UroGen Pharma(US:URGN)2023-03-16 19:51Financial Data and Key Metrics Changes - UroGen Pharma reported net product revenues of $64.4 million for the full year 2022, representing a 34% increase from 2021 [4][21] - For Q4 2022, JELMYTO net revenues were over $18.1 million, compared to $16.1 million for the same period in 2021 [21] - The company ended the year with $100 million in cash, expected to finance operations into the first half of 2024 [24] Business Line Data and Key Metrics Changes - JELMYTO's adoption metrics showed a 21% increase in repeat accounts, rising from 177 to 214 [16] - The number of activated sites increased from 930 to 983 [16] - Research and development expenses for Q4 2022 were $14.4 million, up from $13.1 million in the prior year [21] Market Data and Key Metrics Changes - UroGen anticipates JELMYTO net revenues for 2023 to be in the range of $76 million to $86 million, reflecting a growth of 20% to 30% over 2022 [7][23] - The company expects to report top-line data from both Phase 3 studies of UGN-102 by mid-year 2023 [6][13] Company Strategy and Development Direction - UroGen views JELMYTO as a proof of concept for the larger bladder cancer market, with UGN-102 expected to be a main growth driver if approved [5][8] - The company is focused on solid execution to turn the combined revenue opportunity of JELMYTO and UGN-102 into a reality, estimated at $1 billion [8] - UroGen is exploring multiple avenues to strengthen its balance sheet, including potential strategic partnerships [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data from clinical trials and the potential for UGN-102 to transform treatment paradigms [6][14] - The company is committed to managing expenses diligently while prioritizing cash preservation [24] - Management highlighted the importance of durability data for UGN-102 as a key factor for FDA submission in 2024 [60] Other Important Information - The company has completed enrollment for the ENVISION study in less than a year, indicating strong interest from urologists [5][9] - UroGen's Phase 1 trial with UGN-301 continues to enroll, aimed at identifying suitable doses for future combination therapies [14] Q&A Session Summary Question: What are the expectations for durability data from ENVISION? - Management expects similar results to OPTIMA II, as ENVISION will only include patients with recurrent disease, which was not a differentiating factor in previous studies [27] Question: Are there plans for strategic partnerships related to UGN-102? - Management is always looking for opportunities for strategic partnerships but emphasizes the importance of maintaining cash flow and reducing expenses [28] Question: What drives JELMYTO uptake and how will the company optimize value outside the U.S.? - The main driver is patient identification and physician experience, with plans for additional clinical work to support reimbursement in international markets [31][34] Question: Will additional infrastructure be needed for UGN-102's commercial strategy? - Due to a 95% overlap in prescriber base, significant resource expansion is not anticipated [36] Question: What factors could drive further adoption of JELMYTO in 2023? - Key factors include operational data from the FDA's stability period extension, long-term follow-up data, and real-world evidence supporting JELMYTO's efficacy [39][40] Question: What is the regulatory timeline for UGN-102? - The key rate-limiting step is obtaining durability data, with an expected FDA submission in 2024 [60][61] Question: Will there be additional trials for at-home administration of UGN-102? - No additional large studies are planned, but the company is open to supporting investigator-initiated studies if demand arises [51]