Urogen Pharma (URGN)
NASDAQ:URGN
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Urogen Pharma (URGN) AI Stock Analysis

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URGN

Urogen Pharma

(NASDAQ:URGN)

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Neutral 57 (OpenAI - 4o)
Rating:57Neutral
Price Target:
$24.50
▼(-2.55% Downside)
Urogen Pharma's stock score is primarily influenced by its financial challenges, despite strong technical momentum and positive earnings call highlights. The company's high leverage and negative profitability are significant risks, while promising product growth offers potential upside.
Positive Factors
FDA Approval of ZUSDURI
FDA approval of ZUSDURI opens a significant market opportunity, potentially driving long-term revenue growth and strengthening Urogen's market position in urological therapies.
Strong JELMYTO Revenue Growth
Consistent revenue growth for JELMYTO indicates strong market adoption and supports Urogen's revenue base, contributing to financial stability and future expansion.
Robust Cash Position
A strong cash position provides Urogen with the financial flexibility to invest in R&D, expand operations, and weather potential market challenges, supporting long-term growth.
Negative Factors
Reimbursement Challenges for ZUSDURI
Reimbursement challenges can hinder ZUSDURI's market penetration, affecting revenue potential and slowing the adoption of this newly approved therapy.
Increased Operating Expenses
Rising operating expenses, driven by commercial preparation, could pressure margins and profitability, limiting Urogen's ability to achieve sustainable financial performance.
High Leverage and Negative Equity
High leverage and negative equity pose financial stability risks, potentially restricting Urogen's ability to raise capital and invest in growth initiatives.

Urogen Pharma (URGN) vs. SPDR S&P 500 ETF (SPY)

Urogen Pharma Business Overview & Revenue Model

Company DescriptionUrogen Pharma Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapies for urological diseases. The company specializes in the research and development of products designed to treat conditions such as bladder cancer and other urological disorders, leveraging its proprietary technology platforms to create targeted therapies. Urogen's core products include its lead investigational therapies, which aim to improve patient outcomes and enhance the quality of life for individuals suffering from these conditions.
How the Company Makes MoneyUrogen Pharma generates revenue primarily through the commercialization of its pharmaceutical products. The company earns money by selling its approved therapies to healthcare providers, hospitals, and specialty pharmacies. Key revenue streams include product sales from its marketed therapies and potential royalties from partnerships or licensing agreements related to its drug development programs. Urogen may also engage in collaborations with larger pharmaceutical companies, which can provide upfront payments, milestone payments upon achieving certain development goals, and royalties on future sales. Additionally, the company may receive funding through grants or research partnerships that support its clinical trials and development efforts.

Urogen Pharma Earnings Call Summary

Earnings Call Date:Nov 06, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Mar 12, 2026
Earnings Call Sentiment Neutral
The earnings call presents a balanced view with strong progress in the ZUSDURI launch and JELMYTO revenue growth, offset by challenges in operational execution and increased expenses. The permanent J-code for ZUSDURI is anticipated to drive future growth, but current operational delays and increased net loss are notable concerns.
Q3-2025 Updates
Positive Updates
ZUSDURI Launch Progress
Preliminary demand revenue for October more than doubled the previous three months, indicating increased usage and adoption. Physician enthusiasm and high intent to prescribe remain strong, with market access team securing broad coverage across major payers.
JELMYTO Revenue Growth
Net product revenue for JELMYTO reached $25.7 million, representing a 13% increase in underlying demand revenue compared to the same period in 2024.
Clinical Advancements
The 3-month complete response rate from the UTOPIA study aligns with previous trials, supporting plans for an NDA submission for UGN-103 in the second half of 2026, with potential approval in 2027.
Strong Market Access for ZUSDURI
ZUSDURI is accessible to 95% of covered lives, with approximately 296 million eligible patients, showing excellent market access progress.
Permanent J-code for ZUSDURI
A permanent J-code will go into effect on January 1, 2026, expected to accelerate adoption, particularly in community settings.
Negative Updates
Slow Conversion of Patient Enrollment Forms
There is a 45- to 60-day lag between patient enrollment form submission and patient dosing, attributed to logistical and operational challenges, including reimbursement with a miscellaneous J-code.
UGN-301 Program Discontinuation
The UGN-301 program was discontinued due to an overall clinical profile that did not warrant advancement to a Phase II study.
Increased Operating Expenses
Selling, general, and administrative expenses increased by $8.7 million year-over-year, primarily driven by ZUSDURI commercial preparation and sales force expansion.
Net Loss Increase
The net loss increased to $33.3 million in Q3 2025, compared to $23.7 million in the same period in 2024.
Company Guidance
During UroGen Pharma's third quarter 2025 earnings call, the company provided insights into its financial performance and strategic initiatives. The preliminary demand revenue for ZUSDURI in October more than doubled compared to the previous three months, with sales estimated at $4.5 million, indicating a promising market uptake. The company reported net product revenue of $25.7 million for JELMYTO, showing a 13% increase from the same period in 2024. UroGen anticipates ZUSDURI to become a primary growth driver, targeting a $5 billion annual market, and expects over $1 billion in peak revenue. JELMYTO’s 2025 net product revenues are projected to range between $94 million and $98 million, representing an 8% to 12% increase from 2024. The company also highlighted the strategic discontinuation of UGN-301, deciding to focus resources on UGN-103 and UGN-501. With a cash reserve of $127.4 million as of September 30, 2025, UroGen remains confident in achieving long-term growth and profitability.

Urogen Pharma Financial Statement Overview

Summary
Urogen Pharma shows revenue growth but struggles with profitability and financial stability. High gross profit margins are overshadowed by negative net income and high leverage, posing significant risks.
Income Statement
35
Negative
Urogen Pharma's income statement shows a consistent increase in revenue over the years, with a TTM revenue growth rate of 2.42%. However, the company is struggling with profitability, as indicated by negative net profit margins and EBIT margins. The gross profit margin remains high at 88.54% for TTM, which is a positive sign, but the persistent net losses and negative EBIT margins highlight ongoing operational challenges.
Balance Sheet
25
Negative
The balance sheet reveals significant financial instability, with a negative stockholders' equity and a high debt-to-equity ratio of -1.35 for TTM. This indicates that the company is heavily leveraged and may face difficulties in meeting its financial obligations. The return on equity is also negative, reflecting the company's inability to generate profits from its equity base.
Cash Flow
30
Negative
The cash flow statement shows negative operating and free cash flows, although there is a slight improvement in free cash flow growth at 11.82% for TTM. The operating cash flow to net income ratio is negative, indicating that the company is not generating sufficient cash from its operations to cover its net losses. The free cash flow to net income ratio is slightly above 1, suggesting some efficiency in converting net income into free cash flow.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue72.30M90.40M82.71M64.36M48.04M11.80M
Gross Profit64.22M81.52M73.35M56.70M42.88M10.79M
EBITDA-91.14M-95.35M-60.35M-76.21M-91.46M-122.71M
Net Income-114.70M-126.87M-102.24M-109.78M-110.82M-128.48M
Balance Sheet
Total Assets185.05M285.71M178.31M135.62M119.75M122.00M
Cash, Cash Equivalents and Short-Term Investments127.03M236.69M136.97M99.96M89.14M102.02M
Total Debt129.94M123.39M99.39M99.12M398.00K1.50M
Total Liabilities300.45M294.51M243.52M224.98M111.33M25.65M
Stockholders Equity-115.41M-8.80M-65.21M-89.36M8.41M96.36M
Cash Flow
Free Cash Flow-138.13M-97.06M-76.57M-87.81M-85.64M-107.10M
Operating Cash Flow-137.74M-96.77M-76.38M-87.56M-84.89M-105.89M
Investing Cash Flow94.46M-20.61M-953.00K1.06M4.07M93.24M
Financing Cash Flow8.67M194.62M116.93M97.13M72.32M16.53M

Urogen Pharma Technical Analysis

Technical Analysis Sentiment
Positive
Last Price25.14
Price Trends
50DMA
18.95
Positive
100DMA
18.08
Positive
200DMA
13.98
Positive
Market Momentum
MACD
1.53
Negative
RSI
73.32
Negative
STOCH
84.83
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For URGN, the sentiment is Positive. The current price of 25.14 is above the 20-day moving average (MA) of 20.18, above the 50-day MA of 18.95, and above the 200-day MA of 13.98, indicating a bullish trend. The MACD of 1.53 indicates Negative momentum. The RSI at 73.32 is Negative, neither overbought nor oversold. The STOCH value of 84.83 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for URGN.

Urogen Pharma Risk Analysis

Urogen Pharma disclosed 81 risk factors in its most recent earnings report. Urogen Pharma reported the most risks in the "Legal & Regulatory" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Urogen Pharma Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
61
Neutral
$976.73M460.30%33.03%
57
Neutral
$1.08B8.00%-10.15%
55
Neutral
$1.37B-68.33%
52
Neutral
$1.07B-64.93%-36.36%-945.72%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
51
Neutral
$879.90M-52.82%53.23%35.32%
47
Neutral
$740.49M-29.57%522.13%62.68%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
URGN
Urogen Pharma
25.14
12.98
106.74%
GERN
Geron
1.24
-2.63
-67.96%
ABUS
Arbutus Biopharma
4.84
1.19
32.60%
PHAT
Phathom Pharmaceuticals
14.62
4.87
49.95%
TSHA
Taysha Gene Therapies
4.36
2.15
97.29%
ZBIO
Zenas BioPharma, Inc.
35.80
16.70
87.43%

Urogen Pharma Corporate Events

UroGen Pharma’s ZUSDURI Launch Drives Q3 Growth
Nov 7, 2025

UroGen Pharma Ltd., a biotechnology company, focuses on developing innovative treatments for urothelial and specialty cancers using its proprietary RTGel® technology. In its third-quarter 2025 earnings report, UroGen highlighted the successful launch of ZUSDURI, the first FDA-approved treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, and reported a net product revenue of $1.8 million for ZUSDURI in its first quarter on the market. The company also achieved $25.7 million in net product revenue for JELMYTO, reflecting a 13% year-over-year growth. UroGen’s financial position remains strong with $127.4 million in cash and equivalents, despite a net loss of $33.3 million for the quarter. The company is optimistic about the commercial potential of ZUSDURI, supported by strong patient demand and broad reimbursement coverage. Looking ahead, UroGen plans to submit a New Drug Application for UGN-103 in 2026, aiming for approval in 2027, and continues to advance its pipeline to deliver long-term value for patients and shareholders.

UroGen Pharma’s UGN-104 Study: A Potential Game-Changer in Urothelial Cancer Treatment
Oct 27, 2025

Study Overview: UroGen Pharma is conducting a Phase 3, single-arm, multicenter study to evaluate the efficacy and safety of UGN-104, a novel formulation of UGN-101, for treating patients with low-grade upper tract urothelial cancer (LG-UTUC). This study aims to provide a new therapeutic option for LG-UTUC, a condition with limited treatment alternatives, enhancing patient outcomes and expanding UroGen’s product portfolio.

UroGen Pharma’s Phase 3 Study on UGN-103: A Potential Game-Changer in Bladder Cancer Treatment
Oct 27, 2025

Study Overview: UroGen Pharma is conducting a Phase 3 study titled ‘A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-103, a Novel Formulation of UGN-102, for the Treatment of Patients With Low-grade (LG) Non-muscle Invasive Bladder Cancer (NMIBC) at Intermediate-risk (IR) of Recurrence.’ The study aims to assess the efficacy and safety of UGN-103 in treating patients with low-grade non-muscle invasive bladder cancer, a condition with significant recurrence risk, thereby addressing a crucial need in cancer treatment.

Urogen Pharma’s Jelmyto Registry: Real-World Insights into UTUC Treatment
Oct 27, 2025

Study Overview: The uTRACT Jelmyto Registry is a multicenter, prospective and retrospective registry designed to evaluate real-world experiences and outcomes of patients with Upper Tract Urothelial Cancer (UTUC) treated with Jelmyto. This study is significant as it aims to provide insights into the effectiveness and safety of Jelmyto in a real-world setting, potentially influencing treatment protocols and patient care strategies.

Executive/Board ChangesShareholder Meetings
UroGen Pharma Shareholders Approve Key Proposals at Meeting
Neutral
Aug 27, 2025

UroGen Pharma’s shareholders convened at the Annual Meeting to vote on several key proposals. The shareholders elected seven directors, approved an amended compensation policy, and endorsed the 2017 Amended Plan. Additionally, they approved the executive compensation and decided to hold annual advisory votes on this matter. PricewaterhouseCoopers LLP was appointed as the independent auditor until 2026.

The most recent analyst rating on (URGN) stock is a Buy with a $35.00 price target. To see the full list of analyst forecasts on Urogen Pharma stock, see the URGN Stock Forecast page.

UroGen Pharma’s Earnings Call: Achievements and Challenges
Aug 13, 2025

UroGen Pharma’s recent earnings call painted a picture of both achievement and challenge. The company celebrated significant milestones, such as the FDA approval of ZUSDURI and revenue growth for JELMYTO, while also addressing hurdles like reimbursement issues and an increased net loss. Despite these challenges, UroGen’s robust financial standing and strategic initiatives for future growth contribute to a positive outlook.

UroGen Pharma Reports Q2 2025 Results and Launches ZUSDURI
Aug 8, 2025

UroGen Pharma Ltd., a biotechnology company, focuses on developing and commercializing innovative treatments for urothelial and specialty cancers, utilizing its proprietary RTGel technology for sustained drug delivery.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Nov 07, 2025