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Delcath Systems (DCTH)
NASDAQ:DCTH

Delcath Systems (DCTH) AI Stock Analysis

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Delcath Systems

(NASDAQ:DCTH)

Rating:61Neutral
Price Target:
$17.00
▲(4.87%Upside)
Delcath Systems' stock is bolstered by positive earnings call outcomes and corporate events, indicating a strong growth trajectory and strategic improvements. However, financial performance concerns, especially profitability and cash flow issues, and a weak valuation act as significant constraints.
Positive Factors
Financial Guidance
Delcath also guided gross margin of 83%-85% and positive cash flow in the rest of 2025 quarters, both encouraging metrics for the year.
Market Expansion
Delcath plans to initiate two Phase 2 studies to evaluate HEPZATO in combination with standard-of-care in liver-dominant metastatic colorectal and breast cancers, potentially expanding the market size for HEPZATO by over 10 times.
Revenue Performance
Delcath reported $19.8M in total revenue for 1Q25, over 500% YoY up from $3.1M in 1Q24.
Negative Factors
Discount Impact
Maintain BUY, $21 price target based on expectation for continued, sustained multi-leg growth for Hepzato despite price discount.
Pricing Strategy
Delcath plans to participate in 340b program and introduce a ~23.1% discount on Hepzato sold to all 340b hospitals.
Rebate Implications
Hepzato entrance into Medicaid 340B could expand uptake and adoption, far outweighing additional rebates.

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: 39.62%|
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.
Breakdown
TTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
52.21M37.20M2.06M2.72M3.56M1.65M
Gross Profit
45.72M31.02M1.43M2.03M2.88M1.01M
EBIT
-1.49M-12.41M-38.18M-33.85M-24.53M-21.30M
EBITDA
-3.53M-12.18M-46.11M-33.69M-24.00M-23.79M
Net Income Common Stockholders
-14.21M-26.39M-47.68M-39.16M-26.76M-24.48M
Balance SheetCash, Cash Equivalents and Short-Term Investments
10.00M53.23M32.45M7.67M22.80M28.57M
Total Assets
14.21M76.59M38.61M17.86M33.12M34.63M
Total Debt
2.86M1.04M10.19M15.87M16.25M2.94M
Net Debt
-7.14M-31.37M-2.46M8.20M-6.55M-25.63M
Total Liabilities
20.57M7.84M22.84M23.72M21.17M12.56M
Stockholders Equity
-6.36M68.75M15.78M-5.86M11.95M22.08M
Cash FlowFree 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 Flow
38.64M39.41M51.78M10.14M20.82M42.35M

Delcath Systems Technical Analysis

Technical Analysis Sentiment
Positive
Last Price16.21
Price Trends
50DMA
13.80
Positive
100DMA
14.17
Positive
200DMA
12.31
Positive
Market Momentum
MACD
0.65
Positive
RSI
55.44
Neutral
STOCH
28.06
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 16.21 is below the 20-day moving average (MA) of 16.48, above the 50-day MA of 13.80, and above the 200-day MA of 12.31, indicating a neutral trend. The MACD of 0.65 indicates Positive momentum. The RSI at 55.44 is Neutral, neither overbought nor oversold. The STOCH value of 28.06 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 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 (54)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
61
Neutral
$570.45M-29.95%1068.87%81.29%
55
Neutral
$622.77M-49.97%-14.16%25.80%
54
Neutral
$5.31B3.26-45.10%2.79%16.76%0.02%
52
Neutral
$420.40M-16.96%-14.96%-245.49%
46
Neutral
$610.86M0.71%91657.69%97.21%
43
Neutral
$662.54M-48.45%7.15%
34
Underperform
$453.26M-45.82%10.38%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
DCTH
Delcath Systems
16.21
9.33
135.61%
SRDX
SurModics
29.16
-12.69
-30.32%
AUTL
Autolus Therapeutics
2.33
-1.98
-45.94%
KROS
Keros Therapeutics
13.75
-34.12
-71.28%
ORIC
Oric Pharmaceuticals
9.75
1.74
21.72%
ERAS
Erasca
1.61
-0.64
-28.44%

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.