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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)

Rating:63Neutral
Price Target:
$12.00
▲(3.00% Upside)
Delcath Systems' overall stock score is driven by strong financial performance and positive earnings call sentiment, despite challenges in site activations and valuation concerns. The high P/E ratio suggests potential overvaluation, while technical indicators show mixed signals. The company's strategic expansions and trial prospects provide a positive outlook, but historical volatility in profitability and cash flow generation remains a risk.
Positive Factors
Adoption and Expansion
HEPZATO’s participation in the Medicaid National Drug Rebate Agreement (NDRA) program is expected to increase access and thus overall treatment volumes.
Market Opportunity
Delcath estimates a combined $1.0B market opportunity for Hepzato in liver metastases due to colorectal and breast cancer, an attractive long-term growth opportunity.
Revenue and Growth
Hepzato and Chemosat revenue beat consensus, signaling continued growth.
Negative Factors
Pricing Impact
Delcath plans to participate in 340b program and introduce a ~23.1% discount on Hepzato sold to all 340b hospitals.
Revenue Guidance
Management modestly lowered 2025 revenue guidance to $93M-$96M, from prior $94M-$98M.

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
45
Neutral
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
55
Neutral
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
40
Negative
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
Positive
Last Price11.65
Price Trends
50DMA
11.33
Positive
100DMA
12.87
Negative
200DMA
12.95
Negative
Market Momentum
MACD
-0.04
Negative
RSI
58.67
Neutral
STOCH
70.01
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For DCTH, the sentiment is Positive. The current price of 11.65 is above the 20-day moving average (MA) of 10.79, above the 50-day MA of 11.33, and below the 200-day MA of 12.95, indicating a neutral trend. The MACD of -0.04 indicates Negative momentum. The RSI at 58.67 is Neutral, neither overbought nor oversold. The STOCH value of 70.01 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive 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
63
Neutral
$388.29M256.044.09%491.35%
61
Neutral
$314.98M-85.68%19.68%-13.17%
57
Neutral
$452.95M-46.89%7.67%23.79%
51
Neutral
$7.92B-0.43-41.67%2.21%22.29%-1.85%
46
Neutral
$364.98M-102.61%5.94%25.16%
43
Neutral
$477.40M-15.36%-0.02%-1196.44%
40
Underperform
$237.19M-32.87%17.36%9.38%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
DCTH
Delcath Systems
11.65
1.87
19.12%
SRDX
SurModics
32.38
-6.94
-17.65%
CLPT
ClearPoint Neuro
11.05
-0.79
-6.67%
SENS
Senseonics Holdings
0.46
0.12
35.29%
NNOX
Nano-X Imaging
3.69
-2.31
-38.50%
TMCI
Treace Medical Concepts
7.17
1.98
38.15%

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.

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 06, 2025