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): November 02, 2022 |
|---|
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 November 2, 2022, Acadia Pharmaceuticals Inc. issued a press release announcing its financial results for the third quarter and nine months ended September 30, 2022. 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 November 2, 2022. |
| 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: | November 2, 2022 | By: | /s/ Austin D. Kim |
| Austin D. Kim<br>Executive Vice President, General Counsel & Secretary |
EX-99.1
Exhibit 99.1
.
Acadia Pharmaceuticals Reports
Third Quarter 2022 Financial Results
3Q22 net sales of $130.7 million
Prescription Drug User Fee Act action date set for March 12, 2023
for trofinetide for the treatment of Rett syndrome
SAN DIEGO, CA, November 2, 2022 – Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its financial results for the third quarter ended September 30, 2022.
NUPLAZID delivered net sales of $130.7 million in the third quarter of 2022, driven by sequential demand growth of 2% and an acceleration of growth in the long-term care (LTC) channel, offset by a reduction of in-channel inventory of approximately $7 million.
“Our third quarter results reflect continued growth in demand for NUPLAZID, driven by early signs of improvement in the long-term care channel,” said Steve Davis, Chief Executive Officer. “In the quarter we announced that our new drug application of trofinetide for the treatment of Rett syndrome has been accepted for filing by the FDA and granted a priority review. Furthermore, we continued to advance our late and early-stage portfolio, including our Phase 3 program for pimavanserin for the treatment of the negative symptoms of schizophrenia and our Phase 1 ACP-204 program for neuropsychiatric indications.”
Company Updates
• Trofinetide New Drug Application (NDA) for the treatment of Rett syndrome was accepted for filing by the U.S. Food and Drug Administration (FDA). The FDA granted a priority review and assigned a PDUFA (Prescription Drug User Fee Act) action date of March 12, 2023, and informed the company that they are not planning to hold an Advisory Committee meeting.
• Presented clinical data for trofinetide at medical congresses in October, including the positive Phase 3 Lavender results and the Daffodil study in girls aged 2-4 with Rett syndrome, at the 51st Annual Meeting of the Child Neurology Society (CNS) in Cincinnati, OH and the National Organization for Rare Diseases (NORD) & Orphan Products 2022 Summit in Washington, DC.
• Continue to expect enrollment to complete in ADVANCE-2, a Phase 3 study evaluating pimavanserin for the negative symptoms of schizophrenia, around mid-year 2023.
• Announced that Acadia’s President Serge Stankovic, M.D., M.S.P.H. will retire at the end of the year. A search for a successor to Dr. Stankovic is ongoing. Following his retirement, Dr. Stankovic will provide consulting and advisory services for Acadia on a part-time basis.
• Appointed Adora Ndu, Pharm.D., J.D. to Acadia’s Board of Directors. Dr. Ndu is a biopharma executive with significant regulatory and clinical development experience, combined with an extensive background in rare disease that nicely complements the skill sets of Acadia’s current Board membership.
Financial Results
Revenue
Net sales of NUPLAZID® (pimavanserin) were $130.7 million for the three months ended September 30, 2022, a decrease of 1% as compared to $131.6 million reported for the three months ended September 30, 2021. Net sales for the quarter were driven by sequential demand growth of 2% and an acceleration of growth in the LTC channel, offset by a reduction of in-channel inventory of approximately $7 million. For the nine months ended September 30, 2022, Acadia reported net product sales of $380.7 million, an increase of approximately 8% as compared to $353.4 million reported for the nine months ended September 30, 2021.
Research and Development
Research and development expenses for the three months ended September 30, 2022 were $81.3 million, compared to $58.6 million for the same period of 2021. The increase in research and development expenses during the quarter was primarily due to a $10 million milestone payment accrued to Neuren upon acceptance of the trofinetide NDA filing, as well as increased costs of manufacturing activities for trofinetide and the development of early-stage programs. For the nine months ended September 30, 2022 and 2021, research and development expenses were $285.8 million and $172.5 million. The increase was primarily due to the $60 million upfront payment made to Stoke Therapeutics for a license and collaboration agreement and the previously mentioned $10 million milestone as well as increased costs for trofinetide and early-stage programs.
Selling, General and Administrative
Selling, general and administrative expenses for the three months ended September 30, 2022 were $78.1 million, compared to $81.7 million for the same period of 2021. For the nine months ended September 30, 2022 and 2021, selling, general and administrative expenses were $264.7 million and $290.1 million, respectively. The decrease was primarily due to decreased advertising and promotional costs.
Net Loss
For the three months ended September 30, 2022, Acadia reported a net loss of $27.2 million, or $0.17 per common share, compared to a net loss of $14.5 million, or $0.09 per common share, for the same period in 2021. The net losses for the three months ended September 30, 2022 and 2021 included $18.3 million and $15.5 million, respectively, of non-cash stock-based compensation expense. For the nine months ended September 30, 2022, Acadia reported a net loss of $174.3 million, or $1.08 per common share, compared to a net loss of $124.8 million, or $0.78 per common share, for the same period in 2021. The increase was mainly due to the upfront and milestone payments made for license and collaboration agreements in 2022. The net losses for the nine months ended September 30, 2022 and 2021 included $53.8 million and $50.7 million, respectively, of non-cash stock-based compensation expense.
Cash and Investments
At September 30, 2022, Acadia’s cash, cash equivalents, and investment securities totaled $436.6 million, compared to $520.7 million at December 31, 2021.
2022 Financial Guidance
• NUPLAZID net sales guidance is updated to $510 to $520 million from the previous range of $510 to $540 million.
• GAAP R&D guidance is updated to $345 to $355 million from the previous range of $340 to $360 million, which includes approximately $25 million of stock-based compensation expense.
• GAAP SG&A guidance is updated to $365 to $375 million from the previous range of $360 to $380 million, which includes approximately $45 million of stock-based compensation expense.
Conference Call and Webcast Information
The conference call may 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. The registration link will also be available on Acadia’s website, www.acadia.com under the investors section and will be archived there until December 7, 2022.
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 in other neuropsychiatric conditions.
About Trofinetide
Trofinetide is an investigational drug. It is a novel synthetic analog of the amino‐terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function. Trofinetide is thought to stimulate synaptic maturation and overcome the synaptic and neuronal immaturities that are characteristic of Rett syndrome pathophysiology. In the central nervous system, IGF-1 is produced by both of the major types of brain cells – neurons and glia. IGF-1 in the brain is critical for both normal development and for response to injury and disease. Trofinetide has been shown to inhibit the production of inflammatory cytokines, inhibit the overactivation of microglia and astrocytes, and increase the amount of available IGF-1 that can bind to IGF-1 receptors.
About Acadia Pharmaceuticals
Acadia is advancing breakthroughs in neuroscience to elevate life. For more than 25 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 therapy for hallucinations and delusions associated with Parkinson’s disease psychosis. Our clinical-stage development efforts are focused on treating the negative symptoms of schizophrenia, Rett syndrome 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 related to: the potential opportunity for future growth in sales of NUPLAZID; the timing of ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide; and guidance for full-year 2022 NUPLAZID net sales for Parkinson’s disease psychosis only and certain expense line items. 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 uncertainty of future commercial sales and related items that would impact net sales during 2022, the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. 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, 2021 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.
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Revenues | ||||||||||||
| Product sales, net | $ | 130,714 | $ | 131,612 | $ | 380,745 | $ | 353,387 | ||||
| Total revenues | 130,714 | 131,612 | 380,745 | 353,387 | ||||||||
| Operating expenses | ||||||||||||
| Cost of product sales, license fees and royalties (1) | 2,136 | 6,682 | 7,753 | 16,580 | ||||||||
| Research and development (1) | 81,336 | 58,565 | 285,837 | 172,473 | ||||||||
| Selling, general and administrative (1) | 78,108 | 81,666 | 264,688 | 290,116 | ||||||||
| Total operating expenses | 161,580 | 146,913 | 558,278 | 479,169 | ||||||||
| Loss from operations | (30,866 | ) | (15,301 | ) | (177,533 | ) | (125,782 | ) | ||||
| Interest income, net | 2,295 | 129 | 2,980 | 462 | ||||||||
| Other income | 2,156 | 383 | 1,999 | 706 | ||||||||
| Loss before income taxes | (26,415 | ) | (14,789 | ) | (172,554 | ) | (124,614 | ) | ||||
| Income tax expense (benefit) | 768 | (332 | ) | 1,696 | 162 | |||||||
| Net loss | $ | (27,183 | ) | $ | (14,457 | ) | $ | (174,250 | ) | $ | (124,776 | ) |
| Net loss per common share, basic and diluted | $ | (0.17 | ) | $ | (0.09 | ) | $ | (1.08 | ) | $ | (0.78 | ) |
| Weighted average common shares outstanding, basic and diluted | 161,852 | 160,663 | 161,580 | 159,651 | ||||||||
| (1) Includes the following stock-based compensation expense | ||||||||||||
| Cost of product sales, license fees and royalties | $ | 344 | $ | 439 | $ | 1,013 | $ | 1,025 | ||||
| Research and development | $ | 6,452 | $ | 5,176 | $ | 19,148 | $ | 17,325 | ||||
| Selling, general and administrative | $ | 11,516 | $ | 9,931 | $ | 33,626 | $ | 32,385 |
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
| September 30,<br>2022 | December 31,<br>2021 | |||
|---|---|---|---|---|
| (unaudited) | ||||
| Assets | ||||
| Cash, cash equivalents and investment securities | $ | 436,579 | $ | 520,706 |
| Accounts receivable, net | 55,733 | 64,366 | ||
| Interest and other receivables | 403 | 978 | ||
| Inventory | 5,844 | 7,881 | ||
| Prepaid expenses | 22,993 | 23,892 | ||
| Total current assets | 521,552 | 617,823 | ||
| Property and equipment, net | 6,510 | 8,047 | ||
| Operating lease right-of-use assets | 56,624 | 58,268 | ||
| Restricted cash | 5,770 | 5,770 | ||
| Long-term inventory | 5,992 | 6,217 | ||
| Other assets | 6,043 | 3,997 | ||
| Total assets | $ | 602,491 | $ | 700,122 |
| Liabilities and stockholders’ equity | ||||
| Accounts payable | $ | 10,008 | $ | 6,876 |
| Accrued liabilities | 106,562 | 89,192 | ||
| Total current liabilities | 116,570 | 96,068 | ||
| Operating lease liabilities | 53,769 | 56,126 | ||
| Other long-term liabilities | 6,466 | 7,034 | ||
| Total liabilities | 176,805 | 159,228 | ||
| Total stockholders’ equity | 425,686 | 540,894 | ||
| Total liabilities and stockholders’ equity | $ | 602,491 | $ | 700,122 |
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