Spectrum Pharmaceuticals Reports Profitable Fourth Quarter and Record Revenue Growth for 2010
- Strong Financial Results Include a Nearly Five-Fold and Two-Fold Increase in Fourth Quarter and Fiscal 2010 Product Revenue Vs. Fourth Quarter and Fiscal Year 2009, Respectively
-
Three and 12-Month 2010 Consolidated Revenues Approximately
$34 Million and$74 Million , Respectively -
Three and 12-Month 2010 Product Revenues Approximately
$31 Million and$61 Million ,- ZEVALIN® Fourth Quarter and Fiscal Year 2010 Sales Up 54% and 84% Vs. Fourth Quarter and Fiscal Year 2009, Respectively
- FUSILEV® Fiscal Year 2010 Sales Up 156% Vs. Fiscal Year 2009
-
Approximately
$104 Million In Cash, Cash Equivalents and Investments as ofDecember 31, 2010 , Up From$92 Million as ofSeptember 30, 2010
"We are proud of our many accomplishments in 2010, especially the record
revenue growth of both of our proprietary, marketed, anti-cancer drugs,
FUSILEV® and ZEVALIN®, and the licensing of
belinostat, a late-stage, potentially best-in-class HDAC inhibitor for
potentially multiple indications," said
Fourth Quarter Results Ended
Consolidated revenue of
12-Month Results Ended
Consolidated revenue of
Cash, cash equivalents and investments as of
There are approximately 51 million shares of common stock issued and
outstanding at
2011/2012 Corporate Events and Potential Valuation Catalysts
FUSILEV®
-
FDA PDUFA Action date in metastatic colorectal cancer by
April 29, 2011 .
ZEVALIN®
-
Anticipate
FDA decision on bioscan removal before the end of 2011; - Initiation of a Diffuse Large B-Cell Lymphoma trial in 2011.
Belinostat
- Complete enrollment in registrational study and file rolling NDA for Peripheral T-Cell Lymphoma in 2011/2012.
Apaziquone
- Anticipate filing NDA for bladder cancer in 2012.
Conference Call
Domestic: (877) 837 - 3910
International:
(973) 796 - 5077
Webcast and replays: www.sppirx.com
Audio replays will be available through
Domestic: (800) 642-1687, passcode 43097899
International: (706)
645-9291, passcode 43097899
About ZEVALIN® and the ZEVALIN Therapeutic Regimen
ZEVALIN (ibritumomab tiuxetan) is indicated for the treatment of
patients with previously untreated follicular non-Hodgkin's Lymphoma
(
ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN
therapeutic regimen consists of three components: rituximab, Indium-111
(In-111) radiolabeled ZEVALIN for imaging, and Yttrium-90 (
Full prescribing information can be found at www.ZEVALIN.com.
About FUSILEV® (levoleucovorin) for Injection
FUSILEV, a novel folate analog, is available in vials for injection as freeze-dried powder. FUSILEV rescue is indicated after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. FUSILEV (levoleucovorin or (6S)-leucovorin) is the only commercially available formulation containing only the pharmacologically active isomer of leucovorin.
Full prescribing information can be found at www.FUSILEV.com.
About
Forward-looking statement — This press release may contain
forward-looking statements regarding future events and the future
performance of
© 2011
SPECTRUM PHARMACEUTICALS, INC. AND SUBSIDIARIES |
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CONSOLIDATED STATEMENTS OF OPERATIONS |
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(In thousands, except share and per share data) |
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Three Months Ended | Years Ended | ||||||||||||||||
December 31, | December 31, | ||||||||||||||||
(unaudited) | |||||||||||||||||
2010 | 2009 | 2010 | 2009 | ||||||||||||||
Net revenues | $ | 33,946 | $ | 8,620 | $ | 74,113 | $ | 38,025 | |||||||||
Operating expenses: | |||||||||||||||||
Cost of product sales(excludes amortization of purchased intangibles) | 6,813 | 2,446 | 17,439 | 8,148 | |||||||||||||
Selling, general and administrative | 12,475 | 11,069 | 48,550 | 33,607 | |||||||||||||
Research and development | 6,986 | 3,525 | 57,301 | 21,058 | |||||||||||||
Amortization of purchased intangibles | 930 | 870 | 3,720 | 3,720 | |||||||||||||
Total operating costs and expenses | 27,204 | 17,910 | 127,010 | 66,533 | |||||||||||||
Income (loss) from operations | 6,742 | (9,290 | ) | (52,897 | ) | (28,508 | ) | ||||||||||
Change in fair value of common stock warrant liability | (3,300 | ) | 19,834 | 2,731 | 8,075 | ||||||||||||
Other Income, net | 1,034 | 61 | 1,279 | 662 | |||||||||||||
Income (loss) before provision for income taxes | 4,476 | 10,605 | (48,887 | ) | (19,771 | ) | |||||||||||
Provision for income taxes | (36 | ) | (421 | ) | 43 | (421 | ) | ||||||||||
Net loss attributable to non-controlling interest | — | — | — | 1,146 | |||||||||||||
Net income (loss) attributable to Spectrum Pharmaceuticals, Inc. stockholders | $ | 4,440 | $ | 10,184 | $ | (48,887 | ) | $ | (19,046 | ) | |||||||
Net income (loss) per share: | |||||||||||||||||
Basic | $ | 0.09 | $ | 0.21 | $ | (0.99 | ) | $ | (0.48 | ) | |||||||
Diluted | $ | 0.08 | $ | 0.20 | $ | (0.99 | ) | $ | (0.48 | ) | |||||||
Weighted average shares outstanding: | |||||||||||||||||
Basic | 50,344,177 | 48,425,486 | 49,502,854 | 39,273,905 | |||||||||||||
Diluted | 52,268,739 | 49,704,126 | 49,502,854 | 39,273,905 |
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SUMMARY CONSOLIDATED BALANCE SHEETS
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(In thousands) |
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December 31, |
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2010 |
2009 |
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Cash, cash equivalents and investments | $ | 95,674 | $ | 113,341 | |||
Accounts receivable, net | 21,051 | 8,658 | |||||
Inventories, net | 4,234 | 3,230 | |||||
Prepaid expenses and other current assets | 906 | 1,028 | |||||
Total current assets | 121,865 | 126,257 | |||||
Bank certificates of deposit & treasuries | 8,569 |
11,438 |
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Property and equipment, net | 3,158 | 1,928 | |||||
Zevalin related intangible assets, net | 29,605 | 33,325 | |||||
Other assets | 434 | 185 | |||||
Total Assets | $ | 163,631 | $ | 173,133 | |||
Current liabilities | $ | 63,322 | $ | 39,499 | |||
Deferred revenue and other credits — less current portion | 25,495 | 24,943 | |||||
Other long-term liabilities | 338 | 367 | |||||
Total liabilities | 89,155 | 64,809 | |||||
Total stockholders' equity | 74,476 | 108,324 | |||||
Total liabilities and stockholders' equity | $ | 163,631 | $ | 173,133 |
Non-GAAP Financial Measures
The non-GAAP financial measures contained herein are a supplement to the corresponding financial measures prepared in accordance with generally accepted accounting principles (GAAP). The non-GAAP financial measures presented exclude the items summarized in the below table. Management believes that adjustments for these items assist investors in making comparisons of period-to-period operating results and that these items are not indicative of the Company's on-going core operating performance.
Management uses non-GAAP net income (loss) in its evaluation of the Company's core after-tax results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Management believes that providing these non-GAAP financial measures allows investors to view the Company's financial results in the way that management views the financial results.
The non-GAAP financial measures presented herein have certain limitations in that they do not reflect all of the costs associated with the operations of the Company's business as determined in accordance with GAAP. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. The non-GAAP financial measures presented by the Company may be different from the non-GAAP financial measures used by other companies.
NON-GAAP INCOME (LOSS) RECONCILIATION |
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(In thousands) |
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Three Months Ended | Years Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
(unaudited) | ||||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
GAAP net income (loss) | $ | 4,440 | $ | 10,184 | $ | (48,844 | ) | $ | (19,046 | ) | ||||||
Stock-based compensation | 2,018 | 1,410 | 8,285 | 7,423 | ||||||||||||
Change in fair value of common stock warrant liability | 3,330 | (19,834 | ) | (2,731 | ) | (8,075 | ) | |||||||||
Non-GAAP income (loss) | $ | 9,788 | $ | (8,240 | ) | $ | (43,290 | ) | $ | (19,698 | ) |
Senior Manager, Investor
Relations
949-788-6700x216
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