On May 5, 2016 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 March 31, 2016 (Press release, Spectrum Pharmaceuticals, MAY 5, 2016, View Source [SID:1234512018]). Schedule your 30 min Free 1stOncology Demo! "We are pleased to report strong revenues in the first quarter and solid progress in our product pipeline," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "Spectrum now has six FDA approved drugs on the market, revenues from which continues to help fuel our pipeline. We initiated a Phase 3 trial for our lead pipeline drug SPI-2012 and now have approximately 60 U.S. sites open for enrollment. SPI-2012 has shown strong clinical data in Phase 2 studies and targets a multi-billion dollar market. We also initiated a Phase 2 trial for our breast cancer drug poziotinib, which we believe has the potential to be best in-class among small molecule HER2-directed therapies. Additionally, we expect a response from the FDA on the NDA for apaziquone later this year. We remain focused on these three programs, each of which we believe has the potential to transform the Company."
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Pipeline Update:
SPI-2012, a novel long-acting GCSF: A pivotal Phase 3 study was initiated in Q1 2016 to evaluate SPI-2012 as a treatment for chemotherapy-induced neutropenia in approximately 580 patients with breast cancer. Neutropenia, a possible side effect of chemotherapy, is a condition where the number of neutrophils or white blood cells are too low, and can lead to infection, hospitalization, and even death. The Phase 2 data demonstrated that SPI-2012 was non-inferior to pegfilgrastim at the middle dose tested, and statistically superior in terms of duration of severe neutropenia at the highest dose tested. SPI-2012 was also shown to have an acceptable safety profile with no significant dose-related or unexpected toxicities.
Poziotinib, a potential best-in-class, novel, pan-HER inhibitor: Spectrum initiated a Phase 2 breast cancer program in the U.S., based on promising Phase 1 efficacy data in breast cancer patients who had failed multiple other HER2-directed therapies. In addition, multiple Phase 2 studies are being conducted by Hanmi Pharmaceuticals and National OncoVenture in South Korea.
Apaziquone, a potent tumor-activated drug being investigated for non-muscle invasive bladder cancer: The FDA accepted the NDA and has given Spectrum a PDUFA date of December 11, 2016. The FDA also indicated that it plans to hold an advisory committee meeting regarding the NDA. The Company is actively enrolling an additional randomized, placebo-controlled Phase 3 trial under an SPA agreement. The Phase 3 study has been specifically designed to build on learnings from the previous studies, as well as recommendations from the FDA.
EVOMELA, a propylene-glycol free melphalan formulation: The FDA approved EVOMELA on March 10, 2016, two months ahead of the PDUFA date. Soon after, Spectrum launched EVOMELA with its existing sales force in a market estimated at approximately $100 million.
Three-Month Period Ended March 31, 2016 (All numbers are approximate)
GAAP Results
Total product sales were $35.2 million in the first quarter of 2016. Total product sales decreased 8.3% from $38.4 million in the first quarter of 2015.
Product sales in the first quarter included: FUSILEV (levoleucovorin) net sales of $15.2 million, FOLOTYN (pralatrexate injection) net sales of $13.3 million, ZEVALIN (ibritumomab tiuxetan) net sales of $2.8 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $0.9 million and BELEODAQ (belinostat for injection) net sales of $3.0 million.
Spectrum recorded net loss of $9.3 million, or $(0.14) per basic and diluted share in the three-month period ended March 31, 2016, compared to net loss of $25.6 million, or $(0.39) per basic and diluted share in the comparable period in 2015. Total research and development expenses were $15.5 million in the quarter, as compared to $15.9 million in the same period in 2015. Selling, general and administrative expenses were $22.0 million in the quarter, compared to $23.3 million in the same period in 2015.
Non-GAAP Results
Spectrum recorded non-GAAP net income of $0.3 million, or $0.01 per basic share and less than $0.01 per diluted share in the three-month period ended March 31, 2016, compared to non-GAAP net loss of $4.7 million, or $(0.07) per basic and diluted share in the comparable period in 2015. Non-GAAP research and development expenses were $13.0 million, as compared to $12.4 million in the same period of 2015. Non-GAAP selling, general and administrative expenses were $16.7 million, as compared to $22.9 million in the same period in 2015.