UroGen Pharma Ltd.

Good morning, ladies and gentlemen, and thank you for standing by, and welcome to the EuroGen Pharma Second Quarter 2021 Financial Results and Business Update Conference Call. It is now my pleasure to turn the call over to Sarah Sherman, Head of Investor Relations for EuroGen Pharma. Please go ahead.

Thank you, Operator, and welcome everyone to Eurogen Pharma's second quarter 2021 financial results and business update conference call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended June 30th, 2021. The press release can be accessed on the investors portion of our website at investors.eurogen.com. Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Jeff Bova, Chief Commercial Officer, Dr. Mark Schoenberg, Chief Medical Officer, and Molly Henderson, Chief Financial Officer. Please note that we continue to conduct our calls from different locations, so we appreciate your patience and understanding should we have any technical difficulties. During today's call, we will be making certain forward-looking statements. These may include statements regarding the success and timing of our ongoing commercialization of gel mito, planned clinical trials, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities, 2021 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. A description of potential risk can be found in our earnings press release and latest SEC disclosure documents. Your caution not to place undue reliance on these forward-looking statements and your urgent disclaims and the obligation to update these statements. I will now turn the call over to Liz.

Thank you, Sarah, and thank you all for joining us today as we provide an update on our progress and recent corporate development. At Urogen, we believe patients deserve better options, and we're steadfast in our approach to fundamentally change the way uro-oncology is treated today. As we move into the second half of 2021, one of our key priorities remains the increased adoption of Gemido, the first approved therapy from a novel reverse thermal hydrogel technology platform. As we announced in July, we recorded $13 million in Gelmido net product sales for the second quarter of 2021 and $20.5 million for the first half of 2021. We believe this early success with Gelmido provides proof of concept for the broader platform, both in low-grade disease with UGN-102, as well as our expansion into high-grade disease and other tumor types. We are focused on changing the way urothelial cancers are treated, an area where there have been no significant advances in recent years. And we see gel mito as our first opportunity to make a positive impact for patients. It's critical for patients to have alternatives to invasive and or repetitive surgeries, which have a well-defined associated morbidity, including negative outcomes from the use of general anesthesia. Our novel technology has enabled us to deliver gel mito and expand with our second uro-oncology investigational product candidate, UGN-102, which is being studied in low-grade, intermediate-risk, non-muscle-invasive bladder cancer, a large patient population where there are no non-surgical primary treatment options. Our RT-GEL platform enables us to develop these novel therapeutic approaches, and we are enthusiastic about their potential. Mark will provide a more detailed update on the UGN 102 Phase III Atlas study, but we are pleased with the progress and interest to date from centers around the world. While we focus on expanding our pipeline, we have also made progress in our commitment to expand Gelmido's geographic presence. We announced our first collaboration, which involves a license and supply agreement with Neoform to pursue regulatory approval and commercialization for Gelmido in Israel. Urogen was founded in Israel, and they played a key role in our pivotal trial. We look forward to the possibility of patients in Israel having access to this innovative treatment as quickly as possible. The two other priority regions for near-term expansion are Japan and Europe. Based on the work we have done to date, we believe we have a plan for Gemida regulatory and reimbursement pathways, and look forward to providing more detail on our XUS strategy in the coming months. As we have communicated, our goal remains to establish our first two medicines as standard of care, changing the way these patients with low-grade disease are treated. We believe by doing so, these two lead products set a strong foundation for our company. And assuming regulatory approval of UGM-102, our goal is to deliver peak revenues of over $1 billion by the end of 2027. Given the total market size of low-grade UTUC is over $700 million, and low-grade intermediate-risk non-muscle-invasive bladder cancer over $3 billion, we believe this goal is attainable and positions Urogen as a leader in uro-oncology. Beyond Gelmido and UGM-102, we continue to expand and progress our early-stage pipeline, both internally as well as with academic collaborations, and Mark will talk more about these programs. We are actively seeking opportunities to expand our portfolio with innovative medicines in areas for which there are no adequate treatments and where new technologies and innovation can make a difference for patients. And we will share updates as available. And with that, I'd like to turn the call over to Jeff to provide a commercial update. Jeff?