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

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URGN

Urogen Pharma

(NASDAQ:URGN)

Rating:54Neutral
Price Target:
$18.00
▼(-7.46% Downside)
Urogen Pharma's stock score is primarily impacted by weak financial performance due to profitability and cash flow challenges. Positive technical indicators and corporate events provide some support, but valuation concerns and earnings call challenges limit the overall score.
Positive Factors
Clinical Data
ZUSDURI long-term clinical data appear compelling with a 78% complete response for patients at three months, and 79% of those patients remained event-free 12 months later.
Market Potential
ZUSDURI could reach blockbuster status given the much larger size of the NMIBC target market and the fact that ZUSDURI is currently the only pharmacotherapy approved to treat recurrent LG-IR-NMIBC.
Product Approval
ZUSDURI has been designed for potent tumor ablation, offering a new alternative for recurrent LG-IR-NMIBC patients who often endure multiple resections under general anesthesia.
Negative Factors
Financial Performance
Revenue and earnings miss moderately—lowering price target based on revised sales ramp trajectory.

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:Aug 07, 2025
(Q2-2025)
|
% Change Since: |
Next Earnings Date:Nov 17, 2025
Earnings Call Sentiment Neutral
The earnings call highlighted significant achievements, including FDA approval of ZUSDURI and strong revenue growth for JELMYTO. However, these were balanced by challenges such as reimbursement issues for ZUSDURI and increased operating expenses, resulting in a larger net loss.
Q2-2025 Updates
Positive Updates
FDA Approval of ZUSDURI
ZUSDURI was approved for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer, marking a significant milestone for UroGen and offering a new treatment paradigm.
Strong JELMYTO Revenue Growth
JELMYTO achieved net product revenues of $24.2 million in Q2 2025, representing an 11% increase over the same period in 2024.
Expansion of Sales Force
The sales team expanded from 50 to 82 territories to support the launch of ZUSDURI, positioning the company to reach a broader market.
Positive Clinical Data for ZUSDURI
In the pivotal Phase III ENVISION trial, 79% of patients achieved a complete response at 3 months, with a 24-month duration of response of 72.2%.
Robust Cash Position
UroGen maintains a strong balance sheet with $161.6 million in cash, cash equivalents, and marketable securities as of June 30, 2025.
Negative Updates
Reimbursement Challenges for ZUSDURI
There are significant barriers to adoption due to reimbursement issues, with many physicians waiting for a permanent J-code before prescribing.
Increased Operating Expenses
Operating expenses rose to $43.2 million in Q2 2025 from $30.1 million in Q2 2024, driven by ZUSDURI commercial preparation and overall commercial costs.
Net Loss Increase
Net loss increased to $49.9 million in Q2 2025 from $33.4 million in Q2 2024, reflecting higher R&D and SG&A expenses.
Company Guidance
During the UroGen Pharma Second Quarter 2025 Earnings Call, the company announced several key metrics and guidance for the year. They reported net product revenues of $24.2 million for JELMYTO, an 11% increase over the same period in 2024. UroGen has expanded its sales team to 82 territories to support the launch of ZUSDURI, which was recently approved by the FDA for treating recurrent low-grade intermediate risk non-muscle invasive bladder cancer. The total available market for ZUSDURI exceeds $5 billion annually. The company expects to maintain a strong financial position with $161.6 million in cash and equivalents as of June 30, 2025. UroGen reiterated its guidance for full-year 2025, expecting JELMYTO revenues between $94 million and $98 million and operating expenses in the range of $215 million to $225 million. The company is optimistic about achieving sustainable growth with its two commercial products and advancing pipeline.

Urogen Pharma Financial Statement Overview

Summary
Urogen Pharma shows strong revenue growth, but significant profitability and cash flow challenges persist, coupled with a weak balance sheet marked by negative equity.
Income Statement
45
Neutral
Urogen Pharma has demonstrated strong revenue growth, with Total Revenue increasing from $11.8M in 2020 to $91.9M in TTM 2025, a substantial positive trajectory. However, the company is currently unprofitable, with a net loss of $138.4M in TTM 2025. Gross Profit Margin is high at 89.7% for TTM 2025, indicating effective cost management relative to revenue. The EBIT and EBITDA margins are negative, reflecting significant operational challenges.
Balance Sheet
30
Negative
The balance sheet shows a negative Stockholders' Equity of $-46.5M in TTM 2025, raising concerns about financial stability. The Debt-to-Equity ratio is not calculable due to negative equity, indicating potential financial risk. Total Debt is $124.9M, which is high relative to the negative equity. The Equity Ratio is negative, highlighting balance sheet weaknesses.
Cash Flow
40
Negative
Operating cash flow is negative at $-107.1M in TTM 2025, indicating challenges in generating cash from core operations. Free Cash Flow is also negative, suggesting additional pressure on financial resources. However, the financing activities have provided significant cash inflow, helping to mitigate these cash flow challenges.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue94.24M90.40M82.71M64.36M48.04M11.80M
Gross Profit83.43M81.52M73.35M56.70M42.88M10.79M
EBITDA-117.64M-110.33M-60.35M-76.21M-90.15M-122.71M
Net Income-154.97M-126.87M-102.24M-109.78M-110.82M-128.48M
Balance Sheet
Total Assets208.72M285.71M178.31M136.24M119.75M122.00M
Cash, Cash Equivalents and Short-Term Investments156.95M236.69M136.97M99.96M89.14M102.02M
Total Debt125.92M123.39M100.21M100.06M398.00K1.50M
Total Liabilities302.09M294.51M243.52M224.98M111.33M25.65M
Stockholders Equity-93.38M-8.80M-65.21M-89.36M8.41M96.36M
Cash Flow
Free Cash Flow-123.53M-97.06M-76.57M-87.81M-85.64M-107.10M
Operating Cash Flow-123.13M-96.77M-76.38M-87.56M-84.89M-105.89M
Investing Cash Flow-43.69M-20.61M-953.00K1.06M4.07M93.24M
Financing Cash Flow40.01M194.62M116.93M97.13M72.32M16.53M

Urogen Pharma Technical Analysis

Technical Analysis Sentiment
Positive
Last Price19.45
Price Trends
50DMA
17.01
Positive
100DMA
12.96
Positive
200DMA
11.98
Positive
Market Momentum
MACD
0.66
Positive
RSI
56.58
Neutral
STOCH
55.61
Neutral
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 19.45 is above the 20-day moving average (MA) of 19.37, above the 50-day MA of 17.01, and above the 200-day MA of 11.98, indicating a bullish trend. The MACD of 0.66 indicates Positive momentum. The RSI at 56.58 is Neutral, neither overbought nor oversold. The STOCH value of 55.61 is Neutral, 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
76
Outperform
$789.55M46.1137.36%35.89%
54
Neutral
$899.84M-452.20%10.85%-1.41%
51
Neutral
$7.86B-0.26-41.41%2.22%22.87%-2.01%
50
Neutral
$567.52M-35.41%
46
Neutral
$566.91M-99.30%-21.05%
45
Neutral
$511.09M-31.58%-51.13%7.57%
39
Underperform
$483.17M
-80.09%60.25%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
URGN
Urogen Pharma
19.45
5.89
43.44%
NAGE
Niagen Bioscience
9.90
6.62
201.83%
SVRA
Savara
3.28
-0.93
-22.09%
ARVN
Arvinas Holding Company
7.73
-17.77
-69.69%
BCYC
Bicycle Therapeutics
7.38
-13.45
-64.57%
OPT
Opthea Limited Sponsored ADR
3.20
0.29
9.97%

Urogen Pharma Corporate Events

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.

Product-Related AnnouncementsExecutive/Board Changes
UroGen Pharma Approves Bonuses After FDA Approval
Positive
Jul 3, 2025

On June 30, 2025, UroGen Pharma’s Board of Directors approved special bonuses for key executives, recognizing their leadership in achieving FDA approval for ZUSDURI, a treatment for recurrent low-grade intermediate risk non-muscle invasive bladder cancer. This approval marks a significant milestone for the company, potentially enhancing its market position and benefiting stakeholders by expanding its therapeutic offerings.

Product-Related Announcements
FDA Approves Urogen Pharma’s ZUSDURI for Bladder Cancer
Positive
Jun 13, 2025

On June 12, 2025, the FDA approved Urogen Pharma‘s ZUSDURI™, a sustained-release gel formulation of mitomycin, for treating adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC). This approval is based on the Phase 3 ENVISION trial, where 78% of patients achieved complete response at three months, with 79% maintaining it at 12 months. ZUSDURI is expected to be available in the U.S. by July 1, 2025, and Urogen Pharma has committed to further trials and updates to the FDA to assess long-term benefits.

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: Aug 28, 2025