- 2Q21 net sales of
- Fiscal year 2021 revenue guidance reduced to
- Type A meeting held with FDA regarding DRP; Acadia will continue discussion with FDA in another meeting later this year
“NUPLAZID performed well in the second quarter of 2021, highlighted by our ability to drive growth while still navigating the continued impact from the pandemic,” said
Company Updates
- Completed a Type A End of Review meeting regarding the FDA’s complete response letter (CRL) for the sNDA for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). At the meeting, the FDA reiterated their stated position in the CRL, that pimavanserin should be studied by individual subgroups of dementia, and advised that the best path forward is to conduct an additional clinical study in each of the subgroups for which we seek approval. However, the FDA also indicated that they are open to having another meeting to discuss additional analyses from the HARMONY and -019 studies in support of a potential resubmission without an additional clinical study.
- The
New England Journal of Medicine published the positive results from the Phase 3 HARMONY study evaluating pimavanserin in patients with dementia-related psychosis inJuly 2021 .
- Results from an open-label extension safety study with pimavanserin supporting sustained response in Parkinson’s disease psychosis patients was published online in the
June 2021 issue of Parkinsonism and Related Disorders.
- Completed enrollment of the Phase 3 LAVENDER study evaluating trofinetide for the treatment of Rett syndrome, with top-line results expected in the fourth quarter of 2021.
- Initiated a Phase 2 study of ACP-044 for pain associated with osteoarthritis in the second quarter of 2021.
- Top-line results from the Phase 2 study of ACP-044 for the treatment of postoperative pain following bunionectomy surgery are expected in the fourth quarter of 2021.
Financial Results
Revenue
Net sales of NUPLAZID® (pimavanserin) were
Research and Development
Research and development expenses for the three months ended
Selling, General and Administrative
Selling, general and administrative expenses for the three months ended
Net Loss
For the three months ended
Cash and Investments
At
2021 Financial Guidance
- NUPLAZID net sales guidance is decreased to
$480 to$515 million from the previous range of$510 to$550 million as a result of the continued impact of the pandemic with fewer Parkinson’s disease patient office visits and lower occupancy rates at long-term care facilities, as well as a revised gross-to-net expectation of approximately 20% compared to prior expectation of high teens. - GAAP R&D is decreased to
$250 to$270 million from the previous range of$280 to$300 million . Current R&D guidance includes approximately$25 million of stock-based compensation expense. - GAAP SG&A guidance is reiterated at
$385 to$415 million . Current SG&A guidance includes approximately$50 million of stock-based compensation expense.
Conference Call and Webcast Information
Acadia management will review its second quarter financial results and operations via conference call and webcast today at
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
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. 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
About Acadia Pharmaceuticals
Acadia is trailblazing 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 dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and 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 2021 NUPLAZID net sales for Parkinson’s disease psychosis 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
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Revenues | ||||||||||||||||
Product sales, net | $ | 115,221 | $ | 110,103 | $ | 221,775 | $ | 200,171 | ||||||||
Total revenues | 115,221 | 110,103 | 221,775 | 200,171 | ||||||||||||
Operating expenses | ||||||||||||||||
Cost of product sales, license fees and royalties (1) | 5,206 | 5,474 | 9,898 | 10,448 | ||||||||||||
Research and development (1) | 56,935 | 64,295 | 113,908 | 136,931 | ||||||||||||
Selling, general and administrative (1) | 96,789 | 84,344 | 208,450 | 186,317 | ||||||||||||
Total operating expenses | 158,930 | 154,113 | 332,256 | 333,696 | ||||||||||||
Loss from operations | (43,709 | ) | (44,010 | ) | (110,481 | ) | (133,525 | ) | ||||||||
Interest income, net | 133 | 1,825 | 333 | 4,814 | ||||||||||||
Other income (expense) | 178 | 437 | 323 | (1,060 | ) | |||||||||||
Loss before income taxes | (43,398 | ) | (41,748 | ) | (109,825 | ) | (129,771 | ) | ||||||||
Income tax expense | 473 | 393 | 494 | 393 | ||||||||||||
Net loss | $ | (43,871 | ) | $ | (42,141 | ) | $ | (110,319 | ) | $ | (130,164 | ) | ||||
Net loss per common share, basic and diluted | $ | (0.27 | ) | $ | (0.27 | ) | $ | (0.69 | ) | $ | (0.83 | ) | ||||
Weighted average common shares outstanding, basic and diluted | 160,421 | 156,535 | 160,217 | 155,951 | ||||||||||||
(1) Includes the following stock-based compensation expense | ||||||||||||||||
Cost of product sales, license fees and royalties | $ | 423 | $ | 743 | $ | 586 | $ | 1,592 | ||||||||
Research and development | $ | 7,319 | $ | 7,235 | $ | 12,149 | $ | 15,692 | ||||||||
Selling, general and administrative | $ | 14,263 | $ | 11,529 | $ | 22,454 | $ | 24,571 | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) | ||||||||
2021 | 2020 | |||||||
(unaudited) | ||||||||
Assets | ||||||||
Cash, cash equivalents and investment securities | $ | 556,918 | $ | 631,958 | ||||
Accounts receivable, net | 51,367 | 48,247 | ||||||
Interest and other receivables | 453 | 2,035 | ||||||
Inventory | 10,786 | 9,682 | ||||||
Prepaid expenses | 26,206 | 25,694 | ||||||
Total current assets | 645,730 | 717,616 | ||||||
Property and equipment, net | 9,197 | 9,161 | ||||||
Operating lease right-of-use assets | 61,371 | 47,283 | ||||||
Intangible assets, net | 369 | 1,108 | ||||||
Restricted cash | 5,770 | 5,770 | ||||||
Other assets | 1,992 | 1,678 | ||||||
Total assets | $ | 724,429 | $ | 782,616 | ||||
Liabilities and stockholders’ equity | ||||||||
Accounts payable | $ | 9,065 | $ | 8,493 | ||||
Accrued liabilities | 86,263 | 97,474 | ||||||
Total current liabilities | 95,328 | 105,967 | ||||||
Operating lease liabilities | 59,134 | 44,460 | ||||||
Other long-term liabilities | 5,129 | 5,180 | ||||||
Total liabilities | 159,591 | 155,607 | ||||||
Total stockholders’ equity | 564,838 | 627,009 | ||||||
Total liabilities and stockholders’ equity | $ | 724,429 | $ | 782,616 | ||||
Media Contact:
(858) 914-7161
media@acadia-pharm.com
Investor Contact:
(858) 261-2771
ir@acadia-pharm.com
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