ELUT

Image source: The Motley Fool. Thursday, Aug. 13, 2026 at 5:00 p.m. ET Chief Executive Officer - Randy Mills Chief Financial Officer - Matthew Ferguson Operator: 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. Bernadine Cherniak: 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. C. 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. Matthew Ferguson: 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: [Operator Instructions]. Our first question comes from Frank Takkinen with Lake Street Capital Markets. Frank Takkinen: 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. C. Mills: 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. Frank Takkinen: 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? C. Mills: 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. Frank Takkinen: 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. C. Mills: 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. Frank Takkinen: 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? Matthew Ferguson: 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. Frank Takkinen: Got it. Very helpful. Thanks for taking my question. Appreciate it. Operator: 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. Before you buy stock in Elutia, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Elutia wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $432,621!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,335,314!* That performance is why people listen. With a track record of beating the S&P 500 by nearly 5x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 20, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Elutia (ELUT) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is concentrating all capital and operational focus on the NXT-41x platform, a drug-eluting biological matrix designed to address the 15-20% infection rate in breast reconstruction surgery. The company is executing a deliberate exit from non-core businesses, including the signed sale of SimpliDerm and the ongoing strategic process for the cardiovascular segment. Performance attribution for the quarter was driven by a transition back to direct sales in cardiovascular, which partially offset production disruptions at a contract manufacturer for SimpliDerm. Strategic positioning is built on Elutia owning the manufacturing process end-to-end, avoiding third-party dependencies to maintain quality and margin control. The value proposition targets the 'surgeon burnout' factor, as high infection rates currently force reconstructive surgeons into frequent, unscheduled emergency interventions. Management highlighted that 86% of surveyed surgeons believe current matrices actually increase infection risk, creating a market pull for Elutia's antibiotic-eluting solution. The company anticipates a favorable FDA clearance decision for the NXT-41 biologic matrix in Q4 2026, serving as a precursor to the drug-eluting NXT-41x. NXT-41x is positioned for FDA clearance in the first half of 2027, with a 'soft launch' focused on hospital Value Analysis Committee (VAC) approvals in the second half of 2027. Full commercial scale-up is scheduled for 2028, supported by an automated manufacturing facility in Maryland capable of supporting $300 million in annual revenue. Financial guidance assumes the current $54 million in total cash sources provides a runway through the first full year of commercial launch in 2028 and beyond. Long-term profitability targets include gross margins exceeding 80% at scale, driven by proprietary manufacturing efficiencies and high-value clinical positioning. Secured $26 million in non-dilutive capital through a $15 million credit facility with Avenue Capital and the $11 million SimpliDerm sale. Anticipate the release of $8 million from an escrow account related to the previous EluPro sale to Boston Scientific in early Q4 2026. R&D expenses increased by $1.5 million year-over-year, reflecting the intentional shift of resources toward the NXT-41 and 41x regulatory submissions. The SimpliDerm divestiture includes $8 million in upfront cash and $3 million in potential milestone payments, further de-risking the balance sheet. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management clarified that recent meetings were proactive, intended to ensure responses to FDA questions were fully responsive before formal submission. The dialogue has increased internal confidence in the upcoming NXT-41x submission timeline. The Gaithersburg facility has $300 million in revenue capacity at launch, with expansion requiring only additional shifts rather than new equipment. High margins are expected early in the commercial cycle due to an 'elegant' design that fixed cost-heavy issues identified in first-generation products. The 2027 soft launch will prioritize 'planting seeds' with hospital VACs rather than immediate revenue generation. Sales teams will use hospital-specific complication data to demonstrate the economic benefit of reducing the $48,000 average cost of infected reconstructions. Sales and marketing expenses will decrease significantly following the SimpliDerm exit, proportional to the removed revenue. The company may enter a brief non-commercial period if the cardiovascular sale closes quickly, allowing for further streamlining before the NXT-41x launch.

This article first appeared on GuruFocus. Total Net Sales (Q2 2026): $2.4 million, compared to $2.7 million in the prior year period. Total Net Sales (H1 2026): $5.5 million, compared to $5.7 million in the comparable prior year period. GAAP Gross Margin: 59.6% in Q2 2026, compared to 52.9% a year ago. Adjusted Gross Margin (excl. intangible amortization): 70.7% in Q2 2026, an improvement of 8 percentage points year-over-year. Total Operating Expenses: $9.4 million in Q2 2026, down from $9.8 million in the prior year period. Loss from Operations: Improved to $8.0 million in Q2 2026 from $8.4 million a year ago. Net Loss: $7.6 million in Q2 2026, compared to $9.6 million in the prior year period. Net Loss from Continuing Operations: $7.6 million in Q2 2026, compared to $7.1 million in the prior year period. Adjusted EBITDA: Loss of $4.6 million in Q2 2026, compared to a loss of $3.0 million a year ago. Cash Position: Ended Q2 2026 with $19.9 million in cash, with total current and projected cash sources of $54 million. Warning! GuruFocus has detected 5 Warning Signs with ELUT. Is ELUT fairly valued? Test your thesis with our free DCF calculator. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Elutia Inc (NASDAQ:ELUT) secured up to $26 million in additional capital without an equity offering, including a $15 million credit facility from Avenue Capital Group, ensuring funding through the NXT41X clearance and full commercial launch in 2028. A blinded survey of 50 board-certified plastic and reconstructive surgeons showed 96% interest in adopting NXT41X, 92% willingness to champion it at hospital value analysis committees, and 100% would use it for high-risk patients, indicating strong market demand. The company is advancing regulatory milestones on schedule, with NXT-41 clearance expected in Q4 2026 and NXT-41X clearance in H1 2027, following a productive FDA meeting. Manufacturing readiness is progressing, with the automated drug coating system qualified for commercial production at scale, targeting gross margins greater than 80% and capacity for at least $300 million in revenue at launch. Elutia Inc (NASDAQ:ELUT) is becoming more focused by divesting non-core assets, including the SimpliDerm sale for up to $11 million and the cardiovascular process, concentrating resources on the high-value NXT41X opportunity. The company's financial position is strengthened with total cash sources projected at $54 million, including the $8 million escrow from Boston Scientific and additional funds from the SimpliDerm deal, providing runway through at least 2028. Total net sales for Q2 2026 declined to $2.4 million from $2.7 million in the prior year, driven by a $0.7 million drop in SimpliDerm sales due to a production disruption at its contract manufacturer. Adjusted EBITDA loss widened to $4.6 million in Q2 2026 from $3.0 million a year ago, primarily due to increased R&D expenses supporting NXT41 and NXT41X development. The company continues to incur operating losses, with a net loss from continuing operations of $7.6 million in Q2 2026, slightly worse than the $7.1 million loss in the prior year period. The divestiture of SimpliDerm and potential cardiovascular transaction will reduce revenue streams, potentially leaving the company with no commercial products until NXT41X launch, increasing reliance on pipeline success. Regulatory clearance for NXT41X is not guaranteed, and any delays in FDA decisions could impact the timeline for commercial launch and revenue generation, despite current on-track expectations. The company's focus on NXT41X carries execution risks, including the need to successfully navigate hospital value analysis committees and achieve market adoption, as evidenced by the survey's reliance on surgeon willingness rather than actual purchase commitments. Q: Can you provide more detail on your recent FDA interactions and where you are in the clearance process for NXT-41?A: CEO Randy Mills stated that the team received questions from the FDA on NXT-41 and proactively requested a meeting to ensure their responses would be fully responsive. He noted they came out of the meeting feeling "very good" about the path forward for NXT-41, which remains on track for a clearance decision in Q4 2026. Q: What are your manufacturing capacity goals for the launch, and what level is required to achieve the 80% gross margin target?A: CEO Randy Mills said the company expects to have at least $300 million in revenue capacity at launch, with expansion achievable through additional personnel and shifts rather than new space or equipment. Regarding gross margins, he explained that the NXT-41X process was designed with learnings from EluPro to be more elegant and cost-effective, and while the final margin depends on pricing, he expects to reach acceptable gross margins "not too long into the commercial cycle," rather than measuring it in years. Q: What will the limited launch in the second half of 2027 look like, and what are the key items to check off before the full commercial launch in 2028?A: CEO Randy Mills emphasized that the soft launch will focus on navigating hospital Value Analysis Committees (VACs), which are the primary gating item for adoption. He highlighted that the team has developed a sophisticated process, using targeted data on complications and procedure volumes, to show hospitals their own economic and patient problems. The goal is to plant seeds with VACs early to maximize revenue opportunity in 2028, rather than focusing on immediate revenue during the soft launch. Q: Once the SimpliDerm divestiture is complete, how should we think about the OpEx run rate, excluding litigation costs?A: CFO Matthew Ferguson stated that sales and marketing expenses will come down significantly, roughly in proportion to the revenue being removed from the P&L. He also noted that if a cardiovascular transaction is completed, the company could temporarily become a non-commercial entity, which would allow for greater opportunities for streamlining and savings. Until then, they need to maintain current overhead capabilities. Q: Can you elaborate on the results of the independent surgeon survey for NXT-41X?A: CEO Randy Mills detailed the results of a blinded survey of 50 board-certified plastic and reconstructive surgeons. Key findings included: 86% said the matrices they currently use increase infection risk; 96% rated the rifampin/minocycline combination as effective; 96% expressed interest in incorporating NXT-41X into their practice; and 92% said they would champion the product at their hospital's value analysis committee. Notably, 100% of surgeons said they would use the product for high-risk patients, such as those with diabetes or high BMI. Q: Can you provide more color on the $26 million in new capital raised and the company's runway?A: CFO Matthew Ferguson explained the capital sources: a $15 million credit facility with Avenue Capital Group ($10 million received, $5 million available upon NXT-41X clearance) and up to $11 million from the SimpliDerm sale ($8 million at closing). Combined with the $19.9 million cash balance and the expected $8 million escrow release from Boston Scientific, total cash sources are projected at $54 million. This provides runway through at least 2028, covering the NXT-41 clearance, NXT-41X clearance, soft launch, and full commercial launch. Q: What is the strategic rationale behind the divestitures of SimpliDerm and the cardiovascular business?A: CEO Randy Mills stated the divestitures are intentional to concentrate the company's capital and management attention on the NXT-41X opportunity, which they believe will drive the greatest value for patients and shareholders. Once complete, Elutia will be solely focused on the approximately $1.5 billion plastic and reconstructive surgery market. Q: Can you discuss the significance of the surgeon survey data in the context of the commercial opportunity?A: CEO Randy Mills highlighted that the survey validates the demand for NXT-41X is no longer theoretical. The fact that 92% of surgeons are willing to champion the product at their hospital's VAC is particularly important, as hospital adoption requires internal advocacy. He also noted that the surgeons' perception that current matrices increase infection risk (86%) validates the clinical problem the product addresses. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Independent Blinded Survey of 50 Plastic Surgeons Validates Demand; NXT-41 and NXT-41x Remain On-Track Funded through launch: secured up to $26 million of capital without an equity offering The unmet need is real: 86% of surgeons surveyed say the matrices they use today increase infection risk The demand is strong: 96% of surgeons surveyed are interested in adopting NXT-41x; 92% responded they would champion it at their hospital value analysis committee On track: NXT-41 FDA clearance decision expected in 4Q 2026; NXT-41x FDA clearance decision expected in 1H 2027 GAITHERSBURG, Md., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today provided a business update and announced financial results for the second quarter ended June 30, 2026. Capital Secured to Support NXT-41x Through Clearance and Commercial LaunchElutia has secured up to $26 million of additional capital to support the Company through the anticipated clearance of NXT-41x and its first full year of commercial launch in 2028, without an equity offering: $15 million credit facility, including $10 million funded at closing and an additional $5 million available following NXT-41x FDA clearance Up to $11 million from the SimpliDerm divestiture, including $8 million in cash at closing and up to $3 million in contingent technology transfer and commercial milestone payments In addition, the Company anticipates receiving the full $8 million held in escrow from the 2025 divestiture of the BioEnvelope business, with release expected in the fourth quarter of this year. Independent Blinded Survey Validates Surgeon Demand for NXT-41xAn independent market research firm conducted a blinded survey of 50 board-certified plastic and reconstructive surgeons across 28 states. The surgeons average 11.6 years in practice and perform about 140 complex reconstructive procedures annually. Surgeons Say the Problem Is Real Surgeons estimate a 17% surgical-site infection rate in the published literature for these procedures. 86% (95% confidence interval (CI): 74–93%) report that matrices used today increase infection risk. Surgeons View NXT-41x as Differentiated and Mechanistically Sound 98% (CI: 90–99.6%) rated NXT-41x new and different from products available today. 96% (CI: 87–99%) rated the combination of rifampin and minocycline effective, with 64% (CI: 50–76%) describing it as extremely effective at reducing surgical site infections. No respondents rated the combination ineffective. Surgeon Intent to Adopt NXT-41x Is Strong 100% (CI: 93–100%) indicated they would use NXT-41x in diabetic patients and in patients with high BMI, who together represent approximately one third of all reconstruction patients. 96% (CI: 87–99%) expressed interest in incorporating NXT-41x into their general practice. 92% (CI: 81–97%) indicated willingness to approach their hospital value analysis committee in support of NXT-41x. Interest measures are based on ratings of 4 or 5 on a five-point scale. All results are reported with 95% Wilson confidence intervals; where responses were unanimous, the lower bound of the interval is 93%. Regulatory Review and Manufacturing Progressing on ScheduleRegulatory and development activities for both NXT-41 (biologic surgical matrix without drug) and NXT-41x continue to advance according to plan. Elutia recently held a productive meeting with the FDA regarding the NXT-41 submission, which remains on track. The Company continues to expect FDA clearance for NXT-41 in the fourth quarter of 2026 and for NXT-41x in the first half of 2027. Elutia also completed the installation and operational qualification of its automated drug-coating system for commercial manufacturing. The system is designed to support target gross margins in excess of 80% at scale. Product Divestitures Further Sharpen the Company’s FocusOn July 16, 2026, Elutia signed a definitive agreement to sell its SimpliDerm business for up to $11 million in total consideration, including up to $3 million in contingent technology transfer and commercial milestone payments over the 18 months following closing, with closing expected in the third quarter of 2026. The Company’s previously announced strategic process for its Cardiovascular business also continues to advance. Together with the 2025 divestiture of the BioEnvelope business, these transactions extend Elutia’s runway and focus the organization on the launch of NXT-41x in the second half of 2027. Funded Catalysts Ahead Second Quarter 2026 Financial ResultsNet sales and operating results discussed below reflect continuing operations. For the three-month period ended June 30, 2026, as compared to the same period of 2025: Overall net sales were $2.4 million, compared to $2.7 million. The decrease was the result of $0.7 million reduction in SimpliDerm revenue due to a production disruption with the product’s contract manufacturer, offset by a $0.4 million increase in Cardiovascular revenue due to the transition back to direct sales. Gross margin on a GAAP basis was 59.6%, compared to 52.9%. Adjusted gross margin (a non-GAAP measure which excludes non-cash amortization of intangibles) was 70.7%, compared to 62.7%. A reconciliation of GAAP gross margin to adjusted gross margin is included in the accompanying financial tables. Total operating expenses were $9.4 million, compared to $9.8 million. The decrease was driven by a $1.9 million reduction in net litigation costs, partially offset by a $1.5 million increase in research and development expense supporting the NXT-41 and NXT-41x programs. Loss from operations was $8.0 million, compared to $8.4 million. Net loss from continuing operations was $7.6 million, compared to $7.1 million. There was no loss from discontinued operations in the second quarter of 2026, compared to a loss of $2.5 million in the second quarter of 2025. Net loss was $7.6 million, compared to $9.6 million. Adjusted EBITDA (a non-GAAP measure that excludes from net loss certain non-operating, non-cash and non-recurring items) was a loss of $4.6 million, compared to a loss of $3.0 million. A reconciliation of net loss to adjusted EBITDA is included in the accompanying financial tables. Cash and cash equivalents at June 30, 2026 were $19.9 million. This cash position is expected to be augmented by up to an additional $34 million from signed transactions, including $10 million already received from Avenue Capital Group pursuant to a new loan agreement, $8 million held in escrow in connection with the 2025 divestiture of the BioEnvelope business, up to $11 million from the sale of the SimpliDerm business and an additional $5 million available from the Avenue Capital loan facility following FDA clearance of NXT-41x. Conference CallElutia will host a conference call on August 13, 2026 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its second quarter 2026 financial results and business performance. The conference call can be accessed using the following information: Webcast: Click hereDial-In: Click here To receive the dial-in number, as well as your personalized PIN, you must register at the above link. Once registered, you will also have the option to have the system dial out to you once the conference call begins. If you forget your PIN prior to the conference call, you can simply re-register. Please log in approximately 10 minutes prior to the scheduled start time. A live and archived webcast of the event will be available on the "Investors" section of the Elutia website at http://investors.elutia.com/. About ElutiaElutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com. Non-GAAP DisclosureIn addition to the Company’s financial results determined in accordance with U.S. GAAP, the Company provides non-GAAP measures that it determines to be useful in evaluating its operating performance and liquidity. The Company presents in this press release the following non-GAAP financial measures: earnings before interest, taxes, depreciation and amortization ("EBITDA"), adjusted earnings before interest, taxes, depreciation and amortization ("adjusted EBITDA"), adjusted gross margin and adjusted gross profit. The Company defines EBITDA as GAAP net loss excluding interest expense, income tax expense, depreciation and amortization, and the Company defines adjusted EBITDA as EBITDA excluding income or loss from discontinued operations, stock-based compensation, FiberCel and VBM litigation costs, loss or gain on revaluation of warrant liability, warrant issuance expenses and loss or gain on revaluation of revenue interest obligation. The Company defines adjusted gross profit and adjusted gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. Management believes that presentation of non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. The Company uses this non-GAAP financial information to establish budgets, manage the Company’s business, and set incentive and compensation arrangements. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For a reconciliation of these non-GAAP measures to GAAP, see below "Non-GAAP Reconciliations of EBITDA and Adjusted EBITDA" and "Non-GAAP Reconciliations of Adjusted Gross Profit and Adjusted Gross Margin." Forward-Looking StatementsThis press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential," "promise" or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information concerning our future interactions with the U.S. Food and Drug Administration ("FDA") regarding NXT-41 and NXT-41x; expectations for FDA clearance of NXT-41 and NXT-41x, including the timing and anticipated success thereof; preparations for the commercial launch of NXT-41x, including the timing, scale and anticipated success thereof; the sufficiency of our capital resources to fund the Company through anticipated FDA clearance and the first full year of commercial launch of NXT-41x without an equity offering; the availability of the additional $5 million tranche under our Avenue Capital financing; the expected closing of the sale of our SimpliDerm business and our receipt of the associated contingent technology transfer and commercial milestone payments; the outcome and timing of the previously announced strategic process for our Cardiovascular business; the anticipated release of the $8 million held in escrow in connection with the divestiture of the BioEnvelope business; the results, interpretation and predictive value of the independent blinded surgeon survey described in this press release, including surgeons’ stated intent to adopt NXT-41x and to support it before hospital value analysis committees; the size of the plastic and reconstructive surgery market and the potential of the Company’s next-generation drug-eluting biomatrix pipeline to compete in that market; expectations regarding manufacturing capacity, scale and target gross margins; and any statements regarding future liability with respect to the FiberCel and VBM litigation. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings, including NXT-41 and NXT-41x; our ability to obtain regulatory approval or other marketing authorizations by the U.S. Food and Drug Administration and comparable foreign authorities for our products and product candidates, including NXT-41 and NXT-41x; our ability to comply with the covenants under, and to draw the remaining availability under, our credit facility; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to achieve or sustain profitability; our ability to regain compliance with Nasdaq’s minimum bid price requirement and otherwise maintain compliance with any other listing requirement of Nasdaq Capital Market, and our ability to maintain a listing of our Class A common stock on the Nasdaq Capital Market; our ability to raise funds in the future in the amounts and at the times needed; our ability to service our indebtedness; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; risks relating to the pending sale of the SimpliDerm business, including the occurrence of any event, change or circumstance that could delay the sale of the SimpliDerm business or give rise to termination of the related asset purchase agreement, the risk that the technology transfer and commercial milestone payments from the sale of the SimpliDerm business are reduced, delayed, or not earned or received, the outcome of any legal proceedings instituted against us following announcement of the sale of the SimpliDerm business, the inability to consummate the sale of the SimpliDerm business due to failure to satisfy closing conditions; the risk that the sale of the SimpliDerm business disrupts our current plans and operations, including distraction of management and employees, and costs related to the sale of the SimpliDerm business; our ability to complete any strategic transaction involving our Cardiovascular business, on the anticipated timeline and terms, or at all, and to realize the anticipated benefits of that transaction; our ability to defend against the various lawsuits and claims related to our former FiberCel and other bone viable matrix (“VBM”) products and avoid a material adverse financial consequence; the continued and future acceptance of our products by the medical community; our dependence on independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability; our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the "Risk Factors" section of Elutia’s public filings with the Securities and Exchange Commission ("SEC"), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investors:Elutia Investor [email protected] (1) Represents interest expense recorded on all outstanding long-term debt as well as the revenue interest obligation. (2) Represents the financial results of the BioEnvelope business sold to Boston Scientific Corporation on October 1, 2025. (3) Represents litigation costs consisting primarily of legal fees and the estimated and actual costs to resolve the outstanding FiberCel and VBM litigation cases offset by the amounts recovered and recoverable under insurance, indemnity and contribution agreements for such costs. (4) Represents the non-cash revaluation of Common Warrants and Prefunded Warrants issued in connection with a private offering in September 2023 and registered direct offerings in June 2024 and February 2025. (5) Represents the non-cash revaluation of the revenue interest obligation. At each reporting period, the value of the revenue interest obligation is re-measured based on current estimates of future payments, with changes to be recorded in the consolidated statements of operations using the catch-up method.

Image source: The Motley Fool. May 14, 2026 Chief Executive Officer — C. Mills Chief Financial Officer — Matthew Ferguson [Investor Relations — Bernadine Cherniak] Bernadine Cherniak: Thank you, operator, and thank you all for participating in today's call. Earlier today, Elutia released financial results for the first quarter ended March 31, 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 provisions 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 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 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, May 14, 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 margin, excluding intangible assets, 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 released for the first quarter ended March 31, 2026. This 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 over the call to Elutia's CEO, Randy Mills. C. Mills: Thank you, Bernadine, and thank you, everyone, for joining us today. The first quarter of 2026 was an important quarter for Elutia. We continued to sharpen our strategic focus. We advanced our NXT-41 regulatory program. We brought our automated manufacturing platform online, and we further strengthened our confidence in the commercial opportunity ahead of us in breast reconstruction. Here's how we'll spend our time today. I'll walk you through the headlines of the quarter and where we're headed. Matt will take you through the financials and close with a few thoughts on what's ahead. Then we'll open the line up for questions. Today, Elutia is increasingly becoming a pure-play drug-eluting biomatrix company focused on one of the largest and most underserved opportunities in reconstructive surgery. Four things I would like to highlight from the quarter. First, our FDA review of NXT-41 is progressing through productive interactions with the agency, and the dialogue has increased our confidence in the planned NXT-41x submission. We continue to anticipate NXT-41 clearance in the fourth quarter of 2026 and NXT-41x clearance in the first half of 2027. Second, we brought our automated manufacturing platform online this quarter. That platform supports a target gross margin in excess of 80% at scale, enabling a differentiated value proposition at competitive pricing. Third, direct surgeon engagement by our commercial team is confirming what we have believed all along, a $1.5 billion U.S. market, postoperative infection rates of 15% to 20% and no meaningful innovation in standard of care. And fourth, we ended the quarter with a strong balance sheet, $36.5 million in cash and escrow, and we are actively engaged in 2 strategic processes, the SimpliDerm divestiture we previously announced and a newly disclosed inbound acquisition interest in our Cardiovascular product line. It is increasingly clear that within the $1.5 billion breast surgery market, NXT-41x has the potential to be a blockbuster and to meaningfully improve outcomes for women with breast cancer. For anyone new to the Elutia story, here is the short version of what we do. Our approach is simple but differentiated. We combine a proven biologic matrix platform with sustained local antibiotic delivery designed to prevent bacterial colonization and the cascade of complications like infection that can follow. 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. That prior success gives us confidence not only in the technology itself, but also in our ability to develop, make and commercialize differentiated drug-eluting products. NXT-41x takes that same validated platform into a much larger market with a much larger unmet medical need. We believe the opportunity in front of us is transformational for 3 reasons: One, it's a big market, a $1.5 billion in the U.S. alone. Two, it's a big problem. 15% to 20% of patients develop postoperative infection after mastectomy. And if anything, that number is conservative. And three, we already have a proven solution. The $88 million that Boston Scientific paid for our first-generation product tells you that it works. Let me put the market into concrete numbers. Approximately 168,000 breast reconstruction procedures last year were performed in the United States. Biologic mesh is utilized in more than 85% of those implant-based reconstructions. Biologics account for roughly 65% of the total procedural spend and human biologic mesh today sells for somewhere between $7,500 and $9,500 per breast. Put that all together, and you have $1.5 billion U.S. market opportunity. This is not a market we have to create. It already exists. Biologic matrices are already deeply embedded into the standard of care. Surgeons use them in the vast majority of these procedures. Our job is simpler than building a new category. We just have to give them a better version of what they're already using. In breast reconstruction, the unmet need for this is severe. One in 3 women suffer a serious complication after reconstruction. 15% to 20% develop a postoperative infection, up to 21% experience implant loss and the average hospital cost of a single infection ends up being more than $48,000. But remember why this woman is in the operating room in the first place. She was diagnosed with cancer. Her #1 goal is to beat that cancer. And when infection takes hold, chemotherapy stops, radiation stops, everything stops until the infection is resolved. This is not a minor complication. This is a cancer treatment derailing event and the standard of care today does not solve it. NXT-41x is not a passive support mechanism. It is an active partner in recovery. It is easy to use. It fits the surgical workflow the surgeon already knows. It's cost neutral to the hospital. It replaces legacy products that they're already buying and it delivers powerful, sustained uniform antibiotic coverage right at the surgical site where systemic antibiotics struggle to reach. Unlike legacy biologic matrix with -- that have little functional differentiation, our goal is to deliver differentiated functionality at a competitive economic profile. We believe that matters. With that backdrop, let me walk you through the work we did this quarter to advance the program. Let me first start with the FDA review. We continue to have productive interactions with the FDA regarding the NXT-41 submission. As a reminder, NXT-41 is the base biologic matrix, and it serves as the foundation for NXT-41x drug-eluting version that will follow. While we're not going to comment on every detail of the review process, what I can say is that our dialogue with FDA has increased our confidence in the planned NXT-41x submission strategy. The discussions have helped clarify what FDA views as important from a submission standpoint. We continue to anticipate NXT-41 clearance in the first quarter of 2026 and expect NXT-41x clearance in the first half of 2027. The point I want you to take from this slide is our confidence has increased. Let me shift to manufacturing. One of the most important accomplishments this quarter was bringing our automated manufacturing platform online. We have now installed and operationalized the core automated production equipment intended to support NXT-41x manufacturing at scale. This is strategically important for several reasons: First, the robotic coating system enables precise and reproducible application of the drug-eluting layer onto the biologic matrix. Second, the integrated in-house approach is designed to support scalability, efficiency and quality control. And third, we believe this process creates a meaningful competitive advantage. The integrated process supports a targeted gross margin of above 80% at scale and an 80% plus gross margin gives us real pricing room against incumbent products that sell for between $7,500 to over $9,500 per breast while still delivering best-in-class margins. Said differently, NXT-41x is designed to compete both on outcomes and cost. That is a hard combination for an incumbent to respond to. Now let me turn to commercialization, which I'm particularly excited about. Our commercial readiness work continues to increase our confidence in the market opportunity. Since joining Elutia, our Chief Commercial Officer, Pete Ligotti, has spent a substantial amount of time in the field speaking directly with surgeons and hospital stakeholders and the feedback has been remarkably consistent. The clinical need is real and it is significant. Surgeons describe postoperative infection in downstream complications as one of the most frustrating challenges they face in breast reconstruction. Second, there remains a clear lack of meaningful innovation anywhere within this category. And third, the commercial opportunity appears to be highly concentrated. Look at this funnel. As we discussed, the U.S. breast reconstruction market is $1.5 billion, and there are about 168,000 procedures performed last year. About 1,800 U.S. hospitals perform reconstruction, but only 585 of those hospitals account for 3/4 of the entire market and the top 50 centers alone represent over $300 million in spend. Here's the insight. This is a $1 billion-plus U.S. market, but the real volume is concentrated at a few hundred hospitals, this is not a market that requires thousands of accounts or a massive sales infrastructure to establish meaningful penetration. We believe targeted engagement with high-volume centers can create substantial leverage, and that is exactly the team Pete is putting together. Before Matt walks you through the financials, let me briefly address our strategic process. As we have previously discussed, we continue to evaluate opportunities to further focus the company around NXT-41x in its platform. With SimpliDerm, interest is strong and the process is going well. SimpliDerm is a high-quality business, $2.1 million in revenue in this quarter at a 57% gross margin. We have strong reimbursement coverage with approximately 100 million covered lives across UnitedHealthcare, Anthem and 9 regional plans, and it has a differentiated patent-protected manufacturing process. But separately, we have received inbound acquisition interest in our related Cardiovascular product line. For context, that business did $1 million in revenue this quarter at an 85% gross margin, and that's up from $300,000 just a year ago. These are strong products with differentiated clinical profiles and attractive gross margins. However, as we evaluate the company strategically, our priority is ensuring that capital, resources and management attention are aligned with the largest long-term opportunity for value accretion, which is NXT-41x. So we are going to provide further updates on both processes as appropriate. Now with that, I'd like to turn the call over to Matt. Matthew Ferguson: Okay. Thanks, Randy. I'll begin with a review of our first quarter financial results from continuing operations, which exclude the divested BioEnvelope business that we sold to Boston Scientific in October of last year. Total net sales for the first quarter were $3.1 million compared to $3.0 million in the prior year period, growth of approximately 6% year-over-year. SimpliDerm revenue was $2.1 million compared to $2.6 million a year ago. Cardiovascular revenue was $1.0 million compared to $300,000 in the prior year period. The increase in Cardiovascular was primarily driven by a return to direct distribution, but also to improved procedural volume. Turning to profitability. GAAP gross margin for the quarter was 58% compared to 47% in the prior year period. Adjusted gross margin, which excludes amortization of acquired intangible assets, was 67% compared to 56%. The year-over-year improvement reflects favorable product mix and price improvements. Total operating expenses were $8.2 million, essentially flat year-over-year. Inside that number, we reallocated meaningfully. Litigation costs declined by approximately $2 million as we work through legacy matters, and we redeployed that capacity to achieve the substantial R&D progress and commercial readiness for NXT-41x. Net loss for the quarter was $7.5 million compared to a net loss of $3.9 million in the prior year period. Adjusted EBITDA was a loss of $4.4 million compared to a loss of $2.8 million a year ago. Importantly, the increase in net loss was driven primarily by noncash items and other expense, specifically the revaluation of warrant liabilities and not by any deterioration in the underlying operating business. From a liquidity perspective, we ended the quarter with $28.5 million in cash on hand, plus the $8 million escrow associated with the BioEnvelope divestiture, which we expect to be released in the fourth quarter of this year. Combined, that represents approximately $36.5 million in cash and escrowed receivables. We believe our current capital position provides the resources necessary to support our planned regulatory and operational milestones. For shares outstanding at quarter end, the company had approximately 44.2 million common shares outstanding and 3.2 million prefunded warrants, representing 47.4 million common equivalents outstanding. Now let's look ahead at the catalyst calendar. We continue to actively work towards our strategic transactions, the SimpliDerm and Cardiovascular processes that Randy discussed. Each of these would further bolster the balance sheet. We continue to anticipate NXT-41x FDA clearance in the fourth quarter of 2026. And in the first half of 2027, we anticipate FDA clearance of NXT-41x. In the second half of 2027, we anticipate commercialization and a focused NXT-41x soft launch. Overall, we believe the first quarter reflects continued execution against our strategic priorities. We are maintaining financial discipline while investing in the core capabilities required to support the NXT-41x opportunity. Now taking a step back, we believe Elutia today represents a unique combination of attributes. We have an established drug-eluting biomatrix platform. We have prior experience successfully commercializing and monetizing products developed on this technology, most notably the sale of EluPro to Boston Scientific for $88 million. We have existing GMP manufacturing infrastructure that is now online. We have growing regulatory clarity from our productive dialogue with FDA, and we are pursuing a large market opportunity, $1.5 billion in the U.S. with a meaningful and well-documented unmet medical need. All the pieces are coming together. And most importantly, we have a company capable of creating meaningful value for surgeons, for hospitals, for shareholders and most importantly, for patients. We have the platform, we have the market, we have the team, and we have the resources to make it happen. Operator, we're now ready to open the line for questions. Operator: [Operator Instructions] First question comes from the line of Frank Takkinen of Lake Street Capital Markets. Frank Takkinen: Congrats on all the progress. I was hoping to start with one on the follow-up. I know you said you wouldn't divulge too much detail on it, but I'd be remiss if I didn't ask. So maybe how I will ask is, if I heard you correctly, you said incrementally more confident. So maybe the way for us to understand it is no surprises with perhaps a more detailed roadmap for 41x. Is that a fair way to think about it? And any other detail you would provide? C. Mills: Yes. The way I would describe it is, one, any time that you submit something to FDA, you submit to a particular group. And so while it's the same regulatory pathway that we use with EluPro, we went from cardiovascular with EluPro over to plastic and reconstructive surgery. And what we found with the review team in plastic reconstructive surgery, which is unique than the one in cardiovascular is a group that is significantly more collaborative and engaging and very proactive in the review process. And so given how sort of early on we are in the review, we've had a tremendous amount of dialogue back and forth, substantive communication, direct communication with the agency on this, not just the perfunctory type of letters and initial things that might go back and forth to the state, but real serious meaningful conversations in a productive and collaborative fashion. And that's obviously been helpful in 41 and 41 is moving along the way we anticipated 41 would move along. But sort of keep in mind, as we do, I would hope, Frank, that our eye is actually on the prize and the price is 41x. And what we're really doing with 41 is making sure that our 41x submission is the highest quality submission we can have it, that it's on time and most importantly, that 41x gets approved when we anticipate. And the interactions we've had so far in the 41 process has given us a lot of confidence in where we're going with 41x. I hope that adds sort of the color and commentary around what's going on. Frank Takkinen: No, that's perfect. I appreciate that very much. Maybe on the -- some of the new commercial comments, thanks for that color. It was very educational. I was hoping to ask about maybe a question that's a little bit too far out right now to be thinking about, but I'm sure you're starting to sketch it up. How do you think about rep hiring? Obviously, a very concentrated call point. I think in the past, you've used a hybrid of kind of internal as well as 1099s. Maybe talking about that split and when you start to maybe bring on some of that early talent. C. Mills: Right. So it's certainly a little too early to lay out the full plan. We'll be doing that more now that Pete's on, but I do have a couple of comments on it. So the first, one of the things Pete is doing is Pete is doing a really nice job of going out and assessing the market both qualitatively and quantitatively, Frank. And I mean when you bring a sophisticated guy in-house, right, this is what they do. Quantitatively, it's great to know, hey, what's the actual infection rate? Where are all the procedures done? How -- what are the kinds of infections and complications are they seeing at different hospitals and centers and things like that. The qualitative side of it is what do the surgeons think is going on? I mean the -- anyone to spend any time with the surgeon is their perception of the problem can oftentimes be very different than the actual problem. And the gap between those 2 is actually where the real marketing plan and genius and opportunity come about and take shape. So what we're seeing and what Pete's already uncovered is when you start looking for -- when you start looking at the high concentration in centers, so I think it was 585 accounts for 75% of the market. And then even that ends up being super concentrated, we have $300 million of market opportunity in just 50 accounts. But I mean, let's put that into perspective with what we did with EluPro. We took 12 direct reps with EluPro, pair them up with a handful of 1099s and in 9 months, they activated 193 VAC accounts, right, for submission in 193 accounts. That would be like, I don't know, $0.5 billion of market opportunity in breast reconstruction, right? It's absolutely incredible what's going on here. And then just to go on, I get really excited about this, as you could tell, Frank. But another thing that Pete uncovered is if you look at the postoperative complications that are happening, we mentioned in the press release that he's confirmed the sort of the market size and this concentration effect that we're seeing, but also the severity, it's really interesting because when you look at the complication rates of these high-volume centers, they are really high. You're looking easily at 30% complication rates at these high-volume centers. And so it's kind of nice that the earliest places to go to get some big wins are actually also the ones that need the most help. And intuitively, if you sort of think about it, that's not too surprising because these are the big centers where people are getting referred with the more complicated cases that are -- that have the comorbidities that lead to infection that require the more radical mastectomies and all of those factors that lead to postoperative infection. But it's really, really gratifying to see it come together. So we will have more -- just to go back to your actual question, Frank, we will have more on the launch structure coming up. I think probably by the next conference call, we'll be laying that out a little more clearly with a little more sophistication. But boy, in 60 days, the man has hit the ground running and has confirmed what we know and then has taken it really to the next level with this, and it's super exciting, particularly when you put it in the context of what we were able to accomplish with Little old EluPro. And now you talk about game-changing 41x, and we can't wait. Frank Takkinen: Very helpful. Maybe just my last one. How do you think about maybe time lines around SimpliDerm and Cardiovascular understanding. It's always challenging to predict, but any wise goalposts you provide? C. Mills: Well, we started the SimpliDerm process. We announced that on our last call. Interest was very robust. I think we had something like 38 targets engaged in it. I would say we have confidence -- we have pretty good confidence that a transaction is coming together. Frank, I just -- it's like trying to pick the final 4 or enrollment in the clinical trial, like trying to time when a deal like a divestiture is going to happen, just leads to bad promises and expectations. I will say we are very pleased with how the SimpliDerm process is going. We're looking for a high-quality deal, and we think we're on track to get one. But until it's done, it's not done. And then on the Cardiovascular side, the air was pretty much just a lot of surprise from the upside because we got actually a number of inbound requests on the Cardiovascular side, and there's high-quality interest in that product as well. And as we think about strategic positioning of the company, you could probably tell, right, we are really, really convinced in the 41x opportunity that lies ahead, not just the capital that this would add to our balance sheet and strengthen our balance sheet even further than where it is, but also the strategic focus and the alignment and the management attention and all of those other things. These are 2 great product lines that are used surgically every day and patients benefit from them every day. But they're just not where we're going as a company. And it will -- I think both of these will have a meaningful impact to our balance sheet and to our strategic focus. So did that help? Frank Takkinen: Yes. Very helpful. Operator: Thank you. Ladies and gentlemen, that does end our Q&A session and concludes today's conference call. Thank you for participating. You may now disconnect. 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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Transitioning to a pure-play drug-eluting biomatrix company by divesting non-core assets to concentrate resources on the high-value NXT-41x platform. Operationalized an automated manufacturing platform designed to deliver precise drug-eluting layers and support gross margins in excess of 80% at scale. Identified a $1.5 billion U.S. market opportunity where 15% to 20% of patients suffer postoperative infections, representing a severe unmet medical need. Leveraging a proven technology framework previously validated by the $88 million sale of the first-generation EluPro business to Boston Scientific. Commercial strategy focuses on extreme market concentration, with only 585 hospitals accounting for 75% of total U.S. procedural volume. NXT-41x is positioned to compete on both clinical outcomes and cost-neutrality, replacing legacy products that lack functional differentiation. Anticipate FDA clearance for the base NXT-41 biologic matrix in the fourth quarter of 2026. Targeting first half of 2027 for FDA clearance of the NXT-41x drug-eluting version, followed by a soft launch in the second half of 2027. Strategic divestitures of SimpliDerm and the Cardiovascular product line are expected to further bolster the balance sheet and management focus. Current cash position of $36.5 million, including escrowed funds, is projected to support all planned regulatory and operational milestones. Future commercial infrastructure will likely utilize a targeted hybrid model of direct reps and 1099s to penetrate high-volume surgical centers. Announced inbound acquisition interest for the Cardiovascular product line, which saw revenue grow from $300,000 to $1 million year-over-year. SimpliDerm divestiture process is active with approximately 38 targets engaged, aimed at maximizing capital for the NXT-41x launch. Net loss increase was primarily driven by non-cash items, specifically the revaluation of warrant liabilities, rather than operational deterioration. Reallocated $2 million from declining litigation costs into R&D and commercial readiness for the NXT-41x program. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management reported that the plastic and reconstructive surgery review team is significantly more collaborative and proactive than previous cardiovascular teams. Substantive dialogue during the NXT-41 review has clarified FDA expectations, directly informing and de-risking the upcoming NXT-41x submission strategy. The market is highly concentrated, with the top 50 centers representing over $300 million in spend, allowing for a lean, high-leverage sales force. Early field research shows high-volume centers often have complication rates near 30%, making them the most receptive targets for the NXT-41x value proposition. Management expressed high confidence in the SimpliDerm transaction progress but declined to provide a specific closing date to avoid 'bad promises'. The Cardiovascular interest was described as an 'upside surprise' that will further strengthen the balance sheet for the 2027 launch.

NXT-41 review advancing collaboratively with FDA, informing NXT-41x submission preparations Brought a new automated manufacturing process online, supporting a gross margin target of more than 80% at scale Chief Commercial Officer Pete Ligotti's initial surgeon engagement confirming significant unmet need and market opportunity Strong balance sheet with $36.5 million in cash and escrowed proceeds from the BioEnvelope business divestiture Conference call today at 5:00 p.m. ET / 2:00 p.m. PT GAITHERSBURG, Md., May 14, 2026 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) ("Elutia" or the "Company"), a pioneer in drug-eluting biomatrix technologies, today reported a business update and financial results for the first quarter ended March 31, 2026. Dr. Randy Mills, CEO of Elutia, said: "Up to 20% of women undergoing reconstructive surgery after mastectomy develop serious infections. To us, that is unacceptable. That's why we're developing NXT-41x. "This quarter, we advanced every facet of our mission. The FDA review of NXT-41 is progressing well and is providing valuable insights for the NXT-41x submission. Our new automated manufacturing process is installed and operating, supporting gross margin targets above 80% at scale. Lastly, Pete Ligotti, our new Chief Commercial Officer, is in the field with surgeons, and their feedback confirms both the size and severity of the need. "It is increasingly clear that in the estimated $1.5 billion breast reconstructive surgery market, NXT-41x has the potential to be a blockbuster and improve outcomes for women with breast cancer. I'm proud of what this team has accomplished and their unwavering commitment to humanizing medicine so patients can thrive without compromise." Business Highlights NXT-41 510(k) Review Advancing. FDA review of the 510(k) submission for NXT-41, the base biologic matrix, is progressing through a collaborative dialogue with the agency. Anticipated clearance is on track for the fourth quarter of 2026. The Company's interactions with the FDA during this review have helped to refine the submission package for NXT-41x, an antibiotic-eluting product, with anticipated clearance in the first half of 2027. Manufacturing Automation Supports an Expected Gross Margin Above 80%. Elutia advanced startup work on the at-scale production equipment required for NXT-41x, including a robotic coating system used to apply the drug-eluting layer to the biologic matrix. The Company expects this manufacturing platform to support a gross margin in excess of 80%, while enabling pricing designed to capture significant market share. Commercial Launch Confidence Building. Pete Ligotti, Chief Commercial Officer, has spent his first months at Elutia in direct engagement with surgeons across the U.S. breast reconstruction community. Surgeon feedback is confirming the magnitude of the unmet need, with post-operative infection rates of 15 to 20 percent in a $1.5 billion U.S. market that has seen no meaningful innovation in the standard of care. Elutia is conducting quantitative market research to independently validate the scale of the opportunity, helping refine target accounts, patient populations and commercialization priorities ahead of launch. Strategic Processes for SimpliDerm and Cardiovascular Advancing. The previously announced exploration of a SimpliDerm divestiture is progressing well. Separately, the Company has also received multiple inbound inquiries for the acquisition of its Cardiovascular product line and is evaluating the opportunity. Elutia will provide further updates as appropriate. Balance Sheet. Total cash and escrow funds at March 31, 2026, were $36.5 million, comprised of $28.5 million in cash on hand and $8.0 million held in escrow related to the BioEnvelope business divestiture, with the escrowed funds expected to be released in the fourth quarter of 2026. First Quarter 2026 Financial Results Net sales and operating results discussed below reflect continuing operations. For the three-month period ended March 31, 2026, as compared to the same period of 2025: Overall net sales were $3.1 million, compared to $3.0 million, an increase of 6%. Net sales of SimpliDerm were $2.1 million, compared to $2.6 million. Net sales of Cardiovascular products were $1.0 million, compared to $0.3 million. Gross margin on a GAAP basis was 57.9%, compared to 46.8%. Adjusted gross margin (a non-GAAP measure which excludes non-cash amortization of intangibles) was 66.5%, compared to 55.9%. A reconciliation of GAAP gross margin to adjusted gross margin is included in the accompanying financial tables. Total operating expenses were $8.2 million, consistent with the prior year period. Net loss from continuing operations was $7.9 million, compared to a loss of $1.9 million. The increase in net loss from continuing operations was driven primarily by a $6.7 million unfavorable swing in other expense (income), net, which was comprised largely of a $1.7 million non-cash loss on revaluation of warrant liabilities in Q1 2026 compared to a $5.2 million non-cash gain in Q1 2025. Net loss was $7.5 million, compared to a net loss of $3.9 million. Adjusted EBITDA (a non-GAAP measure that excludes from net loss certain non-operating, non-cash and non-recurring items) was a loss of $4.4 million, compared to a loss of $2.8 million. A reconciliation of net income (loss) to adjusted EBITDA is included in the accompanying financial tables. Cash balance as of March 31, 2026 was $28.5 million. An additional $8.0 million related to the BioEnvelope business divestiture is held in escrow and is expected to be released in the fourth quarter of 2026. As of March 31, 2026, there were 44.2 million shares of Class A common stock outstanding with an additional 3.2 million pre-funded warrants outstanding. Conference Call Elutia will host a conference call today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its first quarter 2026 financial results and performance. The conference call can be accessed using the following information: Webcast: Click here Dial-In: Click here To receive the dial-in number, as well as your personalized PIN, you must register at the above link. Once registered, you will also have the option to have the system dial-out to you once the conference call begins. If you forget your PIN prior to the conference call, you can simply re-register. Please log in approximately 10 minutes prior to the scheduled start time. A live and archived webcast of the event will be available on the “Investors” section of the Elutia website at http://investors.elutia.com/. About Elutia Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com. Non-GAAP Disclosure In addition to the Company’s financial results determined in accordance with U.S. GAAP, the Company provides non-GAAP measures that it believes to be useful in evaluating its operating performance and liquidity. The Company presents in this press release the following non-GAAP financial measures: earnings before interest, taxes, depreciation and amortization (“EBITDA”), adjusted earnings before interest, taxes, depreciation and amortization (“adjusted EBITDA”), adjusted gross margin and adjusted gross profit. The Company defines EBITDA as GAAP net loss excluding interest expense, income tax expense, depreciation and amortization, and the Company defines adjusted EBITDA as EBITDA excluding loss from discontinued operations, stock-based compensation, FiberCel and other Viable Bone Matrix (VBM) litigation costs, loss or gain on revaluation of warrant liability and warrant issuance expenses. The Company defines adjusted gross profit and adjusted gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. Management believes that presentation of non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. The Company uses this non-GAAP financial information to establish budgets, manage the Company’s business, and set incentive and compensation arrangements. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For a reconciliation of these non-GAAP measures to GAAP, see below “Non-GAAP Reconciliations of EBITDA and Adjusted EBITDA” and “Non-GAAP Reconciliations of Adjusted Gross Profit and Adjusted Gross Margin.” Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information regarding the size of the breast reconstruction market and the potential of the Company’s next-generation drug-eluting biomatrix pipeline to compete in that market, anticipated FDA clearances and the future success of new products in Elutia’s breast reconstruction business, including the timing and success of NXT-41 and NXT-41x, as well as any statements regarding any potential strategic process for any other businesses. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: risks associated with shifting focus to our drug-eluting biomatrix solutions in the breast reconstruction area and away from our BioEnvelope business; our ability to successfully execute or achieve expected benefits from the divestiture of our BioEnvelope business; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings, including NXT-41 and NXT-41x; our ability to obtain regulatory approval or other marketing authorizations by the U.S. Food and Drug Administration and comparable foreign authorities for our products and product candidates, including NXT-41 and NXT-41x; our ability to achieve or sustain profitability; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our former FiberCel and other VBM products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; our ability to defend against any other ongoing or future litigation that we are or may become subject to; the continued and future acceptance of our products by the medical community; our dependence on a limited number of third-party suppliers and manufacturers; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated from time to time in Elutia’s other filings with the SEC, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investors: Elutia Investor Relations [email protected]

This article first appeared on GuruFocus. Total Net Sales: $3.1 million, a 6% increase year over year. SimpliDerm Revenue: $2.1 million, down from $2.6 million a year ago. Cardiovascular Revenue: $1.0 million, up from $300,000 in the prior year period. GAAP Gross Margin: 58%, compared to 47% in the prior year period. Adjusted Gross Margin: 67%, compared to 56% in the prior year period. Total Operating Expenses: $8.2 million, flat year over year. Net Loss: $7.5 million, compared to a net loss of $3.9 million in the prior year period. Adjusted EBITDA: Loss of $4.4 million, compared to a loss of $2.8 million a year ago. Cash and Escrow: $36.5 million, including $28.5 million in cash and $8 million in escrow. Shares Outstanding: Approximately 44.2 million common shares and 3.2 million pre-funded warrants. Warning! GuruFocus has detected 5 Warning Signs with ELUT. Is ELUT fairly valued? Test your thesis with our free DCF calculator. Release Date: May 14, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Elutia Inc (NASDAQ:ELUT) advanced its NXT-41 regulatory program with productive interactions with the FDA, increasing confidence in the planned NXT-41x submission. The company successfully brought its automated manufacturing platform online, supporting a target gross margin in excess of 80% at scale. Direct surgeon engagement confirmed a $1.5 billion US market opportunity in breast reconstruction, with significant unmet needs due to high post-operative infection rates. Elutia Inc (NASDAQ:ELUT) ended the quarter with a strong balance sheet, holding $36.5 million in cash and escrow. The company has prior success with its first-generation product, EluPro, which was sold to Boston Scientific for $88 million, providing confidence in its current technology and commercialization strategy. SimpliDerm revenue decreased to $2.1 million from $2.6 million in the prior year period. The company reported a net loss of $7.5 million for the quarter, compared to a net loss of $3.9 million in the prior year period. Adjusted EBITDA was a loss of $4.4 million, up from a loss of $2.8 million a year ago. The increase in net loss was driven by non-cash items and other expenses, specifically the revaluation of warrant liabilities. Elutia Inc (NASDAQ:ELUT) is still in the process of divesting its SimpliDerm and Cardiovascular product lines, which could impact future revenue streams. Q: Can you provide more details on the FDA review process for NXT-41x and your confidence in its approval timeline? A: C. Randal Mills, President, CEO, and Director, explained that the FDA review process for NXT-41 has been collaborative and proactive, which has increased their confidence in the NXT-41x submission strategy. The interactions with the FDA have been substantive, and they anticipate NXT-41x clearance in the first half of 2027. Q: How are you planning to approach the commercial launch of NXT-41x, particularly in terms of sales strategy? A: C. Randal Mills mentioned that the commercial strategy will focus on high-volume centers, as 585 hospitals account for 75% of the market. The company plans to leverage a combination of direct reps and 1099s, similar to their approach with EluPro, to target these concentrated centers effectively. Q: What is the status of the SimpliDerm and Cardiovascular product line divestitures? A: C. Randal Mills stated that the SimpliDerm divestiture process is progressing well with robust interest, and they are confident a transaction will come together. The Cardiovascular product line has also received inbound acquisition interest, which could further strengthen their balance sheet and strategic focus on NXT-41x. Q: Can you elaborate on the market opportunity for NXT-41x in breast reconstruction? A: C. Randal Mills highlighted that the U.S. breast reconstruction market is valued at $1.5 billion, with approximately 168,000 procedures performed annually. The product aims to address significant unmet needs, such as high post-operative infection rates, by providing a differentiated solution that integrates seamlessly into existing surgical workflows. Q: What are the financial highlights from the first quarter of 2026? A: Matthew Ferguson, CFO, reported total net sales of $3.1 million, a 6% increase year-over-year. The GAAP gross margin improved to 58%, and the adjusted gross margin was 67%. The company ended the quarter with $36.5 million in cash and escrowed receivables, providing resources to support planned milestones. For the complete transcript of the earnings call, please refer to the full earnings call transcript.