Acadia Pharmaceuticals Reports Third Quarter 2020 Financial Results
- 3Q20
“This quarter we drove strong performance through the continued growth of new prescribers with more patients benefitting from NUPLAZID® treatment for their Parkinson’s disease psychosis and remain on-track with our supplemental NDA for the treatment of dementia-related psychosis with a PDUFA date of
Company Updates
-
New clinical analyses across multiple studies of pimavanserin are being presented at this week’s 13th Clinical Trials on Alzheimer’s Disease (CTAD) meeting, including:
-
Oral presentation by Dr.
Clive Ballard ,University of Exeter Medical School : “Impact of Pimavanserin on Cognitive Measures in Patients with Neurodegenerative Disease: Results from 4 Placebo-Controlled Clinical Studies.” -
Poster presentation by Dr.
Daniel Weintraub ,Perelman School of Medicine at theUniversity of Pennsylvania : “Impact of Pimavanserin Treatment on Motor Function in Patients with Neurodegenerative Disease: Results from 3 Clinical Studies.”
-
Oral presentation by Dr.
-
In October, Acadia announced a partnership with
The Lewy Body Dementia Association (LBDA) on the release of a disease education adaptation of the new documentary Robin’s Wish©. The film is titled, “SPARK -Robin Williams and his Battle with Lewy Body Dementia©,” and will be available to academic research institutions and universities as part of educational programming for healthcare professionals.
- In October, Acadia presented a poster titled “Healthcare Resource Utilization and Associated Costs for Dementia Patients with Psychosis: A Medicare Database Study,” at the Academy of Managed Care Pharmacy’s (AMCP) Nexus conference, and received a Silver ribbon based on its relevance, originality, quality, bias and clarity of results.
- In August, Acadia acquired CerSci Therapeutics, a clinical-stage biotechnology company with worldwide rights to a portfolio of novel compounds for neurological conditions, including non-opioid therapies for acute and chronic pain. Acadia plans to initiate a Phase 2 program with the lead compound, ACP-044, in the first half of 2021.
-
Appointed Dr. Gudarz Davar as Executive Vice President and Head of Research and Development, reporting to
Serge Stankovic , M.D., M.S.P.H., President of Acadia.
-
Elizabeth (Betsy) Garofalo , M.D. was appointed to the Acadia Board of Directors.
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
2020 Financial Guidance
-
Acadia reiterates its NUPLAZID net sales guidance of
$430 to$450 million . -
GAAP R&D guidance is increased to
$325 to$340 million from the previous range of$265 to$280 million , primarily as a result of the$52.8 million upfront and transaction expenses associated with the acquisition of CerSci Therapeutics. -
GAAP SG&A guidance is decreased to
$385 to$400 million from the previous range of$400 to$420 million . -
Non-cash stock-based compensation expense guidance is decreased to
$80 to$90 million from the previous range of$90 to$100 million . -
2020 year-end cash, cash equivalents, and investment securities guidance of
$570 to$590 million is unchanged.
Conference Call and Webcast Information
Acadia management will review its third 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 FDA-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 through science. 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, 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, ACP-044 and the M1 PAM program; unanticipated impacts of COVID-19 on Acadia’s business, including its commercial sales operations, current and planned clinical trials, supply chain, and guidance for full-year 2020 NUPLAZID net sales 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 2020, 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
Copyright 2020 by Tiburon Sunrise, LLC
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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(in thousands, except per share amounts) |
||||||||||||||||
(Unaudited) |
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|
||||||||||||||||
|
|
Three Months Ended
|
|
Nine Months Ended
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||||||||||||
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
||||||||
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Product sales, net |
$ |
120,577 |
|
$ |
94,586 |
|
$ |
320,748 |
|
$ |
240,750 |
|
||||
Total revenues |
|
120,577 |
|
|
94,586 |
|
|
320,748 |
|
|
240,750 |
|
||||
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of product sales, license fees and royalties (1) |
|
4,801 |
|
|
4,689 |
|
|
15,249 |
|
|
14,264 |
|
||||
Research and development (1) |
|
120,083 |
|
|
62,622 |
|
|
257,014 |
|
|
182,865 |
|
||||
Selling, general and administrative (1) |
|
81,592 |
|
|
72,696 |
|
|
267,909 |
|
|
233,767 |
|
||||
Total operating expenses |
|
206,476 |
|
|
140,007 |
|
|
540,172 |
|
|
430,896 |
|
||||
Loss from operations |
|
(85,899 |
) |
|
(45,421 |
) |
|
(219,424 |
) |
|
(190,146 |
) |
||||
Interest income, net |
|
1,242 |
|
|
2,432 |
|
|
6,056 |
|
|
7,893 |
|
||||
Other (expense) income |
|
(202 |
) |
|
747 |
|
|
(1,262 |
) |
|
506 |
|
||||
Loss before income taxes |
|
(84,859 |
) |
|
(42,242 |
) |
|
(214,630 |
) |
|
(181,747 |
) |
||||
Income tax expense |
|
(199 |
) |
|
(264 |
) |
|
194 |
|
|
476 |
|
||||
Net loss |
$ |
(84,660 |
) |
$ |
(41,978 |
) |
$ |
(214,824 |
) |
$ |
(182,223 |
) |
||||
Net loss per common share, basic and diluted |
$ |
(0.54 |
) |
$ |
(0.29 |
) |
$ |
(1.37 |
) |
$ |
(1.26 |
) |
||||
Weighted average common shares outstanding, basic and diluted |
|
158,129 |
|
|
145,906 |
|
|
156,683 |
|
|
144,741 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
(1) Includes the following stock-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of product sales, license fees and royalties |
$ |
495 |
|
$ |
372 |
|
$ |
2,087 |
|
$ |
2,344 |
|
||||
Research and development |
$ |
7,953 |
|
$ |
8,680 |
|
$ |
23,645 |
|
$ |
24,461 |
|
||||
Selling, general and administrative |
$ |
12,924 |
|
$ |
12,971 |
|
$ |
37,495 |
|
$ |
35,697 |
|
||||
|
||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
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(in thousands) |
||||||
|
||||||
|
|
|
|
|
||
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
||
Cash, cash equivalents and investment securities |
$ |
644,441 |
$ |
697,429 |
||
Accounts receivable, net |
|
46,344 |
|
35,781 |
||
Interest and other receivables |
|
1,440 |
|
2,093 |
||
Inventory |
|
7,979 |
|
6,341 |
||
Prepaid expenses |
|
30,009 |
|
18,606 |
||
Total current assets |
|
730,213 |
|
760,250 |
||
Property and equipment, net |
|
8,427 |
|
3,180 |
||
Operating lease right-of-use assets |
|
48,232 |
|
9,524 |
||
Intangible assets, net |
|
1,477 |
|
2,585 |
||
Restricted cash |
|
5,770 |
|
4,787 |
||
Other assets |
|
1,545 |
|
2,857 |
||
Total assets |
$ |
795,664 |
$ |
783,183 |
||
Liabilities and stockholders’ equity |
|
|
|
|
||
Accounts payable |
$ |
3,471 |
$ |
7,222 |
||
Accrued liabilities |
|
88,385 |
|
67,604 |
||
Total current liabilities |
|
91,856 |
|
74,826 |
||
Operating lease liabilities |
|
45,343 |
|
6,361 |
||
Other long-term liabilities |
|
3,598 |
|
2,861 |
||
Total liabilities |
|
140,797 |
|
84,048 |
||
Total stockholders’ equity |
|
654,867 |
|
699,135 |
||
Total liabilities and stockholders’ equity |
$ |
795,664 |
$ |
783,183 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20201104005622/en/
Media Contact:
(858) 914-7161
media@acadia-pharm.com
Investor Contact:
(858) 261-2771
ir@acadia-pharm.com
Source: