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Delcath Systems, Inc. (DCTH)
:DCTH

Delcath Systems (DCTH) AI Stock Analysis

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Delcath Systems

(NASDAQ:DCTH)

Rating:49Neutral
Price Target:
$12.50
▼(-1.50%Downside)
Delcath Systems' overall score is driven by strong revenue growth and positive corporate events, but is weighed down by ongoing profitability challenges and bearish technical indicators. The company's strategic initiatives and positive earnings call sentiment provide a potential upside.
Positive Factors
Market Expansion
Hepzato's entrance into the Medicaid 340B program could expand uptake and adoption, far outweighing additional rebates.
Market Opportunities
There are large revenue opportunities ahead for Hepzato in breast and colorectal cancer, with potential market size reaching ~$2B in colorectal cancer and ~$1B in breast cancer.
Revenue Growth
Delcath reported $19.8M in total revenue for 1Q25, over 500% YoY up from $3.1M in 1Q24.
Negative Factors
Pricing Strategy
Delcath plans to participate in 340b program and introduce a ~23.1% discount on Hepzato sold to all 340b hospitals.
Rebate Impact
Participating in the NDRA program is intended to expand patient access through rebates and 340B discounts to eligible hospitals.

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 makes money primarily through the commercialization of its CHEMOSAT/Melphalan/HDS system, which is sold to hospitals and cancer treatment centers. The company's revenue model includes direct sales of the device and associated consumables required for its operation. Delcath may also engage in strategic partnerships with healthcare providers and institutions to expand the adoption and distribution of its technology. Additionally, the company might explore licensing agreements or collaborations to broaden the reach of its therapies globally, contributing to its earnings.

Delcath Systems Earnings Call Summary

Earnings Call Date:May 08, 2025
(Q1-2025)
|
% Change Since: 9.30%|
Next Earnings Date:Aug 11, 2025
Earnings Call Sentiment Positive
The earnings call presented a generally positive outlook for Delcath Systems, with strong revenue growth, an increase in active treatment centers, and positive financial metrics highlighting the quarter. However, challenges with European reimbursement and rising expenses tempered the overall sentiment.
Q1-2025 Updates
Positive Updates
Strong Revenue Growth
Combined revenue for HEPZATO and CHEMOSAT reached $19.8 million in Q1 2025, with HEPZATO contributing $18 million and CHEMOSAT contributing $1.8 million. This represents significant growth compared to the previous year.
Increased Active Centers
The company ended Q1 2025 with 17 treating sites and opened an additional two centers, bringing the total to 19 active centers in the U.S., with 10 more centers pending activation.
Positive Financial Metrics
Delcath Systems reported positive cash from operations of $2.2 million, net income of $1.1 million, and a positive adjusted EBITDA of $7.6 million for Q1 2025. The company also ended the quarter with no debt and $59 million in cash and investments.
European Market Growth
The European market for CHEMOSAT grew by 29% over the prior quarter to $1.8 million, despite reimbursement challenges.
Pipeline Expansion
FDA clearance was received for Phase II trials in metastatic colorectal and breast cancer, with plans to start by the end of 2025.
Negative Updates
Reimbursement Challenges in Europe
Despite growth, the European market faces significant reimbursement and pricing challenges, limiting its short-to-medium-term contribution to revenue.
Increase in Operating Expenses
Research and development expenses increased to $5 million from $3.7 million, and selling, general, and administrative expenses rose to $11.3 million from $8.8 million compared to the same period in 2024.
Company Guidance
During the Delcath Systems' First Quarter 2025 Earnings Call, the company reported significant financial and operational achievements. They announced a combined revenue of $19.8 million, with HEPZATO sales contributing $18 million in the U.S. and CHEMOSAT sales adding $1.8 million in Europe. The company ended the quarter with 19 active treating centers in the U.S., up from 17, and a strong financial position with a net income of $1.1 million and positive cash flow from operations of $2.2 million. Delcath's adjusted EBITDA was reported at $7.6 million, and they held $59 million in cash and investments with no debt. Looking ahead, Delcath aims to have 30 active centers by year-end and is actively expanding its reach by increasing its sales territories from four to six, each supported by a specialized team. The company is also advancing clinical trials for liver-dominant metastatic colorectal and breast cancer, with patient enrollment expected to begin later in 2025. These efforts are part of Delcath's broader strategy to expand the applications of its liver treatment platform beyond metastatic uveal melanoma.

Delcath Systems Financial Statement Overview

Summary
Delcath Systems shows strong 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 Revenue52.21M37.20M2.06M2.72M3.56M1.65M
Gross Profit45.72M31.02M1.43M2.03M2.88M1.01M
EBITDA-3.53M-12.18M-46.11M-33.69M-24.00M-23.79M
Net Income-14.21M-26.39M-47.68M-39.16M-26.76M-24.48M
Balance Sheet
Total Assets87.32M76.59M38.61M17.86M33.12M34.63M
Cash, Cash Equivalents and Short-Term Investments58.90M53.23M32.45M7.67M22.80M28.57M
Total Debt1.02M1.04M10.19M15.87M16.25M2.94M
Total Liabilities7.09M7.84M22.84M23.72M21.17M12.56M
Stockholders Equity80.23M68.75M15.78M-5.86M11.95M22.08M
Cash Flow
Free Cash Flow-7.58M-19.24M-31.31M-25.16M-22.75M-23.65M
Operating Cash Flow-6.89M-18.68M-31.25M-24.95M-22.60M-22.87M
Investing Cash Flow-30.79M-981.00K-19.71M-209.00K-143.00K-782.00K
Financing Cash Flow38.64M39.41M51.78M10.14M20.82M42.35M

Delcath Systems Technical Analysis

Technical Analysis Sentiment
Negative
Last Price12.69
Price Trends
50DMA
14.61
Negative
100DMA
13.92
Negative
200DMA
12.65
Positive
Market Momentum
MACD
-0.66
Positive
RSI
33.81
Neutral
STOCH
7.00
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 12.69 is below the 20-day moving average (MA) of 14.53, below the 50-day MA of 14.61, and above the 200-day MA of 12.65, indicating a neutral trend. The MACD of -0.66 indicates Positive momentum. The RSI at 33.81 is Neutral, neither overbought nor oversold. The STOCH value of 7.00 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 57 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 (52)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
53
Neutral
$630.76M-49.91%-14.16%25.88%
52
Neutral
$428.83M-16.96%-14.96%-245.49%
52
Neutral
$7.50B0.31-61.87%2.27%17.10%1.59%
49
Neutral
$441.94M-29.95%1068.87%81.29%
46
Neutral
$546.28M0.71%91657.69%97.21%
43
Neutral
$920.42M-48.45%7.15%
34
Underperform
$407.93M-45.82%10.38%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
DCTH
Delcath Systems
12.69
4.78
60.43%
SRDX
SurModics
29.99
-12.05
-28.66%
AUTL
Autolus Therapeutics
2.37
-1.36
-36.46%
KROS
Keros Therapeutics
13.45
-28.23
-67.73%
ORIC
Oric Pharmaceuticals
10.80
2.30
27.06%
ERAS
Erasca
1.44
-0.91
-38.72%

Delcath Systems Corporate Events

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.Date of analysis: Jul 03, 2025