Elutia Inc. (ELUT) Q2 2026 Earnings Report, Transcript and Summary

Good day, and thank you for standing by. Welcome to the Elutia Q2 2026 Financial Results Conference Call. [Operator Instructions]. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Bernadine Cherniak. Please go ahead.

Thank you, operator, and thank you all for participating in today's call. Earlier today, Elutia released financial results for the second quarter ended June 30, 2026. 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. All forward-looking statements, including, without limitation, those relating to our operating trends and future financial performance are based upon our current estimates and various assumptions. These statements involve material risks, 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 descriptions of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our public filings with the SEC. Including Elutia's annual report on Form 10-K for the year ended December 31, 2025, and in our subsequent periodic reports on Form 10-Q and 10-K accessible on the SEC's website at www.sec.gov. Such factors may be updated from time to time in Elutia's other filings with the SEC. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, August 13, 2026. Elutia disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements because of new information, future events or otherwise. Also, during this presentation, we refer to gross margins, 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 on the company's financial results release for the second quarter ended June 30, 2026, which is accessible on the SEC's website and posted on the Investors page of the Elutia website at www.elutia.com. And with that, I will turn the call over to Elutia's CEO, Randy Mills.

Thank you, Bernadine, and thank you, everyone, for joining us today. The second quarter was another solid quarter of execution for Elutia, so let's get right into it. Here's how we'll spend our time today. I'll start with why we are concentrating the company's efforts on the reconstruction opportunity. I'll walk through the highlights of the quarter, including our strengthened balance sheet and some exciting new survey data. Matt will take you through the financials and capital position, then we'll open the line up for questions. Four things defined this quarter. First, we're funded. Up to $26 million of additional capital with no equity offering, we believe that carries us through the NXT-41x clearance decision in the first full year of commercial launch in 2028 and beyond. Second, the company is becoming more focused as our strategic divestitures are being completed. We signed a definitive agreement to sell SimpliDerm for up to $11 million, and the cardiovascular process is progressing well. The purpose of this activity is to align the company's capital and attention on the one thing that will drive the greatest value for patients and shareholders. The commercialization of NXT-41x. Third, we now have real data on surgeon demand for NXT-41x. In an independent blinded survey of 50 board-certified plastic and reconstructive surgeons, 96% expressed interest in adopting NXT-41x and 92% said that they would champion it at their hospital's value analysis committee. I'm going to spend some time on this study today because it's important. And fourth, our regulatory and manufacturing teams continue to advance towards launch on schedule. This quarter, we had a productive meeting with FDA and the NXT-41 program remains on track for what we believe will be a favorable clearance decision in the fourth quarter. Perhaps more importantly, we believe NXT-41x, the ultimate goal is well positioned for clearance in the first half of 2027. In preparation, our automated manufacturing process has been qualified for commercial production of NXT-41x at scale. For those newer to the Elutia story, here is a short version of what we are uniquely great at. We combined a biological matrix with sustained local antibiotic delivery at the surgical sites. The objective is straightforward, create a surgical implant that can prevent bacterial colonization before it has the chance to become an infection. And importantly, we have done this before. Our first-generation drug-eluting product, EluPro, was the first FDA-cleared antibiotic-eluting bioenvelope. We developed it, we cleared it, we commercialized it. And last October, we sold that business to Boston Scientific for $88 million. We are now applying that same technology to solving the very real problems that exist in plastic and reconstructive surgery. The United States market for breast cancer surgery is valued at $1.5 billion. And importantly, it is an established market. Surgeons already use biological matrices in breast procedures today. We do not have to create a new category. At the same time, the clinical problem is substantial. Published data show postoperative infection rates remain between 15% to 20% following mastectomy. So the opportunity for us comes from the combination of 3 things: a large existing market, a significant unresolved clinical problem and a technology platform that directly addresses it, a platform we created. And the magnitude of the problem is hard to ignore. These are published data, not Elutia estimates. Approximately 1 in 3 women experiences a serious complication following reconstruction, 15% to 20% experience postoperative infection, up to 21% experienced an implant loss. And the average hospital cost of a reconstruction with an infection is more than $48,000. That is a patient problem, a hospital problem and it is a surgeon problem. Now we've shown you infection statistics before. What this slide shows are the consequences. Let's start with the patient. She's fighting cancer. That's why she's in the operating room. When an infection takes hold, chemotherapy stops, radiation stops, and she is looking at pain, fear and more trips to the operating room. And if she loses the implant, more than half of the women in that situation never go back and finish the reconstruction process, it ends. The hospital incurs an added cost, mostly without reimbursement. It gives up revenue-generating operating room time slot and hospital beds, and it takes the reputational hit regarding its infection rate. But the surgeon pays a unique price and they pay it over and over again. Keep this in mind because they are the ultimate decision makers regarding what gets used in the operating room. Let's look at a surgeon who does 140 cases a year and has the average infection rate of 17%. That means they are getting called back into the hospital every 15 days irrespective of the time of day, the day of the week or whether it's a holiday, that significantly impacts their quality of life. If you don't think so, think about this. The reconstructive specialty in plastic surgery is by itself an independent risk factor for burnout among plastic surgeons. And when those surgeons walk away, women lose access to reconstruction. So now that you understand what we are doing and why, let me turn to how we funded the plan. This quarter, we secured up to $26 million of additional capital without an equity offering. It comes from 2 places: First, a $15 million credit facility with Avenue Capital Group, $10 million of which is already in the bank and another $5 million that is available to us upon NXT-41x clearance. That is not only a substantial infusion of cash, but also an unequivocal endorsement of our plan by a sophisticated health care lender who conducted extensive due diligence. The second is the SimpliDerm transaction, which provides for up to $11 million in consideration. That includes $8 million in cash at closing and up to $3 million in tech transfer and commercial milestone payments. On top of that, at the start of the fourth quarter, we anticipate receiving the full $8 million in escrow from Boston Scientific. Now look at the bottom of the slide because the timing is the point. We believe this capital will take us through the NXT-41 clearance decision in the fourth quarter of this year. The anticipated NXT-41x clearance in the first half of 2027 and the full year launch in 2028 and beyond. We are now fully funded. The divestitures are a key part of the strategy. We made a deliberate decision to stop spreading capital and management attention across multiple businesses and concentrate Elutia where we believe we can create the greatest value. The SimpliDerm transaction is now signed with closing expected in the third quarter and the previously announced strategic process for cardiovascular continues to advance with a potential transaction in the 2026. When that work is complete, Elutia will be solely focused on 1 primary opportunity. NXT-41x and the approximately $1.5 billion plastic and reconstructive surgery market. That was intentional, and we are nearly done. Now to the part of the quarter I'm most excited about. For 2 years, we've been telling you the demand for NXT-41x is out there. This quarter, we quantified it. We hired an independent market research firm to run a blinded survey, 50 board-certified plastic and reconstructive surgeons in 28 states. Averaging 11.6 years in practice and about 140 implant-based reconstructions a year. 42% practice in academic hospitals, and the group is split about evenly between east and west of the Mississippi. These are exactly the surgeons who will decide whether NXT-41x is ultimately adopted. A quick word about method. It was blinded. These are not our friends. We did not take the respondents. Elutia was never named. Nobody was being nice to a sponsor because nobody knew who the sponsor was. Interest was measured using the standard -- with Wilson, 95% confidence intervals. The first question was whether surgeons themselves see infection as a significant unresolved problem. They estimated the surgical site infection rate at 17%, and that's right in the range of what the published literature says it is. The more striking result is on the right side. 86% of surgeons surveyed said the matrices they use today actually increase the risk of surgical site infection. And I want to be precise about that. That is not Elutia making a comparative claim about another company's product. It is the surgeons describing the product they currently use as an infection risk factor. Taken together, postoperative infection is a real problem that needs a better solution. The next topic was whether the NXT-41x concept made sense to them. 96% rated the combination of rifampin and minocycline effective at reducing surgical site infection. 64% said it was extremely effective and not a single surgeon rated the antibiotic combination as ineffective. And 98% view NXT-41x as new and different.from products on the market today. The specific product characteristics they found most compelling were also telling. Local antibiotic concentrations above the minimum inhibitory concentration for 30 days, a bactericidal antibiotic combination directed against known surgical site pathogens and prevention of bacterial colonization ranked 1, 2 and 3, respectively. Those are not branding attributes. They are fundamental mechanisms of how our product works. And remember, there was no Elutia brand attached to any of the survey. They were reacting to the actual product specifications. The third question is the one that matters commercially. Would you use it? For high-risk patients, including diabetic patients and those with high BMI, 100%, all 50 surgeons indicated they would use NXT-41x. Those 2 groups together represent approximately 1/3 of reconstruction patients, an enormous opportunity in itself. But a full 96% said they were interested in incorporating NXT-41x into their general practice. And then there's the number on the right, 92% indicated a willingness to approach their hospital's value analysis committee in support of NXT-41x. I think that number deserves particular attention. Hospital adoption is not simply a matter of a surgeon liking a product or a product getting approved. Someone has to be willing to make the case internally and move the product through the hospital's VAC process. 46 out of 50 surgeons indicated they were willing to do that for this product. So let me put the whole study on one slide. We asked if the problem was real. 86% said the matrix they use today increase risk infection. We ask if our approach would work, 96% rate the antibiotic combination effective. We asked if they would use it, 96% expressed interest in incorporating it into their practice. We asked if they would fight for it and 92% said they would champion at their own hospitals back, 50 surgeons blinded and independent. Demand for NXT-41x is no longer theoretical. Turning to regulatory. I am very happy to say that for both programs, they remain on track and on schedule. NXT-41, the underlying biologic surgical matrix without drug is currently under FDA review. We recently had a productive meeting with the agency, and we continue to expect a favorable FDA clearance decision for NXT-41 in the fourth quarter of 2026. That dialogue has also increased our confidence in our preparation of the NXT-41x submission. We expect FDA clearance for NXT-41x in the first half of 2027. Those remain the key regulatory milestones in front of us. Manufacturing readiness is advancing in parallel with the regulatory work. This quarter, we completed installation and operational qualification of the automated drug coating system. That system has already produced NXT-41x. For NXT-41x, we deliberately chose to own the manufacturing process ourselves. There is no contract manufacturer license or sole-source supplier. The product is ours end-to-end. We also developed proprietary quality control assays and test methods to meet the FDA's very specific release criteria. The process is designed for scale, consistency and efficiency, and we continue to target gross margins greater than 80% at scale. And it is now up and running at our GMP facility in Gaithersburg, Maryland. All in all, a very solid quarter for the Elutia crew, and I thank each and every one of them for their remarkable efforts. And with that, let me turn the call over to Matt.

Okay. Thank you, Randy. Great to be here. I'll be hitting the highlights of our second quarter results and financial position. As a reminder, the impact of our bioenvelope business, which we divested in October 2025 shows up as discontinued operations in prior periods. However, the contribution of our SimpliDerm business in the second quarter still shows up in continuing operations even though we entered into a definitive agreement to sell that business on July 11. Assuming the closing of that transaction proceeds as expected, SimpliDerm will also move to discontinued operations in future reports. Now moving to our actual results. Total net sales for the second quarter were $2.4 million compared to $2.7 million in the prior year period. There were 2 offsetting drivers. SimpliDerm was down $0.7 million due to a production disruption at the products contract manufacturer, but that was largely offset by an increase in cardiovascular, which was up $0.4 million on our transition back to direct sales. For the first half of 2026, net sales were $5.5 million compared to $5.7 million in the comparable prior year period. Margins expanded meaningfully in Q2. GAAP gross margin was 59.6% compared to 52.9% a year ago. Adjusted gross margin, which excludes noncash amortization of intangibles, was 70.7% compared to 62.7%, an improvement of 8 percentage points year-over-year. Total operating expenses were $9.4 million, down from $9.8 million. Within that number, we continue to shift spend towards the future. Net litigation costs came down $1.9 million, while research and development increased $1.5 million in support of the continued progress in NXT-41 and 41x. Loss from operations improved to $8 million even from $8.4 million a year ago. Net loss was $7.6 million compared to $9.6 million in the prior year period, an improvement of $2 million that primarily reflects the absence of losses from the divested bioenvelope business. Net loss from continuing operations was $7.6 million compared to $7.1 million and adjusted EBITDA was a loss of $4.6 million compared to a loss of $3.0 million a year ago. The change was driven primarily by the increase in R&D expense. On the balance sheet, we ended the quarter with $19.9 million in cash, but we expect that position to be augmented by up to an additional $34 million from signed transactions. Going through those in a bit more detail, we received the initial $10 million this week from our deal with Avenue Capital. And in the fourth quarter, we expect to receive the full $8 million escrow from the last year's bioenvelope deal. The new SimpliDerm deal adds up to $11 million, with $8 million of that $11 million coming at closing. And next year, upon FDA clearance of NXT-41x, another $5 million becomes available under the Avenue Capital facility following the NXT-41x clearance. So putting this all together, between our cash balance at the end of last quarter and the deals I just walked through, total cash sources, both current and projected for the company add up to $54 million. This puts Elutia in its best financial position in a very long time. As Randy mentioned, this provides runway through at least 2028. And between now and then, this funding covers multiple expected catalysts. First, the closing of the SimpliDerm sales this quarter. Second, a potential cardiovascular transaction. Third, the $8 million escrow release. Fourth, the FDA clearance decisions for NXT-41 in the fourth quarter of this year and for 41x in the first half of 2027. In addition, the soft launch of NXT-41x in the second half of 2027. And finally, the full commercial launch of NXT-41x in 2028. So stepping back, we believe the investment case for Elutia rests on 3 things. First, we have a validated platform. We have developed clear and commercialized -- developed, cleared and commercialized this technology once already in the form of EluPro and sold that business. Second, a blockbuster pipeline. comprised of a $1.5 billion U.S. reconstruction market and unmet medical need based on exceedingly high infection rates and now measured surgeon demand behind our product. Third and finally, we now have a fully resourced company with a proven team, a built-out GMP production facility and the cash to fund the company through anticipated clearance and full commercial launch. The demand is real. The capital is secured. The regulatory path is on track, and the entire company is focused on success. And with that, operator, I'll turn it back to you, and we can open the line for questions.

[Operator Instructions]. Our first question comes from Frank Takkinen with Lake Street Capital Markets.

Congratulations on all the progress. I wanted to start with one on FDA interactions. Maybe talk a little bit more about some of the conversations you've had, obviously, that you're comfortable sharing in a public setting. And then maybe detail what part of the process you're in with that clearance on 41.

So with respect to 41, I won't talk about too much of the inner workings of what we do, Frank. But I will say that Michelle and her team expected questions on 41, they received questions on 41, and they wanted to meet with FDA before submitting those responses to FDA to make sure that their answers to them would be what we hope are fully responsive. And so that was the nature and the reason of the meeting. And we came out of that meeting feeling good about -- very good about where we are going forward with NXT-41.

Okay. Very helpful. And then on the concept of manufacturing, I appreciate the new color today. Curious if you could outline some capacity goals that you're thinking about as you prepare for launch? Maybe what level of capacity would you hope to have secured for the first full year of commercialization. And then what level of capacity might be required to achieve that 80% gross margin goal you laid out?

Yes, so we expect to have at least $300 million of revenue capacity at launch of the product, being able to expand it from there will not be a particularly significant challenge. It will mostly involve additional personnel and additional shift adding not additional space, not additional equipment or production lines. So right out of the gate, we expect to be able to meet a very sizable amount of demand. And frankly, we hope to be in a race to keep up with it. With regards to gross margin, the process for producing NXT-41x. Michelle and her team had the ability of designing 41x with EluPro, we've experienced the EluPro under their belts. They were able to look at the process and parts of the process and things that were inherent to the design of the product that made that product more expensive and more challenging to make and drill up cost of goods of that product. And so when they designed 41x, they did that with that in mind and really have come up with a very elegant process for manufacturing on NXT-41x. And so some of that will depend ultimately on pricing decision. When we talk about gross margins, one of the reasons we're just giving a rough estimate on range. But I think we would expect gross margins to be in an acceptable rate, not too long into the -- not too long into the commercial cycle. It wouldn't be something that we would be measuring in years before we got there.

Got it. Very helpful. Maybe on the commercial launch, maybe talk to what the limited launch might look like in the second half of '27. And then some of the most important items you'll be looking to check the box off, so to speak, before flip into the full commercial launch in '28.

This is one of the great things, Frank, about getting older and having experience, this isn't our first rodeo. And so as we prepare to launch an NXT-41x, we get to look back at the EluPro launch, which was a drug-eluting biologic, going into a surgical procedure in modern times today, where we had to face value analysis committees. Some value analysis committees, Frank, as you know, are the gating item on how fast the product has the even the potential to get adopted. And so with regards to what we're thinking about soft launch activities, in the second half of 2027. It is value analysis committee, value analysis committee, value analysis committee. The more -- we know that the more seeds that we plant early on with the VAC, the more revenue opportunity, we will have as the year continues and throughout 2028. With EluPro, we developed a pretty sophisticated process for being able to go after those VACs. And I would say Pete Ligotti in the work his team has done more recently with some more sophisticated targeting data, complication data, procedure volume data will actually allow us to take, I think, what was some pretty sophisticated VAC machinery and targeted even further. And what I mean by that is being able to go into a value analysis committee and literally show them their own hospital's data and their own hospital's problem and how much we would be able to help them, not just from a patient standpoint, from an economic standpoint as well. So that's what the soft launch for us is all about is getting that done. We don't expect to be blowing the doors off of anything with regards to revenue because we still need to get through the front door of the VAC before anything happens. So that's what we would expect to happen there. And then, Frank, into 2028, I think come January 1, if everything goes according to schedule, we'll be ready to cut it loose.

Very helpful. Maybe last one, if I may. For Matt, once the SimpliDerm divestiture is complete, how should we think about an OpEx run rate if you're excluding the litigation cost?

Yes. I think you can look at the various components of our operating expense. And certainly, sales and marketing will come down significantly, really in proportion, I would say, to the revenue that we're taking out of the P&L. And it is not -- potentially not far behind the SimpliDerm transaction, we could also be looking at something for the CV transaction. And that would actually put us for a short period into a situation where we would not be commercial. And that would potentially allow for greater opportunities for streamlining and savings. But until then, we need to really maintain all the capability that we generally have now from an overhead perspective, but we're working hard on that. And stay tuned, we're hoping to have something done there before too long.

Got it. Very helpful. Thanks for taking my question. Appreciate it.

Thank you. I'm showing no further questions at this time. This concludes the question-and-answer session and today's conference call. Thank you for participating. You may now disconnect.