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Urogen Pharma (URGN)
NASDAQ:URGN
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Urogen Pharma
(NASDAQ:URGN)
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Rating:50Neutral
Price Target:
$21.50
▲(0.23% Upside)
Urogen Pharma's overall stock score is driven by significant financial challenges, including negative profitability and high leverage, which weigh heavily on the score. Positive technical indicators and promising product developments provide some balance, but valuation concerns and operational challenges remain significant risks.
Positive Factors
Product Launch Success
The successful launch of ZUSDURI, with strong demand and coverage, positions Urogen Pharma to capitalize on a significant commercial opportunity, enhancing long-term revenue growth and market presence.
Regulatory Approval
Regulatory support for UGN-103's NDA submission indicates potential for new product approval, which could drive future growth and expand Urogen's market offerings.
Market Access
The permanent J-code for ZUSDURI will streamline billing processes, likely accelerating adoption and enhancing revenue potential in community settings.
Negative Factors
High Leverage
High leverage can strain financial flexibility, posing risks to Urogen's ability to invest in growth opportunities and manage economic downturns.
Negative Cash Flow
Negative cash flows suggest operational inefficiencies and reliance on external funding, which may hinder Urogen's ability to sustain long-term growth without restructuring.
Increased Operating Expenses
Rising operating expenses, driven by commercial preparations, could pressure margins and profitability, challenging Urogen's financial health if not managed effectively.
Urogen Pharma (URGN) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$1.00B
Dividend YieldN/A
Average Volume (3M)704.66K
Price to Earnings (P/E)―
Beta (1Y)0.79
Revenue Growth8.00%
EPS Growth-10.15%
CountryUS
Employees234
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.69
Shares Outstanding46,808,890
10 Day Avg. Volume465,263
30 Day Avg. Volume704,663
Financial Highlights & Ratios
PEG Ratio0.22
Price to Book (P/B)-51.87
Price to Sales (P/S)5.05
P/FCF Ratio-4.70
Enterprise Value/Market Cap0.96
Enterprise Value/Revenue13.28
Enterprise Value/Gross Profit14.95
Enterprise Value/Ebitda-10.54
Forecast
1Y Price Target
$40.25Price Target Upside87.65% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering4
EPS Forecast (FY)N/A
Revenue Forecast (FY)N/A
Urogen Pharma Business Overview & Revenue Model
Company DescriptionUroGen 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.
How the Company Makes MoneyUrogen Pharma generates revenue primarily through the sale of its pharmaceutical products, specifically those that have received regulatory approval and are on the market. The company may also generate income from licensing agreements, collaborations, and partnerships with other pharmaceutical companies for the development and commercialization of its therapies. These partnerships can include milestone payments and royalties based on sales of the partnered products. Additionally, Urogen may benefit from government grants and funding aimed at supporting the research and development of its innovative treatments.
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
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
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
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.| Breakdown | TTM | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 72.30M | 90.40M | 82.71M | 64.36M | 48.04M | 11.80M |
| Gross Profit | 64.22M | 81.52M | 73.35M | 56.70M | 42.88M | 10.79M |
| 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 Assets | 185.05M | 285.71M | 178.31M | 135.62M | 119.75M | 122.00M |
| Cash, Cash Equivalents and Short-Term Investments | 127.03M | 236.69M | 136.97M | 99.96M | 89.14M | 102.02M |
| Total Debt | 129.94M | 123.39M | 99.39M | 99.12M | 398.00K | 1.50M |
| Total Liabilities | 300.45M | 294.51M | 243.52M | 224.98M | 111.33M | 25.65M |
| Stockholders Equity | -115.41M | -8.80M | -65.21M | -89.36M | 8.41M | 96.36M |
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 Flow | 94.46M | -20.61M | -953.00K | 1.06M | 4.07M | 93.24M |
| Financing Cash Flow | 8.67M | 194.62M | 116.93M | 97.13M | 72.32M | 16.53M |
Urogen Pharma Technical Analysis
Neutral
21.45
Price Trends
23.45
Negative
20.95
Positive
16.61
Positive
Market Momentum
-0.34
Positive
42.22
Neutral
40.98
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For URGN, the sentiment is Neutral. The current price of 21.45 is below the 20-day moving average (MA) of 22.75, below the 50-day MA of 23.45, and above the 200-day MA of 16.61, indicating a neutral trend. The MACD of -0.34 indicates Positive momentum. The RSI at 42.22 is Neutral, neither overbought nor oversold. The STOCH value of 40.98 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral 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
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
57 Neutral | $1.13B | -4.10 | ― | ― | 460.30% | 33.03% | |
53 Neutral | $1.33B | -13.82 | -64.93% | ― | -36.36% | -945.72% | |
52 Neutral | $912.85M | -10.90 | -29.57% | ― | 522.13% | 62.68% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
50 Neutral | $1.00B | -5.73 | ― | ― | 8.00% | -10.15% | |
49 Neutral | $865.46M | -21.37 | -45.88% | ― | 116.64% | 47.93% | |
47 Neutral | $1.06B | -4.76 | -68.33% | ― | ― | -38.04% |
* Healthcare Sector Average
URGN
Urogen Pharma
19.83
9.90
99.70%
GERN
Geron
1.31
-1.63
-55.44%
ABUS
Arbutus Biopharma
4.74
1.56
49.06%
PHAT
Phathom Pharmaceuticals
15.63
8.84
130.19%
TSHA
Taysha Gene Therapies
4.90
3.28
202.47%
ZBIO
Zenas BioPharma, Inc.
21.57
13.55
168.95%
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.