Company Performance - Urogen Pharma reported a quarterly loss of $0.92 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.83, and an improvement from a loss of $0.97 per share a year ago, indicating a surprise of -10.84% [1] - The company posted revenues of $20.25 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 3.67%, but showing an increase from $18.78 million in the same quarter last year [2] - Over the last four quarters, Urogen Pharma has surpassed consensus EPS estimates only once and has topped consensus revenue estimates just once [2] Stock Outlook - Urogen Pharma shares have declined approximately 2.5% since the beginning of the year, while the S&P 500 has seen a decline of 3.8%, indicating relative outperformance [3] - The current consensus EPS estimate for the upcoming quarter is -$0.85 on revenues of $24.45 million, and for the current fiscal year, it is -$3 on revenues of $120.83 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Urogen Pharma belongs, is currently ranked in the top 34% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

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 March 31, 2025 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 UROGEN PHARMA LTD. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or ...

[Business and Financial Highlights](index=1&type=section&id=Business%20and%20Financial%20Highlights) UroGen is approaching a pivotal period with the anticipated FDA approval of its lead product, UGN-102, in June 2025, targeting a potential $5 billion market for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer - The company is entering a pivotal period with the anticipated FDA approval of its lead pipeline product, UGN-102, in June 2025, representing a significant commercial opportunity with a total addressable market of over **$5 billion**[3](index=3&type=chunk) Q1 2025 Key Highlights | Metric | Value | Note | | :--- | :--- | :--- | | **UGN-102 PDUFA Date** | June 13, 2025 | FDA target action date | | **JELMYTO® Net Sales** | $20.3 million | Q1 2025 | | **JELMYTO® Underlying Demand Growth** | 12% | Year-over-year | | **Cash and Equivalents** | $200.4 million | As of March 31, 2025 | [Pipeline and Product Updates](index=1&type=section&id=Pipeline%20and%20Product%20Updates) UroGen provided significant updates across its portfolio, with UGN-102 on track for its PDUFA date, JELMYTO showing steady demand growth, and the early-stage pipeline expanding with UGN-501 and UGN-301 advancements [UGN-102 (mitomycin) for intravesical solution](index=1&type=section&id=UGN-102%20%28mitomycin%29%20for%20intravesical%20solution) The New Drug Application (NDA) for UGN-102 is under FDA review with a PDUFA target date of June 13, 2025, supported by positive 18-month data from the Phase 3 ENVISION trial - The FDA has set a PDUFA target action date of **June 13, 2025**, for UGN-102 and scheduled an ODAC meeting for **May 21, 2025**[7](index=7&type=chunk) - Updated 18-month data from the ENVISION trial showed the probability of remaining in complete response was **80.6%**, consistent with prior 12-month estimates[7](index=7&type=chunk) - Patient-reported outcomes from three studies (OPTIMA II, ATLAS, ENVISION) showed that UGN-102 did not have a negative impact on symptom burden, patient function, or quality of life[7](index=7&type=chunk) [JELMYTO (mitomycin) for pyelocalyceal solution](index=1&type=section&id=JELMYTO%20%28mitomycin%29%20for%20pyelocalyceal%20solution) JELMYTO generated $20.3 million in net product revenue in Q1 2025, an 8% increase over Q1 2024, driven by 12% underlying demand growth, with long-term data showing a median duration of response of 47.8 months JELMYTO Q1 Performance | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net Product Revenue | $20.3M | $18.8M | - Year-over-year revenue growth of **8%** was driven by underlying demand growth of **12%**, partially offset by higher 340B chargebacks[11](index=11&type=chunk) - Long-term follow-up from the JELMYTO Phase 3 study showed a median Duration of Response (DOR) of **47.8 months** for all patients achieving complete response[18](index=18&type=chunk) [Other Pipeline Developments](index=2&type=section&id=Other%20Pipeline%20Developments) UroGen is actively advancing its broader pipeline, with enrollment complete for the Phase 1 study of UGN-301, the acquisition of UGN-501, and expected completion of UGN-103 Phase 3 enrollment by mid-2025 - Enrollment is complete in the Phase 1 study of UGN-301 (zalifrelimab) in high-grade NMIBC, with the investigational treatment demonstrating an acceptable safety profile[8](index=8&type=chunk) - In February 2025, UroGen acquired UGN-501 (ICVB-1042), a next-generation oncolytic virus, from IconOVir Bio to expand its nonclinical oncology portfolio[9](index=9&type=chunk) - Enrollment in the Phase 3 UTOPIA trial of UGN-103 is expected to be completed by **mid-2025**, and a Phase 3 trial for UGN-104 is planned to initiate by **mid-2025**[19](index=19&type=chunk) [Q1 2025 Financial Performance](index=2&type=section&id=First%20quarter%202025%20Financial%20Results) UroGen reported a net loss of $43.84 million for Q1 2025, compared to a $32.29 million loss in Q1 2024, primarily due to higher operating expenses for UGN-102 commercial preparations and R&D increases, ending the quarter with $200.41 million in cash and marketable securities [Key Financial Metrics](index=2&type=section&id=Key%20Financial%20Metrics) In Q1 2025, UroGen's revenue grew to $20.25 million from $18.78 million year-over-year, but increased operating expenses led to a higher net loss of $43.84 million, or ($0.92) per share Condensed Consolidated Statements of Operations (in millions USD, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Revenue | $20.25M | $18.78M | | Gross Profit | $17.92M | $17.05M | | R&D Expenses | $19.87M | $15.49M | | SG&A Expenses | $34.97M | $27.30M | | Operating Loss | $(36.91)M | $(25.74)M | | Net Loss | $(43.84)M | $(32.29)M | | Net Loss per Share | $(0.92) | $(0.87) | - The **$4.4 million** increase in R&D expenses was primarily driven by the acquisition of UGN-501, higher manufacturing costs, and costs for the Phase 3 UTOPIA trial[12](index=12&type=chunk) - The **$7.7 million** increase in SG&A expenses was primarily driven by UGN-102 commercial preparation activities[13](index=13&type=chunk) [Financial Position](index=2&type=section&id=Financial%20Position) As of March 31, 2025, UroGen held $200.41 million in cash, cash equivalents, and marketable securities, a decrease from $241.71 million at the end of 2024, resulting in a total shareholders' deficit of $46.46 million Selected Consolidated Balance Sheet Data (in millions USD) | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $200.41M | $241.71M | | Total assets | $247.62M | $285.71M | | Total liabilities | $294.08M | $294.51M | | Total shareholders' deficit | $(46.46)M | $(8.80)M | [2025 Financial Guidance](index=3&type=section&id=2025%20Financial%20Guidance) UroGen reaffirmed its full-year 2025 financial guidance, expecting JELMYTO net product revenues between $94 million and $98 million, and total operating expenses between $215 million and $225 million - Guidance for full-year 2025 net product revenues for JELMYTO remains unchanged at **$94 million to $98 million**[21](index=21&type=chunk) - Full-year 2025 operating expenses are expected to be in the range of **$215 million to $225 million**, including **$11 million to $14 million** in non-cash share-based compensation[21](index=21&type=chunk) [Product and Disease Information](index=3&type=section&id=Product%20and%20Disease%20Information) This section provides background on UroGen's approved product JELMYTO, its lead investigational candidate UGN-102, and the disease they target, Upper Tract Urothelial Cancer (UTUC), all based on the proprietary RTGel® technology [About JELMYTO](index=3&type=section&id=About%20JELMYTO) JELMYTO (mitomycin) is a prescription medicine for adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC), utilizing a reverse thermal gel for prolonged chemoablative therapy, with key safety warnings including ureteric obstruction and bone marrow problems - JELMYTO is a mitomycin-containing reverse thermal gel indicated for the treatment of adult patients with LG-UTUC[28](index=28&type=chunk) - Important safety information includes a contraindication for patients with a hole or tear (perforation) of the bladder or upper urinary tract[30](index=30&type=chunk) - Serious side effects may include swelling and narrowing of the ureter (ureteric obstruction) and bone marrow problems causing a decrease in blood cell counts[36](index=36&type=chunk) [About UGN-102](index=4&type=section&id=About%20UGN-102) UGN-102 is an investigational formulation of mitomycin using UroGen's proprietary RTGel® technology, in Phase 3 development for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), with an FDA PDUFA goal date of June 13, 2025 - UGN-102 is an innovative drug formulation of mitomycin in Phase 3 development for recurrent LG-IR-NMIBC, utilizing UroGen's proprietary RTGel® technology[35](index=35&type=chunk) - The FDA accepted the NDA for UGN-102 and assigned a PDUFA goal date of **June 13, 2025**[37](index=37&type=chunk) [About Upper Tract Urothelial Cancer (UTUC)](index=4&type=section&id=About%20Upper%20Tract%20Urothelial%20Cancer%20%28UTUC%29) Upper Tract Urothelial Cancer (UTUC) accounts for 5-10% of all urothelial cancers, with an estimated 6,000-7,000 new or recurrent low-grade cases annually in the U.S., predominantly affecting patients over 70 years old - UTUC accounts for **five to ten percent** of primary urothelial cancers, with approximately **6,000 - 7,000** new or recurrent LG-UTUC patients annually in the U.S[34](index=34&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This section provides a standard legal disclaimer regarding forward-looking statements, cautioning that actual results could differ materially from expectations due to numerous risks and uncertainties, including regulatory approvals, clinical trial success, and commercialization challenges - The press release contains forward-looking statements regarding the UGN-102 regulatory timeline, market opportunities, clinical trial progress, and financial guidance[39](index=39&type=chunk) - These statements are subject to significant risks, including uncertain outcomes of the ODAC meeting and FDA review, potential clinical trial delays, commercialization complications, and competition[39](index=39&type=chunk)

Urogen Pharma (URGN) shares ended the last trading session 14.1% higher at $11.26. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 11.9% loss over the past four weeks.The stock rallied after the company presented multiple data at the annual meeting of the American Urological Association 2025 on its pipeline candidates that are being studied for different cancer indications.This company is expected to post quarterly ...

Core Insights - UroGen Pharma Ltd. reported a nearly four-year duration of response from a long-term follow-up study with Jelmyto for low-grade upper tract urothelial cancer [1] - The FDA approved Jelmyto in 2020 for treating low-grade upper tract urothelial cancer in adults [1] Group 1: Jelmyto (mitomycin) for LG-UTUC - In the OLYMPUS trial, patients who achieved a complete response had a median duration of response of 47.8 months, with a median follow-up of 28.1 months [2] - Among the 41 patients, 21 had new-onset UTUC and 20 had recurrent UTUC, with no significant differences in durability between the groups [2] - A total of 20 patients entered long-term follow-up, and the Jelmyto uTRACT Registry is enrolling participants to gather real-world usage data [3] Group 2: UGN-102 (mitomycin) for LG-IR-NMIBC - The OPTIMA II Phase 2b study showed a clinically meaningful two-year duration of response of 24.2 months for UGN-102 [4] - Among 41 patients achieving a complete response at three months, 25 remained in complete response at 12 months [4] - The median duration of response for these patients was 24.2 months, with 48.8% experiencing recurrence of low-grade disease [5] Group 3: Regulatory and Safety Updates - UroGen completed the submission of the UGN-102 rolling new drug application to the FDA in August 2024, with a PDUFA goal date of June 13, 2025 [6] - Safety data from the Phase 1 dose-escalation study for UGN-301 indicated no dose-limiting toxicities or treatment-emergent adverse events leading to discontinuation [7][8] - At the 15-month disease assessment, 60% of patients with Ta/T1 disease treated with 300 mg remained recurrence-free [9] Group 4: Market Reaction - UroGen's stock price increased by 7.65% to $10.63 following the announcements [10]

Core Insights - The article reflects on the author's investment journey, emphasizing the learning process from both successes and failures in the investment landscape, particularly in healthcare stocks [1]. Company Analysis - UroGen Pharma (NASDAQ: URGN) is highlighted as a focus of the author's investment research, indicating a long-term beneficial position in the company's shares [2]. - The author has been conducting focused research on various stocks for approximately five years, with a primary emphasis on healthcare stocks, suggesting a deep understanding of the sector [1]. Market Perspective - The article serves as a platform for sharing experiences and insights related to investing, particularly in the context of UroGen Pharma, which may indicate potential investment opportunities in the healthcare sector [1].

Financial Data and Key Metrics Changes - UroGen Pharma reported net product revenues of $90.4 million for the full year 2024, an increase from $82.7 million in 2023, representing a year-over-year growth of approximately 9.3% [17][44] - The net loss for Q4 2024 was $37.5 million, or $0.80 per share, compared to a net loss of $26 million, or $0.72 per share, in Q4 2023 [47] - For the full year 2024, the net loss was $126.9 million, or $2.96 per share, compared to a net loss of $102.2 million, or $3.55 per share, in 2023 [47] Business Line Data and Key Metrics Changes - JELMYTO generated net product revenues of $24.6 million in Q4 2024, up from $23.5 million in Q4 2023, with underlying demand revenue increasing by 15% [44] - The underlying demand revenue for JELMYTO for the full year 2024 was $87.4 million, reflecting a 12% increase compared to the previous year [39][44] - The company reported a compelling complete response rate of 79.6% and a 12-month duration of response of 82.3% for UGN-102 in the ENVISION Phase 3 trial [9][10] Market Data and Key Metrics Changes - The total addressable market for UGN-102 is estimated to be over $5 billion, significantly larger than the market for JELMYTO [15] - UroGen expects to expand its sales force from 52 to approximately 83 representatives to support the anticipated launch of UGN-102 [37][100] Company Strategy and Development Direction - UroGen aims to transition from a rare disease-focused company to a multiproduct specialty-driven team, with a strong emphasis on the launch of UGN-102 [34] - The company has acquired ICVB-1042, a next-generation investigational oncolytic virus, to enhance its pipeline and address critical gaps in cancer care [19][20] - UroGen is preparing for the ODAC meeting to discuss UGN-102, which is expected to be a paradigm shift in treating low-grade intermediate-risk non-muscle invasive bladder cancer [22][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the data package submitted for UGN-102 and its potential to address significant unmet needs in the patient population [14] - The company anticipates a transformative year in 2025 with the expected launch of UGN-102, which is projected to generate over $1 billion in revenue [54][94] - Management highlighted the importance of preparing for reimbursement processes and ensuring smooth integration of UGN-102 into treatment protocols [38][66] Other Important Information - UroGen ended 2024 with $241.7 million in cash, cash equivalents, and marketable securities, providing a solid foundation for executing its strategic initiatives [21][43] - The company expects full-year 2025 JELMYTO revenues to be in the range of $94 million to $98 million, indicating a growth rate of approximately 8% to 12% [48] Q&A Session Summary Question: Will UGN-102 be used off-label for patients ineligible for surgery? - Management indicated that using UGN-102 in this context would be considered off-label, and it would be up to physicians to work with insurance companies for reimbursement [53][54] Question: How should investors think about the initial launch trajectory of UGN-102? - Management expects the launch trajectory to be similar to JELMYTO, with larger absolute numbers due to the patient population, and pricing is anticipated to be in the $18,000 to $19,000 range [61][62] Question: What is the expected reimbursement environment for UGN-102? - Initially, a miscellaneous J-code will be used, which may lead to longer reimbursement times, but a permanent J-code is expected by January 2026, improving the process significantly [66][68] Question: How will UGN-102 and UGN-103 be positioned against each other? - Management plans to fade out UGN-102 after UGN-103 is approved, ensuring no overlap in the market to avoid interchangeability issues [94][95] Question: What are the economies of scale with the increase in sales representatives? - The increase to 83 representatives is based on patient epidemiology, allowing coverage of approximately 85% of the market, which is critical for supporting physician practices [100][104]

Market Potential and Product Development - UGN-102, if approved, could address a treatable population of approximately 82,000 low-grade intermediate risk NMIBC patients in the U.S., with a total addressable market exceeding $5.0 billion [506]. - The company has initiated the Phase 3 ENVISION trial to evaluate UGN-102 as primary chemoablative therapy for low-grade intermediate risk NMIBC [524]. - 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 [530]. - The company entered into a licensing agreement with medac for UGN-103 and UGN-104, aiming for an NDA submission for UGN-103 in 2026 and a commercial launch in 2027 [531]. Clinical Trial Results - The complete response rate for Jelmyto in the OLYMPUS trial was 58%, with a durability of response estimated at 81.8% at 12 months [513]. - In the OPTIMA II trial, 65% of patients achieved a complete response three months after treatment with UGN-102, with a 72.5% probability of durable response at nine months [522]. - In the Phase 3 ATLAS trial, UGN-102 reduced the risk of recurrence, progression, or death by 55% compared to TURBT alone, with a 64.8% complete response (CR) rate at three months for UGN-102 patients [525]. - The ENVISION trial demonstrated a 79.6% CR rate at three months for patients treated with UGN-102, with 60.8% of all enrolled patients in CR at 12 months [526][527]. - Updated 18-month duration of response (DOR) data from the ENVISION trial showed an 80.6% DOR for patients who achieved CR at three months [528]. - The company completed a Phase 3b study indicating that UGN-102 can be administered at home, with 75% of patients achieving CR three months after treatment [529]. Financial Performance - Revenue from Jelmyto sales increased to $90.4 million in 2024 from $82.7 million in 2023 [539]. - The consolidated net revenue for the year ended December 31, 2024, was $90.4 million, an increase from $82.7 million in 2023, representing a growth of approximately 9.3% [628]. - Gross profit for 2024 was $81.5 million, up from $73.4 million in 2023, reflecting an increase of $8.2 million [562]. - The net loss for the year ended December 31, 2024, was $126.9 million, compared to a net loss of $102.2 million in 2023, an increase of $24.6 million [562]. - Selling, general and administrative expenses rose significantly to $121.2 million in 2024, up from $93.3 million in 2023, marking an increase of about 30% [636]. Research and Development Expenses - Research and development expenses increased from $45.6 million in 2023 to $57.1 million in 2024, primarily due to clinical development costs [543]. - Research and development expenses rose to $57.1 million in 2024 from $45.6 million in 2023, an increase of $11.5 million primarily due to higher manufacturing costs and regulatory expenses [565]. - Research and development expenses are expensed as incurred, primarily consisting of salaries, share-based compensation, and costs related to clinical trials and professional services [685]. Cash Flow and Financing - The company expects to finance cash needs through equity or debt financings and collaboration arrangements until substantial product revenue is generated [585]. - As of December 31, 2024, the company had $241.7 million in cash and cash equivalents and marketable securities [572]. - Net cash used in operating activities increased to $96.8 million in 2024 from $76.4 million in 2023, primarily due to higher operating expenses related to UGN-102 [588]. - Net cash provided by financing activities increased to $194.6 million in 2024 from $116.9 million in 2023, driven by proceeds from the issuance of ordinary shares and debt related to the Pharmakon loan [590]. Inventory and Asset Management - As of December 31, 2024, total inventories increased to $9,446,000 from $7,341,000 as of December 31, 2023, representing a year-over-year growth of approximately 28.6% [699]. - The Company commenced capitalization of inventory costs for Jelmyto upon receipt of FDA approval, with inventory valued at the lower of cost or net realizable value [671]. - The company’s inventory assessment includes a review for recoverability each reporting period to determine any necessary write-downs due to excess or obsolete inventories [672]. Regulatory and Compliance - The company has adopted new accounting standards updates, including ASU 2023-07 for segment reporting disclosures, effective for fiscal years beginning after December 15, 2023 [693]. - The Company is party to a loan agreement with Pharmakon Advisors, recognizing interest expense in current earnings and capitalizing financing expenses as a direct offset to long-term debt [676]. Shareholder Information - The company reported a weighted average number of shares outstanding of 42,876,737 for the year ended December 31, 2024, compared to 28,834,303 in 2023, an increase of approximately 48.7% [636]. - The net loss attributable to equity holders of the Company for the year ended December 31, 2024, was $126.874 million, compared to a net loss of $102.244 million for 2023, resulting in a loss per ordinary share of $(2.96) for 2024 and $(3.55) for 2023 [692].

Financial Data and Key Metrics Changes - UroGen Pharma reported net product revenues of $90.4 million for the full year 2024, an increase from $82.7 million in 2023, representing a year-over-year growth of approximately 9.3% [17][44] - The net loss for the fourth quarter of 2024 was $37.5 million, or $0.80 per share, compared to a net loss of $26 million, or $0.72 per share, in the same period in 2023 [47] - For the full year 2024, the net loss was $126.9 million, or $2.96 per share, compared to a net loss of $102.2 million, or $3.55 per share, in 2023 [47] Business Line Data and Key Metrics Changes - JELMYTO generated net product revenues of $24.6 million in Q4 2024, up from $23.5 million in Q4 2023, with underlying demand revenue increasing by 15% [44] - The underlying demand revenue for JELMYTO for the full year 2024 was $87.4 million, reflecting a 12% increase compared to the previous year [39][44] - The company reported a compelling complete response rate of 79.6% at three months and an 82.3% duration of response at 12 months for UGN-102, with updated data showing an 80.6% duration of response at 18 months [9][10] Market Data and Key Metrics Changes - The total addressable market for UGN-102 is estimated to be over $5 billion, significantly larger than the market for JELMYTO [15] - The anticipated launch of UGN-102 is expected to transform UroGen's market position, moving from a rare disease-focused company to a multiproduct specialty-driven team [34] Company Strategy and Development Direction - UroGen aims to enhance its commercial infrastructure by expanding its sales force from 52 to approximately 83 representatives to support the launch of UGN-102 [37][100] - The company is focused on raising awareness of unmet needs in low-grade intermediate risk non-muscle invasive bladder cancer through educational programs and scientific exchanges [35][36] - UroGen has acquired ICVB-1042, a next-generation investigational oncolytic virus, to enhance its pipeline and address critical gaps in cancer care [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the data package submitted for UGN-102 and its potential to address significant unmet needs in the bladder cancer treatment landscape [14] - The company anticipates a transformative year in 2025 with the expected launch of UGN-102, which is projected to generate over $1 billion in revenue [54][109] - Management highlighted the importance of preparing for reimbursement processes and ensuring smooth integration of UGN-102 into treatment protocols [38][66] Other Important Information - UroGen ended 2024 with a strong balance sheet, holding $241.7 million in cash, cash equivalents, and marketable securities [21][43] - The company expects full-year 2025 JELMYTO revenues to be in the range of $94 million to $98 million, indicating a growth rate of approximately 8% to 12% [48] Q&A Session Summary Question: Can UGN-102 be used off-label for patients ineligible for surgery? - Management indicated that using UGN-102 in this context would be considered off-label, and it would be up to physicians to work with insurance companies for reimbursement [53][54] Question: How should investors think about the initial launch trajectory of UGN-102? - The launch trajectory is expected to be similar to JELMYTO, with a larger patient population leading to higher absolute numbers [61][72] Question: What are the expected differences in reimbursement levels with the J-code transition? - Initially, a miscellaneous J-code will be used, which may result in longer reimbursement times, but this will improve with a unique permanent J-code expected in January 2026 [66][68] Question: How will UGN-102 be positioned relative to UGN-103? - UGN-102 is expected to be phased out after UGN-103 is approved, with a focus on ensuring no automatic substitution occurs [94][95] Question: What is the rationale behind increasing the sales force size? - The increase is based on patient epidemiology, ensuring coverage of approximately 85% of the market for low-grade intermediate risk NMIBC [102][104]

Urogen Pharma (URGN) came out with a quarterly loss of $0.80 per share versus the Zacks Consensus Estimate of a loss of $0.74. This compares to loss of $0.72 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -8.11%. A quarter ago, it was expected that this company would post a loss of $0.84 per share when it actually produced a loss of $0.55, delivering a surprise of 34.52%.Over the last four quarters, the company has surpassed ...