ImmuCell Corporation

Good morning, everyone, and welcome to the EmuCell Corporation conference call to discuss strategic change in focus and unaudited 2025 sales results. All participants will be in a listen-only mode. After today's presentation, there will be an opportunity to ask questions. Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Joe Diaz with Lithium Partners. Please go ahead.

Thank you, Jamie. Good morning and welcome. As our operator indicated, my name is Joe Diaz with Lithum Partners. We're the investor relations consulting firm for Emucel. I thank all of you for joining us today to discuss a change in Emucel strategic focus and the unaudited sales results for the fourth quarter and full year, December 31, 2025. Listeners are reminded and cautioned that statements made by management during the course of this call include forward-looking statements. which include any statement that refers to future events or expected future results or predictions about steps the company plans to take in the future. These statements are not guarantees of performance and are subject to risks and uncertainties that could cause actual results, outcomes, or events to differ materially from those discussed today. Additional information regarding forward-looking statements and the risks and uncertainties that could impact future results outcomes, or events is available under the cautionary note regarding forward-looking statements or the safe harbor statement provided with the press release that the company filed last night, along with the company's other periodic files with the SEC. Information discussed on today's call speaks only as of today, Friday, January 9, 2026. The company undertakes no obligation to update any information discussed on today's call. Please note that certain non-GAAP financial measures will be made during today's call. With that said, let me turn the call over to Oliver Tabucor, President and CEO of Emicell Corporation for opening remarks. We will then have further remarks from Tim Fiore, pardon me, the CFO of Emicell, and then we will open the call for your remarks and questions. Oliver?

Thank you, Joe, and good morning, everyone. This continues to be an exciting time at Emusel. We shared in late December that we are shifting our strategy as a company to focus on first defense, and consistent with prior practice, we have an earnings call to discuss our full-year financial results, which will take place in late February, and we will not be commenting on earnings estimates to date. However, the strategic shift is significant for our company, and we decided it would be helpful to review the implications of that decision and our fourth quarter and full year on audited sales results in today's call. So we're happy to report that we had a near record sales quarter, and this one was without tailwinds from catching up on back orders in the fourth quarter of 2025. Our Chief Financial Officer, Tim Fiore, will walk us through the numbers in more detail, but 8.7% growth in the U.S., And 41.3% growth of TriShield in the fourth quarter of 2025 compared to the fourth quarter of 2024 are exciting achievements for the company. We're also seeing substantial improvements to our manufacturing output with more to come. And as recently announced, we are now in a position to repurpose manufacturing assets from Retain to support our long-term growth at Burst Defense after we decided to suspend investment in manufacturing Retain. Our decision to redouble our focus on first defense and pause investment and retain is based on two factors. The first is that we have very high confidence in future sales and profit growth potential in our first defense business that we feel justifies investment and focused execution. The second reason is the unfortunate stumbling block post when the United States Food and Drug Administration, the FDA, issued an incomplete letter for our retain new animal drug applications. The practical implication of the FDA's decision is that we are still years away, rather than just months away, from achieving an FDA-compliant manufacturing solution needed to launch this product. Continuing to invest and retain would have required an increased commitment to fund expenses and capital investments to bring this new product to market, diverting resources that could instead be devoted to expanding an existing successful product franchise, namely First Defense. Let's talk about First Defense. Our First Defense products address a critical industry need for protecting calves. The newborn calf market has evolved rapidly over the past five years as calf values have increased significantly, driven in part by widespread adoption of beef on dairy crossbreeding and the shortage of beef calves related to drought and the closing of the Mexican border, amongst other things. As a result, newborn calves can be worth approximately $1,300 on day one of life, compared to roughly $200 in 2003. Historically, dairies would derive 2-3% of their yearly income from selling the calves they don't need, and now it's up to 20-25%. And this macro trend has raised the economic stakes of early life calf health and survival. Immucel's first defense provides proven protection against neonatal scours, helping to safeguard these high-value cats. So we believe we have great runway in the market for scour protection, which we have estimated is approximately $900 million in total addressable market worldwide. So our strategy is to get out and meet more customers with strong medical, scientific, and outcomes-based arguments for trying and using our products. We also have opportunities for increasing our first defense manufacturing output through operational improvements. In 2025, we increased output of our key bottleneck process, lyophilization, by more than 15%, and we believe we can achieve a similar rate of increase in 2026, and to do so without using significant incremental capital. So more on that later. All these opportunities in our first defense business require, and in our judgment deserve, increased focus and execution. Now, a second reason for our shift is the FDA's incomplete letter for retain. We have been developing this innovative treatment of subclinical mastitis in dairy cows for some time, and thought we were close to obtaining final approval. Immucel passed FDA requirements for safety, efficacy, and four of the five technical sections of our application, and we had expected that our contract manufacturer's completion of the fifth technical section would soon follow. You will recall that we decided to employ this contract manufacturer for filling the active ingredient into syringes in order to limit our capital expenditure and to reduce our risk. And unfortunately, that is not how things worked out. We are not in a position to comment on details, but we understand that the reason the FDA declined to approve Our application was because our contract manufacturer had still not satisfactorily addressed previously cited inspectional deficiencies. So we received the incomplete letter on December 23rd and shared this news with you the next business day. The incomplete letter from the FDA, combined with our contract manufacturer's refusal to extend their contract beyond March 2026, meant that we would have had to restart our manufacturing section and spend an unknown period of time, years, to obtain approval, incurring significant expenses along the way. We decided this is not the highest value use of our company's resources. Instead, we will complete the investigational studies that are underway to document efficacy in the field and then prepare the best case we can for a potential future partner for a retain. In the meantime, we will redeploy most of the manufacturing assets that were built for retained toward expansion of FIRST Defense capacity. FIRST Defense also uses liquid processing equipment, for example, and we have determined that most of the retained equipment can be repurposed. At this point, I'm going to turn the call over to Tim Fiore, our Chief Financial Officer, for a deeper review of the financial implications of this decision and the quarter and full year sales highlights. Tim?

Thank you, Oliver. I'll start with product sales results and then discuss implications of the change in strategy as well as some other balance sheet adjustments. Product sales for the quarter came in at $7.6 million, a decrease of 1.6% as compared to the fourth quarter of 2024. We're pleased with the overall product sales number. As mentioned in the last earnings call, we did anticipate difficult year-over-year growth rate comparison as the fourth quarter of 2024 significantly benefited the backorder situation. Domestic sales for the most recent quarter grew 8.7% as compared to the fourth quarter of 2024 to 7 million dollars. We experienced a decline in international markets, mainly driven by order timing in Canada, with Q4 declining 52.6% year over year. Shifting to full year 2025 results now, we grew 4.3% as compared to the full year 2024 to total product sales of 27.6 million dollars. Similar to the quarterly results, we saw full year over year growth in domestic sales and a decrease in international sales. The other notable trend within the first defense suite of products is that we are seeing a shift towards Tri-Sield in both the quarter and full year, reflecting a migration from dual force products and the acquisition of new dairy and beef customers seeking protection for their calves. Now let's talk a little bit about some balance sheet related items, starting with some items related to the shift in retain strategy. As Oliver discussed, we're shifting our resource allocation away from Retain and to First Defense. As part of that decision, we did an initial evaluation of over $15 million in property, plant, and equipment related to Retain and concluded that the majority of it, including our building and most of the equipment, would be useful for the liquids processing part of our First Defense manufacturing process. There are, however, certain pieces of equipment, such as the aseptic filling machinery, which will not be useful in the manufacture of First Defense. The immediate financial impact of that assessment is a non-cash impairment write-down of some existing assets, which will impact Q4 of 2025, currently estimated at $2.9 million. As we continue to evaluate the repurchasing of the building, it is clear that modifications to the building and additional capital will be necessary, and we are currently in the process of evaluating the company's needs and related costs. In addition to our evaluation of retained assets and the shift in strategy to maximize the return on our assets and future cash expenditure, we conducted a thorough review of other fixed assets and inventories as part of the year-end closing process. In management's evaluation of inventory in conjunction with the manufacturing team, we have decided it would be prudent to take an estimated write-down of approximately $600,000 This write-down mainly concerns previously purchased colostrum that we deemed not suitable for our requirements and which we therefore intend to sell on the open market without further processing. We take the management of assets and inventory seriously, and we have implemented rigorous and disciplined capital allocation processes to drive the highest and best use of our resources. With that, I will turn the call back to Oliver for some closing remarks. Oliver?

Thanks, Tim. We are very focused on the commercial opportunity that we have with the first defense solutions, including new products in the functional feed line that were launched in June. As recently announced, we are expanding our sales team by 50%, creating two new U.S. sales territories and adding an international business development executive to our team. We want to spend more time with more customers to drive growth. We see expanded runway for first defense sales, and we are excited to execute our growth initiatives. We're also very focused on operational excellence to ensure the consistent supply of quality products. Our decision to redeploy former retained manufacturing assets for first-defense liquids processing will help us achieve our long-term capacity expansion objectives and prevent liquids processing throughput from becoming a challenge for us. In the meantime, we are continuously driving optimization of our lyophilization activities, which are typically our bottleneck. In 2025, as mentioned, we saw more than 15% year-over-year increase in liabilization output, and we are implementing more ideas to maintain that rate of improvement during 2026. These two actions give us confidence that we'll be able to meet customer needs for first offense. When we finalize our capacity expansion plans in the coming quarters, we will provide more details. Our top priority at EmuCell will continue to be solid execution across the organization. And with that said, we would be happy to take your questions. Let's have the operator open up the lines.

Ladies and gentlemen, we'll now begin the question and answer session. To ask a question, you may press star and then 1 on your touchtone phones. If you are using a speakerphone, we do ask that you please pick up the handset before pressing the keys. To withdraw your questions, you may press star and 2. Again, that is star and then 1 to join the question queue. We'll pause momentarily to assemble the roster. And our first question today comes from Frank Gaster. Please go ahead with your question.

Hi. Thank you very much for taking my questions. Great quarter. It was anticipated from your previous quarter that sales were kind of iffy, I'll say. but you've managed to have a remarkable quarter. With that being said, I have to say briefly, I've been an investor in MSL for more than 25 years. So, I have a working knowledge of historical performance and questions. So, I do have some questions. in regards to your focus, some of which is not necessarily new, but certainly welcomed, such as the shift to also looking at foreign sales. With that being said, I know that in the past it was certainly brought up And one of the aspects of it was that there's some regionality in the pathogens. So, I guess my question then is, to what degree do you think this impacts foreign development? And secondly, what? qualifications, what requirements are you looking for for this new position in regards to exploring and hopefully increasing foreign sales?

Frank, thank you very much for your question and for your trust in Emucel as a long-term investor. We really appreciate the confidence. International sales are complicated and what we need to do is we need to hire somebody who has experience launching products in international markets because there are very significant differences in product requirements but also go-to-market strategies that should be deployed when considering international sales. Now, as you know, we're already in Canada and some other markets, Korea, et cetera, with our products. But there are differences in specific pathogens that drive scours in different markets. But there's also a lot of similarities. For example, rotavirus is a problem essentially everywhere. So our pivot to focus or double our focus on first offense includes hiring expertise to help us drive those sales. You can't get there without that expertise and experience. So we're negotiating currently with somebody who has that experience and who hopefully will join our team. I hope that answers your question.

It does. I have further questions, but I'm going to get back in the queue and give other opportunity, but I I do have several other questions. Thank you.

Thank you. And our next question comes from David Shampo. Please go ahead with your question.

Thank you. My question relates to the contract manufacturer for Retain. Has the contract manufacturer provided an explanation for its failure or unwillingness to comply with the FDA requirements that resulted in the incomplete letter?

Thank you, David, for your question. We are in the midst of completing our conversations with this contract manufacturer, so I'm going to decline to give you more details at this point. But obviously, we're promoting the best interest of our shareholders in those discussions, as you might imagine.

Okay. I don't know how far you.

I might just add one other thing that based on the letter that we received from the FDA, it is clear that the incomplete that we receive for our application is solely due to the circumstances at the contract manufacturer.

Understood. Thank you. Is it, I mean, you may not be comfortable commenting on this, but I'll ask the question anyway. Is it your view that the contract manufacturer has contractual obligation to Emucel to maintain its facilities in compliance with the FDA requirements?

Yes, that is my view.

Okay. So, I'm not sure what's going on between Emucel and the CM at this point, I would assume that as part of protecting the interest of Imucil, one possibility is pursuing the CM for damages resulting from its protracted and continued failure to comply.

David, unfortunately, we can't comment on that.

Okay. One last question. Thank you for your question. Given the impasse with the FDA and the pause on retained activities, In your view, how realistic is it to expect that a licensee buyer or other strategic partner or retain can be secured on favorable terms to MSL?

Well, there's a lot of different components to your question. We have a high degree of confidence in our product and in its capabilities and in its usefulness to dairy farms everywhere who are trying to combat mastitis without using antibiotics. So our job now is to find the best go-to-market strategy and the best kind of shareholder value-maximizing way to do that. And our determination is that manufacturing retained in-house is not the appropriate use of resources or the highest return use of resources. So after we have completed our investigational studies in 2026 – we will have a good set of arguments to go out and seek partners to help us maximize the value of retain.

Great, thank you.

Thank you. Our next question comes from Felix Hettinger. Please go ahead with your question.

Yes, thank you for taking my question. And I think 50% was also already requested by David, so I will keep it short. So retrain, okay, I think you're in a situation where you cannot give any light on potential strategic, so that's fine for me. So I will focus now on the current business when it comes to the rehires as well as the cash needs in the future. So I read your letter on the 23rd of December as well as the update from your quarter, so congratulations to that. I understood that you currently developed or designed two new territories. I was not sure if this already included new hires of the territories. So my question is, number one, if not, what is your expectation timeline to hire new people to be able to run fully focused on the current portfolio? And number two, I read something that there's also a cash need for the business. So I would like to know if there are any additional, let's say, increasing of shares planned in the future, dilution of shares, anything else that can be funded from current operations. Thank you.

Thank you, Felix, for your two questions. Let me address the first one and then turn it over to Tim for the second question that you asked. So the first question is related to sales team expansion. So what we have done is we've taken a look at the market share and number of animals still to be won over to our product for each of our territories and determined that there are two territories, new ones, that we should create because there is so much potential still in those territories. And so it's a question of number of cows and market share of cows or calves, we should say, that are already on our product. And so we will be hiring two new individuals to augment our current US sales team, field sales team. And those hiring processes are underway. There's quite a lot of interest because of the strength of our brand and our product in the market. So we're going through that hiring process now. We've also, as I mentioned in the answer to a previous question, determined that international requires a dedicated individual. So we are in negotiations with somebody for that now, but have had a lot of interest in that role in all three roles. And so hope to complete those hiring processes as quickly as we possibly can, certainly this quarter. But I think that was your first question. And then I like to turn it over to Tim for your second question.

Yeah, thank you for your question. Yeah, you're correct that we will require investment as the company grows to meet that need in manufacturing. One of the things that we've talked about in the past is the freeze dryer number five. That is still something that's on the radar, and that's around $3 million worth of capital outlay that would be required. Additionally, as we mentioned in the press release, we are – looking at the costs associated with repurposing the former retained facility. As far as how we would fund something like that, I really would decline to comment on that. There are multiple ways. Of course, you can fund things through operating cash flow, also loans and or capital raises, and I wouldn't take anything off the table. It all depends on what the economics of those choices look at the time we want to pull the trigger on investments. But I appreciate the question. Thank you.

Thank you very much.

Our next question comes from Jonathan Rothschild. Please go ahead with your question.

Hello. Congratulations for making some very tough decisions. But I had a question on retained regarding the FDA's view of the API or the material that IndyCell makes itself. Is that something that is distinct from what you refer to as the manufacturer of someone who's just making an intermemory injector and also keeping it separate from their other products? So the reason I'm asking this is, what is the FDA view of the API itself? This would affect efficacy, safety, all the four or five other technical sections that were already approved and what will happen as a result of you answering this question could give shareholders hope that there is an ability to partner this product since you have already decided that you're not going to do it in-house and you were not capable of doing it on scale anyway based on the timeline that was already in effect. So, let me know, please, how you expect the API itself to be judged as a subsection of the CMC section. Thank you.

Jonathan, thank you for your question. Let me try to explain it this way. There's two manufacturing process. There is the manufacturing of our active pharmaceutical ingredient, also called drug substance. And then we have the second part of the process, which is taking that active pharmaceutical ingredient and putting it in an injectable format, a septic injectable format. And we've called that a drug product in various disclosures in the past. So there's two separate processes. The first process, we have proprietary capabilities here at Emucel that we've built over time to be able to do that. And the second process is what we have outsourced to a contact manufacturer who had experience with this process, who had previous FDA approvals, and who was a reputable contact manufacturer, well-known in the industry. The FDA has given us, Emucel, approval for everything other than manufacturing. And then within manufacturing, for our processes, we have passed inspections by the FDA. So, you know, flags on green or lights on green on the parts that we do here at ImmyCell. It is only the part that was done by our contract manufacturer, which is now blocking the FDA from being able to give us an approval. So... we, like I think I mentioned before, have high confidence in our product, believe that the best strategy is to, in fact, find a partner, and that that is a better use of our resources, our cash, rather than investing in our own commercial team and maintaining manufacturing while waiting years for a new FDA approval process to be completed. So, I have I previously mentioned that I believe there is a good product here and that a partner should be able to be found, but that's something that we now have to go do. Thank you very much. We've decided to do that once we have our investigational study results because that gives us really good ammunition or arguments, I should say, for any potential partner.

Yeah, a question on that second point that you mentioned. There is a second pivotal study in process, and do you have an estimated timeline when those results may come out?

I spoke to the chief investigator on that study in late December, and You know, one of the things about these studies, to have really good arguments, you need to have really good thorough study designs. You need to have a large number of animals enrolled in the study. And so we essentially completed our enrollment in December and expect Michigan State University, which is the university that we're working with here, and a key opinion leader in the field of mastitis to complete these studies in the first half of the year. But we're not going to rush that because the quality of the study, the rigor of the study, is going to drive our success in figuring out our partnering strategy.

Thank you for explaining this so clearly.

Thank you. Once again, if you would like to ask a question, please press star and then one. To withdraw your questions, you may press star and two. Our next question comes from Tom Fox. Tom Fox, please go ahead with your question.

Good morning. Thank you for taking my question. Um, I'm just looking for a little bit of clarity on this self-imposed milk discard period for retain. So I'm going to fire off a couple of questions here. Um, you say you're doing this out of abundance of caution. What exactly does that mean? Um, I'm also wondering, is this going to be like a permanent issue and how much milk, how much less milk will be dumped compared to what farmers have to dump with antibiotics? Thank you.

Thank you for your question, Tom. So we've discussed in previous calls and disclosures that our product is so effective against bacteria that it also has a small impact on the good bacteria that you need to make cheese. And so what that requires is that for those farmers who are producing raw milk for use in cheese manufacturing processes, they need to voluntarily withhold the supply of the milk of a cow treated with Retain for a few days while that flushes out of the cow system so that there's no impact on cheese manufacturing processes. So our withdrawal period when we started this project was zero days, which is a very clear argument to be made from the market. And now it's a few days, but it's still less than half of the withdrawal period of the main competition. So there's an advantage, clear advantage of retained. It's, I think, four milkings is the number of withdrawals that we would recommend for our product. It's 10 for the market leader out there. So clear advantage, but not as clear as zero. And so that does mean that we would probably need to invest more in our commercial infrastructure to be successful with this product than we very originally thought. I hope that answers your question. It's certainly a factor in deciding the best use of our cash going forward that we believe a commercial partner might be a really good idea for this product.

So you are open to the idea that this might not be a forever thing, that you could get the discard period down to zero days. Is that what you're saying?

No. I just want to be very clear about that. The discard period for those farmers who are providing raw milk to both cheese as well as fluid milk processing plants, it will always be more than zero. The FDA won't impose a withdrawal period because this does not impact in any way human health, and that is what the FDA imposes withdrawal periods for, to prevent antibiotics from getting into the human supply chain. There is a withdrawal period that the FDA requires for antibiotics used for mastitis or any other reason. The FDA will not require a withdrawal period on our product because our product is not an antibiotic and poses no issue for human health. But in practice, if you are a farmer that is providing raw milk for cheese processing, you should not – we're suggesting a voluntary withdrawal period of those furrow milkings. In the United States, it's increasingly – common for farmers to obviously, you know, to provide raw milk for both uses. There may be some countries where those are still separated, those processes, so that you can sell to some farmers without a withdrawal period. But those are all not kind of – those are not the key points in our decision-making. In our largest market right here, we recommend a four-day – four-milking withdrawal period for retain.

Okay. Thank you. That answers my question. Thank you. Thank you.

Our next question comes from George Melis from MKH Management. Please go ahead with your question.

Good morning. Thanks for taking my question. It's a fairly simple question. Your sales exceeded your expectations. Can you help us understand? I don't know if you've had time to really analyze them, but... How do they exceed your expectations? How do you explain that? Thank you.

So, George, really appreciate your question. As we discussed in, I think, the two last calls, it is complicated to make good estimates of future revenues when you're coming out of a backorder situation, because there are orders that are coming in because folks are trying to get back to regular inventory levels. I mean, our distribution partners and our sub-distributors. And then there's orders that are coming in because we're winning new customers. There's orders that are coming in because we're regaining customers we may have lost. So there's a lot of different drivers, which makes compares kind of complicated. But when we looked at our results at the end of the third quarter, as good management practice, we make estimates as to what we can expect in the fourth quarter and then execute accordingly. And I have to say compliments to the commercial team here at Immucel for achieving a higher level of revenue than we had anticipated just looking at some from run rate trends at the end of the third quarter. So we were very pleased with these results. It will continue to be difficult to completely analyze the effects of former backorder situations on current revenues. So in the next quarter or two, it will still be complicated. But overall, we're very happy with the – I think this is our third highest revenue quarter ever. And once again, we believe that there was very minimal impact of the former backorder situation left in our results.

Yeah, I would just add that we do, you know, we have published the backorder numbers in each 10Q as we've gone through time, so those are available when you're analyzing revenue.

Okay, thank you.

Our next question comes from Ross Tollander from Capital Alliance. Please go ahead with your question.

Yeah, great quarter of sales, and I think it, by my expectation, must have improved over the second half of the quarter, you know, since the previous call was really in the middle of the operating period. Just kind of building on the question that George had just asked, was there, you know, momentum in the last month specifically? And is there any feel for that momentum, you know, kind of continuing here early in this quarter, you know, given that this is really the peak calving season in, you know, domestically? So I guess I'm just looking for a little more color on, the cadence of revenue during the quarter, if you can comment on that.

We wouldn't be able to comment on that. Well, so in Q3 when we were talking, we certainly weren't considering anything in our commentary there related to Q4 or trends in Q4. We really were just presenting Q3 results and not offering anything for looking on that. I don't think I really want to get into commenting on sales trend within the quarter either just for I haven't analyzed that specifically. I wouldn't say there's anything that, you know, struck me. We do have, you know, shipping dates. So the way that we ship required that at the end of the – the very end of the quarter we had a little bit less shipping just due to holidays. But that's the only real trend within the quarter that I think might have been relevant.

Okay. Thank you.

I don't really think there's anything there, to be honest. Yeah.

Thank you. And our next question is a follow-up question from Frank Gasker. Please go ahead with your question.

Yes, again, thank you. To further the previous caller, Q1, actually Q4 and Q1 are historically your best quarters. Do you see any deviation from that trend that's been going on for ever?

No, I think we'll still continue to see some seasonality in the business. Of course, as we move into new products and customer bases such as beef, you know, there might be changes over time, but currently right now we still would expect to see the same type of seasonality, I believe.

OK. And in your statement in December, you referred, and I quote here, improved set of claims. And this is in regard to retain, and I'm assuming that it's also related to the, yeah, Could you elaborate on that a little?

Thanks for your question, Frank. So it's usual when you apply for FDA approval for a product that you start with a claim and you go through the process to get that claim approved. And along the way, you do more studies to see if that claim can be expanded, approved, both for the ability to market it more effectively or to address just a bigger set of problems that, in this case, dairy farmers are finding in their cows. And so, you know, in collaboration with the FDA, we obtained their approval to do some investigational studies to look at an expanded or better set of claims, and we put together a very rigorous study to validate some of our hypotheses about how our product could be best positioned in the market. And we're all very anxious now awaiting the results of these studies because testing the product in the field in an active dairy farm situation and really kind of testing the boundaries of its capabilities is what we're trying to do here. So, we're looking forward to getting those results, and as I mentioned, that won't be for a little while because it needs to be really well done, the study, in order for us to have, you know, claims that we can back.

Presently, by my understanding, the claim is in regards to preclinical mastitis. I imagine that an improved set would indicate use on a clinical aspect. Is that part of or is it potentially further potential for maximizing retain?

Well, expansion of claims in any direction would enhance the value of retain. I don't believe in the past we've disclosed much about the current claims. It's also competitively sensitive information, to be honest. There's a very, very strong competitor out there who is the market leader in this space. So, we're going to wait for what comes out of these studies, and we will be communicating at that time what

what you know what the next steps are um and and can't really comment in the meantime on any of the specifics unfortunately okay um i have one more um and this uh might be a little tough i guess increase the shift in in the increase to try shield very encouraging uh And it's certainly significant. But in previous calls, there was some regard in the fact that one of the reasons of reduced margins was the fact that TriShield requires additional processing. To what degree, my question would be, are you addressing the margin reduction that occurred from this aspect?

Yeah, I think what we've said in the past is that TriShield has the two components we call manufactured units in it, so the cost is higher, but of course, the price is also higher. I don't believe we've ever specifically stated anything about the product's margin. And in this call, we're not planning on covering anything related to margin. Perhaps it's something we can consider for either the quarterly earnings call or future calls.

Okay.

I'll add one more thing just to address your question about improving margin over time. I think that's When we increase the capacity, like we've been talking about in this call, you know, 15% increase in output this year or in 2025, and then, you know, striving for similar results in 2026, that will certainly, you know, help margin over time. But it's not specific to Tri-Shield. It's just general manufacturing improvements where we're looking at bottlenecks and reducing or addressing those bottlenecks over time, so.

Okay. All right, thank you very much.

Thank you. And ladies and gentlemen, at this time, we'll be ending today's question and answer session. I'd like to turn the floor back over to Joe Diaz for closing remarks.

Thank you, Jamie. I would now like to turn the call back to Oliver to boot course for closing remarks. Oliver?

Thank you, Joe. And thank you, everyone, for your excellent questions. Before we leave, I want to thank my predecessor, Michael Brigham, for his 30 years of service to Emucel, including 25 years as CEO, and for his support during my transition. Today is his last day, and he will be missed sorely by all of us here. So thank you, Michael, and congratulations on your well-deserved retirement.

Thanks very much, Oliver. I've enjoyed my time at Emucel very much. I have a lot of confidence in the future of First Defense, and I wish the team the very best.

Okay. Thank you, Oliver, and thank you, Michael. We want to thank everyone participating on today's call. We look forward to talking with you again to review the results for the year ended December 31, 2025, on February 26, 2026. Thank you, and have a great day.

Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We do thank you for joining. You may now disconnect your lines.