Delcath Systems Inc 2026 Q2 Earnings Call

Welcome to Delcath Systems' second quarter 2026 earnings call. With me on the call are Gerard Michel, Chief Executive Officer; Sandra Pennell, Chief Financial Officer; Kevin Muir, Chief Commercial Officer; Bojo 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. 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. 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. We delivered a strong second quarter, driven by $27.2 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 2025. We activated two 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 34 leading cancer centers that help define oncology standards of care. The second is the National Cancer Institute's Comprehensive Care 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 care 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 OHSU Knight Cancer Institute, 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. New patient starts remained solid in the second quarter, averaging approximately 0.5 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 II study published in "The Lancet Oncology" earlier this year, continues to accelerate broader adoption of combination approaches at leading centers. At ASCO this year, investigators from Moffitt Cancer Center presented a trials in progress abstract describing an ongoing phase II 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, 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 II 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. We estimate that approximately 6,000 to 10,000 U.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 in screening with additional sites in the activation process. We estimate a similar-sized 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. 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? Thank you, Gerard. Total revenue in the second quarter of 2026 was $29.1 million, compared with $24.2 million in the second quarter of 2025.

This includes $27.1 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. Turning to 2026 guidance, we are increasing our full-year revenue guidance to range from $104 million-$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. 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%-89%, we also expect to report positive adjusted EBITDA for the full year. Research and development expense in the second quarter was $10.4 million, compared to $6.9 million in the prior year quarter, driven primarily by continued investment in our clinical organization and ongoing phase II trials.