8-K
ACADIA PHARMACEUTICALS INC (ACAD)
UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
| Date of Report (Date of earliest event reported): May 08, 2023 |
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Acadia Pharmaceuticals Inc.
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 000-50768 | 06-1376651 |
|---|---|---|
| (State or Other Jurisdiction<br>of Incorporation) | (Commission File Number) | (IRS Employer<br>Identification No.) |
| 12830 El Camino Real, Suite 400 | ||
| San Diego, California | 92130 | |
| (Address of Principal Executive Offices) | (Zip Code) | |
| Registrant’s Telephone Number, Including Area Code: (858) 558-2871 | ||
| --- | ||
| N/A | ||
| --- |
(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:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br>Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.0001 per share | ACAD | The Nasdaq Stock Market LLC |
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, 2023, Acadia Pharmaceuticals Inc. issued a press release announcing its financial results for the three months ended March 31, 2023. 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<br>Number | Description |
|---|---|
| 99.1 | Press Release dated May 8, 2023. |
| 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, 2023 | By: | /s/ Austin D. Kim |
| Austin D. Kim<br>Executive Vice President, General Counsel & Secretary |
EX-99
Exhibit 99.1
Acadia Pharmaceuticals Reports
First Quarter 2023 Financial Results and Operating Overview
1Q23 NUPLAZID® net sales of $118.5 million
Announced the U.S. FDA Approval of DAYBUE™ (trofinetide) for the Treatment of Rett Syndrome in Adult and Pediatric Patients Two Years of Age and Older on March 10, 2023
Announced DAYBUE Availability on April 17, 2023
SAN DIEGO, CA, May 8, 2023 – Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced its financial results for the first quarter ended March 31, 2023.
“We are excited with the recent approval and subsequent launch of DAYBUE, the first and only FDA-approved medicine for the treatment of Rett syndrome. We are executing on our launch strategy to bring this important new treatment to the Rett patient community, while remaining focused on delivering increasing profitability from our NUPLAZID franchise for Parkinson’s disease psychosis,” said Steve Davis, Chief Executive Officer. “In addition to our commercial business, we’ve made important strides in our pipeline including completion of the Phase 1 development program for ACP-204. And finally, we are nearing enrollment completion of the Phase 3 program for pimavanserin as a potential treatment for the negative symptoms of schizophrenia with top-line results expected in early 2024.”
Company Operational, Scientific, and Regulatory Updates
• On March 10, 2023, DAYBUE™ (trofinetide) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older.
• In connection with the FDA approval of DAYBUE, Acadia received a Rare Pediatric Disease Priority Review Voucher.
• Announced DAYBUE availability on April 17, 2023.
• The Company expects to complete enrollment in ADVANCE-2, a Phase 3 study evaluating pimavanserin for the treatment of the negative symptoms of schizophrenia, around mid-year with top-line results expected in early 2024.
• ACP-204 has completed Phase 1 development. ACP-204 demonstrated a favorable safety and tolerability profile and we identified the doses we plan to evaluate in Phase 2. The Phase 1 data supports ACP-204’s target product profile as a potential treatment for Alzheimer’s disease psychosis. Acadia plans to meet with the FDA to discuss the clinical development plan.
Financial Results
Revenue
Net sales of NUPLAZID® were $118.5 million for the three months ended March 31, 2023, an increase of 3% as compared to $115.5 million reported for the three months ended March 31, 2022. Year over year demand growth was up approximately 2% in the quarter, driven by an increase in new patient starts across both specialty pharmacy and specialty distribution channels. Overall sell-in volume declined approximately 2% year over year as in-channel inventory declined in the first quarter of 2023 compared to an increase in in-channel inventory in the first quarter of 2022.
Research and Development
Research and development expenses for the three months ended March 31, 2023 were $69.1 million, compared to $128.9 million for the same period of 2022. The decrease was primarily due to a $60 million upfront payment made to Stoke Therapeutics for a license and collaboration agreement in the first quarter of 2022.
Selling, General and Administrative
Selling, general and administrative expenses for the three months ended March 31, 2023 were $101.2 million, compared to $96.7 million for the same period of 2022. Selling, general and administrative expense remained relatively steady year over year as a result of a reduction in spend in the PDP commercial franchise which was offset by investments in the DAYBUE launch.
Net Loss
For the three months ended March 31, 2023, Acadia reported a net loss of $43.0 million, or $0.27 per common share, compared to a net loss of $113.1 million, or $0.70 per common share, for the same period in 2022. The difference was primarily due to the $60 million upfront payment made to Stoke Therapeutics for a license and collaboration agreement. The net losses for the three months ended March 31, 2023 and 2022 included $14.7 million and $15.0 million, respectively, of non-cash stock-based compensation expense.
Cash and Investments
At March 31, 2023, Acadia’s cash, cash equivalents, and investment securities totaled $402.9 million, compared to $416.8 million at December 31, 2022.
2023 Financial Guidance
Acadia is reiterating all of its 2023 guidance provided on February 27, 2023.
• NUPLAZID net sales in the range of $520 to $550 million.
• R&D expense in the range of $235 to $255 million, which includes approximately $20 million of stock-based compensation expense.
• SG&A expense in the range of $360 to $380 million, which includes approximately $45 million of stock-based compensation expense.
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 June 7, 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 More information can be found at DAYBUE.com.
About Acadia Pharmaceuticals
Acadia is advancing breakthroughs in neuroscience to elevate life. For almost 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, 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
1 Tropea 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. 2 Acadia 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 March 31, | ||||||
|---|---|---|---|---|---|---|
| 2023 | 2022 | |||||
| Revenues | ||||||
| Product sales, net | $ | 118,462 | $ | 115,468 | ||
| Total revenues | 118,462 | 115,468 | ||||
| Operating expenses | ||||||
| Cost of product sales, license fees and royalties (1) | 1,667 | 2,950 | ||||
| Research and development (1) | 69,144 | 128,855 | ||||
| Selling, general and administrative (1) | 101,235 | 96,679 | ||||
| Total operating expenses | 172,046 | 228,484 | ||||
| Loss from operations | (53,584 | ) | (113,016 | ) | ||
| Interest income, net | 3,800 | 105 | ||||
| Other income | 4,845 | 340 | ||||
| Loss before income taxes | (44,939 | ) | (112,571 | ) | ||
| Income tax (benefit) expense | (1,918 | ) | 485 | |||
| Net loss | $ | (43,021 | ) | $ | (113,056 | ) |
| Net loss per common share, basic and diluted | $ | (0.27 | ) | $ | (0.70 | ) |
| Weighted average common shares outstanding, basic and diluted | 162,263 | 161,231 | ||||
| (1) Includes the following stock-based compensation expense | ||||||
| Cost of product sales, license fees and royalties | $ | 168 | $ | 323 | ||
| Research and development | $ | 3,972 | $ | 5,464 | ||
| Selling, general and administrative | $ | 10,565 | $ | 9,176 |
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
| March 31,<br>2023 | December 31,<br>2022 | |||
|---|---|---|---|---|
| (unaudited) | ||||
| Assets | ||||
| Cash, cash equivalents and investment securities | $ | 402,873 | $ | 416,823 |
| Accounts receivable, net | 65,915 | 62,195 | ||
| Interest and other receivables | 4,335 | 885 | ||
| Inventory | 6,095 | 6,636 | ||
| Prepaid expenses | 23,632 | 21,398 | ||
| Total current assets | 502,850 | 507,937 | ||
| Property and equipment, net | 5,595 | 6,021 | ||
| Operating lease right-of-use assets | 54,151 | 55,573 | ||
| Intangible assets, net | 69,583 | — | ||
| Restricted cash | 5,770 | 5,770 | ||
| Long-term inventory | 4,924 | 4,924 | ||
| Other assets | 12,432 | 7,587 | ||
| Total assets | $ | 655,305 | $ | 587,812 |
| Liabilities and stockholders’ equity | ||||
| Accounts payable | $ | 17,422 | $ | 12,746 |
| Accrued liabilities | 206,879 | 112,884 | ||
| Total current liabilities | 224,301 | 125,630 | ||
| Operating lease liabilities | 51,441 | 52,695 | ||
| Other long-term liabilities | 5,305 | 9,074 | ||
| Total liabilities | 281,047 | 187,399 | ||
| Total stockholders’ equity | 374,258 | 400,413 | ||
| Total liabilities and stockholders’ equity | $ | 655,305 | $ | 587,812 |
Media Contact:
Acadia Pharmaceuticals Inc.
Deb Kazenelson (818) 395-3043
media@acadia-pharm.com
Investor Contact:
Acadia Pharmaceuticals Inc.
Mark Johnson, CFA
(858) 261-2771
ir@acadia-pharm.com