were $75.9 million for the first quarter of 2024. There were no net product sales of DAYBUE in the first quarter of 2023.
Research and Development
Research and development expenses for the first quarter of 2024 were $59.7 million, compared to $69.1 million for the same period of 2023. The decrease in research and development expenses was mainly due
to trofinetide commercial supply build that was expensed in the first quarter of 2023, prior to FDA approval. Post-approval inventory expenditures are expensed as part of cost of goods sold.
Selling, General and Administrative
Selling, general and administrative expenses for the first quarter of 2024 were $108.0 million, compared to $101.2 million for the same period of 2023. The increase in selling, general and administrative expenses was primarily driven by annualization of DAYBUE expenses as well as foundational investments to commercialize trofinetide outside the U.S.
Net Income (Loss)
For the first quarter of 2024, Acadia reported net income of $16.6 million, or $0.10 per common share, compared to a net loss of $43.0 million, or $0.27 per common share, for the same period in 2023. Net income for the three months ended March 31, 2024 included $14.8 million of non-cash stock-based compensation expense. Net loss for the three months ended March 31, 2023 included $14.7 million of non-cash stock-based compensation expense.
Cash and Investments
At March 31, 2024, Acadia’s cash, cash equivalents and investment securities totaled $470.5 million, compared to $438.9 million at December 31, 2023.
Full Year 2024 Financial Guidance
Acadia is reiterating all of its 2024 guidance provided on February 27, 2024.
Conference Call and Webcast Information
Acadia will host a conference call to discuss the first quarter 2024 results today, Wednesday, May 8, 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 June 7, 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.
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 2 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 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, including support for our early-stage pipeline and business development opportunities; (ii) plans for, including timing, development and progress of commercialization or regulatory timelines for, NUPLAZID, DAYBUE (both within and outside the U.S.) and our product candidates; (iii) benefits to be derived from and efficacy of our products, including the potential advantages of NUPLAZID and DAYBUE; (iv) the timing and conduct of our clinical trials, including continued enrollment of our clinical trials in Prader-Willi syndrome and Alzheimer’s disease psychosis, and the timing and content of our presentations regarding our clinical trials; and (v) our estimates regarding our future financial performance, profitability or capital requirements, including our full year 2024 financial guidance. 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; our plans to commercialize DAYBUE outside the U.S.; 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; the risks associated with clinical trials and their outcomes, including risks of unsuccessful enrollment and negative or inconsistent results; 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 March 31, 2024 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 March 31, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Revenues |
|
|
|
|
|
|
||
Product sales, net |
|
$ |
205,831 |
|
|
$ |
118,462 |
|
Total revenues |
|
|
205,831 |
|
|
|
118,462 |
|
Operating expenses |
|
|
|
|
|
|
||
Cost of product sales (1)(2) |
|
|
22,951 |
|
|
|
1,667 |
|
Research and development (2) |
|
|
59,679 |
|
|
|
69,144 |
|
Selling, general and administrative (2) |
|
|
107,991 |
|
|
|
101,235 |
|
Total operating expenses |
|
|
190,621 |
|
|
|
172,046 |
|
Income (loss) from operations |
|
|
15,210 |
|
|
|
(53,584 |
) |
Interest income, net |
|
|
5,506 |
|
|
|
3,800 |
|
Other income |
|
|
286 |
|
|
|
4,845 |
|
Income (loss) before income taxes |
|
|
21,002 |
|
|
|
(44,939 |
) |
Income tax expense (benefit) |
|
|
4,447 |
|
|
|
(1,918 |
) |
Net income (loss) |
|
$ |
16,555 |
|
|
$ |
(43,021 |
) |
Earnings (net loss) per share: |
|
|
|
|
|
|
||
Basic |
|
$ |
0.10 |
|
|
$ |
(0.27 |
) |
Diluted |
|
$ |
0.10 |
|
|
$ |
(0.27 |
) |
Weighted average common shares outstanding: |
|
|
|
|
|
|
||
Basic |
|
|
164,798 |
|
|
|
162,263 |
|
Diluted |
|
|
166,623 |
|
|
|
162,263 |
|
|
|
|
|
|
|
|
||
(1) Includes license fees and royalties |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
(2) Includes the following stock-based compensation expense |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Cost of product sales, license fees and royalties |
|
$ |
153 |
|
|
$ |
168 |
|
Research and development |
|
$ |
4,093 |
|
|
$ |
3,972 |
|
Selling, general and administrative |
|
$ |
10,504 |
|
|
$ |
10,565 |
|
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
|
|
March 31, |
|
|
December 31, |
|
||
|
|
(unaudited) |
|
|
|
|
||
Assets |
|
|
|
|
|
|
||
Cash, cash equivalents and investment securities |
|
$ |
470,520 |
|
|
$ |
438,865 |
|
Accounts receivable, net |
|
|
94,701 |
|
|
|
98,267 |
|
Interest and other receivables |
|
|
5,378 |
|
|
|
4,083 |
|
Inventory |
|
|
61,936 |
|
|
|
35,819 |
|
Prepaid expenses |
|
|
42,761 |
|
|
|
39,091 |
|
Total current assets |
|
|
675,296 |
|
|
|
616,125 |
|
Property and equipment, net |
|
|
4,370 |
|
|
|
4,612 |
|
Operating lease right-of-use assets |
|
|
54,280 |
|
|
|
51,855 |
|
Intangible assets, net |
|
|
110,204 |
|
|
|
65,490 |
|
Restricted cash |
|
|
5,770 |
|
|
|
5,770 |
|
Long-term inventory |
|
|
4,707 |
|
|
|
4,628 |
|
Other assets |
|
|
476 |
|
|
|
476 |
|
Total assets |
|
$ |
855,103 |
|
|
$ |
748,956 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
19,332 |
|
|
$ |
17,543 |
|
Accrued liabilities |
|
|
311,265 |
|
|
|
236,711 |
|
Total current liabilities |
|
|
330,597 |
|
|
|
254,254 |
|
Operating lease liabilities |
|
|
49,189 |
|
|
|
47,800 |
|
Other long-term liabilities |
|
|
11,273 |
|
|
|
15,147 |
|
Total liabilities |
|
|
391,059 |
|
|
|
317,201 |
|
Total stockholders’ equity |
|
|
464,044 |
|
|
|
431,755 |
|
Total liabilities and stockholders’ equity |
|
$ |
855,103 |
|
|
$ |
748,956 |
|
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
Media Contact:
Acadia Pharmaceuticals Inc.
Deb Kazenelson
(818) 395-3043
media@acadia-pharm.com