On November 4, 2015 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported financial results for the three-month period ended September 30, 2015 (Press release, Spectrum Pharmaceuticals, NOV 4, 2015, View Source [SID:1234507977]).
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"The highest priority of the Company remains SPI-2012, which is a late-stage drug that could compete in the multi-billion dollar neutropenia market," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "We had a productive meeting last week with the FDA and expect to finalize our SPA on SPI-2012 quickly. We have a meeting with the FDA this Friday to discuss EVOMELA’s Complete Response Letter and we feel confident in bringing EVOMELA to the market for patients. Before the end of this year, we look forward to filing the NDA for our bladder cancer drug apaziquone and initiating a Phase 2 breast cancer trial for poziotinib in the U.S. shortly. We believe the infrastructure that we have built over the years serves as a strong foundation for continued future growth."
Pipeline Update- Two Potential Blockbusters and One Near-term NDA Submission:
SPI-2012, a novel long-acting GCSF: In a Phase 2 dose ranging study, SPI-2012 was shown to be superior at the higher dose tested and non-inferior at the middle dose in decreasing the duration of severe neutropenia compared to the blockbuster drug pegfilgrastim. SPI-2012 was also shown to have an acceptable safety profile with no significant dose-related or unexpected toxicities. The Phase 2 data will be presented at the San Antonio Breast Cancer Symposium. Spectrum has continued to have productive discussions with the FDA, expects to finalize the pivotal study design this year, and start the study shortly after reaching SPA agreement with the Agency. Over 80 study sites have already been qualified.
Apaziquone, a potent tumor-activated pro-drug for non-muscle invasive bladder cancer: By year end, Spectrum expects to file the NDA based on the previous Phase 3 studies. The Company has also initiated enrollment in an additional randomized, placebo-controlled Phase 3 trial under the SPA agreement, and treated the first patient in late October. This Phase 3 study has been specifically designed to address important lessons learned from the previous apaziquone Phase 3 studies, as well as recommendations made by the FDA.
EVOMELA, a propylene-glycol free melphalan formulation with improved stability: Spectrum is actively addressing the non-clinical issues raised in the Complete Response Letter regarding the EVOMELA NDA. FDA has granted a Type A meeting for November 6, 2015 and the company believes these issues can be swiftly resolved. Spectrum plans to launch this drug with our existing sales force.
Poziotinib, a potential best-in-class, novel, pan-HER inhibitor: The Company plans to initiate a breast cancer program in the U.S., based on compelling Phase 1 efficacy data in breast cancer patients who had failed multiple other HER-2 directed therapies. In addition, multiple Phase 2 studies funded by our partner, Hanmi Pharmaceuticals, are currently ongoing in South Korea.
Three-Month Period Ended September 30, 2015 (All numbers are approximate)
GAAP Results
Total product sales were $28.5 million in the third quarter of 2015. Total product sales decreased 41% from $47.9 million in the third quarter of 2014.
Product sales in the third quarter included: FUSILEV (levoleucovorin) net sales of $11.1 million, FOLOTYN (pralatrexate injection) net sales of $8.7 million, ZEVALIN (ibritumomab tiuxetan) net sales of $4.8 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $1.3 million and BELEODAQ (belinostat for injection) net sales of $2.6 million.
Spectrum recorded net loss of $18.7 million, or $(0.28) per basic and diluted share in the three-month period ended September 30, 2015, compared to net loss of $11.5 million, or $(0.18) per basic and diluted share in the comparable period in 2014. Total research and development expenses were $9.9 million in the quarter, as compared to $14.4 million in the same period in 2014. Selling, general and administrative expenses were $19.4 million in the quarter, compared to $24.1 million in the same period in 2014.
Non-GAAP Results
Spectrum recorded non-GAAP net loss of $7.9 million, or $(0.12) per basic share and diluted share in the three-month period ended September 30, 2015, compared to non-GAAP net income of $5.3 million, or $0.08 per basic and $0.07 per diluted share in the comparable period in 2014. Non-GAAP research and development expenses were $9.4 million, as compared to $14.0 million in the same period of 2014. Non-GAAP selling, general and administrative expenses were $17.2 million, as compared to $21.3 million in the same period in 2014.
2015 Financial Guidance
Spectrum raises guidance on year-end cash to over $125 million, up from the Company’s previous guidance of $110 million excluding any new business development transactions.