Urogen Pharma (URGN) AI Stock Analysis

• Market Cap: $223.16M
• Dividend Yield: N/A
• Average Volume (3M): 1.98M
• Price to Earnings (P/E): ―
• Beta (1Y): 1.11
• Revenue Growth: 8.98%
• EPS Growth: 6.32%
• Country: US
• Employees: 234
• Sector: Healthcare
• Sector Strength: 39
• Industry: Biotechnology
• EPS (TTM): -0.92
• Shares Outstanding: 46,107,452
• 10 Day Avg. Volume: 3,219,970
• 30 Day Avg. Volume: 1,979,839
• PEG Ratio: 0.79
• Price to Book (P/B): -54.55
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -5.32
• Enterprise Value/Market Cap: N/A
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: N/A
• Enterprise Value/Ebitda: N/A
• 1Y Price Target: $20.33
• Price Target Upside: 306.60% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 7

• Rating: 48 Neutral
• 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 Business Overview & Revenue Model

Company Description

Urogen 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 Money

Urogen 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.

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.

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.

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

• Technical Analysis Sentiment: Negative
• Last Price: 5.00
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• 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 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 Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
NAGE	75 Outperform	$923.97M	67.92	33.47%	―	29.77%	―
BCYC	55 Neutral	$591.68M	―	-37.13%	―	-38.14%	29.69%
Sector *	53 Neutral	$5.23B	3.23	-44.27%	2.82%	16.82%	0.11%
ARVN	49 Neutral	$535.03M	―	-35.41%	―	-39.92%	7.38%
URGN	48 Neutral	$223.16M	―	-452.20%	―	8.98%	6.32%
SVRA	46 Neutral	$414.81M	―	-75.77%	―	―	-44.25%
OPT	39 Underperform	$478.27M	―		―	-25.10%	-7.06%

Urogen Pharma Corporate Events

UroGen Pharma Highlights RTGel® Platform and Growth Plans

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.