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Actionable news in SPPI: Spectrum Pharmaceuticals, Inc.,

Spectrum: Vice President, Strategic Planning & Investor Relations

The following excerpt is from the company's SEC filing.


Spectrum Pharmaceuticals Reports Third Quarter 2015 Financial Results and Pipeline Update

Company met with the FDA, made significant progress, and is ready to initiate SPI-2012 Pivotal clinical trial upon agreement on Special Protocol Assessment (SPA)

On track for apaziquone NDA filing by year end based on previous Phase 3 studies; additional Phase 3 trial initiated under SPA

Meeting with FDA scheduled on November 6, 2015 to address the Complete Response Letter on EVOMELA

(melphalan) for injection

Phase 2 poziotinib breast cancer study designed, and will be submitted with IND by year end

Spectrum raises guidance on year-end cash to over $125 million, up from the Company’s previous guidance of $110 million

Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, announced today financial results for the three-month period ended September 30, 2015.

“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.

11500 S. Eastern Ave., Ste. 240 • Henderson, Nevada 89052 • Tel: 702-835-6300 • Fax: 702-260-7405 • • NASDAQ: SPPI

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

quarter of

. Total product sales decreased 41% from

$47.9 million

quarter of 2014.

Product sales in the

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


per basic and diluted share in the three-month period ended

, compared to net loss of

$11.5 million


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

Non-GAAP Results

Spectrum recorded non-GAAP net loss of

$7.9 million


per basic share and diluted share in the three-month period ended

, compared to non-GAAP net income of

$5.3 million

per diluted share in the comparable period in 2014. Non-GAAP research and development expenses were

$9.4 million

$14.0 million

in the same period of 2014. Non-GAAP selling, general and administrative expenses were

$17.2 million

$21.3 million

2015 Financial Guidance

excluding any new business development...