Spectrum Pharmaceuticals Announces First Quarter 2009 Corporate Update and Pipeline Review
“I am pleased to announce that 2009 is a transformative year for Spectrum, as we have fully transitioned into a diversified, commercial stage biotechnology company with two proprietary, oncology drugs on the market,” said
First Quarter Results
Consolidated revenue of approximately
“Following our recent acquisition of full commercial rights to ZEVALIN, our goal is to stabilize ZEVALIN sales by year-end. We are pleased with respect to the strategies and tactics we have been able to implement over the last six weeks in the marketplace. We are confident that we will be able to take advantage of the commercial opportunity that resides with ZEVALIN,” continued Dr. Shrotriya.
Major Value Drivers in the Next 12-18 Months:
July 2009PDUFA action date for 1st line consolidation therapy sBLA under review by FDA; and,
- Establish reimbursement standards in concert with
Centers for Medicare and Medicaid Services(CMS) by early 2010.
October 2009PDUFA action date for advanced metastatic colorectal cancer sNDA under review by FDA; and,
- Expand the uptake of FUSILEV in community practices and institutions following colorectal cancer approval.
- Complete enrollment in ongoing phase 3 registrational trials by year end;
- Enrolled more than 1,000 patients at more than 120 sites to date,
- Initiate trials in BCG-Failure bladder cancer by year end; and,
- Sign an Asian partnership.
Monday, May 18, 2009 @ 1:00 p.m. Eastern/10:00 a.m. Pacific
Webcast and replays: www.spectrumpharm.com.
|Audio replays will be available through May 25, 2009.|
888-286-8010, passcode 53348047
617-801-6888, passcode 53348047
About FUSILEV™ (levoleucovorin) for Injection
FUSILEV™, a novel folate analog, is available in 50-mg vials of freeze-dried powder. It is the pharmacologically active isomer of leucovorin. 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 comprised only of the pharmacologically active isomer of leucovorin.
Full prescribing information can be found at www.FUSILEV.com.
ZEVALIN® (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the ZEVALIN therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell NHL, including patients with rituximab-refractory follicular NHL. ZEVALIN is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naïve, low-grade and follicular NHL. It was approved by the
For more information on ZEVALIN, patients and healthcare professionals can visit www.ZEVALIN.com.
We are a commercial-stage biotechnology company with a focus in oncology. Our strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in our areas of focus; and, leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit our website at www.spectrumpharm.com.
Forward-looking statement – This press release may contain forward-looking statements regarding future events and the future performance of
|SPECTRUM PHARMACEUTICALS, INC. AND SUBSIDIARIES|
|(In thousands, except Share and per share data)|
|Summary Condensed Consolidated Statement of Operations (Unaudited)|
|Quarter Ended March 31,|
|Cost of product sold||1,834||-|
|Research and development||5,654||6,382|
|Amortization of purchased intangibles||950||-|
|Selling, general and administrative||6,351||2,585|
|Total operating expenses||14,789||8,967|
|Loss from operations||(626||)||(8,967||)|
|Other income, net||104||301|
|Loss before minority interest in consolidated entities||(522||)||(8,666||)|
|Minority interest in net loss of consolidated subsidiary||1,146||-|
|Net income (loss)||$||624||$||(8,666||)|
|Basic and diluted net loss per share||$||0.02||$||(0.28||)|
|Basic and diluted weighted average common shares outstanding||32,439,523||31,271,281|
Summary Condensed Consolidated Balance Sheets (Unaudited)
|March 31,||December 31,|
|Cash, cash equivalents and marketable securities||$||63,898||$||78,086|
|Accounts Receivable, net||6,306||5,002|
|Other current assets||736||693|
|Total current assets||72,834||85,622|
|Intangible Assets, net||36,092||37,042|
|Property and equipment, net and other assets||1,922||2,071|
|Commitments & Contingencies||-||-|
|Total liabilities and stockholders’ equity||$||110,848||$||124,735|
Spectrum Pharmaceuticals, Inc.
Russell Skibsted, 949-788-6700 ext. 234
Chief Business Officer
Paul Arndt, 949-788-6700 ext. 216
Senior Manager, Investor Relations