UroGen Pharma Ltd.

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the EuroGen Pharma's first quarter 2021 financial results and business update conference call. It is now my pleasure to turn the call over to Lee Roth of Burns McClellan. Please go ahead. Thank you, operator.

Good morning, everyone, and welcome to EuroGen Pharma's first quarter 2021 financial results and business update conference call. I'm filling in for Sarah Sherman, head of investor relations at EuroGen, who is on maternity leave. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended March 31st, 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 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 Gelmido, planned clinical trials, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities, and 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 risks can be found in our earnings press release, as well as the latest SEC disclosure documents. Your cautions not to place undue reliance on these forward-looking statements, and your urgent disclaims any obligation to update these statements. With that, it's my pleasure to turn the call over to Liz.

Thank you, Lee, and thank you to everyone joining us today. While it has only been eight weeks since we hosted our fourth quarter and full year 2020 earnings call, we have continued to make important progress towards our goal of becoming the leading uro-oncology company. Our ongoing priority is the successful commercialization of Jalmito. Despite facing the unique challenge of launching during a global pandemic, Jalmito's place in the clinic continues to take shape as the only FDA-approved non-surgical treatment for adult patients with low-grade upper tract ulcerative cancer. For the first quarter of 2021, we recorded $7.5 million in net product sales. This brings us to a total of $19.3 million in sales since the June 1, 2020 launch of Jelmido. As mentioned during our year-end earnings call in March, we experienced softness in the beginning of the quarter, which we attribute to the start of the vaccination efforts throughout the United States. And patients, specifically within the age group that are most likely to suffer from UTUC, were delaying treatment appointments until they were vaccinated and felt comfortable going to a healthcare facility. As you have undoubtedly heard as numerous companies report earnings, this impact was seen across the biotech, pharma, and medical device industries. Jeff will provide more detail in a bit, but we are confident in our outlook for Gemido for the remainder of 2021 and beyond. due to the increase in patients treated in March and April and the record number of patient enrollments we received over this same period. We believe the increased demand is driven by the fact that a large percentage of our patient demographic has been vaccinated and COVID-related restrictions are relaxing in many parts of the country. While we have not provided specific financial guidance, we reiterate our position that our internal projection for 2021 is aligned with the analyst revenue consensus. We also want to share that our preliminary results for April represent the highest monthly revenue since launch, making us optimistic about Q2 and the remainder of 2021. Beyond Gemido, we are making progress with our UGN 102 program, and specifically the Phase III Atlas trial, which kicked off in late 2020. We are recruiting and enrolling patients in the U.S., Israel, and Europe, and expect to provide an enrollment update later this year. We are excited about the potential of UGM-102 has to transform the treatment landscape for patients diagnosed with low-grade intermediate risk non-muscular invasive bladder cancer, if approved. There are significant similarities between the therapeutic indications for Gemido and UGM-102, and we expect that we'll be able to successfully leverage our learnings and experience from Gemido as we move the UGN-102 program forward. Another important priority for us is to advance our earlier pipeline and build urogen into a leader in imnio-oncology. Our most advanced IO program is UGN-302, which we are studying as part of a research collaboration with the MD Anderson Cancer Center in high-grade non-muscle-invasive bladder cancer. We have also begun work with the Johns Hopkins University to study in a preclinical setting the potential of checkpoint inhibitors combined with RT gel and glioblastoma multiforme, or GBM, an aggressive form of brain cancer. Mark will provide additional commentary on both of these programs. I'm proud of our continued strong execution during a global pandemic and the significant progress we're making against our strategy. We believe that very few companies are in the unique position we at Urogen enjoy. We have an approved product that alone could be a standalone profitable business, and our second therapy is in a phase three clinical trial and is de-risked given the similarities with gel mito and impressive phase two results. We also have a unique medicine in preclinical that, if successful, has the potential to change the treatment paradigm in high-grade non-muscle-invasive bladder cancer. These three therapies combined reflect what we consider one of the strongest pipelines in uro-oncology and can provide a long-term growth business and a portfolio that can support a sustainable business for many years to come. We will continue to build our presence in urology and oncology and leverage our proprietary technology through partners in other areas that could benefit from a sustained release delivery mechanism. Before I turn things over to Jeff for additional detail on our commercialization efforts, I want to recognize and thank our employees for their hard work and resilience during this challenging time. About three quarters of our employees have been with URGEN for less than two years. This means the majority of their tenure has been significantly impacted by COVID-19. But through it all, they have remained focused and committed to our mission of helping improve outcomes for patients battling urologic malignancies. I could not be prouder to lead this team or more excited about the future of our company. I'd now like to turn the call over to Jeff. Jeff?