Elutia, Inc.

Good day, everyone, and welcome to Ellucia fourth quarter 2025 financial results call. At this time, all participants are in a listen-only mode. After this presentation, there will be a question and answer session. To participate, you will need to press star 1-1 on your telephone. You will then hear a message advising your hand is raised. To withdraw your question, simply press star 1-1 again. Please note, this conference is being recorded. Now it's my pleasure to turn the call over to Sonali Fonseca. Please proceed.

Thank you, operator, and thank you all for participating in today's call. Earlier today, Elluci released financial results for the fourth quarter and full year ended December 31st, 2025. A copy of the press release is available on the company's website. Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements within the meaning of the federal securities laws, which are pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. All statements contained in this call that do not relate to matters of historical facts or relate to expectations or predictions of future events, results, or performance are forward-looking statements. All forward-looking statements, including without limitation those relating to our operating trends and future financial performance, are based upon our current estimates and various assumptions. These statements include material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, You should not place undue reliance on these statements. For lists and descriptions of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our public filings with the SEC, including Alusha's annual report on Form 10-K for the year ended December 31, 2024, and in our subsequent periodic reports on Form 10-Q and 10-K, accessible on the SEC website at www.sec.gov. Such factors may be updated from time to time in Alusha's other filings with the SEC. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, March 11, 2026. Alusha disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements because of new information, future events, or otherwise. Also, during this presentation, we refer to gross margin, excluding intangible asset amortization, which is a non-GAAP financial measure. A reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure is available in the company's financial results released on the fourth quarter and full year ended December 31st, 2025, which is accessible on the SEC's website and posted on the investor's page of the Alusha website at www.alusha.com. With that, I will turn the call over to Alusha CEO, Dr. Randy Mullis.

Thank you Sonali. Good evening and welcome to our fourth quarter 2025 earnings call. We are coming to you live from our Gaithersburg, Maryland facility, and I'm super glad to be here. Wherever you are, however you may be listening, welcome. We are super glad to have you. I'm going to try to keep my comments brief tonight, but on that point, you guys know I may fail. We have so many exciting things going on in Aleutia right now, and I am eager to share them with you. So with that, let's just jump in. Here's a forward-looking statement slide that basically says what Sonali just said. And then really quickly on our conference call, so what's on the agenda today? We're going to go over some of the basics. You guys may have heard this, but we also have a lot of new callers on the call today. So be patient as we go over things like our mission and what we're good at. where we're headed as a company. We made a couple of announcements in that press release that are kind of important, and so we'll be updating some of those things there. Matt's gonna then talk about finance topics, and then lastly, we will close the call and take your questions. So let's start out with our mission. Humanizing medicine so patients can thrive without compromise. Humanizing medicine. Humanizing medicine. Every 98 seconds, a woman in this country is diagnosed with an invasive form of breast cancer. That means even if I keep my remarks short today, there will be 18 new cases diagnosed during this call. Three of those are going to die during this call. Ten will have breast reconstruction. And three are going to have a serious complication from that surgery. Who are these people? These are our mothers. These are our wives. These are our friends. And our daughters. You know them. That is humanizing medicine. I'm looking around this room right now at a group of brilliant, overworked, tired professionals, and the look on every one of their faces is the same. Randy, let's go get at this. So why do we think we can fix this appalling problem? Well, let's look at what we're good at, what we're great at, actually. We are great at combining an optimal biological matrix, and we use the biological matrix to hold an implant in place and regenerate into the patient's own healthy tissue. That's an essential part of the surgery. But what we do that no one else does is we combine that with powerful antibiotics for sustained antibiotic release that prevents infection and these other complications that we're talking about. Infection is the number one complication of surgery, period. And we have the ability to significantly reduce it. And this isn't theoretical, right? We've already done this. LU Pro, we launched In January of last year, we got it through 194 VACs in nine months. We got it up to an $18 million run rate because physicians loved it. And most importantly, it worked. And so that's what we're doing with 41X into breast reconstructions. We can't do this without an incredible team, and I am super pleased to announce that we have done a great job adding some serious horsepower to our team this last quarter. I'd like to welcome Guido Nils as our new board member. He is an operating partner at Essex Woodlands and the former chief operating officer of Guidant Corporation. He's also, importantly, a longtime friend and mentor of mine, and we are blessed to have him join the team. I'd also like to welcome Pete Ligotti as our new Chief Commercial Officer. Pete joins us with a brilliant 30-year career, including 20 years at Integra, some more time at Nuvasiv where he ran a successful business. He's going to be coming in here, and he's going to be spearheading our commercial efforts as we move towards the launch and commercialization of 41X. Welcome to both of these gentlemen to the Alusha crew. Okay, so where are we headed? Where are we going? I want to be really clear about all this so everybody understands. We are going to solve a really big problem that exists right now in breast reconstruction. And why this is such a transformational opportunity for us really comes at the intersection of three things. One is It's a really big market. It's a really big market, and that matters. Breast reconstruction is a billion and a half dollar market. But it's also a really big market that's facing an enormous problem. As I said, 15 to 20% of our breast reconstruction patients will develop a serious post-operative infection. It's just unacceptable. We can do better. We have to do better. And the good news is that our technology platform is almost purpose-built for this specific problem. Our first FDA clear drug-eluting bioenvelope turns out to be a really, really great way of addressing breast reconstruction infection. And so that's what we're going to do. So digging in here a little bit, breast reconstruction is a really big There are 162,000 breasts reconstructed after a mastectomy annually. That means there are a lot of biological meshes that are already being used. Biological meshes are already used in 90% of these surgeries. So what does that mean? It means we don't have to train a surgeon on some brand new technology to solve their problems. We just take a technology that they're used to, that they're familiar with using, and make it much better so it solves their number one problem. Human ADMs, human acellular dermal products, lead this market, and they're expensive. We're talking about $7,500 to $9,500 a breast. That makes them 65% or more of the total implant spend during a breast reconstruction procedure. So this is a really, really big market. But it's a market that confronts some very unique challenges. When I talk about the post-operative infection rate being 15% to 20%, people look at me and think, oh, that just couldn't be. That just couldn't be. It is. It definitively is. And I want to explain just a little bit about why, why we see such high infection. I'm not going to go through all the slides. Some of you may have seen this. I have a longer series on this. But I do want to show you what's really at the root of this. So in a mastectomy, all of the breast tissue has to get removed. If all of the breast tissue isn't removed, the woman's mastectomy isn't complete and they have to go through follow-up and surveillance and mammograms and other types of things and still have a risk for redeveloping breast cancer so all of this tissue has to be moved well one of the things that you should sort of know about breast tissue as that the blood supply for the anterior or the front side of the breath it all goes through this breast tissue that has to get cut out and so when a mastectomy is done and that tissue is removed the blood vessels and therefore the blood supply for the front half of the breast is removed with it and that closes off that blood supply And what does that do? Well, that creates a situation where you have an area of the body that your blood flow can't reach, where your immune system can't readily reach, and very importantly, where post-operative antibiotics can't reach. You can give somebody oral antibiotics or you can give somebody intravenous antibiotics, but if they don't have a vasculature to a particular area, those antibiotics aren't going to flow there. And this is what sets up the very unique problem that we see in breast reconstruction. And that's what leads to these exceedingly high infection rates. As I said, one in three women suffer a serious complication, about 15 to 20% experience an infection. This isn't one paper. This isn't some esoteric citing. This is the registry. This is what all of the data says, in fact, put it into real specific numbers. The registry data says it's 12 to 37% if you want to put the real numbers about it. So when we say 15 to 20%, we are not exaggerating on that number. If anything, we are being conservative. And this is validated every time we go out and talk, particularly with the academic centers, where they really, really, really track these numbers very, very closely. That leads up to a one in five implant loss. So they've got to go back and this whole thing comes out. It leads to a massive economic burden for the hospital, $48,000 economic burden to the hospital. So the hospital certainly should be highly motivated to address this problem. But I just want to keep in mind and go through our mission here in humanized medicine. We're also talking about a woman that started this journey because she was diagnosed with cancer. Not an augmentation, she was diagnosed with cancer. And the number one goal in that woman's mind is curing herself from that cancer. And that involves chemotherapy, it involves surgery, it involves radiation sometimes. And when an infection pops up, all of that stops. None of that can go on until that infection is resolved. This is a significant problem on so many different fronts. And it's one that if you can't tell, we are very, very passionate and committed to solving. So the great thing about this anatomical problem that's set up during the mastectomy is it kind of creates a perfect environment for what we do. So what if we flip the script on this infection? And instead of trying to deliver this antibiotic systemically, We delivered it locally. We actually delivered it where the breast implant and the drain are through the mesh, which is naturally there anyway to hold the implant in place. Well, the exact opposite would happen. Instead of concentrations being very, very low of antibiotic, the concentrations would be very high, and they would stay high for a long period of time. And then the best part? they wouldn't have any systemic effects. So you could have high therapeutic concentrations of antibiotics right there in the breast side without any of these systemic side effects that you sometimes get when you deliver systemic antibiotics. And this was the concept that we started out with a very long time ago. This was the premise behind Eliupro. And when we started using Eliupro in humans, we saw it was completely valid. And then we got more data on this specifically in breast reconstruction. So there's some really great data out there on what happens if you deliver antibiotics locally into the breast reconstruction space. There's two different studies particularly that I'll reference here. One of them uses a plaster antibiotic plate. Now, that doesn't sound like a great way to treat a woman. who's undergoing breast reconstruction to put a piece of plaster in her breast. But when the risk of postoperative infection is 15% to 20%, desperate times call for some pretty desperate measures. So they gave this a shot. They impregnated this plaster with this antibiotic, and they looked at it in just the general breast reconstruction population. What they saw was a 62% reduction in infection risk. We're talking about going from 12.6% 4.8 this is a not a small study we're talking about an end of 593 patients uh in here so a significant proof of concept that if you deliver these antibiotics locally you can do a really really good job of preventing infection another version of this was tried but in a much much higher risk setting Here what they were looking at is instead of using these big plates, they used these little plaster beads. Again, they're this plaster material. And they put those into the breast cavity. But what they were looking at here were women who had very, very poor, in fact, pathologically poor blood flow to the anterior side of the breast, something we call mastectomy skin necrosis. And this is where there's just literally no blood supply to the front part of the breast. And that front breast tissue starts to die. When that happens, your risk of infection skyrockets. And so here they saw an 82% reduction in infection. We're talking about going from 36% down to 6%. Again, N of 75 here. You might say, well, again, maybe this problem is solved. Not really. Even the authors, and these are friends and champions of Alusha who are behind these studies, will tell you this is a suboptimal solution to a very serious problem. No woman wants to have plaster put in there. No plastic surgeon wants to make antibiotic beads off-label in the back part of their surgical center. They don't stay in place. They drop down into the inferior side, into the gutters of the breast. They don't provide uniform coverage, and they elute the antibiotic way, way, way too quickly. But it did show that this concept definitively works. And that's why we created NXT. We're combining these powerful antibiotics, rifampin and minocycline, so these are antibiotics that specifically target the pathogens we know we see in breast infection. And it delivers them in a uniform field for an extended period of time, like 30 days. What's this 30 days about? The drains that are placed at the time of surgery stay in for 17 days. You want a couple of weeks of extra coverage. That's what that's about. And we combine these powerful, sustained antibiotics with an optimal biologic matrix. And that matrix I'll refer to as 41. It's just the matrix by itself. And we put those two things together and we made something purpose-built for the problem that we're trying to solve, which is postoperative infection in breast cancer surgery. So let's talk about the roadmap and how do we get from here to there. Right now, we have a SimpliDerm. We're going to talk about that in just a second, but that's our current product that's used in the breast reconstruction space. It gives us a lot of practical on-the-floor experience in this space, but the real excitement starts with 41 and 41X. is our base matrix. When I say NXT41, I'm talking about just the biological matrix alone without antibiotic. It is a phenomenal matrix in its own right. If we weren't a drug-eluting biologics company, we would be talking about this incredible NXT41, but we can't leave good enough alone, primarily because it doesn't solve the biggest problem in breast reconstruction. But what we do is we use 41 from a regulatory standpoint to set the foundation for 41X. We announced today that we have already submitted to FDA NXG 41. Let me just sort of pause everybody and reality check everybody. We know we're going to get questions from FDA. We know we are going to need to respond to them thoughtfully and professionally, and we know that's probably going to take a little while. So let's be patient. Let's give our incredible R&D team the time to do the professional job they need. If something significant happens, I promise we will update you on it. In the meantime, we expect sometime in the second half of this year, that we will get clearance for NXT 41, and that will serve as the platform for NXT 41X, which is the base matrix combined with the Rifampin and Minocyclin. And if we put the timelines together, we expect clearance for NXT 41X towards the end of the first half of 2027. So we're looking at a second half launch. of that product. Okay, what's going on? A lot of people ask, so what are you guys doing inside the company? Well, you can sort of divide it up into three major work streams. The first one is obviously development. No surprise here, that group is focused pretty heavily on the approval of a highly differentiated product that significantly improves outcomes in plastic and reconstructive surgery. That starts with our 41 base matrix and rolls seamlessly into our 41X drug looting matrix. I said we're here in our beautiful Gaithersburg facility. Well, that allows me to introduce manufacturing because this is our manufacturing facility here where we have enough capacity to make 41X for the foreseeable future. I think we have something like $120 million in revenue generating capacity for 41X. X with just one shift right now. So we have this great manufacturing facility, and basically I could sum up manufacturing's job right now into two things. One, ensuring adequate supply of perfect quality tissue, and two, driving down cost of goods. So that's what they're working on. And then lastly, we now have Pete Liotti coming in and heading commercial, building these KOL partnerships. I'm going to tell you, we do not have a problem getting a meeting and building strong relationships with our KOLs. We have and are continuing to build a very robust KOL team of champions, and there's really no secret to it. We're being able to do it not because we have great personalities, but because we're addressing their number one problem and the number one problem that their patients are facing right now. In addition to that, Pete's working on developing health economic models, obviously spending a lot of time on reimbursement strategies and generally preparing for launch readiness of 41X. So now let's turn a little bit to SimpliDerms. We're exploring simple term strategic options. We announced that on the press release today. You might ask, well, why now? Well, we've gotten to the point where our confidence with the 41X program really dictates that this is now the time for us to focus all of our time all of our resources, all of our energy on making sure we do a great job with that platform. Now, Simple Derm is a great product, and whoever gets this asset is going to get a really, really wonderful product, a cellular dermal matrix that's used in soft tissue reconstruction. It's got great handling. It's sterile. It's hydrated and ready to use, which is what the plastic surgeons want. 100 million lives covered. This is a big deal. Some people think they could introduce their own acellular dermal product really quick and just get it on the market. It turns out reimbursement in the acellular dermal matrix market is a really big deal. So we have 100 million lives covered across from two of the largest payers, Anthem and UnitedHealthcare, as well as nine regional plants. Patent protected, obviously. It's completely standalone. So for us, it's a completely segurable business that doesn't cause any disruption. And whoever gets it, it's EBITDA accretive. So no incremental capital investment is required. It's really a beautiful plug-and-play technology. So we'll keep you updated on this, and we'll see how that process goes. Lastly, I wouldn't be able to say any of the great things that I'm saying today, and we wouldn't have been able to make any of the progress that we're making without our incredible Alusha crew. We are proud to be recognized for something we already knew. Alusha is a great place to work, and we were certified by the Great Place to Work certification. The result, I thought, When I saw them, I was really proud. It proved we are a mission-driven organization. We are also a merit-driven organization. 54% women, 62% of our leadership roles are occupied by women. 50% have advanced degrees. We are a brilliant group. Not me, but the team. An entire third of our organization has a doctorate, and we are a committed group. Our average tenure, 6.3 years. The advantages, if you're wondering, so what's the advantage of this Great Place to Work certification? Well, the certification's kind of nice. I guess you can hang it on the wall. But what it means is that compared to our non-certified peer competitors, We tend to outperform on financial metrics by four fold. We are able to attract job seekers because of the great place to work certification with a 15 times higher attractiveness and our turnover or turnover of certified workforces is about half that of the regular US workplace. So I'm gonna end my comments there.