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Urogen Pharma (URGN)
NASDAQ:URGN
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Urogen Pharma
(NASDAQ:URGN)
42Neutral
Positive Factors
Clinical Efficacy
UGN-102's durability of effect should position it well for timely FDA approval and robust market uptake.
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 Approval
The FDA's acceptance of the NDA for UGN-102 with a set PDUFA date indicates a strong likelihood of approval.
Negative Factors
Revenue Miss
Q1 Jelmyto revenue of $20.3MM was slightly below consensus of $22.9MM, driven by a 12% Y/Y increase in demand, but offset by typical Q1 seasonality including 340B chargebacks.
Urogen Pharma (URGN) vs. S&P 500 (SPY)
Market Cap
$467.53M
Dividend YieldN/A
Average Volume (3M)655.68K
Price to Earnings (P/E)―
Beta (1Y)1.22
Revenue Growth8.98%
EPS Growth6.32%
CountryUS
Employees234
SectorHealthcare
Sector Strength38
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.92
Shares Outstanding46,107,452
10 Day Avg. Volume678,724
30 Day Avg. Volume655,681
Financial Highlights & Ratios
PEG Ratio0.79
Price to Book (P/B)-54.55
Price to Sales (P/S)0.00
P/FCF Ratio-5.32
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$33.71Price Target Upside242.23% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering7
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 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
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.45
Neutral
Balance Sheet
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.30
Negative
Cash Flow
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.50
Neutral
| 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 | 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 Sheet | Cash, Cash Equivalents and Short-Term Investments | |||
| 236.69M | 136.97M | 99.96M | 89.81M | 103.91M | Total Assets |
| 285.71M | 178.31M | 136.24M | 119.75M | 122.00M | Total Debt |
| 123.39M | 100.21M | 99.12M | 398.00K | 1.50M | Net Debt |
| -48.60M | 4.39M | 43.72M | -43.96M | -102.41M | 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
Negative
9.85
Price Trends
10.67
Negative
10.58
Negative
11.80
Negative
Market Momentum
-0.10
Positive
44.86
Neutral
16.38
Positive
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 9.85 is below the 20-day moving average (MA) of 10.45, below the 50-day MA of 10.67, and below the 200-day MA of 11.80, indicating a bearish trend. The MACD of -0.10 indicates Positive momentum. The RSI at 44.86 is Neutral, neither overbought nor oversold. The STOCH value of 16.38 is Positive, 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 0 New Risks
Urogen Pharma Peers Comparison
Overall Rating
UnderperformOutperform
Sector (52)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
75 Outperform | $795.57M | 60.80 | 33.47% | ― | 29.77% | ― | |
55 Neutral | $561.23M | ― | -37.13% | ― | -38.14% | 29.69% | |
52 Neutral | $5.04B | 3.15 | -44.58% | 2.85% | 16.08% | -0.27% | |
48 Neutral | $443.06M | ― | -35.41% | ― | -39.92% | 7.38% | |
46 Neutral | $516.78M | ― | -75.77% | ― | ― | -44.25% | |
42 Neutral | $467.53M | ― | -452.20% | ― | 8.98% | 6.32% | |
39 Underperform | $473.34M | ― | ― | -25.10% | -7.06% |
* Healthcare Sector Average
Performance Comparison
URGN
Urogen Pharma
9.85
-3.36
-25.44%
NAGE
Niagen Bioscience
10.50
7.02
201.72%
SVRA
Savara
3.11
-1.61
-34.11%
ARVN
Arvinas Holding Company
6.26
-25.85
-80.50%
BCYC
Bicycle Therapeutics
8.12
-14.06
-63.39%
OPT
Opthea Limited Sponsored ADR
3.20
-0.38
-10.61%
Urogen Pharma Earnings Call Summary
Earnings Call Date:May 12, 2025
(Q1-2025)
| % Change Since: -5.11%|
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 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.