Q4 2025 Elutia Inc Earnings Call

March 11, 2026

Speaker #1: Good day everyone and welcome to L-u-c-a fourth quarter 2020 financial results . Call . At this time , all participants are in a listen only mode After the presentation , there will be a question and answer session .

Operator: Good day everyone, and welcome to Elutia Q4 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 one one on your telephone. You will then hear a message advising your hand is raised. To withdraw your question, simply press star one one again. Please note this conference is being recorded. Now it's my pleasure to turn the call over to Sonali Fonseca. Please proceed.

Speaker #1: To participate, you will need to press star one one on your telephone. You will then hear a message advising your hand is raised.

Speaker #1: To withdraw your question , simply press star one one again . Please note this conference is being recorded . Now it's my pleasure to turn the call over to Sonali Fonseca .

Speaker #1: Please proceed

Speaker #2: Thank you, operator, and thank you all for participating in today's call. Earlier today, Alicia released financial results for the fourth quarter and full year ended December 31, 2025.

Sonali Fonseca: Thank you, operator, and thank you all for participating in today's call. Earlier today, Elutia released financial results for Q4 and full year ended December 31, 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 forward 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.

Sonali Fonseca: Thank you, operator, and thank you all for participating in today's call. Earlier today, Elutia released financial results for Q4 and full year ended 31 December 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 forward 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.

Speaker #2: 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 provisions of the private Securities Litigation Reform Act of 1995 .

Speaker #2: 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 .

Speaker #2: All forward looking statements , including , without limitation , those relating to our operating trends and future financial performance , are based upon our current estimates and and various assumptions .

Speaker #2: 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 .

Sonali Fonseca: 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 Elutia'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 Elutia'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.

Speaker #2: 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 Elutia's annual report on Form 10-K for the year ended December 31, 2020.

Speaker #2: Four , and in our subsequent periodic reports on Form 10-q and 10-K accessible on the SEC website at dea.gov . Such factors may be updated from time to time in Alicia's other filings with the SEC .

Speaker #2: This conference call contains time sensitive information and is accurate only as of the live broadcast today . March 11th , 2026 . Alicia disclaims any intention or obligation except as required by law , to update or revise any financial projections or forward looking statements .

Sonali Fonseca: Elutia 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 Q4 and full year ended December 31, 2025, which is accessible on the SEC's website and posted on the Investors page of the Elutia website at www.elutia.com. With that, I will turn the call over to Elutia CEO, C. Randal Mills.

Speaker #2: 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 .

Speaker #2: 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 investors page of the Alicia website at w-w-w dot com With that , I will turn the call over to Alicia , CEO Randy Moss .

Speaker #3: 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 .

C. Randal Mills: Thank you, Sonali. Good evening, and welcome to our Q4 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 gonna 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 Elutia right now, and I am eager to share them with you. With that, let's just jump in. Here is a forward-looking statement slide that basically says what Sonali just said. Really quickly on our conference call, what's on the agenda today? We're gonna go over some of the basics.

C. Randal Mills: Thank you, Sonali. Good evening, and welcome to our Q4 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 gonna 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 Elutia right now, and I am eager to share them with you. With that, let's just jump in. Here is a forward-looking statement slide that basically says what Sonali just said. Really quickly on our conference call, what's on the agenda today? We're gonna go over some of the basics.

Speaker #3: And I'm super glad to be here wherever you are . However , you may be listening . Welcome . We are super glad to have you .

Speaker #3: 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 Alicia right now , and I am eager to share them with you .

Speaker #3: 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 .

Speaker #3: 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.

C. Randal Mills: You guys may have heard this, but we also have a lot of new callers on the call today. 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 we'll be updating some of those things there. Matt's gonna then talk about finance topics. Lastly, we will close the call and take your questions. Let's start out with our mission. Humanizing medicine so patients can thrive without compromise. Humanizing medicine. Every 98 seconds, a woman in this country is diagnosed with an invasive form of breast cancer.

Speaker #3: So be patient as we go over things like our mission and what we're what we're good at , where we're headed as a company .

Speaker #3: We made a couple of announcements in that press release that are that are kind of important . And so we'll be updating , we'll be updating some of those things .

Speaker #3: There. Matt's going to then talk about finance topics, and then lastly, we will close the call and take your questions.

Speaker #3: 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 .

Speaker #3: 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?

C. Randal Mills: That means even if I keep my remarks short today, there will be 18 new cases diagnosed during this call. 3 of those are gonna die during this call. 10 will have breast reconstruction, and 3 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." 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.

Speaker #3: 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 .

Speaker #3: 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 ?

Speaker #3: Well , let's look at what we're good at . What we're great . Actually , we are great at combining an optimal biological matrix .

C. Randal Mills: 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. 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. We have the ability to significantly reduce it. This isn't theoretical, right? We've already done this. EluPro, 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 'cause physicians loved it, and most importantly, it worked. That's what we're doing with NXT-41x into breast reconstruction.

Speaker #3: 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.

Speaker #3: But what we do that no one else does is we combine that with powerful antibiotics for sustained antibiotic release that prevents infection in these other complications that we're talking about.

Speaker #3: Infection is the number one complication of surgery periods . And we have the ability to significantly reduce it . And this isn't theoretical , right ?

Speaker #3: We've already done this. You know, we launched in January of last year. We got it through 194 acts in nine months.

Speaker #3: 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 41 X into breast reconstruction We can't do this without an incredible team .

C. Randal Mills: 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 Neels 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 long time 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 NuVasive where he ran a successful business. He's gonna be coming in here, and he's gonna be spearheading our commercial efforts as we move towards the launch and commercialization of NXT-41x.

Speaker #3: And I am super pleased to announce that we have done a great job adding some serious horsepower to our team this last quarter.

Speaker #3: I'd like to welcome Guido Niels as our new board member . He was an operating partner . He is an operating partner at S6 woodlands in the former chief operating officer of Guidant Corporation .

Speaker #3: He's also importantly , a long time 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 .

Speaker #3: Pete joins us with a brilliant 30-year career, including 20 years at Integra, and some more time at NuVasive, where he ran a successful business.

Speaker #3: 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.

C. Randal Mills: Welcome to both of these gentlemen to the Elutia crew. Okay, so where are we headed? Where are we going? I wanna 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 $1.5 billion 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 postoperative infection. It's just unacceptable. We can do better. We have to do better. The good news is that our technology platform is almost purpose-built for this specific problem.

Speaker #3: Welcome to both of these gentlemen , to the Alucia crew . Okay , so where are we headed ? Where are we going ?

Speaker #3: 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 .

Speaker #3: And why this is such a transformational opportunity for us really comes at the intersection of three things . One is a really big market .

Speaker #3: 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 .

Speaker #3: 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.

Speaker #3: 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 cleared drug eluting bio envelope turns out to be a really , really great way of addressing breast reconstruction infection .

C. Randal Mills: Our first FDA-cleared drug-eluting bioenvelope turns out to be a really, really great way of addressing breast reconstruction infection. That's what we're gonna do. Digging in here a little bit, breast reconstruction is a really big market. There are 162,000 breasts reconstructed after mastectomy annually. That means there are a lot of biological meshes that are already being used. Biological mesh is already used in 90% of these surgeries. What does that mean? It means we don't have to train a surgeon on some brand new technology to solve their problem. 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.

Speaker #3: And so, that's what we're going to do. So, digging in here a little bit, breast reconstruction is a really big market.

Speaker #3: There are 162,000 breast reconstructions after 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.

Speaker #3: So what does that mean? It means we don't have to train a surgeon on some brand new technology to solve their problem.

Speaker #3: 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.

Speaker #3: Human , human , acellular , dermal products lead this market and they're expensive . We're talking about 7500 to $9500 a breast . That makes them 65% or more of the total implant spend during a breast reconstruction procedure .

C. Randal Mills: 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. This is a really, really big market. It's a market that confronts some very unique challenges. When I talk about the postoperative 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. I wanna explain just a little bit about why we see such high infection rates. I'm not gonna go through all the slides. Some of you may have seen this, and I have a longer series on this, but I do wanna show you what's really at the root of this.

Speaker #3: So this is a really , really big market , but it's a market that , that , that , that confronts some very unique challenges .

Speaker #3: 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 .

Speaker #3: It is it definitively is . And I want to explain just a little bit about why why we see such high infections . I'm not going to go through all the slides .

Speaker #3: 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.

C. Randal Mills: In a mastectomy, all of the breast tissue has to get removed. If all of the breast tissue isn't removed, then the woman's mastectomy isn't complete, and they have to go through follow-up, surveillance, mammograms, and other types of things, and still have a risk for redeveloping breast cancer. All of this tissue has to be removed. Well, one of the things that you should sort of know about breast tissue is that the blood supply for the anterior or the front side of the breast, it all goes through this breast tissue that has to get cut out. 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. What does that do?

Speaker #3: So when a mastectomy , all of the breast tissue has to get removed , if all of the breast tissue isn't removed , then 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 the risk for redeveloping breast cancer .

Speaker #3: So all of this tissue has to be moved. Well, one of the things that you should sort of know about breast tissue is that the blood supply for the anterior, or the front side, of the breast, it all goes through this breast tissue that has to get cut out.

Speaker #3: 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 .

Speaker #3: 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 , we're 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 .

C. Randal Mills: 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 postoperative 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. This is what sets up the very unique problem that we see in breast reconstruction. That's what leads to these exceedingly high infection rates. As I said, 1 in 3 women suffer a serious complication, but 15% to 20% experience an infection. This isn't one paper. This isn't some esoteric citation. This is the registry. This is what all of the data says.

Speaker #3: 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.

Speaker #3: As I said, one in three women suffer a serious complication. But 15% to 20% experience an infection. This isn't from just one paper.

Speaker #3: This isn't some esoteric sighting. This is the registry. This is what all of the data says. In fact, let me put it into really specific numbers.

C. Randal Mills: In fact, put it into real specific numbers, the registry data says it's 12 to 37% if you wanna put the real numbers about it. When we say 15 to 20%, we are not exaggerating on that number. If anything, we are being conservative. This is validated every time we go out and talk, particularly with the academic centers, where they really track these numbers very closely. That leads to up to one in five implant loss, so they've gotta 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. The hospital certainly should be highly motivated to address this problem.

Speaker #3: 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 .

Speaker #3: If anything , we are being 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 to up to 1 in 5 implant loss .

Speaker #3: So they've got to go back in this whole thing comes out . It leads to a massive economic burden for the hospital . $48,000 economic burden to the hospital .

Speaker #3: So the hospital's certainly should be highly motivated to address this problem . But I just want to keep in mind and go through our our , our mission here and humanize medicine .

C. Randal Mills: I just wanna 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. 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. 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. The great thing about this anatomical problem that's set up during the mastectomy is it kinda creates a perfect environment for what we do.

Speaker #3: 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.

Speaker #3: And the number one goal in that woman's mind is curing herself from that cancer . And that involves chemotherapy . It involves surgery .

Speaker #3: 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.

Speaker #3: And so 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 .

Speaker #3: So the great thing about this , this anatomical problem that set up during the mastectomy is kind of creates a perfect environment for what we do .

C. Randal Mills: 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. Then the best part, they wouldn't have any systemic effects. You could have high therapeutic concentrations of antibiotics right there in the breast site without any of these systemic side effects that you sometimes get when you deliver systemic antibiotics. This was the concept that we started out with a very long time ago. This was the premise behind EluPro.

Speaker #3: So what if we flipped the script on this infection and instead of trying to deliver this antibiotic systemically , we delivered 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 .

Speaker #3: 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.

Speaker #3: 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 site without any of these systemic side effects that you sometimes get when you deliver systemic antibiotics .

Speaker #3: And this was the concept that we started out with a very long time ago . This was the premise behind Leupro . And when we , we , we , we started using leu pro in humans .

C. Randal Mills: When we started using EluPro in humans, we saw it was completely valid, and then we got more data on this specifically in breast reconstruction. 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. When the risk of postoperative infection is 15% to 20%, desperate times call for some pretty desperate measures. They gave this a shot.

Speaker #3: 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 , on what happens if you deliver antibiotics locally into the breast reconstruction space .

Speaker #3: 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 , to , to treat a woman who's undergoing breast reconstruction to put a piece of plaster in her breast .

Speaker #3: But when the risk of post-operative infection is 15 to 20%, desperate times call for some pretty desperate measures. So they gave this a shot.

C. Randal Mills: 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 to 4.8. This is not a small study. We're talking about an n of 593 patients 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. They put those into the breast cavity.

Speaker #3: 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 .

Speaker #3: We're talking about going from 12.6 to 4.8. This is not a small study. We're talking about an N of 593 patients in here.

Speaker #3: So a significant proof of concept that if you deliver these antibiotics locally , you can do a really , really good job of , of preventing infection .

Speaker #3: 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 use these little plaster beads .

Speaker #3: 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 .

C. Randal Mills: 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. This is where there's just literally no blood supply to the front part of the breast, and that front sort of breast tissue starts to die. When that happens, it's your risk of infection skyrockets. 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.

Speaker #3: In fact, pathologically poor blood flow to the anterior side of the breast is something we call mastectomy skin necrosis. And this is where there's just literally no blood supply to the front part of the breast.

Speaker #3: And , and , and that front started start breast tissue starts to die when that happens , it's your risk of infection skyrockets .

Speaker #3: And so here they saw an 82% reduction in infection. We're talking about going from 36% down to 6%. Again, end of '75.

Speaker #3: Here you might say . Well , again , maybe this problem is solved . Not really . Even the authors and and these are friends and champions of Lucia who , who are behind these studies will tell you this is a suboptimal solution to a very serious problem .

C. Randal Mills: Even the authors and these are friends and champions of Elutia 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 too quickly. It did show that this concept definitively works. That's why we created NXT-41x. We're combining these powerful antibiotics, rifampin and minocycline.

Speaker #3: No woman wants to have plaster put in there . Nobody , no plastic surgeon wants to make antibiotic beads off label . In the in the in the back part of their surgical center , they don't stay in place .

Speaker #3: They drop down into the inferior side , into the gutters of the of of the breast . They don't provide uniform coverage . And they they elute the antibiotic way , way , way too quickly .

Speaker #3: But it did show that this concept definitively works . And that's why we created an NXT 41 X . We're combining these powerful antibiotics , rifampin , and minocycline .

C. Randal Mills: These are antibiotics that specifically target the pathogens we know we see in breast infection. It delivers them in a uniform field for an extended period of time, like 30 days. Well, 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. 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. 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. Let's talk about the roadmap and how do we get from here to there. Right now we have a simple term.

Speaker #3: 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 .

Speaker #3: In my 30 days—what's this 30 days about? The drains that are placed at the time of surgery stay in for 17 days.

Speaker #3: And so 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 .

Speaker #3: 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 post-operative infection in breast cancer surgery .

Speaker #3: So let's talk about the roadmap and how do we get from here to there . Right now we have a simple I'm going to talk about that in just a second , but that's our current product .

C. Randal Mills: We're gonna 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, you know, on-the-floor experience in this space. The real excitement starts with 41 and 41x. 41 is our base matrix. When I say NXT-41, 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 NXT-41. We can't leave good enough alone, primarily 'cause it doesn't solve the biggest problem in breast reconstruction.

Speaker #3: That's used in the breast reconstruction space . It gives us a lot of practical on the , you know , on the floor experience in this space .

Speaker #3: But the real excitement starts with with 41 and 41 X . So 41 is our base matrix . So when I'm when I , when I say NXT 41 , I'm talking about just the biological matrix alone without antibiotic .

Speaker #3: 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 NXT 41.

Speaker #3: 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 , we use 41 from a regulatory standpoint to set the foundation for 41 X .

C. Randal Mills: What we do is we use NXT-41 from a regulatory standpoint to set the foundation for NXT-41x. We announced today that we have already submitted to FDA NXT-41. Let me just sort of pause everybody, and reality check everybody. We know we're gonna get questions from FDA. We know we are going to need to respond to them thoughtfully and professionally, and we know that's probably gonna take a little while. 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.

Speaker #3: We announced today that that we have we have already submitted to FDA , NXT 41 . Let me just sort of pause . Everybody .

Speaker #3: In reality, reality check, everybody—we know we're going to get questions from the FDA. We know we are going to need to respond to them thoughtfully and professionally.

Speaker #3: 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.

Speaker #3: They need 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 41 X , which is the base matrix combined with the rifampin and minocycline .

C. Randal Mills: 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 minocycline. If we put the timelines together, we expect clearance for NXT-41X towards the end of the first half of 2027. 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.

Speaker #3: And if we put the timelines together, we expect clearance for NXT 41X towards the end of the first half of 2027.

Speaker #3: So we're looking at a second half launch of that product . Okay , what's going on ? A lot of people ask , what are you guys doing inside the company ?

Speaker #3: Well , you can sort of divide it up into three major workstreams . The first one is obviously development . No surprise here .

C. Randal Mills: 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 NXT-41 base matrix and rolls seamlessly into our NXT-41x drug-eluting matrix. I said we're here in our beautiful Gaithersburg facility. Well, that allows me to introduce manufacturing 'cause this is our manufacturing facility here, where we have enough capacity to make NXT-41x for the foreseeable future. I think we have something like $120 million in revenue generating capacity for NXT-41x with just one shift right now. We have this great manufacturing facility, and basically, I could sum up manufacturing's job right now into two things.

Speaker #3: That group is focused pretty heavily on the approval of a highly differentiated product. That’s improved outcome and outcomes in plastic and reconstructive surgery.

Speaker #3: That starts with our 41 based matrix and roles seamlessly into our 41 X drug eluting matrix . I said , we're here in our beautiful Gaithersburg facility .

Speaker #3: With that, allow me to introduce manufacturing, because this is our manufacturing facility here where we have enough capacity to make 41X for the foreseeable future.

Speaker #3: I think we have something like $120 million in revenue-generating capacity for one X, with just one shift right now. So we have this great manufacturing facility, and basically I could sum up manufacturing jobs right now into two things.

C. Randal Mills: One, ensuring adequate supply of perfect quality tissue, and two, driving down cost of goods. That's what they're working on. Lastly, we now have Pete Ligotti coming in and heading commercial, building these KOL partnerships. Gonna 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 NXT-41x.

Speaker #3: One , ensuring adequate supply of perfect quality tissue and two , driving down cost of goods . So that's what they're working on .

Speaker #3: And then lastly , we now have Pete Liotti coming in and heading commercial building . These col partnerships . I'm going to tell you , we do not have a problem getting a meeting and building strong relationships with our Kols .

Speaker #3: 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 .

Speaker #3: And the number one problem that their patients are facing right now. In addition to that, Pete's working on developing health economic models.

Speaker #3: 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 simpler.

C. Randal Mills: Now let's turn a little bit to SimpliDerm. We're exploring SimpliDerm 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. SimpliDerm is a great product, and whoever gets this asset is going to get a really, really wonderful product. Acellular dermal matrix that's used in soft tissue reconstruction, construction. 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.

Speaker #3: We're we're exploring simple term strategic options . We announced that on the press release today . You might ask , well , why right ?

Speaker #3: 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.

Speaker #3: Now , simple term is a great product and whoever gets this asset is going to get a really , really wonderful product , acellular dermal matrix that's used in soft tissue reconstruction and construction .

Speaker #3: It's got great handling. It's sterile, it's hydrated and ready to use, which is what the plastic surgeons want. A hundred million lives covered.

Speaker #3: This is a big deal. Some people think they could introduce their own acellular dermal product really quickly and just get it on the market.

C. Randal Mills: 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. We have 100 million lives covered across from two of the largest payers, Anthem and UnitedHealthcare, as well as nine regional plans. It's patent protected, obviously. It's completely standalone. For us, it's a completely separable business that doesn't cause any disruption. Whoever gets it's, you know, it's EBITDA accretive, so no incremental capital investment is required. It's really a beautiful plug-and-play technology. We'll keep you updated on this, and we'll see how that process goes.

Speaker #3: It turns out reimbursement in the acellular dermal matrix market is a really big deal. So, we have 100 million lives covered across two of the largest payers.

Speaker #3: Anthem and UnitedHealthCare as well as nine regional plants . Patent protected . Obviously , it's completely standalone . So for us , it's a completely segregated business that doesn't cause any disruption .

Speaker #3: And whoever gets it , it's , it's , you know , it's EBITDA accretive . So no incremental capital investment is required . It's really a beautiful plug and play technology .

Speaker #3: 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.

C. Randal Mills: 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 Elutia crew. We are proud to be recognized for something we already knew. Elutia is a great place to work, and we were certified by the Great Place to Work certification. The results, 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.

Speaker #3: And we wouldn't have been able to make any of the progress that we're making without our incredible Elutia crew. We are proud to be recognized for something we already knew.

Speaker #3: Alicia is a great place to work, and we were certified by the Great Place to Work certification. The results I thought when I saw them, I was.

Speaker #3: 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 .

Speaker #3: 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 .

C. Randal Mills: Our average tenure is 6.3 years. The advantages, if you're wondering, 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 fourfold. We're able to attract job seekers because of the Great Place to Work certification with a 15 times higher attractiveness. Our turnover of certified workforces is about half that of the regular US workplace. I'm gonna end my comments there by thanking this tremendous team for frankly making my job such a joy. With that, I will stop talking, and I will turn it over to Matt Ferguson.

Speaker #3: Our average tenure 6.3 years . The advantages , if you're wondering what's the advantage of this great place to work certification ? Well , the certification is kind of nice .

Speaker #3: 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 fourfold.

Speaker #3: 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 U.S. workplace.

Speaker #3: So I'm going to end my comments there by thanking this tremendous team for , frankly , making my job such a joy . And with that , I will stop talking and I will turn it over to Matt Ferguson Okay .

Matt Ferguson: Okay. Thank you, Randy. Before I start my remarks, I'd just like to say I so appreciate the passion and the leadership that you've brought to the organization, and I support all of the comments that you just made about our mission and our market, our opportunity, and probably most importantly, our team. With that, you know, we put out our earnings press release today with quite a bit of detail in it, and we'll put out our 10-K in a couple of days. That'll have even more detail in it. I'm just gonna hit a few highlights and not take very long here. Moving into a summary of our Q4 financial results.

Matthew Ferguson: Okay. Thank you, Randy. Before I start my remarks, I'd just like to say I so appreciate the passion and the leadership that you've brought to the organization, and I support all of the comments that you just made about our mission and our market, our opportunity, and probably most importantly, our team. With that, you know, we put out our earnings press release today with quite a bit of detail in it, and we'll put out our 10-K in a couple of days. That'll have even more detail in it. I'm just gonna hit a few highlights and not take very long here. Moving into a summary of our Q4 financial results.

Speaker #4: Thank you . Randy . And before I start my remarks , I'd just like to say I so appreciate the the passion and the leadership that you brought to the organization .

Speaker #4: And I support all of the comments that you just made about our mission and our market , our opportunity , and probably most importantly , our team and with that , you know , we put out our earnings press release today with quite a bit of detail in it .

Speaker #4: And we'll put out our 10-K and a couple of days I'll even more detail in it . So I'm just going to hit a few highlights and not take very long here , but moving into a summary of our for our fourth quarter financial results from a revenue perspective , we did 3.3 million in revenue and that compares to 2.8 million in the year ago quarter .

Matt Ferguson: From a revenue perspective, we did $3.3 million in revenue, and that compares to $2.8 million in the year-ago quarter. That's up 16%, so we were very pleased with that performance. That was really driven by the return to direct distribution for both our cardiovascular and our SimpliDerm product lines, as we've talked about. The return to direct distribution has also had a very positive effect on our gross margins. On an adjusted basis, which is probably the better indication of how things are really performing from a business perspective, we had a gross margin for Q4 of 66.8%. That was up 12 points from the prior-year quarter when it was 56.5%.

Matthew Ferguson: From a revenue perspective, we did $3.3 million in revenue, and that compares to $2.8 million in the year-ago quarter. That's up 16%, so we were very pleased with that performance. That was really driven by the return to direct distribution for both our cardiovascular and our SimpliDerm product lines, as we've talked about. The return to direct distribution has also had a very positive effect on our gross margins. On an adjusted basis, which is probably the better indication of how things are really performing from a business perspective, we had a gross margin for Q4 of 66.8%. That was up 12 points from the prior-year quarter when it was 56.5%.

Speaker #4: That's up 16%, so we were very pleased with that performance. That was really driven by the return to direct distribution for both our cardiovascular and our product lines.

Speaker #4: As we've we've talked about the the return to direct distribution has also had a very positive effect on our gross margins . So on an adjusted basis , which is probably the more , the better indication of how things are really performing from a business perspective .

Speaker #4: We had a gross margin for the fourth quarter of 66.8%. That was up 12 points from the prior year quarter, when it was 56.5%.

Matt Ferguson: Really nice results there. Our net loss from continuing operations, so that's excluding the BioEnvelope business that was divested on 1 October, that net loss from continuing operations was $6.5 million versus $7.2 million a year ago. Probably a more relevant metric in terms of our operating performance is adjusted EBITDA, which is a non-GAAP metric, but excludes certain non-cash, non-recurring, non-core operational metrics. That was a loss of $4.2 million in the quarter compared to $3.4 million in the year ago quarter. On our balance sheet, a lot has changed in the last quarter. As you know, our total cash on hand, plus the $8 million that we have in escrow, is $44.4 million.

Matthew Ferguson: Really nice results there. Our net loss from continuing operations, so that's excluding the BioEnvelope business that was divested on 1 October, that net loss from continuing operations was $6.5 million versus $7.2 million a year ago. Probably a more relevant metric in terms of our operating performance is adjusted EBITDA, which is a non-GAAP metric, but excludes certain non-cash, non-recurring, non-core operational metrics. That was a loss of $4.2 million in the quarter compared to $3.4 million in the year ago quarter. On our balance sheet, a lot has changed in the last quarter. As you know, our total cash on hand, plus the $8 million that we have in escrow, is $44.4 million.

Speaker #4: So really nice results there . Our net loss from continuing operations . So that's excluding the bio envelope business that was divested on October 1st .

Speaker #4: That net loss from continuing operations was $6.5 million versus $7.2 million a year ago. And then, probably a more relevant metric in terms of our operating performance, our adjusted EBITDA, which is a non-GAAP metric.

Speaker #4: But excludes certain non-cash , non-recurring , non-core operational metrics . That was a loss of 4.2 million in the quarter compared to three and 3.4 million in the year ago quarter On our balance sheet , a lot has changed in the last quarter .

Speaker #4: As you know, our total cash on hand, plus the $8 million that we have in escrow, is $44.4 million. So that puts us in a really nice position from an overall cash point of view.

Matt Ferguson: Puts us in a really nice position from an overall cash point of view. That is after having paid off all of our debt with SWK. That took place at the beginning of the Q4 as well. That was about $28 million that went to pay off that debt. Then just from a share count point of view, we have 42.8 million common shares outstanding as of the end of the year. In addition to that, there are 4.5 million pre-funded warrants that are outstanding, so a total of 47.3 million. All of those common shares outstanding now are Class A common shares.

Matthew Ferguson: Puts us in a really nice position from an overall cash point of view. That is after having paid off all of our debt with SWK. That took place at the beginning of the Q4 as well. That was about $28 million that went to pay off that debt. Then just from a share count point of view, we have 42.8 million common shares outstanding as of the end of the year. In addition to that, there are 4.5 million pre-funded warrants that are outstanding, so a total of 47.3 million. All of those common shares outstanding now are Class A common shares.

Speaker #4: That is after having paid off all of our debt with S K that took place at the beginning of the fourth quarter as well.

Speaker #4: That was about $28 million that went to pay off that debt . And , and then just from a share count point of view , we have 42.8 million common shares outstanding as of the end of the year .

Speaker #4: And in addition to that , they're 4.5 million pre-funded warrants that are outstanding . So a total of 47.3 million . And all of those common shares outstanding now are class A common shares .

Matt Ferguson: What that means is that all of our Class B common shares, which were held by one entity, were converted during the quarter and sold into the market. That, you know, is essentially an overhang that is gone now, and we're very pleased to get that behind us. One of the effects that we've seen as that has gotten behind us is that we recently came back into compliance with all of Nasdaq's continued listing requirements. We put out that press release at the beginning of last week, and I'd just like to thank all of our investors out there who've put their trust and their capital into Elutia and helped support that return to compliance there.

Matthew Ferguson: What that means is that all of our Class B common shares, which were held by one entity, were converted during the quarter and sold into the market. That, you know, is essentially an overhang that is gone now, and we're very pleased to get that behind us. One of the effects that we've seen as that has gotten behind us is that we recently came back into compliance with all of Nasdaq's continued listing requirements. We put out that press release at the beginning of last week, and I'd just like to thank all of our investors out there who've put their trust and their capital into Elutia and helped support that return to compliance there.

Speaker #4: So what that means is that all of our Class B common shares, which were held by one entity, were converted during the quarter and sold into the market.

Speaker #4: So that , you know , essentially an overhang that is gone now . And we're very pleased to get that behind us . One of the effects that we've seen is that has gotten behind us is that we recently came back into compliance with all of Nasdaq's continued listing requirements .

Speaker #4: We put out that press release at the beginning of last week , and I'd just like to thank all of our investors out there who've put their trust and their capital into Alicia and and helped support that , that return to compliance .

Matt Ferguson: Moving on, just to take a step back and at a big picture level, the Q4 2025, and really all of 2025, represented a real strategic reset for the company. The biggest event in that really was the $88 million sale of our BioEnvelope business to Boston Scientific, which again that allowed us to pay off all of our outstanding senior debt to SWK, left us with $44.4 million of cash on the balance sheet and in escrow that will come in later this year. It really allows us to be completely focused and extremely well-resourced for the continued development and the launch of NXT-41, which we truly believe will be transformational in the market starting next year.

Speaker #4: There . So moving on , just to , to take a step back and at a big picture level , the fourth quarter of 2025 and really all of 2025 represented a real strategic reset for the company .

Matthew Ferguson: Moving on, just to take a step back and at a big picture level, the Q4 2025, and really all of 2025, represented a real strategic reset for the company. The biggest event in that really was the $88 million sale of our BioEnvelope business to Boston Scientific, which again that allowed us to pay off all of our outstanding senior debt to SWK, left us with $44.4 million of cash on the balance sheet and in escrow that will come in later this year. It really allows us to be completely focused and extremely well-resourced for the continued development and the launch of NXT-41, which we truly believe will be transformational in the market starting next year.

Speaker #4: And the biggest event in that really was the $88 million sale of our bio envelope business to Boston Scientific , which , again , that allowed us to , to pay off all of our outstanding senior debt to s k Left us with 44.4 million of cash on the balance sheet and in escrow .

Speaker #4: That will come in later this year. And it really allows us to be completely focused and extremely well resourced for the continued development and the launch of XT-41, which we truly believe will be transformational in the market starting next year.

Matt Ferguson: I guess with that, the last thing I'd like to mention is just that, you know, we've tried to be very active in getting this story out, which we truly believe in. We've been active in getting it out to investors, and we're gonna continue to do that. We have two conferences coming up in the next couple of months. The first will be just next week, the Sidoti Small Cap Conference, which is an online conference. In May, we have the LD Micro Conference, which is a live conference in Los Angeles. If any of you are attending those events, we'd very much love to meet with you there.

Speaker #4: So I guess with that , the last thing I'd like to mention is just that , you know , we've tried to be very active in getting this story out , which we truly believe in .

Matthew Ferguson: I guess with that, the last thing I'd like to mention is just that, you know, we've tried to be very active in getting this story out, which we truly believe in. We've been active in getting it out to investors, and we're gonna continue to do that. We have two conferences coming up in the next couple of months. The first will be just next week, the Sidoti Small Cap Conference, which is an online conference. In May, we have the LD Micro Conference, which is a live conference in Los Angeles. If any of you are attending those events, we'd very much love to meet with you there.

Speaker #4: We've been active in getting it out to investors, and we're going to continue to do that. We have two conferences coming up in the next couple of months.

Speaker #4: The first will be just next week . The small cap conference , which is an online conference , and then in May , we have the LD Micro Conference , which is a live conference in Los Angeles .

Speaker #4: So if any of you are attending those events , we'd very much love to to meet with you there . So with that , in summary , before turning it over to questions , just like to to reiterate that the three key points of our story , we have a validated technology platform that's been proven by the sale of our product and our bio envelope business last quarter to Boston Scientific , $88 million .

Matt Ferguson: With that, in summary, before turning it over to questions, just like to reiterate that the three key points of our story. We have a validated technology platform that's been proven by the sale of our EluPro product and our BioEnvelope business last quarter to Boston Scientific, $88 million. We have a truly blockbuster pipeline underway, which is really starting with NXT-41x in a $1.5 billion market. We are in a great position from a resource point of view. We have a fantastic team. We have a great facility that we're sitting in here today. We have a strong balance sheet, which will take us through that approval and into commercialization.

Matthew Ferguson: With that, in summary, before turning it over to questions, just like to reiterate that the three key points of our story. We have a validated technology platform that's been proven by the sale of our EluPro product and our BioEnvelope business last quarter to Boston Scientific, $88 million. We have a truly blockbuster pipeline underway, which is really starting with NXT-41x in a $1.5 billion market. We are in a great position from a resource point of view. We have a fantastic team. We have a great facility that we're sitting in here today. We have a strong balance sheet, which will take us through that approval and into commercialization.

Speaker #4: We have a truly blockbuster pipeline underway, which is really starting with XT 41X and a $1.5 billion market. And then we are in a great position from a resource point of view.

Speaker #4: We have a fantastic team, we have a great facility that we're sitting in here today, and we have a strong balance sheet, which will take us through that approval and into commercialization.

Matt Ferguson: With that, I'll open it up to questions and back to you, Carmen, to start that off. Thanks.

Matthew Ferguson: With that, I'll open it up to questions and back to you, Carmen, to start that off. Thanks.

Speaker #4: So with that , I'll open it up to questions and back to you , Carmen , to start that off , thanks .

Operator 1: Thank you so much. As a reminder, to ask a question, simply press star one one to get in the queue and wait for your name to be announced. To remove yourself, press star one one again. We have a question from the line of Frank Takkinen with Lake Street Capital Markets. Please proceed.

Operator: Thank you so much. As a reminder, to ask a question, simply press star one one to get in the queue and wait for your name to be announced. To remove yourself, press star one one again. We have a question from the line of Frank Takkinen with Lake Street Capital Markets. Please proceed.

Speaker #1: Thank you so much . And as a reminder to ask a question , simply press star one one to get in the queue and wait for your name to be announced to remove yourself , press star one one again We have a question from the line of Frank Tachykinin with Lake Street Capital Markets .

Speaker #1: Please proceed

Frank Takkinen: Great. Thanks. Taking the questions. Congrats on the progress. Congrats on the 41 submission to the FDA. I was hoping to start with a few questions around that. I know it's a question along the lines of trying to predict the unpredictable, but as you're working internally, what kind of questions are you preparing for from the FDA, and kinda how do you think about the challenges you might have to go through to get it to market, or if it should be a relatively streamlined process? And then secondly, once you do get 41 across the goal line, how quickly can you shift the filing to 41X and resubmit? Yeah. Okay. I'm just making some notes, Frank. Frank, thanks for the questions. I think everyone should-

Speaker #5: Great . Thanks for taking the questions . Congrats on the progress . Congrats on the 41 submission to the FDA . I was hoping to start with a few questions around that .

Speaker #5: I know it's a question along the lines of trying to predict the unpredictable, but as you're working internally, what kind of questions?

Speaker #5: Are you preparing for from the FDA ? And how do you think about the challenges you might have to go through to get it to market , or if it should be a relatively streamlined process , and then secondly , once you do get 41 across the goal line , how quickly can you shift the filing to 41 X and resubmit ?

C. Randal Mills: Yeah. Okay. I'm just making some notes, Frank. Frank, thanks for the questions. I think everyone should-

Speaker #3: Okay I'll just write it , making some notes . Frank . So , Frank , thanks for the questions . I think everyone should I think everyone should should view the review process and respect the review process .

C. Randal Mills: I think everyone should view the review process and respect the review process, I would say the way we do. The timelines that we've laid out for clearance. They're fairly conservative. They're fairly conservative because we wanna make sure that we do a really professional job. Now, I'd say first and foremost, we submit a high quality application with everything in it that we think is necessary for, you know, a clearance. We do retain a lot of backup data on, and supporting data on all the necessary points. As a matter of sort of regulatory strategy and sort of best practices in regulatory science, you don't over answer a question with FDA.

Speaker #3: I would say the way , the way we do the timelines that we've laid out for clearance have a there's , they're fairly they're fairly conservative and they're fairly conservative because we want to make sure that we do a really professional job .

Speaker #3: Now , I'd say first and foremost , we submit a high quality application with everything in it that we think is necessary for , you know , a clearance .

Speaker #3: We do retain a lot of backup data Up on and supporting data on all the necessary points . But as a matter of sort of regulatory strategy and sort of best practices in , in , in regulatory science , you don't over answer a question with FDA .

C. Randal Mills: You just be prepared to sort of explain the rationale for the things that you did answer. That's really the strategy that we have going on. There's no question that biocompatibility for a product like this is a big question in the minds and a big focus right now in the Food and Drug Administration. We know that. We feel pretty good about our product there. We know, you know, that when we get into NXT-41x, if we just remember back to the days from EluPro, that things like in vitro elution was a real big point with them. You probably remember the IVE days, Frank.

Speaker #3: You just be prepared to sort of explain the rationale for the things that you did that you did answer . And so that's really the strategy that we have going on the there's no question that that biocompatibility for some , a product like this is a big question in the minds .

Speaker #3: And a big focus right now in the food and drug Administration , we know that we feel pretty good about our our product .

Speaker #3: There . We know , you know , that when we get into 41 X , if we just remember back to the days from from that , things like in vitro elution was , was , you know , a real big , a real big point with them .

Speaker #3: You probably remember the IVF days , Frank , or IV . ID e days . And so , you know , we're we're prepared for any and all of it , but we're prepared for it in a , a very humble and respectful way .

C. Randal Mills: you know, we're prepared for any and all of it, but we're prepared for it in a very humble and respectful way. That's the timelines we've set up, you know, have that in place. I would just sort of encourage everyone to just kinda keep that in mind. I wouldn't be pulling forward any timelines until I tell you that's probably a good idea. With regards to, you know, how fast we roll into NXT-41x, I would say just to kind of keep in mind, the whole purpose of NXT-41 is to improve the efficiency of NXT-41x. We have no intention of commercializing NXT-41.

C. Randal Mills: You know, we're prepared for any and all of it, but we're prepared for it in a very humble and respectful way. That's the timelines we've set up, you know, have that in place. I would just sort of encourage everyone to just kinda keep that in mind. I wouldn't be pulling forward any timelines until I tell you that's probably a good idea. With regards to, you know, how fast we roll into NXT-41x, I would say just to kind of keep in mind, the whole purpose of NXT-41 is to improve the efficiency of NXT-41x. We have no intention of commercializing NXT-41.

Speaker #3: And that's the timelines we've set up . You know , have that in place . And , and I would just sort of encourage everyone to just kind of keep that in mind .

Speaker #3: I wouldn't be , I wouldn't be , I wouldn't be pulling forward any timelines . And until we tell you that's probably a good idea , until I tell you that's probably a good idea .

Speaker #3: With regards to , you know , how how fast we roll into 41 x , I would say just kind of keep in mind the whole purpose of 41 is to improve the efficiency of 41 x .

Speaker #3: We have no intention of commercializing 41 . It's a it's not a drug eluting matrix . And so it doesn't , you know , it doesn't fit with our high level thesis .

C. Randal Mills: It's not a drug-eluting matrix, and so it doesn't, you know, it doesn't fit with our high-level thesis. Really the only reason that we're doing it is for regulatory efficiency. Therefore, the team, you know, will learn from the NXT-41 submission. You know, they'll call any audibles that they need to as a result of what we learned from the NXT-41 submission. Clearly their plan is to go pretty efficiently from NXT-41x or from NXT-41 into NXT-41x. If at any point we think that that might not, you know, that NXT-41 might, you know, no longer serve that purpose, well, then, you know, we might change the plans.

Speaker #3: So really, the only reason that we're doing it is for regulatory efficiency, and therefore the team, you know, will learn from the 41 submission.

Speaker #3: You know , they'll call any audibles that they need to as a result of what we learned from the 41 submission . But but clearly there plan is , is , is to go .

Speaker #3: Pretty efficiently from 41 X or from 41 in , in to 41 x . And if any point we think that that might not , you know , that that that 41 might , you know , no longer serve that purpose .

Speaker #3: Well , then , you know , we might , we might change the plan . We might , you know , even pull forward a 41 X submission .

C. Randal Mills: We might, you know, even pull forward a NXT-41X submission. Right now, we anticipate in the timelines an approval pretty efficiently after NXT-41.

Speaker #3: But right now we anticipate in the timelines we anticipate , we , we anticipate , you know , we anticipate an approval pretty efficiently after 41 .

Frank Takkinen: Got it. Very helpful color. Was hoping to ask a little bit more about commercial. Appreciate some of the comments you made there. Kind of related to SimpliDerm, I think we've talked about just having experience in that space via SimpliDerm could help kind of the commercial readiness of the organization once NXT-41x is approved. How do you kinda think about balancing that readiness that SimpliDerm could have helped with versus the strategic process? Then at the same time, what are you maybe doing from a commercial readiness perspective in light of kinda that transition that is occurring?

Speaker #5: Got it . Very helpful color . I was hoping to ask a little bit more about commercial . Appreciate some of the comments you made there , but kind of related to simply derm .

Speaker #5: I think we've , we've talked about just having experience in the , in that space via derm could help kind of the commercial readiness of the organization .

Speaker #5: Once 41X is approved, how do you kind of think about balancing that readiness that Symphony Derm could have helped with versus the strategic process?

Speaker #5: And then, at the same time, what are you maybe doing from a commercial readiness perspective in light of kind of that transition that is occurring?

C. Randal Mills: Right. Frank, let's kinda go through this with the three things that really help us get ready for NXT-41x. One is just a base understanding of this market, how it works, and that includes the reimbursement, right? We've done that. We do know and we do understand how this current, you know, market works, how reimbursement works here, who the players are, literally the logistics of a breast reconstruction product. We think we check that. You will remember by far the most important thing in the commercialization of EluPro was the value analysis committees, like the VACs.

Speaker #3: Right . So , Frank , let's kind of go through this with the three things that that really help us get ready for 40 1X1 is just the base understanding of this market , how it works .

Speaker #3: And that includes the reimbursement , right ? So we , we've , we've done that . We , we do know , we do understand how this current You know , market works , how reimbursement works here , who the players are literally , literally the logistics of , of , of a breast reconstruction project .

Speaker #3: So we think we , we think we , we check that you will remember by far the most important thing in the commercialization of value pro was the value analysis committees like the VAX and , and I'll be , I'll be completely honest here .

C. Randal Mills: I'll be completely honest here, we learned more about how to do that efficiently with EluPro than probably we learned or are learning from SimpliDerm. 194 VACs in the time that we did that, I mean, that was so key to the explosive growth of that product. We see and we have a, you know, a team that understands that. We know what to do from a VAC package standpoint. We feel pretty good about that. The third piece, though, was KOLs and, you know, key opinion leaders and who are the thought leaders in this space.

Speaker #3: We learned more about how to do that efficiently with LU Pro than probably we learned or are learning from simple Derm 194 of X.

Speaker #3: In the time that we did that, I mean, that was—that was so key to the explosive growth of that product.

Speaker #3: And we, and we have, you know, a team that understands that we know what to do from a VAC package standpoint.

Speaker #3: So we feel pretty good about that . The third piece , though , was k o and you know , key opinion leaders and who are the thought leaders in this space .

C. Randal Mills: Here's, Frank, where our thought process has really flipped, and it really started flipping when we were able to go last October to you know the big plastics and breast reconstruction meeting in New Orleans. Just cold call some of these marquee leaders in the field of plastic and reconstructive surgery and say, "Hey, would you mind having a conversation with us? We're trying to develop a locally delivering biological matrix for breast reconstruction. Like you deliver antibiotics to try to prevent infection." Our dance card filled with some of the brightest, strongest thought leaders in this space. That continues to this day.

Speaker #3: And here's Frank , where our our thought process has really flipped . And it really started flipping when we , when we were able to go last October to the , you know , to the big plastics and breast reconstruction meeting .

Speaker #3: In New Orleans. And just cold call some of these marquee leaders in the field of plastic and reconstructive surgery and say, hey, would you mind having a conversation with us?

Speaker #3: We're trying to develop . We're trying to develop a locally delivering biological matrix for breast reconstruction and , you know , deliver antibiotics to try to prevent infection .

Speaker #3: Our dance card filled, and it filled with some of the brightest, strongest thought leaders in this space. And that continues to this day.

C. Randal Mills: We have no problem getting meetings with these KOLs and engaging in very meaningful, very enthusiastic conversations with them on how we can best design, build, and deliver a product that is exactly what we need. When that last piece sort of started to happen was when we sort of made the decision we're probably pretty good here and can start moving on, particularly with the progress the R&D team's making with the filings.

Speaker #3: We have no problem getting meetings with these KOLs and engaging in very meaningful, very enthusiastic conversations with them on how we can best design, build, and deliver a product that is exactly what we need.

Speaker #3: And so when that last piece sort of started to happen was when we , we sort of made the decision , we're , we're , we're probably pretty good here .

Speaker #3: And can, and can, start moving on, particularly with the progress the R&D team's making with the filings.

Frank Takkinen: Yep. That's perfectly clear. I got it. One last one I wanted to ask, Randy. Obviously the data is really impressive with the plate as well as the powder with 60% and 80%+ reductions. How do you think, and it's a speculative question, but how do you think NXT-41x could compare from an infection reduction perspective in relation to some of these other techniques that are being used today?

Speaker #5: Yep , yep . That's perfectly clear . I got it , got it . One one last one . I wanted to ask Randy .

Speaker #5: Obviously, the data is really impressive with the plate as well as the powder, with 60% and 80% plus reductions. How do you think?

Speaker #5: And it's a speculative question, but how do you think 41X could compare from an infection reduction perspective in relation to some of these other techniques that are being used today?

C. Randal Mills: Yeah. We would be thrilled with a 50% reduction. Anyone would be thrilled with something like that. We have some advantages, though, over those techniques that are delivering those results. Those advantages are uniform distribution. So as I said, you know, with the plates and the beads, those things, you know, they have mass to them, and they notoriously sort of fall down into the breast gutters and don't provide uniform coverage. The second thing is, the teams that were doing that work, they know that antibiotic comes out of that real fast. Therefore, it doesn't provide a particularly long-term coverage. We, you know, we targeted this 30 days, and we targeted the 30 days because the drains come out at day 17.

Speaker #3: Yeah We would be thrilled with the 50% reduction . Anyone would be thrilled with with something like that . We have some advantages though , over those techniques that are delivering those results , those advantages are Uniform distribution .

Speaker #3: So as I said , you know , with the plates and the beads , those things are , you know , they have mass to them and they know they notoriously sort of fall down into the breast gutters and don't provide uniform coverage .

Speaker #3: The second thing is, the teams that were doing that work, they know that antibiotic comes out of that real fast, and therefore it doesn't provide a particularly long-term coverage.

Speaker #3: We, you know, we targeted this 30 days, and we targeted the 30 days because the drains come out at day 17.

C. Randal Mills: If the drains are still in, you know, particularly with this, there's a pistoning that can happen with these drains from the outside to the inside. You're constantly introducing and have the potential to introduce bacteria, you know, back into that surgical field. We felt pretty strongly, you know, that you needed to have antibiotic coverage after the, you know, that persisted after the drains were filled. We feel like we've probably built a better solution than the ones, you know, than what you're seeing with these really fantastic results. You can't knock what they're seeing. I think I wanna caution, you know, everyone here again, too, a little bit of humility and perspective. There is a percentage of these cases that have such severe necrosis.

Speaker #3: And and if the drains are still in , you know , particularly with this , this there's a piston ring that can happen .

Speaker #3: With the drains from the outside to the inside . You're constantly introducing and have the potential to introduce bacteria , you know , back into that surgical field .

Speaker #3: So we felt pretty strongly that , you know , that you needed to have antibiotic coverage after the , you know , that persisted after the drains were filled .

Speaker #3: So we feel like we've probably built a better solution than the ones , you know , than , than , than what you're seeing with these really , really fantastic results .

Speaker #3: You can't knock what they're seeing . But I think I want to caution , you know , everyone here again , to a little bit of humility and perspective , there is a percentage of these cases that have such severe necrosis .

C. Randal Mills: This is where the vasculature to the breast is so compromised that it doesn't matter what you would put in there, the tissue just dies. In that case, you know, we can add antibiotics all day long, but we're not gonna prevent, you know, what's ultimately gonna become something more like a gangrenous infection and the complications for those. That's really just an unsolvable, at least at this time, consequence of the base mastectomy. Does that help?

Speaker #3: This is where the vasculature to the breast is so compromised that it doesn't matter what you would put in there. The tissue just dies.

Speaker #3: And in that case , you know , those we can add antibiotics all day long , but we're not going to prevent , you know , what , what's ultimately going to become something more like a gangrenous infection .

Speaker #3: And , and , and the complications for those . And that's really just a , un , at least at this time , consequence of the base mastectomy .

Speaker #3: So does that help ?

Frank Takkinen: Yeah. That was perfect. Appreciate the comment. Thanks, guys.

Speaker #5: Yeah . That's perfect . Appreciate the color . Thanks , guys .

Operator 2: Thank you so much. Ladies and gentlemen, this concludes our Q&A session and our conference for today. Thank you for participating. You may now disconnect.

Operator: Thank you so much. Ladies and gentlemen, this concludes our Q&A session and our conference for today. Thank you for participating. You may now disconnect.

Speaker #1: Thank you so much . And ladies and gentlemen , this concludes our Q&A session . And our conference for today . Thank you for participating .

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