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1. Company Snapshot

1.a. Company Description

UroGen Pharma Ltd., a biotechnology company, engages in the development and commercialization novel solutions for specialty cancers and urothelial diseases.It offers RTGel, a polymeric biocompatible and reverse thermal gelation hydrogel to improve therapeutic profiles of existing drugs; and Jelmyto for pyelocalyceal solution.The company's lead product candidate is UGN-102, which is in Phase III clinical trials for the treatment of several forms of non-muscle invasive urothelial cancer that include low-grade upper tract urothelial carcinoma and low-grade non-muscle invasive bladder cancer.


It is also developing UGN-301 for the treatment of high-grade non-muscle invasive bladder cancer.The company has a license agreement with Allergan Pharmaceuticals International Limited for developing and commercializing pharmaceutical products that contain RTGel and clostridial toxins; Agenus Inc.to develop, make, use, sell, import, and commercialize products of Agenus for the treatment of cancers of the urinary tract via intravesical delivery; and strategic research collaboration with MD Anderson to advance investigational treatment for high-grade bladder cancer.


UroGen Pharma Ltd.was incorporated in 2004 and is based in Princeton, New Jersey.

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1.b. Last Insights on URGN

UroGen Pharma Ltd.'s recent performance was negatively impacted by the FDA's Oncologic Drugs Advisory Committee's (ODAC) vote against the risk/benefit profile of its bladder cancer therapy, UGN-102. This decision, announced on May 21, 2025, led to a significant drop in the company's stock price. Furthermore, the FDA's statement on May 16, 2025, highlighted the difficulty in interpreting the primary endpoints of complete response (CR) and duration of response (DOR) due to the lack of a concurrent control arm in the ENVISION trial. This raised concerns about the efficacy of UGN-102. Additionally, several law firms have initiated investigations into potential securities law violations by UroGen Pharma Ltd., further contributing to the negative sentiment surrounding the company.

1.c. Company Highlights

2. UroGen Pharma's Q3 2025 Earnings: Progress in Commercializing JELMYTO and ZUSDURI

UroGen Pharma reported a net product revenue of $25.7 million for JELMYTO, representing a 13% increase in underlying demand revenue compared to the same period in 2024. ZUSDURI generated $1.8 million in sales during the quarter, with a preliminary demand revenue estimate of $4.5 million for October, indicating encouraging early momentum. The company's actual EPS came out at -$0.69, beating estimates of -$0.72. The financial performance was in line with expectations, with operating expenses expected to be in the range of $215 million to $225 million for 2025.

Publication Date: Nov -14

📋 Highlights
  • JELMYTO Revenue Growth:: Generated $25.7M in net product revenue, reflecting 13% growth in underlying demand compared to 2024.
  • ZUSDURI Early Momentum:: Preliminary October demand revenue estimate of $4.5M, with $1.8M in Q3 sales despite operational challenges.
  • J-Code Impact on ZUSDURI:: 45-60 day lag between enrollment and dosing due to temporary J-code, expected to resolve in 2026 with permanent J-code adoption.
  • 2025 Financial Guidance:: JELMYTO revenue projected at $94–$98M (8–12% YoY growth), with operating expenses of $215–$225M and $127.4M cash reserves.

Commercial Progress and Launch Dynamics

The launch of ZUSDURI has faced logistical and operational challenges, including reimbursement concerns with a miscellaneous J-code, resulting in a 45- to 60-day lag between patient enrollment form submission and patient dosing. However, the company has secured broad coverage across major payers, with over 95% of covered lives and approximately 296 million eligible patients having access to ZUSDURI. UroGen's CEO, Liz Barrett, expressed confidence in the long-term potential for ZUSDURI to deliver an important advance for patients and become the standard of care.

Financial Guidance and Valuation

The company's financial guidance for 2025 JELMYTO net product revenues remains unchanged, in the range of $94 million to $98 million. With a cash position of $127.4 million, UroGen believes it will be sufficient to deliver on their core priorities and reach profitability. The current valuation metrics indicate a P/S Ratio of 11.88 and an EV/EBITDA of -9.8, suggesting that the market is pricing in significant growth potential. Analysts estimate next year's revenue growth at 123.0%, indicating a strong expected increase in sales.

Pipeline Updates and Future Prospects

UroGen is also making progress in its pipeline, with UGN-103 expected to be submitted for approval in 2026, and UGN-501, a next-generation oncolytic virus, anticipated to start a Phase I trial in 2026. The company is seeing a "reverse halo effect" for their new product, ZUSDURI, as new physicians using JELMYTO are generating demand. The expansion of their sales organization is allowing them to reach more doctors, with some first prescribers of ZUSDURI being JELMYTO users.

3. NewsRoom

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UroGen Pharma: Strong Potential As Zusduri Commercialization Accelerates

Nov -25

Source: seekingalpha.com

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UroGen Pharma to Present at the Piper Sandler 37th Annual Healthcare Conference

Nov -25

Source: globenewswire.com

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UroGen Pharma Ltd. (URGN) Q3 2025 Earnings Call Transcript

Nov -07

Source: seekingalpha.com

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Urogen Pharma (URGN) Reports Q3 Loss, Misses Revenue Estimates

Nov -06

Source: zacks.com

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UroGen Reports Third Quarter 2025 Financial Results as ZUSDURI™ Launch Gains Momentum

Nov -06

Source: globenewswire.com

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UroGen Reports 77.8% Three-Month Complete Response Rate from Phase 3 UTOPIA Trial of UGN-103 and Receives FDA Agreement on NDA Submission Strategy in Recurrent LG-IR-NMIBC Based on UTOPIA Trial

Nov -06

Source: globenewswire.com

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UroGen Pharma to Present at Guggenheim Securities Healthcare Innovation Conference

Nov -04

Source: globenewswire.com

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Urogen Pharma (URGN) Projected to Post Quarterly Earnings on Thursday

Nov -04

Source: defenseworld.net

4. Business Breakdown

4.a. Revenues by Country

4.b. Revenues by Segment

5. Expected revenues mid-term growth (9.27%)

6. Segments

RTGel Reverse-Thermal Hydrogel

Expected Growth: 9.27%

RTGel's 9.27% growth is driven by increasing adoption in urology clinics, expanding treatment of non-muscle invasive bladder cancer, and growing demand for minimally invasive therapies. Additionally, UroGen Pharma's strategic partnerships and investments in clinical trials have enhanced product visibility and accessibility, contributing to the segment's growth.

7. Detailed Products

Jelmyto

Jelmyto is a mitomycin gel for urinary tract infection treatment. It is a sterile, gel-like formulation of mitomycin, an antibiotic, for intravesical use.

UGN-102

UGN-102 is a mitomycin gel for the treatment of low-grade non-muscle invasive bladder cancer (LG-NMIBC).

RTGel

RTGel is a reverse thermal gelation technology for the sustained release of therapeutic agents in the bladder.

8. UroGen Pharma Ltd.'s Porter Forces

Forces Ranking

Threat Of Substitutes

UroGen Pharma Ltd. has a unique product portfolio, which reduces the threat of substitutes. The company's focus on uro-oncology and uro-urology provides a competitive advantage, making it difficult for substitutes to enter the market.

Bargaining Power Of Customers

UroGen Pharma Ltd. has a diverse customer base, including hospitals, clinics, and patients. While customers have some bargaining power, the company's strong relationships and customer service mitigate this threat.

Bargaining Power Of Suppliers

UroGen Pharma Ltd. has a diversified supplier base, which reduces dependence on individual suppliers. The company's strong relationships with suppliers and its ability to negotiate prices mitigate the bargaining power of suppliers.

Threat Of New Entrants

The biotechnology industry is highly competitive, and new entrants can easily enter the market. UroGen Pharma Ltd. faces a high threat of new entrants, which could lead to increased competition and reduced market share.

Intensity Of Rivalry

The biotechnology industry is highly competitive, and UroGen Pharma Ltd. faces intense rivalry from established companies. The company must continuously innovate and improve its products to maintain its market position.

9. SWOT Analysis

Strength

Weaknesses

Opportunities

Threats

10. Capital Structure

10.a. Balance Sheet

10.b. Weighted Average Cost of capital

Value
Debt Weight 290.91%
Debt Cost 9.37%
Equity Weight -190.91%
Equity Cost 9.37%
WACC 9.37%
Leverage -152.38%

11. Quality Control: UroGen Pharma Ltd. passed 4 out of 9 key points

12.a Historical Valuation

12.b Price/Earnings Ratio

12.c Margin Valuation

12.d Peers Valuation

Peers Group Analysis

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CytomX Therapeutics

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Value: 5.7

Growth: 6.2

Quality: 9.8

Yield: 0.0

Momentum: 10.0

Volatility: 0.3

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MiMedx

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UroGen Pharma

A-Score: 4.9/10

Value: 8.2

Growth: 5.6

Quality: 6.1

Yield: 0.0

Momentum: 9.0

Volatility: 0.7

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Growth: 5.8

Quality: 5.8

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Armata Pharmaceuticals

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Value: 8.0

Growth: 4.6

Quality: 6.1

Yield: 0.0

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Volatility: 0.0

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Liquidia

A-Score: 4.0/10

Value: 6.0

Growth: 2.4

Quality: 3.2

Yield: 0.0

Momentum: 10.0

Volatility: 2.3

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Peers Metrics

12.e Scoring Insights

12.f DCF BETA

Parameters

Short Term Growth

Short term Time

Long-Term Growth

WACC

Target Price

23.09$

Current Price

23.09$

Potential

-0.00%

Expected Cash-Flows