IMMUCELL CORP /DE/ — Call Transcript 2026

Good morning, everyone, and welcome to the ImmuCell 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 Lytham Partners. Please go ahead. Thank you, Jamie. Good morning and welcome. As our operator indicated, my name is Joe Diaz with Lytham Partners. We're the investor relations consulting firm for ImmuCell. I thank all of you for joining us today to discuss a change in ImmuCell's 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 filings with the SEC. Information discussed on today's call speaks only as of today, Friday, January 9th, 2026. The company undertakes no obligation to update any information discussed on today's call. Please note that references to certain non-GAAP financial measures will be made during today's call. With that said, let me turn the call over to Oliver Taboukos, President and CEO of ImmuCell Corporation, for opening remarks. We will then have further remarks from Tim Fiori, pardon me, the CFO of ImmuCell, 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 ImmuCell. 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 today. 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 unaudited 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 Fiori, will walk us through the numbers in more detail, but 8.7% growth in the US and 41.3% growth of Tri-Shield 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 and with more to come. And as recently announced, we are now in a position to repurpose manufacturing assets from Re-Tain to support our long-term growth in First Defense after we decided to suspend investment in manufacturing Re-Tain. Our decision to redouble our focus on First Defense and pause investment in Re-Tain 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 Re-Tain new animal drug application. 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 in Re-Tain 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. So 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 cross-breeding and the shortage of beef calves related to drought and the closing of the Mexican border, among 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. ImmuCell's First Defense provides proven protection against neonatal scours, helping to safeguard these high-value calves. 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. 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 Re-Tain. 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. ImmuCell 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 Re-Tain. In the meantime, we will redeploy most of the manufacturing assets that were built for Re-Tain toward expansion of First Defense capacity. First Defense also uses liquid processing equipment, for example, and we have determined that most of the Re-Tain equipment can be repurposed. At this point, I'm going to turn the call over to Tim Fiori, 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 from orders related to the catch-up of a back order situation. I'd like to note that the first half of 2025 also significantly benefited from orders related to catching up from the back order situation. Domestic sales for the most recent quarter grew 8.7% as compared to the fourth quarter of 2024 to $7 million. 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. Similarly to the quarterly results, we saw full-year 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-Shield 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 Re-Tain strategy. As Oliver discussed, we're shifting our resource allocation away from Re-Tain 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 Re-Tain 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 manufacturing 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 Re-Tain 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 lyophilization 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 Defense. When we finalize our capacity expansion plans in the coming quarters, we will provide more details. Our top priority at ImmuCell 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 one on your touch-tone 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 two. Again, that is star and then one. To join the question queue, we'll pause momentarily to assemble the roster, and our first question today comes from Frank Gasker. 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 ImmuCell for more than 25 years, so I have a working knowledge of the 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 questioned, 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? 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 ImmuCell 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, etc., 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 Defense 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 do have several other questions. Thank you. Thank you. And our next question comes from David Champeau. Please go ahead with your question. Thank you. My question relates to the contract manufacturer for Re-Tain. 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 Letter that we received for our application is solely due to the circumstances at the contract manufacturer. Understood. Thank you. 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 a contractual obligation to ImmuCell 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 ImmuCell and the CM at this point, but I would assume that as part of protecting the interests of ImmuCell, one possibility is pursuing the CM for damages resulting from its protracted and continued failure to comply? So, 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 Re-Tain activities, in your view, how realistic is it to expect that a licensee buyer or other strategic partner for Re-Tain can be secured on favorable terms to ImmuCell? 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. Our job now is to find the best go-to-market strategy and the best kind of shareholder value-maximizing way to do that. Our determination is that manufacturing Re-Tain in-house is not the appropriate use of resources or the highest return use of resources. 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 Re-Tain. 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 Re-Tain, okay. I think you're in a situation where you cannot give any light on potential strategics, so that's fine for me. So I will focus now on the current business when it comes to the rehires and 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 U.S. 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. So I think that answers your first question, and then I'm going 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 cost associated with repurposing the former Re-Tain 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 that wouldn't take anything off the table. It all depends on what the economics of those choices look like 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 Re-Tain regarding the FDA's view of the API or the material that ImmuCell makes itself. Is that something that is distinct from what you refer to as the manufacturer of someone who's just making an intramammary 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 processes. 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, aseptic injectable format. And we've called that drug product in various disclosures in the past. So there's two separate processes. The first process, we have proprietary capabilities here at ImmuCell that we've built over time to be able to do that. And the second process is what we have outsourced to a contract manufacturer who had experience with this process, who had previous FDA approvals, and who was a reputable contract manufacturer well-known in the industry. The FDA has given us, ImmuCell, approval for everything other than manufacturing. Then within manufacturing, for our processes, we have passed inspections by the FDA. So flags on green or lights on green on the parts that we do here at ImmuCell. 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. I have 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. One of the things about these studies is 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. 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. 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. I'm just looking for a little bit of clarity on this self-imposed milk discard period for Re-Tain. So I'm going to fire off a couple of questions here. You say you're doing this out of abundance of caution. What exactly does that mean? I'm also wondering, is this going to be a permanent issue? And 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 Re-Tain for a few days while that flushes out of the cow system so that there is 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 in 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 Re-Tain. 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 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 four milkings. In the United States, it's increasingly common for farmers to obviously 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 not the key points in our decision-making in our largest market right here. We recommend a four-milking withdrawal period for Re-Tain. Okay. Thank you. That answers my question. Thank you. Thank you. Our next question comes from George Malice 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 did they exceed your expectations? How do you explain that? Thank you. So George, really appreciate your question. As we've 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 are orders that are coming in because we're winning new customers. There are orders that are coming in because we're regaining customers we may have lost. So there's a lot of different drivers, which makes comparing 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. I have to say compliments to the commercial team here at ImmuCell for achieving a higher level of revenue than we had anticipated just looking at some 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'll still be complicated. But overall, we're very happy with. I think this is our third highest revenue quarter ever. Once again, we believe that there is very minimal impact of the former backorder situation left in our results. Yeah. I would just add that we have published the backorder numbers in each 10-Q as we've gone through time. So those are available when you're analyzing revenue. Okay. Thank you. Our next question comes from Russ Tolander from Capital Alliance. Please go ahead with your question. Yeah. Great quarter of sales. And I think, by my expectation, must have improved over the second half of the quarter since the previous call was really in the middle of the operating period. So I guess just kind of building on the question that George had just asked, was there momentum in the last month specifically? And is there any feel for that momentum kind of continuing here early in this quarter, given that this is really the peak calving season 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. 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 because we haven't analyzed that specifically. I wouldn't say there's anything that struck me. We do have shipping dates, so the way that we ship required that at 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. 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 forever? 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, there might be changes over time. But currently, right now, we still would expect to see the same type of seasonality, I believe. Okay. And in your statement in December, you referred, and I quote here, "Improved set of claims." And this is in regard to Re-Tain, and I'm assuming that it's also related to the, yeah, the study. 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 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. 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. We're looking forward to getting those results. 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 claims that we can back. Presently, by my understanding, the claim is in regards to subclinical mastitis. I would just imagine that an improved set would indicate use on a clinical aspect. Is that part of, or is it potentially further potential for maximizing Re-Tain? Expansion of claims in any direction would enhance the value of Re-Tain. 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 is 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 the next steps are. And I can't really comment in the meantime on any of the specifics, unfortunately. Okay. I have one more. And this might be a little tough, I guess. The shift in the increase to Tri-Shield, very encouraging, and it's certainly significant. But in previous calls, there was some regard to the fact that one of the reasons of reduced margins was the fact that Tri-Shield 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 think you answered that. I'll add one more thing just to address your question about improving margin over time. I think that when we increase the capacity, like we've been talking about in this call, 15% increase in output this year or in 2025, and then striving for similar results in 2026, that will certainly 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. 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 Albert Cebucor 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 ImmuCell, 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 have enjoyed my time at ImmuCell 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.

Speaker 9: Good morning, everyone, and welcome to the ImmuCell 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 Lytham Partners. Please go ahead. Good morning, everyone, and welcome to the ImmuCell Corporation conference call to discuss strategic change in focus and unaudited 2025 sales results. good morning everyone and welcome to the immucell corporation conference call to discuss strategic change in focus and unaudited 2025 sales results All participants will be in a listen-only mode. all participants will be in a listen-only mode After today's presentation, there will be an opportunity to ask questions. after today's presentation there will be an opportunity to ask questions Please also note today's event is being recorded. please also note today's event is being recorded At this time, I'd like to turn the floor over to Joe Diaz with Lytham Partners. at this time i'd like to turn the floor over to joe diaz with lytham partners Please go ahead. please go ahead

Speaker 3: Thank you, Jamie. Good morning and welcome. As our operator indicated, my name is Joe Diaz with Lytham Partners. We're the investor relations consulting firm for ImmuCell. I thank all of you for joining us today to discuss a change in ImmuCell's 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. Thank you, Jamie. thank you jamie Good morning and welcome. good morning and welcome As our operator indicated, my name is Joe Diaz with Lytham Partners. as our operator indicated my name is joe diaz with lytham partners We're the investor relations consulting firm for ImmuCell. we're the investor relations consulting firm for immucell I thank all of you for joining us today to discuss a change in ImmuCell's strategic focus and the unaudited sales results for the fourth quarter and full year, December 31, 2025. i thank all of you for joining us today to discuss a change in immucell's 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. 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. 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 filings with the SEC. Information discussed on today's call speaks only as of today, Friday, January 9th, 2026. The company undertakes no obligation to update any information discussed on today's call. Please note that references to certain non-GAAP financial measures will be made during today's call. With that said, let me turn the call over to Oliver Taboukos, President and CEO of ImmuCell Corporation, for opening remarks. We will then have further remarks from Tim Fiori, pardon me, the CFO of ImmuCell, and then we will open the call for your remarks and questions. Oliver? 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 filings with the SEC. 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 filings with the sec Information discussed on today's call speaks only as of today, Friday, January 9th, 2026. information discussed on today's call speaks only as of today friday january 9th 2026 The company undertakes no obligation to update any information discussed on today's call. the company undertakes no obligation to update any information discussed on today's call Please note that references to certain non-GAAP financial measures will be made during today's call. please note that references to certain non-gaap financial measures will be made during today's call With that said, let me turn the call over to Oliver Taboukos, President and CEO of ImmuCell Corporation, for opening remarks. with that said let me turn the call over to oliver taboukos president and ceo of immucell corporation for opening remarks We will then have further remarks from Tim Fiori, pardon me, the CFO of ImmuCell, and then we will open the call for your remarks and questions. we will then have further remarks from tim fiori pardon me the cfo of immucell and then we will open the call for your remarks and questions Oliver? oliver

Speaker 5: Thank you, Joe, and good morning, everyone. This continues to be an exciting time at ImmuCell. 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 today. 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 unaudited 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. Thank you, Joe, and good morning, everyone. thank you joe and good morning everyone This continues to be an exciting time at ImmuCell. this continues to be an exciting time at immucell We shared in late December that we are shifting our strategy as a company to focus on First Defense. 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 today. 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 today 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 unaudited 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. 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 unaudited 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 Fiori, will walk us through the numbers in more detail, but 8.7% growth in the US and 41.3% growth of Tri-Shield 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 and with more to come. And as recently announced, we are now in a position to repurpose manufacturing assets from Re-Tain to support our long-term growth in First Defense after we decided to suspend investment in manufacturing Re-Tain. Our decision to redouble our focus on First Defense and pause investment in Re-Tain 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. Our Chief Financial Officer, Tim Fiori, will walk us through the numbers in more detail, but 8.7% growth in the US and 41.3% growth of Tri-Shield in the fourth quarter of 2025 compared to the fourth quarter of 2024 are exciting achievements for the company. our chief financial officer tim fiori will walk us through the numbers in more detail but 8.7% growth in the us and 41.3% growth of tri-shield 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 and with more to come. we're also seeing substantial improvements to our manufacturing output and with more to come And as recently announced, we are now in a position to repurpose manufacturing assets from Re-Tain to support our long-term growth in First Defense after we decided to suspend investment in manufacturing Re-Tain. and as recently announced we are now in a position to repurpose manufacturing assets from re-tain to support our long-term growth in first defense after we decided to suspend investment in manufacturing re-tain Our decision to redouble our focus on First Defense and pause investment in Re-Tain is based on two factors. our decision to redouble our focus on first defense and pause investment in re-tain 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 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 Re-Tain new animal drug application. 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 in Re-Tain 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. So let's talk about First Defense. Our First Defense products address a critical industry need for protecting calves. 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 Re-Tain new animal drug application. 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 re-tain new animal drug application 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. 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 in Re-Tain 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. continuing to invest in re-tain 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 So let's talk about First Defense. so let's talk about first defense Our First Defense products address a critical industry need for protecting calves. 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 cross-breeding and the shortage of beef calves related to drought and the closing of the Mexican border, among 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. ImmuCell's First Defense provides proven protection against neonatal scours, helping to safeguard these high-value calves. 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. 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 cross-breeding and the shortage of beef calves related to drought and the closing of the Mexican border, among other things. 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 cross-breeding and the shortage of beef calves related to drought and the closing of the mexican border among other things As a result, newborn calves can be worth approximately $1,300 on day one of life compared to roughly $200 in 2003. 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%. 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. and this macro trend has raised the economic stakes of early-life calf health and survival ImmuCell's First Defense provides proven protection against neonatal scours, helping to safeguard these high-value calves. immucell's first defense provides proven protection against neonatal scours helping to safeguard these high-value calves 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 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 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 Re-Tain. 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. Our strategy is to get out and meet more customers with strong medical, scientific, and outcomes-based arguments for trying and using our products. 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. 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. 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. so more on that later All these opportunities in our First Defense business require, and in our judgment, deserve increased focus and execution. 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 Re-Tain. now a second reason for our shift is the fda's incomplete letter for re-tain 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. 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 ImmuCell 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. ImmuCell 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. immucell 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. 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. 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. 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. 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 Re-Tain. In the meantime, we will redeploy most of the manufacturing assets that were built for Re-Tain toward expansion of First Defense capacity. First Defense also uses liquid processing equipment, for example, and we have determined that most of the Re-Tain equipment can be repurposed. 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. 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. 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 Re-Tain. 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 re-tain In the meantime, we will redeploy most of the manufacturing assets that were built for Re-Tain toward expansion of First Defense capacity. in the meantime we will redeploy most of the manufacturing assets that were built for re-tain toward expansion of first defense capacity First Defense also uses liquid processing equipment, for example, and we have determined that most of the Re-Tain equipment can be repurposed. first defense also uses liquid processing equipment for example and we have determined that most of the re-tain equipment can be repurposed At this point, I'm going to turn the call over to Tim Fiori, our Chief Financial Officer, for a deeper review of the financial implications of this decision and the quarter and full-year sales highlights. Tim? At this point, I'm going to turn the call over to Tim Fiori, our Chief Financial Officer, for a deeper review of the financial implications of this decision and the quarter and full-year sales highlights. at this point i'm going to turn the call over to tim fiori our chief financial officer for a deeper review of the financial implications of this decision and the quarter and full-year sales highlights Tim? tim

Speaker 8: 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 from orders related to the catch-up of a back order situation. I'd like to note that the first half of 2025 also significantly benefited from orders related to catching up from the back order situation. Domestic sales for the most recent quarter grew 8.7% as compared to the fourth quarter of 2024 to $7 million. Thank you, Oliver. 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. 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. 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. 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 from orders related to the catch-up of a back order situation. 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 from orders related to the catch-up of a back order situation I'd like to note that the first half of 2025 also significantly benefited from orders related to catching up from the back order situation. i'd like to note that the first half of 2025 also significantly benefited from orders related to catching up from the back order situation Domestic sales for the most recent quarter grew 8.7% as compared to the fourth quarter of 2024 to $7 million. domestic sales for the most recent quarter grew 8.7% as compared to the fourth quarter of 2024 to $7 million 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. Similarly to the quarterly results, we saw full-year 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-Shield 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 Re-Tain strategy. As Oliver discussed, we're shifting our resource allocation away from Re-Tain and to First Defense. We experienced a decline in international markets, mainly driven by order timing in Canada, with Q4 declining 52.6% year-over-year. 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. 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 Similarly to the quarterly results, we saw full-year year-over-year growth in domestic sales and a decrease in international sales. similarly to the quarterly results we saw full-year 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-Shield 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. the other notable trend within the first defense suite of products is that we are seeing a shift towards tri-shield 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 Re-Tain strategy. now let's talk a little bit about some balance sheet-related items starting with some items related to the shift in re-tain strategy As Oliver discussed, we're shifting our resource allocation away from Re-Tain and to First Defense. as oliver discussed we're shifting our resource allocation away from re-tain 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 Re-Tain 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 manufacturing 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. As part of that decision, we did an initial evaluation of over $15 million in property, plant, and equipment related to Re-Tain 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. as part of that decision we did an initial evaluation of over $15 million in property plant and equipment related to re-tain 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 manufacturing of First Defense. there are however certain pieces of equipment such as the aseptic filling machinery which will not be useful in the manufacturing 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. 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. 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? 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 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. 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. 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. 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. with that i will turn the call back to oliver for some closing remarks Oliver? oliver

Speaker 5: 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 Re-Tain 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. Thanks, Tim. 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. 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. 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 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 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. we're also very focused on operational excellence to ensure the consistent supply of quality products Our decision to redeploy former Re-Tain 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. our decision to redeploy former re-tain 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 lyophilization 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 Defense. When we finalize our capacity expansion plans in the coming quarters, we will provide more details. Our top priority at ImmuCell 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. In the meantime, we are continuously driving optimization of our lyophilization activities, which are typically our bottleneck. 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 lyophilization output, and we are implementing more ideas to maintain that rate of improvement during 2026. in 2025 as mentioned we saw more than 15% year-over-year increase in lyophilization 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 Defense. these two actions give us confidence that we'll be able to meet customer needs for first defense When we finalize our capacity expansion plans in the coming quarters, we will provide more details. when we finalize our capacity expansion plans in the coming quarters we will provide more details Our top priority at ImmuCell will continue to be solid execution across the organization. our top priority at immucell will continue to be solid execution across the organization And with that said, we would be happy to take your questions. and with that said we would be happy to take your questions Let's have the operator open up the lines. let's have the operator open up the lines

Speaker 9: Ladies and gentlemen, we'll now begin the question and answer session. To ask a question, you may press star and then one on your touch-tone 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 two. Again, that is star and then one. To join the question queue, we'll pause momentarily to assemble the roster, and our first question today comes from Frank Gasker. Please go ahead with your question. Ladies and gentlemen, we'll now begin the question and answer session. ladies and gentlemen we'll now begin the question and answer session To ask a question, you may press star and then one on your touch-tone phones. to ask a question you may press star and then one on your touch-tone phones If you are using a speakerphone, we do ask that you please pick up the handset before pressing the keys. 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 two. to withdraw your questions you may press star and two Again, that is star and then one. again that is star and then one To join the question queue, we'll pause momentarily to assemble the roster, and our first question today comes from Frank Gasker. to join the question queue we'll pause momentarily to assemble the roster and our first question today comes from frank gasker Please go ahead with your question. 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 ImmuCell for more than 25 years, so I have a working knowledge of the 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 questioned, 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? Hi, thank you very much for taking my questions. hi thank you very much for taking my questions Great quarter. 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. 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 ImmuCell for more than 25 years, so I have a working knowledge of the historical performance and questions. with that being said i have to say briefly i've been an investor in immucell for more than 25 years so i have a working knowledge of the 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. 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 questioned, and one of the aspects of it was that there's some regionality in the pathogens. with that being said i know that in the past it was certainly brought up and questioned 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? so i guess my question then is to what degree do you think this impacts foreign development Secondly, what qualifications, what requirements are you looking for for this new position in regards to exploring and hopefully increasing foreign sales? Secondly, what qualifications, what requirements are you looking for for this new position in regards to exploring and hopefully increasing foreign sales? secondly what qualifications what requirements are you looking for for this new position in regards to exploring and hopefully increasing foreign sales

Speaker 5: Frank, thank you very much for your question and for your trust in ImmuCell 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, etc., 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 Defense includes hiring expertise to help us drive those sales. You can't get there without that expertise and experience. Frank, thank you very much for your question and for your trust in ImmuCell as a long-term investor. frank thank you very much for your question and for your trust in immucell as a long-term investor We really appreciate the confidence. 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. 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, etc., with our products, but there are differences in specific pathogens that drive scours in different markets. now as you know we're already in canada and some other markets korea etc with our products but there are differences in specific pathogens that drive scours in different markets But there's also a lot of similarities. but there's also a lot of similarities For example, rotavirus is a problem essentially everywhere. for example rotavirus is a problem essentially everywhere So our pivot to focus or double our focus on First Defense includes hiring expertise to help us drive those sales. so our pivot to focus or double our focus on first defense includes hiring expertise to help us drive those sales You can't get there without that expertise and experience. 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. So we're negotiating currently with somebody who has that experience and who hopefully will join our team. so we're negotiating currently with somebody who has that experience and who hopefully will join our team I hope that answers your question. 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 do have several other questions. Thank you. It does. it does I have further questions, but I'm going to get back in the queue and give other opportunity, but I do have several other questions. i have further questions but i'm going to get back in the queue and give other opportunity but i do have several other questions Thank you. thank you Thank you. Thank you. thank you

Speaker 9: And our next question comes from David Champeau. Please go ahead with your question. And our next question comes from David Champeau. and our next question comes from david champeau Please go ahead with your question. please go ahead with your question Thank you. My question relates to the contract manufacturer for Re-Tain. 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. thank you My question relates to the contract manufacturer for Re-Tain. my question relates to the contract manufacturer for re-tain Has the contract manufacturer provided an explanation for its failure or unwillingness to comply with the FDA requirements that resulted in the Incomplete Letter? has the contract manufacturer provided an explanation for its failure or unwillingness to comply with the fda requirements that resulted in the incomplete letter

Speaker 5: 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. Thank you, David, for your question. 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. 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. Okay. okay I don't know how far you. 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 Letter that we received for our application is solely due to the circumstances at the contract manufacturer. I might just add one other thing, that based on the letter that we received from the FDA, it is clear that the Incomplete Letter that we received for our application is solely due to the circumstances at the contract manufacturer. i might just add one other thing that based on the letter that we received from the fda it is clear that the incomplete letter that we received for our application is solely due to the circumstances at the contract manufacturer Understood. Thank you. 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 a contractual obligation to ImmuCell to maintain its facilities in compliance with the FDA requirements? Understood. understood Thank you. thank you I mean, you may not be comfortable commenting on this, but I'll ask the question anyway. 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 a contractual obligation to ImmuCell to maintain its facilities in compliance with the FDA requirements? is it your view that the contract manufacturer has a contractual obligation to immucell to maintain its facilities in compliance with the fda requirements Yes, that is my view. Yes, that is my view. yes that is my view Okay, so I'm not sure what's going on between ImmuCell and the CM at this point, but I would assume that as part of protecting the interests of ImmuCell, one possibility is pursuing the CM for damages resulting from its protracted and continued failure to comply? Okay, so I'm not sure what's going on between ImmuCell and the CM at this point, but I would assume that as part of protecting the interests of ImmuCell, one possibility is pursuing the CM for damages resulting from its protracted and continued failure to comply? okay so i'm not sure what's going on between immucell and the cm at this point but i would assume that as part of protecting the interests of immucell one possibility is pursuing the cm for damages resulting from its protracted and continued failure to comply So, David, unfortunately, we can't comment on that. So, David, unfortunately, we can't comment on that. so david unfortunately we can't comment on that Okay. One last question. Okay. okay One last question. one last question Thank you for your question. Thank you for your question. thank you for your question Given the impasse with the FDA and the pause on Re-Tain activities, in your view, how realistic is it to expect that a licensee buyer or other strategic partner for Re-Tain can be secured on favorable terms to ImmuCell? Given the impasse with the FDA and the pause on Re-Tain activities, in your view, how realistic is it to expect that a licensee buyer or other strategic partner for Re-Tain can be secured on favorable terms to ImmuCell? given the impasse with the fda and the pause on re-tain activities in your view how realistic is it to expect that a licensee buyer or other strategic partner for re-tain can be secured on favorable terms to immucell 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. Our job now is to find the best go-to-market strategy and the best kind of shareholder value-maximizing way to do that. Our determination is that manufacturing Re-Tain in-house is not the appropriate use of resources or the highest return use of resources. 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 Re-Tain. There's a lot of different components to your question. 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. 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 Our job now is to find the best go-to-market strategy and the best kind of shareholder value-maximizing way to do that. our job now is to find the best go-to-market strategy and the best kind of shareholder value-maximizing way to do that Our determination is that manufacturing Re-Tain in-house is not the appropriate use of resources or the highest return use of resources. our determination is that manufacturing re-tain in-house is not the appropriate use of resources or the highest return use of resources 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 Re-Tain. 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 re-tain Great. Thank you. Great. great Thank you. thank you Thank you. Thank you. thank you

Speaker 9: Our next question comes from Felix Hettinger. Please go ahead with your question. Our next question comes from Felix Hettinger. our next question comes from felix hettinger Please go ahead with your question. 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 Re-Tain, okay. I think you're in a situation where you cannot give any light on potential strategics, so that's fine for me. So I will focus now on the current business when it comes to the rehires and 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? Yes. yes Thank you for taking my question. thank you for taking my question And I think 50% was also already requested by David, so I will keep it short. and i think 50% was also already requested by david so i will keep it short So Re-Tain, okay. so re-tain okay I think you're in a situation where you cannot give any light on potential strategics, so that's fine for me. i think you're in a situation where you cannot give any light on potential strategics so that's fine for me So I will focus now on the current business when it comes to the rehires and as well as the cash needs in the future. so i will focus now on the current business when it comes to the rehires and 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. 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 understood that you currently developed or designed two new territories I was not sure if this already included new hires of the 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? 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. And number two, I read something that there's also a cash need for the business. 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. 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

Speaker 5: 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 U.S. sales team, field sales team. And those hiring processes are underway. Thank you, Felix, for your two questions. 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 U.S. sales team, field sales team. 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 u.s sales team field sales team And those hiring processes are underway. 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. So I think that answers your first question, and then I'm going to turn it over to Tim for your second question. There's quite a lot of interest because of the strength of our brand and our product in the market. 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. 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. 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. 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 So I think that answers your first question, and then I'm going to turn it over to Tim for your second question. so i think that answers your first question and then i'm going to turn it over to tim for your second question

Speaker 8: 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 cost associated with repurposing the former Re-Tain 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 that wouldn't take anything off the table. It all depends on what the economics of those choices look like at the time we want to pull the trigger on investments. Yeah. yeah Thank you for your question. thank you for your question Yeah, you're correct that we will require investment as the company grows to meet that need in manufacturing. 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. 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. 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 cost associated with repurposing the former Re-Tain facility. additionally as we mentioned in the press release we are looking at the cost associated with repurposing the former re-tain facility As far as how we would fund something like that, I really would decline to comment on that. as far as how we would fund something like that i really would decline to comment on that There are multiple ways. there are multiple ways Of course, you can fund things through operating cash flow, also loans and/or capital raises, and that wouldn't take anything off the table. of course you can fund things through operating cash flow also loans and/or capital raises and that wouldn't take anything off the table It all depends on what the economics of those choices look like at the time we want to pull the trigger on investments. it all depends on what the economics of those choices look like at the time we want to pull the trigger on investments But I appreciate the question. Thank you. But I appreciate the question. but i appreciate the question Thank you. thank you Thank you very much. Thank you very much. thank you very much

Speaker 9: Our next question comes from Jonathan Rothschild. Please go ahead with your question. Our next question comes from Jonathan Rothschild. our next question comes from jonathan rothschild Please go ahead with your question. please go ahead with your question Hello. Congratulations for making some very tough decisions. But I had a question on Re-Tain regarding the FDA's view of the API or the material that ImmuCell makes itself. Is that something that is distinct from what you refer to as the manufacturer of someone who's just making an intramammary 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? Hello. hello Congratulations for making some very tough decisions. congratulations for making some very tough decisions But I had a question on Re-Tain regarding the FDA's view of the API or the material that ImmuCell makes itself. but i had a question on re-tain regarding the fda's view of the api or the material that immucell makes itself Is that something that is distinct from what you refer to as the manufacturer of someone who's just making an intramammary injector and also keeping it separate from their other products? is that something that is distinct from what you refer to as the manufacturer of someone who's just making an intramammary 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? 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. 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. 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. so let me know please how you expect the api itself to be judged as a subsection of the cmc section Thank you. thank you

Speaker 5: Jonathan, thank you for your question. Let me try to explain it this way. There's two manufacturing processes. 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, aseptic injectable format. And we've called that drug product in various disclosures in the past. So there's two separate processes. The first process, we have proprietary capabilities here at ImmuCell that we've built over time to be able to do that. And the second process is what we have outsourced to a contract manufacturer who had experience with this process, who had previous FDA approvals, and who was a reputable contract manufacturer well-known in the industry. The FDA has given us, ImmuCell, approval for everything other than manufacturing. Jonathan, thank you for your question. jonathan thank you for your question Let me try to explain it this way. let me try to explain it this way There's two manufacturing processes. there's two manufacturing processes There is the manufacturing of our active pharmaceutical ingredient, also called drug substance. 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, aseptic injectable format. and then we have the second part of the process which is taking that active pharmaceutical ingredient and putting it in an injectable format aseptic injectable format And we've called that drug product in various disclosures in the past. and we've called that drug product in various disclosures in the past So there's two separate processes. so there's two separate processes The first process, we have proprietary capabilities here at ImmuCell that we've built over time to be able to do that. the first process we have proprietary capabilities here at immucell that we've built over time to be able to do that And the second process is what we have outsourced to a contract manufacturer who had experience with this process, who had previous FDA approvals, and who was a reputable contract manufacturer well-known in the industry. and the second process is what we have outsourced to a contract manufacturer who had experience with this process who had previous fda approvals and who was a reputable contract manufacturer well-known in the industry The FDA has given us, ImmuCell, approval for everything other than manufacturing. the fda has given us immucell approval for everything other than manufacturing Then within manufacturing, for our processes, we have passed inspections by the FDA. So flags on green or lights on green on the parts that we do here at ImmuCell. 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. Then within manufacturing, for our processes, we have passed inspections by the FDA. then within manufacturing for our processes we have passed inspections by the fda So flags on green or lights on green on the parts that we do here at ImmuCell. so flags on green or lights on green on the parts that we do here at immucell 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. 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 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 I have 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. I have 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. i have 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. Thank you very much. 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. 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. 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? Yeah. yeah A question on that second point that you mentioned. a question on that second point that you mentioned There is a second pivotal study in process. there is a second pivotal study in process And do you have an estimated timeline when those results may come out? 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. One of the things about these studies is 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. 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. 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. I spoke to the chief investigator on that study in late December. i spoke to the chief investigator on that study in late december One of the things about these studies is to have really good arguments. one of the things about these studies is to have really good arguments You need to have really good, thorough study designs. you need to have really good thorough study designs You need to have a large number of animals enrolled in the study. you need to have a large number of animals enrolled in the study 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. 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 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. 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 for explaining this so clearly. thank you for explaining this so clearly Thank you. Thank you. thank you

Speaker 9: 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. Once again, if you would like to ask a question, please press Star and then one. 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. to withdraw your questions you may press star and two Our next question comes from Tom Fox. our next question comes from tom fox Tom Fox, please go ahead with your question. tom fox please go ahead with your question Good morning. Thank you for taking my question. I'm just looking for a little bit of clarity on this self-imposed milk discard period for Re-Tain. So I'm going to fire off a couple of questions here. You say you're doing this out of abundance of caution. What exactly does that mean? I'm also wondering, is this going to be a permanent issue? And how much less milk will be dumped compared to what farmers have to dump with antibiotics? Thank you. Good morning. good morning Thank you for taking my question. thank you for taking my question I'm just looking for a little bit of clarity on this self-imposed milk discard period for Re-Tain. i'm just looking for a little bit of clarity on this self-imposed milk discard period for re-tain So I'm going to fire off a couple of questions here. so i'm going to fire off a couple of questions here You say you're doing this out of abundance of caution. you say you're doing this out of abundance of caution What exactly does that mean? what exactly does that mean I'm also wondering, is this going to be a permanent issue? i'm also wondering is this going to be a permanent issue And how much less milk will be dumped compared to what farmers have to dump with antibiotics? and how much less milk will be dumped compared to what farmers have to dump with antibiotics Thank you. thank you

Speaker 5: 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 Re-Tain for a few days while that flushes out of the cow system so that there is 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 in 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 Re-Tain. Thank you for your question, Tom. 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. 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 Re-Tain for a few days while that flushes out of the cow system so that there is no impact on cheese manufacturing processes. 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 re-tain for a few days while that flushes out of the cow system so that there is 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 in the market. so our withdrawal period when we started this project was zero days which is a very clear argument to be made in the market And now it's a few days, but it's still less than half of the withdrawal period of the main competition. 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 Re-Tain. so there's an advantage clear advantage of re-tain 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. It's, I think, four milkings is the number of withdrawals that we would recommend for our product. 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. 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. 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. 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? 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. 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? 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 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 four milkings. No. no I just want to be very clear about that. 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 will always be more than zero. the discard period for those farmers who are providing raw milk to both cheese as well as fluid milk processing plants 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. 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. 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. 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. 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 four milkings. we're suggesting a voluntary withdrawal period of those four milkings In the United States, it's increasingly common for farmers to obviously 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 not the key points in our decision-making in our largest market right here. We recommend a four-milking withdrawal period for Re-Tain. In the United States, it's increasingly common for farmers to obviously provide raw milk for both uses. in the united states it's increasingly common for farmers to obviously 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. 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 not the key points in our decision-making in our largest market right here. but those are not the key points in our decision-making in our largest market right here We recommend a four-milking withdrawal period for Re-Tain. we recommend a four-milking withdrawal period for re-tain Okay. Thank you. That answers my question. Thank you. Okay. okay Thank you. thank you That answers my question. that answers my question Thank you. thank you Thank you. Thank you. thank you

Speaker 9: Our next question comes from George Malice from MKH Management. Please go ahead with your question. Our next question comes from George Malice from MKH Management. our next question comes from george malice from mkh management Please go ahead with your question. 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 did they exceed your expectations? How do you explain that? Thank you. Good morning. good morning Thanks for taking my question. thanks for taking my question It's a fairly simple question. it's a fairly simple question Your sales exceeded your expectations. your sales exceeded your expectations Can you help us understand? can you help us understand I don't know if you've had time to really analyze them, but how did they exceed your expectations? i don't know if you've had time to really analyze them but how did they exceed your expectations How do you explain that? how do you explain that Thank you. thank you

Speaker 5: So George, really appreciate your question. As we've 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 are orders that are coming in because we're winning new customers. There are orders that are coming in because we're regaining customers we may have lost. So there's a lot of different drivers, which makes comparing 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. So George, really appreciate your question. so george really appreciate your question As we've 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. as we've 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. i mean our distribution partners and our sub-distributors And then there are orders that are coming in because we're winning new customers. and then there are orders that are coming in because we're winning new customers There are orders that are coming in because we're regaining customers we may have lost. there are orders that are coming in because we're regaining customers we may have lost So there's a lot of different drivers, which makes comparing kind of complicated. so there's a lot of different drivers which makes comparing 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. 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 I have to say compliments to the commercial team here at ImmuCell for achieving a higher level of revenue than we had anticipated just looking at some 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'll still be complicated. But overall, we're very happy with. I think this is our third highest revenue quarter ever. Once again, we believe that there is very minimal impact of the former backorder situation left in our results. I have to say compliments to the commercial team here at ImmuCell for achieving a higher level of revenue than we had anticipated just looking at some run rate trends at the end of the third quarter. i have to say compliments to the commercial team here at immucell for achieving a higher level of revenue than we had anticipated just looking at some run rate trends at the end of the third quarter So we were very pleased with these results. 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. 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'll still be complicated. so in the next quarter or two it'll still be complicated But overall, we're very happy with. but overall we're very happy with I think this is our third highest revenue quarter ever. i think this is our third highest revenue quarter ever Once again, we believe that there is very minimal impact of the former backorder situation left in our results. once again we believe that there is very minimal impact of the former backorder situation left in our results

Speaker 8: Yeah. I would just add that we have published the backorder numbers in each 10-Q as we've gone through time. So those are available when you're analyzing revenue. Yeah. yeah I would just add that we have published the backorder numbers in each 10-Q as we've gone through time. i would just add that we have published the backorder numbers in each 10-q as we've gone through time So those are available when you're analyzing revenue. so those are available when you're analyzing revenue Okay. Thank you. Okay. okay Thank you. thank you

Speaker 9: Our next question comes from Russ Tolander from Capital Alliance. Please go ahead with your question. Our next question comes from Russ Tolander from Capital Alliance. our next question comes from russ tolander from capital alliance Please go ahead with your question. please go ahead with your question Yeah. Great quarter of sales. And I think, by my expectation, must have improved over the second half of the quarter since the previous call was really in the middle of the operating period. So I guess just kind of building on the question that George had just asked, was there momentum in the last month specifically? And is there any feel for that momentum kind of continuing here early in this quarter, given that this is really the peak calving season 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? Yeah. yeah Great quarter of sales. great quarter of sales And I think, by my expectation, must have improved over the second half of the quarter since the previous call was really in the middle of the operating period. and i think by my expectation must have improved over the second half of the quarter since the previous call was really in the middle of the operating period So I guess just kind of building on the question that George had just asked, was there momentum in the last month specifically? so i guess just kind of building on the question that george had just asked was there momentum in the last month specifically And is there any feel for that momentum kind of continuing here early in this quarter, given that this is really the peak calving season domestically? and is there any feel for that momentum kind of continuing here early in this quarter given that this is really the peak calving season 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? 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

Speaker 8: We wouldn't be able to comment on that. 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 because we haven't analyzed that specifically. I wouldn't say there's anything that struck me. We do have shipping dates, so the way that we ship required that at 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. We wouldn't be able to comment on that. we wouldn't be able to comment on that In Q3, when we were talking, we certainly weren't considering anything in our commentary there related to Q4 or trends in Q4. 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. 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 because we haven't analyzed that specifically. i don't think i really want to get into commenting on sales trend within the quarter either just because we haven't analyzed that specifically I wouldn't say there's anything that struck me. i wouldn't say there's anything that struck me We do have shipping dates, so the way that we ship required that at 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. we do have shipping dates so the way that we ship required that at 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. Okay. okay Thank you. thank you I don't really think there's anything there, to be honest. Yeah. I don't really think there's anything there, to be honest. i don't really think there's anything there to be honest Yeah. yeah Thank you. Thank you. thank you

Speaker 9: Our next question is a follow-up question from Frank Gasker. Please go ahead with your question. Our next question is a follow-up question from Frank Gasker. our next question is a follow-up question from frank gasker Please go ahead with your question. 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 forever? Yes. yes Again, thank you. again thank you To further the previous caller, Q1, actually Q4 and Q1 are historically your best quarters. 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 forever? do you see any deviation from that trend that's been going on forever

Speaker 8: 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, there might be changes over time. But currently, right now, we still would expect to see the same type of seasonality, I believe. No. no I think we'll still continue to see some seasonality in the business. 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, there might be changes over time. of course as we move into new products and customer bases such as beef there might be changes over time But currently, right now, we still would expect to see the same type of seasonality, I believe. but currently right now we still would expect to see the same type of seasonality i believe Okay. And in your statement in December, you referred, and I quote here, "Improved set of claims." And this is in regard to Re-Tain, and I'm assuming that it's also related to the, yeah, the study. Could you elaborate on that a little? Okay. okay And in your statement in December, you referred, and I quote here, "Improved set of claims." And this is in regard to Re-Tain, and I'm assuming that it's also related to the, yeah, the study. and in your statement in december you referred and i quote here "improved set of claims." and this is in regard to re-tain and i'm assuming that it's also related to the yeah the study Could you elaborate on that a little? could you elaborate on that a little

Speaker 5: 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 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. Thanks for your question, Frank. 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. 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 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 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 so 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 put together a very rigorous study to validate some of our hypotheses about how our product could be best positioned in the market 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. We're looking forward to getting those results. 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 claims that we can back. 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. 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 We're looking forward to getting those results. we're looking forward to getting those results 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 claims that we can back. 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 claims that we can back Presently, by my understanding, the claim is in regards to subclinical mastitis. I would just imagine that an improved set would indicate use on a clinical aspect. Is that part of, or is it potentially further potential for maximizing Re-Tain? Presently, by my understanding, the claim is in regards to subclinical mastitis. presently by my understanding the claim is in regards to subclinical mastitis I would just imagine that an improved set would indicate use on a clinical aspect. i would just imagine that an improved set would indicate use on a clinical aspect Is that part of, or is it potentially further potential for maximizing Re-Tain? is that part of or is it potentially further potential for maximizing re-tain Expansion of claims in any direction would enhance the value of Re-Tain. 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 is 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 the next steps are. And I can't really comment in the meantime on any of the specifics, unfortunately. Expansion of claims in any direction would enhance the value of Re-Tain. expansion of claims in any direction would enhance the value of re-tain I don't believe in the past we've disclosed much about the current claims. i don't believe in the past we've disclosed much about the current claims It's also competitively sensitive information, to be honest. it's also competitively sensitive information to be honest There is a very, very strong competitor out there who is the market leader in this space. there is 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 the next steps are. so we're going to wait for what comes out of these studies and we will be communicating at that time what the next steps are And I can't really comment in the meantime on any of the specifics, unfortunately. and i can't really comment in the meantime on any of the specifics unfortunately Okay. I have one more. And this might be a little tough, I guess. The shift in the increase to Tri-Shield, very encouraging, and it's certainly significant. But in previous calls, there was some regard to the fact that one of the reasons of reduced margins was the fact that Tri-Shield requires additional processing. To what degree my question would be, are you addressing the margin reduction that occurred from this aspect? Okay. okay I have one more. i have one more And this might be a little tough, I guess. and this might be a little tough i guess The shift in the increase to Tri-Shield, very encouraging, and it's certainly significant. the shift in the increase to tri-shield very encouraging and it's certainly significant But in previous calls, there was some regard to the fact that one of the reasons of reduced margins was the fact that Tri-Shield requires additional processing. but in previous calls there was some regard to the fact that one of the reasons of reduced margins was the fact that tri-shield requires additional processing To what degree my question would be, are you addressing the margin reduction that occurred from this aspect? to what degree my question would be are you addressing the margin reduction that occurred from this aspect

Speaker 8: 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. Yeah. yeah I think what we've said in the past is that TriShield has the two components we call manufactured units in it. 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. 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. 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. 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. perhaps it's something we can consider for either the quarterly earnings call or future calls Okay. I think you answered that. Okay. okay I think you answered that. i think you answered that I'll add one more thing just to address your question about improving margin over time. I think that when we increase the capacity, like we've been talking about in this call, 15% increase in output this year or in 2025, and then striving for similar results in 2026, that will certainly 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. I'll add one more thing just to address your question about improving margin over time. i'll add one more thing just to address your question about improving margin over time I think that when we increase the capacity, like we've been talking about in this call, 15% increase in output this year or in 2025, and then striving for similar results in 2026, that will certainly help margin over time. i think that when we increase the capacity like we've been talking about in this call 15% increase in output this year or in 2025 and then striving for similar results in 2026 that will certainly help margin over time But it's not specific to Tri-Shield. 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. 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. Okay. okay All right. all right Thank you very much. thank you very much Thank you. Thank you. thank you

Speaker 9: 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. Ladies and gentlemen, at this time, we'll be ending today's question and answer session. 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. 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 Albert Cebucor for closing remarks. Oliver? Thank you, Jamie. thank you jamie I would now like to turn the call back to Albert Cebucor for closing remarks. i would now like to turn the call back to albert cebucor for closing remarks Oliver? oliver

Speaker 5: 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 ImmuCell, 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. Thank you, Joe. thank you joe And thank you, everyone, for your excellent questions. 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 ImmuCell, including 25 years as CEO, and for his support during my transition. before we leave i want to thank my predecessor michael brigham for his 30 years of service to immucell 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. 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. so thank you michael and congratulations on your well-deserved retirement

Speaker 3: Thanks very much, Oliver. I have enjoyed my time at ImmuCell very much. I have a lot of confidence in the future of First Defense, and I wish the team the very best. Thanks very much, Oliver. thanks very much oliver I have enjoyed my time at ImmuCell very much. i have enjoyed my time at immucell very much I have a lot of confidence in the future of First Defense, and I wish the team the very best. 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. Okay. okay Thank you, Oliver, and thank you, Michael. thank you oliver and thank you michael We want to thank everyone participating on today's call. 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. 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. thank you and have a great day

Speaker 9: 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. Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. ladies and gentlemen with that we'll conclude today's conference call and presentation We do thank you for joining. we do thank you for joining You may now disconnect your. you may now disconnect your