Full Press Release Details
Acadia Pharmaceuticals Reports
Fourth Quarter and Full Year 2020 Financial Results
- Full year 2020 net sales grew to $441.8 million, a 30% increase over 2019
- Upcoming PDUFA action date of April 3, 2021 for supplemental New Drug Application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis
SAN DIEGO, CA, February 24, 2021 - Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced financial results for the fourth quarter and full year ended December 31, 2020.
"Acadia delivered strong financial results in the fourth quarter and full year 2020, driven by robust sales of NUPLAZID in Parkinson's disease psychosis. Additionally, we made significant advancements in two Phase 3 programs and further expanded our pipeline in pain and neuropsychiatry through strategic business development," said Steve Davis, Chief Executive Officer. "In 2021, we are focused on delivering continued growth of NUPLAZID, the upcoming potential approval and launch of pimavanserin for dementia-related psychosis and advancing our business development strategy."
Net sales of NUPLAZID (pimavanserin) were $121.0 million for the fourth quarter of 2020, an increase of 23% as compared to $98.3 million reported for the fourth quarter of 2019. For the years ended December 31, 2020 and 2019, Acadia reported net product sales of $441.8 million and $339.1 million, respectively, an increase of 30% year-over-year.
Research and Development
Research and development expenses for the fourth quarter of 2020 were $62.1 million, compared to $57.5 million for the same period of 2019. For the years ended December 31, 2020 and 2019, research and development expenses were $319.1 million and $240.4 million, respectively. The increase in full year 2020 was primarily due to the upfront expenses of $52.8 million related to the acquisition of CerSci Therapeutics and a $10.0 million upfront payment to Vanderbilt University related to the license agreement and collaboration for novel therapeutic programs targeting muscarinic M1 receptors.
Selling, General and Administrative
Selling, general and administrative expenses for the fourth quarter of 2020 were $120.8 million, compared to $91.9 million for the same period of 2019. For the years ended December 31, 2020 and 2019, selling, general and administrative expenses were $388.7 million and $325.6 million, respectively. This increase during the 2020 period as compared to 2019 was primarily due to increased advertising and promotional costs, dementia-related psychosis launch preparation expenses, as well as an increase in personnel and related costs.
For the fourth quarter of 2020, Acadia reported a net loss of $66.8 million, or $0.42 per common share, compared to a net loss of $53.0 million, or $0.34 per common share, for the same period in 2019. The net losses for the fourth quarters of 2020 and 2019 included $21.2 million and $19.8 million, respectively, of non-cash stock-based compensation expense. For the year ended December 31, 2020, Acadia reported a net loss of $281.6 million, or $1.79 per common share, compared to a net loss of $235.3 million, or $1.60 per common share, for the same period in 2019. The net losses for the years ended December 31, 2020 and 2019 included $84.4 million and $82.3 million, respectively, of non-cash stock-based compensation expense.
Cash and Investments
At December 31, 2020, Acadia's cash, cash equivalents, and investment securities totaled $632.0 million, compared to $697.4 million at December 31, 2019.
2021 Financial Guidance
Conference Call and Webcast Information
Acadia management will review its fourth quarter and full year 2020 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 9576845). A telephone replay of the conference call may be accessed through March 10, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 9576845). 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 through March 24, 2021.
About NUPLAZID (pimavanserin)
NUPLAZID is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson's disease psychosis. NUPLAZID is a selective serotonin inverse agonist/antagonist preferentially targeting 5-HT2A receptors that are thought to play an important role in Parkinson's disease psychosis. NUPLAZID is an oral medicine taken once a day with a recommended dose of 34 mg. NUPLAZID is not FDA-approved for dementia-related psychosis, schizophrenia, major depressive disorder, or depressive symptoms in patients with Parkinson's disease. Acadia discovered and developed this new chemical entity and holds worldwide rights to develop and commercialize NUPLAZID.
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. 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 granted Fast Track Status and Orphan Drug Designation in the U.S. and Orphan Drug Designation in Europe for both Rett syndrome and Fragile X syndrome.
About Acadia Pharmaceuticals
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 2021 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 2021, 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, 2019 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)
| Three Months Ended December 31, | Years Ended December 31, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenues | ||||||||||||||||
| Product sales, net | $ | 121,007 | $ | 98,326 | $ | 441,755 | $ | 339,076 | ||||||||
| Total revenues | 121,007 | 98,326 | 441,755 | 339,076 | ||||||||||||
| Operating expenses | ||||||||||||||||
| Cost of product sales, license fees and royalties (1) | 5,301 | 5,334 | 20,550 | 19,598 | ||||||||||||
| Research and development (1) | 62,116 | 57,520 | 319,130 | 240,385 | ||||||||||||
| Selling, general and administrative (1) | 120,752 | 91,871 | 388,661 | 325,638 | ||||||||||||
| Total operating expenses | 188,169 | 154,725 | 728,341 | 585,621 | ||||||||||||
| Loss from operations | (67,162 | ) | (56,399 | ) | (286,586 | ) | (246,545 | ) | ||||||||
| Interest income, net | 554 | 3,272 | 6,610 | 11,165 | ||||||||||||
| Other income (expense) | 265 | 491 | (997 | ) | 997 | |||||||||||
| Loss before income taxes | (66,343 | ) | (52,636 | ) | (280,973 | ) | (234,383 | ) | ||||||||
| Income tax (benefit) expense | 417 | 400 | 611 | 876 | ||||||||||||
| Net loss | $ | (66,760 | ) | $ | (53,036 | ) | $ | (281,584 | ) | $ | (235,259 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.42 | ) | $ | (0.34 | ) | $ | (1.79 | ) | $ | (1.60 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 159,263 | 154,492 | 157,331 | 147,199 | ||||||||||||
| (1) Includes the following share-based compensation expenses | ||||||||||||||||
| Cost of product sales, license fees and royalties | $ | 545 | $ | 592 | $ | 2,632 | $ | 2,936 | ||||||||
| Research and development | $ | 7,669 | $ | 8,072 | $ | 31,314 | $ | 32,533 | ||||||||
| Selling, general and administrative | $ | 12,981 | $ | 11,099 | $ | 50,476 | $ | 46,796 |
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| December 31, 2020 | December 31, 2019 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Cash, cash equivalents and investment securities | $ | 631,958 | $ | 697,429 | ||||
| Accounts receivable, net | 48,247 | 35,781 | ||||||
| Interest and other receivables | 2,035 | 2,093 | ||||||
| Inventory | 9,682 | 6,341 | ||||||
| Prepaid expenses | 25,694 | 18,606 | ||||||
| Total current assets | 717,616 | 760,250 | ||||||
| Property and equipment, net | 9,161 | 3,180 | ||||||
| Operating lease right-of-use assets | 47,283 | 9,524 | ||||||
| Intangible assets, net | 1,108 | 2,585 | ||||||
| Restricted cash | 5,770 | 4,787 | ||||||
| Other assets | 1,678 | 2,857 | ||||||
| Total assets | $ | 782,616 | $ | 783,183 | ||||
| Liabilities and stockholders' equity | ||||||||
| Accounts payable | $ | 8,493 | $ | 7,222 | ||||
| Accrued liabilities | 97,474 | 67,604 | ||||||
| Total current liabilities | 105,967 | 74,826 | ||||||
| Operating lease liabilities | 44,460 | 6,361 | ||||||
| Long-term liabilities | 5,180 | 2,861 | ||||||
| Total liabilities | 155,607 | 84,048 | ||||||
| Total stockholders' equity | 627,009 | 699,135 | ||||||
| Total liabilities and stockholders' equity | $ | 782,616 | $ | 783,183 |
Acadia Pharmaceuticals Inc.
Acadia Pharmaceuticals Inc.