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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 Q4 2025 Earnings: A Strong Launch and Pipeline Advancements

UroGen Pharma reported revenues of $109.8 million for the year ended December 31, 2025, compared to $90.4 million in 2024, representing a 21.5% increase. The company's net loss was $153.5 million, or $3.19 per basic and diluted share, for the year ended December 31, 2025. The actual EPS loss was $0.54 for the quarter, beating estimates of -$0.66. Jelmyto generated net product revenue of $94 million in 2025, while Zasturi revenue was $15.8 million, reflecting early launch dynamics.

Publication Date: Mar -08

📋 Highlights
  • Zasturi Revenue & Potential:: Generated $15.8 million in 2025 with a >$1B peak revenue potential for recurrent bladder cancer.
  • Jelmyto Performance:: Delivered $94 million net revenue in 2025, with 2026 guidance of $97–$101 million (3–7% YoY growth).
  • UGN-103 Progress:: 77.8% complete response rate in Phase 3 Utopia trial, NDA planned for 2026, potential FDA approval in 2027.
  • 2026 Financials:: Operating expenses projected at $240–$250 million, including $20–$24 million noncash share-based compensation.
  • Commercial Momentum:: Zasturi adoption accelerated post-permanent J code, with 2026 growth driven by community urologist participation.

Commercial Update

The Zasturi launch is developing as expected, with a noticeable step up in adoption and utilization trends. The company has seen growing participation from community-based urologists, which is expected to contribute to growth in 2026. David Lin, Chief Commercial Officer, stated that once physicians experience a positive outcome with Zasturi, they are more likely to become repeat prescribers.

Pipeline Advancements

UroGen Pharma is advancing its pipeline in a disciplined manner, with UGN-103 demonstrating compelling complete response results in the Phase 3 Utopia trial. The company plans to submit an NDA in 2026, with potential FDA approval in 2027. Mark P. Schoenberg, Chief Medical Officer, highlighted the results from the ENVISION trial, which supported approval of Zasturi.

Financial Guidance and Valuation

The company provided 2026 guidance for Jelmyto net product revenue and total company operating expenses. Analysts estimate next year's revenue growth at 74.9%. With a P/S Ratio of 8.72 and an EV/EBITDA of -7.64, the market is pricing in significant growth expectations. The company's ROE is 170.21%, and the Net Debt / EBITDA is -0.14, indicating a strong financial position.

Future Prospects

Elizabeth A. Barrett highlighted positive trends in patient enrollment and dosing for Zasturi, surpassing Jelmyto indicators in February. The company is investing in Zasturi as if UGN-103 did not exist and will continue to do so. With a strengthened balance sheet and a disciplined approach to pipeline advancements, UroGen Pharma is poised for long-term sustainable growth.

3. NewsRoom

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UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Mar -06

Source: globenewswire.com

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UroGen: ZUSDURI Poised To Replace TURBT Surgery As SOC In Certain Bladder Cancers

Mar -05

Source: seekingalpha.com

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UroGen Pharma Ltd. (URGN) Q4 2025 Earnings Call Transcript

Mar -02

Source: seekingalpha.com

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Urogen Pharma (URGN) Reports Q4 Loss, Beats Revenue Estimates

Mar -02

Source: zacks.com

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UroGen Announces ZUSDURI™ Launch is On-Track and Reports Fourth Quarter and Full Year 2025 Financial Results

Mar -02

Source: globenewswire.com

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UroGen Announces Refinanced Term Loan Agreement with Pharmakon Advisors

Mar -02

Source: globenewswire.com

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ZUSDURI™ Achieves Durable Complete Responses Across EORTC Risk Groups in Patients with Recurrent LG-IR-NMIBC

Feb -27

Source: globenewswire.com

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UroGen Pharma to Present at the TD Cowen 46th Annual Health Care Conference

Feb -24

Source: globenewswire.com

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

Stock-Card
UroGen Pharma

A-Score: 5.1/10

Value: 8.0

Growth: 5.6

Quality: 6.1

Yield: 0.0

Momentum: 10.0

Volatility: 1.0

1-Year Total Return ->

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CytomX Therapeutics

A-Score: 4.9/10

Value: 3.2

Growth: 6.2

Quality: 9.4

Yield: 0.0

Momentum: 10.0

Volatility: 0.3

1-Year Total Return ->

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Armata Pharmaceuticals

A-Score: 4.8/10

Value: 8.0

Growth: 4.7

Quality: 5.9

Yield: 0.0

Momentum: 10.0

Volatility: 0.0

1-Year Total Return ->

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Stock-Card
MiMedx

A-Score: 4.3/10

Value: 3.4

Growth: 7.3

Quality: 8.5

Yield: 0.0

Momentum: 2.5

Volatility: 4.3

1-Year Total Return ->

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Stock-Card
Liquidia

A-Score: 4.1/10

Value: 6.0

Growth: 2.4

Quality: 3.6

Yield: 0.0

Momentum: 10.0

Volatility: 2.3

1-Year Total Return ->

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Stock-Card
Akebia Therapeutics

A-Score: 2.8/10

Value: 4.4

Growth: 5.7

Quality: 3.9

Yield: 0.0

Momentum: 1.5

Volatility: 1.3

1-Year Total Return ->

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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

17.62$

Current Price

17.62$

Potential

-0.00%

Expected Cash-Flows