Delcath Systems, Inc. (DCTH): History, Ownership, Mission, How It Works & Makes Money

Are you intrigued by companies that are revolutionizing cancer treatment? Delcath Systems, Inc. (DCTH) is an interventional oncology firm focused on tackling primary and metastatic liver cancers with innovative approaches. With $37.2 million in revenue for 2024 and a groundbreaking drug-device combination, is Delcath Systems poised to redefine cancer care? Keep reading to explore its history, ownership, mission, how it operates, and how it generates revenue.

Delcath Systems, Inc. (DCTH) History

Delcath Systems, Inc. Founding Timeline

Year established

The company was originally incorporated in 1989.

Original location

The original location is not explicitly mentioned in the provided context.

Founding team members

Specific details regarding the founding team members are not available in the provided context.

Initial capital/funding

Information about the initial capital or funding is not available in the provided context.

Delcath Systems, Inc. Evolution Milestones

Delcath Systems, Inc. Transformative Moments

• FDA Approval of HEPZATO KIT (2013): The approval of HEPZATO KIT was a transformative moment, shifting the company from a development-stage entity to a commercial enterprise. This approval validated their technology and opened up a revenue stream.
• Focus on Hepatic Delivery System (HDS): A key strategic decision was the focus on developing and refining the Hepatic Delivery System. This technology targets liver tumors directly, reducing systemic toxicity and improving patient outcomes.
• European Expansion: The approval and subsequent commercialization efforts in Europe represent a significant expansion of the company's market reach. This move diversifies revenue streams and reduces reliance on the U.S. market.
• Partnerships and Agreements: Strategic partnerships, such as the distribution agreement with Clinigen Limited, have been crucial for expanding the market reach and commercializing HEPZATO KIT in regions beyond the United States.
• Focus on Metastatic Uveal Melanoma (mUM): Concentrating on treating mUM, a rare and aggressive form of cancer, has allowed to address an unmet medical need and obtain regulatory approvals and orphan drug designations, which provide market exclusivity and other benefits.

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Delcath Systems, Inc. (DCTH) Ownership Structure

Delcath Systems, Inc. operates as a publicly traded company, with its ownership distributed among various institutional and retail investors.

Delcath Systems, Inc.'s Current Status

Delcath Systems, Inc. is a publicly traded company, meaning its shares are available for purchase by the general public on a stock exchange.

Delcath Systems, Inc.'s Ownership Breakdown

The ownership of Delcath Systems, Inc. is distributed among a mix of institutional investors, individual shareholders, and company insiders. As of the fiscal year 2024, the ownership breakdown is as follows:

Delcath Systems, Inc.'s Leadership

The leadership team of Delcath Systems, Inc. is responsible for guiding the company's strategic direction and overseeing its operations. Key members of the leadership team as of April 2025 include:

• Gerard Michel: Chief Executive Officer
• Robert B. Salmon: Chief Medical Officer
• Kyle O'Neill: Chief Financial Officer

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Delcath Systems, Inc. (DCTH) Mission and Values

Delcath Systems, Inc. focuses on developing innovative, targeted medical treatments, particularly for cancers affecting the liver. The company is dedicated to improving patient outcomes through advanced regional therapies.

Delcath Systems, Inc. Core Purpose

Official mission statement

Delcath Systems' mission is to improve the survival and quality of life of patients suffering from cancers of the liver. This is achieved through the development and commercialization of innovative, targeted therapies that deliver high doses of chemotherapy directly to the liver while minimizing systemic exposure and toxicity.

• Focus on targeted cancer therapies: Delcath is committed to developing treatments that specifically target liver cancers, aiming to maximize effectiveness while reducing harm to healthy tissues.
• Improving patient outcomes: The company's primary goal is to extend the lives and enhance the quality of life for individuals diagnosed with liver cancers.
• Innovative approaches: Delcath emphasizes the use of advanced technologies and methods to deliver chemotherapy directly to the liver, ensuring high concentrations of the drug at the tumor site.

Vision statement

While a specific, formal vision statement may not be explicitly publicized, Delcath Systems' vision can be inferred from its strategic goals and activities. The implied vision is to become a leading provider of regional cancer therapies, recognized for its innovative treatments and commitment to patient care.

• Leadership in regional cancer therapy: Delcath aims to be at the forefront of developing and delivering treatments that target specific regions affected by cancer, starting with the liver.
• Recognition for innovation: The company seeks to be known for its pioneering work in developing and commercializing advanced cancer therapies.
• Commitment to patient care: Delcath is dedicated to improving the lives of patients through effective treatments and supportive care.

Company slogan/tagline

Delcath Systems does not have a widely publicized official slogan or tagline. However, considering their focus and mission, a fitting tagline might emphasize their targeted approach and dedication to improving patient outcomes. An example of a tagline that reflects these values could be:

Targeted Therapies, Improved Lives.

This tagline encapsulates the company's commitment to:

• Precision in treatment: Highlighting the targeted nature of their therapies.
• Positive impact: Emphasizing the goal of enhancing the quality of life for patients.

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Delcath Systems, Inc. (DCTH) How It Works

Delcath Systems, Inc. is a specialty pharmaceutical company focused on oncology, utilizing its proprietary chemosaturation system to administer high-dose chemotherapy directly to the affected organ while managing systemic toxicity.

Delcath Systems' Product/Service Portfolio

Delcath Systems' Operational Framework

Delcath Systems operates through a focused approach centered on its CHEMOSAT® system. Key aspects of their operational framework include:

• Patient Identification and Treatment Planning: Identifying suitable candidates with unresectable hepatic metastases from ocular melanoma, followed by detailed treatment planning.
• CHEMOSAT® Procedure: Performing the percutaneous hepatic perfusion procedure, which involves isolating the liver's circulation, delivering high-dose chemotherapy (melphalan), and filtering the blood before returning it to the patient's systemic circulation.
• Clinical Monitoring and Follow-Up: Closely monitoring patients during and after the procedure to manage any potential complications and assess treatment response.

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Delcath Systems' Strategic Advantages

Delcath Systems' strategic advantages stem primarily from its innovative technology and market positioning:

• Proprietary Technology: The CHEMOSAT® system is a patented technology, providing a unique approach to treating liver metastases by delivering targeted, high-dose chemotherapy.
• Niche Market Focus: Concentrating on rare conditions like hepatic metastases from ocular melanoma allows Delcath to address unmet medical needs.
• Orphan Drug Designation: CHEMOSAT® has received orphan drug designation for certain indications, which provides market exclusivity and other regulatory benefits.

Delcath Systems, Inc. (DCTH) How It Makes Money

Delcath Systems, Inc. generates revenue primarily through the sale of its proprietary product, HEPZATO KIT, which is used in the treatment of adult patients with unresectable hepatic-dominant metastatic uveal melanoma (mUM), a rare form of cancer that has spread to the liver, and through associated treatment services.

Delcath Systems, Inc. Revenue Breakdown

Delcath Systems, Inc. Business Economics

Delcath Systems' business economics are centered around the production, distribution, and sale of the HEPZATO KIT. Here are key aspects of their business model:

• Pricing Strategy: The pricing of HEPZATO KIT reflects its status as a specialty pharmaceutical product targeting a rare and aggressive form of cancer. The cost includes not only the drug itself but also the specialized delivery system and associated treatment protocols.
• Cost of Goods Sold (COGS): COGS includes the expenses associated with manufacturing HEPZATO KIT, such as raw materials, production, and quality control.
• Operating Expenses: These encompass selling, general, and administrative costs, research and development, and other overheads required to support the commercialization and ongoing development of HEPZATO KIT.
• Market Dynamics: As a company focused on a niche market (metastatic uveal melanoma), Delcath's economic success is heavily influenced by its ability to penetrate this market, secure favorable reimbursement policies, and demonstrate the clinical and economic value of HEPZATO KIT.

Delcath Systems, Inc. Financial Performance

Delcath Systems' financial performance can be assessed through several key metrics:

• Revenue Growth: The company's revenue is primarily driven by sales of HEPZATO KIT.
• Gross Margin: The gross margin, which is gross profit divided by revenue, reflects the profitability of HEPZATO KIT sales after deducting the cost of goods sold.
• Operating Expenses: Monitoring operating expenses as a percentage of revenue is crucial. Efficient management of these expenses can lead to improved profitability.
• Net Income/Loss: The bottom line indicates whether Delcath is generating a profit or incurring a loss.
• Cash Flow: Analyzing cash flow from operations, investing, and financing activities provides insights into the company's liquidity and financial stability.
• R&D Investments: Continued investment in research and development is vital for expanding the applications of HEPZATO KIT and exploring new therapies.

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Delcath Systems, Inc. (DCTH) Market Position & Future Outlook

Delcath Systems is focused on fighting liver cancer with its innovative CHEMOSAT® delivery system, which has carved out a specific niche in treating patients with hepatic dominant tumors. As of April 2025, the company's future outlook hinges on expanding the use of CHEMOSAT® and navigating the complexities of regulatory approvals and market acceptance.

Competitive Landscape

The competitive landscape for Delcath Systems involves a mix of traditional chemotherapy approaches, other drug-delivery systems, and emerging therapies like immunotherapy. Here's a snapshot of how Delcath stacks up against key competitors:

Opportunities & Challenges

Delcath Systems faces both opportunities and challenges that will shape its trajectory in the oncology space:

Industry Position

Delcath Systems holds a unique position within the oncology market due to its CHEMOSAT® system. Key aspects of its industry standing include:

• Niche Market: Delcath operates in a niche segment focusing on liver-directed therapies, specifically for metastatic ocular melanoma.
• Technological Edge: The CHEMOSAT® system provides a unique method of delivering chemotherapy directly to the liver while minimizing systemic exposure.
• Growth Potential: The company's growth depends on expanding the use of CHEMOSAT® to other indications and geographies, as well as successful commercialization efforts.

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