Q4 2025 Delcath Systems Inc Earnings Call

February 26, 2026

Operator: Greetings, welcome to Delcath Systems' Q4 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. It is now my pleasure to turn the conference over to Mr. David Hoffman, Delcath's General Counsel. Thank you. You may begin.

Speaker #3: If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. It is now my pleasure to turn the conference over to Mr. David Hoffman, DELCATH's general counsel.

Speaker #3: Thank you. You may begin.

Speaker #2: Thank you. And welcome to DELCATH SYSTEMS, fourth quarter and year-end 2025 earnings call. With me on the call are Gerard Michele, chief executive officer; Sandra Pennell, chief financial officer; Kevin Muir, general manager interventional oncology; Voyo Vukovic, chief medical officer; and Martha Rook, chief operating officer.

David Hoffman: Thank you, welcome to Delcath Systems' Q4 and year-end 2025 Earnings Call. With me on the call are Gerard Michel, Chief Executive Officer; Sandra Pennell, Chief Financial Officer; Kevin Muir, General Manager, Interventional Oncology; 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. All 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.

Speaker #2: This statement is made pursuant to the Safe Harbor for Forward-Looking Statements described in the Private Securities Litigation Reform Act of 1995. All statements made on this call with the exception of historical facts may be considered forward-looking statements within the meaning of Section 27(a) of the Securities Act of 1933 and Section 21(e) of the Securities Exchange Act of 1934.

Speaker #2: 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.

Speaker #2: Actual results may differ in a material manner from those expressed or implied in forward-looking statements due to various risk and uncertainties. For discussion of such risk 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.

David Hoffman: 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.

Speaker #2: 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.

Speaker #2: 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 our press release with our 2025 results is available on our website under the investor section.

David Hoffman: Our press release with our 2025 results is available on our website under the investor section and includes additional details about our financial results. 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.

Speaker #2: It includes additional details about our financial results. 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.

Speaker #2: Now, I would like to turn the call over to Gerard Michele. Gerard, please proceed.

Speaker #3: Thanks, David. 2025 was a pivotal year, delivering over 40% volume growth and record revenue of $85.2 million. Including 20.7 million in the fourth quarter alone, today we operate 28 active treatment centers and the highly anticipated Chopin data demonstrating clear clinical benefit when PHP is seeking for checkpoint inhibitors is slated for publication.

Gerard Michel: Thanks, David. 2025 was a pivotal year, delivering over 40% volume growth and record revenue of $85.2 million, including $20.7 million in the Q4 alone. Today, we operate 28 active treatment centers, and the highly anticipated CHOPIN data, demonstrating clear clinical benefit when PHP is sequenced with checkpoint inhibitors, is slated for publication. Entering our third year of launch with strong momentum, we are confident that continued site activations, commercial expansion, and the CHOPIN results will drive meaningful revenue acceleration and create substantial shareholder value. 2025 was a pivotal year in which we achieved over 40% volume growth and achieved record annual revenue of $85.2 million. We currently have... Excuse me for that. A little bit of a glitch on the screen here.

Speaker #3: Entering our third year of launch with strong momentum, we are confident that continued site activations, commercial expansion, and the Chopin results will drive meaningful revenue acceleration and create substantial shareholder value.

Speaker #3: 2025 was a pivotal year. In which we achieved over 40% volume growth and achieved record annual revenue of $85.2 million. We currently have—excuse me for that—a little bit of a glitch on the screen here.

Speaker #3: We have organized our commercial strategy around three priorities: expanding site capacity, changing prescribing patterns, and building referral networks. We track our progress against these priorities through three internal KPIs: the number of site activations, the rate of new patient starts per site per month, and the average number of treatments per patient.

Gerard Michel: We have organized our commercial strategy around 3 priorities: expanding site capacity, changing prescribing patterns, and building referral networks. We track our progress against these priorities through 3 internal KPIs: the number of site activations, the rate of new patient starts per site per month, and the average number of treatments per patient. We use these KPIs internally to model our projections and set guidance. The latter KPI, treatment number per patient, has remained consistent at approximately 4 cycles per patient since launch. The first two KPIs have shown significant variability as expected in the launch phase of any product, especially when treating an ultra-orphan patient population, where small changes in patient numbers can have a large impact. Despite this variability, we are very encouraged by the trends we are seeing.

Speaker #3: We use these KPIs internally to model our projections and set guidance. The latter KPI, treatment number per patient, has remained consistent at approximately four cycles per patient since launch.

Speaker #3: The first two KPIs have in the launch phase of any product. Especially when treating an ultra-orphan patient population, where small changes in patient numbers can have a large impact.

Speaker #3: Despite this we are seeing. The first strategic priority, expanding site capacity, is a function of the number of active sites and the volume of patients our sites can treat.

Gerard Michel: The first strategic priority, expanding site capacity, is a function of the number of active sites and the volume of patients our sites can treat. We had a strong surge in activations early this year, bringing three new sites online, specifically MD Anderson, UT Southwestern, and Mayo Clinic Scottsdale. We now have 28 Risk Evaluation Mitigation Strategy, REMS, certified treatment sites. Leading cancer centers continue to engage, and we are targeting 40 active treatment centers by the end of 2026. The pace of activations will likely be variable. Given the planned timing of the salesforce expansion, as well as the anticipated increase in interest and support following the pending publication of CHOPIN results, we expect more activations to occur in the second half of 2026 compared to the first half. The expansion of US commercial team divides the country into nine regions.

Speaker #3: We had a strong surge in activations early this year, bringing three new sites online. Specifically, MD Anderson, UT Southwestern, and Mayo Clinic Scottsdale. We now have 28 risk evaluation and mitigation strategy REMs certified treatment sites.

Speaker #3: Leading cancer centers continue to engage and we are targeting 40 active treatment centers by the end of 2026. The pace of activations will likely be variable.

Speaker #3: Given the planned timing of the Salesforce expansion, as well as the anticipated increase in interest and support following dependent publication of Chopin results, we expect more activations to occur in the second half of 2026 compared to the first half.

Speaker #3: The expansion of US commercial team divides the country into nine regions. Consistent with our current structure, each region will be staffed with a liver-directed therapy manager, an oncology manager, and a clinical specialist.

Gerard Michel: Consistent with our current structure, each region will be staffed with a liver-directed therapy manager, an oncology manager, and a clinical specialist. This structure allows us to maintain a steady pace of site onboarding while also servicing our existing accounts. In addition to the expanded commercial team, we have revamped our medical affairs team with both new leadership and a new team of MSLs. Total site capacity is a function of open sites and the total number of patients a center can treat. Our 2026% projections regarding total site capacity, which can vary by month, assumes a similar summer seasonality pattern that we experienced last year. Seasonality is partially driven by the small number of REMS-certified team members at a treating site. For instance, when key personnel take vacations, sites cannot easily add new patients.

Speaker #3: This structure allows us to maintain a steady pace of site onboarding while also servicing our existing accounts. In addition to the expanded commercial team, we have revamped our medical affairs team with both new leadership and a new team of MSLs.

Speaker #3: Total site capacity is a function of open sites and the total number of patients a center can treat. Our 2026 projections regarding total site capacity—which can vary by month—assume a similar summer seasonality pattern that we experienced last year.

Speaker #3: Seasonality is partially driven by the small number of REM-certified team members at a treating site. For instance, when key personnel take vacation, sites cannot easily add new patients.

Speaker #3: While we are working to minimize these seasonality by increasing bench strength, we anticipate some seasonal loss of capacity in the late summer. Our second strategic priority is changing prescribing patterns that expand the set of patients our treating oncologists consider appropriate for PHP.

Gerard Michel: While we are working to minimize the seasonality by increasing bench strength, we anticipate some seasonal loss of capacity in the late summer. Our second strategic priority is changing prescribing patterns by expanding the set of patients our treating oncologists consider appropriate for PHP. We are off to a strong start in 2026, having treated new patients per site per month at a rate of approximately 0.75 for the first 2 months of 2026. Similar to the pace we saw in the Q1 of 2025. For context, for the full year in 2025, the average rate was 0.5 new patients per site per month, with significant seasonality. For those modeling projections, keep in mind, new patient starts impact revenue for the next 3 quarters.

Speaker #3: We are off to a strong start in 2026, having treated new patients per site per month at a rate of approximately 0.75 for the first two months of 2026.

Speaker #3: Similar to the pace we saw in the first quarter of 2025, for context, for the full year in 2025, the average rate was 0.5 new patients per site per month, with significant seasonality.

Speaker #3: For those modeling projections, keep in mind new patient starts impact revenue for the next three quarters. The expansion of both the commercial and medical field forces previously mentioned will also support our efforts to ensure all treating professionals are properly educated about hepatitis kit, and thus can appropriately consider its usage.

Gerard Michel: The expansion of both the commercial and medical field force, as previously mentioned, will also support our efforts to ensure all treating professionals are properly educated about HEPZATO KIT, and thus can appropriately consider its usage. Oncologist feedback remains positive, with PHP clearly addressing a significant unmet need in liver metastases from uveal melanoma. Recent 2025 publications and real-world evidence have reinforced the value of early and effective limited directed therapy. In a recent uveal melanoma webinar hosted by A Cure In Sight, several of our strongest HEPZATO advocates highlighted that initiating PHP treatment earlier in the disease course can meaningfully improve outcomes by reducing tumor burden, and that combining HEPZATO with systemic therapies can further enhance effectiveness. We expect increasing impact from the CHOPIN Phase II data.

Speaker #3: Oncologist feedback remains positive, with PHP clearly addressing a significant unmet need in liver metastases from UV melanoma. Recent 2025 publications and real-world evidence have reinforced the value of early and effective liver-directed therapy.

Speaker #3: In a recent UV melanoma webinar, hosted by Acure Insight, several of our strongest hepatitis advocates highlighted that initiating PHP treatment early in the earlier in the disease course can meaningfully improve outcomes by reducing tumor burden, and that combining hepatitis with systemic therapies can further enhance effectiveness.

Speaker #3: We expect increasing impact from the Chopin phase two data. As a reminder, this investigator initiated trials showed that sequencing PHP with ipilimumab and nivolimumab delivers statistically significant and clinically meaningful improvements one year progression-free survival, overall survival, and objective response rates versus PHP alone.

Gerard Michel: As a reminder, this investigator-initiated trial showed that sequencing PHP with ipilimumab, nivolumab, delivers statistically significant and clinically meaningful improvements in one-year progression-free survival, overall survival, and objective response rates versus PHP alone, all within a very short 10-week treatment window. The ability to quickly initiate this combination therapy addresses concerns about delaying systemic therapy. The combination itself addresses concerns regarding treating patients with extrahepatic disease. Leading centers at UCL, such as UCLA, Massachusetts General Hospital, are already adopting CHOPIN-inspired protocols, including flexible sequencing and combination use with agents like dabrafenib in eligible patients. These data are helping both to establish HEPZATO as a preferred first-line liver-directed option and to expand the patient populations our treating oncologists are comfortable referring for PHP treatment.

Speaker #3: All within a very short 10-week treatment window. The ability to quickly initiate this combination therapy addresses concerns about delaying systemic therapy. And the combination itself addresses concerns regarding treating patients with extrahepatic disease.

Speaker #3: Leading centers at UCL, such as UCLA, Massachusetts General Hospital, are already adopting Chopin-inspired protocols. Including Flexible sequencing and combination use with agents like terbentavust in eligible patients.

Speaker #3: These data are helping both to establish hepatitis as a preferred first-line liver-directed option and to expand the patient population our treating oncologists are comfortable referring for PHP treatment.

Speaker #3: We are also actively engaging key opinion leaders to support potential updates to the NCCN guidelines for metastatic UV melanoma, a, following publication of the Chopin data, with the goal of further highlighting the established role of hepatitis kit in this disease.

Gerard Michel: We are also actively engaging key opinion leaders to support potential updates to the NCCN guidelines for metastatic uveal melanoma, following publication of the CHOPIN data, with the goal of further highlighting the established role of HEPZATO KIT in this disease. Our third strategic priority, developing referral patterns, is critical to ensure eligible patients are identified and efficiently referred to one of our treating centers. The majority of patients with uveal melanoma are initially diagnosed with metastatic disease and manage a community or non-PHP institutions, making early referral a critical lever for both patient capture and better outcomes. To address this systematically, we are currently leveraging a variety of data sources to identify oncologists who have a patient who has very recently been diagnosed with metastatic disease before treatment decisions are locked in.

Speaker #3: Our third strategic priority: developing referral patterns is critical to ensure eligible patients are identified and efficiently referred to one of our treating centers. The majority of patients with UV melanoma are initially diagnosed with metastatic disease and managed at community or non-PHP institutions.

Speaker #3: Making early referral a critical lever for both patient capture and better outcomes. To address this systematically, we are currently leveraging a variety of data sources to identify oncologists who have a patient who has very recently been diagnosed with metastatic disease.

Speaker #3: Before treatment decisions are locked in. Our oncology managers then engage those physicians to provide education on treatment options and the locations of our treating centers.

Gerard Michel: Our oncology managers engage those physicians to provide education on treatment options and the locations of our treating centers. The expansion of both the commercial and medical field forces will also support this third strategic priority, the development of referral networks to our treating centers. We believe this upstream approach is already producing results. Strengthen these referral networks across the country is a top priority and will be a meaningful driver of new patients per site going forward. Collectively, these three priorities and the underlying KPIs support the 2026 guidance Sandra will share shortly. We are confident that consistent execution in expanding site capacity, higher utilization at existing centers, and the active referral development will deliver continued long-term growth. I will now turn to an update in our clinical development programs.

Speaker #3: Again, the expansion of both the commercial and medical field forces will also support this third strategic priority: the development of referral networks to our treating centers.

Speaker #3: We believe this upstream approach is already producing results, and strengthening these referral networks across the country is a top priority and will be a meaningful driver of new patients per site going forward.

Speaker #3: Collectively, these three priorities and the underlying KPIs support the 2026 guidance Sandra will share shortly. We are confident that consistent execution and expanding site capacity, higher utilization at existing centers, and the active referral development will deliver continued long-term growth.

Speaker #3: I will now turn to an update in our clinical development programs. In our ongoing metastatic colorectal cancer trial, we continue activation of new trial sites and now have a total of eight centers actively screening patients.

Gerard Michel: In our ongoing metastatic colorectal cancer trial, we continue activation of new trial sites and now have a total of eight centers actively screening patients. While opening and training sites for a medical device clinical trial is more complex than a clinical trial with conventional drugs, we are on track to activate nearly all of the currently targeted 26 trial sites by mid-2026, and to present interim data results in late 2027. Our second program in metastatic breast cancer has one active clinical trial site, and additional sites are opening soon. Compared to physicians who treat metastatic colorectal cancer patients, breast cancer doctors have much less experience with liver-directed therapies. This lower level of awareness requires extensive communication and education on the potential benefits of PHP for patients with metastatic breast cancer.

Speaker #3: While opening and training sites for medical device clinical trials more complex than a clinical trial with conventional drugs, we are on track to activate nearly all of the currently targeted 26 trial sites by mid-2026 and to present interim data results in late 2027.

Speaker #3: Our second program in metastatic breast cancer has one active clinical trial site, an additional sites are opening soon. Compared to physicians who treat metastatic colorectal cancer patients, breast cancer doctors have much less experience with liver-directed therapies.

Speaker #3: This lower level of awareness requires extensive communication and education on the potential benefits of PHP for patients with metastatic breast cancer. We are now targeting 15 trial sites and expect to activate them by late 2026.

Gerard Michel: We are now targeting 15 trial sites and expect to activate them by late 2026. We will provide guidance related to the readouts from the metastatic breast cancer trial later this year, once progress of operational activities allows for more precise forecasting. Based on the results of the CHOPIN trial and the resulting interest in the medical community, we are evaluating combination PHP immune checkpoint inhibitor trials in various tumor types, where there are clear areas of unmet need in the subset of these patients with liver metastases. We have had numerous well-attended advisory boards. It will take another three to six months to finalize development plans for future combination trials and other indications. I look forward to sharing future updates on this topic. I will now ask Sandra to review our financial results.

Speaker #3: We will provide guidance related to the readouts from the metastatic breast cancer trial later this year, once progress of operational activities allows for more precise forecasting.

Speaker #3: Based on the results of the CHOPIN trial and the resulting interest in the medical community, we are evaluating combination PHP immune checkpoint inhibitor trials in various tumor types, where there are clear areas of unmet need in the subset of these patients with liver metastases.

Speaker #3: We have had numerous well-attended advisory boards and it will take another three to six months to finalize development plans for future combination trials in other indications.

Speaker #3: I look forward to sharing future updates on this topic. I will now ask Sandra to review our financial results.

Speaker #1: Thank you, Gerard. Revenue from our sales of hepatitis was $19 million, and chemo set was $1.7 million, for the fourth quarter of 2026, compared to $13.7 million for hepatitis and $1.4 million for chemo set.

Sandra Pennell: Thank you, Gerard. Revenue from our sales of HEPZATO was $19 million, and CHEMOSAT was $1.7 million for Q4 2026, compared to $13.7 million for HEPZATO and $1.4 million for CHEMOSAT during the same periods in 2025. Full year 2025 revenue was $78.8 million from HEPZATO and $6.4 million from CHEMOSAT, compared to $32.3 million for HEPZATO and $4.9 million for CHEMOSAT in 2024. We recognized gross margins of 85% in Q4 and 86% for the full year, compared to 86% and 83% for the same periods in the prior year.

Speaker #1: During the same periods in 2025. Full year 2025 revenue was $78.8 million from hepatitis and $6.4 million from chemo set, compared to $32.3 million for hepatitis and $4.9 million for chemo set in 2024.

Speaker #1: We recognize growth margins of 85% in the fourth quarter and 86% for the full year, compared to 86% and 83% for the same periods in the prior year.

Speaker #1: Research and development expenses for the quarter were $9.4 million, compared to $2.9 million for the same periods in the prior year, while full R&D expenses in 2025 were $29.2 million, compared to $13.9 million in 2024.

Sandra Pennell: Research and development expenses for Q4 were $9.4 million, compared to $2.9 million for the same periods in the prior year, while full R&D expenses in 2025 were $29.2 million, compared to $13.9 million in 2024. The growth in R&D spending was primarily driven by ongoing investments in our clinical team and the initiation of a phase II clinical trial evaluating HEPZATO in combination with standard of care for MCRC and MBC. We do expect our R&D expenses to increase in 2026 by nearly 90%. Selling general and administrative expenses for Q4 were $10.5 million, compared to $7.7 million for the same period in the prior year. Full year 2025 SG&A was $43 million, compared to $29.6 million in 2024.

Speaker #1: The growth in R&D spending was primarily driven by ongoing investments in our clinical team and the initiation of the phase two clinical trial evaluating hepatitis, in combination with standard of care for MCRC and MBC.

Speaker #1: We do expect our R&D expenses to increase in 2026 by nearly 90%. Selling general and administrative expenses for the fourth quarter were $10.5 million, compared to $7 million for the same period in the prior year.

Speaker #1: Full year 2025 SGNA was $43.0 million, compared to $29.6 million in 2024. SGNA expenses versus last year have increased primarily due to continued commercial expansion and overall increase in general business functions.

Sandra Pennell: SG&A expenses versus last year have increased primarily due to continued commercial expansion and overall increase in general business functions. We also expect our SG&A expenses to increase in 2026 by nearly 50%. Our Q4 2025 net loss was $1.9 million, compared to $3.4 million net loss in the Q4 of the previous year, while full year 2025 net income was $2.7 million, compared to a loss of $26.4 million in 2024. Non-GAAP positive adjusted EBITDA for the Q4 was $2.4 million, compared to positive adjusted EBITDA of $4.6 million for the same period last year. Adjusted EBITDA for the full year was $25.1 million, compared to adjusted EBITDA loss of $2.5 million for the same period in 2024.

Speaker #1: We also expect our SGNA expenses to increase in 2026 by nearly 50%. Our fourth quarter 2025 net loss was $1.9 million, compared to $3.4 million net loss in the fourth quarter of the previous year, while full year 2025 net income was $2.7 million, compared to a loss of $26.4 million in 2024.

Speaker #1: Non-GAAP positive adjusted EBITDA for the fourth quarter was $2.4 million, compared to positive adjusted EBITDA of $4.6 for the same period last year. Adjusted EBITDA for the full year was $25.1 million, compared to adjusted EBITDA loss of $2.5 million for the same period 2024.

Speaker #1: We ended the year with approximately $91 million in cash and investments, and quarterly positive operating cash flow of $8.3 million, and full year operating cash flow of $22.5 million.

Sandra Pennell: We ended the year with approximately $91 million in cash and investments, and quarterly positive operating cash flow of $8.3 million, and full year operating cash flow of $22.5 million. 628,572 common shares were repurchased for $6 million through 31 December 2025, under the approved $25 million share buyback program. As of today, we have no outstanding debt obligation and no outstanding warrants. Turning to 2026 guidance, we are guiding to total revenue of at least $100 million for the year, which represents greater than a 20% increase in HEPZATO KIT procedure volume and greater than 10% growth in CHEMOSAT.

Speaker #1: $628,572 common shares were repurchased for $6 million through December 31, 2025, under the approved $25 million share buyback program. As of today, we have no outstanding debt obligation and no outstanding warrant.

Speaker #1: Turning to 2026 guidance, we are guiding to total revenue of at least $100 million for the year, which represents greater than a 20% increase in hepatitis kit procedure volume and greater than 10% growth in chemo set.

Speaker #1: The revenue guidance reflects a 340B pricing change, and based on our current and projected customer mix, we do expect a 340B pricing impact to result in an average selling price of around $175,000 per kit for hepatitis, approximately a 10% discount of our published list price.

Sandra Pennell: The revenue guidance reflects a 340B pricing change, and based on our current and projected customer mix, we do expect a 340B pricing impact to result in an average selling price of around $175,000 per kit for HEPZATO, approximately a 10% discount of our published list price. Given the concentrated nature of our customer base, this dynamic will continue to introduce some variability in realized pricing as we add new sites and as centers 340B eligibility kind of fluctuates quarter-to-quarter. Forecast for 2026 growth margins are between 84% and 87%. We appreciate your participation today. This does conclude our prepared remarks. I'll ask the operator now to open the phone lines for Q&A. Thank you.

Speaker #1: Given the concentrated nature of our customer base, this dynamic will continue to introduce some variability and realize pricing as we add new sites and as centers 340B eligibility kind of fluctuates quarter to quarter.

Speaker #1: Forecast for 2026 growth margins are between 84% and 87%. We appreciate your participation today. This does conclude our prepared remarks, and I'll ask the operator now to open the phone lines for Q&A.

Speaker #1: Thank you.

Speaker #2: Thank you. We will now conduct our question and answer session. If you would like to ask a question, please press star one on your telephone keypad.

Operator: Thank you. We will now conduct our question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question comes from the line of Marie Thibault with BTIG. Please proceed with your question.

Speaker #2: A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue.

Speaker #2: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question comes from the line of Mary Thibault with BTIG.

Speaker #2: Please proceed with your question.

Speaker #3: Hi, good morning, Gerard and Sandra. Thanks for taking the questions. Wanted to ask my first one here on some of the assumptions around your guidance.

Marie Thibault: Hi, good morning, Gerard and Sandra. Thanks for taking the questions. Wanted to ask my first one here on some of the assumptions around your guidance. You gave us a lot of details on pricing and volume expectations, but I just wanted to clarify. You know, you mentioned seasonality. Is that your Q3 that you're talking about when you talk about summer seasonality? Because we had the IRA come in last year, maybe you could remind us on the magnitude of that seasonality, just because things were a little bit noisy with that pricing change. Sandra, on the pricing, you said 175, I think, for this year. That's a little higher than where you kind of exited the year. Just love to hear a little bit about the trends behind that.

Speaker #3: You gave us a lot of details on pricing and volume expectations, but I just wanted to clarify you mentioned seasonality. Is that your third quarter that you're talking about when you talk about summer seasonality?

Speaker #3: And because we had the NDRA come in last year, maybe you could remind us on the magnitude of that seasonality just because things were a little bit noisy with that pricing change.

Speaker #3: And Sandra, on the pricing, you said $175, I think, for this year. That's a little higher than where you kind of exited the year.

Speaker #3: Just love to hear a little bit about the trends behind that.

Speaker #4: Sure, thanks. I'll deal with the seasonality at a high level. Yeah, we do expect seasonality in the third quarter. While not all of the seasonality last year was due to physicians, perhaps patients taking time off.

Gerard Michel: Sure. Thanks. I'll deal with the seasonality at a high level. Yeah, we do expect seasonality in Q3. While not all of the seasonality last year was due to physicians or perhaps patients taking time off, a great deal of it was. Although we are trying to increase staffing at the hospitals or REMS certified teams at the hospitals, it is a, you know, a tall order to get docs to sign up for this when they're only going to be occasionally doing it. Expect to see it again this year. Sandra, maybe you can count on the magnitude of the seasonality as well as the pricing question.

Speaker #4: A great deal of it was. And although we are trying to increase staffing at the hospitals or REM-certified teams at the hospitals, it is a tall order to get docs to sign up for this when they're only going to be occasionally doing it.

Speaker #4: So expect to see it again this year. Sandra, maybe you can count on the magnitude of the seasonality as well as the pricing question.

Speaker #2: Thank you, Gerard. Yes. We want to remind everyone that each patient is worth three-quarters of a million dollars. So we're going to try to temper this seasonality in the third quarter.

Sandra Pennell: Thank you, Gerard. Yes. You know, we want to remind everyone that, you know, each patient is worth three-quarters of a million dollars. We're going to try to temper the seasonality in Q3. You may see a bit of a maybe flat to modest growth from Q2 to Q3, similar to what we saw in 2025, and then with that growth, you know, starting back up from Q3 to Q4. From a pricing perspective, yeah, we did have a slight price increase. Our list price went from $187.5 last year to $189.1. Again, this is limited by inflation. We're seeing a more favorable mix.

Speaker #2: So you may see a bit of a maybe flat to modest growth from Q2 to Q3, similar to what we saw in 2025. And then with that growth, starting back up from Q3 to Q4.

Speaker #2: So from a pricing perspective, yeah, we did have a slight price increase. Our list price went from $187.5 last year to $189.1. Again, this is limited by inflation.

Speaker #2: And then we're seeing a more favorable mix. I think we have said Marie in previous calls that we thought we were going to have more of a 20% discount on the list price.

Sandra Pennell: I think, you know, we have said, Marie, in previous calls that we thought we were going to have more of a 20% discount on the list price. Seeing that some of our higher-end users are not 340B eligible at the moment, we have had some, you know, favorability there and really more of a 10% decrease in price per unit. Again, we'll continue to update everyone if that changes significantly outside of $175,000.

Speaker #2: But seeing that some of our higher-end users tend to are not 340B eligible at the moment, we have had some favorability there and really more of a 10% decrease in price per unit.

Speaker #2: Again, we'll continue to update everyone if that changes significantly outside of $175,000.

Speaker #4: And just quickly to summarize, because we're throwing a lot at you there, from Q2 to Q3, from a volume perspective, because it was noisy last year with the pricing, we expect only modest growth, perhaps even flat.

Gerard Michel: Just quickly to summarize, because we're throwing a lot at you there. From Q2 to Q3, from a volume perspective, because it was noisy last year with the pricing, we expect only modest growth, perhaps even flat, given the seasonality we saw last year. We have small numbers to work with, but that's small amount of history, that's what we're assuming. As Sandra mentioned, we were tracking closer to 12% net effect of reduction on price due to 340B across all our customers. It's looking like it's closer now to getting closer to 10%, so a bit, a bit in our favor.

Speaker #4: Given the seasonality, we saw it last year. We have small numbers to work with, but that's a small amount of history. That's what we're assuming.

Speaker #4: And as Sandra mentioned, we were tracking closer to 12% net effective reduction on price due to 340B. Across all our customers, it's looking like it's closer now to getting closer to 10%.

Speaker #4: So a bit in our favor.

Speaker #3: All right. Very clear. Thank you for that detail. And then one, we look at your websites from time to time. You mentioned the REMs certification process.

Marie Thibault: All right. Very clear. Thank you for that detail. One, you know, we look at your websites, from time to time. You mentioned, you know, the REMS certification process. You also mentioned some clinical trial centers. I wonder if you could just remind me of the difference between your HEPZATO KIT REMS site, your HEPZATO KIT site, and then how we should be thinking about the differentiation between the sites that are, you know, commercial and those that are purely clinical as we keep track of some of these metrics. Thanks.

Speaker #3: You also mentioned some clinical trial centers. So I wonder if you could just remind me of the difference between your hepatitis kit REMs site, your hepatitis kit site, and then how we should be thinking about the differentiation between the sites that are commercial and those that are purely clinical as we keep track of some of these metrics.

Speaker #3: Thanks.

Speaker #4: Yeah. I'm glad you asked that. Our intention is for the hepatitis kit REMs site to be compliant. And for it to be compliant for the FDA, we can't put we can't put hospitals on that are accepting referrals but have yet to do their first patient.

Gerard Michel: Yeah, I'm glad you asked that. It's our intention is for the HEPZATO KIT REMS site to be compliant, and for it to be compliant per the FDA, we can't put hospitals on that are accepting referrals but have yet to do their first patient. We want patients to know where to find treating centers, even if they have yet to do their first, but are accepting referrals. That's why we put together the hepzatokit.com website with a physician finder on that as well. Now, I did say in the past that we believed REMS certified centers, even if they are clinical trial centers, needed to be put on that first FDA website.

Speaker #4: We want patients to know where to find treating centers. Even if they have yet to do their first, but are accepting referrals. So that's why we put together the hepatitis kit.com website with a physician finder on that as well.

Speaker #4: Now, I did say in the past that we believed REM-certified centers even if they are a clinical trial centers needed to be put on that first FDA website.

Speaker #4: Upon further digging, it's a bit of a gray area. But on further digging, we've reached the determination that it's probably best not to put them on.

Gerard Michel: Upon further digging, it's a bit of a gray area, on further digging, we've reached the determination that it's probably best not to put them on. Actually, I'm glad you asked the question, because this is a change. If investors want to know, and analysts, how many treating centers there are, you just go to hepzatokitrems.com. Everybody there is either actively treating lung patients, or is REMS certified and will soon treat a lungs patient. We do have some clinical trial overlap, we'll only put those on there that are going to be commercial centers. Short answer is look at hepzatokitrems.com for the number of treating centers. If you're a patient, go to hepzatokit.com, because that's all the centers that are accepting referrals.

Speaker #4: So actually, I'm glad you asked the question because this is a change. So if investors want to know and analysts how many treating centers there are, you just go to hepatitis kit.rems.com.

Speaker #4: Everybody there is either actively treating lung patients or is REM-certified and will soon treat a lung patient. So we do have some clinical trial overlap.

Speaker #4: But we'll only put those on there that are going to be commercial centers. So short answer is look at a hepatitis kit rems.com for the number of treating centers.

Speaker #4: If you're a patient, go to hepatitis kit.com because that's all the centers that are accepting referrals. And if I confuse the matter that I confuse the matter even more.

Marie Thibault: All right. Very helpful.

Gerard Michel: Did I confuse the matter even more?

Marie Thibault: No, that was pretty clear. Thank you, Gerard. Thanks.

Speaker #3: Well, no, that was pretty clear. Thank you, Gerard. Thanks.

Gerard Michel: All right. Thanks.

Speaker #4: All right. Thanks.

Speaker #2: Thank you. Our next question comes from the line of John Newman with Canica Genuity. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of John Newman with Canaccord Genuity. Please proceed with your question.

Speaker #5: Hi, team. Good morning. And thanks for taking my question. I just had two here. On the Chopin study, really impressive data last year. Gerard, just curious on the timing on the publication there.

John Newman: Hi, team. Good morning, and thanks for taking my question. I just had two here. On the CHOPIN study, really impressive data last year. Gerard, just curious on the timing on the publication there, anything you could tell us? Also just how you plan to use that study in the United States and when we might start to see an effect. From an operations perspective on the business, you've got two really interesting and important clinical studies running in colorectal and breast cancer. Just curious if you're more focused on those studies and making sure that they enroll quickly and proceed, or if you're kind of balancing that with keeping the business cash flow positive this year. Thanks.

Speaker #5: Anything you could tell us? And then also just how you plan to use that study in the United States and when we might start to see an effect.

Speaker #5: And then from an operations perspective on the business, you've got two really interesting and important clinical studies running in colorectal and breast cancer. Just curious if you're more focused on those studies and making sure that they enroll quickly and proceed, or if you're kind of balancing that with keeping the business cash flow positive this year.

Speaker #5: Thanks.

Speaker #4: Okay. Thanks for the questions. In terms of timing of Chopin, as I think everyone on the call knows, this is an investigator-initiated trial. So we're told that it's imminent.

Gerard Michel: Okay, thanks for the questions. In terms of timing of CHOPIN, as I think everyone on the call knows, this is an investigator-initiated trial, so, you know, we're told that it's imminent. I think probably within the next month or so, it will be published, but I can't absolutely promise that. In terms of how we will use it's going to be used in a multifaceted way. You know, the medical affairs, I mean, the sales reps, will certainly make the treating physicians aware that it exists and give them access to the publication. We will make our Medical Science Liaisons and our senior medics at the company available to answer detailed questions about how the, you know, how doctors might interpret the data and safely use the combination.

Speaker #4: I think probably within the next month or so, it will be published, but I can't absolutely promise that. In terms of how we will use it, it's going to be used in a multifaceted way.

Speaker #4: The medical affairs, I mean, the sales reps will certainly make the treating physicians aware that it exists, and give them access to the publication.

Speaker #4: We'll make our medical science liaisons and our senior medics at the company available to ask answer detailed questions about how the doctors might interpret the data and safely use the combination.

Speaker #4: And thirdly, I do believe a number of KOLs believe that the guidelines should be updated based on these data. Both with respect of highlighting hepatitis was probably the liver direct therapy to use for most patients.

Gerard Michel: Thirdly, I do believe a number of KOLs believe that the guidelines should be updated based on these data, both from the perspective of highlighting HEPZATO as probably the liver-directed therapy to use for most patients, as well as showing that this combination therapy with ipiniva can be safely utilized and perhaps even downgrading the role of clinical trials in the guidelines. That's another critical way we're going to try to utilize the data. In terms of prioritizing clinical development versus cash flow positive, we have a very healthy balance sheet of over $90 million. I don't think there's any need for us to focus on positive cash flow from quarter to quarter. That would simply hinder the long-term value of the company for, you know, perceived optical gain.

Speaker #4: As well as showing its combination therapy, would it be nevo can be safely utilized. And perhaps even downgrading the role of clinical trials in the guidelines.

Speaker #4: So that's another clinical critical way we're going to try to utilize the data. In terms of prioritizing clinical development versus cash flow positive, we have a very healthy balance sheet.

Speaker #4: Over $90 million I don't think there's any need for us to focus on positive cash flow from quarter to quarter. That would simply hinder the long-term value of the company for perceived optical gain.

Speaker #4: So we may go cash flow negative on some quarters, but we think that's the right thing to do for the long-term value of the business.

Gerard Michel: We may go cash flow negative on some quarters, but we think that's the right thing to do for the long-term value of the business.

Speaker #5: Okay. Great. Thanks very much.

Yale Jen: Great. Thanks very much.

John Newman: Great. Thanks very much.

Speaker #2: Thank you. Our next question comes from the line of Chase Knickerbocker with Craig Hallam. Please proceed with your question.

Sandra Pennell: Thank you. Our next question comes from the line of Chase Knickerbocker with Craig-Hallum. Please proceed with your question.

Speaker #5: Good morning. Thanks for taking the questions. Just a quick one to start. As far as commercially, can you give us a sense for kind of the average treatments per patient, kind of an update there?

Chase Knickerbocker: Good morning. Thanks for taking the questions. Just a quick one to start. As far as commercially, can you give us a sense for, you know, kind of the average treatments per patient, kind of an update there? You know, even more so, like how long it's taking a single patient to kind of get to that average number of treatments. Is it kind of been every six to eight weeks, or are we seeing a little bit longer in the real world?

Speaker #5: But even more so, how long it's taking a single patient to kind of get to that average number of treatments? Is it kind of been every six to eight weeks, or are we seeing a little bit longer in the real world?

Gerard Michel: Average still is spot on within probably 4.1. That has changed very little. How long it takes them, you know, it's more of a decay curve. You know, what's the probability of getting to the next treatment? You know, any single patient might just get one or up to six. Some are going past six. In terms of the interval before treatment, it's probably stretching out closer to eight than to six. Every site is different. The actual interview is probably 7 point some odd at this moment. I think in the low sevens, like 7.2, 7.3. That does vary a fair amount, quarter-to-quarter, but, well, a modest amount quarter-to-quarter. I don't think it's gonna go past eight.

Speaker #4: Average still is spot on within probably four, 4.1. That has changed very little. How long it takes them, it's more of a decay curve.

Speaker #4: What's the probability of getting to the next treatment? Any single patient might just get one, or up to six. Some are going past six.

Speaker #4: In terms of the interval before treatment, it's probably stretching out closer to eight than to six. Every site is different. The actual interview is probably 7-point some odd at this moment.

Speaker #4: I think in the low sevens, like 7.2, 7.3. That does vary a fair amount. Quarter to quarter, but well, a modest amount quarter to quarter.

Speaker #4: I don't think it's going to go past eight. I don't think it's going to drop down to six. It's going to be in that realm.

Gerard Michel: I don't think it's gonna drop down to six. It's gonna be in that, in that realm.

Speaker #5: And just on your guide, kind of with that in mind, can you kind of walk us through what it assumes as far as new patient starts?

Chase Knickerbocker: Just on your guide, kind of with that in mind, can you kind of walk us through what it assumes as far as new patient starts? Because if you use that kind of number that you gave around kind of 0.75, you know, you could theoretically get to a number that, you know, can be above $100 million, right?

Speaker #5: Because if you use that kind of number that you gave, around kind of 0.75, you could theoretically get to a number that can be above 100 million, right?

Speaker #5: So should we think about it conceptually as a floor and then just walk us through what your kind of assuming as far as new patient starts of the year?

Gerard Michel: Mm-hmm.

Chase Knickerbocker: Should we think about it conceptually as a floor, and then just walk us through what you're kind of assuming as far as new patient starts through the year?

Speaker #4: Yeah. We're assuming we average close to 0.5. Which is what we saw last year. And we're growing sites that means growing revenue. We're assuming as we said before that the first two quarters of the year are stronger than the third quarter and then the fourth quarter rebounds, which is what we saw last year.

Gerard Michel: Yeah. We're assuming we average close to 0.5, which is what we saw last year. With growing sites, that means growing, you know, growing revenue. We're assuming, as we said before, that the Q1 and Q2 of the year are stronger than the Q3, and then the Q4 rebounds, which is what we saw last year. We think it's prudent to think that, you know, as we gain more sites, and we keep the average new patient per site per month consistent with what we saw last year. In other words, the average site doesn't get incrementally more productive as we add new sites, which is, you know, some of the older sites get more productive, then reach a cap.

Speaker #4: We think it's prudent to think that as we gain more sites, which we keep the average new patient per site per month consistent with what we saw last year.

Speaker #4: In other words, the average site doesn't get incrementally more productive. As we add new sites, which is some of the older sites get more productive than reach a cap.

Gerard Michel: The newer sites take a while to reach their stride on average. As we add more sites, we are delving further and further into the overall TAM. You know, I think it should be encouraging to investors that we don't think the average productivity will decline. It'll keep steady as we add sites.

Speaker #4: The newer sites take a while to reach their stride on average. But as we add more sites, we are delving further and further into the overall TAM.

Speaker #4: And I think it's should be encouraging investors that we don't think the average productivity will decline; it'll keep steady as we add sites.

Speaker #5: And then I may have missed this Gerard, but just kind of an updated thought as far as kind of cadence of new center ads this year.

Chase Knickerbocker: I may have missed this, Gerard, but just kind of an updated thought as far as kind of cadence of new center adds this year. I realize it's, you know, can be pretty variable, but just as we think about our models and kind of the pipeline that you have right now. I'm sorry if I missed it again.

Speaker #5: And I realize it can be pretty variable, but just as we think about our models and kind of the pipeline that you have right now.

Speaker #5: And sorry if I missed it again.

Speaker #4: Yeah. No. I think there are two things that will, I I think, increase the pace. It's in the back half of the year. That's the addition of more reps because we're going from six to nine regions.

Gerard Michel: Yeah, no, I think, there are two things that will, I think, increase the pace. In the back half of the year. That's the addition of more reps, we're going from six to nine regions, as well as we reinvigorated our medical affairs group. We have an expanded team in the field right now. Increased field presence. The second thing will be with the publication of the CHOPIN results. You know, we believe that'll take a bit of time to really make its mark. I think that'll be in the back half of the year. As a function of all of that, we expect more centers being activated in the back half of the year than the front half of the year.

Speaker #4: As well as we reinvigorated our medical affairs group. We have an expanded team in the field right now. So increased field presence. And then the second thing will be with the publication of Chopin results.

Speaker #4: We believe that'll take a bit of time to really make its mark. And I think that'll be in the back half of the year.

Speaker #4: So as a function of all of that, we expect more centers being activated in the back half of the year than the front half of the year.

Speaker #5: Got it. And then Sandra, maybe just last one. Any sort of guidepost that you'd be willing to give us just around either kind of R&D spend or kind of EBITDA?

Chase Knickerbocker: Got it. Sandra, maybe just last one. Any sort of guideposts that you'd be willing to give us just around, you know, either kind of R&D spend or kind of EBITDA, kind of same kind of question, but any sort of help as you kind of think about how, you know, you're kind of modeling patient enrollment in your ongoing studies?

Speaker #5: Kind of same kind of question, but any sort of help as you kind of think about how you're kind of modeling patient enrollment in your ongoing studies?

Speaker #6: Yeah. So, we are expecting, like I said, a healthy growth of nearly 90% in 2026 over 2025. Now, again, this is dependent on making sure we get those sites open and enrolled.

Sandra Pennell: Yeah. You know, we are expecting, like I said, a healthy growth of nearly 90% in 2026 over 2025. Now, again, this is dependent on making sure we get those sites open and enrolled. You know, R&D just in Q1 alone should increase over Q4, probably nearly 20% and go up about, I don't know, maybe 15% each quarter thereafter. We see a big bolus this Q1 with primarily due to CRC. With regards to SG&A, again, we're expecting nearly 50% increase overall this year, primarily due to the sales and marketing initiatives and the commercial expansion. Q1 alone will probably go up, you know, nearly 30% to 40% over Q4, and then more of a flat or modest increase each quarter thereafter.

Speaker #6: R&D just in the first quarter alone should increase over Q4 probably nearly 20% and go up about, I don't know, maybe 15% each quarter thereafter.

Speaker #6: So we see a big bull if this first quarter with primarily due to CRC. With regards to SG&A, again, we're expecting nearly 50% increase overall this year, primarily due to the sales and marketing initiatives and the commercial expansion.

Speaker #6: Q1 alone will probably go up nearly 30 to 40 percent over Q4. And then more of a flat or modest increase each quarter thereafter.

Sandra Pennell: Hopefully that'll give you a little bit more information for your modeling from an expense side. Yes. Thank you, Sandra. Thanks, guys.

Speaker #6: So hopefully, that'll give you a little bit more information for your modeling from an expense side.

Sandra Pennell: Hopefully that'll give you a little bit more information for your modeling from an expense side. Yes. Thank you, Sandra. Thanks, guys.

Speaker #5: Yes. Thank you, Sandra. Thanks, guys.

Speaker #1: Thank you. Our next question comes from the line of Sudan. Logan Nathan with Stevens. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Sudan Loganathan with Stephens. Please proceed with your question.

Speaker #7: Hi. Thanks. Gerard and Sandra. My first question is around the third quarter you mentioned kind of having a potential seasonality to be mindful about in that for that specific quarter.

Sudan Loganathan: Hi. Thanks, Jordan, Sandra. My first question is around the Q3. You mentioned kind of having a potential seasonality to be mindful about in that, for that specific Q3. But, you know, you guys have a lot of other potential catalysts coming through, such as the CHOPIN publication and also the focus on the new regions that you kind of split out for the sales force. You know, is there any catalysts or anything else to kind of rally around for the Q3 that could maybe help mitigate some of the seasonality? Also, maybe even some more site starts coming online that Q3 that could potentially help. Is there anything you can kind of give details on?

Speaker #7: But you guys have a lot of other potential catalysts coming through such as the Chopin publication and also the focus on the new regions that you kind of split out for the sales force.

Speaker #7: So is there any catalysts or anything else to kind of rally around for the third quarter that could maybe help mitigate some of the seasonality?

Speaker #7: Also, maybe even some more site starts coming online that quarter that could potentially help? Is there anything you can kind of give details on?

Speaker #4: Yeah. I think the one aspect of the seasonality that will take probably will always be with us to some extent is that there's just at our high-producing sites, they're flat out.

Gerard Michel: Yeah, I think the one aspect of the seasonality that will take, probably will always be with us to some extent, is that there's just at our high producing sites, they're flat out. They book, excuse me, room time and position schedules ahead of time, and they fill it with patients. excuse me. When some of the one or two of those members take time off, they lose capacity, and they generally just treat existing patients. They don't bring on new patients. For us to kind of counter that effect, we'd have to efficiently kind of refer patients to other centers that seem to have capacity, and that's tough to do.

Speaker #4: They book—excuse me—room time and position schedules ahead of time, and they fill it with patients. The—excuse me—the when some of the one or two of those members take time off, they lose capacity and they generally just treat existing patients.

Speaker #4: They don't bring on new patients. So for us to kind of counter that effect, we'd have to efficiently kind of refer patients to other centers that seem to have capacity.

Speaker #4: And that's tough to do. So we just think it's prudent despite the fact that we're trying to increase bench strength at these various centers.

Gerard Michel: We just think it's prudent, despite the fact that we're trying to increase bench strength at these various centers, we think it's prudent just to take that into account, to assume it's going to happen again. Are there upside potentials? Yeah. Could CHOPIN have an even larger impact than we're anticipating? Yes, of course. Could we increase the number of site activations because of CHOPIN? Yeah, that's an upside as well. Yeah, we're hopeful for upside, but we think it's prudent just to be, you know, I think not overly conservative, but reasonably conservative in our guidance.

Speaker #4: We think it's prudent just to take that into account, to assume it's going to happen again. Are there upside potentials? Yeah. Could Chopin have an even larger impact than we're anticipating?

Speaker #4: Yes, of course. Could we increase the number of site activations because of Chopin? Yeah, that's an upside as well. So yeah, we're hopeful for upside.

Speaker #4: But we think it's prudent just to be—I think not overly conservative, but reasonably conservative in our guidance.

Speaker #7: Gotcha. And then one quick one. Again, I got to run the Chopin potential. If you could potentially quantify that into new patient start number—I know I think you mentioned kind of leveling off around that 0.5 patients per site per month—could Chopin add 0.1 or 0.2 to that?

Sudan Loganathan: Gotcha. One quick one. Again, around the CHOPIN potential is, you know, if you could potentially quantify that into a new patient start number, I know, I think you mentioned kind of leveling off around the 0.5 patients per site per month. Could you know, CHOPIN add 0.1 or 0.2 to that? Just kind of curious if you have a quantified.

Speaker #7: Just kind of curious if you have a quantified.

Speaker #4: I'm going to stay as far away from that question as possible.

Gerard Michel: I'm gonna stay as far away from that question as possible.

Speaker #7: I have to ask it though, but I appreciate it. Thank you.

Sudan Loganathan: I have to ask it, though, but I appreciate it. Thank you.

Gerard Michel: All right. All right.

Speaker #4: All right. All right.

Speaker #1: Thank you. Our next question comes from the line of Charles Wallace with HC Wainwright. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Charles Wallace with H.C. Wainwright. Please proceed with your question.

Speaker #8: Hi. This is Charles on for RK. Thanks for taking my question. So on the seasonality, you mentioned that the procedure growth and also the site activation may be weighted in the back half.

Charles Wallace: Hi, this is Charles on for RK. Thanks for taking my question. On the seasonality, you mentioned that the procedure growth and also the site activation may be weighted in the back half. As you add more patients from these sites, do you expect that the discount will expand from the current 10%, and are you still targeting a 20% discount as potentially more 340B patients get added to this mix? Thank you.

Speaker #8: But as you add more patients from these sites, do you expect that the discount will expand from the current 10%? And are you still targeting a 20% discount as potentially more 340B patients get added to this mix?

Speaker #8: Thank you.

Speaker #4: Yeah. So I think the discount for the 340B centers is 23.1. What matters then after that number is the mix obviously that we see.

Gerard Michel: I think the discount for the 340B centers is 23.1%. What matters then, after that number is the mix, obviously, that we see. It's very difficult for us to be precise as to what we think the discount will be. It was running close to 12%. It swung closer to 10%. When I use those numbers, I mean, the effective average value per kit that we're getting, the discount off of AMP or ASP. I think we've modeled 10% for the year, which is a little bit better than we were seeing probably in Q3. It's closer to what we saw in Q4.

Speaker #4: It's very difficult for us to be precise as to what we think the discount will be. It was running close to 12%. It swung closer to 10% when I used those numbers.

Speaker #4: I mean, the effective average value per kit that we're getting. The discount off of AMP or ASP. I think we're just going to—we've modeled 10% for the year, which is a little bit better than we were seeing probably in the third quarter.

Speaker #4: It's closer to what we saw in the fourth quarter. Looking forward and doing the best we can at the mix of hospitals that we think will come on board.

Gerard Michel: Looking forward and doing the best we can at the mix of hospitals that we think will come on board, we came up with the 10%, but it's. Sometimes we don't know until we're finishing, we're ready to ship a product to a hospital. Sometimes it's even after the fact that we find out whether or not they want to claim 340B pricing. Because some of them roll on and off, the DSH eligibility, that's Disproportionate Share Hospital. Some of them actually choose not to use it because they want to use a different legal entity. It's highly complex, but I think for now, you know, just stick with the 10%. That's what we're modeling.

Speaker #4: We came up with the 10%. But it's sometimes we don't know until we're finishing—we're ready to ship a product to a hospital. And sometimes it's even after the fact that we find out whether or not they want to claim 340B pricing.

Speaker #4: Because some of them roll on and off the dish eligibility that's disproportionate share hospital. And some of them actually choose not to use it because they want to use a different legal entity.

Speaker #4: So it's highly complex. But I think for now, just stick with the 10%. That's what we're modeling.

Speaker #7: Perfect. And then on one more question. On gross margin, you reached 86% in 2025. Do you expect to maintain this level in 2026?

Charles Wallace: Perfect. On one more question on gross margin. You reached 86% in 2025. Do you expect to maintain this level in 2026?

Gerard Michel: Sandra?

Speaker #1: Yeah. We're guiding right now. Yeah. Oh, sorry. Thank you. Yes, we are guiding right now. 84 to 87 percent in 2026. So I think it's obviously dependent on the quarter sales as well as any pricing impacts over this next year.

Sandra Pennell: Yeah, we're guiding right now. Yeah. Oh, sorry. Thank you. Yes, we are guiding right now from, you know, 84% to 87% in 2026. I think it's, you know, obviously dependent on each the Q sales as well as any pricing impacts over this next year, but, you know, even potentially hitting close to 90% in 2027 and beyond.

Speaker #1: But even potentially hitting close to 90% in 2027 and beyond.

Charles Wallace: Perfect. Thanks, for taking my questions.

Speaker #7: Perfect. Thanks for taking my questions.

Speaker #1: Thank you. Our next question comes from the line of Bill Maughan with ClearStreet. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Bill Maughan with Clear Street. Please proceed with your question.

Speaker #9: Hey, good morning and thanks. So, with the pricing reset around mid-'25, are you pleased with the amount of volume increase that you feel you've gotten from that expansion into 340B hospitals?

Bill Maughan: Hey, good morning, and thanks. With the pricing reset around mid-2025, are you pleased with the amount of volume increase that you feel you've gotten from that expansion into 340B hospitals? You've spoken before about one of HEPZATO's major competitors for patients being competitive trials. Can you just comment on anything you've seen from those competitive trials in terms of increasing or finishing enrollment that might leave more patients available to you? Thank you.

Speaker #9: And then you've spoken before about one of Hepsato's major competitors for patients being competitive trials. So can you just comment on anything you've seen from those competitive trials in terms of increasing or finishing enrollment that might lead more patients available to you?

Speaker #9: Thank you.

Speaker #4: Sure. I think it's impossible for us to state whether or not we are getting increased volume due to 340B pricing. Just as a reminder, it's not that there wasn't access to these hospitals.

Gerard Michel: Sure. I think it's impossible for us to state whether or not we are getting increased volume, due to 340B pricing. Just as a reminder, it's not that there wasn't access to these hospitals, it was a matter of, you know, how much margin, frankly, would they make for each kit. Not surprisingly, you know, we're not going to have a hospital tell us, Hey, we're using more of this because we make more money, just to be blunt about it. I think in such a severe disease, such as this, I don't think it's going to have a huge impact, and we'll never know, my jokingly saying, unless we have a kind of a parallel universe experiment, we just won't know. In term... It certainly isn't a hindrance.

Speaker #4: It was a matter of how much margin, frankly, would they make for each kit. And not surprisingly, we're not going to have a hospital tell us, "Hey, we're using more of this because we make more money," just to be blunt about it.

Speaker #4: I think in such a severe disease such as this, I don't think it's going to have a huge impact. And we'll never know. My jokingly saying unless we have kind of a parallel universe experiment.

Speaker #4: We just won't know. It certainly isn't a hindrance. I think that we could just be certain of that. In terms of competitive pressure from clinical trials, around the second quarter of last year, there was a large expansion of Replimune active sites.

Gerard Michel: I think that we could just be certain of that. In terms of competitive pressure from clinical trials, you know, around the Q2 of last year, there was a large expansion of Replimune active sites, as well as Thomas Jefferson, bringing on a number of single center trials at their center, which definitely took some patients out of the mix. Thankfully, the SCANDIUM trial, which was a big one, finished enrolling late last year. That pressure has diminished. I think, you know, we have a steady headwind. It's definitely a bit less than we saw than that was going ongoing last year. We just simply count the number of patients being recruited by the ongoing trials that you can see listed on ClinicalTrials.gov.

Speaker #4: As well as Thomas Jefferson bringing on a number of single-center trials at their center. Which is definitely took some patients out of the mix.

Speaker #4: Thankfully, the idea trial, which was a big one, finished enrolling late last year. So that pressure has diminished. So I think we have a steady headwind.

Speaker #4: It's definitely a bit less than we saw going on last year. We just simply count the number of patients being recruited by the ongoing trials that you can see listed on clinicaltrials.gov.

Speaker #9: Got it. Thank you.

Bill Maughan: Got it. Thank you.

Operator: Thank you. Our next question comes from the line of Yale Jen with Laidlaw. Please proceed with your question.

Speaker #1: Thank you. Our next question comes from the line of Yale Jen with Laidlaw. Please proceed with your question.

Speaker #10: Good morning, and thanks for taking the questions. Just two up here. The first one is, I appreciate you highlighting some of the major efforts in terms of last year.

Yale Jen: Good morning. Thanks for taking the questions. Just two up here. The first one is, appreciate you highlight some of the major efforts in terms of last year. One of those is the referral development. I'm just curious whether, going forward, would that be more of an emphasis, giving that will potentially create much more flow, you know, patients, from much large sources?

Speaker #10: One of those is the referral developments. I'm just curious whether going forward, would that be more of an emphasis giving that will potentially create much more flow of patients from a much larger sources?

Speaker #4: Yeah, it has to be. Thanks for the question. It has to be, because as we dip deeper into the TAM, we're now going to be looking for patients that are less, let's call it, educated.

Gerard Michel: Yeah, it has to be. You know, thanks for the question. It has to be because, you know, as we get deeper into the TAM, we're now gonna be looking for patients that are, you know, less, let's call it, educated, and who are seeking out our sites. To do that, we have to get patients who their, you know, doctor, who is likely a doctor who treats cutaneous melanoma, just quickly says, Hey, Ipilimumab and Nivolumab, for those that are HLA-A2 negative or Tebentafusp for HLA-A2 positive. Cutaneous melanoma docs don't, in their normal, you know, mixed practice, don't refer a lot of patients for liver-directed therapy. It's not first on their mind. We need to get in front of those docs who have patients who aren't, like, online, looking for the latest and greatest.

Speaker #4: And we're seeking out our sites. And to do that, we have to get patients who— their doctor, who is likely a doctor who treats cutaneous melanoma.

Speaker #4: Just quickly says, "Hey, it'd be nevo." For though they're HLA2 negative or TEBI for HLA2 positive. Cutaneous melanoma docs don't in their normal mixed practice don't refer a lot of patients for liver-directed therapy.

Speaker #4: It's not first on their mind. So we need to get in front of those docs who have patients who aren't like online looking for the latest and greatest.

Speaker #4: We need to get in front of those docs early, introduce them to a physician at one of our treating centers and educate them on the product so they can offer that option to their patient.

Gerard Michel: We need to get in front of those docs early, introduce them to a physician at one of our treating centers, educate them on the product, so they can offer that option to their patient. Yeah, it is a critical, important, activity for us to continue to deliver growth.

Speaker #4: So yeah, it is a critical, important activity for us to continue to deliver growth.

Speaker #10: Okay, great. That's very helpful. One other question is that given some of the sites already being treating patients for quite a while, maybe a couple of quarters up to now, do you feel the most of those sites are having would you be able to deepen the patient to be treated over there?

Yale Jen: Okay, great. That's very helpful. One other question is that, given some of the sites already been treating patients for quite a while, or maybe a couple quarters up to now, do you feel, you know, would you be able to deepen the patient to be treated over there? You feel that for all those sites, you are pretty much reach a steady state, that fewer patient, fewer, less more patients can be added in per site?

Speaker #10: Or do you feel that for all those sites, you are pretty much at a steady state, that fewer patients or more patients can be added in per site?

Speaker #4: Yeah, there's certain centers that we have a set of centers I think NGH would be a good example that for them to do a lot more patients, they're going to have to book more room time and get another team.

Gerard Michel: Yeah, there are certain centers. We have a set of centers, you know, I think MGH would be a good example, that for them to do a lot more patients, they're gonna have to book more room time and get another team. We'd love it if they did that. We're ready and willing to help them on the training of the new team members. That would be the dial that has to be turned to increase their capacity. There are other centers that we are, you know, much lower share than we should be, and it's usually a mix of reasons, clinical trials being one of them.

Speaker #4: We'd love it if they did that. We're ready and willing to help them on the train of the new team members. But that would be the dial that has to be turned to increase their capacity.

Speaker #4: There are other centers that we are in a much lower share than we should be. And it's usually a mix of reasons. Clinical trials being one of them.

Gerard Michel: Another reason being that the physicians just think of a narrow set of patients like no, let's say, no extrahepatic disease, which is not a limiter, shouldn't for our label, but some of these docs just say, Hey, cancer is a systemic disease. I will only treat this patient if they only have hepatic disease. The first one of those is, you know, we'll try to impact by changing guidelines, if at all possible, to de-emphasize clinical trials. The second one, we'll try to put the data in front of the doc saying: Look, you can treat these patients with extrahepatic disease, with the systemic and our product at the same time. That's kind of a, you know, an educational component.

Speaker #4: Another reason being that the physicians just think of a narrow set of patients like no let's say no extra hepatic disease, which is not a limiter.

Speaker #4: Per our label, but some of these docs just say, "Hey, cancer is a systemic disease." I will only treat this patient if they only have hepatic disease.

Speaker #4: So the first one of those is we'll try to impact with by changing guidelines if at all possible to de-emphasize clinical trials. And the second one, we'll try to put the data in front of the doc saying, "Look, you can treat these patients with extra hepatic disease." With the systemic and our product at the same time.

Speaker #4: And that's kind of an educational component. So trying to change guidelines, which again, is not a slam dunk. Or modify guidelines as well as educating these doctors in some of the higher volume centers where we have a low share that's the second component of it.

Gerard Michel: trying to change guidelines, which again, is not a slam dunk, or modify guidelines as well as educating these doctors in some of the higher volume centers where we have a low share. That's the second component of it. Our high volume centers that are believers, if they can expand their capacity, which we have modest ability to influence, that's one driver. The second is, you know, changing treating patterns at our lower share hospitals, where there is a high volume and, you know, the expanded MSL force, the expanded sales force, the CHOPIN data, perhaps some changes in the guidelines, all should help us there.

Speaker #4: So our high volume centers that are believers if they can expand their capacity. Which we have modest ability to influence. That's one driver. The second is changing treating patterns at our lower share hospitals where there is a high volume.

Speaker #4: And the expanded MSL force, the expanded sales force, the CHOPIN data, perhaps some changes in the guidelines—all should help us.

Speaker #1: And maybe the last question here . To squeeze in I know it's awfully , awfully difficult to predict or . But do you feel the NCCN guideline potential addition to that could happen ?

Yale Jen: Maybe the last question here to squeeze in. I know it's awfully difficult to predict. Do you feel the NCCN guideline, potential addition to that could happen maybe later this year, or maybe early next year, or that's too elusive to predict?

Speaker #1: Maybe later this year , or maybe early next year or . That's too elusive to predict

Gerard Michel: They've all been known to have off-cycle meetings.

Speaker #2: They've all been known to have off cycle meetings . I think this one is the schedule is November They've all been known to have off cycle meetings .

Gerard Michel: They've all been known to have off-cycle meetings.

Yale Jen: Right.

Gerard Michel: The schedule is November. They've all been known to have off-cycle meetings. You know, all we can do is discuss, you know, the available data with the KOLs. Share our perspective that perhaps there's some areas of the guidelines that should be modified based on the latest data, and they really need to drive it. You know, we can send notes in, pharma companies, you know, requests in or information into the guideline committees. At the end of the day, when guidelines change, it's because the KOLs believe. We can help, you know, foster the conversation amongst them, but then it really is up to them to drive it. We're hopeful that they will. Again, this is more of a physician-initiated activity than a company-initiated activity.

Speaker #2: That is , you know , all we can do is discuss , you know , the available data with with the Kols us share our perspective that perhaps there's some areas the guidelines that should be modified based on the latest data and they really need to drive it .

Speaker #2: You know , we can send notes in pharma companies . You know , requests in or information into the guideline committees . But at the end of the day , when guidelines change , it's because the Kols believe us .

Speaker #2: So we can help , you know , foster the conversation amongst amongst them . But then it really is up to them to to drive it .

Speaker #2: And we're hopeful that they will . But again , this is more of a physician initiated activity than a company in that initiated activity .

Speaker #1: I just do understood . Well , congrats on the great years and look forward to additional growth

Yale Jen: Understood. Understood. Well, congrats on the great years, and I look forward to additional growth.

Speaker #3: Thank you .

[Company Representative] (Delcath Systems): Thank you.

Yale Jen: Thank you.

Speaker #4: This concludes our question and answer session . I'd like to turn the floor back over to Gerard Michel for closing comments .

Operator: This concludes our question and answer session. I'd like to turn the floor back over to Gerard Michel for closing comments.

Speaker #2: Thank you all for joining us today and for your continued support and thoughtful questions . Our mission at the company is simple to improve survival and quality of life for patients with liver metastases by delivering the most effective liver directed therapy available .

Gerard Michel: Thank you all for joining us today and for your continued support and thoughtful questions. Our mission at the company is simple: to improve survival and quality of life for patients with liver metastases by delivering the most effective liver-directed therapy available. None of this progress would be possible without the dedication and hard work of our entire team and the support of our investors, who are in many ways part of the team, and I want to thank every one of them. We look forward to sharing our continued momentum with you throughout 2026. Have a great day.

Speaker #2: None of this progress would be possible without the dedication and hard work of our entire team and the support of our investors , who are in many ways part of the team .

Speaker #2: And I want to thank every one of them . We look forward to sharing our continued momentum with you throughout 2026 . Have a great day .

Operator: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation, have a wonderful day.

Q4 2025 Delcath Systems Inc Earnings Call

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