Delcath Systems, Inc. Price & Performance (DCTH)

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, 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 ks. Those contained in subsequently 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 fourth quarter and full year 2024 results is available on our website under the Investors section and includes additional details about our financial results. Our website also has our latest SE 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, and thank you all for joining us today. 2024 was truly a transfer formative year for Delcalf given The U. S. Launch of Hebsado in January of that year. We generated $32,300,000 of HEPsado revenue in The U. S. For the year, including $13,700,000 in the fourth fourth quarter from 14 active U. S. Treatment centers. Importantly, in 2024, we secured both a permanent J code a new technology add on payment commonly called NTAP. While incremental revenue from Europe remains modest, reimbursement structures, European growth in 2024 over 2023 was 137% and this growth remains an important strategic component of the business. These achievements reflect the strength of our world class commercial team, has successfully navigated the complexities of launching Hipsato and expanded ChemoSat usage. Their ability to train multidisciplinary healthcare providers, secure hospital formulary approvals and drive procedural adoption at major academic centers has been exceptional. In the fourth quarter, our cash burn was only at $1,000,000 and we achieved $4,600,000 in positive adjusted EBITDA, a first for the company and ended the year with $53,200,000 in cash and investments with no debt. During the year, we received over $41,000,000 in proceeds from the exercise of warrants.

This financial stability enables us to expand R and D and and new initiatives to maximize the hepatic delivery systems potential treat other liver dominant cancers. Shifting focus to the specifics of Q4 results and 2025 plans. During the fourth quarter, we activated three new U. S. Treatment centers Duke University of Utah and Mayo Jacksonville. So far in 2025, we have activated another two centers bringing the total to 16 with an additional center scheduled for its first treatment in March. And eight more centers accepting referrals. Our goal remains 30 active centers by year end. It is important to note that the centers we have activated or are in the process of being activated are leading academic centers such as Mayo Clinic, MGH, Cleveland Clinic and Thomas Jefferson all of which are active as well as Northwestern and but accepting referrals. In Q4, the average treatment rate per site was slightly under two per month, a rate expected to continue in 2025 as we bring on new centers. Typically start at lower utilization rates. Before ramping up To support this expansion, we are increasing our commercial team and expanding from four to six regions. Each structure with that liver directed therapy manager, an oncology manager and a clinical specialist.

The liver directed therapy manager drives the hospital approval process and ensures the Huxedo Kid procedure team is appropriately trained and once the site is active supports the site as they manage the patient flow. The oncology managers engage community based medical oncologists outside of our treatment centers to a goal of building peer to peer referral networks between the community oncologists and the treating centers. The clinical specialists support the treatment teams in preparation for and during the treatment. With the goal of ensuring patient safety and improving patient outcomes. Additionally, we are enhancing the field's support to assist centers with administrative processes ensure accurate coding and efficient claims submissions. Which will facilitate broader adoption. Since the field force will be expanded by mid year, we expect more than half of the incremental centers to be added this year to come on board in the second half of the year. ChemoSat volumes in Europe grew 137% in 2024 with Germany up 75% and other markets including The UK and Turkey doubling year over year. There were two new centers activated and one existing center reactivated in Germany. We expect modest steady growth moving forward, maintaining a breakeven strategy in the region. [indiscernible] The strategic value of our European presence lies in supporting clinical trials and generating publications.

In 2024, over 10 studies from Europe seen centers were published including research on chemo sets used in intrahepatic gliocarcinoma. In 2025, we plan to expand into France, Italy and Spain complementing our strong presence in The UK, Germany and The Netherlands.

We continue to engage oncologists to both The U. S. And Europe to integrate HEBSADO into treatment algorithms. In 2024, the SCANDIUM three trial in Sweden began at screening patients This 40 patient study compares two cycles of ChemoSat followed by ipilimumab and nivolumab versus ipilimumab and nivolumab. Alone. Meanwhile, the CHOPAN trial in The Netherlands, which sequences two chemo sites treatments after initial ipilimumab and ipilimumab treatment therapy completed enrollment with seventy six patients in the third quarter of twenty twenty four. We expect the primary endpoint analysis of progression free survival at one year to be reported in the second half of the year. In 2024, expert consensus identified liver dominant metastatic colorectal cancer and metastatic breast cancer as promising new indications for Hipsauto. Our Phase two trial in in metastatic CRC received FDA clearance in December plus trifloridine tipuracil vabasumab, versus standard of care alone in ninety patients. Enrollment is expected to begin in the second half of twenty twenty five across 20 plus U. S. And European sites. The primary endpoint hepatic PFS is expected readout by the end of twenty twenty seven with overall survival data following in '20 Our market research estimates a total addressable market of 6,000 to ten thousand patients annually in the third line liver metastatic CRC.

The Phase two metastatic breast cancer trial in a third line setting of liver dominant patients is expected to begin in the fourth quarter of twenty twenty five, pending FDA IND clearance. Additional details of the trial design will be shared upon clearance. To drive further innovation, we are expanding our internal R and D capabilities As an example, we recently appointed Doctor. Michael Brunner a former President of the Society of Interventional Radiology over twenty five years of experience in academia and biotech leadership Senior Vice President of International Oncology to advance procedural improvements and exploring new indications.

In summary, the first year of U. S. Launch of Tabsado has been a success. In 2024, we have been able to provide a novel treatment to patients suffering for metastatic uveo melanoma. This success has brought us very close to cash flow breakeven and has directly led to a stronger balance sheet. We now have over $50,000,000 in cash and investments in no doubt no debt. We are well positioned to continue to grow revenue while investing in high impact R and D initiatives. Future for DelPath has never been brighter. I will now hand the call over to Sandra to share further details on our financial position. Thank you, Gerard.

Revenue from our sales of Hubsado was $13,700,000 and ChemoSet was $1,400,000 for the three months ended 12/31/2024, compared to $500,000 for ChemoSat during the same period in Quarter and 83% for the full year. Research and development expenses for the quarter and year ended 12/31/2024 were $2,900,000 and 30 and million dollars and $17,500,000 for the same period as the prior year. Selling, general and administrative expenses for the quarter and year ended $7,000,000 and 29,600,000.0 respectively compared to $7,000,000 and $22,100,000 for the same periods in the previous Fourth quarter and full year net loss was $3,400,000 and $26,400,000 compared to net losses of $11,100,000 and $47,700,000 for same periods in 2023. Non GAAP positive adjusted EBITDA for the fourth quarter was $4,600,000 and full year adjusted EBITDA loss was $2,500,000 compared to adjusted EBITDA losses of $9,300,000 and $30,000,000 for the same periods in 2023. As Gerard mentioned, we ended the year with $53,200,000 in cash and investments and cash used in operations was million dollars of operating cash burn in the previous quarter. Again, as of today, we have no outstanding debt obligations. Thank you all for participating today. Last year was truly an amazing year.

That concludes our prepared remarks. And I'd ask the operator to open the phone lines for Q and A. Thank you. Today comes from the line of John Newman with Canaccord Genuity.

Please proceed with your questions. There. Good morning. Thanks for taking my question and congratulations on all the excellent execution in 2024. The question I have is, as you are bringing new sites online in The United States for Habsado, I'm wondering if you're seeing any sort of change to the number of treatment cycles that patients are receiving given that perhaps some of the centers have some familiarity with the product through colleagues at other centers or if you're tending to see the initial number of treatment cycles around the same place and then sort of increase over time? Thanks. Sure. As you know, the label allows up to six treatments. And in the FOCUS trial, in that setting, it averaged out to 4.1 treatments. It takes about a year to know whether patients are going to go to full six. But if we look at the kind of what's called the decay curve, of patients when they start or for the patients who have gone a full year, where it looks like we're going to be at least the 404.1 that we saw in the trial. So it's premature for me to say it's going to be much over that.

But I'd be very surprised if a year from now it's under the 4.1. So but it's been remarkably steady to be honest. We haven't seen much of a change. Now the from center to center as they more treatments. Now with that said, You wouldn't expect It really is driven by patients either not tolerating the product or alternatively having disease progression. I think the tolerability is at least as good as we saw in the trial. And I would say the results the docs are seeing anecdotally are at least are better than what's seen in the trial. So those are the reasons it would end up greater 4.1. I'm hopeful it might. But premature to say that with any degree of certainty.

Great. Thank you. Our next question is from the line of Marie Thibault with BTIG, Please proceed with your questions.

Good morning, Gerard and Sandra, and congrats as well on a great 2024. I wanted to ask here about the plans on the sales add, expanding from four to six regions. Help us think through how we should be thinking about your SG and A ramp. You've certainly a very nice job of controlling OpEx, but we want to sort of understand the cadence of that coming through this year.

Sure. Sandra, can you Help with that.

Yes. For SG and A, I expect expenses in 2024, we're probably going to see about anywhere from a 30% to 40% increase over the year of 2024 into 2025, I think a lot of those expenses will come probably starting in second quarter. And mid year as we've been beginning to expand, but I know the sales and commercial team has already started that in Q1 a bit, but fully staffed, I guess, by midyear. Of this year. Okay, very good. And I guess a quick one on the pipeline. Thanks for sizing up the opportunities there. And updating us on the timeline. What's left to do on the device itself on making some modifications for those possible indications? And then what's left to do on kind of preparing for the trial in terms of finding interested sites, etcetera?

Sure.

In terms of device modifications, none are necessary. This is we're treating the METs and the liver. So whether or not the METs are from breast cancer, colorectal, uveolitic it doesn't really matter.

In terms of getting up and running for the trial, I've been asked by you to add some color in terms of the basics of IND approval for breast etcetera?

Fair. Thank you, Gerard. So in order to get the clinical trial started for the colorectal trial and for the breast cancer trial, our strategy is to focus on existing treatment sites and engage in a set of doctors who treat the respective diseases.

We expect this strategy will facilitate the activation of new sites because we'll be going to sites that are already trained and experienced in delivering the treatment. And engagement is primarily to generate interest and support of the breast cancer and colorectal cancer medical oncology communities.

Okay.

Very good. Thanks. For taking the questions.

Our next questions are from the line of Sudan Loganathan with Stephens. Please proceed with your question.

Hi, Gerard. It's Andrew. Thank you for the the update here and congrats on the progress. My first question is regarding R and D OpEx and your aggressiveness to be enough aggressive to have meaningful progress on that front yet maintain kind of a potential cash flow breakeven or profitability profile, which goal is the most important for you in 2025 to be EPA profitable?

Or be breakeven and maybe more robust on the R and D front. As I frequently tell investors and new investors and existing investors, don't count on us always being cash flow positive. If we have adequate R and D opportunities for this platform and the cost of capital is reasonable, and that second part is critical. We will invest Now, I would say that the bad news in my mind is that we can't get moving fast enough where there are the opportunities to spend all our money. So we'll be cash flow positive this year without a doubt. And perhaps follow year and for a while. But I'm purposely not making any promises of maintaining positive cash flow because I think that is an unnecessary [indiscernible] when they have quite a few high potential R and D [indiscernible] Got it. And my second question is, I noticed I think a price increase to about 187,500. In early February. I think that's about 2.74% price increase. Is that expected, that cadence going to be expected every six months now or once every year for Obsado? Or kind of curious how you're doing? It depends on inflation. Because with the legislation is that for CMS, you can't price higher than increase the price increases in faster than the rate inflation.

So, that's essentially it depends on what happens with inflation.

Got it. Thank you. And I Our next questions are from the line of Bill Maum with Clear Street. Please proceed with your questions.

Hey, good morning and thank you. So I just wanted to ask about your referral network.

What have you seen so far from that network Do you believe that most patients who should be referred are being referred? Or how much growth is there from strengthening that outreach effort to the more local centers?

Okay. Let me ask Devin to answer this.

Sure. Thanks, George. Our referral network is is working well to this point. We are getting referrals from the community into the larger academic centers. Even some of our new sites that are waiting for product approval are referring their patients to existing treating sites. And those patients will return back to the site once it is opened. We have built each of our regions out with a structure that Gerard mentioned in the in the where we have a dedicated oncology manager that is out talking to the community understanding their needs and helping facilitate referrals to active treating sites. And I will add that any good management team adapts strategy [indiscernible] if you dig through the archives and find what I said we would need in terms of centers, years ago. Definitely looking at more centers, almost twice as many as I thought we would need. I maybe said maybe 20 max two or three years ago or moving to 40. And that isn't because academic centers aren't willing to accept referrals and it's not that we are getting referrals there, but it's become pretty clear that to have patients fly four hours or drive seven hours, we're going to lose patients.

So we need more centers. So we're working hard on referrals. But the referrals are probably we need more centers that referral pipeline probably isn't going to be as big a mix of the business as I personally anticipated a couple of years back. But again, nobody has a perfect crystal ball.

Okay. And on the expansion of the recommendation from just liver confined to liver dominant, How many patients in your target patient population are hepatic, confined versus dominant?

Almost all patients eventually get extrahepatic bets. So it really is a matter, it's a moving target. It's a matter of when their primary when they're diagnosed initially, when they're first diagnosed, under half have extra hepatic meds, whether it's twenty percent or forty percent, it's hard to have the exact data. Our label includes patients with meds. The guidelines recently changed. It was strange when the guidelines got updated just around the time we were approved. They actually isolated liver mets which made no sense. We got on the phone with the KOLs around the country, talked to them, they thought it made no sense. They reached out to the guy in like a Mitty and it got changed pretty quickly. So there's no incremental patients in terms of our TAM because we've always included them. But that was a unexpected potential headwind, especially for docs out in the community who don't see a lot of these, if they just refer to the guidelines, that would have been a headwind for us. So we're thankful we got that changed.

Okay. And last one, I know there's no guidance, but looking at consensus numbers for 2025, I'm seeing $77,000,000 as dollars as consensus. So would you at least describe that as conservative or aggressive? I'm going to say no comment.

I figured I'd try. Thanks though.

Yes.

Our next questions are from the line of Yael Jen with Laidlaw.

Please proceed with your question.

Good morning and thanks for taking the question and congrats on the progress. Just want to get a sense of your CRC trial to start later this year, In terms of how many cycles do you think the patient may have or was there any adjustment in terms of dose or duration anything of that compared to your approved label or approved the things on the label orders any other adjustments?

Sure. Sure. Let me ask Valjia to take that question.

Sure. Thank you for the question. After discussing with leading experts in colorectal cancer, we decided to put forward a design that we believe will facilitate the adoption of liver derived therapy into this line of treatment of metastatic colorectal cancer patients. So we basically took as a basis the standard of care and we added the treatments for TIBSOVO at the beginning to make sure that we control the liver dominant disease So we plan to deliver two cycles. Of PHP followed by standard of care. Should patients progress after initially benefiting from the treatment, we have the option to pretreat them to continue to patient benefit that was delivered by the first treatment. So the base in certain cases.

Okay, great. That's very helpful. Maybe just I want to get a little bit more deeper, the order or sequence of treatment Why you have the upside of first followed by standard of care versus the other way around? Was there any differences? In that kind of Yes, absolutely. And the reason why we sequence PHP first followed by standard of care is that the definition of the patient population are those patients with the liver metastases dominate the clinical presentation. And for that reason, deliver tumor is the real problem and that needs to be addressed first and then the actual bad disease can be addressed later.

Okay, great. That is very helpful. Maybe the last question here is that I know you guys have start to expand in Europe. And in the prepared remarks you mentioned some of those. What is the sort of expectation of this year 2025 for that that effort particularly from a revenue perspective? And thanks. [indiscernible] The expectation and I may be setting the bar rather low, but the expectation is I said modest growth and I don't know whether or not it's 20% or 30%. In Europe, it's step changes will occur when we get reimbursement. We really only have reimbursement in Germany In The Netherlands, the hospitals that use it and they consider standard of care for taking it out of their own budget. In The UK, it's been private pay. If we do get reimbursement in a major market, it would rather probably be The UK is the one that's up, maybe The Netherlands We could see a step change those particular markets. But because it's not that's really the big big driver of future growth, new markets, which can take a while to get started as well as reimbursement. And they're kind of binary outcomes. I'm setting the the bar a little on the low side perhaps and just saying modest growth for now.

But again, the real value there for us is not the economic value, it's strategic value. The more centers that do it in Europe with its device label, which means and it can be used to treat any cancer, I think the more we see docs trying to use it and us getting publications.

Okay, great. Maybe the last sort of tag on that is that you guys need to do some sort of pharmacoeconomic, some sort of those studies or whether you already have that. [indiscernible] request for the reimbursement. Yes, we're not going to do a specific pharmacoeconomic study, but we have to we end up having to pay consultants to do models And the models according to the particular countries And we will do it for the every yes, no, I know, Toyo mostly, but yes, every country needs its own model and so The UK, we put a model together The Netherlands, we'll put a model together. Eventually, we're starting out in Sweden. I suspect we'll have to put a model together for them. Italy, France, etcetera, etcetera. But they're all basically we're gathering data we already have and putting into the country's particular model that I'd like to see.

Okay, great. Thanks a lot and congrats on the progress. All right. Thank you. Next question comes from the line of Chase Nikkerbacher with Craig Hallum.

Please proceed with your questions.

Good morning. Thanks for taking the questions. Gerard, I feel like I ask this question kind of every quarter, but I'll ask it again. Sorry. But just kind of in those eight centers, now that I guess we have 16 active and those eight centers that are in queue approaching being ready to treat patients. Do you have a sense for kind of when our expectation should be that those are online? Is that something we're in the first half of the year, we should have all eight of those centers at some point?

Activating and treating patients. And then so basically to get to 30 end of the year, we kind of need six incremental from there in the back half?

Yes. So we need 16 overall for the year. We've got two now. To reach the 30. Okay? I expect of the the balance of them more will come on board in the second half of the year. Because we're expanding the sales force, so we'll be hit the ground running and really be active in the second half of the year. So if you assume it was if you just divide by four, we need four quarter, I think going to be closer to 3.25 for the first two quarters and closer to five point two five for the back half of the year. Now my ability to predict this has been really poor, so we're doing well. But if I had to put some money on it, that's the pace I would Got it. And just if you could give us us a sense for kind of what percentage of volume is being driven by kind of top three accounts Are you starting to see some of that kind of broaden out to a lot of your other recently activated centers or just kind of idea on that? Yes. The percentage of business coming from the top three accounts has definitely been decreasing as we add more accounts.

But the Pareto rule probably still holds. I don't think it's quite eightytwenty. But maybe it's sixty-thirty. In terms of a distribution.

Got it. And then just last for me. There's going to be a readout that will be registrational on the HLA negative disease sounds like by the end of the year. Can you just remind us how you think about that program competitively with HEPsado and how you see Hepsotto fitting into the treatment paradigm if they are successful and things change in kind of a highly negative disease as well? Look, there are oncologists like systemic therapies.

Our job is to remind them, I don't want to say educate, but remind them that, hey, look, these patients die of liver failure. And if you let the liver disease get out of control, at some point, even we can't help them, our product can't help them. We think these patients should survive long enough to get both a systemic and the liver directed and I think they need a systemic on top of our product. It wouldn't be appropriate just to use our product in these patients. I think the systemics will battle it out amongst themselves We will be the only liver director that's appropriate for this patient population. Now, a second thing I would mention is we already faced a headwind from these products even before they're approved This is a very small patient population. And most of these patients end up getting treated at academic centers that are involved in these trials. So we're already faced you want to call it a headwind or understanding how to work with these treatments and that many of our patients already first going into the trials and getting ours as most of these trials dictate that you have to be treatment naive So we're already living it and I think it's appropriate that they get systemics on top of us.

Do you ultimately think we could move to something where there's some sequencing of therapy? Is that something you're looking to Yes. As a matter of fact, just yesterday, I was we had a small panel of docs. We were having a conversation with and that's what they do. It takes up to six to eight weeks to from a patient presenting and to them being ready to treat with our product for a variety of reasons ranging from prior auth to just having to map the patient and do a variety of evaluations with the patient. And these docs put them on TAB here at VIVO immediately. Treat them for two months or so, then take them off and start sequencing with our product. When I asked them, do you put them back on or do you do the full six? They do the full six service as far as they can go before progression or, tolerability. Tolerability issues arise. And then they put them back on the systemic thereafter. Now that's one doctor's or one center's protocol, but I think that's going to become increasingly common. Got it. And then just last for me, Gerard, Any meaningful off label use that you've seen so far in other tumor types in your experience in The U. S?

No. And as I said before, we've had centers approach who want to get open to do off label use. And we've said no, we have to start U. V. Melanoma.

I suspect we will start seeing some centers doing cases here and there. I would not bake into your model anytime in the near future like the next year or so any meaningful revenue from that though.

Great. Thanks, guys. [indiscernible] Our next question is from the line of Swamkullo Ramakanth with H. C. Wainwright. Please proceed with your questions.

Thank you.

Gerard, congratulations. I was looking into my email archive and just about four years ago, you and I were talking about how to get all the data from the FOCUS trial [indiscernible] And filed the application and here we are with $37,000,000 in annual revenue after four years. So huge congratulations to you and your team Having said that, so with with 16 centers now that have incorporated HPSALO, So What do you see any of them influencing the sales cycle? In terms of getting new sites on board?

Do I see it being changing in terms of the process to get new centers on board?

Is that or then in terms of competition saying that, hey, the other centers in the neighborhood have it, so we need to have it so that we can draw some papers. Yes, yes. Okay. I got it. Yes, so definitely, if we use the term fear of missing out or FOMO, there's definitely a little bit of that going on among the centers. So you had your typical early adopters who jump on board. And then maybe it flattens out a little bit and then that definitely has been a bit of a, I think, an uptick in interest as more and it's not necessarily vocal centers, but other name brand centers. XYZ has it, we have to have it. So I think there's a little bit of that going on. In terms of the learnings in getting centers on board, I would say each I've said this multiple times, each center is so unique that it's tough to have a well honed plan. I think the reps can anticipate potential problems and try to get ahead of them and they're trying to do that. But it's still a very almost say torturous process to get this thing up and running because it's a unique bird.

It's not because it's particularly difficult to do or anything like that. It's It doesn't fit into any particular it's a square peg round hole when it comes to approval, but we get it done.

Then coming down to gross margin, you exited 2024 with an 83%. What's the push and pull on that number? Especially thinking about $25,000,000 and beyond, at least in the short term? [indiscernible] Thank you. So R and D expenses, Q4 was a bit flat versus previous quarters, but we definitely are going to see a ramp up of R and D in 2025, anywhere from $35,000,000 to $40,000,000 As Boyo and his team continues to start the trial and get sites open. Of course, there's some some wiggle room in there and how fast. Sure mentioned we can spend money. But yes, there's definitely going to be a significant increase in R and D over 2024.

Did you ask puts and takes on gross margin as well?

Yes. That's what I was wondering. Like What's the push pull on that number?

Gross margin.

Gross margin. Gross margin.

Gross margin. I'm sorry. So we ended Q4 with 86% gross margin and we do expect that to continue into 2025 and you'd probably could reach 90% by the end of twenty twenty five. [indiscernible] most of the expenses are just our personnel. The bill of materials is is what it is, that's fixed. But we have a fair amount of leverage still with the existing team in terms of capacity putting more through. We have a tremendous amount of excess capacity in terms of just the physical infrastructure. So I don't see any large increases in expense CapEx, which would get loaded on over time on cost of goods. So I think we'll see incremental improvement. But with any high, high price drug like this, obviously, you kind of reached diminishing returns on a percentage basis. Even with higher throughput.

Yes.

Okay. And then on the expansion of the R and D what's the mandate that this group has now? What I mean is, is it more on the device improvement or is it trying to add [indiscernible] either chemotherapy or biological in terms of administering them either to the liver tissue itself or other tissues.

Yes. So the short term and the relatively low hanging fruit, although it's not that low hanging in anything in this industry, is to get up treat other liver dominant cancers. I'd love to be able to do a basket trial and have the FDA waive that through, but that's just not likely to happen. So yes, CRC breast, others that might make some sense to the future. I'm not saying this will happen, but ICC, pancreatic, to pick up two others that might make sense. Thereafter sequencing there sequencing therapy with immuno oncology agents of CHOPAN looks good.

There are lots of other that's one place maybe we would do a basket trial. You were doing well on an IO agent got a liver MET started progressing. That we might do as a basket trial. In terms of other agents, other chemo agents, even biologics, yes, we have a long list of ideas. I think we're walking now and getting ready to jot. Picking up other compounds is something we're definitely going to start looking at. But it's too premature for us to give any specifics. But I think it does speak to the fact that this is a platform. That can treat many different diseases in the liver. And we anticipate we as I said earlier in my remarks, if it looks like compelling R and D opportunity, we're going to make sure we have the right team to do it, but we're going to fund it.

Perfect. So talking about starting to jog, The ex U. S. Growth has been pretty decent in 2025 according to what you were saying at to us earlier. So in terms of Geographic expansion, what What geographies could be low hanging for '25 Are your scientists ensure first deeper penetration of ChemoSat in the current geographies and then worry about expansion new geographies. I'm trying to figure out how you're going to do this.

Yes. So we sold about as many units in Europe this year as we did in The U. S. Last year, excuse me. That gives you a sense of the differential in pricing and the value we could get. So again, I want to manage Europe where I'm not losing millions and millions of dollars every year. And expand it so that we can get the clinical data out of there. Now are there other such sites where now if we ended up getting a broad first line colorectal indication about half of those patients end up with Liberimax and that's not our trial. It's third line. It's a much smaller market. But if we end up getting, for example, first line colorectal, first line pancreatic which are huge numbers in terms of liver involvement. Then it might make sense to really push hard in other markets where we have lower pricing because the volume would help make up for it and we probably might have to consider lowering the price in The U. S. To get on policy and such. But right now with the pricing structure in Europe, with this particular set of data we have, which drives usage.

I think Europe is going to be modest growth, but strategically important. Might we go to Japan at some point? Perhaps it's again one of the long list of things the team is considering. But for now, I think again for the near term model of the company, think we think about The U. S. If we're thinking about a terminal value in your spreadsheet, I would factor in ex U. S. Sales. Yes.

Yes. Perfect. Thank you very much, Gerard and Sandler for our technology questions.

Sure.

Thank you. That concludes our question and answer session. I will also