Delcath Systems Q2 2026 Earnings Call Transcript

Delcath Systems (NASDAQ: DCTH ) reported second-quarter financial results on Thursday. The transcript from the company's second-quarter earnings call has been provided below. APIs provide real-time access to earnings call transcripts and financial data. Visit to learn more.

1 million, reflecting a 30% volume growth versus 2025. The company activated 2 new treatment centers, bringing the total to 31, and plans to reach 37 by year-end, focusing on prominent cancer centers. Delcath raised its full-year revenue guidance to $104-108 million, driven by strong first-half performance and new patient starts. Gross margin improved to 90% in Q2 from 86% a year ago, with a full-year guidance of 86% to 89% due to better overhead absorption and increased volume.

Ongoing clinical trials in liver-dominant cancers show promise, with recruitment improvements in colorectal and breast cancer studies. Management highlighted strategic efforts to mitigate seasonal treatment capacity constraints by training backup teams at high-volume centers. Full Transcript OPERATOR (Operator) Good morning, ladies and gentlemen, and welcome to the Delcath Systems second quarter 2026 earnings conference call. At this time, all lines are in listen-only mode.

Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, August 6, 2026. I would now like to turn the conference over to Mr.

David Hoffman, Delcath General Counsel. Please go ahead, sir. David Hoffman, General Counsel Thank you, and welcome to Delcath Systems' second quarter 2026 earnings call. With me on the call are Gerard Michel, Chief Executive Officer; Sandra Brooks Pennell, Chief Financial Officer; Kevin Muir, Chief Commercial Officer; Vojo Vukovic, Chief Medical Officer; and Martha Rook, Chief Operating Officer.

This statement is made pursuant to the safe harbor for forward-looking statements described in the Private Securities Litigation Reform Act of 1995. Statements made on this call, with the exception of historical facts, may be considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Although the Company believes that expectations and assumptions reflected in these forward-looking statements are reasonable, it makes no assurance that such expectations will prove to have been correct.

Actual results may differ in a material manner from those expressed or implied in forward-looking statements due to various risks and uncertainties. For a discussion of such risks and uncertainties which could cause actual results to differ from those expressed or implied in the forward-looking statements, please see risk factors detailed in the Company's Annual Report on Form 10-K, those contained in filed quarterly reports on Form 10-Q, as well as in other reports that the Company files from time to time with the Securities and Exchange Commission. Any forward-looking statements included in this call are made only as of the date of this call.

We do not undertake any obligation to update or supplement any forward-looking statements to reflect subsequent knowledge, events, or circumstances. A press release with our second quarter 2026 results is available on our website under the Investors section and includes additional details. Our website also has our latest SEC filings, which we encourage you to review. A recording of today's call will be available on our website.

Now I would like to turn the call over to Gerard Michel. Gerard, please proceed. Gerard Michel, Chief Executive Officer Thank you for joining us today. Now well into our third year of commercial launch, we continue to deliver revenue growth and operate as a profitable business, supported by a platform with the potential to address larger patient populations well beyond metastatic uveal melanoma.

2 million in Hepzato Kit revenue, up 21% over the second quarter of 2025, a significant achievement given the introduction of 340B pricing. In July of 2026, we activated 2 new treatment centers, bringing our total to 31, and sustained a healthy flow of new patients into our existing sites. Our commercial execution in metastatic uveal melanoma is now self-funding the investment needed to extend our liver-directed platform into other cancers where the liver is a dominant site of disease. We remain on track to activate approximately six additional centers by year end, which would bring us to 37 active centers.

We are not simply opening more centers; we are opening the right centers. Most of our targets are part of one of two overlapping groups of institutions. The first is National Comprehensive Cancer Network member institutions, or NCCN, an alliance of 30 leading cancer centers that help define oncology standards of care. The second is the National Cancer Institute's comprehensive cancer centers, 58 institutions federally designated for excellence in cancer research, clinical trials, and multidisciplinary patient care.

Today, approximately 80% of our active treatment centers hold NCI Comprehensive designation. Nationally, we are now represented at 41% of the 58 NCI comprehensive cancer centers and approximately half of the 34 NCCN member institutions. Our 2026 activations continued that pattern. This year we added MD Anderson, UT Southwestern, Mayo Clinic Scottsdale, the Knight Cancer Institute at OHSU, and the Herbert Irving Comprehensive Cancer Center at Columbia, all NCI Comprehensive Cancer Centers, with MD Anderson, UT Southwestern, and Mayo Clinic also NCCN member institutions.

These are among the nation's leading referral destinations for complex oncology care and liver-directed therapy. By adding institutions with this level of academic influence and referral reach, we are building a network that supports both near-term growth and long-term leadership in metastatic uveal melanoma and in the additional indications we intend to pursue. Beyond activating new centers, we are focused on increasing physician awareness and consideration of PHP for appropriate patients through targeted medical education, peer-to-peer engagement, and continued evidence generation. 5 new patients per site per month.

Because patients typically receive a series of Hepzato treatments over up to three quarters, second quarter starts generate volume that flows into the back half of the year and support our full-year revenue outlook. The data from the CHOPIN trial, a randomized Phase 2 study published in The Lancet Oncology earlier this year, continues to accelerate broader adoption of combination approaches at leading centers. And at ASCO this year, investigators from MAPA Cancer Center presented a Trials in Progress abstract describing an ongoing Phase 2 study of Hepzato followed by tebentafusp in HLA-A2—positive patients with metastatic uveal melanoma.

We believe this and future planned combination therapy trials will be critical to moving Hepzato more consistently to a co—first-line setting. Turning to clinical development beyond metastatic uveal melanoma, we remain confident in Hepzato Kit's potential in other liver-dominant cancers, and we continue to work with investigators to generate supporting data. At ESMO Breast Cancer in May 2026, independent investigators presented a retrospective analysis of 15 heavily pretreated patients with liver-dominant metastatic breast cancer treated with percutaneous hepatic perfusion.

Nine of the 15 patients showed a hepatic partial response, supporting further evaluation of this approach in that setting. Turning to our sponsored trials: In our sponsored Phase 2 trial in metastatic colorectal cancer, we now have 13 centers actively screening. Consistent with the acceleration we anticipated on our last call, recruitment has improved as we have added sites and applied specialized training and streamlined onboarding. S.

patients annually have liver-dominant disease in the third-line setting. In HER2-negative metastatic breast cancer, we recently dosed the first patient at the European Institute of Oncology in Milan. Six sites are activated and screening, with additional sites in the activation process. We estimate a similar-size addressable population in this indication.

Beyond these two programs, we continue to evaluate additional liver-dominant indications through our scientific advisory board and physician feedback, and we are preparing for pre-IND meetings with the FDA later this year to discuss new potential indications. Based on our first-half results and trends early in the third quarter, we are raising our full-year revenue guidance. Sandra will take you through the numbers and our updated outlook. Sandra Brooks Pennell, Chief Financial Officer Thank you, Gerard.

2 million in the second quarter of 2025. 1 million of Hepzato Kit revenue and $2 million of ChemoSat revenue. This represents 17% sequential Hepzato volume growth over the first quarter and 30% volume growth versus the same period in 2025. Now turning to 2026 guidance, we are increasing our full-year revenue guidance to a range from $104 million to $108 million, which reflects at least a 28% growth in Hepzato Kit volume over 2025.

Our decision to raise guidance is driven primarily by first-half performance, particularly the pace of new patient starts. We've also modestly reduced the seasonal step-down we had assumed for the third and fourth quarters. A part of last year's seasonality came from centers operating with a single REMS-certified treatment team, where staff absences translated directly into lost treatment capacity. We have since worked with centers to train backup teams, including some of our highest-volume sites, which should ease that constraint.

In addition, enrollment in ongoing clinical trials during 2025 reduced the number of patients available for our treatment. Gross margin for the quarter was 90% compared to 86% in the second quarter of 2025. We are guiding to full-year 2026 gross margin between 86% to 89%, and we also expect to report positive adjusted EBITDA for the full year. 9 million in the prior-year quarter, driven primarily by continued investment in our clinical organization and ongoing Phase 2 trials.

4 million in the prior-year quarter, reflecting our investment into continued commercial expansion and increasing marketing activities. 7 million. 8 million in the second quarter of 2025. 9 million.

7 million in the quarter, and we purchased a small amount of common shares in the second quarter under the Company's approved $25 million share buyback program. To date, we have purchased approximately $9 million worth of common shares. I want to thank you all for participating today, and I'll ask the operator to open the lines for Q&A. Thank you.

OPERATOR (Operator) Thank you, ladies and gentlemen. We will now begin the question-and-answer session. If you'd like to ask a question, please press star followed by the number one on your telephone keypad. If your question has been answered and you would like to withdraw from the queue, please press star followed by the number two.

And if you're using a speakerphone, please lift your handset before pressing any keys. One moment, please, while we compile the roster. Your first question comes from Marie Thibault with BTIG. Please go ahead.

Marie Thibault, Analyst at BTIG Hi. Thank you for taking the questions. I wanted to ask a question here just sort of on the referral pathway and some of the efforts I know that you've been making on the commercial side. So, you know, wanted to understand how the referral network efforts have been progressing.

I know you've been working on it for a few quarters. Are there ways to sort of describe the outreach that you've been making to the medical oncologists that is translating into incremental new patient starts? And then second, I'll just ask my follow-up here. I wanted to follow up, I think there was an effort to try to mitigate summer seasonality, get, you know, second treatment teams trained at various centers.

Just an update on how that has been progressing as well. Thanks for taking the questions. Gerard Michel, Chief Executive Officer Sure. Marie, good to hear from you.

In terms of the referral network, I would say about a third of the referral network is a static network, and that is within the institutions we are currently part of. Any oncology networks that are, you know, are part of that. So there, you know, we know who the oncologists are. They have, you know, a meaningful number of patients.

Meaningful could be two, three, four, but on a relatively consistent basis. The other part of the referral network, and probably should be kind of called a just-in-time referral, are the many, many doctors who just get one patient. Now, most of those patients eventually make their way to one of our treating sites or one of our targeted sites that will open in the next one month to two years as we continue to expand. But many of those are not.

And what we have to do is find them in real time if we want to get them first line. If we don't want to lose patients who progress too quickly, our efforts there right now are multifaceted. What's—hearing me? Can everyone hear me?

Marie Thibault, Analyst at BTIG We lost you for a while, Gerard. We lost you for a minute. Gerard Michel, Chief Executive Officer Okay. All right.

So where did I—where did you lose me? The perils of cell phones. Marie Thibault, Analyst at BTIG We were just past kind of talking about those folks that only see one patient. We got a little bit past that.

Gerard Michel, Chief Executive Officer Right. So what we need to do is get a just-in-time network is kind of the term I'm using internally with the team now. Right now we're using claims data that lags, but we generally know patients who've been recently diagnosed—recently could be anywhere from a month to six months given claims lags. And we try to get in front of those doctors a number of different ways.

We'd like to do better than that. We're investigating the use of other forms of data that are refreshed more frequently. That's not in place yet, but we will get it in place. We recognize that we have a higher hill to climb in terms of execution than something like an Immunocore, in that community oncologists can't use our product, but we have a definitive plan.

We are definitely working that right now. So we are actively finding patients who've had a recent biopsy and stuff, and we're working to improve that over time. It is and will be a core part of our strategy. Now, your second question was about training additional docs and centers.

We've had several centers that I think our efforts led to backup teams. And, you know, at least one or more of those are very high-volume centers that it was critical to do that in. I wouldn't say that we have backup teams everywhere we would like to, but a meaningful percentage of our volume now is covered by centers with backup teams. Marie Thibault, Analyst at BTIG Thank you so much.

OPERATOR (Operator) Thank you. Your next question comes from John Newman with Canaccord Genuity. Please go ahead. John Newman, Analyst at Canaccord Genuity Hey guys, thanks for taking my question.

Really nice execution on the quarter. Had a couple of questions here. So I'm curious as to how much of the increased guidance for the year could be related to better uptake—excuse me—due to the CHOPIN data. Also wondering if you can discuss your enrollment expectations for both colorectal and the breast cancer studies.

And I'm wondering with those two studies if you're able to utilize overlap between existing centers that are already using Hepzato for liver mets due to uveal melanoma. Gerard Michel, Chief Executive Officer Thank you. All right, so first part of your question in terms of how much of the increase is from CHOPIN, you know, it's all anecdotal. The data, the claims data, is rather thin for some reason.

Our claims data comes in very slow relative to other treatments. But our anecdotal experience is that more and more of these patients are getting combination therapy, and that's undoubtedly a result of the CHOPIN data. In terms of site recruitment, which I think was your third question, we're not going to give guidance on that. I think the only guidance we're going to give is that we expect an interim readout for colorectal sometime late next year.

And we're not providing guidance on breast, but we are encouraged by both—an uptick of both trials in terms of site activation and enrollment. And there was a second question there. Embarrassed to say I lost it. Could you remind me, John, what it was?

John Newman, Analyst at Canaccord Genuity Sure. Just curious if you're able to utilize existing centers that are using Hepzato in terms of also signing them up for enrollment with breast and colorectal cancer. S. already were, you know, already REMS-activated for mUM.