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Delcath Systems (DV3R) AI Stock Analysis

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DE:DV3R

Delcath Systems

(Stuttgart:DV3R)

Rating:―N/A
Action:N/A
Date:―

No summary available

Positive Factors
Revenue Scale and Gross MarginRevenue expansion combined with exceptionally high gross margins indicates that Hepzato is generating substantial value per dollar of sales as commercialization scales. If maintained, this profile can support reinvestment, strengthen operating leverage, and improve the company’s ability to build durable earnings over the next several quarters.
Negative Factors
Fragile ProfitabilityNear-breakeven net profitability and a return to slightly negative operating income show that revenue growth has not yet translated into durable operating leverage. Earnings remain sensitive to spending and sales mix, which could constrain internally funded expansion and make results less predictable over the next several quarters.

Delcath Systems (DV3R) vs. iShares MSCI Germany ETF (EWG)

-25%0%25%50%75%100%125%DE:DV3R+75.03%EWG+3.55%Dec '25Jan '26Feb '26Mar '26Apr '26May '26Jun '26Jul '26Aug '26Sep '26Oct '26Nov '26
Market Cap
EUR 502.79M
Dividend Yield
―
Average Volume (3M)
155
Price to Earnings (P/E)
1317.3
Beta (1Y)
1.03
Revenue Growth
26.94%
EPS Growth
-75.77%
Country
Germany
Employees
156
Sector
Healthcare
Sector Strength
51
Industry
Medical - Devices

Delcath Systems Business Overview & Revenue Model

Company Description

Delcath Systems, Inc. is an interventional oncology firm operating in the United States and Europe, dedicated to developing treatments for both primary and secondary liver cancers. Its leading investigational product is the HEPZATO KIT, a unique hepa...

Delcath Systems Earnings Call Summary

Earnings Call Date:May 06, 2026(Q1-2026)|% Change Since:34.43%|Next Earnings Date:May 10, 2021
Earnings Call SentimentNeutral

The call presents a balanced mix of positive commercial and clinical momentum (record new patient starts, robust volume growth, encouraging CHOPIN data driving adoption, solid revenue growth and strong cash balance) alongside meaningful near-term operational and financial headwinds (slower-than-expected site activations and trial enrollment, higher R&D and SG&A spend, a quarter-over-quarter decline in adjusted EBITDA and a small net loss, plus European reimbursement constraints and seasonality risks). Management remains optimistic about hitting at least $100M in revenue for 2026 and returning to positive adjusted EBITDA for the year, but several execution and enrollment risks temper the outlook.

Positive Updates

Top-Line Revenue Growth
Total revenue for Q1 2026 was $25.0M vs $19.8M in Q1 2025, an increase of approximately 26.3% year-over-year. HEPZATO KIT revenue was $23.3M and CHEMOSAT revenue was $1.7M.

Negative Updates

Slower Site Activation Pace
Company reduced its year-end active center target to 37 activated centers (with 40 active center treatment centers expected by Q1 2027), citing visibility limitations and slower-than-expected short-term site openings.

Company Guidance

Management guided to at least $100 million in total 2026 revenue (driven by an expected 20% increase in HEPZATO kit volume vs. 2025), with gross margins forecast at 85–87% and the company expecting to report positive adjusted EBITDA for the remainder of the year; Q1 results supporting guidance included $25.0M total revenue (HEPZATO kit $23.3M, CHEMOSAT $1.7M), Q1 gross margin 85% (vs. 86% a year ago), Q1 adjusted EBITDA $3.4M (vs. $7.6M YA), $89.3M cash and investments with no debt, $0.9M cash from operations, and ~300k shares bought for ~$3M in Q1 ( ~$9M repurchased to date under a $25M buyback); operational assumptions include seasonality similar to 2025 (Q3/Q4 softness), a revised site activation plan of 37 active centers in 2026 (40 by Q1 2027), Q1 new patient starts ~0.7 per site per month, Q1 volume growth +36% YoY (mid‑20% Q1 over Q4), R&D spending now expected to rise ~70–75% YoY (previously guided ~90%) with Q2 R&D ≈20% above Q1 and ~10% above thereafter, and SG&A ~60% higher vs. 2025 with Q2 SG&A ≈10–15% above Q1.

Delcath Systems Risk Analysis

Delcath Systems disclosed 60 risk factors in its most recent earnings report. Delcath Systems reported the most risks in the "Tech & Innovation" category.

Higher RiskSector Avg.Lower RiskFinance & CorporateTech & InnovationLegal & RegulatoryProductionAbility to SellMacro & Political
Tech & Innovation - Risks related to the company’s reliance on technology and ability to make innovative products

Latest Risks Added

0 New Risks

Delcath Systems Peers Comparison

Overall Rating

UnderperformOutperform
Sector (51)

Financial Indicators

DE:DV3R against its peers
NameOverall RatingMarket CapP/E RatioROEDividend YieldRevenue GrowthEPS Growth
TMDXTMDX68Neutral$2.52B16.4232.97%―25.82%108.84%
PENPEN67Neutral$12.71B80.4810.44%―16.98%-5.62%
NVCRNVCR53Neutral$1.71B-12.78-35.81%―12.94%33.87%
Sector *51Neutral$7.86B-0.30-43.30%2.27%22.53%-2.21%
TLSITLSI45Neutral$239.53M-2.71273.71%―25.25%-9.85%
SRTSSRTS44Neutral$53.50M-3.11-34.09%―-53.40%-1719.88%

* Healthcare Sector Average

Performance Comparison

-50%0%50%100%DE:DV3RPENNVCRSRTSTMDXTLSIDec '25Jan '26Feb '26Mar '26Apr '26May '26Jun '26Jul '26Aug '26Sep '26Oct '26Nov '26
DE:DV3R and its peers over the selected period
Show on chartTickerCompany NamePriceChange% Change
DE:DV3RDelcath Systems, Inc.12.875.5275.03%
PENPenumbra Inc.319.2148.6617.99%
NVCRNovoCure Ltd.13.282.0117.83%
SRTSSensus Healthcare, Inc.2.86-1.48-34.10%
TMDXTransmedics Group88.24-34.15-27.90%
TLSITrisalus Life Sciences, Inc.3.25-0.75-18.75%
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.