Elutia Q2 2026 Earnings Call Transcript

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August 13, 2026

Key Takeaways

  • Positive Sentiment: Elutia secured up to $26 million in additional non-equity capital, including a $15 million Avenue Capital credit facility and proceeds from the planned SimpliDerm sale. Management believes total projected cash sources of up to $54 million provide runway through the anticipated NXT-41x launch in 2028.
  • Positive Sentiment: An independent blinded survey of 50 reconstructive surgeons found strong potential demand for NXT-41x: 96% expressed interest in using it, 100% would use it for high-risk patients, and 92% would champion it before their hospital’s value analysis committee.
  • Positive Sentiment: Management reiterated that NXT-41 is expected to receive an FDA clearance decision in the fourth quarter of 2026, while NXT-41x remains targeted for clearance in the first half of 2027. Commercial manufacturing qualification is complete, with initial production capacity expected to support at least $300 million in annual revenue.
  • Negative Sentiment: Second-quarter net sales declined to $2.4 million from $2.7 million, primarily because of a contract-manufacturer disruption affecting SimpliDerm. Continuing-operations net loss widened to $7.6 million from $7.1 million, and adjusted EBITDA loss increased to $4.6 million from $3.0 million as R&D spending rose.
  • Neutral Sentiment: Elutia is narrowing its focus to NXT-41x by selling SimpliDerm and continuing a strategic process for its cardiovascular business. While this should reduce commercial expenses and concentrate resources, the transactions remain subject to closing and could temporarily leave the company without a commercial product before NXT-41x launches.
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Earnings Conference Call
Elutia Q2 2026
00:00 / 00:00

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Operator

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
Bernadine Cherniak
Executive Assistant to the President and CEO at Elutia

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.

Bernadine Cherniak
Bernadine Cherniak
Executive Assistant to the President and CEO at Elutia

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 lists and descriptions of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our public filings with the SEC, including Elutia's annual report on Form 10-K for the year ended December 31, 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.

Bernadine Cherniak
Bernadine Cherniak
Executive Assistant to the President and CEO at Elutia

Elutia disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements because of new information, future events, or otherwise. Also, during this presentation, we refer to gross margin, excluding intangible asset amortization, which is a non-GAAP financial measure. A reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure is available on the company's financial results released 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. With that, I will turn the call over to Elutia's CEO, Randy Mills.

Randy Mills
Randy Mills
President and CEO at Elutia

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 and 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.

Randy Mills
Randy Mills
President and CEO at Elutia

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. Fourth, our regulatory and manufacturing teams continue to advance towards launch on schedule.

Randy Mills
Randy Mills
President and CEO at Elutia

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 combine 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. Importantly, we have done this before.

Randy Mills
Randy Mills
President and CEO at Elutia

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%-20% following mastectomy. The opportunity for us comes from the combination of three things, a large existing market, a significant unresolved clinical problem, and a technology platform that directly addresses it, a platform we created.

Randy Mills
Randy Mills
President and CEO at Elutia

The magnitude of the problem is hard to ignore. These are published data, not Elutia estimates. Approximately one in three women experiences a serious complication following reconstruction, 15%-20% experience postoperative infection, up to 21% experience 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. We have shown you infection statistics before. What this slide shows are the consequences. Let us start with the patient. She is fighting cancer. That is why she is 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. If she loses the implant, more than half of the women in that situation never go back and finish the reconstruction process. It ends.

Randy Mills
Randy Mills
President and CEO at Elutia

The hospital incurs an added cost, mostly without reimbursement. It gives up revenue-generating operating room time slot and hospital bed, and it takes the reputational hit regarding its infection rate. 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 us 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 is a holiday. That significantly impacts their quality of life. If you do not think so, think about this. The reconstructive specialty in plastic surgery is by itself an independent risk factor for burnout among plastic surgeons.

Randy Mills
Randy Mills
President and CEO at Elutia

When those surgeons walk away, women lose access to reconstruction. 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 two 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 an NXT-41x clearance. That is not only a substantial infusion of cash, but also an unequivocal endorsement of our plan by a sophisticated healthcare 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.

Randy Mills
Randy Mills
President and CEO at Elutia

On top of that, at the start of the fourth quarter, we anticipate receiving the full $8 million in escrow from Boston Scientific. 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 2026.

Randy Mills
Randy Mills
President and CEO at Elutia

When that work is complete, Elutia will be solely focused on one 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 am most excited about. For two years, we have 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, eight 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 pick the respondents.

Randy Mills
Randy Mills
President and CEO at Elutia

Elutia was never named. Nobody was being nice to a sponsor because nobody knew who the sponsor was. Interest was measured using the standard 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 is 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. 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.

Randy Mills
Randy Mills
President and CEO at Elutia

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. 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 one, two, and three, respectively. Those are not branding attributes. They are fundamental mechanisms of how our product works. 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?

Randy Mills
Randy Mills
President and CEO at Elutia

For high-risk patients, including diabetic patients and those with high BMI, 100%, all 50 surgeons, indicated they would use NXT-41x. Those two groups together represent approximately one-third of reconstruction patients, an enormous opportunity in itself. A full 96% said they were interested in incorporating NXT-41x into their general practice. Then there is 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. Let me put the whole study on one slide. We asked if the problem was real.

Randy Mills
Randy Mills
President and CEO at Elutia

86% said the matrices they use today increase risk infection. We ask if our approach would work. 96% rate the antibiotic combination as 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 it at their own hospital's VAC. 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.

Randy Mills
Randy Mills
President and CEO at Elutia

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 coding 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. It is now up and running at our GMP facility in Gaithersburg, Maryland.

Randy Mills
Randy Mills
President and CEO at Elutia

All in all, a very solid quarter for the Elutia crew, and I thank each and every one of them for their remarkable efforts. With that, let me turn the call over to Matt.

Matt Ferguson
Matt Ferguson
CFO at Elutia

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 two offsetting drivers.

Matt Ferguson
Matt Ferguson
CFO at Elutia

SimpliDerm was down $0.7 million due to a production disruption at the product's 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 non-cash 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 continued to shift spend towards the future.

Matt Ferguson
Matt Ferguson
CFO at Elutia

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 NXT-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.

Matt Ferguson
Matt Ferguson
CFO at Elutia

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. Next year, upon FDA clearance of NXT-41x, another $5 million becomes available under the Avenue Capital facility following the NXT-41x clearance.

Matt Ferguson
Matt Ferguson
CFO at Elutia

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 Mills mentioned, this provides runway through at least 2028. Between now and then, this funding covers multiple expected catalysts. First, the closing of the SimpliDerm sale 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 NXT-41x in the first half of 2027. In addition, the soft launch of NXT-41x in the second half of 2027. Finally, the full commercial launch of NXT-41x in 2028.

Matt Ferguson
Matt Ferguson
CFO at Elutia

Stepping back, we believe the investment case for Elutia rests on three things. First, we have a validated platform. We have 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, an 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. With that, operator, I'll turn it back to you, and we can open the line for questions.

Operator

As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from Frank Takkinen with Lake Street Capital Markets. Your line is open.

Frank Takkinen
Analyst at Lake Street Capital Markets

Great. Thank you for taking the questions, and congratulations on all the progress. I wanted to start

Randy Mills
Randy Mills
President and CEO at Elutia

Thanks, Frank.

Frank Takkinen
Analyst at Lake Street Capital Markets

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.

Randy Mills
Randy Mills
President and CEO at Elutia

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. That was the nature and the reason of the meeting, and we came out of that meeting feeling very good about where we are going forward with NXT-41.

Frank Takkinen
Analyst at Lake Street Capital Markets

Okay. Very helpful. Then on the concept of manufacturing, 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?

Randy Mills
Randy Mills
President and CEO at Elutia

Yeah. 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 the experience of 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

Randy Mills
Randy Mills
President and CEO at Elutia

That made that product more expensive and more challenging to make and drove up cost of goods of that product. When they designed NXT-41x, they did that with that in mind and really have come up with a very elegant process for manufacturing NXT-41x. 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. I think we would expect gross margins to be in an acceptable rate 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
Analyst at Lake Street Capital Markets

Got it. Very helpful. Maybe on the commercial launch, maybe talk to what the limited launch might look like in the second half of 2027, then some of the most important items you'll be looking to check the box off, so to speak, before flipping to the full commercial launch in 2028.

Randy Mills
Randy Mills
President and CEO at Elutia

Yeah. This is one of the great things, Frank, about getting older and having experience. This isn't our first rodeo. As we prepare to launch 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. Value analysis committees, Frank, as you know, are the gating item on how fast the product has even the potential to get adopted. With regards to what we're thinking about soft launch activities in the second half of 2027, it is value analysis committee. The more we know that the more seeds that we plant early on with the VACs, the more revenue opportunity we will have as the year continues and throughout 2028.

Randy Mills
Randy Mills
President and CEO at Elutia

With EluPro, we developed a pretty sophisticated process for being able to go after those VACs. I would say Peter 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 VACs machinery and target it even further. 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.

Randy Mills
Randy Mills
President and CEO at Elutia

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 VACs before anything happens. That's what we would expect to happen there. Then Frank, into 2028, I think come January 1st, if everything goes according to schedule, we'll be ready to cut it loose.

Frank Takkinen
Analyst at Lake Street Capital Markets

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

Matt Ferguson
Matt Ferguson
CFO at Elutia

Yeah. I think you could 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. In a potentially not far behind the SimpliDerm transaction, we could also be looking at something for the CV transaction. That would actually put us, for a short period, into a situation where we would not be commercial. 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
Analyst at Lake Street Capital Markets

Got it. Very helpful. Thanks for taking the questions. Appreciate it.

Matt Ferguson
Matt Ferguson
CFO at Elutia

Okay. Thank you, Frank.

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.

Executives
    • Bernadine Cherniak
      Bernadine Cherniak
      Executive Assistant to the President and CEO
    • Randy Mills
      Randy Mills
      President and CEO
    • Matt Ferguson
      Matt Ferguson
      CFO
Analysts
    • Frank Takkinen
      Analyst at Lake Street Capital Markets
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