Acadia Pharmaceuticals Reports First Quarter 2021 Financial Results
- 1Q21 net sales of
- Reiterating FY21 net sales guidance of
“NUPLAZID delivered strong year-over-year performance in the first quarter of 2021. Looking ahead, we see positive signs in the Parkinson’s disease psychosis market supporting revenue growth for the remainder of the year as we anticipate continued improvements in the conditions related to the pandemic,” said
Company Updates
-
The Company received a Complete Response Letter (CRL) from the
U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The Company plans to conduct a Type A meeting with the FDA to discuss the CRL and potential next steps to support an approval.
- Top-line results from the Phase 3 LAVENDER study evaluating trofinetide for the treatment of Rett syndrome are expected in the fourth quarter of 2021.
-
A Phase 2 study was initiated evaluating ACP-044, a novel, first-in-class, orally administered, non-opioid analgesic for the treatment of postoperative pain following bunionectomy surgery in
March 2021 .
- A Phase 2 study evaluating ACP-044 for the treatment of pain associated with osteoarthritis is expected to commence in the second 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
-
Acadia is reiterating its NUPLAZID net sales guidance of
$510 to$550 million . -
GAAP R&D guidance is decreased to
$280 to$300 million from the previous range of$300 to$320 million . Current R&D guidance includes approximately$25 million of stock-based compensation expense. -
GAAP SG&A guidance is decreased to
$385 to$415 million from the previous range of$560 to$590 million . Previous guidance included additional investments associated with the potential DRP launch in 2021 and updated guidance reflects a reduction in these expenses. Current SG&A guidance includes approximately$50 million of stock-based compensation expense.
Conference Call and Webcast Information
Acadia management will review its first quarter financial results and operations via conference call and webcast today at
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 approved for any other neuropsychiatric disorders. Acadia discovered and developed this new chemical entity and holds worldwide rights to develop and commercialize NUPLAZID.
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 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.
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
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) |
||||||||
|
|
Three Months Ended |
|
|||||
|
|
2021 |
|
|
2020 |
|
||
Revenues |
|
|
|
|
|
|
|
|
Product sales, net |
|
$ |
106,554 |
|
|
$ |
90,068 |
|
Total revenues |
|
|
106,554 |
|
|
|
90,068 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Cost of product sales, license fees and royalties (1) |
|
|
4,692 |
|
|
|
4,974 |
|
Research and development (1) |
|
|
56,973 |
|
|
|
72,636 |
|
Selling, general and administrative (1) |
|
|
111,661 |
|
|
|
101,973 |
|
Total operating expenses |
|
|
173,326 |
|
|
|
179,583 |
|
Loss from operations |
|
|
(66,772 |
) |
|
|
(89,515 |
) |
Interest income, net |
|
|
200 |
|
|
|
2,989 |
|
Other income (expense) |
|
|
145 |
|
|
|
(1,497 |
) |
Loss before income taxes |
|
|
(66,427 |
) |
|
|
(88,023 |
) |
Income tax expense |
|
|
21 |
|
|
|
— |
|
Net loss |
|
$ |
(66,448 |
) |
|
$ |
(88,023 |
) |
Net loss per common share, basic and diluted |
|
$ |
(0.42 |
) |
|
$ |
(0.57 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
160,011 |
|
|
|
155,368 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Includes the following stock-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales, license fees and royalties |
|
$ |
163 |
|
|
$ |
849 |
|
Research and development |
|
$ |
4,830 |
|
|
$ |
8,457 |
|
Selling, general and administrative |
|
$ |
8,191 |
|
|
$ |
13,042 |
|
CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) |
||||||||
|
|
|
|
|
|
|
||
|
|
(unaudited) |
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Cash, cash equivalents and investment securities |
|
$ |
577,768 |
|
|
$ |
631,958 |
|
Accounts receivable, net |
|
|
56,832 |
|
|
|
48,247 |
|
Interest and other receivables |
|
|
558 |
|
|
|
2,035 |
|
Inventory |
|
|
10,311 |
|
|
|
9,682 |
|
Prepaid expenses |
|
|
28,515 |
|
|
|
25,694 |
|
Total current assets |
|
|
673,984 |
|
|
|
717,616 |
|
Property and equipment, net |
|
|
9,757 |
|
|
|
9,161 |
|
Operating lease right-of-use assets |
|
|
63,111 |
|
|
|
47,283 |
|
Intangible assets, net |
|
|
738 |
|
|
|
1,108 |
|
Restricted cash |
|
|
5,770 |
|
|
|
5,770 |
|
Other assets |
|
|
1,813 |
|
|
|
1,678 |
|
Total assets |
|
$ |
755,173 |
|
|
$ |
782,616 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
8,849 |
|
|
$ |
8,493 |
|
Accrued liabilities |
|
|
100,524 |
|
|
|
97,474 |
|
Total current liabilities |
|
|
109,373 |
|
|
|
105,967 |
|
Operating lease liabilities |
|
|
60,581 |
|
|
|
44,460 |
|
Other long-term liabilities |
|
|
3,613 |
|
|
|
5,180 |
|
Total liabilities |
|
|
173,567 |
|
|
|
155,607 |
|
Total stockholders’ equity |
|
|
581,606 |
|
|
|
627,009 |
|
Total liabilities and stockholders’ equity |
|
$ |
755,173 |
|
|
$ |
782,616 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20210505006004/en/
Media Contact:
(858) 914-7161
media@acadia-pharm.com
Investor Contact:
(858) 261-2771
ir@acadia-pharm.com
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