Delcath Systems (DCTH) AI Stock Analysis

• Market Cap: $298.82M
• Dividend Yield: N/A
• Average Volume (3M): 505.98K
• Price to Earnings (P/E): 137.2
• Beta (1Y): 1.76
• Revenue Growth: 251.54%
• EPS Growth: N/A
• Country: US
• Employees: 96
• Sector: Healthcare
• Sector Strength: 45
• Industry: Medical - Devices
• EPS (TTM): -0.05
• Shares Outstanding: 34,746,185
• 10 Day Avg. Volume: 542,624
• 30 Day Avg. Volume: 505,980
• PEG Ratio: -1.24
• Price to Book (P/B): 3.25
• Price to Sales (P/S): 4.24
• P/FCF Ratio: 17.25
• Enterprise Value/Market Cap: 0.86
• Enterprise Value/Revenue: 3.00
• Enterprise Value/Gross Profit: 3.48
• Enterprise Value/Ebitda: 99.65
• 1Y Price Target: $25.25
• Price Target Upside: 193.60% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 5
• EPS Forecast (FY): -0.4
• Revenue Forecast (FY): $104.32M

• Rating: 61 Neutral
• Price Target: $9.50 ▲(10.47% Upside)
• Action: Reiterated Date: 03/04/26
• Date: Action: Reiterated 03/04/26

The score is driven primarily by improved financial strength (stronger balance sheet and positive 2025 cash generation) and a generally positive outlook/catalyst backdrop (2026 revenue guidance and CHOPIN publication). These are offset by weak technical momentum and a demanding valuation (very high P/E), plus a key data-quality risk around the reported 2025 revenue figure and higher planned operating expenses.

Positive Factors

Balance sheet strength

Debt near zero and materially stronger equity provide a durable financial buffer to fund commercialization, R&D and site expansion without immediate external financing. This reduces solvency risk and gives management flexibility to execute multi-quarter growth and clinical plans.

Improved cash generation

Positive operating and free cash flow in 2025 represent a structural turnaround from prior multi-year cash burn, supporting internal funding for growth and R&D. Combined with ~ $91M cash on hand and no debt, the company has runway to scale centers and absorb planned spending increases.

Procedure-driven revenue and high gross margins

High gross margins and procedure-linked revenue imply strong unit economics and pricing power for Hepzato kits. Durable margin structure supports scalability as the REMS-certified center base grows and recurring procedure volumes drive sustained revenue per treatment over multiple quarters.

Negative Factors

Top-line data quality risk

Anomalous reporting (zero revenue despite gross profit) undermines confidence in the reported growth and margin improvements. This complicates forecasting, investor and payer trust, and makes it harder to assess whether the 2025 profitability turnaround is durable or partly an accounting/data issue.

Rising operating expenses

Planned large increases in R&D and SG&A will pressure near-term EBITDA and require execution to generate proportional revenue or clinical progress. If adoption or trial timelines slip, higher operating spend could erode the recent cash flow gains and force tougher capital-allocation tradeoffs.

Commercial & clinical execution dependency

Revenue scaling depends on guideline influence, center activations, referrals and timely trial/ publication outcomes. Delays in adoption, elevated adverse events or slow referral development can materially slow procedure growth and push expected revenue gains further into the back half of 2026 or beyond.

Delcath Systems Business Overview & Revenue Model

Company Description

Delcath 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 Money

Delcath 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 Financial Statement Overview

Summary

Balance sheet and cash flow are meaningfully improved (very low leverage, higher equity, and positive operating/free cash flow in 2025). However, the income statement quality is a concern given the unusual 2025 revenue figure (reported as zero despite substantial gross profit) and a history of multi-year losses and cash burn, making durability of the turnaround less certain.

Income Statement

The company shows a sharp profitability inflection in 2025, moving from a large loss in 2024 to positive operating profit and net income. Earlier years (2020–2024) were characterized by heavy losses despite generally strong gross profitability. A key concern is that 2025 revenue is reported as zero alongside substantial gross profit, which makes margin and growth figures for that year unreliable and raises questions about the quality/consistency of the top-line data.

Balance Sheet

Leverage has improved materially, with debt now very low relative to equity (debt-to-equity near zero in 2024–2025) and equity rising substantially versus prior years. The balance sheet is much stronger than 2021–2023, when leverage was higher and returns were deeply negative, and 2022 even showed negative equity. The main weakness is the historical volatility in equity/returns, indicating the capital base has been sensitive to operating performance and financing over time.

Cash Flow

Cash generation strengthened significantly in 2025, with positive operating cash flow and positive free cash flow, a major reversal from persistent cash burn in 2020–2024. Free cash flow also grew strongly year-over-year in 2025, supporting improving self-funding capacity. The drawback is that cash flow quality has been inconsistent historically (multiple years of sizable negative operating and free cash flow), so sustaining the 2025 improvement is the key risk.

Breakdown	Dec 2025	Dec 2024	Dec 2023	Dec 2022	Dec 2021
Income Statement
Total Revenue	85.23M	37.20M	2.06M	2.72M	3.56M
Gross Profit	73.43M	31.02M	1.43M	2.03M	2.88M
EBITDA	3.86M	-12.18M	-37.78M	-33.69M	-24.32M
Net Income	2.70M	-26.39M	-47.68M	-36.51M	-25.65M
Balance Sheet
Total Assets	123.63M	76.59M	38.61M	17.86M	33.12M
Cash, Cash Equivalents and Short-Term Investments	91.04M	53.23M	32.45M	7.67M	22.80M
Total Debt	936.00K	1.04M	10.19M	15.87M	16.25M
Total Liabilities	12.41M	7.84M	22.84M	23.72M	21.17M
Stockholders Equity	111.22M	68.75M	15.78M	-5.86M	11.95M
Cash Flow
Free Cash Flow	20.97M	-19.24M	-31.31M	-25.16M	-22.75M
Operating Cash Flow	22.52M	-18.68M	-31.25M	-24.95M	-22.60M
Investing Cash Flow	-26.59M	-981.00K	-19.71M	-209.00K	-143.00K
Financing Cash Flow	15.05M	39.41M	51.78M	10.14M	20.82M

Delcath Systems Technical Analysis

• Technical Analysis Sentiment: Negative
• Last Price: 8.60
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Positive
• RSI: Neutral
• STOCH: 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 8.6 is below the 20-day moving average (MA) of 9.54, below the 50-day MA of 9.96, and below the 200-day MA of 11.25, indicating a bearish trend. The MACD of -0.20 indicates Positive momentum. The RSI at 39.41 is Neutral, neither overbought nor oversold. The STOCH value of 19.93 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for DCTH.

Delcath Systems Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
DCTH	61 Neutral	$298.82M	137.16	3.00%	―	251.54%	―
SENS	52 Neutral	$285.08M	-4.00	-129.29%	―	31.94%	36.59%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
CLPT	51 Neutral	$262.83M	-10.69	-103.13%	―	12.83%	-19.53%
NNOX	47 Neutral	$165.14M	-2.93	-34.75%	―	15.19%	-3.32%
TMCI	43 Neutral	$101.41M	-1.68	-51.63%	―	7.90%	19.92%

Delcath Systems Corporate Events

Delcath Highlights CHOPIN Phase 2 Results in Uveal Melanoma

On March 3, 2026, Delcath Systems announced that full results from the investigator-initiated CHOPIN Phase 2 trial in metastatic uveal melanoma were published in The Lancet Oncology. The single-centre randomized study at Leiden University Medical Center evaluated percutaneous hepatic perfusion (PHP) with melphalan using Delcath’s CHEMOSAT system alone versus in combination with the immunotherapies ipilimumab and nivolumab.

The combination arm showed markedly improved outcomes, with 1-year progression-free survival of 54.7% versus 15.8%, median progression-free survival of 12.8 versus 8.3 months, and median overall survival of 23.1 versus 19.6 months, alongside higher response rates but more grade 3 or higher adverse events. Investigators and Delcath management highlighted that the superior progression-free and overall survival, enhanced hepatic control, and deeper, durable responses validate the synergy between Delcath’s liver-directed PHP and immune checkpoint inhibition, reinforcing the clinical value of the company’s platform in metastatic uveal melanoma and supporting its positioning in liver-directed oncology despite the increased toxicity profile.

The most recent analyst rating on (DCTH) stock is a Buy with a $30.00 price target. To see the full list of analyst forecasts on Delcath Systems stock, see the DCTH Stock Forecast page.

Delcath Systems Reports Strong Preliminary 2025 Results

On January 9, 2026, Delcath Systems released preliminary, unaudited financial and operational results for the fourth quarter and full year 2025, reporting expected total revenue of about $20.7 million for the quarter and $85.2 million for the year, driven largely by HEPZATO KIT sales of approximately $19.0 million and $78.8 million, respectively, with CHEMOSAT contributing $1.7 million in the quarter and $6.4 million for the year. As of December 31, 2025, the company reported 25 active centers using HEPZATO KIT, approximately 34.7 million shares outstanding, positive operating cash for the quarter, $91.0 million in cash and short-term investments with no debt, and the repurchase of 628,572 common shares for $6.0 million under its $25.0 million buyback program, while highlighting roughly 140% growth in HEPZATO procedure volume in 2025 versus 2024 and new clinical and publication data supporting its percutaneous hepatic perfusion platform; management emphasized that the figures are preliminary and subject to change pending completion of the year-end audit.

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.