Elutia Q1 2026 Earnings Call - NXT-41X Clearance Targeted for H1 2027 Amid Strategic Divestitures and Manufacturing Scale-Up

Operator: I would now like to hand the call over to Bernadine Cherniak. Please go ahead.

Bernadine Cherniak, Investor Relations / Call Moderator, Elutia, Inc.: 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 31st, 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 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 31st, 2025, and under 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 14th, 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. 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 first quarter ended March 31st, 2026. This 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 over the call to Elutia’s CEO, Randy Mills.

Randy Mills, Chief Executive Officer, Elutia, Inc.: Thank you, Bernadine. 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. 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.

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. 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. 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%-20%, and no meaningful innovation in standard of care.

Fourth, we ended the quarter with a strong balance sheet, $36.5 million in cash in escrow, and we are actively engaged in two 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. 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. 1, it’s a big market, a $1.5 billion in the U.S. alone. 2, it’s a big problem. 15%-20% of patients develop postoperative infection after mastectomy. If anything, that number is conservative. 3, 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 U.S. 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, you have a $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 three women suffer a serious complication after reconstruction.

15%-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. Remember why this woman is in the operating room in the first place. She was diagnosed with cancer. Her number 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, it delivers powerful, sustained, uniform antibiotic coverage right at the surgical site where systemic antibiotics struggle to reach. Unlike legacy biologic matrix 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, it serves as the foundation for NXT-41x drug-eluting version that will follow. We’re not gonna 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 an important from a submission standpoint. We continue to anticipate NXT-41 clearance in the 1st quarter of 2026 and expect NXT-41X clearance in the 1st 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 coding 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. Third, we believe this process creates a meaningful competitive advantage.

The integrated process supports a targeted gross margin of above 80% at scale. 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. 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, Peter 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 and 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. Third, the commercial opportunity appears to be highly concentrated. Look at this funnel. As we discussed, the U.S. breast reconstruction market is a billion and a half dollars. There are about 168,000 procedures performed last year. About 1,800 U.S. hospitals perform reconstruction. Only 585 of those hospitals account for three-quarters of the entire market. The top 50 centers alone represent over $300 million in spend. Here’s the insight. This is a billion-dollar-plus U.S. market. 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. 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 and its platform. With SimpliDerm, interest is strong. 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 nine regional plans. It has a differentiated patent-protected manufacturing process. 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. 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. We are gonna provide further updates on both processes as appropriate. Now, with that, I’d like to turn the call over to Matt.

Matt, Chief Financial Officer, Elutia, Inc.: 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 our return to direct distribution, 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 worked through legacy matters. 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 non-cash 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 pre-funded 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, 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, most importantly, we have a company capable of creating meaningful value for surgeons, for hospitals, for shareholders, most importantly, for patients. We have the platform, we have the market, we have the team, we have the resources to make it happen. Operator, we’re now ready to open the line for questions.

Operator: Thank you. As a reminder, to ask a question, you will need to press star one one on your telephone. To remove yourself from the queue, you may press star one one again. Please stand by while we compile the Q&A roster. First question comes from the line of Frank Takkinen of Lake Street Capital Markets. Your line is open, Frank.

Frank Takkinen, Analyst, Lake Street Capital Markets: Great. Thank you for taking the questions. Congrats on all the progress. Was hoping to start with 1 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. Maybe how I will ask is, if I heard you correctly, you said incrementally more confident. Maybe the way for us to understand it is, no surprises with perhaps a more detailed roadmap for NXT-41x. Is that a fair way to think about it and any other detail you would provide?

Randy Mills, Chief Executive Officer, Elutia, Inc.: Yeah. The way I would describe it is, one, you know, anytime that you submit something to FDA, you submit to a particular, you know, a particular group. While it’s the same regulatory pathway that we used with ELUPRO, we went from cardiovascular with ELUPRO over to plastic and reconstructive surgery. 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.

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, you know, letters and initial things that might go back and forth at this stage, but real serious, meaningful conversations in a productive and collaborative fashion. That’s obviously, you know, been helpful in 41 and 41 is moving along, you know, the way we anticipated 41 would move along. Sort of keep in mind as we do, I would hope, Frank, that our eye is actually on the prize, and the prize is 41 X.

What we’re really doing with NXT-41 is making sure that our NXT-41x submission is the highest quality submission we can have it, that it’s on time, and most importantly, that NXT-41x gets approved when we anticipate it. The interactions we’ve had so far in the NXT-41 process.

Have 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, Analyst, Lake Street Capital Markets: No, that’s perfect. I appreciate that very much. Maybe on the some of the new commercial comments, thanks for that color. It’s 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 kinda internal as well as 1099s. Maybe talking about that split and when do you start to bring on some of that early talent.

Randy Mills, Chief Executive Officer, Elutia, Inc.: Right. It’s certainly a little too early to lay out the full plan. We’ll be doing that more now that, now that Pete’s on. I do have a couple of comments on it. You know, the first one of the thing Pete’s doing is Pete’s doing a really nice job of going out and assessing the market both qualitatively and quantitatively, Frank. I mean, it’s 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, you know, where are all the procedures done? How, you know, 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, there’s, you know, anyone that’s spent any time with a surgeon is their perception of the problem can oftentimes be very different than the actual problem. The gap between those two is actually where the real marketing plan and genius and opportunity come about and take shape. What we’re seeing and what Pete’s already uncovered is, when you start looking at the high concentration centers, I think it was 585 account for 75% of the market. Even that ends up being super concentrated, we have $300 million of market opportunity in just 50 accounts. Right? I mean, let’s put that into perspective with what we did with EluPro.

We took 12 direct reps with EluPro, paired them up with a handful of 1099s, and in 9 months they activated 193 VAC accounts, right? Through submission in 193 accounts. That would be like, I don’t know, a half a billion dollars of market opportunity in breast reconstruction, right? It’s absolutely incredible what’s going on here. Just to go on, I get really excited about this, as you can tell, Frank. Another thing that Pete’s uncovered is, if you look at the postoperative complications that are happening, and we mentioned in the press release that he’s confirmed, you know, 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 know, you’re looking easily at 30% complication rates at these high volume centers. It’s kinda nice that, you know, the earliest places to go to get some big wins are actually also the ones that need the most help. 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, you know, that have the comorbidities that lead to infection, that require the more radical mastectomies, that, you know, and all of those factors that lead to postoperative infection. It’s really gratifying to see it come together.

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. Boy, in 60 days, the man has hit the ground running and has, you know, confirmed what we know and then has taken it really to the, to the next level with this. It’s super exciting, particularly when you put it in the context of what we were able to accomplish with little old EluPro. Now you talk about game-changing NXT-41x and, you know, we can’t wait.

Frank Takkinen, Analyst, Lake Street Capital Markets: Very helpful. Maybe on just my last one. How do you think about maybe timelines around SimpliDerm and cardiovascular understanding? It’s always challenging to predict, but any wide goalposts you’d provide?

Randy Mills, Chief Executive Officer, Elutia, Inc.: Well, you know, we started the SimpliDerm process. You know, we announced that on our last 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 you know, it’s like, it’s like, you know, trying to trying to pick the final four or enrollment in the clinical trial, like trying to time, you know, when a deal like a, you know, a divestiture is gonna 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, you know, for a high quality deal and we think we’re on track to get one. You know, until it’s, until it’s done, it’s not done. On the cardiovascular side, there 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. As we think about strategic positioning of the company, and you could probably tell, right? We are really convinced in the NXT-41x opportunity that lies ahead.

You know, 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 two great product lines that are used surgically every day, and patients benefit from them any day, every day. They’re just not where we’re going as a company. It will-- I think both of these will have a meaningful impact to our, to our, you know, to our balance sheet and to our, and to our strategic focus. Did that help?

Frank Takkinen, Analyst, Lake Street Capital Markets: Yep, very helpful. Thank you. I appreciate the color as always.

Randy Mills, Chief Executive Officer, Elutia, Inc.: All right, then.

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.