Spectrum Pharmaceuticals Reports Record Profit and Record Revenue for First Quarter 2011, a Four-Fold Revenue Increase over First Quarter 2010
-
Record Quarterly Net Income of
$13 Million , or$0.25 Per Basic Share -
First Quarter 2011 Total Revenues Were
$44 Million Compared to$11 Million in First Quarter 2010 -
Approximately
$141 Million in Cash, Cash Equivalents, Investments and Receivables as ofMarch 31, 2011
Conference Call
"We are very pleased to report record profit and record revenue in the
first quarter," said
First Quarter Ended
The Company recorded net income of
Cash, cash equivalents, investments and receivables as of
There are approximately 52 million shares of common stock issued and
outstanding as of
2011/2012 Corporate Events and Potential Valuation Catalysts
FUSILEV®
- Promote FUSILEV in colorectal cancer and continue to grow revenue
- Initiate additional clinical studies to expand FUSILEV use in colorectal cancer
ZEVALIN®
- Initiate studies for aggressive lymphomas in 2011
-
Bioscan removal PDUFA Date —
November 20, 2011
Belinostat
- Complete enrollment in PTCL Trial in 2011
- File NDA in 2012
Apaziquone
- File NDA in 2012
Conference Call
Domestic: (877) 837-3910,
Conference ID# 60326117
International: (973) 796-5077, Conference
ID# 60326117
Webcast and replays: www.sppirx.com |
|||
Conference Call audio replays will be available through June 1, 2011 | |||
Domestic: | (800) 642-1687, Conference ID# 60326117 | ||
International: | (706) 645-9291, Conference ID# 60326117 |
About FUSILEV® (levoleucovorin)
FUSILEV, a novel folate analog, is now approved for use in combination
with 5-fluorouracil in the palliative treatment of patients with
advanced metastatic colorectal cancer. FUSILEV is also indicated for
rescue 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 is now approved as a RTU (ready-to-use)
(FUSILEV Injection) solution in 175 mg and 250 mg vials, and as
freeze-dried powder (FUSILEV for Injection) in 50 mg vials. FUSILEV,
under various trade names, is marketed outside
Important FUSILEV® (levoleucovorin) Safety Considerations
FUSILEV is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid. Due to calcium content, no more than 16-mL (160-mg) of levoleucovorin solution should be injected intravenously per minute. FUSILEV enhances the cyto-toxicity of fluorouracil. Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for pneumocystis carinii pneumonia in HIV patients was associated with increased rates of treatment failure in a placebo-controlled study. Allergic reactions were reported in patients receiving FUSILEV. Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue after high dose methotrexate therapy. The most common adverse reactions (>50%) in patients with advanced colorectal cancer receiving FUSILEV in combination with 5-fluorouracil were diarrhea, nausea and stomatitis. FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.
Full prescribing information can be found at www.FUSILEV.com.
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 (NHL), who achieve a partial or complete response to first-line chemotherapy. ZEVALIN is also indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell 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
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 | ||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||
(In thousands, except share and per share data) |
||||||||||
(Unaudited) |
||||||||||
Three Months Ended March 31, | ||||||||||
2011 | 2010 | |||||||||
Net revenues | $ | 43,598 | $ | 11,089 | ||||||
Operating expenses: | ||||||||||
Cost of product sales (excludes amortization of purchased intangibles) | 6,580 | 3,245 | ||||||||
Selling, general and administrative | 12,751 | 10,862 | ||||||||
Research and development | 5,830 | 36,544 | ||||||||
Amortization of purchased intangibles | 930 | 930 | ||||||||
Total operating costs and expenses | 26,091 | 51,581 | ||||||||
Income (loss) from operations | 17,507 | (40,492 | ) | |||||||
Change in fair value of common stock warrant liability | (5,250 | ) | 1,575 | |||||||
Other income (loss), net | 520 | (97 | ) | |||||||
Income (loss) before provision for income taxes | 12,777 | (39,014 | ) | |||||||
Provision for income taxes | — | — | ||||||||
Net income (loss) | $ | 12,777 | $ | (39,014 | ) | |||||
Net income (loss) per share: | ||||||||||
Basic | $ | 0.25 | $ | (0.80 | ) | |||||
Diluted | $ | 0.23 | $ | (0.80 | ) | |||||
Weighted average shares outstanding: | ||||||||||
Basic | 51,297,523 | 48,667,653 | ||||||||
Diluted | 55,529,536 | 48,667,653 | ||||||||
SUMMARY CONSOLIDATED BALANCE SHEETS |
|||||||
(In thousands, except share and per share data) |
|||||||
|
December 31, |
||||||
March 31, |
|||||||
Cash, cash equivalents and investments | $ | 80,139 | $ | 95,674 | |||
Accounts receivable, net | 51,997 | 21,051 | |||||
Inventories, net | 6,620 | 4,234 | |||||
Prepaid expenses and other current assets | 802 | 906 | |||||
Total current assets | 139,558 | 121,865 | |||||
Bank certificates of deposit and treasuries | 8,836 | 8,569 | |||||
Property and equipment, net | 3,116 | 3,158 | |||||
ZEVALIN related intangible assets, net |
28,675 | 29,605 | |||||
Other assets | 5,392 | 434 | |||||
Total Assets | $ | 185,577 | $ | 163,631 | |||
Current liabilities | 70,278 | 63,322 | |||||
Deferred revenue and other credits — less current portion | 22,419 | 25,495 | |||||
Other long-term liabilities | 331 | 338 | |||||
Total liabilities | 93,028 | 89,155 | |||||
Total stockholders' equity | 92,549 | 74,476 | |||||
Total liabilities and stockholders' equity | $ | 185,577 | $ | 163,631 | |||
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 | ||||||||
(In thousands) |
||||||||
(Unaudited) |
||||||||
Three Months Ended March 31 | ||||||||
2011 | 2010 | |||||||
GAAP net income (loss) | $ | 12,777 | $ | (39,014 | ) | |||
Stock-based compensation | 4,064 | 2,475 | ||||||
Change in fair value of common stock warrant liability | 5,250 | (1,575 | ) | |||||
Non-GAAP income (loss) | $ | 22,091 | $ | (38,114 | ) |
Senior Manager,
Investor Relations
702-835-6300
Source:
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