NASDAQ:ELUT Elutia Q1 2025 Earnings Report $2.08 +0.09 (+4.52%) As of 04:00 PM Eastern Earnings HistoryForecast Elutia EPS ResultsActual EPS-$0.21Consensus EPS -$0.20Beat/MissMissed by -$0.01One Year Ago EPSN/AElutia Revenue ResultsActual Revenue$6.03 millionExpected Revenue$6.65 millionBeat/MissMissed by -$620.00 thousandYoY Revenue GrowthN/AElutia Announcement DetailsQuarterQ1 2025Date5/8/2025TimeAfter Market ClosesConference Call DateThursday, May 8, 2025Conference Call Time5:00PM ETUpcoming EarningsElutia's Q2 2025 earnings is scheduled for Monday, July 28, 2025Conference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Elutia Q1 2025 Earnings Call TranscriptProvided by QuartrMay 8, 2025 ShareLink copied to clipboard.There are 5 speakers on the call. Operator00:00:00ladies and gentlemen. Welcome to the Illustra First Quarter twenty twenty five Financial Results Conference Call. Please be advised that today's conference call is being recorded. I would now like to hand the conference over to Matt Steinberg with Fin Partners. Please go ahead. Speaker 100:00:20Thank you, operator, and thank you all for participating in today's call. Earlier today, Elluci released financial results for the quarter ended 03/31/2025. A copy of the press release is available on the company's website. Before we begin, I would like 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. Any 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 100:01:07All forward looking statements, without limitation, those relating to our operating trends and future financial performance are based upon our current estimates and various assumptions. These statements involve 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 a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our public filings with the SEC, including Aleutia's Annual Report on Form 10 ks for the year ended 12/31/2024, accessible on the SEC's website at www.sec.gov. Such factors may be updated from time to time in Ellucius' other filings with the SEC. Speaker 100:01:58The conference call contains time sensitive information and is accurate only as of the live broadcast today, 05/08/2025. Ellucius disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward looking statements, whether 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 release for the first quarter ended 03/31/2025, which accessible on the SEC's website and posted on the Investor page of the Aleutia website at www.aleutia.com. And with that, I will turn the call over to Aleutia's CEO, Randy Mills. Speaker 200:02:55Thank you, Matt, and hello, and welcome, all of you joining us today to our first quarter twenty twenty five conference call. I'll start off like I always do, just briefly describing our mission. Our mission, our true north, the thing that guides us in this company, humanizing medicine so that so patients can thrive without compromise. We're interested in, believe strongly in this intersection of biological materials being superior than metals or synthetics and then combining those with active pharmaceutical agents. That is what humanizing medicine means to us. Speaker 200:03:39All right. So let's get into it. We've got a lot of time to talk about. I know we're starting a little later than normal today. So I'll try be pithy in my comments. Speaker 200:03:48We had a fantastic quarter and there's a lot we need to get you up to speed on. So let's jump into it. Looking at an overview of what we're going to be talking about today. First, we couldn't start this conversation without talking about the success of Eliupro, and its start to the full launch exceeding expectations far and away. We're also going to talk a little bit about the future growth that we see coming, through our new partnership with Boston Scientific that starts up this quarter, the second quarter, that we're currently in right now. Speaker 200:04:33We're also, been out there doing some really significant and targeted marketing efforts, we're going to talk through some of those scientific and marketing recognition that we're getting. I do want to make a few quick comments on regaining our cardiovascular portfolio from LeMaitre. And then obviously, Matt's going to talk to you about, our finances and our financial position, which we were also able to materially strengthen during the quarter. So with that, let's jump right into it. Elupro first quarter launch, this is the priority for the company that's the most important thing going on in the organization. Speaker 200:05:18And during our first full quarter launch of the product, we really experienced some tremendous performance. So BioEnvelope, this combines our legacy Kangaroo product with our EleuPro product, up 31% year over year to $3,100,000 for context. It is also up 16% sequentially, and that was off of a really strong, in fact, our best quarter that we had for BioEnvelope. So really, really strong overall results for our BioEnvelope franchise. But this was all driven by Elupro. Speaker 200:06:03In fact, all driven by Elupro offset by some cannibalization, that was expected going on in Kangaroo. Elupro jumped 84% from the fourth quarter, to the first quarter and now, constitutes 52 of our bio envelope revenue. And as it's climbing out, will become far and away, we think the dominant, factor in bio envelope revenue. How did we do that? How was that possible? Speaker 200:06:34Well, that was all made possible by the outstanding performance turned in by our team in securing VAC approvals. We've said this from the beginning that our work with value analysis committees and getting through the value analysis committees and on contract with the hospitals was the essential prerequisite. It has to happen before any sale can happen. And we are currently through 125 hospitals that are now actively ordering the product. And I want to take a moment to thank the team for such a tremendous effort, there. Speaker 200:07:12So digging a little bit deeper into, the Value Analysis Committee, approval process and also what we have going on with our GPOs. So as I said, 125 institutions currently through a VAC and actively ordering the product. You can see here, this is actually, so since September, how we've done month to month by adding hospitals through contract and through the value analysis committee on a monthly basis. I will say we do not add an institution merely by getting through the value analysis committee process or even getting on contract for us to add them and for them to make this chart and for to make this graphic, they actually have to be actively ordering, the product as well. So 125 institutions through that process, another 130 VACs in process. Speaker 200:08:10We're currently adding about 10 to 12 VACs, a month. Again, just so everyone understands the universe. So we're in 125, we're targeting about 1,000 hospitals, to ultimately run this process out through with. We get there by taking only hospitals, so not ambulatory surgery centers and then gating on those hospitals that do greater than 100 pacemaker or defibrillator cases a year. So absolutely outstanding work, going on here with our value analysis committee efforts. Speaker 200:08:47And really what we think this does is we think this reads on our second half of this year and we think this sets us up in a very, very strong position for us, a very strong second half to twenty twenty five. Okay. Other work we've done in here though. So value analysis committees are great to have. Another thing that really helps us along is having these GPO agreements in place and we were able to add two more to the list in the first quarter. Speaker 200:09:21So we're super excited about that. We also, have a lot more work going on with GPOs and hope to be adding to this list of seven, within, the year 2025. So a lot of great stuff going on from a VAC standpoint, from a contracting standpoint, the back office machine at Osiris is really, really starting, to come into its own and work. All right. Now, want to talk about how we are planning on supercharging that with our Boston Scientific relationship. Speaker 200:09:57Now, we've been talking to our friends over at Boston Scientific for some time now on some bigger ways, of working together. And we are still doing that. We're still working through that. But while we were going through that process, we said, you know what? This product Speaker 200:10:15We need to get this thing launched and we need to get it into the hands of our reps. And so our two organizations came together. We decided to put this construct in place to be able to do that right now. So this is a distribution agreement that is able to leverage the Boston Scientific reps. Basically the way it works is Boston Scientific reps get paid a direct commission for keeping Medtronic out of their cases. Speaker 200:10:41I mean, what could be better than that? You're already in the case, you're already there putting in the pacemaker, why not get some money keeping Medtronic out of your case? And so that's basically what this deal does. It gives us a combined commercial footprint of over 900 sales professionals coast to coast. Now for context, we have 12, territory managers, another 35 1099s of our own. Speaker 200:11:12We were in before this arrangement, we were already in 35 states, not bad. But with this Boston Scientific arrangement, it's game changing for us. It gives us 900 sales reps covering coast to coast. It also gives us really great economics under this model. So this model allows us to recognize end market revenue and actually pay a fairly modest commission to the Boston Scientific reps each time they actually sell Elupro in a case. Speaker 200:11:47So they're incentivized to make Elupro more successful. The Boston reps actually help us in two ways, right? So one way that they help us is Boston Scientific actually helps us drive the VAC process by introducing us and making those essential connections with the physicians and with the purchasing people inside, these hospitals, they can actually help us get back approvals more efficiently. And when we talk about going from where we are now really to scale, this becomes essential for us. The other way they help us is just actually case coverage and adoption within the procedure. Speaker 200:12:28So the Boston Rep is in every single case right there with the pacemaker when the pacemaker is going in and it's just super easy for them to say, hey, how about we also protect, this pacemaker and this patient by putting the best antibiotic eluting envelope available on the market around this and getting paid to do it. So with that, our sales training of the organization, the initial sales training and rollout has already been completed. Kimberly and her team are doing a fantastic job and get this, Boston Scientific reps have already gone out and started generating sales at over 52 hospitals, as of today, where Boston Scientific reps are actively selling ellipro at. So a lot going on with Boston Scientific. We have a great partnership. Speaker 200:13:23We're fully engaged with them talking about what we're doing now and talking about bigger ways of working together. But in the meantime, we have really put together a tremendous package that helps us get the most out of EleuPro and get the most out of the launch of this product. Okay. With all of that, great work going on commercially from an operational standpoint, we need to make sure that we can keep up and we need to make sure we can keep getting more and more efficient. So, our production of Elupro takes place at our Roswell, Georgia facility that also supports our Kangaroo manufacturing process as well. Speaker 200:14:00It has capacity to do about $140,000,000 in revenue of Elupro at about a 70 plus percent gross margin. But we were finding ourselves a little constrained, by the production of the antibiotic component of it. So our team in Roswell, Georgia can actually crank out Lupro all day long provided that they have the subcomponents necessary. And one of those critical ones is the antibiotic disc that we use. And so, we have actually expanded and opened a new facility in Gaithersburg, Maryland that adds GMP manufacturing capacity to us that allows us to make, the antibiotic discs. Speaker 200:14:46That's important one because it removes a bottleneck. But the other reason that's important is it's actually a pretty significant component of the cost of the product. And so by making that antibiotic disc directly ourselves, we remove the supply constraint and the bottleneck on it and significantly reduce the cost of goods, of the product. So we're super thrilled to have that facility. We're moving into that facility right now and getting that up and running. Speaker 200:15:14We hope to have that site manufacturing and contributing by the end of the year. We were also able to get really exceptional lease terms for this facility. And so we were able to gain all of this space and this capacity from existing GMP space in really favorable economic terms. All right. And then, certainly, a fun thing to do is to get out and spend time with physicians and other partners that we have and market the product. Speaker 200:15:51And we had a phenomenal kickoff of ElluPro at American, or sorry, at the Heart Rhythm Society meeting in San Diego, just a few weeks ago, where we launched our ad campaign, putting an end to unnecessary roughness, feel the difference biology makes. And I'll just tell you, you can see here is a photograph of our booth. I would say rather strategically placed in the middle of this conference center next to our partners of Boston Scientific and in real serious proximity to some of our competitors. And it stood out. It was very eye catching and we had a tremendous presence at our booth. Speaker 200:16:38It was great getting to speak with our physician partners who were stopping by engaging with us. I would thank many actually investors, and other partners of you who stopped by and said hello at HRS. I hope you enjoy the experience as much as we did, but it was a great kickoff to Eliupro and it was a great kickoff to this marketing campaign where we think, really underscores the value proposition that we add. The same phenomenal antibiotics, rifampin and minocycline proven, to protect patients from, postoperative infections combined with a biological envelope that makes it easier for the physician to use and more comfortable for the patient, to have. So a great kickoff. Speaker 200:17:30Adding right to that, it was my extreme honor, to be present at the twenty twenty five Edison Awards to accept an Edison Award on behalf of the entire Aleutia crew for innovation in post surgical recovery. Eleupro already starting to win awards, the words getting out, and it was fantastic. The science team wants to know that they will not be left out of this conference call. They have enrolled the first patients in our real world clinical study going on. Our first patients were enrolled at UCSD. Speaker 200:18:11We're enrolling patients in this study across the country, gaining the kinds of clinical outcome data that physicians care about. And then lastly, they were able to notch another win with a peer reviewed publication confirming the broad spectrum antibacterial effect of Elupro against all different kinds of bacteria and showing just how robust, the antibacterial properties of Elupro are when implanted. Okay. So those are my comments about Elupro. Lastly, I will just make a few comments on our reacquisition of our cardiovascular products from MELINATE. Speaker 200:18:55This was a process that really went as seamless as it possibly could. There was really minimal customer disruption. We were able to assemble a team so far 26, 10 90 nine sales reps that are out there selling the product. Direct sales are now underway, and this has already begun. And again, this one, we think really has a possibility of adding and contributing from a financial standpoint right away. Speaker 200:19:29So I want to make these couple of these points really clear, because we got some questions about it. One is, yes, it's going to help our top line revenue because we are capturing top line revenue. Our gross margins, will go up predictably to about 80%. But here's the important thing. We expect this to, essentially immediately contribute positively on the cash flow line. Speaker 200:19:52So this isn't a change that will cost us money. This isn't a change where we will have to make an investment. This is something that contributes right away, to the bottom line. And then lastly, it does increase our strategic flexibility with this product line. Having this back from Molgrade and fully in our control, lets us make other strategic decisions with it. Speaker 200:20:14This is a product line where we've been approached, from other strategics about. And so it gives us that opportunity to consider a lot of different options with this cardiovascular line. So with that, I will, pause my comments. I'll turn it over to Matt. I'll be back with, after Matt's rundown of our financial update with a few parting comments. Speaker 200:20:38Okay. Thanks, Randy. Thanks for all of you for being on the call today. I'm just going to hit a few of our highlights from our financials, of course, refer you to our earnings release and our 10 Q, which will come out early next week for all of the gory details of those. Course, leading the way, as Randy mentioned on the top line, our BioEnvelope division, or device protection as we sometimes call it, came in at 3,100,000 in revenue. Speaker 200:21:04That's compared to $2,400,000 a year ago. That represents 31% growth year over year and, also great sequential growth there compared to the Q4 number, which was pretty darn good in and of itself. For Simploderm, we were at $2,600,000 for the quarter. That is down admittedly from, last year's number of $3,600,000 but it's up quite a bit, from the number that we had in Q4, up about 13% from Q4 number. So we're pleased with what's happening there and feel like we're on the right trajectory. Speaker 200:21:45Our cardiovascular products division, as Randy mentioned, the number for Q1 represented sales that were still going through our outside distributor, at only about $300,000 We would expect that as we're taking that back and starting to capture, the top line sales, 100% of the top line sales, and also reinvigorating the actual sales efforts there through a really great organization of contract salespeople that we have in place already, that we'll see some significant growth there going forward as well as better contributions to our bottom line. So overall, adding those things up, we came in at $6,000,000 in sales, down a bit from last year, but again up sequentially from Q4 by about 10%. So moving down the P and L, I'll skip down to our adjusted gross margin, which is sort of how we look at it internally, excludes noncash amortization of intangible expense. That came in at 54.8%, really basically unchanged from last year when we were at 55.2%. But we also believe that there will be a number of positive changes going forward there, particularly as we make some efficiencies in the manufacturing of Elupro, as we take some of that in house and increase volumes there. Speaker 200:23:15And then also, as I mentioned, the capturing of direct revenue on the cardiovascular side of things. So we actually expect gross margin to improve going forward. We also did a good job in Q1, even in spite of what really was a lot of focus on the launch of Eliupro, we were able to control expenses quite well. Operating expense actually went down year over year by close to $1,000,000 10 point 4 million dollars versus 11.3 And that translated down to what I consider to be our most salient profitability or loss measure. Our adjusted EBITDA number came in at $3,300,000 and that is an improvement from last year when we were at $4,500,000 for a comparable measure. Speaker 200:24:02So feel like we're getting nice control around our operations and seeing the leverage associated with the growth that we're generating on the top line. From a cash point of view, we ended the quarter at $17,400,000 and that reflects a number of things that were going on in the quarter. One of those was a registered direct offering, which took place in February, where we had $15,000,000 in gross proceeds, so that added about $13,700,000 in net proceeds. We also just today have announced a couple of amendments to important relationships that we have with Ligand Pharmaceuticals, who has a royalty interest agreement with us, and SWK Holdings, which is our lender. And, both of those amendments are designed to help us conserve cash, both in the current quarter and also going forward. Speaker 200:24:57So in the case of SWK, that includes an additional potential term loan that we can draw on of $5,000,000 as well as a full deferral of our cash interest payment in the second quarter and a number of other changes to terms and covenants. In the case of Ligand, we actually have agreed that we will satisfy the payments for the first half of the year in stock, so that completely eliminates the cash outlay, which would have been $2,200,000 in the first quarter. So I think this really is a great indicator of the relationship that we have with these lenders and financial partners and the support that they're showing going forward. So very pleased to have those done and appreciate their work with us to get those done today. So that's sort of the recap on the, financials. Speaker 200:25:54And with that, I will turn it back to Randy. All right. So I'm just going to conclude with a wrap up of where are we going. We don't give guidance, but I do like to be really explicit and really transparent with the direction of the organization. So not a surprise to anyone. Speaker 200:26:12Our number one priority is to continue to drive top line growth of Elupro, and we're doing this by expanding our VAC and our GPO coverage. Two, everything we've done up to date, I should say, everything we reported in this quarter, the Eliupro team was able to do on their own. They are now joined in that effort with 900 Boston Scientific sales reps, that are really interested in this product. And so our second point is to continue building on the momentum that we've already started through the engagement of our Boston Scientific partnership. And we're really excited about that. Speaker 200:26:55Number three, we need to continue with our production capacity efforts and increase or in lowering the cost of goods for Allupro. Our target here, again, is we think this is a product that has gross margins ultimately in the mid-seventy percent range. And our operations team is hard at work in making that come true. Number four, now that we are at a position in our relationship with our Sientra contract, which was acquired by Tiger, to explore strategic alternatives. We're actually going to do that. Speaker 200:27:39We're actually starting that process. We're exploring different strategic options for simpler. I might have more clarity around that, but I will hopefully, coming up in future calls. And then lastly, continue to advance drug eluting biologic pipeline that we have for, reconstructive surgery. We will be introducing some of this stuff more explicitly later on in the year. Speaker 200:28:07And I think you're going to find it absolutely stunning. The same team that brought you EluPro and was able to get that technology through the FDA has been hard at work on some absolutely game changing technologies. And we're really excited about those and actually getting some of those technologies through FDA in a relatively near term horizon. So with that, I will conclude my comments today and turn the call over to Latanya for any questions that you might have. Operator00:28:48Thank you. We will now conduct a question and answer session. The first question comes from Frank Takin with Lake Street Capital. Please proceed. Speaker 300:29:21Great. Thanks for taking the questions. Congrats on the really strong start to the year. I was hoping to start with one on Boston Scientific. I know it's kind of early days still, but was excited to see you're in the 50 accounts selling with BSX already. Speaker 300:29:33How have those relationships with the physicians gone in those cases? Are they fully switching out their TYRX use for LUpro? Is it testing it a few times and then they shift it gradually from there? Just trying to get a feel for how quickly the Boston Reps can flip the competitive accounts. Speaker 200:29:53Yes. Thanks, Frank. The way we're finding the adoption patterns for Elupro sort of goes like this. And I'll tell you sort of a little bit of story about this because it relates to originally we saw a surge in Elupro ordering over historical kangaroo ordering and we thought, well, might be a stocking order, but what we found was subsequent orders in general are higher than the initial order that's placed. We're spending a lot of time in the field. Speaker 200:30:28Obviously, I've been out riding with our reps and sort of experiencing this firsthand. We saw this again at HRS. And here's generally what happens is historically, there might be one physician who likes or is interested in using LUPRO in their center and they'll bring the product in and they'll use it. And what happens is they tend to like the experience, particularly if they've used Tyrex in the past. The use of Value Pro is completely different experience. Speaker 200:31:05But what we found is it spreads through practices, pretty predictably and pretty consistently. And so what we find is that we might originally have one physician in a practice that's interested in getting it on the shelf and ordering and Boston Scientific is essential in giving us that introduction. But when other physicians in that practice see the product, hear about the product, they try it, and they're also adopting it, and using it. Now, this is a game, obviously we've got to play hospital by hospital, but we certainly like that dynamic. Frank, the second thing that I think it's important to understand is once this conversion tends to happen with an electrophysiologist, it tends not to be just with their Boston Scientific cases. Speaker 200:32:04So it's rare that you find an electrophysiologist that only uses one particular brand of pacemaker. Usually they might use 40% of 40% of another and 20% of a third. And so if they're in there and they've experienced the use of Elupro with, their Boston Scientific rep on their Boston Scientific pacemaker, what tends to happen is they tend to also carry that usage over to their other cases where they might be using a competitive pacemaker. There's really, it really becomes part of their surgical practice more so than related to which particular can that they're using. So this is really a great way for us, to leverage the Boston Scientific relationship even beyond, those individual cases that Boston is able to take us into, take the product into and ramp it to. Speaker 200:33:17And I think this is also a feature that Boston Scientific is pretty excited about as well, because I think they like the idea of LUPRO going into cases other than their own. Speaker 300:33:34Got it. That's helpful. Maybe the second one on manufacturing. Just curious if you think about your current business without the Gaithersburg facility, how much capacity do you have? Or in other words, how much revenue can you get to before you start to get pretty constricted on from a capacity standpoint? Speaker 200:33:53Out of our current manufacturing capacity that we have, we are able to generate about $140,000,000 in Elupro revenue. That requires our component suppliers and really the chief component being the antibiotic disc to be able to keep up with that. Without expansion of the antibiotic disc, the capacity on an annualized basis is more in the 25,000,000 to $30,000,000 range. Speaker 300:34:37Okay. That's helpful. And then maybe just one for Matt. Obviously, lot of moving pieces in the related to cash use and reduction of cash use. How should we kind of think about the burn profile going forward with LUPro growing cardiovascular coming in house, some of the ligand stuff, just any, help you can provide us in kind of anchoring to what a reasonable burn rate on a go forward should be? Speaker 200:35:05Yes. There were a lot of puts and takes in the first quarter. I would say that, when you see our cash flow statement, when it comes out on Monday or Tuesday in our 10 Q, it'll show cash flow from operations of about eight point some million, and that includes about 4,000,000 that was related to settlement of litigation. That will largely be behind us for after Q2, I would say, at least in terms of anything that's already been committed to. So I would see that probably staying at kind of a similar range in Q2, but coming down a bit and coming down after that as we move through the year. Speaker 200:35:58Probably more into that more historical range that was like in the 4,000,000 to $5,000,000 range. Speaker 300:36:06Okay. That's helpful. Thanks for the questions. Operator00:36:13Our next question comes from Ross Osborne with Cantor Fitzgerald. Please proceed. Speaker 400:36:20Hey guys, this is Matt Park on for Ross today. Thanks for taking the questions and congrats on the solid progress with the Alupro. I guess I want to start off with the registry study. How are you guys thinking about the role of that data in supporting commercial conversions or broader clinical adoption over the next, call it twelve to eighteen months? Speaker 200:36:41Yes, Matt. So this is, obviously when you're doing human clinical studies, not much comes fast. And so this is something that we see being helpful more in the second half of next year when publications come out. Now, I mean, this will be just one study that alongside of all of the other great work that we already have clinically using the ECM technology as well as the different scientific studies that the science group continues to publish on. Basically, what do we do with that stuff? Speaker 200:37:29Well, we do a couple of things. I mean, one of the reasons that we hit on that science stuff so hard is a lot of the VAC process leans on those types of publications. So when our we had a press release earlier about another scientific publication that got published in a peer reviewed journal about LUPRO. That's one of the many things that goes into the portfolio that makes up our vax submission. So anything that we can do to bolster that, obviously improves our chances with the vax. Speaker 200:38:03Now, if you look at how it's going, it's kind of hard to imagine we could be doing better with the vax, but we're always thinking about the next one. The other thing that we do, with this and particularly the real world study, the clinical study that we have going on is, we're starting to prepare for, regulatory submissions outside of The United States. And it's in those OUS regulatory submissions where this type of stuff becomes, really important, to have, particularly going into EU. So Matt, that's what, the plan is there, not just with the real world study that's underway, but with basically that entire package of scientific work that the science teams put together. Speaker 400:38:52Got it. Super helpful color. And then one more from me on Lupro. I want to ask about the mix shift between LUPRO and the whole bio envelope category. How should we think about the pace of continued mix shift towards LUPRO in the second quarter and beyond? Speaker 400:39:11And then how can they increase conversions from Kangaroo over to the next gen LU Pro device? Speaker 200:39:19Yes. I mean, we think this is a product that's going to end up doing about $200,000,000 or so in U. S. Revenue, when it reaches, when it starts to reach maturity. Kangaroo did $10,000,000 in revenue when it reached maturity. Speaker 200:39:43So in pretty short order, we certainly hope that our LU Pro revenue, Elupro revenue dwarfs what we have and what we were able to do with Kangaroo. Now with that said, don't expect Kangaroo to go away too soon. There are a couple of indications and then there are a couple of patient populations where the non antibiotic version is really actually pretty important. And so we are a patient first company. So we'll be keeping the product line around for that. Speaker 200:40:24But I think, I want to say something like LUPRO was 32% in the fourth quarter of last year, was 32% of bio envelope revenue, now it's over 50%. And I think you're just going to see that continue to take greater and greater share of that market. But that's primarily just because of how fast LUPRO is growing offset by a little cannibalization of Kangaroo. Speaker 400:40:54Understood. Thanks again for taking the questions and congrats on all the progress. Operator00:40:59Thank you, Matt. Thank you. This does conclude today's teleconference and webcast. We thank you for your participation. You may disconnect your lines at this time and have a great day. 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Ends Distribution Agreement with LeMaitreMay 6 at 5:18 PM | tipranks.comHere’s How to Claim Your Stake in Elon’s Private Company, xAIEven though xAI is a private company, tech legend and angel investor Jeff Brown found a way for everyday folks like you… To partner with Elon on what he believes will be the biggest AI project of the century… Starting with as little as $500.May 9, 2025 | Brownstone Research (Ad)Elutia Transitions to Direct Distribution of Its Cardiovascular Product PortfolioMay 1, 2025 | globenewswire.comElutia to Report First Quarter 2025 Financial Results on Thursday, May 8, 2025May 1, 2025 | globenewswire.comElutia to Participate in Chardan’s Trending Issues in Drug Development Conference Series on April 29April 23, 2025 | finance.yahoo.comSee More Elutia Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Elutia? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Elutia and other key companies, straight to your email. Email Address About ElutiaElutia (NASDAQ:ELUT), a commercial-stage company, develops and commercializes drug-eluting biologics products for neurostimulation, wound care, and breast reconstruction in the United States. The company operates in three segments: Device Protection; Women's Health; and Cardiovascular. It offers CanGaroo Envelope, which is used to accommodate cardiac implantable electronic devices, such as pacemakers and internal defibrillators. The company also develops CanGarooRM, a combination of the CanGaroo envelope with antibiotics, to reduce the risk of infection after surgical implantation of an electronic device. In addition, it provides ProxiCor for cardiac tissue repair and pericardial closure; Tyke, an extracellular material that is used in the repair of cardiac structures for neonate and infant patients; and VasCure, a patch material to repair or reconstruct the peripheral vasculature. Further, the company offers SimpliDerm, which uses human acellular dermal matrices for tissue repair and reconstruction in various applications, such as sports medicine, hernia repair, trauma reconstruction, and breast reconstruction surgeries following mastectomy. It serves hospitals and healthcare facilities through its direct sales force, independent sales agents, and distributors. The company was formerly known as Aziyo Biologics, Inc. and changed its name to Elutia Inc. in September 2023. 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There are 5 speakers on the call. Operator00:00:00ladies and gentlemen. Welcome to the Illustra First Quarter twenty twenty five Financial Results Conference Call. Please be advised that today's conference call is being recorded. I would now like to hand the conference over to Matt Steinberg with Fin Partners. Please go ahead. Speaker 100:00:20Thank you, operator, and thank you all for participating in today's call. Earlier today, Elluci released financial results for the quarter ended 03/31/2025. A copy of the press release is available on the company's website. Before we begin, I would like 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. Any 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 100:01:07All forward looking statements, without limitation, those relating to our operating trends and future financial performance are based upon our current estimates and various assumptions. These statements involve 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 a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our public filings with the SEC, including Aleutia's Annual Report on Form 10 ks for the year ended 12/31/2024, accessible on the SEC's website at www.sec.gov. Such factors may be updated from time to time in Ellucius' other filings with the SEC. Speaker 100:01:58The conference call contains time sensitive information and is accurate only as of the live broadcast today, 05/08/2025. Ellucius disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward looking statements, whether 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 release for the first quarter ended 03/31/2025, which accessible on the SEC's website and posted on the Investor page of the Aleutia website at www.aleutia.com. And with that, I will turn the call over to Aleutia's CEO, Randy Mills. Speaker 200:02:55Thank you, Matt, and hello, and welcome, all of you joining us today to our first quarter twenty twenty five conference call. I'll start off like I always do, just briefly describing our mission. Our mission, our true north, the thing that guides us in this company, humanizing medicine so that so patients can thrive without compromise. We're interested in, believe strongly in this intersection of biological materials being superior than metals or synthetics and then combining those with active pharmaceutical agents. That is what humanizing medicine means to us. Speaker 200:03:39All right. So let's get into it. We've got a lot of time to talk about. I know we're starting a little later than normal today. So I'll try be pithy in my comments. Speaker 200:03:48We had a fantastic quarter and there's a lot we need to get you up to speed on. So let's jump into it. Looking at an overview of what we're going to be talking about today. First, we couldn't start this conversation without talking about the success of Eliupro, and its start to the full launch exceeding expectations far and away. We're also going to talk a little bit about the future growth that we see coming, through our new partnership with Boston Scientific that starts up this quarter, the second quarter, that we're currently in right now. Speaker 200:04:33We're also, been out there doing some really significant and targeted marketing efforts, we're going to talk through some of those scientific and marketing recognition that we're getting. I do want to make a few quick comments on regaining our cardiovascular portfolio from LeMaitre. And then obviously, Matt's going to talk to you about, our finances and our financial position, which we were also able to materially strengthen during the quarter. So with that, let's jump right into it. Elupro first quarter launch, this is the priority for the company that's the most important thing going on in the organization. Speaker 200:05:18And during our first full quarter launch of the product, we really experienced some tremendous performance. So BioEnvelope, this combines our legacy Kangaroo product with our EleuPro product, up 31% year over year to $3,100,000 for context. It is also up 16% sequentially, and that was off of a really strong, in fact, our best quarter that we had for BioEnvelope. So really, really strong overall results for our BioEnvelope franchise. But this was all driven by Elupro. Speaker 200:06:03In fact, all driven by Elupro offset by some cannibalization, that was expected going on in Kangaroo. Elupro jumped 84% from the fourth quarter, to the first quarter and now, constitutes 52 of our bio envelope revenue. And as it's climbing out, will become far and away, we think the dominant, factor in bio envelope revenue. How did we do that? How was that possible? Speaker 200:06:34Well, that was all made possible by the outstanding performance turned in by our team in securing VAC approvals. We've said this from the beginning that our work with value analysis committees and getting through the value analysis committees and on contract with the hospitals was the essential prerequisite. It has to happen before any sale can happen. And we are currently through 125 hospitals that are now actively ordering the product. And I want to take a moment to thank the team for such a tremendous effort, there. Speaker 200:07:12So digging a little bit deeper into, the Value Analysis Committee, approval process and also what we have going on with our GPOs. So as I said, 125 institutions currently through a VAC and actively ordering the product. You can see here, this is actually, so since September, how we've done month to month by adding hospitals through contract and through the value analysis committee on a monthly basis. I will say we do not add an institution merely by getting through the value analysis committee process or even getting on contract for us to add them and for them to make this chart and for to make this graphic, they actually have to be actively ordering, the product as well. So 125 institutions through that process, another 130 VACs in process. Speaker 200:08:10We're currently adding about 10 to 12 VACs, a month. Again, just so everyone understands the universe. So we're in 125, we're targeting about 1,000 hospitals, to ultimately run this process out through with. We get there by taking only hospitals, so not ambulatory surgery centers and then gating on those hospitals that do greater than 100 pacemaker or defibrillator cases a year. So absolutely outstanding work, going on here with our value analysis committee efforts. Speaker 200:08:47And really what we think this does is we think this reads on our second half of this year and we think this sets us up in a very, very strong position for us, a very strong second half to twenty twenty five. Okay. Other work we've done in here though. So value analysis committees are great to have. Another thing that really helps us along is having these GPO agreements in place and we were able to add two more to the list in the first quarter. Speaker 200:09:21So we're super excited about that. We also, have a lot more work going on with GPOs and hope to be adding to this list of seven, within, the year 2025. So a lot of great stuff going on from a VAC standpoint, from a contracting standpoint, the back office machine at Osiris is really, really starting, to come into its own and work. All right. Now, want to talk about how we are planning on supercharging that with our Boston Scientific relationship. Speaker 200:09:57Now, we've been talking to our friends over at Boston Scientific for some time now on some bigger ways, of working together. And we are still doing that. We're still working through that. But while we were going through that process, we said, you know what? This product Speaker 200:10:15We need to get this thing launched and we need to get it into the hands of our reps. And so our two organizations came together. We decided to put this construct in place to be able to do that right now. So this is a distribution agreement that is able to leverage the Boston Scientific reps. Basically the way it works is Boston Scientific reps get paid a direct commission for keeping Medtronic out of their cases. Speaker 200:10:41I mean, what could be better than that? You're already in the case, you're already there putting in the pacemaker, why not get some money keeping Medtronic out of your case? And so that's basically what this deal does. It gives us a combined commercial footprint of over 900 sales professionals coast to coast. Now for context, we have 12, territory managers, another 35 1099s of our own. Speaker 200:11:12We were in before this arrangement, we were already in 35 states, not bad. But with this Boston Scientific arrangement, it's game changing for us. It gives us 900 sales reps covering coast to coast. It also gives us really great economics under this model. So this model allows us to recognize end market revenue and actually pay a fairly modest commission to the Boston Scientific reps each time they actually sell Elupro in a case. Speaker 200:11:47So they're incentivized to make Elupro more successful. The Boston reps actually help us in two ways, right? So one way that they help us is Boston Scientific actually helps us drive the VAC process by introducing us and making those essential connections with the physicians and with the purchasing people inside, these hospitals, they can actually help us get back approvals more efficiently. And when we talk about going from where we are now really to scale, this becomes essential for us. The other way they help us is just actually case coverage and adoption within the procedure. Speaker 200:12:28So the Boston Rep is in every single case right there with the pacemaker when the pacemaker is going in and it's just super easy for them to say, hey, how about we also protect, this pacemaker and this patient by putting the best antibiotic eluting envelope available on the market around this and getting paid to do it. So with that, our sales training of the organization, the initial sales training and rollout has already been completed. Kimberly and her team are doing a fantastic job and get this, Boston Scientific reps have already gone out and started generating sales at over 52 hospitals, as of today, where Boston Scientific reps are actively selling ellipro at. So a lot going on with Boston Scientific. We have a great partnership. Speaker 200:13:23We're fully engaged with them talking about what we're doing now and talking about bigger ways of working together. But in the meantime, we have really put together a tremendous package that helps us get the most out of EleuPro and get the most out of the launch of this product. Okay. With all of that, great work going on commercially from an operational standpoint, we need to make sure that we can keep up and we need to make sure we can keep getting more and more efficient. So, our production of Elupro takes place at our Roswell, Georgia facility that also supports our Kangaroo manufacturing process as well. Speaker 200:14:00It has capacity to do about $140,000,000 in revenue of Elupro at about a 70 plus percent gross margin. But we were finding ourselves a little constrained, by the production of the antibiotic component of it. So our team in Roswell, Georgia can actually crank out Lupro all day long provided that they have the subcomponents necessary. And one of those critical ones is the antibiotic disc that we use. And so, we have actually expanded and opened a new facility in Gaithersburg, Maryland that adds GMP manufacturing capacity to us that allows us to make, the antibiotic discs. Speaker 200:14:46That's important one because it removes a bottleneck. But the other reason that's important is it's actually a pretty significant component of the cost of the product. And so by making that antibiotic disc directly ourselves, we remove the supply constraint and the bottleneck on it and significantly reduce the cost of goods, of the product. So we're super thrilled to have that facility. We're moving into that facility right now and getting that up and running. Speaker 200:15:14We hope to have that site manufacturing and contributing by the end of the year. We were also able to get really exceptional lease terms for this facility. And so we were able to gain all of this space and this capacity from existing GMP space in really favorable economic terms. All right. And then, certainly, a fun thing to do is to get out and spend time with physicians and other partners that we have and market the product. Speaker 200:15:51And we had a phenomenal kickoff of ElluPro at American, or sorry, at the Heart Rhythm Society meeting in San Diego, just a few weeks ago, where we launched our ad campaign, putting an end to unnecessary roughness, feel the difference biology makes. And I'll just tell you, you can see here is a photograph of our booth. I would say rather strategically placed in the middle of this conference center next to our partners of Boston Scientific and in real serious proximity to some of our competitors. And it stood out. It was very eye catching and we had a tremendous presence at our booth. Speaker 200:16:38It was great getting to speak with our physician partners who were stopping by engaging with us. I would thank many actually investors, and other partners of you who stopped by and said hello at HRS. I hope you enjoy the experience as much as we did, but it was a great kickoff to Eliupro and it was a great kickoff to this marketing campaign where we think, really underscores the value proposition that we add. The same phenomenal antibiotics, rifampin and minocycline proven, to protect patients from, postoperative infections combined with a biological envelope that makes it easier for the physician to use and more comfortable for the patient, to have. So a great kickoff. Speaker 200:17:30Adding right to that, it was my extreme honor, to be present at the twenty twenty five Edison Awards to accept an Edison Award on behalf of the entire Aleutia crew for innovation in post surgical recovery. Eleupro already starting to win awards, the words getting out, and it was fantastic. The science team wants to know that they will not be left out of this conference call. They have enrolled the first patients in our real world clinical study going on. Our first patients were enrolled at UCSD. Speaker 200:18:11We're enrolling patients in this study across the country, gaining the kinds of clinical outcome data that physicians care about. And then lastly, they were able to notch another win with a peer reviewed publication confirming the broad spectrum antibacterial effect of Elupro against all different kinds of bacteria and showing just how robust, the antibacterial properties of Elupro are when implanted. Okay. So those are my comments about Elupro. Lastly, I will just make a few comments on our reacquisition of our cardiovascular products from MELINATE. Speaker 200:18:55This was a process that really went as seamless as it possibly could. There was really minimal customer disruption. We were able to assemble a team so far 26, 10 90 nine sales reps that are out there selling the product. Direct sales are now underway, and this has already begun. And again, this one, we think really has a possibility of adding and contributing from a financial standpoint right away. Speaker 200:19:29So I want to make these couple of these points really clear, because we got some questions about it. One is, yes, it's going to help our top line revenue because we are capturing top line revenue. Our gross margins, will go up predictably to about 80%. But here's the important thing. We expect this to, essentially immediately contribute positively on the cash flow line. Speaker 200:19:52So this isn't a change that will cost us money. This isn't a change where we will have to make an investment. This is something that contributes right away, to the bottom line. And then lastly, it does increase our strategic flexibility with this product line. Having this back from Molgrade and fully in our control, lets us make other strategic decisions with it. Speaker 200:20:14This is a product line where we've been approached, from other strategics about. And so it gives us that opportunity to consider a lot of different options with this cardiovascular line. So with that, I will, pause my comments. I'll turn it over to Matt. I'll be back with, after Matt's rundown of our financial update with a few parting comments. Speaker 200:20:38Okay. Thanks, Randy. Thanks for all of you for being on the call today. I'm just going to hit a few of our highlights from our financials, of course, refer you to our earnings release and our 10 Q, which will come out early next week for all of the gory details of those. Course, leading the way, as Randy mentioned on the top line, our BioEnvelope division, or device protection as we sometimes call it, came in at 3,100,000 in revenue. Speaker 200:21:04That's compared to $2,400,000 a year ago. That represents 31% growth year over year and, also great sequential growth there compared to the Q4 number, which was pretty darn good in and of itself. For Simploderm, we were at $2,600,000 for the quarter. That is down admittedly from, last year's number of $3,600,000 but it's up quite a bit, from the number that we had in Q4, up about 13% from Q4 number. So we're pleased with what's happening there and feel like we're on the right trajectory. Speaker 200:21:45Our cardiovascular products division, as Randy mentioned, the number for Q1 represented sales that were still going through our outside distributor, at only about $300,000 We would expect that as we're taking that back and starting to capture, the top line sales, 100% of the top line sales, and also reinvigorating the actual sales efforts there through a really great organization of contract salespeople that we have in place already, that we'll see some significant growth there going forward as well as better contributions to our bottom line. So overall, adding those things up, we came in at $6,000,000 in sales, down a bit from last year, but again up sequentially from Q4 by about 10%. So moving down the P and L, I'll skip down to our adjusted gross margin, which is sort of how we look at it internally, excludes noncash amortization of intangible expense. That came in at 54.8%, really basically unchanged from last year when we were at 55.2%. But we also believe that there will be a number of positive changes going forward there, particularly as we make some efficiencies in the manufacturing of Elupro, as we take some of that in house and increase volumes there. Speaker 200:23:15And then also, as I mentioned, the capturing of direct revenue on the cardiovascular side of things. So we actually expect gross margin to improve going forward. We also did a good job in Q1, even in spite of what really was a lot of focus on the launch of Eliupro, we were able to control expenses quite well. Operating expense actually went down year over year by close to $1,000,000 10 point 4 million dollars versus 11.3 And that translated down to what I consider to be our most salient profitability or loss measure. Our adjusted EBITDA number came in at $3,300,000 and that is an improvement from last year when we were at $4,500,000 for a comparable measure. Speaker 200:24:02So feel like we're getting nice control around our operations and seeing the leverage associated with the growth that we're generating on the top line. From a cash point of view, we ended the quarter at $17,400,000 and that reflects a number of things that were going on in the quarter. One of those was a registered direct offering, which took place in February, where we had $15,000,000 in gross proceeds, so that added about $13,700,000 in net proceeds. We also just today have announced a couple of amendments to important relationships that we have with Ligand Pharmaceuticals, who has a royalty interest agreement with us, and SWK Holdings, which is our lender. And, both of those amendments are designed to help us conserve cash, both in the current quarter and also going forward. Speaker 200:24:57So in the case of SWK, that includes an additional potential term loan that we can draw on of $5,000,000 as well as a full deferral of our cash interest payment in the second quarter and a number of other changes to terms and covenants. In the case of Ligand, we actually have agreed that we will satisfy the payments for the first half of the year in stock, so that completely eliminates the cash outlay, which would have been $2,200,000 in the first quarter. So I think this really is a great indicator of the relationship that we have with these lenders and financial partners and the support that they're showing going forward. So very pleased to have those done and appreciate their work with us to get those done today. So that's sort of the recap on the, financials. Speaker 200:25:54And with that, I will turn it back to Randy. All right. So I'm just going to conclude with a wrap up of where are we going. We don't give guidance, but I do like to be really explicit and really transparent with the direction of the organization. So not a surprise to anyone. Speaker 200:26:12Our number one priority is to continue to drive top line growth of Elupro, and we're doing this by expanding our VAC and our GPO coverage. Two, everything we've done up to date, I should say, everything we reported in this quarter, the Eliupro team was able to do on their own. They are now joined in that effort with 900 Boston Scientific sales reps, that are really interested in this product. And so our second point is to continue building on the momentum that we've already started through the engagement of our Boston Scientific partnership. And we're really excited about that. Speaker 200:26:55Number three, we need to continue with our production capacity efforts and increase or in lowering the cost of goods for Allupro. Our target here, again, is we think this is a product that has gross margins ultimately in the mid-seventy percent range. And our operations team is hard at work in making that come true. Number four, now that we are at a position in our relationship with our Sientra contract, which was acquired by Tiger, to explore strategic alternatives. We're actually going to do that. Speaker 200:27:39We're actually starting that process. We're exploring different strategic options for simpler. I might have more clarity around that, but I will hopefully, coming up in future calls. And then lastly, continue to advance drug eluting biologic pipeline that we have for, reconstructive surgery. We will be introducing some of this stuff more explicitly later on in the year. Speaker 200:28:07And I think you're going to find it absolutely stunning. The same team that brought you EluPro and was able to get that technology through the FDA has been hard at work on some absolutely game changing technologies. And we're really excited about those and actually getting some of those technologies through FDA in a relatively near term horizon. So with that, I will conclude my comments today and turn the call over to Latanya for any questions that you might have. Operator00:28:48Thank you. We will now conduct a question and answer session. The first question comes from Frank Takin with Lake Street Capital. Please proceed. Speaker 300:29:21Great. Thanks for taking the questions. Congrats on the really strong start to the year. I was hoping to start with one on Boston Scientific. I know it's kind of early days still, but was excited to see you're in the 50 accounts selling with BSX already. Speaker 300:29:33How have those relationships with the physicians gone in those cases? Are they fully switching out their TYRX use for LUpro? Is it testing it a few times and then they shift it gradually from there? Just trying to get a feel for how quickly the Boston Reps can flip the competitive accounts. Speaker 200:29:53Yes. Thanks, Frank. The way we're finding the adoption patterns for Elupro sort of goes like this. And I'll tell you sort of a little bit of story about this because it relates to originally we saw a surge in Elupro ordering over historical kangaroo ordering and we thought, well, might be a stocking order, but what we found was subsequent orders in general are higher than the initial order that's placed. We're spending a lot of time in the field. Speaker 200:30:28Obviously, I've been out riding with our reps and sort of experiencing this firsthand. We saw this again at HRS. And here's generally what happens is historically, there might be one physician who likes or is interested in using LUPRO in their center and they'll bring the product in and they'll use it. And what happens is they tend to like the experience, particularly if they've used Tyrex in the past. The use of Value Pro is completely different experience. Speaker 200:31:05But what we found is it spreads through practices, pretty predictably and pretty consistently. And so what we find is that we might originally have one physician in a practice that's interested in getting it on the shelf and ordering and Boston Scientific is essential in giving us that introduction. But when other physicians in that practice see the product, hear about the product, they try it, and they're also adopting it, and using it. Now, this is a game, obviously we've got to play hospital by hospital, but we certainly like that dynamic. Frank, the second thing that I think it's important to understand is once this conversion tends to happen with an electrophysiologist, it tends not to be just with their Boston Scientific cases. Speaker 200:32:04So it's rare that you find an electrophysiologist that only uses one particular brand of pacemaker. Usually they might use 40% of 40% of another and 20% of a third. And so if they're in there and they've experienced the use of Elupro with, their Boston Scientific rep on their Boston Scientific pacemaker, what tends to happen is they tend to also carry that usage over to their other cases where they might be using a competitive pacemaker. There's really, it really becomes part of their surgical practice more so than related to which particular can that they're using. So this is really a great way for us, to leverage the Boston Scientific relationship even beyond, those individual cases that Boston is able to take us into, take the product into and ramp it to. Speaker 200:33:17And I think this is also a feature that Boston Scientific is pretty excited about as well, because I think they like the idea of LUPRO going into cases other than their own. Speaker 300:33:34Got it. That's helpful. Maybe the second one on manufacturing. Just curious if you think about your current business without the Gaithersburg facility, how much capacity do you have? Or in other words, how much revenue can you get to before you start to get pretty constricted on from a capacity standpoint? Speaker 200:33:53Out of our current manufacturing capacity that we have, we are able to generate about $140,000,000 in Elupro revenue. That requires our component suppliers and really the chief component being the antibiotic disc to be able to keep up with that. Without expansion of the antibiotic disc, the capacity on an annualized basis is more in the 25,000,000 to $30,000,000 range. Speaker 300:34:37Okay. That's helpful. And then maybe just one for Matt. Obviously, lot of moving pieces in the related to cash use and reduction of cash use. How should we kind of think about the burn profile going forward with LUPro growing cardiovascular coming in house, some of the ligand stuff, just any, help you can provide us in kind of anchoring to what a reasonable burn rate on a go forward should be? Speaker 200:35:05Yes. There were a lot of puts and takes in the first quarter. I would say that, when you see our cash flow statement, when it comes out on Monday or Tuesday in our 10 Q, it'll show cash flow from operations of about eight point some million, and that includes about 4,000,000 that was related to settlement of litigation. That will largely be behind us for after Q2, I would say, at least in terms of anything that's already been committed to. So I would see that probably staying at kind of a similar range in Q2, but coming down a bit and coming down after that as we move through the year. Speaker 200:35:58Probably more into that more historical range that was like in the 4,000,000 to $5,000,000 range. Speaker 300:36:06Okay. That's helpful. Thanks for the questions. Operator00:36:13Our next question comes from Ross Osborne with Cantor Fitzgerald. Please proceed. Speaker 400:36:20Hey guys, this is Matt Park on for Ross today. Thanks for taking the questions and congrats on the solid progress with the Alupro. I guess I want to start off with the registry study. How are you guys thinking about the role of that data in supporting commercial conversions or broader clinical adoption over the next, call it twelve to eighteen months? Speaker 200:36:41Yes, Matt. So this is, obviously when you're doing human clinical studies, not much comes fast. And so this is something that we see being helpful more in the second half of next year when publications come out. Now, I mean, this will be just one study that alongside of all of the other great work that we already have clinically using the ECM technology as well as the different scientific studies that the science group continues to publish on. Basically, what do we do with that stuff? Speaker 200:37:29Well, we do a couple of things. I mean, one of the reasons that we hit on that science stuff so hard is a lot of the VAC process leans on those types of publications. So when our we had a press release earlier about another scientific publication that got published in a peer reviewed journal about LUPRO. That's one of the many things that goes into the portfolio that makes up our vax submission. So anything that we can do to bolster that, obviously improves our chances with the vax. Speaker 200:38:03Now, if you look at how it's going, it's kind of hard to imagine we could be doing better with the vax, but we're always thinking about the next one. The other thing that we do, with this and particularly the real world study, the clinical study that we have going on is, we're starting to prepare for, regulatory submissions outside of The United States. And it's in those OUS regulatory submissions where this type of stuff becomes, really important, to have, particularly going into EU. So Matt, that's what, the plan is there, not just with the real world study that's underway, but with basically that entire package of scientific work that the science teams put together. Speaker 400:38:52Got it. Super helpful color. And then one more from me on Lupro. I want to ask about the mix shift between LUPRO and the whole bio envelope category. How should we think about the pace of continued mix shift towards LUPRO in the second quarter and beyond? Speaker 400:39:11And then how can they increase conversions from Kangaroo over to the next gen LU Pro device? Speaker 200:39:19Yes. I mean, we think this is a product that's going to end up doing about $200,000,000 or so in U. S. Revenue, when it reaches, when it starts to reach maturity. Kangaroo did $10,000,000 in revenue when it reached maturity. Speaker 200:39:43So in pretty short order, we certainly hope that our LU Pro revenue, Elupro revenue dwarfs what we have and what we were able to do with Kangaroo. Now with that said, don't expect Kangaroo to go away too soon. There are a couple of indications and then there are a couple of patient populations where the non antibiotic version is really actually pretty important. And so we are a patient first company. So we'll be keeping the product line around for that. Speaker 200:40:24But I think, I want to say something like LUPRO was 32% in the fourth quarter of last year, was 32% of bio envelope revenue, now it's over 50%. And I think you're just going to see that continue to take greater and greater share of that market. But that's primarily just because of how fast LUPRO is growing offset by a little cannibalization of Kangaroo. Speaker 400:40:54Understood. Thanks again for taking the questions and congrats on all the progress. Operator00:40:59Thank you, Matt. Thank you. This does conclude today's teleconference and webcast. We thank you for your participation. You may disconnect your lines at this time and have a great day. Operator00:41:09Goodbye.Read morePowered by