Spectrum Pharmaceuticals, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the Spectrum Pharmaceuticals fourth quarter and full year 2020 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. To ask a question during the session, you'll need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Kirk Gustafson, Spectrum Chief Financial Officer. Please go ahead.

Thank you, Operator, and good afternoon to everyone. Thank you for joining us today for Spectrum Pharmaceutical's fourth quarter and full year 2020 financial results conference call. Our fourth quarter and full year financial results press release was sent out earlier this afternoon and is available on our website at www.spectrumpharmaceuticals.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, our 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. Good afternoon, everybody, and thank you for joining us on the call today. We appreciate your interest in Spectrum, and I'm excited to be here. Spectrum has made great progress over the course of 2020, and that momentum is continuing in 2021, despite the challenges of the pandemic and the impact it's had across the biopharma industry. Throughout 2020, the Spectrum team demonstrated dedication, creativity, and focus to maintain our overall momentum, which allowed us to achieve a strong finish in 2020. We achieved a number of important recent milestones that will form the basis for key activities in 2021. During the fourth quarter, we met with the FDA to review the filing strategy for the submission of an NDA for posiatinib based on the data from cohort two of our phase two clinical trial, Zenith 20. This trial evaluated previously treated patients with non-small cell lung cancer with HER2 exon 20 insertion mutations. These positive results with HER2 exon 20 mutations demonstrated that posiatinib met the pre-specified primary endpoint in these patients. Based on our discussions, we reached agreement with the FDA to proceed with the submission of a new drug application for posiatinib. Adding to this positive news is the recent fast-track designation that was granted by the FDA for this indication. This is welcome news for Spectrum and for the patients with this devastating disease. We're currently preparing an NDA and look forward to a submission to the FDA later this year. Regarding our office, the FDA is scheduled to perform the pre-approval inspection of our manufacturing facility in May. As you may recall, FDA informed us last year that it was deferring action on the BLA due to their inability to inspect the Hanmi Bioplant in South Korea as a result of travel restrictions related to the COVID-19 pandemic. Hanmi Pharmaceuticals is an experienced biopharmaceutical manufacturer with a world-class facility, and they're ready for this inspection. As a matter of fact, Hanmi has received recently approval for Rolantis in Korea, which further raises our confidence in their manufacturing readiness. In addition to advancing our late-stage clinical programs, we remain active with business development. In the fourth quarter, we entered into a licensing transaction for a new immuno-oncology asset. Our strategy is to build a portfolio of oncology assets that are synergistic with our existing products, and this is a great example of that strategy in action. Dr. Francois Labelle, our CMO, will have more to say about this later. I'm pleased and excited by our progress in our two lead clinical development programs and the further addition to our product portfolio. It shows the dedication of the Spectrum team to execute on our goals. I'm confident in our ability to meet our corporate objectives and advance our programs with the aspiration of bringing new treatments to the patients with cancer who need them. With that, I'd like to turn over the call to Dr. Francois Lebel, our CMO. Dr. Francois.