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Delcath Systems, Inc. (DCTH)
: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 58 (OpenAI - 4o)
Rating:58Neutral
Price Target:
$9.50
▲(9.95% Upside)
Delcath Systems' overall stock score is driven by strong financial performance and positive earnings call highlights, including revenue growth and clinical trial advancements. However, the high valuation and bearish technical indicators weigh negatively on the score.
Positive Factors
Revenue Growth
Strong revenue growth indicates successful market penetration and product adoption, supporting long-term business expansion.
Cash Position
A robust cash position with no debt enhances financial stability, providing flexibility for strategic investments and growth.
Clinical Trials Expansion
Expanding clinical trials into new indications can drive future growth and diversify revenue streams, strengthening market position.
Negative Factors
Delayed Site Activations
Delays in site activations could slow revenue growth and market expansion, impacting the company's ability to meet strategic goals.
Increased R&D Expenses
Rising R&D expenses may pressure margins and profitability, requiring careful management to ensure sustainable financial performance.
Revenue Guidance Adjustment
Lowered revenue guidance reflects operational challenges, potentially affecting investor confidence and future financial projections.

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:Nov 04, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Mar 31, 2026
Earnings Call Sentiment Neutral
The earnings call presented a mixed picture with significant advancements in clinical trials and revenue growth, but also highlighted challenges such as reduced revenue per kit and increased operating expenses impacting profitability.
Q3-2025 Updates
Positive Updates
Increased Revenue from HEPZATO
Revenue from HEPZATO sales increased to $19.3 million in Q3 2025 compared to $10 million in the same period in 2024.
Positive CHOPIN Trial Results
CHOPIN trial showed significant improvements in the primary endpoint with 1-year PFS at 54.7% in the combination group versus 15.8% in the perfusion group.
Expansion of Treatment Sites
25 REMS-certified treatment sites with plans to expand to 40 by the end of 2026.
High Gross Margins
The company recognized gross margins of 87% in Q3 2025 compared to 85% in the same period last year.
Strong Cash Position
Ended the quarter with approximately $89 million in cash and investments and positive operating cash flow of $4.8 million.
Negative Updates
Reduction in Revenue per Kit
340B pricing related to NDRA participation resulted in an approximate 13% reduction in average revenue per kit sold versus the prior quarter.
Increased Operating Expenses
Research and development expenses increased to $8.0 million from $3.9 million in the same period last year, and SG&A expenses rose to $10.3 million from $7.0 million.
Competition and Seasonality Impact
Competition for clinical trials and summer seasonality led to a slowdown in new patient starts and site activation.
Decreased Net Income
Net income decreased to $0.8 million in Q3 2025 from $1.9 million in the third quarter of the previous year.
Company Guidance
During the Delcath Systems Third Quarter 2025 Earnings Conference Call, the company provided guidance on future site activations, financial projections, and clinical trial progress. Delcath expects to increase the number of active treating centers from the current 25 to 26-28 by the end of 2025, and further to 40 by the end of 2026. Revenue from HEPZATO reached $19.3 million in Q3 2025, with projected gross margins between 85% and 87% for the year. The company also adjusted its 2025 annual revenue guidance to $83-85 million. Delcath highlighted the positive results of the CHOPIN trial, demonstrating a 1-year progression-free survival (PFS) rate of 54.7% in the combination group versus 15.8% in the perfusion group, with statistically significant improvements in median overall survival and best overall response rate. The company plans to expand its sales force from 4 to 6 regions in 2025, and further to 9 regions by Q2 2026, to support site activation and build referral networks. Additionally, Delcath is conducting trials for liver-dominant metastatic colorectal and breast cancers, with interim data expected by 2027 and primary endpoint results in 2028 and 2029, respectively.

Delcath Systems Financial Statement Overview

Summary
Delcath Systems shows strong revenue growth and improved profitability, supported by a stable balance sheet with low leverage. However, historical volatility in profitability and cash flow generation poses potential risks.
Income Statement
75
Positive
Delcath Systems has shown a strong revenue growth rate of 31.39% in the TTM, indicating a positive trajectory in sales. The company has improved its profitability with a net profit margin of 5.02% and a gross profit margin of 135.70%, reflecting efficient cost management. However, historical data shows volatility with previous negative margins, suggesting potential risks in maintaining consistent profitability.
Balance Sheet
68
Positive
The balance sheet is stable with a low debt-to-equity ratio of 0.009, indicating minimal leverage and financial risk. The return on equity is modest at 3.40%, showing moderate efficiency in generating returns from equity. The equity ratio stands at 89.82%, suggesting a strong equity base relative to total assets. However, historical fluctuations in equity and returns highlight potential risks in financial stability.
Cash Flow
65
Positive
The cash flow statement shows a decline in free cash flow growth at -151.02%, indicating challenges in generating cash. The operating cash flow to net income ratio of 0.46 suggests moderate cash generation efficiency. Despite a positive free cash flow to net income ratio of 0.80, historical negative cash flows highlight potential liquidity risks.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue59.04M37.20M2.06M2.72M3.56M1.65M
Gross Profit68.69M31.02M1.43M2.03M2.88M1.01M
EBITDA14.08M-12.18M-46.11M-33.69M-24.00M-23.79M
Net Income1.20M-26.39M-47.68M-39.16M-26.76M-24.48M
Balance Sheet
Total Assets124.30M76.59M38.61M17.86M33.12M34.63M
Cash, Cash Equivalents and Short-Term Investments88.91M53.23M32.45M7.67M22.80M28.57M
Total Debt965.00K1.04M10.19M15.87M16.25M2.94M
Total Liabilities9.45M7.84M22.84M23.72M21.17M12.56M
Stockholders Equity114.85M68.75M15.78M-5.86M11.95M22.08M
Cash Flow
Free Cash Flow12.04M-19.24M-31.31M-25.16M-22.75M-23.65M
Operating Cash Flow13.26M-18.68M-31.25M-24.95M-22.60M-22.87M
Investing Cash Flow-41.26M-981.00K-19.71M-209.00K-143.00K-782.00K
Financing Cash Flow61.38M39.41M51.78M10.14M20.82M42.35M

Delcath Systems Technical Analysis

Technical Analysis Sentiment
Negative
Last Price8.64
Price Trends
50DMA
10.79
Negative
100DMA
11.23
Negative
200DMA
12.72
Negative
Market Momentum
MACD
-0.57
Positive
RSI
30.51
Neutral
STOCH
12.24
Positive
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 8.64 is below the 20-day moving average (MA) of 10.38, below the 50-day MA of 10.79, and below the 200-day MA of 12.72, indicating a bearish trend. The MACD of -0.57 indicates Positive momentum. The RSI at 30.51 is Neutral, neither overbought nor oversold. The STOCH value of 12.24 is Positive, 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
60
Neutral
$482.70M-22.81-85.68%19.68%-13.17%
58
Neutral
$306.52M1,004.651.94%251.54%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
50
Neutral
$411.89M-46.89%7.67%23.79%
45
Neutral
$272.51M-129.29%31.94%36.59%
43
Neutral
$393.18M-15.36%-0.02%-1196.44%
40
Underperform
$207.86M-32.87%17.36%9.38%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
DCTH
Delcath Systems
8.64
-2.42
-21.88%
SRDX
SurModics
26.42
-12.04
-31.31%
CLPT
ClearPoint Neuro
18.23
6.58
56.48%
SENS
Senseonics Holdings
6.22
0.05
0.81%
NNOX
Nano-X Imaging
3.15
-2.95
-48.36%
TMCI
Treace Medical Concepts
6.23
-1.81
-22.51%

Delcath Systems Corporate Events

Delcath Systems Reports Strong Q3 2025 Growth
Nov 5, 2025

Delcath Systems, Inc. is an interventional oncology company specializing in the treatment of primary and metastatic liver cancers through its proprietary products, HEPZATO KIT and CHEMOSAT, which deliver high-dose chemotherapy to the liver while minimizing systemic exposure.

Delcath Systems’ Promising Study on Liver-Directed Chemotherapy for Colorectal Cancer
Oct 27, 2025

Delcath Systems, Inc. is conducting a clinical study titled ‘An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment With Melphalan/HDS Followed by Consolidation Treatment With Trifluridine-Tipiracil Plus Bevacizumab Versus Trifluridine-Tipiracil Plus Bevacizumab Alone in Patients With Refractory Metastatic Colorectal Cancer With Liver Dominant Disease.’ The study aims to assess the safety and effectiveness of a liver-directed high-dose chemotherapy treatment followed by standard cancer therapy compared to standard therapy alone in patients with metastatic colorectal cancer that has spread to the liver.

Delcath Systems’ New Study on Liver-Directed Chemotherapy for Metastatic Breast Cancer
Oct 27, 2025

Delcath Systems, Inc. has announced a new clinical study titled An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment With Melphalan/HDS Followed by Consolidation Treatment With Eribulin or Vinorelbine or Capecitabine Versus Eribulin or Vinorelbine or Capecitabine Alone in Patients With Metastatic Breast Cancer With Liver Dominant Disease. The study aims to assess the safety and efficacy of a liver-directed therapy using high-dose chemotherapy for patients with metastatic breast cancer that has spread to the liver. This research is significant as it explores potential advancements in treatment options for this challenging condition.

Financial DisclosuresProduct-Related Announcements
Delcath Systems Reports Positive CHOPIN Trial Results
Positive
Oct 20, 2025

On October 18, 2025, Delcath Systems announced the results of the CHOPIN Trial, which showed that the combination of their CHEMOSAT Hepatic Delivery System with immune checkpoint inhibitors significantly improved progression-free survival in patients with metastatic uveal melanoma compared to PHP alone. Additionally, Delcath reported preliminary third-quarter financial results, revealing a total revenue of approximately $20.5 million, a net income of $0.8 million, and positive cash flow, indicating a strong financial position with no debt as of September 30, 2025.

The most recent analyst rating on (DCTH) stock is a Hold with a $12.00 price target. To see the full list of analyst forecasts on Delcath Systems stock, see the DCTH Stock Forecast page.

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.

Delcath Systems Reports Strong Q2 2025 Results
Aug 7, 2025

Delcath Systems, Inc. is an interventional oncology company specializing in the treatment of primary and metastatic liver cancers, utilizing its proprietary HEPZATO KIT and CHEMOSAT systems to deliver high-dose chemotherapy directly to the liver while minimizing systemic exposure.

Delcath Systems Reports Strong Q2 Growth Amid Challenges
Aug 7, 2025

Delcath Systems, Inc. recently held its second-quarter earnings call, revealing a balanced outlook for the company. While there was notable revenue growth and positive cash flow, challenges such as slower site activations and increased expenses were acknowledged. Adjustments in financial guidance due to the 340B program also posed potential hurdles. However, the company’s proactive initiatives in research and development and pipeline expansion position it well for future growth.

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: Nov 05, 2025