ACADIA Pharmaceuticals Reports Second Quarter 2019 Financial Results
- 2019 Net Sales Guidance Increased to
SAN DIEGO-(BUSINESS WIRE)--Jul. 31, 2019--ACADIA Pharmaceuticals Inc.(Nasdaq: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced its financial results for the second quarter ended June 30, 2019.
“Continued execution of our commercial initiatives led to strong quarterly performance for NUPLAZID and a significant increase in our sales guidance for the full year,” said
Recent Highlights
- Announced top-line results from the Phase 3 ENHANCE study of pimavanserin for adjunctive treatment in patients with schizophrenia. In the study, adding pimavanserin to existing antipsychotic treatment showed a consistent trend in improvement of psychotic symptoms, however the results did not achieve statistical significance on the primary endpoint, the Positive and Negative Syndrome Scale (PANSS) total score (p=0.0940). Significant improvements were observed on the secondary endpoint of PANSS negative symptoms scale sub-score (unadjusted p=0.0474). Additional details from the study are included in the press release issued by the Company on
July 22, 2019 . - Presented positive Phase 2 CLARITY results for pimavanserin as an adjunctive treatment in major depressive disorder at the 2019
American Psychiatric Association Annual Meeting inMay 2019 . - Initiated the international Phase 3 CLARITY-3 study with pimavanserin for adjunctive treatment in patients with major depressive disorder in
July 2019 . - Announced in
June 2019 , alongside theMichael J. Fox Foundation for Parkinson’s Research, the launch of “Parkinson’s IQ + You”, a series of local events acrossthe United States to educate and empower patients with Parkinson’s disease and their care partners.
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
2019 Financial Guidance
- 2019 NUPLAZID net sales guidance is increased to
$320 million to $330 million from the previous range of$280 million to $300 million . - 2019 GAAP R&D guidance of
$250 million to $265 million is unchanged compared to prior guidance. - 2019 GAAP SG&A guidance is increased to
$300 million to $315 million from the previous range of$280 million to $295 million . - Non-cash stock-based compensation expense guidance of
$80 million to $90 million is unchanged compared to prior guidance.
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)
NUPLAZID is the first and only
About
ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, schizophrenia, major depressive disorder, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.
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, including through sales of new dosages and forms; the timing of ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide; and guidance for full-year 2019 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 2019, 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
ACADIA PHARMACEUTICALS INC. |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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(in thousands, except per share amounts) |
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(Unaudited) |
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2019 |
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2018 |
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2019 |
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2018 |
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Revenues |
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Product sales, net |
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$ |
83,205 |
|
|
$ |
57,063 |
|
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$ |
146,164 |
|
|
$ |
105,931 |
|
Total revenues |
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|
83,205 |
|
|
|
57,063 |
|
|
|
146,164 |
|
|
|
105,931 |
|
Operating expenses |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales, license fees and royalties (1) |
|
|
4,995 |
|
|
|
5,078 |
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|
|
9,575 |
|
|
|
8,563 |
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Research and development (1) |
|
|
67,320 |
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|
|
46,592 |
|
|
|
120,243 |
|
|
|
85,868 |
|
Selling, general and administrative (1) |
|
|
67,981 |
|
|
|
69,472 |
|
|
|
161,071 |
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|
|
130,398 |
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Total operating expenses |
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140,296 |
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|
|
121,142 |
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|
|
290,889 |
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|
|
224,829 |
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Loss from operations |
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(57,091 |
) |
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|
(64,079 |
) |
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(144,725 |
) |
|
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(118,898 |
) |
Interest income, net |
|
|
2,527 |
|
|
|
1,279 |
|
|
|
5,461 |
|
|
|
2,449 |
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Other expense |
|
|
(12 |
) |
|
|
(247 |
) |
|
|
(241 |
) |
|
|
(247 |
) |
Loss before income taxes |
|
|
(54,576 |
) |
|
|
(63,047 |
) |
|
|
(139,505 |
) |
|
|
(116,696 |
) |
Income tax expense |
|
|
365 |
|
|
|
219 |
|
|
|
740 |
|
|
|
866 |
|
Net loss |
|
$ |
(54,941 |
) |
|
$ |
(63,266 |
) |
|
$ |
(140,245 |
) |
|
$ |
(117,562 |
) |
Net loss per common share, basic and diluted |
|
$ |
(0.38 |
) |
|
$ |
(0.51 |
) |
|
$ |
(0.97 |
) |
|
$ |
(0.94 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
144,314 |
|
|
|
124,910 |
|
|
|
144,148 |
|
|
|
124,819 |
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(1) Includes the following stock-based compensation expense |
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Cost of product sales, license fees and royalties |
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$ |
803 |
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$ |
1,137 |
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|
$ |
1,798 |
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|
$ |
2,187 |
|
Research and development |
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$ |
7,901 |
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$ |
7,894 |
|
|
$ |
15,781 |
|
|
$ |
15,551 |
|
Selling, general and administrative |
|
$ |
11,718 |
|
|
$ |
11,521 |
|
|
$ |
22,726 |
|
|
$ |
23,256 |
|
ACADIA PHARMACEUTICALS INC. |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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(in thousands) |
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June 30, |
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December 31, |
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(unaudited) |
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Assets |
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Cash, cash equivalents and investment securities |
|
$ |
381,887 |
|
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$ |
473,520 |
|
Accounts receivable, net |
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31,781 |
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|
26,090 |
|
Interest and other receivables |
|
|
941 |
|
|
|
1,699 |
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Inventory |
|
|
3,824 |
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|
|
4,070 |
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Prepaid expenses |
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|
18,507 |
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|
|
20,727 |
|
Total current assets |
|
|
436,940 |
|
|
|
526,106 |
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Property and equipment, net |
|
|
3,427 |
|
|
|
3,309 |
|
Operating lease right-of-use assets |
|
|
10,818 |
|
|
|
— |
|
Intangible assets, net |
|
|
3,323 |
|
|
|
4,062 |
|
Restricted cash |
|
|
4,787 |
|
|
|
4,826 |
|
Other assets |
|
|
1,588 |
|
|
|
1,899 |
|
Total assets |
|
$ |
460,883 |
|
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$ |
540,202 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
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Accounts payable |
|
$ |
4,650 |
|
|
$ |
3,167 |
|
Accrued liabilities |
|
|
59,164 |
|
|
|
56,398 |
|
Total current liabilities |
|
|
63,814 |
|
|
|
59,565 |
|
Operating lease liabilities |
|
|
6,742 |
|
|
|
— |
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Other long-term liabilities |
|
|
1,413 |
|
|
|
1,558 |
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Total liabilities |
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|
71,969 |
|
|
|
61,123 |
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Total stockholders’ equity |
|
|
388,914 |
|
|
|
479,079 |
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Total liabilities and stockholders’ equity |
|
$ |
460,883 |
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|
$ |
540,202 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20190731005929/en/
Source:
Investor Contact:
ACADIA Pharmaceuticals Inc.
Mark Johnson, CFA
(858) 261-2771
ir@acadia-pharm.com
Media Contact:
ACADIA Pharmaceuticals Inc.
Maurissa Messier
(858) 768-6068
media@acadia-pharm.com