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Delcath Systems (DCTH)
NASDAQ:DCTH
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Delcath Systems (DCTH) AI Stock Analysis

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DCTH

Delcath Systems

(NASDAQ:DCTH)

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Neutral 64 (OpenAI - 4o)
Rating:64Neutral
Price Target:
$12.00
▲(10.50% Upside)
Delcath Systems' overall stock score reflects strong financial performance and positive earnings call insights, tempered by high valuation concerns and moderate technical indicators. The company's strategic expansions and future prospects are promising, but historical volatility and valuation risks require caution.
Positive Factors
Revenue Growth
Consistent revenue growth indicates strong demand for Delcath's products, enhancing its market position and supporting long-term financial stability.
Cash Generation
Positive cash flow from operations suggests efficient management and operational success, providing resources for future growth and investment.
Clinical Trial Expansion
Expansion into new clinical trials reflects Delcath's commitment to innovation and could lead to new revenue streams and market opportunities.
Negative Factors
Delayed Site Activations
Delays in site activations may hinder revenue growth and limit the company's ability to scale operations as planned, impacting long-term expansion.
Revenue Guidance Adjustment
Lowered revenue guidance reflects potential challenges in achieving sales targets, which could affect investor confidence and future financial performance.
Increased R&D Expenses
Rising R&D costs may pressure margins and cash flow, requiring careful management to ensure continued investment in innovation without compromising financial health.

Delcath Systems (DCTH) vs. SPDR S&P 500 ETF (SPY)

Delcath Systems Business Overview & Revenue Model

Company DescriptionDelcath Systems, Inc., an interventional oncology company, focuses on the treatment of primary and metastatic liver cancers in the United States and Europe. The company's lead product candidate is HEPZATO KIT, a melphalan for injection/hepatic delivery system to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. Its clinical development program for HEPZATO is the FOCUS clinical trial for patients with metastatic hepatic dominant Uveal Melanoma to investigate objective response rate in metastatic uveal melanoma. It also provides HEPZATO as a stand-alone medical device under the CHEMOSAT Hepatic Delivery System trade name for Melphalan or CHEMOSAT for medical centers to treat a range of liver cancers in Europe. Delcath Systems, Inc. was incorporated in 1988 and is headquartered in New York, New York.
How the Company Makes MoneyDelcath Systems generates revenue primarily through the sale of its Chemosaturation Technology System and associated consumables used in its procedures. The company may also earn revenue through collaborations, licensing agreements, and grants related to the development and commercialization of its therapies. Key revenue streams include reimbursement from healthcare providers and insurance companies for the use of its CTS in clinical settings. Additionally, strategic partnerships with research institutions or pharmaceutical companies can provide funding and support for clinical trials, which may further enhance Delcath's market presence and revenue potential.

Delcath Systems Earnings Call Summary

Earnings Call Date:Aug 06, 2025
(Q2-2025)
|
% Change Since: |
Next Earnings Date:Nov 11, 2025
Earnings Call Sentiment Neutral
The earnings call highlighted the company's strong revenue growth and positive financial performance, along with strategic expansions and future trial prospects. However, the call also noted challenges in site activations, revenue guidance adjustments, and increased R&D expenses. The participation in the 340B program presents both opportunities and challenges.
Q2-2025 Updates
Positive Updates
Revenue Increase and Site Growth
Quarterly revenue reached $24.2 million, an increase of over 20% compared to the first quarter of 2025. The company has achieved five consecutive quarters of site and HEPZATO volume growth.
Positive Financial Performance
Generated $7.3 million in positive cash from operations, net income of $2.7 million, and adjusted EBITDA of $9.8 million. Ended the quarter with no debt and approximately $81 million in cash and investments.
Expansion and Future Prospects
Activated several new treating sites and expanded U.S. sales force from 4 to 6 regions. Anticipate the release of interim data for metastatic colorectal trial in 2027 and primary endpoint results in 2028.
R&D and Trial Developments
Received FDA clearance for Phase II trials in liver-dominant metastatic colorectal and breast cancer. Anticipate patient dosing for colorectal trial to begin within weeks.
Negative Updates
Delayed Site Activations
The number of operational centers by the end of the fourth quarter is expected to be 25 to 28, fewer than the previously projected 30.
Revenue Guidance Adjustment
Due to slower U.S. site activations, full-year revenue guidance has been adjusted to $93 million to $96 million.
340B Program Impact
Participation in the 340B program expected to lead to a 10% to 15% reduction in average revenue per HEPZATO kit in the third quarter.
Increased R&D Expenses
Research and development expenses for the quarter were $6.9 million compared to $3.4 million for the same period in the prior year.
Company Guidance
In the Delcath Systems Second Quarter 2025 Earnings Call, the company provided updated guidance and key metrics, showcasing strong performance and strategic goals. Quarterly revenue reached $24.2 million, marking a more than 20% increase from the first quarter, driven by U.S. HEPZATO sales of $22.5 million. The company achieved positive cash flow from operations at $7.3 million, net income of $2.7 million, and an adjusted EBITDA of $9.8 million. Delcath ended the quarter with $81 million in cash and investments. The company has 20 treating sites and aims for 25 to 28 operational centers by year-end, with a target of 40 by the end of 2026. The guidance was adjusted due to slower U.S. site activations, now forecasting full-year revenue between $93 million and $96 million, with gross margins projected at 83% to 85%. Delcath expects a 175% increase in HEPZATO treatment volume in 2025 compared to 2024. Additionally, the company is expanding its clinical trials, with Phase II trials cleared by the FDA for liver-dominant metastatic colorectal and breast cancers.

Delcath Systems Financial Statement Overview

Summary
Delcath Systems shows promising revenue growth, yet faces significant challenges in achieving profitability and positive cash flows. The strong equity position is a positive indicator of financial stability, but persistent cash flow issues and operating losses highlight the need for strategic improvements.
Income Statement
75
Positive
The income statement shows a significant increase in revenue over the last period, from $37.2 million to $52.2 million, marking a strong growth trajectory. However, the company remains unprofitable, with negative EBIT and net income margins, indicating ongoing operational challenges. The gross profit margin is healthy at approximately 87.5%, but the inability to convert this into net profits is a major area of concern.
Balance Sheet
68
Positive
The balance sheet reflects a strong equity position with stockholders' equity at $80.23 million, leading to a favorable equity ratio. The debt-to-equity ratio is low, suggesting minimal leverage risk. However, the company has consistently reported negative equity in previous years, which could imply volatility in financial stability.
Cash Flow
65
Positive
Cash flow analysis reveals negative free cash flow of $7.58 million in the TTM, indicating cash burn issues. The operating cash flow to net income ratio is also negative, reflecting difficulties in turning operations into cash. This trend emphasizes the need for improved cash management strategies.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue68.60M37.20M2.06M2.72M3.56M1.65M
Gross Profit60.31M31.02M1.43M2.03M2.88M1.01M
EBITDA13.31M-12.18M-46.11M-33.69M-24.00M-23.79M
Net Income2.23M-26.39M-47.68M-39.16M-26.76M-24.48M
Balance Sheet
Total Assets116.88M76.59M38.61M17.86M33.12M34.63M
Cash, Cash Equivalents and Short-Term Investments81.00M53.23M32.45M7.67M22.80M28.57M
Total Debt993.00K1.04M10.19M15.87M16.25M2.94M
Total Liabilities11.89M7.84M22.84M23.72M21.17M12.56M
Stockholders Equity104.99M68.75M15.78M-5.86M11.95M22.08M
Cash Flow
Free Cash Flow3.87M-19.24M-31.31M-25.16M-22.75M-23.65M
Operating Cash Flow4.85M-18.68M-31.25M-24.95M-22.60M-22.87M
Investing Cash Flow-41.49M-981.00K-19.71M-209.00K-143.00K-782.00K
Financing Cash Flow56.13M39.41M51.78M10.14M20.82M42.35M

Delcath Systems Technical Analysis

Technical Analysis Sentiment
Negative
Last Price10.86
Price Trends
50DMA
10.99
Negative
100DMA
12.78
Negative
200DMA
12.99
Negative
Market Momentum
MACD
0.01
Positive
RSI
45.46
Neutral
STOCH
24.97
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For DCTH, the sentiment is Negative. The current price of 10.86 is below the 20-day moving average (MA) of 11.17, below the 50-day MA of 10.99, and below the 200-day MA of 12.99, indicating a bearish trend. The MACD of 0.01 indicates Positive momentum. The RSI at 45.46 is Neutral, neither overbought nor oversold. The STOCH value of 24.97 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for DCTH.

Delcath Systems Risk Analysis

Delcath Systems disclosed 58 risk factors in its most recent earnings report. Delcath Systems reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Delcath Systems Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
64
Neutral
$385.84M242.424.09%491.35%
60
Neutral
548.08M-24.70-74.50%19.68%-13.17%
46
Neutral
382.90M-4.50-327.88%5.94%25.16%
44
Neutral
428.31M-8.51-50.38%7.67%23.79%
43
Neutral
435.51M-24.92-15.84%-0.02%-1196.44%
40
Underperform
252.50M-4.17-28.30%17.36%9.38%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
DCTH
Delcath Systems
10.86
1.72
18.82%
SRDX
SurModics
30.82
-7.67
-19.93%
CLPT
ClearPoint Neuro
21.55
10.36
92.58%
SENS
Senseonics Holdings
0.46
0.11
31.43%
NNOX
Nano-X Imaging
3.77
-2.39
-38.80%
TMCI
Treace Medical Concepts
6.68
0.91
15.77%

Delcath Systems Corporate Events

Business Operations and Strategy
Delcath Systems Updates Bylaws for Governance Efficiency
Neutral
Aug 15, 2025

On August 12, 2025, Delcath Systems, Inc. amended and restated its Bylaws to clarify procedural requirements for stockholder nominations and proposals, update officer election provisions, and describe indemnification rights. These changes aim to modernize and streamline the company’s governance framework, potentially impacting its operational efficiency and stakeholder engagement.

The most recent analyst rating on (DCTH) stock is a Buy with a $21.00 price target. To see the full list of analyst forecasts on Delcath Systems stock, see the DCTH Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

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.Date of analysis: Sep 24, 2025