Delcath Systems Inc (DCTH) 2025 Q4 法說會逐字稿

Greetings and welcome to Delcath Systems fourth quarter 2025, earnings conference call. (Operator Instructions). 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.

Thank you and welcome to Delcath Systems fourth quarter and year-end 2025 earnings call. With me on the call are Gerard Michel, Chief Executive Officer, Sandra Pinnell, Chief Financial Officer, Kevin Muir, General Manager, Interventional oncology, Boyo 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. Actual results may differ in a material manner from those expressed or implied in forward-looking statements due to various risks 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, 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.

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.

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 when PHP is sequenced with checkpoint inhibitors is slated for publication. Entering our 3rd 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. We have organized our com 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.

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.

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. 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 earlier this year, bringing three new sites online, specifically MD Anderson, UT Southwestern, and Mayo Clinic Scottsdale. We now have 28 Risk evaluation mitigation strategy, REMSs, 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 vaccinations 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 Chopan 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. 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 REM certified team members at a treating site. For instance, when key personnel take vacation, sites cannot easily add new patients. 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 two months of 2026, 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. 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 Hepzato kit and thus can appropriately consider its usage.

Oncologists 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 melanoma webinar hosted by Acure insight, several of our strongest Hepzato 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 Hepzato with systemic therapies can further enhance effectiveness.

We expect increasing impact from the Chopin phase 2 data. As a reminder, this investigator initiated trial showed that sequencing PHP with ipilimumab nivolumumab.

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, and the combination itself addresses concerns regarding treating patients with extrahepatic disease.

Leading centers at UC such as UCLA, Massachusetts General Hospital are already adopting Chopin inspired protocols, including flexible sequencing and combination use with agents like bentiusst in eligible patients. These data are helping both to establish zado as a preferred first line liver directed option and to expand the patient populations our treating oncologists are comfortable referring for PHP treatment.

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 hepzatoki 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 managed at 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. Our oncology managers then engage those physicians to provide education on treatment options and the locations of our treating centers.

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. 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.

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. In our ongoing metastatic colorectal cancer trial, we continue activation of new trial sites and now have a total of 8 centers actively screening patients.

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.

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. We are now targeting 15 trial sites and expect to activate activate them by late 2026.

We will provide guidance related to the readouts for 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 and various tumor types where there are clear areas of unmet need in the subset of these patients with liver metastases. We've had numerous well attended advisory boards and it will take another three to six months to finalize development plans for future combination trials and other invitations. I look forward to sharing future updates on this topic. I will now ask Sandra to review our financial results.

Thank you, Gerard. Revenue from our sales of Hepzato was $19 million and Chemosat was $1.7 million for the fourth quarter of 2026 compared to $13.7 million for Hepzato and $1.4 million for Chemosat during the same period 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 recognize gross 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. 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.

The growth in R&D spending was primarily driven by ongoing investments in our clinical team and the initiation of the phase 2 clinical trial evaluating Hepzado in combination with standard of care for MCRC and NBC. 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 $7.7 million for the same period in the prior year.

Full year 2025 SG&A was $43 million compared to $29.6 million in 2024. 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 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.

Non-GAAP positive adjusted EBITDA for the fourth quarter 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.

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

628,572 common shares were repurchased for $6 million through December 30th, 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 hephao kit procedure volume and greater than 10% growth in chemo stat.

The revenue guidance reflects the 340B pricing change and based on our current and projected customer mix, we do expect the 340B pricing back to result in an average selling price of around $175,000 per kit for Hipsato, 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 and realize pricing as we add new sites and the center's 340B eligibility kind of fluctuates quarter to quarter.

Forecasts for 2026, gross 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.

Thank you.

Thank you.

(Operator Instructions)

Marie Thibault, BTIG.

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 mentioned seasonality. Is that your third quarter that you're talking about when you talk about summer seasonality? 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 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. Just love to hear a little bit about the trends behind that.

Sure, thanks, I'll deal with the seasonality, at a high level, yeah, we do expect seasonality in the 3rd quarter, well not all of the seasonality last year was due to. Physicians and perhaps, patients, taking time off, a great deal of it was, and, although we are trying to increase staffing at the hospitals or RE 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. So expect to see it again, this year. Senator, you can count on the magnitude of the seasonality as well as the price in question.

Thank you Gerard. Yes, we want to remind everyone that, each patient is worth three quarter of a million dollars, so they're, we're going to try to temper the seasonality in the third quarter, 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.

So from a pricing perspective, yeah, we did have a slight price increase. Our list price went from 1875 last year to 1891. Again this is limited by inflation 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 on the list price, but seeing that some of our higher.

End users tend to 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 the 175,000.

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 time 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, or small amount of history, that's what we're assuming. 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%, so a bit in our favor.

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. You also mentioned some clinical trial centers, so, I wonder if you could just remind me of the difference between your Hepzato kit REMS site. Hepzoto kit site and then how we should be thinking about the differentiation between the sites that are, commercial and those that are that are purely clinical as we as we keep track of some of these metrics. Thanks.

Yeah, I'm glad you asked that. It's our intention is for the hepsato 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.

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 Hepzatokit.com. Website with a physician finder on that as well. Now, I did say in the past that we believed rem certified centers, even if they are clinical trial centers, needed to be put on that first FDA website.

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. So actually I'm glad you asked the question because this is a change.

So if investors want to know an analyst, how many treating centers there are, you just go to hepsatokitrems.com. Everybody there is either actively treating MUMS patients or is REM certified and we'll soon treat a MUMS patients.

So we do have some clinical trial overlap, but we'll only put those on there that are going to be commercial centers. So the short answer is look at hepsatokitrems.com for the number of treating centers. If you're a patient. Go to Hepzato tip.com because that's all the centers that are accepting referrals.

All right, very helpful.

Confuse the matter? Did I confuse the matter even more?

No, that was pretty clear.

Thank you, sir.

Thank you, thanks.

John Newman, Kocore Genuity.

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. And then also just how you plan to use that study in the United States and when we might start to see an effect. 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. Thanks.

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. 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, 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 doc, how doctors might interpret the data and safely use the combination.

And thirdly, I do believe a number of KOLs believe that the guidelines should be updated based on these data, both in perspective of highlighting. Hepzada is probably the liver directed therapy to use, for most patients, as well as showing that combination therapy with Ipiniva can be safely utilized and perhaps even downgrading the role of clinical trials in the guidelines.

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, 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. 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.

Great, thanks very.

Chase Knickerbocker, Craig Hallam.

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, but, 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 is it, are we seeing a little bit longer in the real world?

Average still is spot on within probably four, one that has changed very little. How long it takes them, it's more of a decay curve, what's the probability of getting to the next treatment.

Any single treatment patient might just get 1 or up to 6. Some are going past 6. In terms of the interval before treatment, it's probably stretching out closer to 8 than to 6. Every site is different. It's, the actual interview is probably 7 point some odd at this moment. I think in the low 7s, 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 going to go past 8. I don't think it's going to drop down to 6, it's going to be in that realm.

And then just on your guide, kind of with that in mind.

Can you kind of walk us through what it assumes as far as new patients 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 can can be above 100 million right? So should we think about it conceptually as a floor and then just walk us through what what you're kind of assuming as far as new patients starts through the year.

Yeah, we're assuming we average close to 0.5, which is what we saw last year, and with 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.

We think it's prudent to think that, as we gain more sites, which means we keep the average.

New patient per site per month, consistent with what we saw 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, some of the older sites get more productive than reach a cap.

The newer sites take a while to reach their stride on average, but as we add more sites, we're delving further and further into.

The overall TAM and, I think it's encourage should be encouraging investors that we don't think the average productivity will decline. It'll keep steady as we add sites.

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 and I realize it's, 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.

Yeah, no, I think, there are two things that will, I think, increase the pace. It's 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.

So increased field field presence and then the second thing will be with the publication of Chopin results, we believe that will take a bit of time to really make its mark, and I think that'll be in the back half of the year. 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.

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 even 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.

Yeah, so you know we are expecting, like I said, a healthy growth of nearly 90% in 2026, 2025. Now again this is dependent on making sure we get those sites open and enrolled, 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, so we see a big bolus 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. Marketing initiatives and the commercial expansion, Q1 alone will probably go up, nearly 30% to 40% over Q4 and then more of a flat or modest increase each quarter thereafter, so hopefully that'll give you a little bit more information for your modeling from an expense side.

Yes, thank you Sandra thanks guys.

Sudan Loganathan, Stevens.

Hi, thanks, Jordan Sandra. Well, 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. 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 so you know is there any catalyst or anything else to kind of rally around for the third quarter that could maybe help mitigate some of the seasonality 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?

I think the one aspect of the seasonality that we'll 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. The book excuse me, room time. And, physician 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. 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 and that's 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, 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. So yeah, we're hopeful for upside, but we think it's prudent just to be, I think not overly conservative but reasonably conservative in our guidance.

Got you. And then, one quick one, again, I don't run the Chopin, potential is, if you could potentially quantify that into, new patient start number, I know, I think you mentioned, kind of leveling off, around the 0.5, per patients per site per month. Could, Chopin add 0.1 or 0.2 to that? Just kind of curious if you have a quant quantified.

I'm going to stay as far away from that question as possible.

I have to ask it though, but I appreciate it.

Thank you.

Charles Wallace, HC Wainwright.

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

Thank you.

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. 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 a or ASP, it's, I think we're just going to we modeled 10% for the year, which is a little bit better than we were seeing, probably in the third quarter 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.

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, and.

Some of them actually choose not to use it because they want to use a different legal entity, so it's highly complex, but I think for now, just stick with the 10% that's what we're modeling.

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

Yeah, we're guiding right now, yeah, oh sorry, thank you, yes, we are guiding right now, 84% to 87%, in 2026, so I think it's, obviously dependent on the quarter sales as well as any, pricing impacts over this next year but even potentially hitting close to 90% in 2027, and beyond.

Perfect. Thanks for taking my questions.

Bill Maugin, Clear Street.

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? And then you've spoken before about one of Hepzano'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, leave more patients available to you.

Thank you.

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, 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. I think in such a severe disease such as this, I don't think It will, it's going to have a huge impact and we'll never know, I jokingly say unless we have a kind of a parallel universe experiment, we just won't know.

In turn, 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 Relimune 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 EBITDA trial, which was a big one.

Finished enrolling, late last year. So that pressure has diminished. So, I think, we have a steady headwind. It's definitely a bit less than we saw, and 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.

Yale Jen, Laidlaw.

Good morning and thanks for taking the questions.

Just two up here. The first one is, I 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 of, patients, from much larger sources.

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 and we're seeking out our sites. The, and to do that, we have to get patients who, Their, doctor who is likely a doctor who treats cutaneous melanoma, just quickly says, hey, for the HLA 2 negative or TEBI for HLA-2 positive.

Cutaneous melanoma docs don't, in their normal, mixed practice, don't refer a lot of patients for liver directed therapy. 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. 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. So yeah, it is a critical important activity for us to continue to deliver growth.

Okay, great. That's very helpful. One other question is that, given some of the sites already, been, 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, or you feel that, for all those sites you are pretty much rich, steady state that fewer patients, fewer less more patients can be added in per side.

Yeah, there, 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. We'd love it if they did that, we're ready and willing to help them on the training the new team members, but that would be the dial that has to be turned to increase their capacity. 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.

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. It shouldn't it's for our label, but some of these docs just say, hey, cancer is a systemic disease. I'll only treat this patient if they only have hepatic disease.

So the first one of those is, we'll try to impact with, by changing guidelines, if at all possible, to deemphasize clinical trials. And the second one, we'll try to put the date 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 and that's kind of a, an educational component so trying to change guidelines which again is not a slam dunk or modified 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 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 and, the expanded MSL force, the expanded sales force, the Japan data, perhaps some changes in the guidelines all should help us there.

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 that could happen maybe later this year or maybe early next year or that's too elusive to predict.

They, 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. That is, all we can do is discuss.

The available, data with the KOLs, 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, we can send notes in pharma companies, request in or information into the guideline committees, but at the end of the day.

When guidelines change it's because the KOLs believe so we can help, foster the conversation amongst them amongst them, but then it really is up to them to drive it and we're hopeful that they will, but again this is more of a physician initiated activity than a company in that initiated activity.

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

Thank you. This concludes our question-and-answer session. I'd like to turn the flat floor back over to Gerard Michelle for closing comments.

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.

This concludes today's teleconference. You may disconnect your lines at this time.

Thank you for your participation and have a wonderful day.