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): February 28, 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 February 28, 2022, Acadia Pharmaceuticals Inc. issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2021. 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 February 28, 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: | February 28, 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
Fourth Quarter and Full Year 2021 Financial Results
Full year 2021 net sales grew to $484.1 million, a 10% increase over 2020
Resubmitted sNDA for pimavanserin
for the treatment of Alzheimer's disease psychosis
- Delivered positive top-line results from the pivotal Phase 3 Lavender trial evaluating
trofinetide for the treatment of Rett syndrome
SAN DIEGO, CA, February 28, 2022 – Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced financial results for the fourth quarter and full year ended December 31, 2021.
“Acadia delivered strong fourth quarter and full year results with an increase in net sales of 10 percent year over year, driven by growth in both NUPLAZID prescriptions and market share,” said Steve Davis, Chief Executive Officer. “We recently resubmitted our sNDA for pimavanserin for Alzheimer’s disease psychosis to the FDA. In addition, this year we plan to submit an NDA for trofinetide for the treatment of Rett syndrome, complete enrollment in our pivotal ADVANCE-2 study for pimavanserin for the negative symptoms of schizophrenia, and deliver results from two Phase 2 studies for ACP-044 in postoperative and osteoarthritis pain.”
Company Highlights
• Grew NUPLAZID® (pimavanserin) total prescriptions and market share, and outperformed other branded drugs in neurology, the Parkinson’s market, and long-term care facilities.
• Resubmitted supplemental New Drug Application (sNDA) of NUPLAZID (pimavanserin) for the treatment of the hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP) to the U.S. Food and Drug Administration (FDA).
• Delivered positive top-line results from the pivotal Phase 3 Lavender study of trofinetide in Rett syndrome and plan to submit an NDA to the FDA around mid-year 2022.
• Announced collaboration with Stoke Therapeutics to pursue multiple RNA-based treatments for severe and rare genetic neurodevelopmental diseases for SYNGAP1 syndrome, Rett syndrome (MECP2), and an undisclosed neurodevelopmental target of mutual interest.
• Expect top-line results from a Phase 2 study evaluating ACP-044 for the treatment of postoperative pain following bunionectomy surgery around the end of the first quarter of 2022.
• Published results from the ADVANCE study evaluating pimavanserin for the treatment of the negative symptoms of schizophrenia in The Lancet Psychiatry.
Financial Results
Revenue
Net sales of NUPLAZID (pimavanserin) were $130.8 million for the fourth quarter of 2021, an increase of 8% as compared to $121.0 million reported for the fourth quarter of 2020. For the years ended December 31, 2021 and 2020, Acadia reported net product sales of $484.1 million and $441.8 million, respectively, an increase of 10% year-over-year.
Research and Development
Research and development expenses for the fourth quarter of 2021 were $67.1 million, compared to $62.1 million for the same period of 2020. For the years ended December 31, 2021 and 2020, research and development expenses were $239.4 million and $319.1 million, respectively. The decrease was primarily due to the $52.8 million in upfront consideration and transaction costs paid for the acquisition of CerSci and $10.0 million upfront payment to Vanderbilt University for the M1 PAM program in 2020, partially offset by an increase in costs related to trofinetide.
Selling, General and Administrative
Selling, general and administrative expenses for the fourth quarter of 2021 were $105.8 million, compared to $120.8 million for the same period of 2020. For the years ended December 31, 2021 and 2020, selling, general and administrative expenses were $396.0 million and $388.7 million, respectively.
Net Loss
For the fourth quarter of 2021, Acadia reported a net loss of $43.1 million, or $0.27 per common share, compared to a net loss of $66.8 million, or $0.42 per common share, for the same period in 2020. The net losses for the fourth quarters of 2021 and 2020 included $12.9 million and $21.2 million, respectively, of non-cash stock-based compensation expense. For the year ended December 31, 2021, Acadia reported a net loss of $167.9 million, or $1.05 per common share, compared to a net loss of $281.6 million, or $1.79 per common share, for the same period in 2020. The net losses for the years ended December 31, 2021 and 2020 included $63.6 million and $84.4 million, respectively, of non-cash stock-based compensation expense.
Cash and Investments
At December 31, 2021, Acadia’s cash, cash equivalents, and investment securities totaled $520.7 million, compared to $632.0 million at December 31, 2020.
2022 Financial Guidance
• NUPLAZID net sales guidance in Parkinson’s disease psychosis is $510 to $560 million.
• GAAP R&D guidance is $355 to $375 million and includes approximately $25 million of stock-based compensation expense.
• GAAP SG&A guidance is $360 to $380 million and includes approximately $45 million of stock-based compensation expense.
Conference Call and Webcast Information
Acadia management will review its fourth quarter and full year financial results and operations via conference call and webcast today at 4:30 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 6887457). A telephone replay of the conference call may be accessed through March 14, 2022 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 6887457). The conference call also will be webcast live on Acadia’s website, www.acadia-pharm.com under the investors section and will be archived there until March 28, 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. NUPLAZID is not approved for Alzheimer’s disease psychosis. 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. Trofinetide has been granted Fast Track Status and Orphan Drug Designation for Rett syndrome and has also been granted Rare Pediatric Disease (RPD) designation by the FDA.
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 late-stage development efforts are focused on treating psychosis in patients with dementia, the negative symptoms of schizophrenia and Rett syndrome. Our early-stage development efforts are focused on novel approaches to pain management, cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.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, 2020 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 December 31, | Years Ended December 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2021 | 2020 | |||||||||
| Revenues | ||||||||||||
| Product sales, net | $ | 130,758 | $ | 121,007 | $ | 484,145 | $ | 441,755 | ||||
| Total revenues | 130,758 | 121,007 | 484,145 | 441,755 | ||||||||
| Operating expenses | ||||||||||||
| Cost of product sales, license fees and royalties (1) | 2,561 | 5,301 | 19,141 | 20,550 | ||||||||
| Research and development (1) | 67,084 | 62,116 | 239,415 | 319,130 | ||||||||
| Selling, general and administrative (1) | 105,770 | 120,752 | 396,028 | 388,661 | ||||||||
| Total operating expenses | 175,415 | 188,169 | 654,584 | 728,341 | ||||||||
| Loss from operations | (44,657 | ) | (67,162 | ) | (170,439 | ) | (286,586 | ) | ||||
| Interest income, net | 129 | 554 | 591 | 6,610 | ||||||||
| Other income (expense) | 1,623 | 265 | 2,329 | (997 | ) | |||||||
| Loss before income taxes | (42,905 | ) | (66,343 | ) | (167,519 | ) | (280,973 | ) | ||||
| Income tax (benefit) expense | 189 | 417 | 351 | 611 | ||||||||
| Net loss | $ | (43,094 | ) | $ | (66,760 | ) | $ | (167,870 | ) | $ | (281,584 | ) |
| Net loss per common share, basic and diluted | $ | (0.27 | ) | $ | (0.42 | ) | $ | (1.05 | ) | $ | (1.79 | ) |
| Weighted average common shares outstanding, basic and diluted | 160,866 | 159,263 | 160,493 | 157,331 | ||||||||
| (1) Includes the following share-based compensation expenses | ||||||||||||
| Cost of product sales, license fees and royalties | $ | 261 | $ | 545 | $ | 1,286 | $ | 2,632 | ||||
| Research and development | $ | 4,644 | $ | 7,669 | $ | 21,969 | $ | 31,314 | ||||
| Selling, general and administrative | $ | 7,975 | $ | 12,981 | $ | 40,360 | $ | 50,476 |
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
| December 31,<br>2021 | December 31,<br>2020 | |||
|---|---|---|---|---|
| (unaudited) | ||||
| Assets | ||||
| Cash, cash equivalents and investment securities | $ | 520,706 | $ | 631,958 |
| Accounts receivable, net | 64,366 | 48,247 | ||
| Interest and other receivables | 978 | 2,035 | ||
| Inventory | 7,881 | 9,682 | ||
| Prepaid expenses | 23,892 | 25,694 | ||
| Total current assets | 617,823 | 717,616 | ||
| Property and equipment, net | 8,047 | 9,161 | ||
| Operating lease right-of-use assets | 58,268 | 47,283 | ||
| Intangible assets, net | — | 1,108 | ||
| Restricted cash | 5,770 | 5,770 | ||
| Long-term inventory | 6,217 | — | ||
| Other assets | 3,997 | 1,678 | ||
| Total assets | $ | 700,122 | $ | 782,616 |
| Liabilities and stockholders’ equity | ||||
| Accounts payable | $ | 6,876 | $ | 8,493 |
| Accrued liabilities | 89,192 | 97,474 | ||
| Total current liabilities | 96,068 | 105,967 | ||
| Operating lease liabilities | 56,126 | 44,460 | ||
| Long-term liabilities | 7,034 | 5,180 | ||
| Total liabilities | 159,228 | 155,607 | ||
| Total stockholders’ equity | 540,894 | 627,009 | ||
| Total liabilities and stockholders’ equity | $ | 700,122 | $ | 782,616 |
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