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Delcath Systems (DCTH)
NASDAQ:DCTH
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Delcath Systems
(NASDAQ:DCTH)
Rating:63Neutral
Price Target:
$12.00
▲(14.61% Upside)
Positive Factors
Expansion and Adoption
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 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)
Market Cap
$366.25M
Dividend YieldN/A
Average Volume (3M)825.08K
Price to Earnings (P/E)230.1
Beta (1Y)1.15
Revenue Growth491.35%
EPS GrowthN/A
CountryUS
Employees96
SectorHealthcare
Sector Strength41
IndustryMedical - Devices
Share Statistics
EPS (TTM)0.07
Shares Outstanding34,981,255
10 Day Avg. Volume1,108,647
30 Day Avg. Volume825,084
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)N/A
P/FCF RatioN/A
Enterprise Value/Market Cap1.28
Enterprise Value/Revenue6.82
Enterprise Value/Gross Profit7.75
Enterprise Value/Ebitda35.13
Forecast
1Y Price Target
$23.00Price Target Upside119.68% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering6
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 primarily operates in the oncology sector, specializing in its proprietary Chemosaturation Technology System (CTS), which is designed to deliver high-dose chemotherapy directly to tumors while minimizing systemic exposure. Delcath's core product offerings include the CTS for the treatment of liver cancers, particularly in patients with metastatic melanoma and other tumors that have spread to the liver.
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: -0.48%|
Next Earnings Date:Nov 11, 2025
Earnings Call Sentiment Neutral
The earnings call reflected a balanced outlook. While Delcath Systems showcased strong revenue growth, positive cash flow, and strategic expansion of treating sites, challenges such as slower site activations and increased expenses were noted. Adjustments in financial guidance due to the 340B program also posed potential challenges. However, the company's proactive initiatives in R&D and pipeline expansion position it well for future growth.Q2-2025 Updates
Positive Updates
Significant Revenue Growth
Quarterly revenue reached $24.2 million, an increase of over 20% compared to the first quarter of 2025, with U.S. sales of HEPZATO contributing $22.5 million.
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. The company ended the quarter with no debt and approximately $81 million in cash and investments.
Expansion of Treating Sites
Activated Northwestern Memorial Hospital, University of Miami Hospital, and the University of Virginia Medical Center. 20 treating sites were active by the end of the second quarter, with expectations to reach 25 to 28 operational centers by the end of the fourth quarter.
R&D and Pipeline Expansion
Initiated company-sponsored trials in liver-dominant metastatic colorectal cancer and liver-dominant metastatic breast cancer, with FDA clearance and CTA authorization in Europe and the U.K.
Successful Financial Management
Gross margins increased to 86% from 80% in the prior year. Non-GAAP positive adjusted EBITDA of $9.8 million compared to a loss of $0.8 million in 2024.
Negative Updates
Slower U.S. Site Activations
Due to slower U.S. site activations, full year revenue guidance has been adjusted to $93 million to $96 million, fewer operational centers than previously projected.
Impact of 340B Drug Pricing Program
Approximately 50% of HEPZATO kits sold at discounted 340B prices, leading to an estimated net effect of a 10% to 15% reduction from the second quarter average revenue per kit.
Increased R&D and SG&A Expenses
Research and development expenses increased to $6.9 million from $3.4 million, and selling, general, and administrative expenses rose to $11.4 million from $6.8 million compared to the prior year.
Company Guidance
During the Delcath Systems Second Quarter 2025 Earnings Call, the company provided updated guidance reflecting their business progress and future expectations. Quarterly revenue reached $24.2 million, marking a more than 20% increase compared to the previous quarter, with U.S. sales of HEPZATO at $22.5 million and CHEMOSAT sales in Europe at $1.7 million. The company generated $7.3 million in positive cash from operations and reported a net income of $2.7 million, alongside an adjusted EBITDA of $9.8 million. Delcath ended the quarter with no debt and approximately $81 million in cash and investments. The company adjusted its full-year revenue guidance to $93 million to $96 million due to slower U.S. site activations, while maintaining projections for 83% to 85% gross margins and continued positive non-GAAP adjusted EBITDA. The total HEPZATO treatment volume for 2025 is expected to increase by over 175% compared to 2024. Delcath plans to expand to 25 to 28 operational centers by the end of the fourth quarter, anticipating 40 sites by the end of 2026. The company also discussed future clinical trials, including those for liver-dominant metastatic colorectal and breast cancer, with trials anticipating interim data releases beginning in 2027.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
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.45
Neutral
Balance Sheet
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.55
Neutral
Cash Flow
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.40
Negative
| Breakdown | TTM | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 68.60M | 37.20M | 2.06M | 2.72M | 3.56M | 1.65M |
| Gross Profit | 60.31M | 31.02M | 1.43M | 2.03M | 2.88M | 1.01M |
| EBITDA | 13.31M | -12.18M | -46.11M | -33.69M | -24.00M | -23.79M |
| Net Income | 2.23M | -26.39M | -47.68M | -39.16M | -26.76M | -24.48M |
Balance Sheet | ||||||
| Total Assets | 116.88M | 76.59M | 38.61M | 17.86M | 33.12M | 34.63M |
| Cash, Cash Equivalents and Short-Term Investments | 81.00M | 53.23M | 32.45M | 7.67M | 22.80M | 28.57M |
| Total Debt | 993.00K | 1.04M | 10.19M | 15.87M | 16.25M | 2.94M |
| Total Liabilities | 11.89M | 7.84M | 22.84M | 23.72M | 21.17M | 12.56M |
| Stockholders Equity | 104.99M | 68.75M | 15.78M | -5.86M | 11.95M | 22.08M |
Cash Flow | ||||||
| Free Cash Flow | 3.87M | -19.24M | -31.31M | -25.16M | -22.75M | -23.65M |
| Operating Cash Flow | 4.85M | -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 Flow | 56.13M | 39.41M | 51.78M | 10.14M | 20.82M | 42.35M |
Delcath Systems Technical Analysis
Negative
10.47
Price Trends
12.51
Negative
13.04
Negative
12.92
Negative
Market Momentum
-0.51
Negative
39.81
Neutral
21.76
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 10.47 is below the 20-day moving average (MA) of 10.87, below the 50-day MA of 12.51, and below the 200-day MA of 12.92, indicating a bearish trend. The MACD of -0.51 indicates Negative momentum. The RSI at 39.81 is Neutral, neither overbought nor oversold. The STOCH value of 21.76 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 |
|---|---|---|---|---|---|---|---|
63 Neutral | $366.25M | 230.11 | 4.09% | ― | 491.35% | ― | |
61 Neutral | $330.14M | ― | -85.68% | ― | 19.68% | -13.17% | |
54 Neutral | $538.16M | ― | -15.36% | ― | -0.02% | -1196.44% | |
53 Neutral | $439.05M | ― | -46.89% | ― | 7.67% | 23.79% | |
51 Neutral | $7.46B | -0.16 | -46.00% | 2.25% | 22.76% | -2.28% | |
46 Neutral | $391.78M | ― | -102.61% | ― | 5.94% | 25.16% | |
42 Neutral | $286.93M | ― | -32.87% | ― | 17.36% | 9.38% |
* Healthcare Sector Average
Performance Comparison
DCTH
Delcath Systems
10.36
2.36
29.50%
SRDX
SurModics
37.46
-2.66
-6.63%
CLPT
ClearPoint Neuro
11.55
0.52
4.71%
SENS
Senseonics Holdings
0.47
0.06
14.63%
NNOX
Nano-X Imaging
4.42
-2.82
-38.95%
TMCI
Treace Medical Concepts
6.89
0.51
7.99%
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.
Business Operations and StrategyFinancial Disclosures
Delcath Systems Announces 2025 Financial Guidance
Positive
May 22, 2025
On May 22, 2025, Delcath Systems announced its full-year 2025 financial guidance, projecting total revenue between $94 to $98 million, marking a significant increase of over 150% from 2024. The company also plans to enter into a National Medicaid Drug Rebate Agreement with the Centers for Medicare & Medicaid Services, expected to take effect in the third quarter of 2025, which aims to expand patient access and accelerate the adoption of its HEPZATO treatment in the U.S.
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.
Shareholder MeetingsBusiness Operations and Strategy
Delcath Systems Shareholders Approve Key Amendments at Meeting
Positive
May 16, 2025
At the annual meeting on May 15, 2025, Delcath Systems‘ stockholders approved amendments to increase the number of shares available under the company’s 2020 Omnibus Equity Incentive Plan and 2021 Employee Stock Purchase Plan. Additionally, stockholders elected Class I directors, ratified the selection of the company’s independent public accounting firm, and approved a non-binding advisory vote on executive compensation, reflecting shareholder support for the company’s strategic initiatives.
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.