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Delcath Systems (DCTH)
NASDAQ:DCTH

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:
$10.50
▲(4.37% Upside)
Delcath Systems shows strong financial performance with robust cash flow and minimal leverage. Positive clinical trial results and a share buyback plan enhance future prospects. However, the stock's high P/E ratio suggests overvaluation, and mixed technical indicators point to potential volatility. The earnings call provided a balanced view of growth opportunities and challenges.
Positive Factors
Strong Cash Position
A robust cash position provides financial flexibility, enabling Delcath to invest in growth opportunities and withstand economic uncertainties.
Positive Clinical Trial Results
Successful trial outcomes enhance Delcath's product credibility and market potential, supporting long-term revenue growth and competitive positioning.
High Gross Margins
Sustaining high gross margins indicates effective cost management, contributing to profitability and enabling reinvestment in business expansion.
Negative Factors
Increased Operating Expenses
Rising operating expenses can pressure margins and profitability, potentially limiting the company's ability to invest in growth initiatives.
Reduction in Revenue per Kit
Decreased revenue per kit could impact overall revenue growth and profitability, challenging Delcath's ability to maintain financial performance.
Decreased Net Income
A decline in net income indicates potential challenges in maintaining profitability, which could affect long-term financial health and investor confidence.

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

Delcath Systems Business Overview & Revenue Model

Company DescriptionDelcath Systems, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of cancer. The company specializes in a proprietary drug delivery system, known as the Delcath Hepatic Perfusion System, which is designed to deliver high doses of chemotherapy directly to the liver while minimizing systemic exposure. Delcath operates primarily in the oncology sector, targeting patients with liver cancers, including metastatic melanoma and other liver tumors.
How the Company Makes MoneyDelcath Systems generates revenue primarily through the sale of its proprietary medical devices and associated consumables, which are essential for its Hepatic Perfusion System. The company also pursues partnerships with healthcare institutions and pharmaceutical companies to expand the reach of its technology and enhance its product offerings. In addition to device sales, Delcath may generate revenue through clinical trial collaborations and potential licensing agreements for its technology. As the company seeks to gain regulatory approvals and expand its market presence, successful commercialization of its products and therapies will be crucial to its financial performance.

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 significant financial improvement with strong gross profit margins and positive revenue growth. The balance sheet is solid with minimal leverage, and cash flow generation is robust. However, historical volatility in revenue and profitability metrics suggests potential risks.
Income Statement
65
Positive
Delcath Systems shows a strong gross profit margin of 87.92% in the TTM, indicating efficient cost management. The net profit margin has improved significantly to 3.25% from negative margins in previous years, reflecting a turnaround in profitability. Revenue growth is positive at 13.33% in the TTM, although it has fluctuated in past years. The EBIT and EBITDA margins have also turned positive, suggesting operational improvements.
Balance Sheet
70
Positive
The company has a very low debt-to-equity ratio of 0.009, indicating minimal leverage and financial risk. Return on equity has improved to 3.40% in the TTM, showing better utilization of equity. The equity ratio stands at 92.37%, reflecting a strong equity base relative to total assets, enhancing financial stability.
Cash Flow
75
Positive
Free cash flow growth is robust at 211.25% in the TTM, indicating strong cash generation capabilities. The operating cash flow to net income ratio is 0.46, suggesting moderate cash conversion efficiency. The free cash flow to net income ratio is 0.80, showing that a significant portion of earnings is being converted into free cash flow.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue79.60M37.20M2.06M2.72M3.56M1.65M
Gross Profit68.69M31.02M1.43M2.03M2.88M1.01M
EBITDA14.27M-12.18M-37.78M-33.69M-24.32M-23.81M
Net Income1.20M-26.39M-47.68M-36.51M-25.65M-24.16M
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
Positive
Last Price10.06
Price Trends
50DMA
9.78
Positive
100DMA
10.34
Negative
200DMA
11.83
Negative
Market Momentum
MACD
0.16
Negative
RSI
55.90
Neutral
STOCH
36.38
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 10.06 is above the 20-day moving average (MA) of 9.77, above the 50-day MA of 9.78, and below the 200-day MA of 11.83, indicating a neutral trend. The MACD of 0.16 indicates Negative momentum. The RSI at 55.90 is Neutral, neither overbought nor oversold. The STOCH value of 36.38 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
64
Neutral
$355.26M1,169.771.94%251.54%
59
Neutral
$422.43M-17.19-103.13%12.83%-19.53%
54
Neutral
$190.65M-3.38-34.75%15.19%-3.32%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
45
Neutral
$251.28M-3.60-129.29%31.94%36.59%
45
Neutral
$163.76M-51.63%7.90%19.92%
43
Neutral
-15.36%-0.02%-1196.44%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
DCTH
Delcath Systems
10.06
-0.95
-8.63%
SRDX
SurModics
42.98
3.23
8.13%
CLPT
ClearPoint Neuro
14.20
-1.34
-8.62%
SENS
Senseonics Holdings
6.15
-3.05
-33.15%
NNOX
Nano-X Imaging
2.99
-3.77
-55.77%
TMCI
Treace Medical Concepts
2.57
-4.39
-63.07%

Delcath Systems Corporate Events

Stock Buyback
Delcath Systems Announces $25M Share Buyback Plan
Positive
Nov 20, 2025

On November 19, 2025, Delcath Systems, Inc.’s board of directors approved a share repurchase program, allowing the company to buy back up to $25 million of its common stock, contingent on market conditions. This strategic move could potentially enhance shareholder value and indicates the company’s confidence in its financial position and future prospects.

Product-Related AnnouncementsFinancial Disclosures
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.

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: Dec 09, 2025