Mucositis may occur. If greater-than or equal to Grade 2 mucositis is observed, omit or modify dose. Patients should be instructed to take folic acid and receive vitamin B12 to potentially reduce treatment-related hematological toxicity and mucositis.
Fatal dermatologic reactions may occur. Dermatologic reactions may be progressive and increase in severity with further treatment. Patients with dermatologic reactions should be monitored closely, and if severe, FOLOTYN should be withheld or discontinued. Tumor lysis syndrome may occur. Monitor patients and treat if needed.
FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while being treated with FOLOTYN and pregnant women should be informed of the potential harm to the fetus.
Use caution and monitor patients when administering FOLOTYN to patients with moderate to severe renal function impairment.Elevated liver function test abnormalities may occur and require monitoring. If liver function test abnormalities are greater-than or equal to Grade 3, omit or modify dose. Adverse Reactions The most common adverse reactions were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse events are pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia. Use in Specific Patient Population Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother. Drug Interactions Co-administration of drugs subject to renal clearance (e.g., probenecid, NSAIDs, and trimethoprim/sulfamethoxazole) may result in delayed renal clearance. Please see FOLOTYN ® Full Prescribing Information at www.FOLOTYN.com. Forward-looking statement — This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management's current beliefs and expectations. These statements include but are not limited to statements that relate to our business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of sustained revenue history, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. SPECTRUM PHARMACEUTICALS, INC. ® , FUSILEV ® , FOLOTYN ® and ZEVALIN ® , are registered trademarks of Spectrum Pharmaceuticals, Inc and its affiliates. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. © 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved. Source: Spectrum Pharmaceuticals, Inc.
|SPECTRUM PHARMACEUTICALS, INC. AND SUBSIDIARIES|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except share and per share data)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Product sales, net||$||65,871||$ 47,949||$||188,282||$||130,759|
|License and contract revenue||3,171||3,075||9,321||9,225|
|Total revenues||$||69,042||$ 51,024||$||197,603||$||139,984|
|Operating costs and expenses:|
|Cost of product sales (excludes amortization of purchased intangible assets)||11,155||8,845||31,402||23,555|
|Selling, general and administrative||23,114||15,811||64,723||47,261|
|Research and development||10,183||7,388||28,657||20,904|
|Amortization of purchased intangibles||1,834||930||4,400||2,790|
|Total operating costs and expenses||46,286||32,974||129,182||94,510|
|Income (loss) from operations||22,756||18,050||68,421||45,474|
|Change in fair value of common stock warrant liability||—||2,999||—||(3,488||)|
|Other income, net||293||(144||)||(1,076||)||550|
|Income (loss) before provision for income taxes||23,049||20,905||67,345||42,536|
|Provision for income taxes||(1,737||)||(650||)||18,579||(2,300||)|
|Net income (loss)||$||21,312||$ 20,255||$||85,924||$||40,236|
|Net income (loss) per share:|
|Weighted average shares outstanding:|
|SUMMARY CONSOLIDATED BALANCE SHEETS|
|September 30,||December 31,|
|Cash, cash equivalents||143,283||121,202|
|Accounts receivable, net||90,943||51,703|
|Prepaid expenses and other current assets||3,853||2,074|
|Deferred tax asset||11,351||—|
|Total current assets||265,716||225,801|
|Property and equipment, net||2,988||2,681|
|Intangible assets, net||204,633||41,654|
|Deferred revenue and other credits – less current portion||5,500||14,029|
|Deferred development costs – less current portion||11,600||—|
|Deferred payment contingency||2,200||—|
|Other long-term liabilities||893||307|
|Revolving line of credit||75,000||—|
|Total stockholders’ equity||279,688||187,907|
|Total liabilities and stockholders’ equity||$||509,541||$||280,780|
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