Urogen Pharma (URGN) AI Stock Analysis

• Market Cap: $820.96M
• Dividend Yield: N/A
• Average Volume (3M): 1.32M
• Price to Earnings (P/E): ―
• Beta (1Y): 1.03
• Revenue Growth: 8.98%
• EPS Growth: 6.32%
• Country: US
• Employees: 234
• Sector: Healthcare
• Sector Strength: 37
• Industry: Biotechnology
• EPS (TTM): -1.05
• Shares Outstanding: 46,201,336
• 10 Day Avg. Volume: 1,236,055
• 30 Day Avg. Volume: 1,322,266
• PEG Ratio: N/A
• Price to Book (P/B): 0.00
• Price to Sales (P/S): 0.00
• P/FCF Ratio: 0.00
• Enterprise Value/Market Cap: 0.76
• Enterprise Value/Revenue: 6.79
• Enterprise Value/Gross Profit: 7.57
• Enterprise Value/Ebitda: -6.13
• 1Y Price Target: $33.71
• Price Target Upside: 90.02% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 7

• Rating: 61 Neutral
• Price Target: $18.00 ▲(1.47% Upside)

Urogen Pharma's overall stock score is driven by its recent FDA approval and positive market momentum. However, financial weaknesses and valuation concerns weigh down the score. Technical analysis and earnings call results provide additional support, but the stock's financial challenges remain significant.

Positive Factors

Clinical Trials

UTOPIA trial completes enrollment on schedule, a key milestone in life cycle management strategy.

Market Potential

ZUSDURI delivers 78% complete response for patients at 3 months, and of those patients, 79% remained event-free 12 months later.

Product Approval

UroGen Pharma announced that the FDA had approved ZUSDURI, the first and only FDA-approved medication for adults with recurrent low-grade, intermediate-risk non-muscle-invasive bladder cancer.

Negative Factors

Financial Projections

Revised projections indicate a significant decline in revenue forecasts for 2025 and 2026 due to the expected non-approval of UGN-102.

Regulatory Challenges

Deficiencies in the pivotal ENVISION trial, such as its non-randomized, single-arm design, and early termination of the ATLAS trial have been highlighted, challenging the approval of UGN-102.

Regulatory Requirements

The FDA may require additional clinical efficacy data from a randomized, controlled study, which could take two to three years to complete, increasing uncertainty for UGN-102's approval.

Urogen Pharma Business Overview & Revenue Model

Company Description

Urogen Pharma (URGN) is a biopharmaceutical company focused on developing and commercializing innovative therapies for urological and uro-oncological diseases. The company's core products include proprietary formulations designed to improve therapeutic outcomes for conditions such as low-grade upper tract urothelial cancer and other specialty cancers. Urogen Pharma leverages its unique drug delivery technology to address unmet medical needs in the urology sector.

How the Company Makes Money

Urogen Pharma makes money primarily through the commercialization of its proprietary drug products and formulations. Its revenue model is centered around the sales of approved therapies, particularly for niche urological and uro-oncological conditions. The company may also engage in strategic partnerships and collaborations with other pharmaceutical companies, which can contribute to revenue through licensing agreements, milestone payments, and royalties. Additionally, Urogen Pharma may receive funding from grants and research collaborations that support its development pipeline, although these are supplementary to its primary revenue streams from product sales.

Urogen Pharma Financial Statement Overview

Summary

Despite strong revenue growth, Urogen Pharma's financial performance is hampered by significant profitability and cash flow challenges, coupled with a weak balance sheet marked by negative equity and high debt levels.

Income Statement

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

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

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.

Breakdown	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	90.40M	82.71M	64.36M	48.04M	11.80M
Gross Profit	81.52M	73.35M	56.70M	42.88M	10.79M
EBITDA	-110.33M	-63.83M	-78.03M	-90.15M	-122.71M
Net Income	-126.87M	-102.24M	-109.16M	-110.82M	-128.48M
Balance Sheet
Total Assets	285.71M	178.31M	136.24M	119.75M	122.00M
Cash, Cash Equivalents and Short-Term Investments	236.69M	136.97M	99.96M	89.81M	103.91M
Total Debt	123.39M	100.21M	99.12M	398.00K	1.50M
Total Liabilities	294.51M	243.52M	224.98M	111.33M	25.65M
Stockholders Equity	-8.80M	-65.21M	-88.74M	8.41M	96.36M
Cash Flow
Free Cash Flow	-97.06M	-76.57M	-87.81M	-85.64M	-107.10M
Operating Cash Flow	-96.77M	-76.38M	-87.56M	-84.89M	-105.89M
Investing Cash Flow	-20.61M	-953.00K	1.06M	4.07M	93.24M
Financing Cash Flow	194.62M	116.93M	97.13M	72.32M	16.53M

Urogen Pharma Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 17.74
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Positive
• RSI: Neutral
• STOCH: 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 17.74 is above the 20-day moving average (MA) of 17.70, above the 50-day MA of 13.65, and above the 200-day MA of 11.45, indicating a bullish trend. The MACD of 1.57 indicates Positive momentum. The RSI at 54.85 is Neutral, neither overbought nor oversold. The STOCH value of 41.79 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for URGN.

Urogen Pharma Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
NAGE	70 Outperform	$776.00M	45.32	37.36%	―	29.77%	―
URGN	61 Neutral	$820.96M	―	-452.20%	―	8.98%	6.32%
BCYC	51 Neutral	$529.40M	―	-31.58%	―	-38.14%	29.69%
Sector *	51 Neutral	$7.27B	-0.06	-62.84%	2.34%	15.16%	-2.86%
ARVN	48 Neutral	$461.80M	―	-35.41%	―	―	―
SVRA	46 Neutral	$456.29M	―	-75.77%	―	―	-44.25%
OPT	39 Underperform	$482.12M	―		―	-25.10%	-7.06%

Urogen Pharma Corporate Events

UroGen Pharma Approves Bonuses After FDA Approval

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.

The most recent analyst rating on (URGN) stock is a Buy with a $36.00 price target. To see the full list of analyst forecasts on Urogen Pharma stock, see the URGN Stock Forecast page.

FDA Approves Urogen Pharma’s ZUSDURI for Bladder Cancer

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.

The most recent analyst rating on (URGN) stock is a Buy with a $53.50 price target. To see the full list of analyst forecasts on Urogen Pharma stock, see the URGN Stock Forecast page.