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Urogen Pharma (URGN)
:URGN
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Urogen Pharma
(NASDAQ:URGN)
50Neutral
Positive Factors
Financial Health
UroGen Pharma has sufficient funds to support operations through the launch of UGN-102 and possibly achieve cash flow break-even.
Market Potential
UGN-102 could become the first FDA-approved medicine for the treatment of low-grade, intermediate-risk, non-invasive bladder cancer, with a target market that may be larger than $5 billion annually.
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
Clinical Data Uncertainty
Proof-of-concept clinical data with ICVB-1042 in bladder cancer is awaited before attributing value to this program.
Revenue Performance
The long-term outlook for UroGen Pharma remains promising despite a modest revenue miss.
Urogen Pharma (URGN) vs. S&P 500 (SPY)
Market Cap
$516.26M
Dividend YieldN/A
Average Volume (3M)396.23K
Price to Earnings (P/E)―
Beta (1Y)1.42
Revenue Growth9.29%
EPS Growth13.49%
CountryUS
Employees235
SectorHealthcare
Sector Strength71
IndustryBiotechnology
Share Statistics
EPS (TTM)-3.22
Shares Outstanding46,094,353
10 Day Avg. Volume411,203
30 Day Avg. Volume396,225
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)6.19
Price to Cash Flow (P/CF)-10.30
P/FCF Ratio0.00
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$39.40Price Target Upside251.79% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering5
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 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
Neutral
11.20
Price Trends
10.66
Positive
11.09
Positive
12.80
Negative
Market Momentum
0.32
Negative
53.20
Neutral
29.74
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 11.2 is above the 20-day moving average (MA) of 10.94, above the 50-day MA of 10.66, and below the 200-day MA of 12.80, indicating a neutral trend. The MACD of 0.32 indicates Negative momentum. The RSI at 53.20 is Neutral, neither overbought nor oversold. The STOCH value of 29.74 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 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 (49)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
52 Neutral | $5.67B | ― | -31.26% | ― | 104.04% | 87.80% | |
50 Neutral | $516.26M | ― | -452.20% | ― | 9.29% | 13.49% | |
49 Neutral | $498.95M | ― | 91.25% | ― | -17.75% | -19.17% | |
49 Neutral | $6.85B | 0.81 | -52.91% | 2.50% | 19.94% | 1.20% | |
48 Neutral | $19.64M | ― | -634.71% | ― | 0.44% | 16.44% | |
47 Neutral | $1.90B | ― | -600.68% | ― | -98.62% | -86.21% | |
42 Neutral | $31.67M | ― | 60.38% | ― | 5.59% | 83.59% |
* Healthcare Sector Average
Performance Comparison
URGN
Urogen Pharma
11.20
-3.00
-21.13%
ARWR
Arrowhead Pharmaceuticals
13.82
-14.42
-51.06%
CRIS
Curis
2.32
-10.36
-81.70%
AKBA
Akebia Therapeutics
1.91
0.28
17.18%
FGEN
FibroGen
0.31
-2.05
-86.86%
BPMC
Blueprint Medicines
88.72
-7.70
-7.99%
Urogen Pharma Earnings Call Summary
Earnings Call Date: Mar 10, 2025 | % Change Since: 14.05% | Next Earnings Date: May 8, 2025
Earnings Call Sentiment Positive
The call was generally positive, highlighting significant progress with the UGN-102 NDA submission, strong clinical trial results, and JELMYTO revenue growth. However, challenges include increased net loss and anticipated limitations in UGN-102's initial approval setting.Highlights
UGN-102 NDA Submission and FDA Review
UGN-102, aimed at treating intermediate risk, low-grade, non-muscle invasive bladder cancer, has been submitted for FDA review ahead of schedule, with a PDUFA target date of June 13.
Strong Phase 3 Trial Results
ENVISION Phase 3 trial data for UGN-102 showed a complete response rate of 79.6% at three months and 80.6% at 18 months, with a median duration of response not yet reached.
JELMYTO Revenue Growth
JELMYTO generated net product revenues of $90.4 million in 2024, up from $82.7 million in 2023, marking a 12% increase in underlying demand.
Acquisition of ICVB-1042
The acquisition of ICVB-1042, a next-generation oncolytic virus, aligns with UroGen's strategic focus and enhances its pipeline.
Strong Financial Position
UroGen ended 2024 with $241.7 million in cash, providing a solid foundation to continue executing strategic initiatives.
Lowlights
Increased Net Loss
Net loss for 2024 was $126.9 million, up from $102.2 million in 2023, primarily due to increased R&D and SG&A expenses.
High Operating Expenses
Operating expenses are expected to increase in 2025, driven by planned sales force expansion and additional commercial and medical activities.
Recurrent Setting Approval Limitation
UGN-102 is anticipated to be approved only in the recurrent setting, requiring off-label use for approximately 10% of patients ineligible for surgery.
Company Guidance
In the UroGen Pharma earnings call for the fourth quarter and full year 2024, the company provided detailed guidance and projections for 2025. Key metrics highlighted included anticipated full-year JELMYTO revenues between $94 million and $98 million, reflecting a year-over-year growth rate of 8% to 12% compared to 2024's $87.4 million in demand-driven revenues. Operating expenses for 2025 are forecasted to be in the range of $215 million to $225 million, inclusive of $11 million to $14 million in non-cash share-based compensation expenses. UroGen expects to ramp up its sales force from 52 to approximately 83 representatives in preparation for the potential launch of UGN-102, which boasts a significant market opportunity estimated at over $5 billion. The company also shared positive clinical trial outcomes, such as a complete response rate of 79.6% at three months and an 18-month duration of response at 80.6% for UGN-102. Additionally, UroGen reported a strong cash position of $241.7 million at the end of 2024, positioning them well for upcoming commercialization efforts and further R&D advancements.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.