Financial Data and Key Metrics Changes - UroGen Pharma reported net product revenues of $25.2 million for JELMYTO in Q3 2024, a 21% increase from $20.9 million in Q3 2023, driven by strong underlying demand and a significant increase in new patient enrollments [7][20] - The net loss for Q3 2024 was $23.7 million, or $0.55 per share, compared to a net loss of $21.9 million, or $0.68 per share, in the same period in 2023 [24] - Cash and cash equivalents as of September 30, 2024, stood at $254.2 million, providing a strong balance sheet to support business objectives [24] Business Line Data and Key Metrics Changes - JELMYTO's revenue growth was partially offset by gross-to-net erosion due to the Medicare wastage provision and increased 340B utilization [20] - New patient enrollments for JELMYTO increased over 30% year-over-year, marking an all-time high since its launch [7] - UGN-102 is expected to address a market of over 80,000 patients annually in the US, representing a total addressable market of over $5 billion, significantly larger than the JELMYTO market [6] Market Data and Key Metrics Changes - The market for low-grade intermediate-risk non-muscle invasive bladder cancer is widespread, with nearly all urologists managing these cases, contrasting with the rare disease nature of JELMYTO [6] - The company anticipates low double-digit revenue growth for JELMYTO for the full year 2024 despite gross-to-net headwinds [25] Company Strategy and Development Direction - UroGen is focused on the commercialization of UGN-102, with a PDUFA target date of June 13, 2025, and is initiating pre-commercial activities to ensure a robust launch [5][14] - The company aims to expand its sales force from approximately 42 to over 80 representatives to enhance market engagement and support for UGN-102 [15] - A Notice of Allowance for a patent covering key technology for UGN-103 and UGN-104 was received, extending intellectual property protection through December 2041 [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of clinical data supporting UGN-102 and its potential to transform treatment for bladder cancer [14] - The company is preparing for an advisory committee meeting (ODAC) and expects to receive notification regarding the timing early in 2025 [11][43] - Management acknowledged the challenges posed by the Miscellaneous J code for billing upon UGN-102's approval but is committed to providing robust reimbursement support [17][42] Other Important Information - The company reported an increase in R&D expenses to $11.4 million in Q3 2024, primarily due to costs associated with the Phase 3 UTOPIA trial for UGN-103 [21] - Selling, general, and administrative expenses rose to $28.9 million, driven by pre-commercialization activities for UGN-102 [22] Q&A Session Summary Question: Clarity on the FDA's decision for standard review of UGN-102 - Management indicated that the FDA did not provide specific reasons for the standard review designation and noted that they had not yet reviewed the clinical data at the time of the letter [28] Question: Commercial points regarding gross-to-net discounting for JELMYTO - Management explained that the gross-to-net headwinds are primarily due to 340B and Medicare wastage provisions, which are not expected to significantly impact UGN-102 [31][32] Question: Timeline for ODAC and impact of Miscellaneous J code on UGN-102 uptake - Management expects the ODAC to occur in April or May 2025, with preparations already underway [43][41] Question: Updates on the Teva litigation and implications for UGN-102 - Management stated that they are awaiting a trial date, expected around 2026, and indicated that outcomes could impact UGN-102 due to overlapping IP [37][38] Question: Cash runway and financial position ahead of UGN-102 launch - Management confirmed a strong cash position of $254 million, sufficient to support business objectives leading up to the anticipated launch of UGN-102 [49]

Company Performance - Urogen Pharma reported a quarterly loss of $0.55 per share, better than the Zacks Consensus Estimate of a loss of $0.84, and an improvement from a loss of $0.68 per share a year ago, representing an earnings surprise of 34.52% [1] - The company posted revenues of $25.2 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 4.06%, compared to year-ago revenues of $20.85 million [2] - Over the last four quarters, Urogen Pharma has surpassed consensus EPS estimates just once and topped consensus revenue estimates two times [2] Stock Performance - Urogen Pharma shares have declined approximately 18.6% since the beginning of the year, contrasting with the S&P 500's gain of 21.2% [3] - The current estimate revisions trend for Urogen Pharma is unfavorable, resulting in a Zacks Rank 4 (Sell) for the stock, indicating expected underperformance in the near future [6] Future Outlook - The current consensus EPS estimate for the coming quarter is -$0.83 on revenues of $27.27 million, and for the current fiscal year, it is -$3.49 on revenues of $92.1 million [7] - The outlook for the industry, specifically the Medical - Biomedical and Genetics sector, is currently in the top 38% of Zacks industries, suggesting potential for better performance compared to lower-ranked industries [8]

Market Potential - UGN-102, if approved, could address a treatable population of approximately 82,000 low-grade intermediate risk NMIBC patients, with a total addressable market exceeding $5.0 billion[142]. - Approximately 68% of low-grade intermediate risk NMIBC patients experience two or more recurrences, highlighting the need for effective non-surgical treatments[143]. Product Performance - Jelmyto achieved a complete response rate of 58% in the Phase 3 OLYMPUS trial, with a durability of response estimated at 81.8% at 12 months[150][151]. - The median duration of response for patients in a follow-up study of Jelmyto was reported at 28.9 months, with 75% of patients showing no disease recurrence at the four-year data cutoff[154][156]. - In the Phase 2b OPTIMA II trial, 65.1% (41 out of 63) of patients treated with UGN-102 achieved a complete response (CR) three months after therapy initiation[162]. - The Phase 3 ENVISION trial demonstrated a CR rate of 79.6% at three months for patients treated with UGN-102[165]. - The ATLAS trial showed a 64.8% CR rate at three months for patients receiving only UGN-102, compared to 63.6% for TURBT alone[165]. - The median duration of response (DOR) for UGN-102 in a follow-up study was reported as 24.4 months for patients who achieved CR[163]. - The ENVISION trial reported that 60.8% of all enrolled patients were in CR at 12 months[169]. - UGN-102 was found suitable for at-home administration, with 75% of patients achieving CR three months after treatment[167]. Regulatory Approvals - The FDA approved Jelmyto on April 15, 2020, for the treatment of low-grade UTUC, with Orphan Drug exclusivity extending until April 15, 2027[148]. - The FDA accepted the NDA for UGN-102 with a PDUFA goal date of June 13, 2025, potentially making it the first FDA-approved treatment for low-grade intermediate-risk NMIBC[170]. Financial Performance - Revenue for the three months ended September 30, 2024, was $25.2 million, an increase of $4.3 million from $20.9 million in the same period of 2023, primarily due to increased sales volume of Jelmyto[200]. - Revenue for the nine months ended September 30, 2024, was $65.8 million, up $6.6 million from $59.2 million in 2023, attributed to increased sales volume of Jelmyto[210]. - The net loss for the three months ended September 30, 2024, was $23.7 million, compared to a net loss of $21.9 million in the same period of 2023[199]. - The operating loss for the nine months ended September 30, 2024, was $69.1 million, an increase of $18.2 million from $50.9 million in 2023[209]. Expenses - Research and development expenses for the three months ended September 30, 2024, were $11.4 million, up $1.2 million from $10.2 million in 2023, mainly due to costs associated with the Phase 3 UTOPIA trial for UGN-103[202]. - Selling and marketing expenses increased to $17.8 million for the three months ended September 30, 2024, from $12.6 million in 2023, reflecting higher UGN-102 brand marketing costs and expansion of the sales force[203]. - General and administrative expenses rose to $11.2 million for the three months ended September 30, 2024, compared to $9.2 million in 2023, driven by higher compensation and pre-commercialization readiness support for UGN-102[204]. - Research and development expenses increased by $8.0 million to $42.3 million for the nine months ended September 30, 2024, compared to $34.3 million in 2023, primarily due to higher manufacturing costs and regulatory expenses[212]. - Selling and marketing expenses rose by $13.1 million to $53.8 million for the nine months ended September 30, 2024, compared to $40.7 million in 2023, mainly driven by UGN-102 brand marketing costs[213]. - General and administrative expenses increased by $4.4 million to $32.5 million for the nine months ended September 30, 2024, compared to $28.1 million in 2023, primarily due to higher compensation and communication expenses related to UGN-102[214]. Cash Flow and Liquidity - As of September 30, 2024, the company had $254.2 million in cash and cash equivalents and marketable securities, indicating a strong liquidity position[217]. - Net cash used in operating activities was $83.1 million for the nine months ended September 30, 2024, compared to $63.4 million for the same period in 2023, reflecting a $19.7 million increase due to higher operating expenses[246]. - Net cash used in investing activities was $81.2 million for the nine months ended September 30, 2024, a decrease of $91.6 million compared to net cash provided of $10.4 million in the same period of 2023, primarily due to increased investments in marketable securities[247]. - Net cash provided by financing activities was $194.5 million for the nine months ended September 30, 2024, an increase of $77.6 million from $116.9 million in the same period of 2023, mainly due to proceeds from share issuance and debt related to the Pharmakon loan[248]. Future Outlook - The company expects research and development expenses to increase over the next several years as clinical programs progress and additional product candidates are developed[185]. - The company may need to raise additional capital in the future to fund operations and product development, with no assurances that sufficient financing will be secured[228]. Legal and Regulatory Matters - The company is currently involved in a lawsuit against Teva Pharmaceuticals for patent infringement, seeking to prevent market entry of a generic product prior to patent expiry[259]. - The company reported no material changes in internal control over financial reporting during the quarter ended September 30, 2024[257]. Miscellaneous - Inflation has not materially affected the company's business or financial condition during the nine months ended September 30, 2024[251]. - The company does not currently engage in currency hedging activities but may consider it in the future to manage foreign currency exposure[253]. - A 10% change in interest rates or NIS-to-Dollar exchange rates would not have had a material effect on the company's cash and cash equivalents or operating expenses as of September 30, 2024[249][252].

Financial Performance - UroGen Pharma reported net product sales of JELMYTO® at $25.2 million for Q3 2024, a 20.6% increase from $20.9 million in Q3 2023[4] - Research and development expenses for Q3 2024 were $11.4 million, up from $10.2 million in Q3 2023[7] - Selling, general and administrative expenses increased to $28.9 million in Q3 2024 from $21.8 million in Q3 2023[8] - UroGen reported a net loss of $23.7 million, or ($0.55) per share, compared to a net loss of $21.9 million, or ($0.68) per share, in the same period last year[10] - As of September 30, 2024, UroGen had cash, cash equivalents, and marketable securities totaling $254.2 million[1][13] - The company expects JELMYTO to achieve low double-digit year-over-year revenue growth for the full year 2024, although total revenues are anticipated to be below the low end of previous guidance[11] Product Development and Clinical Trials - The New Drug Application for UGN-102 was accepted by the US FDA, with a PDUFA target action date set for June 13, 2025, representing a market opportunity exceeding $5 billion[2][3] - The Phase 3 ENVISION trial for UGN-102 demonstrated a complete response rate of 79.6% at three months and a 12-month duration of response of 82.3%, the highest reported in this patient population[3] - UroGen initiated the Phase 3 UTOPIA clinical trial for UGN-103 in October 2024, a next-generation formulation for low-grade intermediate-risk non-muscle invasive bladder cancer[5] - UroGen Pharma is developing UGN-102, an innovative drug formulation for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), currently under FDA review with a decision expected by June 13, 2025[22] - The U.S. market for LG-IR-NMIBC that UGN-102 can address, if approved, is valued at approximately $5 billion[22] - UroGen's proprietary RTGel technology enables sustained release of medications, potentially improving therapeutic profiles and effectiveness of local treatments[23] - UroGen plans to follow the potential FDA approval and launch of UGN-102 with the development of UGN-103 and UGN-104[24] Market and Patient Insights - Approximately 6,000 to 7,000 new or recurrent low-grade upper tract urothelial cancer (UTUC) patients are diagnosed annually in the U.S.[21] - UroGen's first product targets low-grade upper tract urothelial cancer, aiming to provide non-surgical treatment options[23] - The company anticipates potential patient benefits and market opportunities for UGN-102 upon approval[24] Management and Strategic Direction - UroGen appointed Chris Degnan as Chief Financial Officer in October 2024, bringing extensive financial expertise to the company[6] - The company faces risks related to the timing and success of clinical trials, regulatory approvals, and market acceptance of its products[25] - UroGen's financial guidance for 2024 will be provided in upcoming reports[24] - The company is headquartered in Princeton, NJ, with operations in Israel, focusing on innovative solutions for urothelial and specialty cancers[23]

Investment Rating - The report maintains a Neutral rating on UroGen Pharma (URGN) with a 12-month price target of $22, indicating a potential upside of 51.6% from the current price of $14.51 [42][43]. Core Insights - UroGen Pharma's Jelmyto sales remained flat year-over-year at $21.8 million, slightly below estimates, with challenges related to Medicaid/Medicare discounting impacting revenue guidance for FY24 [2][42]. - The company is focused on completing the rolling NDA submission for UGN-102, with expectations for priority review and potential commercialization in early 2025 [2][42]. - Management expressed confidence in the company's capitalization to reach profitability as it launches UGN-102 and advances its pipeline, despite caution regarding UGN-102's ability to replace TURBT surgery in the near term [2][42]. Financial Summary - UroGen Pharma reported total operating expenses of $184.9 million for 2Q24, slightly above expectations, driven by pre-commercial manufacturing costs for UGN-102 and increased R&D expenses for UGN-103 [2][42]. - The gross margin improved to 90.1%, while R&D expenses increased by 7.1% year-over-year [15][42]. - The company anticipates revenue growth, with projections of $95 million to $102 million for FY24, contingent on the uptake of Jelmyto and the successful launch of UGN-102 [2][42]. Model Adjustments - The report updates its model to reflect actuals from 2Q24 and adjusts near-term operating expense assumptions based on recent trends [2][42].

Financial Data and Key Metrics Changes - UroGen Pharma reported net product revenues of $21.8 million for JELMYTO in Q2 2024, reflecting a 16% sequential growth and a 3% year-over-year growth [10][23] - The net loss for Q2 2024 was $33.4 million, or $0.91 per share, compared to a net loss of $24.1 million, or $1.03 per share, in the same period of 2023 [27] - Cash, cash equivalents, and marketable securities as of June 30, 2024, were approximately $241.3 million, with expectations to end the year with about $220 million on the balance sheet [27][11] Business Line Data and Key Metrics Changes - JELMYTO's revenue growth was impacted by headwinds from 340B and wastage provisions, as well as a contraction in past conversions [10] - Patient enrollment forms for JELMYTO grew by 14% in the first half of 2024 compared to the same period in 2023, indicating potential future demand despite lower conversion rates [10] Market Data and Key Metrics Changes - The estimated market opportunity for UGN-102 is over $5 billion, with approximately 82,000 patients treated annually in the U.S. for low-grade intermediate risk non-muscle invasive bladder cancer [7][12] - UGN-102 is expected to transform the treatment paradigm for this patient population, significantly larger than the JELMYTO market [7] Company Strategy and Development Direction - The immediate priority for UroGen is to complete the NDA submission for UGN-102, with expectations for approval as early as Q1 2025 [6] - UroGen plans to transition from a focus on rare diseases to a specialty product with broader potential, scaling commercial capabilities and increasing the sales force [21][41] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued growth of JELMYTO despite recent revenue results being below expectations, citing a strong clinical conviction among physicians [10][55] - The company is confident in obtaining priority review for UGN-102 based on compelling data and the absence of approved alternatives for the target patient population [54] Other Important Information - UroGen completed a public offering in June 2024, raising approximately $116.2 million to support the launch of UGN-102 and evaluate business development opportunities [11][28] - The company is also developing UGN-301, an immuno-oncology candidate, with plans to report safety and tolerability data in late 2024 [18] Q&A Session Summary Question: Expectations for JELMYTO revenue by quarter - Management refrained from providing quarterly guidance due to variability in conversion rates and gross-to-net increases, but sees a path to the lower end of revenue guidance for the year [31] Question: High-touch support for JELMYTO - The company is focusing on increasing support for physicians to ensure patient conversion and treatment adherence, emphasizing the importance of being present during patient identification [32][33] Question: Commercial introduction of UGN-102 - Plans for UGN-102 include educating physicians on the unmet need and ensuring seamless integration into their workflows, with a modest increase in the sales force anticipated [35][39] Question: Impact of UGN-102 on JELMYTO sales - Management believes that the introduction of UGN-102 could create a "reverse halo" effect, potentially boosting JELMYTO sales as physicians become more engaged with a larger patient population [43] Question: Development timelines for UGN-103 and UGN-104 - The company is accelerating the development of UGN-103 and UGN-104, with expectations for timely patient dosing and potential interim data updates in 2025 or 2026 [44][45]

Urogen Pharma (URGN) came out with a quarterly loss of $0.91 per share versus the Zacks Consensus Estimate of a loss of $0.82. This compares to loss of $1.03 per share a year ago. These figures are adjusted for nonrecurring items. This quarterly report represents an earnings surprise of -10.98%. A quarter ago, it was expected that this company would post a loss of $0.93 per share when it actually produced a loss of $0.97, delivering a surprise of -4.30%. Over the last four quarters, the company has surpasse ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38079 Israel 98-1460746 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 400 Al ...

Exhibit 99.1 UroGen Pharma Ahead of Schedule to Complete UGN-102 NDA Submission and Reports 2024 Second Quarter Financial Results and Business Highlights • Potential for an FDA decision as early as the first quarter of 2025, assuming priority review • UGN-102 Phase 3 ENVISION trial demonstrated an unprecedented 82.3% Duration of Response at 12 Months by Kaplan-Meier analysis in LG-IR-NMIBC patients who achieved a complete response at three months • Ended Q2 2024 with $241.3 million in cash, cash equivalents ...

Shares of Urogen Pharma (URGN) have gained 5.4% over the past four weeks to close the last trading session at $15.82, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $42.88 indicates a potential upside of 171.1%. The average comprises four short-term price targets ranging from a low of $18 to a high of $60, with a standard deviation of $18.56. While the lowest estimate indicates ...