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1. Company Snapshot

1.a. 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.

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1.b. Last Insights on DCTH

Delcath Systems, Inc.'s recent performance was impacted by weak Q3 results, with total CHEMOSAT and HEPZATO KIT revenue of approximately $20.5 million. The company's growth was affected by seasonality and pricing headwinds. However, the Board of Directors authorized a $25 million share repurchase program, which could boost shareholder value. Additionally, the publication of real-world evidence supporting the early use of liver-directed therapy with PHP in achieving long-term survival for metastatic uveal melanoma patients was a positive development. Analysts have a "Moderate Buy" rating on the stock, with a target price of $24.00.

1.c. Company Highlights

2. Delcath Systems' Q3 2025 Earnings: A Closer Look at Financial Performance

Delcath Systems reported revenue from HEPZATO sales of $19.3 million and CHEMOSAT sales of $1.3 million for the third quarter of 2025. The company's gross margins were 87% in the third quarter, compared to 85% for the same period in the prior year. The earnings per share (EPS) was $0.02, in line with analyst estimates. The company's net income was $0.8 million, and non-GAAP positive adjusted EBITDA was $5.3 million. Research and development expenses were $8.0 million, and selling, general, and administrative expenses were $10.3 million.

Publication Date: Nov -17

📋 Highlights
  • Revenue Growth Despite Pricing Pressure:: HEPZATO sales rose 93% YoY to $19.3M, and CHEMOSAT increased 8% to $1.3M, driven by expanded adoption despite 13% QoQ revenue per kit decline due to NDRA.
  • Profitability Metrics Strengthen:: Gross margin improved to 87% in Q3 2025 (vs. 85% prior year), with adjusted EBITDA at $5.3M and net income of $0.8M, reflecting cost efficiencies.
  • Site Expansion Progress:: Activated 4 new REMS-certified sites in Q3, totaling 25, with a target of 26–28 active centers by year-end and 40 by 2026, despite slower site activation in Q2–Q3.
  • CHOPIN Trial Clinical Success:: 54.7% 1-year PFS in combination therapy vs. 15.8% in perfusion group, with plans to expand HEPZATO into breast, CRC, and other cancers leveraging checkpoint inhibitor synergy.
  • Guidance and Future Data Milestones:: 2025 revenue guidance raised to $83–85M, with interim metastatic CRC and breast cancer trial data expected in Q2 2027 and Q4 2027, respectively.

Revenue Growth and Pricing Impact

The company's commercial performance was impacted by 340B pricing related to NDRA participation, resulting in a 13% reduction in average revenue per kit sold versus the prior quarter. Delcath expects a similar average price level in the fourth quarter. Despite this, the company is confident in its revenue growth prospects, with analysts estimating next year's revenue growth at 40.6%. The company's guidance for 2025 has been adjusted to $83 million to $85 million.

Operational Updates and Pipeline Progress

Delcath activated 4 new sites in the past 2 months, bringing the total to 25 REMS-certified treatment sites. The company aims to have 26-28 active treating centers by the end of 2025 and 40 centers by the end of next year. The CHOPIN trial results, presented at ESMO, showed promising data, with a 1-year PFS of 54.7% in the combination group versus 15.8% in the perfusion group. The company plans to advance research and development for HEPZATO in various cancer indications.

Valuation and Growth Prospects

Delcath's current valuation metrics indicate a P/E Ratio of 143.18, P/B Ratio of 3.04, and P/S Ratio of 4.52. The EV/EBITDA ratio is 20.78. With a healthy cash balance and no need to raise capital, the company is well-positioned for growth. The company's gross margins are expected to be around 85%-80% into 2026, with potential high 80% beyond 2026, depending on cost efficiencies.

Future Plans and Potential Risks

The company is exploring areas where immunotherapies are established and have good efficacy, such as non-small cell lung cancer and melanoma. However, the SCANDIUM-3 trial, a European investigator-sponsored study, is recruiting slowly, and no timeline is available for data readout. Thomas Jefferson hospital's single-center trial with 109 patients may compete with Delcath's patient enrollment, potentially impacting the company's trial progress.

3. NewsRoom

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Delcath Systems Board of Directors Authorizes $25 Million Share Repurchase Program

Nov -20

Source: businesswire.com

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Delcath Systems Announces Publication of Real-World Evidence Supporting Early Use of Liver-Directed Therapy with PHP in Achieving Long-Term Survival for Metastatic Uveal Melanoma Patients

Nov -13

Source: businesswire.com

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Delcath: Temporary Headwinds Are No Cause For Concern

Nov -06

Source: seekingalpha.com

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Delcath Systems, Inc. (DCTH) Q3 2025 Earnings Call Transcript

Nov -04

Source: seekingalpha.com

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Delcath Systems, Inc. (DCTH) Q3 Earnings Match Estimates

Nov -04

Source: zacks.com

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Analysts Set Delcath Systems, Inc. (NASDAQ:DCTH) Target Price at $24.00

Oct -31

Source: defenseworld.net

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Delcath Systems, Inc. (DCTH) Discusses CHOPIN Trial Results and Preliminary Q3 Financials Transcript

Oct -20

Source: seekingalpha.com

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Delcath: Large Upside With Limited Downside Risk

Oct -20

Source: seekingalpha.com

4. Business Breakdown

4.a. Revenues by Country

4.b. Revenues by Segment

5. Expected revenues mid-term growth (12.40%)

6. Segments

Hepzato Kit

Expected Growth: 12.4%

Growing incidence of liver cancer, increasing adoption of targeted therapies, and Delcath's Hepzato Kit's ability to deliver high doses of chemotherapy directly to the liver drive market growth.

7. Detailed Products

CHEMOSAT

CHEMOSAT is a hepatic delivery system that allows for the administration of high doses of chemotherapy directly to the liver, while controlling systemic exposure to the chemotherapy agent.

Melphalan/HDS

Melphalan/HDS is a chemotherapeutic agent used in conjunction with CHEMOSAT to treat liver cancer.

GENERIC Melphalan

A generic version of the chemotherapeutic agent melphalan, used to treat various types of cancer.

8. Delcath Systems, Inc.'s Porter Forces

Forces Ranking

Threat Of Substitutes

Delcath Systems, Inc. operates in a niche market with limited substitutes, but the threat of substitutes is still present due to the ongoing development of new technologies.

Bargaining Power Of Customers

Delcath Systems, Inc. has a diverse customer base, which reduces the bargaining power of individual customers. Additionally, the company's products are specialized, making it difficult for customers to switch to alternative suppliers.

Bargaining Power Of Suppliers

Delcath Systems, Inc. relies on a few key suppliers for critical components, which gives these suppliers some bargaining power. However, the company's strong relationships with its suppliers and its ability to negotiate contracts mitigate this risk.

Threat Of New Entrants

The barriers to entry in Delcath Systems, Inc.'s market are relatively high, including significant capital expenditures and regulatory hurdles. This makes it difficult for new entrants to join the market.

Intensity Of Rivalry

Delcath Systems, Inc. operates in a highly competitive market with several established players. The company must continually innovate and improve its products to maintain its market share.

9. SWOT Analysis

Strength

Weaknesses

Opportunities

Threats

10. Capital Structure

10.a. Balance Sheet

10.b. Weighted Average Cost of capital

Value
Debt Weight 39.31%
Debt Cost 6.72%
Equity Weight 60.69%
Equity Cost 6.72%
WACC 6.72%
Leverage 64.78%

11. Quality Control: Delcath Systems, Inc. passed 4 out of 9 key points

12.a Historical Valuation

12.b Price/Earnings Ratio

12.c Margin Valuation

12.d Peers Valuation

Peers Group Analysis

Stock-Card
Radius Health

A-Score: 4.9/10

Value: 6.8

Growth: 3.4

Quality: 1.4

Yield: 5.0

Momentum: 9.0

Volatility: 3.7

1-Year Total Return ->

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NeueHealth

A-Score: 4.8/10

Value: 9.8

Growth: 3.6

Quality: 4.6

Yield: 0.0

Momentum: 7.5

Volatility: 3.7

1-Year Total Return ->

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Ligand Pharmaceuticals

A-Score: 4.8/10

Value: 4.4

Growth: 4.4

Quality: 3.9

Yield: 0.0

Momentum: 10.0

Volatility: 6.0

1-Year Total Return ->

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Stock-Card
Delcath Systems

A-Score: 3.9/10

Value: 1.2

Growth: 5.8

Quality: 6.5

Yield: 0.0

Momentum: 8.0

Volatility: 2.0

1-Year Total Return ->

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Stock-Card
BeyondSpring

A-Score: 3.7/10

Value: 8.3

Growth: 5.8

Quality: 6.7

Yield: 0.0

Momentum: 0.5

Volatility: 0.7

1-Year Total Return ->

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Stock-Card
Accuray

A-Score: 3.6/10

Value: 7.8

Growth: 5.0

Quality: 2.2

Yield: 0.0

Momentum: 4.0

Volatility: 2.7

1-Year Total Return ->

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Peers Metrics

12.e Scoring Insights

12.f DCF BETA

Parameters

Short Term Growth

Short term Time

Long-Term Growth

WACC

Target Price

9.78$

Current Price

9.78$

Potential

-0.00%

Expected Cash-Flows