Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) Q2 2020 Earnings Conference Call - Final Transcript

Good afternoon, ladies and gentlemen, and welcome to the Spectrum Pharmaceuticals Second Quarter 2000 Earnings Call. [Operator Instructions] I would now like to turn the conference over to your host, Mr. Kurt Gustafson, Chief Financial Officer of Spectrum Pharmaceuticals. Please go ahead.

Thank you, operator, and good afternoon to everyone. Thank you for joining us today for Spectrum Pharmaceuticals' second quarter 2020 financial results conference call. Our second quarter financial results press release was sent out earlier this afternoon and is available on our website at www.sppirx.com.

Joining me on the call today from Spectrum Pharmaceuticals will be Joe Turgeon, President and CEO; Dr. Francois Lebel, Chief Medical Officer; and Tom Riga, Chief Operating Officer.

Before we get started, I would like to reference the notice regarding forward-looking statements included in today's press release. This notice emphasizes the major uncertainties and risks inherent in the forward-looking statements that we will make this afternoon. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements.

With that, let me hand the call over to Joe Turgeon, CEO of Spectrum.

Thank you, Kurt and good afternoon everyone and thank you for joining us on the call today. It's been quite a year already and we're even more excited about what's to come in the second half. We've made some great progress and continue to rapidly advance our development pipeline despite the challenges of the pandemic. And speaking to that, I want to thank our dedicated employees who have remained focused on the advancements of our clinical development programs. And in addition investigator interest in our pipeline remains strong as we pursue new solutions for cancer patients and for healthcare professionals.

Let me turn to some brief updates of our programs. In late July, we announced that poziotinib met the pre-specified primary endpoint in Cohort 2 of the Phase 2 ZENITH20 clinical trial. The success of this cohort is a significant achievement for Spectrum and for the patients with this devastating disease. There is no approved therapy for patients with HER2 exon 20 insertion mutations, and we're looking forward to meeting with the FDA. Dr. Francois Lebel, our CMO will provide a discussion of the Cohort 2 results on the call later today.

ROLONTIS, our most advanced program is under active review at the FDA for the treatment of chemotherapy-induced neutropenia with a PDUFA date of October 24, 2020. If approved, ROLONTIS could be the first novel granulocyte-colony stimulating factor available to healthcare providers in over 15 years. As the PDUFA date approaches, our launch preparations for ROLONTIS are accelerating. I look forward to getting back into this market, an area I know well personally, and the potential of competing in this multi-billion dollar growth factor market. Tom