On August 6, 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 June 30, 2015 (Press release, Spectrum Pharmaceuticals, AUG 6, 2015, View Source [SID:1234507104]).

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"The results from this quarter demonstrate our ability to maintain financial discipline while continuing to fund our highest priority projects," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "The second half of 2015 marks key milestones for several of Spectrum’s drugs. With the potential approval of Evomela in October, we could have six drugs on the market. Pending alignment with the FDA, we expect to initiate a non-inferiority Phase 3 study for SPI-2012 which would be powered at 80% to show superiority against pegfilgrastim. Also, our potentially best-in-class novel pan-HER inhibitor, poziotinib, will target breast cancer in a Phase 2 clinical program. Additionally, with apaziquone, we plan to file an NDA and initiate a confirmatory Phase 3 trial under a SPA by year end. Our pipeline has never been as exciting as it is today, and provides a sound foundation for future growth of the company."

Pipeline Update:

Two Potential Blockbusters, One Near-term FDA Decision and One Near-term NDA Submission

SPI-2012, a novel long-acting GCSF: In Phase 2 trials earlier this year, SPI-2012’s efficacy was shown to be non-inferior at the middle dose, and superior to the blockbuster drug pegfilgrastim at the higher dose tested. Based on discussion with the FDA, the Company plans to initiate a Phase 3 study this year, and is seeking an SPA for this study that would be powered at over 90% to demonstrate non-inferiority and at 80% to demonstrate superiority to pegfilgrastim.

EVOMELA, a propylene-glycol free formulation of melphalan with improved stability: NDA review is ongoing and is on track for an FDA decision on October 23, 2015. This drug is expected to be launched using Spectrum’s existing sales force, and pre-launch activities have commenced.

Poziotinib, a potential best-in-class, novel, pan-HER inhibitor: The Company plans to initiate a U.S. based breast cancer program based on compelling Phase 1 efficacy data demonstrated in breast cancer patients who had failed multiple other HER-2 directed therapies. In addition, multiple Phase 2 studies funded by Hanmi Pharmaceuticals are currently ongoing.

Apaziquone, a potent pro-drug being investigated for non-muscle-invasive bladder cancer: Apaziquone is a bio-reductive agent activated by reductase enzymes, such as DT-diaphorase, expressed by bladder tumor cells, to form a cytotoxic alkylating agent. Spectrum expects to file an NDA by year-end. Additionally, the Company is seeking an SPA with the FDA before commencing an additional confirmatory Phase 3 Study.

Three-Month Period Ended June 30, 2015 (All numbers are approximate)

GAAP Results

Total product sales were $35.1 million in the second quarter of 2015. Total product sales decreased 25% from $46.9 million in the second quarter of 2014.

Product sales in the second quarter included: FUSILEV (levoleucovorin) net sales of $14.3 million, FOLOTYN (pralatrexate injection) net sales of $12.2 million, ZEVALIN (ibritumomab tiuxetan) net sales of $4.8 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $2.1 million and BELEODAQ (belinostat for injection) net sales of $1.7 million.

Spectrum recorded net loss of $2.3 million, or $(0.04) per basic and diluted share in the three-month period ended June 30, 2015, compared to net loss of $3.6 million, or $(0.06) per basic and diluted share in the comparable period in 2014. Total research and development expenses were $9.6 million in the quarter, as compared to $11.3 million in the same period in 2014. Selling, general and administrative expenses were $22.6 million in the quarter, compared to $25.4 million in the same period in 2014.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $0.5 million, or $(0.01) per basic share and diluted share in the three-month period ended June 30, 2015, compared to non-GAAP net income of $6.8 million, or $0.11 per basic share and $0.09 per diluted share in the comparable period in 2014. Non-GAAP research and development expenses were $9.1 million, as compared to $10.8 million in the same period of 2014. Non-GAAP selling, general and administrative expenses were $19.7 million, as compared to $21.8 million in the same period in 2014.

2015 Financial Guidance

Spectrum projects year-end aggregate cash and cash equivalents and marketable securities of over $110 million, up from the Company’s previous guidance of $100 million excluding any new business development transactions.