Hello, everyone, and thank you all for joining us during the Lytham Partners Spring 2025 Investor Conference. My name is Joe Diaz. I'm a managing partner at Lytham Partners. Today, Michael Brigham, President and CEO, and Tim Fiori, CFO of ImmuCell Corporation, will be taking us through a brief slide presentation followed by a Q&A discussion. ImmuCell trades on the Nasqad under the ticker symbol of ICCC. Before we begin with the presentation, I'd like to inform our viewers of the applicable safe harbor announcements as reflected in the second slide of this presentation. Please review the language and recognize there may be forward-looking statements afforded the protections of the Private Securities Litigation Reform Act of 1995. Now, let me introduce Michael Brigham, President and CEO, and Tim Fiori, CFO. They will run us through the presentation and answer a few questions along the way. Michael, kick it off, please.
Hi, Joe. Thank you. Welcome. Thank you, everyone, for joining. We did pick just a few slides out of our full deck to share today. The full deck is available on our website. Starting with this company overview, I always feel like real estate tells our story pretty well. We own these two buildings. The top building is our headquarters. It's also where we produce First Defense. So it's a USDA-licensed facility. As we grew production capacity, we expanded across the street into about 30,000 sq ft of leased facility to expand that production capacity. The bottom picture shows the Re-Tain facility. That's an FDA-regulated facility. And adjacent to it is a small warehouse and closed-doors facility that we also own. At the high level, we're just doing some pretty exciting things with First Defense commercially.
We are anticipating the end of a long development period with Re-Tain, the initial commercial sales coming in the future here. We'll talk more about Re-Tain later. Okay, what role does ImmuCell play at a high level? A common link between our two products is the reduction in use of antibiotics. First Defense is displayed here with a couple of different formats. All formats of First Defense help reduce antibiotics by avoiding treatment antibiotics. If you do not prevent scours, you are going to treat that calf with antibiotics. Re-Tain, perhaps more directly, is a really novel first-of-kind alternative to traditional antibiotics. Whereas mastitis today is treated with traditional antibiotics like penicillins, cephalosporins are active. It is called Nisin. This bacteriocin is not used in human medicine and is an alternative to those traditional antibiotics.
Just to get an idea of the market, the addressable market, and where we are today, I'd like to look at scours. Again, I'm talking just here First Defense, our USDA-approved product. I break it down into three kind of groups here, if you will. Some people choose to do nothing. They're going to treat. They're going to use those traditional antibiotics to treat scours if they do not effectively prevent it. There's a large group that treats the baby calf. Those are those products by Zoetis and Merck and ImmuCell. You give them to the calf to prevent the scours right after birth. Then there's a bigger group that uses vaccines to the mother. They are immunizing the mother so that she produces more antibodies and more specific antibodies in the feed that is then given to the baby as feed.
What's exciting, and Tim's going to talk about some of our sales progress and growth. What's creating a lot of that is our most recent format, the addition of rotavirus to our claim set. We have always had the bivalent coronavirus and E. coli. With rotavirus, we now look like and perform like a vaccine. We can go up to these prospective customers and say, you know, we've got similar coverage that you're looking for in your vaccine. With our product, you can leave mom alone and you can just treat the baby. What does that translate to? We see these pie charts here, and we see a whole bunch of blue space. That's our opportunity. I do feel, considering my bias, that we have better technology.
Again, as we compete at both the calf level and the dam level, and so that story of less antibiotics and leave mom alone and use First Defense for the baby, once we're unlimited by production supply, which we're just reaching that point, we want to make those pies much more red. That's kind of a setup to where sales are. Tim's going to talk about that.
All right, let's take a minute and just take a look at sales over time. This goes from 2011 all the way through 2024, revenue per year for all the full years that have passed. As you can see, from 2011 to 2018, we grew by 11.6% CAGR, compound annual growth rate. In 2018, we launched TriShield. That did create a different vector for growth. As you can see after that, from 2018 to 2024, we've grown at 15.8% CAGR. Definitely an acceleration over historical rates. The second thing that I'd like to note is that during this entire period of time and even through to today, we've been more or less supply limited and not demand limited.
You can see that there was a period of time in 2022 and 2023 where we had some issues in production that was even a stronger limit on supply. In 2024 and this year, we've seen a recovery from that. The last thing that I'd like to point out is something that's not visible on the chart, but just our 2024, our 2025 Q1 growth was 11% or $8.1 million. When you look at trailing six-month growth, we're at $15.8 million and trailing 12-month growth of $27.3 million. The story there is that it's just a continuation of the strong growth that we've seen in the past. It also demonstrates that we've recovered from some of the difficulties that we faced in 2022 and 2023.
Tim, I might add for this audience, if you've read our disclosures, if you've been following us, you know what we're talking about. We were set out to double capacity from, say, $15 million, $16 million to $30 million. That path took longer and was more difficult than we would have anticipated. We did run into contamination problems in that expanding capacity during late 2022, all of 2023, early 2024. The numbers that Tim just reviewed kind of show how we've come out of that. We've reached our capacity. We've reached the double up north of $30 million. We've been running without contamination since April of 2024 now.
Interesting. Let me go back to some elemental issues relating to your products and the benefits that they deliver. In terms of your phrase, immediate immunity to the newborn, what does that mean? Why is that possible given the level of immunity that the newborn has, which may not be very much? Can you talk about that to some extent?
Yeah, that's exactly how we compete in the market. We sell immediate immunity as opposed to a vaccine, which is going to have a delayed response. It's going to have a delayed response in the mother and then delayed into the feed. We do all that work that mom's doing. We do that work for the animal. We deliver a finished dose to the newborn baby, giving that absorbable immediate boost of antibody protection.
How does what you deliver differ from what your competitors might deliver to that newborn calf?
If I come back to that slide where we showed calf and dam, you know what people do to the calf, they deliver a product, largely a product by Zoetis that is a vaccine. They're immunizing a naive immune system. The calf has just hit the ground, just hit the barn floor, and her immune system is not working yet. She's looking for protection from mom or from ImmuCell. There is a lot to be said about not expecting a really robust response from a modified live virus vaccine to a newborn. That's why the science behind First Defense is that we've done that work in our processing plant so we can deliver those antibodies directly and ready to go for that newborn.
Describe pretty elementary, what is scours and what does your formulation, what major pathogens is it working against?
Yeah, so we don't exclude any antibodies, but our USDA claim is for E. coli, coronavirus, and rotavirus. Those are the big causes of scours. Scours, quite simply, is diarrhea. That diarrhea can lead to a lagging growth profile. She suffered and she lags, or it can lead to death as well.
As it relates to vaccinating the mother cow, dam vaccinations, what are the issues? What surrounds non-essential vaccinations? How do you approach that?
In modern dairy practice, cows are subject to a number of vaccines. We position First Defense as avoiding the use of one. You do not need to stick a needle in your cow in order to improve her feed for the baby. We will focus on delivering that protective dose directly to the baby and let mom be. Let her go do what she needs to do next after freshening. She needs to produce good quality, good volume milk.
Right. One last thing as it relates to traditional antibiotic super bugs. Where are you, ImmuCell, First Defense, in that continuam? How do you guys approach this? How do you treat it?
We just take every conversation we can. We're proud of the product. We're proud of its efficacy. It's proven with USDA claims, which makes it quite different from a lot of the other alternatives, say, egg antibody products without claims that are on the market. We just go and talk some mother nature science, simply. Antibodies are what mother nature develops to prevent disease. We've just purified it and concentrated it and made it very specific to give that effective dose to the newborn.
From an operational standpoint, you've made some great progress in terms of dealing with the contamination issues of a year and a half, two years ago. You're making some progress on eating into that backlog. Talk to us about the backlog and how you see that coming along.
I always say a backlog is a good problem to have compared to the alternative of not having any customer demand. All that said, it is a problem. Customers want our product, and we have not been able to supply enough of it. We are working it down. It was over $4 million. We brought it down to just over $3 million. As we go forward into the rest of the second quarter and third quarter, I think we are going to move right through backlog and get back to where we want to be at this higher production capacity, meeting demand when a customer sends a purchase order in.
In terms of the progress that you're now making, you've made an important move to the extent that your operations and the efficiencies of those operations are really growing quarter by quarter. It seems that your manufacturing capacity has really moved up. What's the next step? How do you plan on the next level of growth in that regard?
Yeah, we do talk about that a lot. We were forced to freeze some capital expenditures that would have addressed that during this period of the contaminations, the slow production, the controlled and reduced production. That was around $3 million of CapEx funds. That is approximately what it would take to move us from the $30 million annual capacity up towards $40 million per year. That next step is to, with the benefit of the ATM and the proceeds raised there, and the benefit of the sales and the improving margin, finance the next level of capital expenditures into our equipment. I think our facilities are now adequate, but it is new equipment to bring, again, move that number from $30 million to $40 million per year.
You mentioned the ATM. It's been a very useful tool. You've been judicious in your use of it. Talk to us about your strategy with that ATM and how you expect to use it going forward.
Yeah, we do disclose ATM activity quarterly in our filings with the SEC. What those show you is we were very active when we needed to be in 2024. The activity here in 2025 is very minimal. We find it to be a very flexible tool. We use it, as you said, judiciously. We're opportunistic, but nothing in 2025 is remotely close to 2024. 2024 was the big ask of the ATM. It is very low activity today. That could change in the future, or it may not. It is just something that we keep evaluating, the need for cash versus the cost of dilution. It is a great flexible asset to have in our toolbox.
Yeah. On your previous, on your last quarterly conference call, you spoke of First Defense as being a suite of products. Can you talk to us about how that's come about and what new formulation are you working on?
Yeah, it's worth noting First Defense was first approved by the USDA in 1991. So it's been out there a very, very long time. The original format was in a capsule, about four grams or so, four and a half maybe, a blue pill taken orally again. But this was just two claims, E. coli and coronavirus. And that was our world for years and years. Around 2018, we introduced TriShield. That was taking the same two antibodies against E. coli and coronavirus and adding the rotavirus. That's where we became to look more like the coverage that's offered by a vaccine. That many antibodies would not fit into our blue capsule. So we developed a gel formula.
The suite is really just antibodies to the customer's preference, whether it be just the bivalent or all the trivalent in a gel tube for the trivalent, in a capsule, or in a gel tube for the bivalent.
Let's talk about the potential catalyst that's out there as it relates to Re-Tain. I know that there's something you cannot speak about because it's an FDA issue that's in progress right now. You did issue a press release not too long ago about initiating some investigational use of Re-Tain. Can you talk about that? What is the expectation coming out of that investigational use process?
Yeah, I appreciate the emphasis and focus on First Defense. That's how we pay our bills. We are trying to sort out Re-Tain. It has been delayed. We would have thought we'd be FDA approved long before now. It's recently, as in like the last year or so, been held up due to an inspection at the facilities of our contract manufacturer. We make the drug substance, the Nisin, the active ingredient. We do not aseptically fill it into the syringes. We use a contractor for that. They're having difficulties with their inspectional approval. We are waiting for resolution on that. The good news, that's bad news. The good news is the FDA is working with us on what you just referred to as investigational product use.
Regardless of licensure, we're going to get to market with current inventory in the second half, beginning here in June, going through the second half of 2025, where we may not be generating revenue, but we are generating what I'll argue at this point is more important data, field data. Since those original effectiveness studies, we've not been in cows. This will get us on farm in cows and collect critical data that will inform our next steps with this product. We are very open in our disclosures of we are sorting out strategic options for this product. That effort will be enhanced by some good performance in the field that the data will collect from the investigational product use over the second half of 2025.
Circling back to your recently announced financial results for the quarter, sales were very strong. Margins are up. Talk to us about how that's come about. Is the first quarter historically a strong period for you? What are the next two or three quarters likely to look like given the progress that you've made from a manufacturing standpoint? Certainly, the sales team is doing a great job.
Yeah, I think I'll take that one. We had some issues during the last couple of years with the contamination events and experienced margins all the way down at 22%. Relatively recently in Q4, we had a really nice quarter where production is working very smoothly. We haven't had any contamination events, as we mentioned during the call, for around a year and got up to margins of 37% in Q4 with the help of continued good yields and good production. Also a price increase coming into 2025, we experienced margin at 42% in Q1. Feeling really good about that trend and where we are with gross margin. I think we have some room to go. We're always looking to improve manufacturing. It's kind of a constant improvement mindset in a variety of different ways. We have a goal of 45% that we put out there.
We've just about come to the end of our time. Michael, any last thoughts you want to leave the audience with?
No, I'm glad Tim got in that gross margin improvement. That's as critical to us as was the ATM. Yeah, we have a challenging and exciting and more optimistic about the last half of 2025. You know from this discussion exactly what we're up to with growing First Defense with this new capacity, this increased capacity, and finding resolution to the best strategic option for Re-Tain.
We greatly appreciate your time. Thank you, Michael and Tim. And thanks to everyone watching here today. If you have any questions or if you would like to schedule a meeting with ImmuCell, send me an email at Diaz. That's diaz@lithumpartners.com. If you'd like to learn more about Lithium Partners, you can visit our website at lithumpartners.com or follow us on LinkedIn to stay connected about future events. We hope you all enjoy the rest of the conference and that you have a great day. Thank you.
Thank you, Joe. Thank you all.