Delcath Systems, Inc. (DCTH): Business Model Canvas [Dec-2025 Updated]

You're looking at Delcath Systems, Inc. right in the middle of its commercial scale-up, and honestly, understanding the mechanics behind the recent figures is key to assessing the risk. This company is staking its future on the HEPZATO KIT being the only FDA-approved liver-directed therapy for metastatic uveal melanoma, which drove U.S. sales to $19.3 million in Q3 2025 as they target a full-year revenue between $83 million and $85 million. Still, you see the investment required: Q3 Selling, General, and Administrative costs were $10.3 million to expand their direct sales force supporting just 25 active U.S. treatment centers. This canvas lays out exactly how they plan to manage that spend, protect their proprietary Hepatic Delivery System technology, and convert that unique value proposition into sustainable revenue streams; check below for the full strategic breakdown.

Delcath Systems, Inc. (DCTH) - Canvas Business Model: Key Partnerships

You're looking at the core relationships Delcath Systems, Inc. relies on to get its specialized therapy, HEPZATO KIT, to patients. These aren't just vendors; they are critical links in the chain for a complex drug/device combination.

The core product, HEPZATO KIT, is a partnership in itself, being comprised of the chemotherapeutic drug melphalan and Delcath Systems, Inc.'s proprietary Hepatic Delivery System (HDS). The HDS is the device component used to isolate the liver during the percutaneous hepatic perfusion (PHP) procedure. For the European market, the device-only configuration is known as CHEMOSAT Hepatic Delivery System. The company's 2025 full-year financial guidance projects total CHEMOSAT and HEPZATO KIT revenue in the range of $83 million to $85 million, with gross margins expected between 85% to 87%.

The physical delivery of the treatment hinges on a network of specialized medical centers. As of the third quarter ended September 30, 2025, Delcath Systems, Inc. reported having 25 active centers across the U.S.. The company has been actively expanding this footprint, having previously reported 19 active centers in Q1 2025. Management reiterated a target to operate between 26 to 28 active treating centers by the end of 2025, with a goal of reaching 40 centers by the end of 2026.

Clinical validation and platform expansion are driven by collaborations with major research institutions. These academic partnerships are key to broadening the use of PHP technology beyond its initial indication.

• The National Cancer Institute (NCI) remains a partner via a Cooperative Research and Development Agreement (CRADA), which was previously extended for five years in 2007 to collaborate on the joint development and evaluation of the Delcath Systems device.
• In August 2025, the first patient was dosed at City of Hope National Medical Center for the global Phase 2 trial of HEPZATO in combination for liver-dominant metastatic colorectal cancer (mCRC).
• This mCRC study is planned to enroll approximately 90 patients across 20+ sites in the U.S. and Europe.
• Results from the investigator-initiated Phase 2 CHOPIN trial, conducted at Leiden University Medical Center evaluating CHEMOSAT with ipilimumab and nivolumab, were presented at the October 2025 European Society of Medical Oncology Annual Congress.
• A 10-year retrospective study published in Cancers involved 38 consecutive patients treated at Asklepios Hospital Barmbek in Hamburg.

Finally, getting the specialized drug/device product to these centers requires careful handling. Delcath Systems, Inc. depends on third-party logistics providers to manage the specialized drug/device distribution necessary for a product like HEPZATO KIT, ensuring the cold chain and regulatory compliance for shipment to the active treatment centers. Honestly, for a product requiring such specific handling, the logistics chain is almost as important as the clinical training itself.

Finance: draft 13-week cash view by Friday.

Delcath Systems, Inc. (DCTH) - Canvas Business Model: Key Activities

You're looking at the core engine driving Delcath Systems, Inc. right now, which is all about getting the HEPZATO KIT into more treatment centers and proving its value in new settings. The key activities are intensely focused on execution following regulatory milestones.

Commercialization and market penetration of the HEPZATO KIT in the U.S.

This is where the rubber meets the road. You saw strong sequential growth in the middle of the year, though the third quarter showed some expected seasonality and the impact of the new pricing structure. The goal is clearly to scale the number of treating sites, which directly drives revenue.

• U.S. HEPZATO KIT revenue for the third quarter ending September 30, 2025, was $19.3 million.
• This followed a stronger second quarter, with U.S. HEPZATO sales reaching $22.5 million for the quarter ending June 30, 2025.
• The company finished the third quarter with 25 active U.S. centers.
• Management revised the full-year 2025 guidance for operational centers down slightly to 25 to 28 sites by the end of the fourth quarter.
• The expected total revenue for fiscal year 2025, including CHEMOSAT, was tightened to a range of $83 million to $85 million.
• This revenue range reflects an anticipated increase in total HEPZATO treatment volume of approximately 150% over 2024.

Here's the quick math on the revenue trajectory based on the reported quarters versus guidance: Q1 2025 revenue was $19.8 million, Q2 was $24.2 million, and Q3 was $20.6 million. What this estimate hides is the impact of the Medicaid National Drug Rebate Agreement (NDRA), which started in the third quarter and lowered realized revenue per unit but aimed to expand access.

Research and development (R&D) for new oncology indications (e.g., colorectal cancer)

Delcath Systems, Inc. is definitely ramping up R&D spending to move beyond the initial metastatic uveal melanoma (mUM) indication. The focus is clearly on proving the platform utility, especially in colorectal cancer.

• Research and development expenses for the third quarter ending September 30, 2025, were $8.0 million.
• This compares to $6.9 million in the second quarter of 2025 and $3.9 million in the third quarter of 2024.
• The increase is tied to expanding the clinical team and initiating the Phase 2 clinical trial evaluating HEPZATO in combination with standard of care for metastatic colorectal cancer (mCRC).
• The first patient was dosed in the global Phase 2 trial for liver-dominant mCRC during the third quarter of 2025.
• The company also received FDA clearance for an IND application for a Phase 2 trial in liver-dominant metastatic breast cancer.

Manufacturing and supply chain management for the combination product

Managing the supply chain for a drug/device combination product like HEPZATO KIT is a critical, ongoing activity. The focus here is on maintaining high product quality and strong margins as volume increases.

The company is successfully managing cost of goods sold, as evidenced by the gross margin performance.

You'll note that Delcath Systems, Inc. reported having no debt as of September 30, 2025.

Training and certification of interventional oncology teams

This activity is directly reflected in the site activation pace. Getting a new center operational involves training the interventional oncology teams on the procedure and the combination product use.

• The company activated three new U.S. centers in Q1 2025 and two more in Q2 2025, reaching 20 active centers by the end of Q2.
• The total number of active centers reached 25 by the end of Q3 2025.
• Average treatments per center remained steady at approximately two per month across the treating sites in Q2 2025.

Securing and maintaining regulatory approvals (FDA, EU)

While the initial FDA approval for the mUM indication was in August 2023, maintaining compliance and expanding the regulatory footprint are constant activities.

• The HEPZATO KIT first commercial use in the U.S. was in January 2024.
• The company initiated the process to enter the Medicaid National Drug Rebate Agreement (NDRA), expecting it to take effect at the beginning of the third quarter of 2025.
• In the second quarter of 2025, Delcath Systems, Inc. received authorization from European Union and United Kingdom regulatory authorities for the clinical study of Melphalan for Injection/Hepatic Delivery System in patients with refractory metastatic colorectal cancer with liver dominant disease.

Delcath Systems, Inc. (DCTH) - Canvas Business Model: Key Resources

You're looking at the core assets Delcath Systems, Inc. needs to execute its strategy right now, late in 2025. These aren't just line items; they are the engines driving revenue and future potential.

Proprietary Hepatic Delivery System (HDS) Technology

The foundation of Delcath Systems, Inc.'s offering is its proprietary Hepatic Delivery System (HDS). This is the hardware component that makes the treatment unique. The HDS is integral to the HEPZATO KIT, which is a combination drug and device product regulated as a drug by the FDA in the United States. The system's function is to isolate the hepatic venous blood from the systemic circulation during the melphalan infusion and subsequent washout. This allows for loco-regional delivery of a high dose of melphalan, aiming for a meaningful tumor response while minimizing systemic toxicity. In Europe, the device-only configuration is known as the CHEMOSAT Hepatic Delivery System.

FDA Approval for HEPZATO KIT in Metastatic Uveal Melanoma (mUM)

The primary regulatory asset is the U.S. Food and Drug Administration (FDA) approval for HEPZATO KIT. This approval, secured in August 2023, positions the product as the only liver-directed therapy that can treat the whole liver for adult patients with metastatic uveal melanoma (mUM) under specific conditions. Specifically, it is for patients with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or limited extrahepatic disease amenable to resection or radiation. The approved product carries a boxed warning for severe peri-procedural complications, necessitating a Risk Evaluation and Mitigation Strategy (REMS) program that limits availability to qualified facilities.

Cash and Investments of $88.9 million as of September 30, 2025

Financially, the balance sheet provides the runway for current operations and expansion. As of the close of the third quarter on September 30, 2025, Delcath Systems, Inc. reported $88.9 million in cash and investments, with no debt. This capital supports the ongoing commercial rollout and clinical development efforts. Here's a quick look at the financial context from that date:

Intellectual Property Portfolio

Delcath Systems, Inc. maintains a portfolio of intellectual property rights across the world to protect its product and technologies. Filing, prosecuting, and defending these patents globally is a significant, ongoing operational consideration. While the specific current count isn't immediately available, the company's strategy hinges on this protection to prevent competitors from infringing on its methods and devices. The focus is on maintaining the breadth of patent claims to secure a commercial advantage for the HDS technology.

Specialized Commercial and Medical Affairs Teams

The execution of the commercial strategy relies on specialized personnel. The company has been actively expanding these functions, which is reflected in the increase in Selling, General and Administrative expenses. These teams include liver directed therapy managers, clinical specialist representatives, oncology area managers, and medical science liaisons. Their primary role is working directly with cancer centers to secure the necessary training for administering HEPZATO KIT. This network expansion is a tangible measure of the team's reach:

• Active treatment centers across the U.S. as of Q3 2025: 25.
• Commercial team growth noted as a driver for increased SG&A expenses in 2025.
• Medical affairs and clinical team expansion supporting new Phase 2 trials, such as the one for liver-dominant metastatic colorectal cancer.

Finance: draft 13-week cash view by Friday.

Delcath Systems, Inc. (DCTH) - Canvas Business Model: Value Propositions

Delcath Systems, Inc.'s value proposition centers on delivering targeted, high-dose chemotherapy directly to the liver via its proprietary drug/device combination.

Only FDA-approved liver-directed therapy for unresectable hepatic-dominant mUM

The HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

High-dose chemotherapy delivery to the liver with controlled systemic exposure

The proprietary Hepatic Delivery System (HDS) isolates the hepatic venous blood from the systemic circulation while filtering the blood during melphalan infusion and washout. This results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure.

Minimally-invasive, repeatable Percutaneous Hepatic Perfusion (PHP) procedure

The Percutaneous Hepatic Perfusion (PHP) procedure, utilizing the CHEMOSAT Hepatic Delivery System in Europe and the HEPZATO KIT in the US, supports short-stay hospital admissions with discharge within 24 hours. A 10-year single-center experience reported 99 procedures performed on 38 consecutive patients.

Significant improvement in one-year progression-free survival in mUM trials

Clinical data supports improved survival outcomes. A Phase 2 study goal was to increase one-year progression-free survival from 20% in the PHP only arm to 50% in the combination arm. A retrospective analysis showed PHP achieved a progression-free survival of 10.28 months in long-term survivors.

The following table summarizes key clinical outcome data associated with PHP therapy:

Treatment option for patients with limited alternative therapies

The therapy is positioned as a treatment for patients with limited alternatives, and data suggests advantages over other liver-directed therapies, such as reduced risk of hepatic fibrosis compared to radioembolization in whole-liver treatments. In the Tubingen analysis, the majority of long-term survivors (82%) received liver-directed therapy as their first-line treatment in the metastatic setting.

The commercial performance reflects adoption:

• Full Year 2025 Total CHEMOSAT and HEPZATO KIT revenue guidance: $83 million to $85 million.
• Expected total HEPZATO treatment volume increase in 2025 versus 2024: at least 150%.
• Anticipated 2025 Gross Margins: 85% to 87%.
• Q3 2025 Total Revenue: $20.6 million.
• Cash and investments as of September 30, 2025: $88.9 million with no debt.

Delcath Systems, Inc. (DCTH) - Canvas Business Model: Customer Relationships

You're looking at how Delcath Systems, Inc. maintains its connection with the specialized centers and physicians who use the HEPZATO KIT and CHEMOSAT for percutaneous hepatic perfusion (PHP) procedures. This isn't a simple over-the-counter sale; it's a high-stakes, procedural relationship.

High-touch, dedicated field support for complex PHP procedures

The nature of the PHP procedure demands a very hands-on approach from Delcath Systems, Inc. because it requires a team including a trained perfusionist, an anesthesiologist, and an interventional radiologist after the initial assessment period. This complexity means relationship management is tied directly to operational readiness at the hospital level.

The focus on getting centers operational and supporting them is clear in the growth trajectory:

The company is actively working to overcome site activation hurdles, which include perfusion service bottlenecks and administrative barriers, by adapting onboarding processes. This effort directly supports the high-touch requirement for each new customer site.

Direct sales force engagement with interventional oncologists and radiologists

The commercial team's engagement is focused on these key specialists and the institutions they work within. The goal is to drive adoption and utilization within the established network of centers. The increase in Selling, general and administrative expenses reflects this push; SG&A for the quarter ending September 30, 2025, was $10.3 million, up from $7.0 million for the same period in 2024, supporting these commercial expansion activities and additional personnel.

The success of this engagement is reflected in the projected volume growth:

• Total HEPZATO treatment volume in 2025 is projected to increase by nearly 150% versus 2024.
• Total CHEMOSAT and HEPZATO KIT revenue for full year 2025 is guided to be in the range of $83 million to $85 million.

Medical affairs team providing clinical education and data dissemination

Clinical validation is a core part of maintaining relationships with prescribing physicians. The Medical Affairs team supports this by disseminating data from key studies. For instance, compelling positive results from the CHOPIN trial were presented at ESMO, showing a 1-year Progression-Free Survival of 54.7% in the combination group versus 15.8% in the perfusion-only group. Furthermore, a 10-year single-center experience showed a median Overall Survival (OS) of 29.1 months from the first PHP treatment, with procedure-related adverse events graded ≥2 occurring in 10.5% of patients.

Patient support programs for access and reimbursement navigation

Access is a major factor in complex care, and Delcath Systems, Inc. has taken steps to simplify this for eligible hospitals and patients. The company initiated the process of entering into a National Medicaid Drug Rebate Agreement (NDRA) expected to take effect at the beginning of the third quarter of 2025. This is intended to simplify Medicaid access and enable 340B drug pricing for eligible entities. However, management noted that the NDRA discounts pressured the average kit price, leading to an approximate 13% step-down versus Q2 revenue per kit in Q3 2025.

Long-term relationship focus to drive repeat procedures

The relationship isn't transactional; it's built on continued patient response. The feedback from oncologists consistently indicates HEPZATO addresses a significant unmet need. This translates directly into repeat procedures, which is the hallmark of a successful long-term relationship in this space. Patients currently under treatment continue to return at expected rates, averaging 4 treatments per patient.

Delcath Systems, Inc. (DCTH) - Canvas Business Model: Channels

You're looking at how Delcath Systems, Inc. gets its products, HEPZATO KIT and CHEMOSAT, into the hands of specialized oncologists and patients. The channel strategy is clearly focused on a high-touch, direct engagement model in the U.S. for HEPZATO KIT, supported by direct distribution, while maintaining a direct sales approach for the CHEMOSAT device in Europe.

The core of the U.S. channel strategy centers on the network of certified treatment centers administering the HEPZATO KIT procedure. As of the third quarter of 2025, Delcath Systems, Inc. reported having 25 active centers across the U.S.. Management reiterated the goal to reach 26 to 28 active treating centers by the end of 2025, with an eye toward a larger footprint of 40 centers by the end of the following year. This expansion is supported by the commercial team, which is completing the expansion of its footprint from four to six territories within 2025, with plans to grow further to nine regions by Q2 2026.

The direct sales force is tasked with driving adoption within these specialized U.S. cancer centers and hospitals. This direct sales model is necessary because the HEPZATO KIT is a combination drug and device product requiring specialized procedural expertise. The company expects the average monthly treatment rate per site to remain just under two for the remainder of 2025. Furthermore, access for eligible patients is being streamlined through the HEPZATO KIT Access 360 platform, which aims to reduce out-of-pocket costs.

Distribution for the HEPZATO KIT is direct to these certified hospital pharmacies, as it is regulated and approved for sale as a drug by the FDA in the United States. This ensures control over the supply chain for the complex product. The company also utilizes clinical trial sites as a channel for future indication development, which broadens the potential reach of the technology platform.

The company is actively using clinical trial sites to expand its channel for new indications. For the global Phase 2 trial of HEPZATO in liver-dominant metastatic colorectal cancer, patient enrollment began in August 2025. This study will enroll approximately 90 patients across 20+ sites in the U.S. and Europe. Additionally, company-sponsored Phase II trials for metastatic breast cancer have FDA clearance, with patient enrollment targeted for the first quarter of 2026.

European sales channels focus on the CHEMOSAT device-only product, which operates under a direct sales and marketing model. Revenue from CHEMOSAT in the third quarter of 2025 was reported at $1.3 million. This compares to $1.8 million in the first quarter of 2025 and $1.7 million in the second quarter of 2025. The growth in Europe is heavily influenced by penetration in Germany, where PHP has consistent reimbursement.

Here is a summary of the key channel metrics as of late 2025:

The direct distribution model for the HEPZATO KIT is critical for maintaining the integrity of the loco-regional delivery process. The company's ability to expand its commercial footprint directly correlates with the activation of new sites, which saw a return to a steadier pace with 4 new sites activated in the two months leading up to the Q3 2025 report.

The European channel, while smaller in revenue contribution, is vital for the CHEMOSAT device. The recent publication of a 10-year retrospective study from a high-volume center in Hamburg, Germany, provides strong clinical evidence that can be used by the direct sales team to drive adoption in other European centers, especially where reimbursement is being sought.

• Direct sales force focused on specialized U.S. centers for HEPZATO KIT.
• Network of 25 active U.S. treatment centers as of September 30, 2025.
• Targeting 26 to 28 active centers by the close of 2025.
• Clinical trial sites supporting new indications, including a CRC trial with enrollment across 20+ sites.
• Direct distribution of the HEPZATO KIT to certified hospital pharmacies.
• European sales of the CHEMOSAT device-only product, generating $1.3 million in Q3 2025 revenue.

Finance: draft 13-week cash view by Friday.

Delcath Systems, Inc. (DCTH) - Canvas Business Model: Customer Segments

You're looking at the core groups Delcath Systems, Inc. (DCTH) serves with its liver-directed therapies like HEPZATO KIT and CHEMOSAT. It's a focused, high-acuity set of customers, which is key to understanding their revenue drivers.

Adult patients with unresectable hepatic-dominant metastatic uveal melanoma (mUM)

This is the primary, FDA-approved segment for HEPZATO KIT in the U.S. The target patient has unresectable hepatic metastases affecting less than 50% of the liver and limited extrahepatic disease, or disease amenable to resection/radiation. Delcath Systems, Inc. is focused on this niche, which sees approximately 1,700 patients annually diagnosed in the U.S..

Clinical data supports the value proposition for this group. A 10-year retrospective study reported a median Overall Survival (OS) of 29.1 months from the first Percutaneous Hepatic Perfusion (PHP) treatment for mUM patients. Furthermore, patients receiving ≥3 PHP cycles showed a numerically improved median OS of 29.8 months versus 21.4 months for those receiving ≤2 cycles.

Interventional oncologists and radiologists performing PHP procedures

These are the specialists who actually administer the treatment using the proprietary systems. Their segment is defined by their capability and willingness to adopt the high-dose, liver-directed therapy. Feedback from treating physicians has been positive, increasing confidence in long-term growth prospects.

The safety profile from a high-volume center study showed procedure-related adverse events graded ≥2 occurring in 10.5% of patients, with no treatment-related deaths. This safety data is critical for physician adoption.

U.S. and European hospitals/cancer centers with interventional oncology capabilities

Center activation is a major driver for Delcath Systems, Inc. As of the second quarter of 2025, the company had 20 active U.S. centers, with an additional 10 centers accepting referrals. By the third quarter of 2025, this grew to 25 active centers across the U.S.. The company's 2025 guidance anticipated total HEPZATO treatment volume to increase at least 200% versus 2024, based on current center activation rates.

For European expansion, a global Phase 2 trial for metastatic colorectal cancer will enroll approximately 90 patients across 20+ sites in the U.S. and Europe.

Government payers (e.g., Medicaid) and private insurance companies

Payer access is crucial for patient volume. Delcath Systems, Inc. initiated the process of entering into a Medicaid National Drug Rebate Agreement (NDRA) with the Centers for Medicare and Medicaid Services, expecting it to take effect at the beginning of the third quarter of 2025. This move is intended to simplify Medicaid access and enable eligible hospitals to access 340B drug pricing, accelerating adoption. The preliminary Q3 2025 revenue of approximately $20.5 million was noted as being modestly lower than Q2 due to the NDRA discounts and seasonality.

Patients with other liver-dominant metastatic cancers in clinical trials

This segment represents the near-term growth pipeline beyond the initial mUM indication. Delcath Systems, Inc. is actively pursuing expansion indications.

• Phase 2 trial for liver-dominant metastatic colorectal cancer enrolling approximately 90 patients across 20+ sites in the U.S. and Europe.
• Phase 2 clinical trial for liver-dominant metastatic breast cancer, for which the company secured FDA clearance for an Investigational New Drug (IND) application.

Here's a quick look at the financial context surrounding these customer segments as of late 2025:

The company expects positive adjusted EBITDA and cashflow in each quarter of 2025, which shows they are managing the commercial expansion costs well. Finance: draft 13-week cash view by Friday.

Delcath Systems, Inc. (DCTH) - Canvas Business Model: Cost Structure

You're looking at the expenses Delcath Systems, Inc. incurs to bring its combination drug/device products, like the HEPZATO KIT, to market and expand its reach. For a company scaling commercial operations and advancing its pipeline, these costs are significant and directly tied to growth initiatives.

The third quarter of 2025 showed a clear ramp-up in operating expenses as Delcath Systems pushed forward on multiple fronts. We can map out the major cost drivers from the preliminary Q3 2025 results.

High R&D expenses, totaling $8.0 million in Q3 2025, for clinical expansion. This nearly doubled R&D spend compared to the $3.9 million reported in Q3 2024. Honestly, this jump signals a heavy investment in future revenue streams.

Selling, General, and Administrative (SG&A) costs for commercial team expansion, at $10.3 million in Q3 2025. This $3.3 million increase over Q3 2024's $7.0 million is the cost of building out the sales and support infrastructure necessary to drive the expected 150% increase in treatment volume for fiscal year 2025.

The R&D increase is directly tied to pipeline advancement. Here's what that spending is supporting:

• Initiation of Phase 2 clinical trial evaluating HEPZATO in combination with standard of care for metastatic colorectal cancer.
• Initiation of Phase 2 clinical trial in metastatic breast cancer.
• Costs associated with expanding the clinical team, including share-based compensation expense.

Costs associated with the Medicaid National Drug Rebate Agreement (NDRA) discounts. While a specific dollar figure for the discount cost isn't itemized here, CEO Gerard Michel noted that the Q3 revenue was 'modestly lower than the second quarter' primarily due to these NDRA discounts, which began taking effect around the start of Q3 2025, alongside summer seasonality.

Manufacturing and supply chain costs for the combination drug/device product. Specific line-item costs for manufacturing aren't broken out in the preliminary release, but successful management of the HEPZATO KIT supply chain is cited as a key factor in achieving the projected gross margins. Delcath Systems forecasts quarterly gross margins to remain between 85% to 87% for the full year 2025, which suggests relatively controlled Cost of Goods Sold (COGS) relative to revenue.

The company is aiming for strong profitability on the product itself, targeting gross margins of 85% to 87% for the full year 2025, while simultaneously incurring high operating expenses to support commercial and clinical growth. Finance: draft 13-week cash view by Friday.

Delcath Systems, Inc. (DCTH) - Canvas Business Model: Revenue Streams

You're looking at the core engine driving Delcath Systems, Inc.'s financial performance right now, which is heavily concentrated on product sales from its liver-directed cancer treatments. The revenue streams are clearly delineated between the U.S. market product and the European device sales.

For the third quarter ended September 30, 2025, the total revenue hit approximately $20.5 million. This revenue is split between the two primary offerings, which you can see broken down here:

That $19.2 million from the HEPZATO KIT in the U.S. is the lion's share of the current top line. Anyway, the company has set its sights high for the full year, updating its 2025 full-year revenue guidance to a range of $83 million to $85 million. This projection reflects what management sees as an impressive 150% increase in treatment volume compared to 2024.

Profitability on these sales looks strong, too. Delcath Systems projects quarterly gross margins to remain stable within the range of 85% to 87% for 2025. For the third quarter specifically, the expected gross margin was reported at 87%.

The underlying mechanism supporting these sales involves securing payment for the procedures themselves. This means a significant portion of revenue is derived from procedures reimbursed by payers, which is a critical component of the revenue cycle.

• Revenue from procedures reimbursed by government payers.
• Revenue from procedures reimbursed by private payers.
• Specific reimbursement mechanisms, such as the established J-Code reimbursement pathway in the U.S.
• The company also reported a positive adjusted EBITDA of $5.3 million for Q3 2025.

To be fair, the Q3 revenue of $20.5 million was slightly below some expectations, attributed to NDRA discounts and summer seasonality affecting patient scheduling. Still, the underlying unit economics, evidenced by those high gross margins, are what you want to watch.