Urogen Pharma (URGN) AI Stock Analysis

• Market Cap: $621.99M
• Dividend Yield: N/A
• Average Volume (3M): 5.14M
• Price to Earnings (P/E): ―
• Beta (1Y): 1.08
• Revenue Growth: 8.98%
• EPS Growth: 6.32%
• Country: US
• Employees: 234
• Sector: Healthcare
• Sector Strength: 42
• Industry: Biotechnology
• EPS (TTM): -0.92
• Shares Outstanding: 46,107,452
• 10 Day Avg. Volume: 6,986,466
• 30 Day Avg. Volume: 5,140,573
• PEG Ratio: 0.54
• Price to Book (P/B): -2.28
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -2.30
• Enterprise Value/Market Cap: 0.40
• Enterprise Value/Revenue: 0.69
• Enterprise Value/Gross Profit: 2.99
• Enterprise Value/Ebitda: -0.70
• 1Y Price Target: $33.43
• Price Target Upside: 147.81% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 7

• Rating: 61 Neutral
• Price Target: $14.00 ▲(3.78%Upside)

The most significant factor is the FDA approval of ZUSDURI, which strongly boosts growth potential. However, financial stability concerns and valuation risks weigh down the score. Positive technical indicators and strategic advancements offset some risks.

Positive Factors

Analyst Rating

Analyst is upgrading the rating to Buy from Neutral, and instituting a 12-month price target of $50.

Efficacy

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

FDA 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

FDA 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.

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.

Revenue Forecast

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

Urogen Pharma Business Overview & Revenue Model

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.

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

Urogen Pharma shows impressive revenue growth but struggles with profitability, as indicated by a negative net income and cash flow. The balance sheet is weak with negative equity, and operational challenges persist.

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	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	91.87M	90.40M	82.71M	64.36M	48.04M	11.80M
Gross Profit	82.39M	81.52M	73.35M	56.70M	42.88M	10.79M
EBITDA	-101.77M	-110.33M	-63.83M	-78.03M	-90.15M	-122.71M
Net Income	-138.43M	-126.87M	-102.24M	-109.16M	-110.82M	-128.48M
Balance Sheet
Total Assets	247.62M	285.71M	178.31M	136.24M	119.75M	122.00M
Cash, Cash Equivalents and Short-Term Investments	195.89M	236.69M	136.97M	99.96M	89.81M	103.91M
Total Debt	124.95M	123.39M	100.21M	99.12M	398.00K	1.50M
Total Liabilities	294.08M	294.51M	243.52M	224.98M	111.33M	25.65M
Stockholders Equity	-46.46M	-8.80M	-65.21M	-88.74M	8.41M	96.36M
Cash Flow
Free Cash Flow	-107.39M	-97.06M	-76.57M	-87.81M	-85.64M	-107.10M
Operating Cash Flow	-107.06M	-96.77M	-76.38M	-87.56M	-84.89M	-105.89M
Investing Cash Flow	-60.09M	-20.61M	-953.00K	1.06M	4.07M	93.24M
Financing Cash Flow	140.00M	194.62M	116.93M	97.13M	72.32M	16.53M

Urogen Pharma Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 13.49
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Negative
• 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 13.49 is above the 20-day moving average (MA) of 10.08, above the 50-day MA of 9.36, and above the 200-day MA of 10.92, indicating a bullish trend. The MACD of 1.74 indicates Negative momentum. The RSI at 64.66 is Neutral, neither overbought nor oversold. The STOCH value of 48.87 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	71 Outperform	$1.12B	82.34	33.47%	―	29.77%	―
URGN	61 Neutral	$621.99M	―	-452.20%	―	8.98%	6.32%
Sector *	54 Neutral	€4.82B	18.16	-49.50%	1.91%	13.92%	-2.48%
ARVN	54 Neutral	$550.36M	―	-35.41%	―	-39.92%	7.38%
BCYC	48 Neutral	$501.03M	―	-37.13%	―	-38.14%	29.69%
SVRA	46 Neutral	$381.97M	―	-75.77%	―	―	-44.25%
OPT	39 Underperform	$483.08M	―		―	-25.10%	-7.06%

Urogen Pharma Corporate Events

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.