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Spectrum Pharmaceuticals Reports Record Revenues, Profits, And Cash Generated From Operations For The Twelve-Month Period Ended December 31, 2012

Stocks in this article: SPPI

Non-GAAP Results

The Company recorded non-GAAP net income of $17.6 million, or $0.30 per basic share and $0.27 per diluted share in the three-month period ended December 31, 2012, compared to a net income of $16.2 million, or $0.29 per basic and $0.26 per diluted share in the comparable period in 2011. Non-GAAP research and development adjustments were $13.4 million in the fourth quarter of 2012, as compared to $6.4 million in the same period of 2011. Non-GAAP selling, general and administrative adjustments were $22.2 million in the fourth quarter of 2012, as compared to $18.7 million in the same period in 2011.

Conference Call

Thursday, February 21, 2013 @ 1:30 p.m. Eastern/10:30 a.m. Pacific
Domestic:           (877) 837-3910, Conference ID# 94256900
International: (973) 796-5077, Conference ID# 94256900

On the conference call, management will review the financial results, provide an update on the Company's business and discuss expectations for the future.

Key Catalysts

FUSILEV ® (levoleucovorin) for injection

  • Continue to gain market share and grow revenue
  • Initiate additional clinical studies to expand indications

FOLOTYN ® (pralatrexate injection)

  • Continue to grow the market for this recent addition to the Spectrum product portfolio
  • Explore synergies, including clinical studies for combined treatment with FUSILEV

ZEVALIN ® (ibritumomab tiuxetan) injection for intravenous use

  • Continue progress of Spectrum-sponsored or supported studies, including:
    • Phase 3 ZEST clinical trial in patients with Diffuse Large B-Cell Lymphoma (DLBCL);
    • International SPINOZA (IIS) trial in patients with relapsed DLBCL who receive autologous stem cell transplantation (ASCT), and
    • RoZetta study, a head-to-head evaluation of ZEVALIN consolidation treatment vs. rituximab maintenance in previously untreated patients with follicular non-Hodgkin’s lymphoma.

Robust Pipeline

  • Plan to file 2 NDAs in the next the 12 months
  • Plan Phase 2 program for RenaZorb ® (an orally available, lanthanum-based nanotechnology compound with potent phosphate-binding properties), based on positive Phase 1 clinical data
  • Continue Phase 2 study for SPI-2012
  • Initiate Phase 2 trials for SPI-1620

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in oncology and hematology. Spectrum and its affiliates market three oncology drugs ─ FUSILEV ® (levoleucovorin) for Injection in the U.S.; FOLOTYN ® (pralatrexate injection), also marketed in the U.S.; and ZEVALIN ® (ibritumomab tiuxetan) Injection for intravenous use, for which the Company has worldwide marketing rights. Spectrum's strong track record in in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.

About FUSILEV ® (levoleucovorin) for injection

FUSILEV, a novel folate analog, is approved as a ready-to-use solution (FUSILEV ® Injection), and as freeze-dried powder (FUSILEV for Injection). FUSILEV is indicated for use in combination chemotherapy 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, under various trade names, is marketed outside the United States by Pfizer, Sanofi-Aventis, and Takeda.

Important FUSILEV ® (levoleucovorin) Safety Considerations

FUSILEV is dosed at one-half the usual dose of racemic d,l-leucovorin. 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 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.

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