NASDAQ:ELUT Elutia Q2 2024 Earnings Report $1.98 -0.06 (-2.70%) As of 09:48 AM Eastern This is a fair market value price provided by Polygon.io. Learn more. Earnings HistoryForecast Elutia EPS ResultsActual EPS-$1.14Consensus EPS N/ABeat/MissN/AOne Year Ago EPSN/AElutia Revenue ResultsActual Revenue$6.29 millionExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/AElutia Announcement DetailsQuarterQ2 2024Date8/7/2024TimeN/AConference Call DateWednesday, August 7, 2024Conference Call Time4:30PM ETUpcoming EarningsElutia's Q1 2025 earnings is scheduled for Thursday, May 8, 2025, with a conference call scheduled at 5:00 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Elutia Q2 2024 Earnings Call TranscriptProvided by QuartrAugust 7, 2024 ShareLink copied to clipboard.There are 5 speakers on the call. Operator00:00:00Greetings. Welcome to the Aleutia Second Quarter 20 24 Financial Results Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded. Operator00:00:21At this time, I'll turn the conference over to Matt Steinberg with FIM Partners. Please go ahead, Matt. Speaker 100:00:28Thank you, operator, and thank you all for participating in today's call. Earlier today, Alucia released financial results for the quarter ended June 30, 2024. A copy of the press release is available on the company's website. Before we begin, I would like to remind you that management will make statements during this call that include forward looking statements within the meaning of the federal securities laws, which are pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. 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 100:01:09All forward looking statements include, 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 Alloocia's Annual Report on Form 10 ks for the year ended December 31, 2023, that's accessible on the SEC's website atwww.sec.gov. Such factors may be updated from time to time in Alush's other filings with the SEC. Speaker 100:02:02The conference call contains time sensitive information and is accurate only as of the live broadcast today, August 7, 2024. Alucia disclaims any intention or obligation, except as required by applicable 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 Q2 ended June 30, 2024, which is accessible on the SEC's website and posted on the Investor page of the Allusia website at www.alusia.com. And with that, I will turn the call over to Allusia's CEO, Randy Mills. Speaker 100:02:59Thank you, Matt, and thank you for joining us today on this conference call. Starting out as we always do, let's just really quickly review the mission of Aleutia. It's why we exist as a company. So it's humanizing medicine so that patients can thrive without compromise. And when we talk about this concept of humanizing medicine, we're talking about combining traditional therapeutics with biologics, so that the actual implant for the first time ever isn't some type of synthetic or plastic or polymer or metal that simply elutes a drug or a therapeutic, but instead is this living implant that can remodel and incorporate and become the patient's own living tissue over time with the addition of this sophisticated therapeutic payload. Speaker 100:03:50And we do that so that our patients can thrive without compromise. This word humanizing medicine also means another thing to us. And it means that we recognize and realize that every single customer out there, every single market demographic out there is also a mother, a father, a husband, a brother, a son, a loved one. And we take that very seriously and we care for those patients and provide them with quality products as if they were our own. If you are new to Aleutia, let's start off really quickly with a high level investment summary and why we think you should be interested in what we think is a very compelling story. Speaker 100:04:31So our it's just about elu pro now. Allucia's elu pro envelope is the 1st and only antibiotic eluting envelope on the market. We designed it really specifically to protect patients by combining this idea of an active biological matrix with drug deployment technology. And what we're talking about when we say drug deployment with EleuPro, we're talking about the powerful antibiotics, rifampin and minocycline. We build Eleupro on our earlier successful track record of selling our kangaroo product, which was like Eleupro, but it didn't have the drug elution technology. Speaker 100:05:11This monumental event for us happened in the Q2. This was a June 20 24 event, and we were very, very excited and deadly focused on the planned commercial launch of this product, soft launch starting in the second half of this year, full launch starting in January of 2025. So why is it such a big deal to have an antibiotic eluting envelope for pacemakers and the like? Well, the pacemaker device protection market is a $600,000,000 market with only one other competitor. There is $350,000,000 of white space out there that's uncontested. Speaker 100:05:58But I'll say that's not enough for us because this isn't a me too product. We believe EluPro to be a fully superior product to the other competitor on the market and we look forward to that challenge. Worth noting, we also received FDA clearance for indications beyond pacemakers and implantable defibrillators, we collectively call the CID market. And these include the other aspects of neurostimulation. So pain management, incontinence, both fecal and urinary, sleep apnea and epilepsy. Speaker 100:06:35And we're talking about an additional $8,000,000,000 device market. So one that is collectively equal in size to the cardiac indication. So we'll talk a little bit more about our efforts going into exploiting those markets as well. And lastly, I'd like to point out, we didn't develop EluPro to end with EluPro. We developed EluPro as a platform technology of drug eluting biologics that we are actively growing and building over time. Speaker 100:07:05So we're super excited about all that. We'll go into that more, but that is a snapshot of the investment summary of Aleutia at a high level. So today, with our conference call, I actually wanted to sort of share more granularity to the plan as we talk about it and as we execute it internally. So these are actually the words we use internally. So I'm inviting you in to the company to take a look at how we're executing on our plan to continually build the value of Ellucia. Speaker 100:07:38So we go through it very methodically. The first thing we had to do was clear it. Last quarter was all about clearing it. Then we have to make sure that we can produce the product, make it. We have to introduce it to the hospital systems. Speaker 100:07:51And then lastly, it's not enough for us to introduce it, but we've got to grow it so that this technology can reach every patient that is needed, but also this technology can reach every indication that it's needed. And in order to do all of that kind of great stuff that I get to be super involved in, we also needed to have a strong sound financial position and I think we made really tremendous progress this quarter solidifying our financial position so that we have the resources that we need to go and execute on this strategy. So this is going to be the game plan for the call today. We're going to go through each of these different boxes in some granularity. So let's kick it off with Clearance. Speaker 100:08:34And under the category of Clearance, this was monumental for us. We received regulatory approval for the first drug eluting bio envelope product that was in June as we talked about. We were really happy for a couple of reasons. One of them was that we received all of the shelf life we asked for this product. So we received the full 9 month shelf life. Speaker 100:08:58We received a great indication. And again, a great product level, right? If you're new, this is what LU Pro looks like. It has the extended release, powerful antibiotics rifampin and minocycline all wrapped up in this biological matrix. That matrix, from a primary standpoint, prevents that device from migrating and moving down the patient's chest wall and eroding out. Speaker 100:09:23We have an indication that allows it to be used both in de novo procedures. So as soon as the pacemaker is put in and change out a procedure. So when it comes time for a battery change, if there's a lead problem, it can be used in both of those. Physicians love this product because you can kind of see from the picture there, this is a product that perfectly and completely conforms to the underlying pacemaker. And as it's recontinent and wet, it is really like a beautiful slippery, we felt lubricity of the product, allows it to just simply slide easily into the patient's chest wall with absolutely no need to upsize the pocket. Speaker 100:10:07And when we hear it when we hear from the physicians that we've talked to at HRS and others, this is a really, really big deal for them. And then lastly, this is an envelope that regenerates. This is not a synthetic. This is not a plastic. This is not a polymer. Speaker 100:10:23This is not a metal that sits there or dissolves over time. But instead, it remodels into the patient's own healthy vascularized tissue. And you can't have a foreign body response, you don't have a foreign body anymore. And so it completely eliminates in the long term that type of problem for taking place. So as we talked about, we were going after and we were super excited about the cardiac rhythm management market. Speaker 100:10:51That device market is an $8,000,000,000 market, meaning the devices that get implanted there are currently doing about $8,000,000,000 in sales. And that was the primary approval we were seeking. But there's also this neurostimulation market that we went after for strategic purposes just so everyone realizes that is an additional $8,000,000,000 device market that we have now opportunity and we have label claim in order to be able to go in and protect. And so I want to really make sure we describe both of these markets adequately. Let's first start for us with the most important market and the one we're focused on, which is cardiac rhythm management. Speaker 100:11:29So let's dig into that a little bit. This is a market that only has 4 players, 4 primary players in the pacemaker and defibrillator space. Medtronic is the largest at 40%. Behind them, we have Boston and Scientific and Abbott at 25% and then lastly, BIOTRONIC at 10%. Now Medtronic from a competitive standpoint introduced a product. Speaker 100:11:54They actually acquired a product line in the company called TYRX back in 2014. And TYRX is a pretty interesting story in that this is a product with very little sales when it was acquired. And it's a fully synthetic antibiotic eluting envelope. And so it's after it's implanted, the envelope kind of dissolves over time. And as it dissolves, it liberates the same antibiotics we use, rifampin and minocycline. Speaker 100:12:25And what Medtronic was able to do is acquire this product that they went out into the pacemaker and defibrillator market space and they said, hey, this is a really good idea for you guys to have this product as you're implanting them. And they were right and they did a really beautiful job creating this market. And we estimate their sales right now are somewhere between $250,000,000 $300,000,000 a year with this product. And so they have really derisked the marketplace around this idea of will an antibiotic luting pouch be accepted? The answer to that is definitively yes. Speaker 100:13:01Now it's a product we think that can be improved upon. And so when we look at this, we look at these markets that have at least 60% of the market really uncontested right now, 60% of the market that doesn't have access to a pouch. And you might look at those favorable market dynamics and say, that's really pretty good. Like if all you did was have a Me too product to that, you have 60% white space in this. This is pretty fantastic. Speaker 100:13:32But I'm here to tell you, we do not have a Me too product. We believe fully that we have a far superior product to Medtronic's TYRX product because of we've taken those same powerful antibiotics, rifampin and minocycline and we have paired them with this biological envelope that does all those great things that biologic does. And we hear this over and over again from physicians. It is a product they love to use. And so we're really excited about going after the rest of this market space. Speaker 100:14:06Okay, that's the cardiac market. And we also picked up this neurostimulation market, which is another $8,000,000,000 in devices. And it worked just briefly looking at what that market looks like. So neurostimulation market is growing at 12 percent. So quite a healthy rate. Speaker 100:14:23It has 4 major components to it pain management, incontinence, both urinary and fecal, epilepsy market and sleep apnea. And here's the thing you've got to look at across all of these markets, 30% complication rate, 41% complication, 21% 27% complication rate, 42% complication rate in sleep apnea, with 24% of those devices requiring revisions. These are markets that are streaming for AluPro and where we think we can go in and really add significant value, not only to the procedures and the underlying devices, but frankly to the patients that are having these put in. They're having devices put in for a reason. They need the underlying technology. Speaker 100:15:12We believe we can make that underlying technology more successful as it relates to compatibility with the patients. Okay. So that wraps up clearing why we were so excited about having EleuPro finally cleared. Now let's move on. The next step we've got to do is we've got to make that product. Speaker 100:15:30I am let me just sort of take you in really quickly. First, we manufacture EluPro in the same place we manufacture Kangaroo, which is our facility manufacturing facility in Roswell, Georgia. We've had operations there since 2013 and have turned out 75,000 units. So this isn't a risky thing for us like are you going to be able to manufacture this product this first time you're doing it. We've been at it for a long time. Speaker 100:15:56To be sure, the addition of antibiotic into this manufacturing process increases the complexity, but we're not new at this. We've been at it for a while. We have a facility that has really great clean rooms. It also has a lot of capacity. So we're talking about the ability in the current facility to manufacture the run rate of $140,000,000 of EluPro and to build out from there actually doesn't require a whole lot of sophisticated space. Speaker 100:16:25So we certainly have the capacity to be able to launch and get this thing going. And when the time comes, we will be able to efficiently expand and open that up and increase that capacity. And by the way, we do think we will need more capacity in time beyond $140,000,000 of revenue. Lastly, and something I'm really proud about of the team is, while we were going through review of LU Pro submission at FDA, the site also went through a complete FDA audit and inspection in the month of June. It was an inspection that lasted about a week. Speaker 100:17:03It was comprehensive, and I'm super proud of the group down there. Completed that inspection with no deficiencies, no observations noted from the FDA whatsoever. So we've got a clean bill of health on the approval side and we've got a clean bill of health on the facility side and we are ready to manufacture products. And so let's talk about that. This, ladies and gentlemen, I am super happy to say this is the first unit of EleuPro that has ever been manufactured for commercial use. Speaker 100:17:35Hanalee, our senior operations associate in Roswell, Georgia, manufactured it. And to say she was a proud parent is an understatement. There was applause and cheers that went up in this facility. I will also say the entire leadership team was there to see this monumental event. And so there you go. Speaker 100:17:55We are well underway on manufacturing of this product. It's currently in the first lots are in QA review and are expected off the line shortly. All right. We've cleared it. We've made it. Speaker 100:18:11Now we've got to introduce it into the hospital system. And you maybe have heard me talk about this before, but the introduction of this product in the hospital systems is not trivial and we actually think it's the rate limiting step. So the first thing we needed was all of the collateral in order to do that. And so you can see over there, whether it be packaging or promotional material for it or value analysis committee packages, this is what the new look of EluPro looks like. We love it. Speaker 100:18:41We think it's very consistent with the brand. We think it is very differentiated and really talks about the freshness that this product brings to really what's been a stagnant market for the last 10 years. So where are we on this? Well, we currently have Kangaroo out there in the market and then we talked about before, we continue to add new hospitals. And so it says approximately 400 active accounts. Speaker 100:19:05I like specificity, 398 accounts are active, which is a significant increase since the last time we've talked and we continue to build out this hospital network. We are also though so just because we have a hospital on account with Tangaroo, it's important to know, doesn't mean they one for 1 just transfer over with EluPro. EluPro has to go through the value analysis or vac committee submission, and that process is underway. So we have completed that assembly of the packages that you need to do in order to submit to VAX. So that is being done. Speaker 100:19:47It's done sort of on an account by account basis. Our KOLs, our physician champions that these are going in hand in hand with the reps in those territories and they are personally submitting them into the VACs. We are obviously prioritizing that from a standpoint of we are going to our key accounts first for a launch. So our soft launch in the second half of this year is started now. In conjunction with that is the initiation of a registry where we're beginning to collect clinical data and the full launch of this product starts in the Q1 of 2025 January of 2025. Speaker 100:20:29All right. So it wouldn't be complete without talking about the reception that we're receiving out there. And I've gone through this before where 88% of TYRX users basically want to become EluPro users. This was a market survey that we did where we were pulling 50 TYRX users and explaining to them about the benefits of having a biologic envelope instead of a synthetic envelope and asking them if they would switch some or all other business, 88% said yes. And so that that was really gratifying as we were building these products. Speaker 100:21:01We thought, hey, we're on the right track here. We're onto something that physicians care about. But I think what's validating this more for us is the enthusiastic reception we are receiving since approval. So not only treating physicians and by the way, if you're a treating physician out there, I appreciate the enthusiasm. No need to text me in the middle of the night. Speaker 100:21:21That is happening. And it actually text me in the middle of the night. I love it. That is going on. Hey, how can I get my hands on this? Speaker 100:21:31How can I bring this into my hospital system? How can I show this to my colleagues? But also other industry partners out there are we're receiving inbound calls of interest saying, hey, we're super interested and excited about this product. And we are evaluating all of that way we should responsibly and sorting through making those kinds of decisions. But the important thing to understand is what that's telling us and what that's validating for us is that this is a product that the industry thinks can move the mark, right? Speaker 100:22:06This is a product that the industry thinks can move the CIED market and the neurostim market. And therefore, we think that is clearly validating the value of the product that we've developed. So we'll work through all that stuff responsibly as we should, but it's a very, very exciting time as we get ready for launch. Okay. And then the last thing we need to do, it's not enough for us to introduce it and stay stagnant. Speaker 100:22:31We've got to grow it. And when I say grow it, I mean the brand, I mean the team, I mean the value of the company. So let's talk about how we're doing that right now. First thing is, we are methodically, systematically building out our commercial teams. We are now up to 26 reps for the EluPro team and growing and I put in parentheses there intelligently. Speaker 100:22:54I want to be really clear that we're not just doing this indiscriminately. We are not throwing reps at this thing and hoping a market comes. We are adding them methodically. We are adding quality people to places where we think they can have a significant contribution. Same thing as it goes with Simplederm. Speaker 100:23:10So we haven't talked much about Simplederm. It's largely been the EleuPro show today. But Simplederm is a great product and it continues to be a great product. And it's one where we are investing more and more on a direct sales team and really controlling the destiny of that asset as well. We can't do any of this sales stuff if we don't have the product on hand to make. Speaker 100:23:33And so towards that end, we're really excited about adding Ryan Marquise to the team as Vice President of Operations to oversee the manufacturing and production of both of these product lines. Ryan is a really solid guy that we've, as a leadership team, got to spend a lot of time with and really I think he's going to be a really quality add to this organization. I also talked a lot about these new adjacent markets that we all of a sudden have indications for, for EluPro. And what we're doing there is we're going on and we are starting and intensifying BD efforts into these adjacent markets, so that we can see if they make sense to have different partnerships or other types of arrangements there. And then lastly, we didn't develop eluapro to get to the finish line. Speaker 100:24:30We developed eluapro to get to the starting line. This is the 1st drug eluting biometrics that is out there. We think all of the success that we've got to have with EluPro really just validates the sector. We have a platform technology that our R and D teams are aggressively building on. And as they do that from a product level, they are also building out a very broad and robust intellectual property position, which we think makes the products and make the company disproportionately more valuable. Speaker 100:25:02So all in all, really exciting times at Aleutia. Couldn't be more proud of the team, and I thank them so much for an incredibly successful quarter. We couldn't do any of this though without the financial resources that we need. And so we went to pretty great extents to make sure that we had a solid financial position in which we can really execute on this growth plan. And I will now stop talking and turn it over to our Chief Financial Officer, Matt Ferguson, who will go through some of the financial details. Speaker 200:25:38Okay. Well, thank you, Randy. It is no doubt a very exciting time to be in Aleutia and Q2 was really an extremely important quarter and even what's happened in the week since then have been a very important time for us as well. I'm just going Speaker 100:25:52to hit a few of the Speaker 200:25:53highlights of our financials. Of course, the full financials are available in our earnings release and our 10 Q will come out early next week. So from an overall net sales point of view, there was little change this year in Q2 compared to the prior year coming in at $6,300,000 less than $100,000 difference from $6,400,000 last year. But what that masks a bit is the growth that we saw in our 2 most important product lines, Kangaroo and Symploderm. Kangaroo, we a 19% increase to $2,600,000 Symploderm also came in at $2,600,000 which is an increase year over year of 7%. Speaker 200:26:32That will as you may know, that was a decline from Q1 of this year, which really related to the dislocation associated with our U. S. Distributor that went through bankruptcy and a sale during the quarter and is now being integrated into that new organization and we've actually seen a nice return to those earlier levels of production that we were getting out of that distributor. So we're doing a number of things in the symptoderm area to drive growth that we will keep you apprised of. But overall, we feel very positive about that part of the organization. Speaker 200:27:13And of course, we're very excited about what will occur when we have EleuPro actually on the market here in the second half of the year. So in addition to that, cardiovascular, which we don't focus on quite as much that is exclusively distributed in the U. S. By our distribution partner, Lebate, had a good quarter with $1,100,000 in overall sales. We put that relationship in place during the Q2 of 2023. Speaker 200:27:42So on a year over year basis that was a decline, but some of the sales last year were at the full end user price whereas this year they're at a transfer price. So that was a decline, but we actually were quite pleased with the $1,100,000 performance, which was up sequentially from earlier in the year. On a gross margin basis, we came in on an adjusted gross margin basis, which excludes non cash amortization expense overall at 58% versus 56%. So we're seeing some nice gains in efficiency overall there. And then I would like to note, while people are not quite as focused usually on our net loss, we had a large number there, but most of that was from a non cash charge associated with the warrants that were exercised in July of this year. Speaker 200:28:32But because it does change with our stock price, the warrant liability charge, we had a large an $18,000,000 non cash charge, which will primarily wash out of the P and L as we move forward here. More importantly and more reflective of our actual operating performance on an adjusted EBITDA basis, we came in at $2,900,000 for the quarter and that was an improvement compared to $3,400,000 last year. So we're seeing with the revenue growth and improvement in gross margin and control of operating expenses, we're seeing nice results on the adjusted EBITDA bottom line level. And then last, but certainly not least, we've made a lot of progress in terms of the overall cash position for the company. We did a financing that brought in $13,300,000 during Q2 of the year in a registered direct offering. Speaker 200:29:29And then as I mentioned, the warrants that were exercised in July of this year, so following the end of the quarter actually brought in an additional $13,800,000 which is not reflected in quarter end cash balance. But if you think of it more on a pro form a basis, that would put us a little over $30,000,000 in cash on our balance sheet, which is quite an improvement for where we've been over the last year or 2 really. So excited about what we are looking at here for the second half of the year and beyond. And with that, I think we are going to open it up to your questions. Thank you. Operator00:30:06Thank you. At this time, we'll be conducting a question and answer Thank you. And the first question is from the line of Ross Osborne with Cantor Fitzgerald. Please proceed with your question. Speaker 300:30:42Hi, guys. This is Matthew Park on for Ross today. Congrats on the progress and thank you for taking the question. I just want to start off with LU Pro and get some additional color on how conversations with VAX have gone. How are you guys feeling about the overall adoption as you ramp towards full commercial launch? Speaker 100:30:59Hey, Matthew. It was a little hard to hear, but I think the question was, how is the process going with our VAC submissions, the value analysis committee submissions. Is that correct, Rob or Matthew? Yes. Okay. Speaker 100:31:18Yes. No, it's going exactly as we expected it. So our VAC submission strategy is a very methodical targeted one. And so the first hospitals that we are submitting to are ones that are part of our soft launch, pilot launch process for the first half. They're ones where we have very, very strong physician champions and those physicians want this technology in their hospital system. Speaker 100:31:56They want to be the ones using it first and they're aggressively walking it walking the packages through. So we're really excited about that. With that said, there will still be a range just based on how each individual hospital's VAC process works and how long it takes. But we think we will basically have full demand for the quantities that we're targeting in the soft launch from the hospitals. And then more importantly, preparing and starting the VAC submission process so that when our commercial the full commercial launch comes January 1, that will have a much broader universe of hospital systems. Speaker 100:32:50So very positive. Speaker 300:32:54Got it. That makes sense. And then I guess just one more from me moving down to P and L. In terms of OpEx cadence in the back half of the year, how should we think about sales and marketing spend in the second half? Should we expect more of a gradual buildup of reps or would these additions be more skewed towards the Q4? Speaker 300:33:10Thanks. Speaker 200:33:14Yes, I could speak to that, Matthew. I would think we are actively recruiting for new sales representatives both in the LU Pro and the simpliderm categories. So we may see some additional expense there, maybe some additional marketing expense would also show up on that line. However, probably the biggest driver would be as we continue to grow, we will see additional sales commissions associated with that. So I would expect to see some increase in that line as we move through the year, but it will be roughly it will be generally in line with increased revenue, I would say, as we go through the second half of this year and certainly into 2025. Speaker 300:34:03Got it. That makes sense. Thanks for taking the questions and congrats again on the progress. Speaker 100:34:09Thank you, Matt. Operator00:34:12Our next question is from the line of Frank Tafkanian with Lake Street Capital Markets. Please proceed with your question. Speaker 400:34:18Great. Thanks for taking the questions guys. Congrats on an exciting quarter. Happy to see how UPRO make it to market. I will apologize upfront, I've been bouncing between a couple of calls. Speaker 400:34:27So if I ask a repetitive question, I apologize upfront. I wanted to first start with clarifying. Randy, I heard you say 26 reps. Is that today or the goal? And 2, how should we think about the right rep count over a longer period of time, say 12, 18, 24 months and what the adequate size selling organization looks like? Speaker 100:34:50Yes, Frank, that is 26 reps as of today that are on board. We are using a hybrid of direct reps and we also will add the 1099 reps. That's sort of what Matt was alluding to in terms of why we don't have a real significant hit to the P and L that doesn't scale really nicely with revenue because a lot of those are just commission based reps. But we are taking that number up. We're taking that number up and I frankly Frank, I don't want to be more specific than that right now, but it will continue to climb as we approach January and launch. Speaker 400:35:53Okay, fair enough. That's helpful. And then maybe shifting over to the some pricing discussion. I'm sure you don't want to speak too clearly about it given for competitive reasons, but any thoughts on directional pricing versus Kangaroo Classic or versus TYRX on the market today for Eleupro? Speaker 100:36:13Oh, I can talk directionally about it. No problem. It's obviously Tangaroo plus the addition of rifamp and minocycline. So it's a better product that and we think it is a much better product than TYRX. It does more. Speaker 100:36:28It has the biological features. And so we expect directionally it will be priced in the premium to both of us. Speaker 400:36:41Got it. That's helpful. And then maybe last one, just an update on simploderm. I think last quarter there were discussions around the partnership with now Tiger and whether or not that partnership made the most sense for Lucia on a go forward basis. What's the latest update on that? Speaker 400:36:58And any other thoughts around any partnership opportunities in that side of the business? Speaker 100:37:05Well, right now, we have a partnership with Tiger. And because of that, that is a result of Tiger acquiring the distribution contract from the assets of Sientra. So they paid money to acquire that agreement. So right now, we have an agreement in place. As Matt said, there was, as you would expect, significant disruption when a company goes bankrupt and gets sold in an auction and acquired and integrated all in the Q2, that's a lot and it's a lot to expect that there wasn't going to be some disruption there. Speaker 100:38:06And also, as Matt said, we're seeing, I would say, in general, a return to more significant growth. With all of that happening, we still had the product still grew in the Q2 and that's largely due to our own distribution network. But right now, we have both of those distribution networks in place and they're both performing reasonably well. But we are putting a lot of emphasis on growing our own distribution network just because they're doing so well, why wouldn't we do more of that? It's proprietary. Speaker 100:38:56For a lot of reasons, it makes sense for us to do that. But right now, we have both of those in place and we're seeing the product actually return to, I would say, more simploderm like growth numbers. Operator00:39:21Thank you. Ladies and gentlemen, this concludes our question and answer session and this also concludes today's conference. You may now disconnect your lines at this time. ThankRead morePowered by Conference Call Audio Live Call not available Earnings Conference CallElutia Q2 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) Elutia Earnings HeadlinesElutia 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.comURGENT: Someone's Moving Gold Out of London...People who don’t understand the gold market are about to lose a lot of money. Unfortunately, most so-called “gold analysts” have it all wrong… They tell you to invest in gold ETFs - because the popular mining ETFs will someday catch fire and close the price gap with spot gold. May 6, 2025 | Golden Portfolio (Ad)Elutia to Participate in Chardan’s Trending Issues in Drug Development Conference Series on April 29April 23, 2025 | finance.yahoo.comElutia to Participate in Chardan's Trending Issues in Drug Development Conference Series on April 29April 22, 2025 | globenewswire.comElutia Stock Short Interest Report | NASDAQ:ELUT | BenzingaApril 21, 2025 | benzinga.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. Operator00:00:00Greetings. Welcome to the Aleutia Second Quarter 20 24 Financial Results Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded. Operator00:00:21At this time, I'll turn the conference over to Matt Steinberg with FIM Partners. Please go ahead, Matt. Speaker 100:00:28Thank you, operator, and thank you all for participating in today's call. Earlier today, Alucia released financial results for the quarter ended June 30, 2024. A copy of the press release is available on the company's website. Before we begin, I would like to remind you that management will make statements during this call that include forward looking statements within the meaning of the federal securities laws, which are pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. 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 100:01:09All forward looking statements include, 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 Alloocia's Annual Report on Form 10 ks for the year ended December 31, 2023, that's accessible on the SEC's website atwww.sec.gov. Such factors may be updated from time to time in Alush's other filings with the SEC. Speaker 100:02:02The conference call contains time sensitive information and is accurate only as of the live broadcast today, August 7, 2024. Alucia disclaims any intention or obligation, except as required by applicable 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 Q2 ended June 30, 2024, which is accessible on the SEC's website and posted on the Investor page of the Allusia website at www.alusia.com. And with that, I will turn the call over to Allusia's CEO, Randy Mills. Speaker 100:02:59Thank you, Matt, and thank you for joining us today on this conference call. Starting out as we always do, let's just really quickly review the mission of Aleutia. It's why we exist as a company. So it's humanizing medicine so that patients can thrive without compromise. And when we talk about this concept of humanizing medicine, we're talking about combining traditional therapeutics with biologics, so that the actual implant for the first time ever isn't some type of synthetic or plastic or polymer or metal that simply elutes a drug or a therapeutic, but instead is this living implant that can remodel and incorporate and become the patient's own living tissue over time with the addition of this sophisticated therapeutic payload. Speaker 100:03:50And we do that so that our patients can thrive without compromise. This word humanizing medicine also means another thing to us. And it means that we recognize and realize that every single customer out there, every single market demographic out there is also a mother, a father, a husband, a brother, a son, a loved one. And we take that very seriously and we care for those patients and provide them with quality products as if they were our own. If you are new to Aleutia, let's start off really quickly with a high level investment summary and why we think you should be interested in what we think is a very compelling story. Speaker 100:04:31So our it's just about elu pro now. Allucia's elu pro envelope is the 1st and only antibiotic eluting envelope on the market. We designed it really specifically to protect patients by combining this idea of an active biological matrix with drug deployment technology. And what we're talking about when we say drug deployment with EleuPro, we're talking about the powerful antibiotics, rifampin and minocycline. We build Eleupro on our earlier successful track record of selling our kangaroo product, which was like Eleupro, but it didn't have the drug elution technology. Speaker 100:05:11This monumental event for us happened in the Q2. This was a June 20 24 event, and we were very, very excited and deadly focused on the planned commercial launch of this product, soft launch starting in the second half of this year, full launch starting in January of 2025. So why is it such a big deal to have an antibiotic eluting envelope for pacemakers and the like? Well, the pacemaker device protection market is a $600,000,000 market with only one other competitor. There is $350,000,000 of white space out there that's uncontested. Speaker 100:05:58But I'll say that's not enough for us because this isn't a me too product. We believe EluPro to be a fully superior product to the other competitor on the market and we look forward to that challenge. Worth noting, we also received FDA clearance for indications beyond pacemakers and implantable defibrillators, we collectively call the CID market. And these include the other aspects of neurostimulation. So pain management, incontinence, both fecal and urinary, sleep apnea and epilepsy. Speaker 100:06:35And we're talking about an additional $8,000,000,000 device market. So one that is collectively equal in size to the cardiac indication. So we'll talk a little bit more about our efforts going into exploiting those markets as well. And lastly, I'd like to point out, we didn't develop EluPro to end with EluPro. We developed EluPro as a platform technology of drug eluting biologics that we are actively growing and building over time. Speaker 100:07:05So we're super excited about all that. We'll go into that more, but that is a snapshot of the investment summary of Aleutia at a high level. So today, with our conference call, I actually wanted to sort of share more granularity to the plan as we talk about it and as we execute it internally. So these are actually the words we use internally. So I'm inviting you in to the company to take a look at how we're executing on our plan to continually build the value of Ellucia. Speaker 100:07:38So we go through it very methodically. The first thing we had to do was clear it. Last quarter was all about clearing it. Then we have to make sure that we can produce the product, make it. We have to introduce it to the hospital systems. Speaker 100:07:51And then lastly, it's not enough for us to introduce it, but we've got to grow it so that this technology can reach every patient that is needed, but also this technology can reach every indication that it's needed. And in order to do all of that kind of great stuff that I get to be super involved in, we also needed to have a strong sound financial position and I think we made really tremendous progress this quarter solidifying our financial position so that we have the resources that we need to go and execute on this strategy. So this is going to be the game plan for the call today. We're going to go through each of these different boxes in some granularity. So let's kick it off with Clearance. Speaker 100:08:34And under the category of Clearance, this was monumental for us. We received regulatory approval for the first drug eluting bio envelope product that was in June as we talked about. We were really happy for a couple of reasons. One of them was that we received all of the shelf life we asked for this product. So we received the full 9 month shelf life. Speaker 100:08:58We received a great indication. And again, a great product level, right? If you're new, this is what LU Pro looks like. It has the extended release, powerful antibiotics rifampin and minocycline all wrapped up in this biological matrix. That matrix, from a primary standpoint, prevents that device from migrating and moving down the patient's chest wall and eroding out. Speaker 100:09:23We have an indication that allows it to be used both in de novo procedures. So as soon as the pacemaker is put in and change out a procedure. So when it comes time for a battery change, if there's a lead problem, it can be used in both of those. Physicians love this product because you can kind of see from the picture there, this is a product that perfectly and completely conforms to the underlying pacemaker. And as it's recontinent and wet, it is really like a beautiful slippery, we felt lubricity of the product, allows it to just simply slide easily into the patient's chest wall with absolutely no need to upsize the pocket. Speaker 100:10:07And when we hear it when we hear from the physicians that we've talked to at HRS and others, this is a really, really big deal for them. And then lastly, this is an envelope that regenerates. This is not a synthetic. This is not a plastic. This is not a polymer. Speaker 100:10:23This is not a metal that sits there or dissolves over time. But instead, it remodels into the patient's own healthy vascularized tissue. And you can't have a foreign body response, you don't have a foreign body anymore. And so it completely eliminates in the long term that type of problem for taking place. So as we talked about, we were going after and we were super excited about the cardiac rhythm management market. Speaker 100:10:51That device market is an $8,000,000,000 market, meaning the devices that get implanted there are currently doing about $8,000,000,000 in sales. And that was the primary approval we were seeking. But there's also this neurostimulation market that we went after for strategic purposes just so everyone realizes that is an additional $8,000,000,000 device market that we have now opportunity and we have label claim in order to be able to go in and protect. And so I want to really make sure we describe both of these markets adequately. Let's first start for us with the most important market and the one we're focused on, which is cardiac rhythm management. Speaker 100:11:29So let's dig into that a little bit. This is a market that only has 4 players, 4 primary players in the pacemaker and defibrillator space. Medtronic is the largest at 40%. Behind them, we have Boston and Scientific and Abbott at 25% and then lastly, BIOTRONIC at 10%. Now Medtronic from a competitive standpoint introduced a product. Speaker 100:11:54They actually acquired a product line in the company called TYRX back in 2014. And TYRX is a pretty interesting story in that this is a product with very little sales when it was acquired. And it's a fully synthetic antibiotic eluting envelope. And so it's after it's implanted, the envelope kind of dissolves over time. And as it dissolves, it liberates the same antibiotics we use, rifampin and minocycline. Speaker 100:12:25And what Medtronic was able to do is acquire this product that they went out into the pacemaker and defibrillator market space and they said, hey, this is a really good idea for you guys to have this product as you're implanting them. And they were right and they did a really beautiful job creating this market. And we estimate their sales right now are somewhere between $250,000,000 $300,000,000 a year with this product. And so they have really derisked the marketplace around this idea of will an antibiotic luting pouch be accepted? The answer to that is definitively yes. Speaker 100:13:01Now it's a product we think that can be improved upon. And so when we look at this, we look at these markets that have at least 60% of the market really uncontested right now, 60% of the market that doesn't have access to a pouch. And you might look at those favorable market dynamics and say, that's really pretty good. Like if all you did was have a Me too product to that, you have 60% white space in this. This is pretty fantastic. Speaker 100:13:32But I'm here to tell you, we do not have a Me too product. We believe fully that we have a far superior product to Medtronic's TYRX product because of we've taken those same powerful antibiotics, rifampin and minocycline and we have paired them with this biological envelope that does all those great things that biologic does. And we hear this over and over again from physicians. It is a product they love to use. And so we're really excited about going after the rest of this market space. Speaker 100:14:06Okay, that's the cardiac market. And we also picked up this neurostimulation market, which is another $8,000,000,000 in devices. And it worked just briefly looking at what that market looks like. So neurostimulation market is growing at 12 percent. So quite a healthy rate. Speaker 100:14:23It has 4 major components to it pain management, incontinence, both urinary and fecal, epilepsy market and sleep apnea. And here's the thing you've got to look at across all of these markets, 30% complication rate, 41% complication, 21% 27% complication rate, 42% complication rate in sleep apnea, with 24% of those devices requiring revisions. These are markets that are streaming for AluPro and where we think we can go in and really add significant value, not only to the procedures and the underlying devices, but frankly to the patients that are having these put in. They're having devices put in for a reason. They need the underlying technology. Speaker 100:15:12We believe we can make that underlying technology more successful as it relates to compatibility with the patients. Okay. So that wraps up clearing why we were so excited about having EleuPro finally cleared. Now let's move on. The next step we've got to do is we've got to make that product. Speaker 100:15:30I am let me just sort of take you in really quickly. First, we manufacture EluPro in the same place we manufacture Kangaroo, which is our facility manufacturing facility in Roswell, Georgia. We've had operations there since 2013 and have turned out 75,000 units. So this isn't a risky thing for us like are you going to be able to manufacture this product this first time you're doing it. We've been at it for a long time. Speaker 100:15:56To be sure, the addition of antibiotic into this manufacturing process increases the complexity, but we're not new at this. We've been at it for a while. We have a facility that has really great clean rooms. It also has a lot of capacity. So we're talking about the ability in the current facility to manufacture the run rate of $140,000,000 of EluPro and to build out from there actually doesn't require a whole lot of sophisticated space. Speaker 100:16:25So we certainly have the capacity to be able to launch and get this thing going. And when the time comes, we will be able to efficiently expand and open that up and increase that capacity. And by the way, we do think we will need more capacity in time beyond $140,000,000 of revenue. Lastly, and something I'm really proud about of the team is, while we were going through review of LU Pro submission at FDA, the site also went through a complete FDA audit and inspection in the month of June. It was an inspection that lasted about a week. Speaker 100:17:03It was comprehensive, and I'm super proud of the group down there. Completed that inspection with no deficiencies, no observations noted from the FDA whatsoever. So we've got a clean bill of health on the approval side and we've got a clean bill of health on the facility side and we are ready to manufacture products. And so let's talk about that. This, ladies and gentlemen, I am super happy to say this is the first unit of EleuPro that has ever been manufactured for commercial use. Speaker 100:17:35Hanalee, our senior operations associate in Roswell, Georgia, manufactured it. And to say she was a proud parent is an understatement. There was applause and cheers that went up in this facility. I will also say the entire leadership team was there to see this monumental event. And so there you go. Speaker 100:17:55We are well underway on manufacturing of this product. It's currently in the first lots are in QA review and are expected off the line shortly. All right. We've cleared it. We've made it. Speaker 100:18:11Now we've got to introduce it into the hospital system. And you maybe have heard me talk about this before, but the introduction of this product in the hospital systems is not trivial and we actually think it's the rate limiting step. So the first thing we needed was all of the collateral in order to do that. And so you can see over there, whether it be packaging or promotional material for it or value analysis committee packages, this is what the new look of EluPro looks like. We love it. Speaker 100:18:41We think it's very consistent with the brand. We think it is very differentiated and really talks about the freshness that this product brings to really what's been a stagnant market for the last 10 years. So where are we on this? Well, we currently have Kangaroo out there in the market and then we talked about before, we continue to add new hospitals. And so it says approximately 400 active accounts. Speaker 100:19:05I like specificity, 398 accounts are active, which is a significant increase since the last time we've talked and we continue to build out this hospital network. We are also though so just because we have a hospital on account with Tangaroo, it's important to know, doesn't mean they one for 1 just transfer over with EluPro. EluPro has to go through the value analysis or vac committee submission, and that process is underway. So we have completed that assembly of the packages that you need to do in order to submit to VAX. So that is being done. Speaker 100:19:47It's done sort of on an account by account basis. Our KOLs, our physician champions that these are going in hand in hand with the reps in those territories and they are personally submitting them into the VACs. We are obviously prioritizing that from a standpoint of we are going to our key accounts first for a launch. So our soft launch in the second half of this year is started now. In conjunction with that is the initiation of a registry where we're beginning to collect clinical data and the full launch of this product starts in the Q1 of 2025 January of 2025. Speaker 100:20:29All right. So it wouldn't be complete without talking about the reception that we're receiving out there. And I've gone through this before where 88% of TYRX users basically want to become EluPro users. This was a market survey that we did where we were pulling 50 TYRX users and explaining to them about the benefits of having a biologic envelope instead of a synthetic envelope and asking them if they would switch some or all other business, 88% said yes. And so that that was really gratifying as we were building these products. Speaker 100:21:01We thought, hey, we're on the right track here. We're onto something that physicians care about. But I think what's validating this more for us is the enthusiastic reception we are receiving since approval. So not only treating physicians and by the way, if you're a treating physician out there, I appreciate the enthusiasm. No need to text me in the middle of the night. Speaker 100:21:21That is happening. And it actually text me in the middle of the night. I love it. That is going on. Hey, how can I get my hands on this? Speaker 100:21:31How can I bring this into my hospital system? How can I show this to my colleagues? But also other industry partners out there are we're receiving inbound calls of interest saying, hey, we're super interested and excited about this product. And we are evaluating all of that way we should responsibly and sorting through making those kinds of decisions. But the important thing to understand is what that's telling us and what that's validating for us is that this is a product that the industry thinks can move the mark, right? Speaker 100:22:06This is a product that the industry thinks can move the CIED market and the neurostim market. And therefore, we think that is clearly validating the value of the product that we've developed. So we'll work through all that stuff responsibly as we should, but it's a very, very exciting time as we get ready for launch. Okay. And then the last thing we need to do, it's not enough for us to introduce it and stay stagnant. Speaker 100:22:31We've got to grow it. And when I say grow it, I mean the brand, I mean the team, I mean the value of the company. So let's talk about how we're doing that right now. First thing is, we are methodically, systematically building out our commercial teams. We are now up to 26 reps for the EluPro team and growing and I put in parentheses there intelligently. Speaker 100:22:54I want to be really clear that we're not just doing this indiscriminately. We are not throwing reps at this thing and hoping a market comes. We are adding them methodically. We are adding quality people to places where we think they can have a significant contribution. Same thing as it goes with Simplederm. Speaker 100:23:10So we haven't talked much about Simplederm. It's largely been the EleuPro show today. But Simplederm is a great product and it continues to be a great product. And it's one where we are investing more and more on a direct sales team and really controlling the destiny of that asset as well. We can't do any of this sales stuff if we don't have the product on hand to make. Speaker 100:23:33And so towards that end, we're really excited about adding Ryan Marquise to the team as Vice President of Operations to oversee the manufacturing and production of both of these product lines. Ryan is a really solid guy that we've, as a leadership team, got to spend a lot of time with and really I think he's going to be a really quality add to this organization. I also talked a lot about these new adjacent markets that we all of a sudden have indications for, for EluPro. And what we're doing there is we're going on and we are starting and intensifying BD efforts into these adjacent markets, so that we can see if they make sense to have different partnerships or other types of arrangements there. And then lastly, we didn't develop eluapro to get to the finish line. Speaker 100:24:30We developed eluapro to get to the starting line. This is the 1st drug eluting biometrics that is out there. We think all of the success that we've got to have with EluPro really just validates the sector. We have a platform technology that our R and D teams are aggressively building on. And as they do that from a product level, they are also building out a very broad and robust intellectual property position, which we think makes the products and make the company disproportionately more valuable. Speaker 100:25:02So all in all, really exciting times at Aleutia. Couldn't be more proud of the team, and I thank them so much for an incredibly successful quarter. We couldn't do any of this though without the financial resources that we need. And so we went to pretty great extents to make sure that we had a solid financial position in which we can really execute on this growth plan. And I will now stop talking and turn it over to our Chief Financial Officer, Matt Ferguson, who will go through some of the financial details. Speaker 200:25:38Okay. Well, thank you, Randy. It is no doubt a very exciting time to be in Aleutia and Q2 was really an extremely important quarter and even what's happened in the week since then have been a very important time for us as well. I'm just going Speaker 100:25:52to hit a few of the Speaker 200:25:53highlights of our financials. Of course, the full financials are available in our earnings release and our 10 Q will come out early next week. So from an overall net sales point of view, there was little change this year in Q2 compared to the prior year coming in at $6,300,000 less than $100,000 difference from $6,400,000 last year. But what that masks a bit is the growth that we saw in our 2 most important product lines, Kangaroo and Symploderm. Kangaroo, we a 19% increase to $2,600,000 Symploderm also came in at $2,600,000 which is an increase year over year of 7%. Speaker 200:26:32That will as you may know, that was a decline from Q1 of this year, which really related to the dislocation associated with our U. S. Distributor that went through bankruptcy and a sale during the quarter and is now being integrated into that new organization and we've actually seen a nice return to those earlier levels of production that we were getting out of that distributor. So we're doing a number of things in the symptoderm area to drive growth that we will keep you apprised of. But overall, we feel very positive about that part of the organization. Speaker 200:27:13And of course, we're very excited about what will occur when we have EleuPro actually on the market here in the second half of the year. So in addition to that, cardiovascular, which we don't focus on quite as much that is exclusively distributed in the U. S. By our distribution partner, Lebate, had a good quarter with $1,100,000 in overall sales. We put that relationship in place during the Q2 of 2023. Speaker 200:27:42So on a year over year basis that was a decline, but some of the sales last year were at the full end user price whereas this year they're at a transfer price. So that was a decline, but we actually were quite pleased with the $1,100,000 performance, which was up sequentially from earlier in the year. On a gross margin basis, we came in on an adjusted gross margin basis, which excludes non cash amortization expense overall at 58% versus 56%. So we're seeing some nice gains in efficiency overall there. And then I would like to note, while people are not quite as focused usually on our net loss, we had a large number there, but most of that was from a non cash charge associated with the warrants that were exercised in July of this year. Speaker 200:28:32But because it does change with our stock price, the warrant liability charge, we had a large an $18,000,000 non cash charge, which will primarily wash out of the P and L as we move forward here. More importantly and more reflective of our actual operating performance on an adjusted EBITDA basis, we came in at $2,900,000 for the quarter and that was an improvement compared to $3,400,000 last year. So we're seeing with the revenue growth and improvement in gross margin and control of operating expenses, we're seeing nice results on the adjusted EBITDA bottom line level. And then last, but certainly not least, we've made a lot of progress in terms of the overall cash position for the company. We did a financing that brought in $13,300,000 during Q2 of the year in a registered direct offering. Speaker 200:29:29And then as I mentioned, the warrants that were exercised in July of this year, so following the end of the quarter actually brought in an additional $13,800,000 which is not reflected in quarter end cash balance. But if you think of it more on a pro form a basis, that would put us a little over $30,000,000 in cash on our balance sheet, which is quite an improvement for where we've been over the last year or 2 really. So excited about what we are looking at here for the second half of the year and beyond. And with that, I think we are going to open it up to your questions. Thank you. Operator00:30:06Thank you. At this time, we'll be conducting a question and answer Thank you. And the first question is from the line of Ross Osborne with Cantor Fitzgerald. Please proceed with your question. Speaker 300:30:42Hi, guys. This is Matthew Park on for Ross today. Congrats on the progress and thank you for taking the question. I just want to start off with LU Pro and get some additional color on how conversations with VAX have gone. How are you guys feeling about the overall adoption as you ramp towards full commercial launch? Speaker 100:30:59Hey, Matthew. It was a little hard to hear, but I think the question was, how is the process going with our VAC submissions, the value analysis committee submissions. Is that correct, Rob or Matthew? Yes. Okay. Speaker 100:31:18Yes. No, it's going exactly as we expected it. So our VAC submission strategy is a very methodical targeted one. And so the first hospitals that we are submitting to are ones that are part of our soft launch, pilot launch process for the first half. They're ones where we have very, very strong physician champions and those physicians want this technology in their hospital system. Speaker 100:31:56They want to be the ones using it first and they're aggressively walking it walking the packages through. So we're really excited about that. With that said, there will still be a range just based on how each individual hospital's VAC process works and how long it takes. But we think we will basically have full demand for the quantities that we're targeting in the soft launch from the hospitals. And then more importantly, preparing and starting the VAC submission process so that when our commercial the full commercial launch comes January 1, that will have a much broader universe of hospital systems. Speaker 100:32:50So very positive. Speaker 300:32:54Got it. That makes sense. And then I guess just one more from me moving down to P and L. In terms of OpEx cadence in the back half of the year, how should we think about sales and marketing spend in the second half? Should we expect more of a gradual buildup of reps or would these additions be more skewed towards the Q4? Speaker 300:33:10Thanks. Speaker 200:33:14Yes, I could speak to that, Matthew. I would think we are actively recruiting for new sales representatives both in the LU Pro and the simpliderm categories. So we may see some additional expense there, maybe some additional marketing expense would also show up on that line. However, probably the biggest driver would be as we continue to grow, we will see additional sales commissions associated with that. So I would expect to see some increase in that line as we move through the year, but it will be roughly it will be generally in line with increased revenue, I would say, as we go through the second half of this year and certainly into 2025. Speaker 300:34:03Got it. That makes sense. Thanks for taking the questions and congrats again on the progress. Speaker 100:34:09Thank you, Matt. Operator00:34:12Our next question is from the line of Frank Tafkanian with Lake Street Capital Markets. Please proceed with your question. Speaker 400:34:18Great. Thanks for taking the questions guys. Congrats on an exciting quarter. Happy to see how UPRO make it to market. I will apologize upfront, I've been bouncing between a couple of calls. Speaker 400:34:27So if I ask a repetitive question, I apologize upfront. I wanted to first start with clarifying. Randy, I heard you say 26 reps. Is that today or the goal? And 2, how should we think about the right rep count over a longer period of time, say 12, 18, 24 months and what the adequate size selling organization looks like? Speaker 100:34:50Yes, Frank, that is 26 reps as of today that are on board. We are using a hybrid of direct reps and we also will add the 1099 reps. That's sort of what Matt was alluding to in terms of why we don't have a real significant hit to the P and L that doesn't scale really nicely with revenue because a lot of those are just commission based reps. But we are taking that number up. We're taking that number up and I frankly Frank, I don't want to be more specific than that right now, but it will continue to climb as we approach January and launch. Speaker 400:35:53Okay, fair enough. That's helpful. And then maybe shifting over to the some pricing discussion. I'm sure you don't want to speak too clearly about it given for competitive reasons, but any thoughts on directional pricing versus Kangaroo Classic or versus TYRX on the market today for Eleupro? Speaker 100:36:13Oh, I can talk directionally about it. No problem. It's obviously Tangaroo plus the addition of rifamp and minocycline. So it's a better product that and we think it is a much better product than TYRX. It does more. Speaker 100:36:28It has the biological features. And so we expect directionally it will be priced in the premium to both of us. Speaker 400:36:41Got it. That's helpful. And then maybe last one, just an update on simploderm. I think last quarter there were discussions around the partnership with now Tiger and whether or not that partnership made the most sense for Lucia on a go forward basis. What's the latest update on that? Speaker 400:36:58And any other thoughts around any partnership opportunities in that side of the business? Speaker 100:37:05Well, right now, we have a partnership with Tiger. And because of that, that is a result of Tiger acquiring the distribution contract from the assets of Sientra. So they paid money to acquire that agreement. So right now, we have an agreement in place. As Matt said, there was, as you would expect, significant disruption when a company goes bankrupt and gets sold in an auction and acquired and integrated all in the Q2, that's a lot and it's a lot to expect that there wasn't going to be some disruption there. Speaker 100:38:06And also, as Matt said, we're seeing, I would say, in general, a return to more significant growth. With all of that happening, we still had the product still grew in the Q2 and that's largely due to our own distribution network. But right now, we have both of those distribution networks in place and they're both performing reasonably well. But we are putting a lot of emphasis on growing our own distribution network just because they're doing so well, why wouldn't we do more of that? It's proprietary. Speaker 100:38:56For a lot of reasons, it makes sense for us to do that. But right now, we have both of those in place and we're seeing the product actually return to, I would say, more simploderm like growth numbers. Operator00:39:21Thank you. Ladies and gentlemen, this concludes our question and answer session and this also concludes today's conference. You may now disconnect your lines at this time. ThankRead morePowered by