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Urogen Pharma (URGN)
NASDAQ:URGN

Urogen Pharma (URGN) AI Stock Analysis

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Urogen Pharma

(NASDAQ:URGN)

Rating:48Neutral
Price Target:
$5.00
▲(0.00%Upside)
Urogen Pharma's stock score is primarily influenced by its strong revenue growth potential and positive earnings call highlights regarding UGN-102. However, the company's financial instability, significant net losses, and bearish technical indicators weigh heavily on the overall score.
Positive Factors
FDA Review
The UGN-102 advisory committee meeting is expected to proceed uneventfully with a positive vote outcome recommending approval, as the efficacy data is considered highly compelling.
Financial Stability
UroGen ended with $200.4M in cash, cash equivalents, and marketable securities, which are believed to be sufficient to support operations through the approval and launch of UGN-102.
Regulatory Precedent
There is a clear regulatory precedent with UroGen's lead marketed product, JELMYTO, which employs the same active ingredient and delivery technology as UGN-102.
Negative Factors
Clinical Trial Design
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.
FDA Advisory Panel Vote
A negative panel vote from the FDA's Oncologic Drugs Advisory Committee suggests a high likelihood of rejection for UGN-102, leading to a downgrade to Neutral without a price target.
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 (URGN) vs. SPDR S&P 500 ETF (SPY)

Urogen Pharma Business Overview & Revenue Model

Company DescriptionUrogen Pharma (URGN) is a biopharmaceutical company that specializes in developing and commercializing innovative therapies for urological conditions. The company focuses on advancing drug delivery technology and treatments for diseases that are often underserved by existing therapies. Urogen is particularly known for its proprietary platform technology, RTGel, which is designed to improve the delivery and efficacy of drugs in the urinary tract.
How the Company Makes MoneyUrogen Pharma generates revenue primarily through the sale of its proprietary pharmaceutical products. The company's key revenue streams include sales of Jelmyto (mitomycin) for pyelocalyceal solution, a treatment for low-grade upper tract urothelial cancer (LG-UTUC). Urogen's revenue model also involves potential milestone payments and royalties from licensing agreements related to its RTGel technology and other pipeline products. Strategic partnerships and collaborations with other pharmaceutical companies contribute to its earnings by leveraging shared resources and expertise in drug development and commercialization.

Urogen Pharma Earnings Call Summary

Earnings Call Date:May 12, 2025
(Q1-2025)
|
% Change Since: -51.83%|
Next Earnings Date:Aug 19, 2025
Earnings Call Sentiment Neutral
The earnings call highlights significant progress in UGN-102's FDA review process, strong clinical trial results, and a substantial market opportunity. JELMYTO's revenue growth and a strong financial position also contribute positively. However, there are concerns about the single-arm nature of the ENVISION trial, increased expenses, and net loss. The highlights and lowlights are relatively balanced.
Q1-2025 Updates
Positive Updates
UGN-102 FDA Review Progress
UGN-102 is in the final stages of FDA review with a PDUFA target date of June 13th. An ODAC meeting is scheduled for May 21st, and the company is well-prepared to present a strong case for approval.
Strong Clinical Trial Results
Updated data from the pivotal ENVISION trial showed that 80.6% of patients who achieved a complete response at three months remained in response at 18 months.
Commercial Readiness and Market Opportunity
UGN-102 represents a transformative growth opportunity, targeting an addressable population of approximately 60,000 patients annually and a market opportunity of over $5 billion.
JELMYTO Revenue Growth
Reported $20.3 million in first-quarter sales, an 8% year-over-year growth compared to the first quarter of 2024, driven by underlying demand growth of 12%.
Strong Financial Position
Supported by a strong balance sheet with over $200 million in cash, cash equivalents, and marketable securities as of March 31st, 2025.
Negative Updates
Single-Arm Study Concerns
Concerns regarding the ENVISION trial being a single-arm study and the need to compare its results in the context of existing data.
340B Impact on JELMYTO
Higher 340B chargebacks have impacted JELMYTO's year-over-year revenue growth, although this is expected to stabilize going forward.
R&D and SG&A Expense Increase
R&D expenses increased to $19.9 million from $15.5 million year-over-year, and SG&A expenses rose to $35 million from $27.3 million, primarily due to UGN-102 commercial preparation activities.
Net Loss
Reported a net loss of $43.8 million or $0.92 per basic and diluted share in the first quarter of 2025, compared with a net loss of $32.3 million or $0.87 per share in the same period in 2024.
Company Guidance
During UroGen Pharma's first-quarter 2025 earnings call, the company provided detailed guidance on several key metrics and strategic initiatives. They highlighted the potential impact of their lead candidate, UGN-102, which is under FDA review with a PDUFA target date of June 13th, 2025. UGN-102 is expected to be UroGen's primary growth driver, with an estimated market opportunity exceeding $5 billion, targeting approximately 60,000 patients annually. The company reported first-quarter JELMYTO sales of $20.3 million, reflecting an 8% year-over-year increase. As part of their commercialization strategy, UroGen plans to expand their sales force from 50 to over 80 representatives by launch. The company also reported having $200.4 million in cash, cash equivalents, and marketable securities as of March 31st, 2025, ensuring a strong financial footing to support their growth and commercialization efforts.

Urogen Pharma Financial Statement Overview

Summary
Urogen Pharma has demonstrated strong revenue growth, particularly with JELMYTO sales, but continues to face profitability challenges. The balance sheet shows financial instability with negative stockholders' equity, although the strong cash position provides some liquidity cushion. The cash flow situation is weak due to ongoing operating losses, though financing efforts have been successful in maintaining operations.
Income Statement
45
Neutral
Urogen Pharma has shown revenue growth over the years, with a notable increase from $11.8 million in 2020 to $90.4 million in 2024. However, despite the revenue growth, the company continues to operate at a loss, with negative EBIT and net income margins indicating challenges in achieving profitability. The gross profit margin is strong, but the high operating expenses are impacting the overall profitability.
Balance Sheet
30
Negative
The balance sheet reflects significant financial leverage, with a negative stockholders' equity indicating that liabilities exceed assets. The debt-to-equity ratio is not meaningful due to negative equity, highlighting financial instability. The cash position is relatively strong, which provides some liquidity cushion, but the negative equity and high liabilities present risks.
Cash Flow
50
Neutral
The cash flow statement shows consistent negative free cash flow, driven by operating losses. However, the company has managed to secure financing to support its operations, evidenced by positive financing cash flows. The operating cash flow to net income ratio suggests that cash flow generation is weak relative to the reported net losses.
Breakdown
Dec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
90.40M82.71M64.36M48.04M11.80M
Gross Profit
81.52M73.35M56.70M42.88M10.79M
EBIT
-96.78M-65.54M-79.04M-92.29M-126.74M
EBITDA
-110.33M-63.83M-78.03M-90.15M-122.71M
Net Income Common Stockholders
-126.87M-102.24M-109.16M-110.82M-128.48M
Balance SheetCash, Cash Equivalents and Short-Term Investments
236.69M136.97M99.96M89.81M103.91M
Total Assets
285.71M178.31M136.24M119.75M122.00M
Total Debt
123.39M100.21M99.12M398.00K1.50M
Net Debt
-48.60M4.39M43.72M-43.96M-102.41M
Total Liabilities
294.51M243.52M224.98M111.33M25.65M
Stockholders Equity
-8.80M-65.21M-88.74M8.41M96.36M
Cash FlowFree 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-953.00K1.06M4.07M93.24M
Financing Cash Flow
194.62M116.93M97.13M72.32M16.53M

Urogen Pharma Technical Analysis

Technical Analysis Sentiment
Negative
Last Price5.00
Price Trends
50DMA
9.25
Negative
100DMA
9.90
Negative
200DMA
11.19
Negative
Market Momentum
MACD
-1.62
Positive
RSI
34.53
Neutral
STOCH
43.77
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For URGN, the sentiment is Negative. The current price of 5 is below the 20-day moving average (MA) of 7.16, below the 50-day MA of 9.25, and below the 200-day MA of 11.19, indicating a bearish trend. The MACD of -1.62 indicates Positive momentum. The RSI at 34.53 is Neutral, neither overbought nor oversold. The STOCH value of 43.77 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for URGN.

Urogen Pharma Risk Analysis

Urogen Pharma disclosed 82 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 1 New Risks
1.
The data from our pivotal Phase 3 ENVISION trial and supporting ATLAS and OPTIMA II trials may be insufficient to support regulatory approval of UGN-102. Q4, 2024

Urogen Pharma Peers Comparison

Overall Rating
UnderperformOutperform
Sector (53)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
75
Outperform
$923.97M67.9233.47%29.77%
55
Neutral
$591.68M-37.13%-38.14%29.69%
53
Neutral
$5.23B3.23-44.27%2.82%16.82%0.11%
49
Neutral
$535.03M-35.41%-39.92%7.38%
48
Neutral
$223.16M-452.20%8.98%6.32%
46
Neutral
$414.81M-75.77%-44.25%
OPOPT
39
Underperform
$478.27M
-25.10%-7.06%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
URGN
Urogen Pharma
5.00
-8.08
-61.77%
NAGE
Niagen Bioscience
11.78
8.99
322.22%
SVRA
Savara
2.40
-1.62
-40.30%
ARVN
Arvinas Holding Company
7.00
-22.12
-75.96%
BCYC
Bicycle Therapeutics
8.30
-14.44
-63.50%
OPT
Opthea Limited Sponsored ADR
3.20
0.68
26.98%

Urogen Pharma Corporate Events

Product-Related AnnouncementsBusiness Operations and Strategy
UroGen Pharma Highlights RTGel® Platform and Growth Plans
Positive
Jan 14, 2025

On January 2025, UroGen Pharma Ltd. presented an investor update highlighting the potential of their proprietary RTGel® technology platform to transform urothelial cancer treatment paradigms. JELMYTO is already FDA-approved for treating low-grade upper tract urothelial carcinoma (LG-UTUC) non-surgically. UGN-102, pending approval, aims to become the standard of care for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) with a significant market opportunity. The company also discussed ongoing and planned studies for UGN-301 in high-grade non-muscle invasive bladder cancer (HG-NMIBC) and its expansion into immuno-oncology. UroGen’s strategic focus includes advancing pre-commercial activities for UGN-102, extending leadership in unmet needs for urothelial cancers, and ensuring sustainable growth.

Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.

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.