UroGen Pharma Ltd.

Good morning, ladies and gentlemen, and thank you for standing by. And welcome to EuroGen Pharma's fourth quarter and full year 2021 financial results and business update conference call. It is now my pleasure to turn the call over to Vincent Perrone, Senior Director of Investor Relations for EuroGen Pharma. Please go ahead.

Thank you, Operator. Good morning, everyone, and welcome to Eurogen Pharma's fourth quarter and full year 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 and year ended December 31st, 2021. The press release is available 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, Dr. Mark Schoenberg, Chief Medical Officer, Jeffrey Bova, Chief Commercial Officer, and Molly Henderson, Chief Financial Officer. 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, and 2022 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 on our earnings press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and NeuroGen disclaims any obligation to update these statements. I'll now turn the call over to Liz. Liz?

Thank you, Vincent, and thank you to everyone joining us today. We remain focused on developing novel solutions for urothelial and specialty cancers with the goal of fundamentally transforming the treatment paradigm for what is largely an underserved patient population. In this pursuit, I am proud of the progress we've made throughout 2021 and in early 2022 further solidifying Gelmito's place in the market as the only FDA-approved non-surgical treatment for low-grade UTUC, and setting the stage for several important commercial and clinical milestones in the year ahead. Despite challenges on our commercial efforts stemming from the global COVID-19 pandemic, we continue to help new patients gain access to Gelmito, which is a testament to the resilience and perseverance of our commercial team. Growing patient access and awareness continued to drive adoption of Gemido as we set new records for revenue, new patient enrollment, and site activations in the fourth quarter, setting us up for strong growth in 2022. Jeff will provide more detail on our commercialization efforts, but at a high level, our commercial team did an excellent job adapting to added challenges placed on the healthcare system. by rising cases of the Omicron variant as well as staff shortages in Q4. This led to an all-time quarterly high in new product revenue of $16.2 million in Q4, a 42% increase over Q3. Total net product revenue for 2021, our first full year of product sales of Gelmido, was $48 million, which was in line with guidance. Molly will review our financial results and provide guidance for 2022 shortly. However, we remain confident in the outlook for the business as we expect continuing and accelerating adoption of Gemido in our second full year post-launch. Late last year, we announced the launch of a pilot named Patient Supply Program for Gemido, which included five European countries, France, Germany, Switzerland, Austria, and the U.K., During the fourth quarter of 2021, we continued to expand this program with the addition of Australia to the pilot. The NPS program, in partnership with Neoform in Israel, saw the identification of the first four patients with product for two of those patients delivered to Neoform in Q4. I'm pleased to report that as a result of these efforts, two of these Israeli patients received gel mito, representing the first time patients outside of the U.S. have been treated with gel mito in a commercial setting. Beyond gel mitre, we made important progress in the clinic, advancing our lead development program, UGM-102, and positioning UGN-301, our immuno-oncology program for human trials. Turning first to UGM-102, which is in development to treat low-grade intermediate-risk non-muscle-based bladder cancer, an indication impacting approximately 80,000 underserved patients in the United States annually. Last month, we initiated the Phase III Envision trial, a single-arm, open-label, pivotal trial, which replaced the previously announced Phase III Atlas trial. Envision is similar in design to the Phase II Optima II trial, and as a result, we believe care is a very high probability of success. I'm pleased to report that earlier in the first quarter, we completed the shift to Envision, opening the first clinical site and recently dosing the first patient. We expect Envision to complete enrollment by the end of 2022, and assuming positive findings, we anticipate submitting an NDA in 2024. Importantly, UGN-102, if approved, would share a prescriber base with Gemido, which would ensure an efficient and expedient product launch. We continue to believe Gemido and UGN-102 together represent well over a billion-dollar revenue opportunity for Urigin, And the start of the Envision trial moves us closer to realizing the full potential of these two high-promising innovative therapies. For UGN 301, we announced results from a toxicology study, which formed the foundation of an IND application we submitted to the FDA last month, putting our first RT-gel-based immuno-oncology candidate on track to initiate a first in human study in the first half of 2022. Mark will discuss plans for our multi-arm combination study that represents a unique approach to treating high-grade bladder cancer. We recently closed an up to $100 million senior secured term loan facility with funds managed by Pharmacon advisors. This non-dilutive capital gives us the financial flexibility to continue expanding our commercial and development efforts. And based upon our current financial projections, provides us with what we believe to be the necessary runway to reach cash flow break-even by 2025. Formicon Advisors have been great partners, and this facility demonstrates their belief in the impact our company can have on patients, and I want to thank them for their partnership. Finally, I want to address a disclosure made earlier today announcing a transition in our financial leadership team, as Molly has decided to leave her role as CFO of Urgent, to assume a broader role with another company. Molly led our efforts and successfully strengthened our balance sheet, leaving us well-positioned to continue advancing our strategic vision. While Molly will be missed, it is a good time to transition her finance responsibilities to her successor, Don Kim, currently Vice President of Finance, who will assume the CFO role effective March 25th. Don is a seasoned financial professional with extensive Bioforma industry experience. Prior to joining Urogen, Don held leadership position with Zoetis, Sun Pharma, and most recently with Strides Pharma, where he served as head of finance and as a member of the board of directors. Lastly, given the critical role investor relations continues to play in our success, this function will now report directly to me. At Urogen, one of our primary goals is to give patients better options by continuing to shift the treatment paradigms in neuro and specialty oncology away from repeated surgeries and disease management to minimally invasive therapeutic ablation of tumors and locally administered immunotherapy approaches. We expect 2022 to be a pivotal year for URGEN as we expect a more normal environment for gel miters launch. To fully enroll our pivotal study for UGN-102, which represents a major advancement in care for patients, and a billion-dollar revenue potential for our company, and to expand our development efforts into immunotherapy with a unique combinatorial approach for high-grade disease. I'm extremely proud of the progress we continue to make toward our goal of bringing novel solutions to patients that deserve better. With that, I'll turn the call over to Mark to discuss our recent clinical and development updates. Mark?