Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) Q2 2015 Earnings Conference Call Transcript

Aug 06, 2015 • 04:30 pm ET

Previous

Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) Q2 2015 Earnings Conference Call Transcript

Share
Close

Loading Event

Loading Transcript

Presentation
Operator
operator

Good day, ladies and gentlemen, thank you for standing by, and welcome to the Spectrum Pharmaceuticals, Inc. Second Quarter 2015 Financial Results Conference Call. (Operator Instructions) As a reminder, this conference maybe recorded.

It's now my pleasure to turn the conference over to Shiv Kapoor, Vice President of Strategic Planning and Investor Relations. Please begin.

Executive
Shiv Kapoor

Thanks. Good afternoon and thank you for joining us today for Spectrum's second quarter 2015 financial results conference call. I'm Shiv Kapoor, Vice President of Strategic Planning and Investor Relations for Spectrum Pharmaceuticals.

With me today are Dr. Raj Shrotriya, Chairman and CEO; Joe Turgeon, President and Chief Operating Officer; Kurt Gustafson, Chief Financial Officer; Dr. Lee Allen, Chief Medical Officer; Tom Riga, Chief Commercial Officer; and other senior members of Spectrum's management team.

Here's an outline of today's call. First, Dr. Shrotriya will provide you with the highlights of the second quarter and discuss our overall direction and strategy. Kurt will then provide a summary of our second quarter financial performance. Following this, Joe will review the company's operations, and Dr. Allen will review the pipeline. We will then open up the call to questions.

(Forward-looking Cautionary Statements)

I now would like to hand the call over to Dr. Shrotriya.

Executive
Rajesh Shrotriya

Thank you, Shiv, and thank you everyone for joining us this afternoon. I'm very pleased with our performance this quarter. We have maintained a strong fiscal discipline, while advancing our pipeline. We have four exciting events coming to fruition within next several months.

With two potential blockbuster drugs under development making progress, one in Phase 3, a registrational trial, and other entering Phase 2 study in the United States, one drug pending an FDA approval decision and with yet another drug the filing on an NDA, we believe that the second half of this year promises to be full of exciting events. In my further brief remarks, I'll focus on these four top priorities.

First, SPI-2012, a novel long-acting GCSF or granulocyte colony-stimulating factor, this drug has shown strong efficacy in Phase 2 clinical studies conducted in about 148 patients. It targets a blockbuster market of nearly $6 billion. It has the potential to change the face of our company and remains our highest priority.

We're taking several steps that will ensure the success of this drug. To ensure alignment with the FDA, we're pursuing a special protocol assessment, or SPA; we plan to initiate a Phase 3 non-inferiority study; after reviewing our Phase 2 data and after discussion with several key opinion leaders, we have proposed powering the study at 80% to show superiority compared to pegfilgrastim.

Second, I'm very excited about EVOMELA's potential approval later this year. The discussions with the FDA are proceeding well and if approved, EVOMELA will become our sixth commercial drug that will be launched with our existing sales force.

Let me now talk about our second potential blockbuster drug Poziotinib. Based on our assessment of the market opportunity and the strong clinical data that we have seen in