Q1 2026 Elutia Inc Earnings Call
Operator: Thank you for standing by, welcome to Elutia's first quarter 2026 Earnings Conference Call. Currently, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. To remove yourself from the queue, you may press star 11 again. I would now like to hand the call over to Bernadine Cherniak. Please go ahead.
Operator: Thank you for standing by, and welcome to Elutia's first quarter 2026 Earnings Conference Call. Currently, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. To remove yourself from the queue, you may press star one, one again. I would now like to hand the call over to Bernadine Cherniak. Please go ahead.
Speaker #1: To ask a question during the session, you will need to press star 11 on your telephone. To remove yourself from the queue, you may press star 11 again.
Speaker #1: I would now like to hand the call over to Bernadine Cherniak. Please go ahead. Thank you, operator, and thank you all for participating in today's call.
Bernadine Cherniak: Thank you, operator, and thank you all for participating in today's call. Earlier today, Elutia released financial results for Q1 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.
Bernadine Cherniak: Thank you, operator, and thank you all for participating in today's call. Earlier today, Elutia released financial results for Q1 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.
Speaker #1: 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.
Speaker #1: 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.
Speaker #1: 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 are performance are forward-looking statements.
Speaker #1: 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.
Speaker #1: 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.
Bernadine Cherniak: 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 31 December 2025. 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, 14 May 2026.
Bernadine Cherniak: 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 31 December 2025. 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, 14 May 2026.
Speaker #1: Accordingly, you should not place undue reliance on these statements. For lists and descriptions of the risks and uncertainties, see 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.
Speaker #1: 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.
Speaker #1: 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.
Bernadine Cherniak: 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 Q1 ended 31 March 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 CEO, Randy Mills.
Bernadine Cherniak: 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 Q1 ended 31 March 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 CEO, Randy Mills.
Speaker #1: 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 31st, 2026.
Speaker #1: 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 CEO Randy Mills.
Speaker #1: 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.
Randy Mills: 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 pro-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.
Randy Mills: 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 pro-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.
Speaker #1: 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.
Speaker #1: I'll walk you through the headlines, the quarter, and where we're headed. Matt will take you through the financials and close with a few thoughts on what's ahead.
Speaker #1: 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.
Speaker #1: 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.
Randy Mills: 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 Q4 2026 and NXT-41x clearance in H1 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 US market, postoperative infection rates of 15% to 20%, and no meaningful innovation in standard of care.
Randy Mills: 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 Q4 2026 and NXT-41x clearance in H1 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 US market, postoperative infection rates of 15% to 20%, and no meaningful innovation in standard of care.
Speaker #1: 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.
Speaker #1: That platform supports a target gross margin in excess of 80% at scale. Enabling a differentiated value proposition at competitive pricing. Third, direct surge in engagement by our commercial team is confirming what we have believed all along: a 1.5 billion US market.
Speaker #1: Post-operative infection rates of 15 to 20 percent, and no meaningful innovation in standard of care. In fourth, we ended the quarter with a strong balance sheet.
Randy Mills: Fourth, we ended the quarter with a strong balance sheet, $36.5 million in cash and 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.
Randy Mills: Fourth, we ended the quarter with a strong balance sheet, $36.5 million in cash and 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.
Speaker #1: $36.5 million in cash and escrow, and we are actively engaged in two strategic processes: the simple-term divestiture we previously announced, and a newly disclosed inbound acquisition interest in our cardiovascular product line.
Speaker #1: 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.
Speaker #1: 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.
Speaker #1: 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.
Randy Mills: 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 three reasons. One, it's a big market, a $1.5 billion in the US alone. Two, it's a big problem. 15% to 20% of patients develop postoperative infection after mastectomy. If anything, that number is conservative. Three, we already have a proven solution.
Randy Mills: 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 three reasons. One, it's a big market, a $1.5 billion in the US alone. Two, it's a big problem. 15% to 20% of patients develop postoperative infection after mastectomy. If anything, that number is conservative. Three, we already have a proven solution.
Speaker #1: 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.
Speaker #1: 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 three reasons.
Speaker #1: One, it's a big market. A 1.5 billion in the US alone. Two, it's a big problem. 15 to 20 percent of patients develop post-operative infection after mastectomy, and if anything, that number is conservative.
Speaker #1: 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.
Randy Mills: 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, you have a billion and a half dollar US 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.
Randy Mills: 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, you have a billion and a half dollar US 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.
Speaker #1: 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.
Speaker #1: 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 a billion and a half dollar US market opportunity.
Speaker #1: 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.
Speaker #1: 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.
Randy Mills: 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. 1 in 3 women suffer a serious complication after reconstruction. 15% to 20% develop a postoperative infection. Up to 21% experience implant loss. 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, and 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.
Randy Mills: 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% to 20% develop a postoperative infection. Up to 21% experience implant loss. 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, and 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.
Speaker #1: One in three women suffer a serious complication after reconstruction. Fifteen to twenty percent develop a post-operative infection, up to 21% experience implant loss, and the average hospital cost of a single infection ends up being more than $48,000.
Speaker #1: But remember why this woman is in the operating room in the first place? She was diagnosed with cancer. Her number one goal is to beat that cancer, and when infection takes hold, chemotherapy stops, radiation stops, everything stops until the infection is resolved.
Speaker #1: 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.
Speaker #1: 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.
Randy Mills: 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 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.
Randy Mills: 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 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.
Speaker #1: 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.
Speaker #1: Unlike legacy biologic matrix, which has little functional differentiation, our goal is to deliver differentiated functionality at a competitive economic profile. We believe that matters.
Speaker #1: 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.
Speaker #1: We continued 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.
Speaker #1: 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 plan NXT 41X submission strategy.
Randy Mills: 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 an important from a submission standpoint. We continue to anticipate NXT-41 clearance in Q1 2026 and expect NXT-41x clearance in H1 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.
Randy Mills: 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 an important from a submission standpoint. We continue to anticipate NXT-41 clearance in Q1 2026 and expect NXT-41x clearance in H1 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.
Speaker #1: The discussions have helped clarify what FDA views as an important from a submission standpoint. We continue to anticipate NXT 41 clearance in the first quarter of 2026 and expect 41 NXT 41X clearance in the first half of 2027.
Speaker #1: 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.
Speaker #1: 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.
Speaker #1: 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.
Randy Mills: 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. 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.
Randy Mills: 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. 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.
Speaker #1: 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.
Speaker #1: 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.
Speaker #1: Our commercial readiness work continues to increase our confidence in the market opportunity. Since joining ELUTIA, our chief commercial officer, Pete Legatti, has spent a substantial amount of time in the field speaking directly with surgeons and hospital stakeholders and the feedback has been remarkably consistent.
Randy Mills: 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 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 US breast reconstruction market is $1.5 billion, and there are about 168,000 procedures performed last year.
Randy Mills: 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 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 US breast reconstruction market is $1.5 billion, and there are about 168,000 procedures performed last year.
Speaker #1: The clinical need is real and it is significant. Surgeons describe post-operative infection in downstream complications as one of the most frustrating challenges they face in breast reconstruction.
Speaker #1: 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.
Speaker #1: As we discussed, the US breast reconstruction market is a billion and a half dollars and there are about 168,000 procedures performed last year. About 1,800 US hospitals perform reconstruction, but only 585 of those hospitals account for three quarters of the entire market.
Randy Mills: About 1,800 US 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 billion-dollar-plus US 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 and its platform. With SimpliDerm, interest is strong, and the process is going well.
Randy Mills: About 1,800 US 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 billion-dollar-plus US 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 and its platform. With SimpliDerm, interest is strong, and the process is going well.
Speaker #1: And the top 50 centers alone represent over 300 million dollars in spend. Here's the insight. This is a billion-dollar-plus US 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.
Speaker #1: 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.
Speaker #1: As we have previously discussed, we continue to evaluate opportunities to further focus the company around NXT 41X and its platform. With SimpleDerm, interest is strong and the process is going well.
Speaker #1: SimpleDerm is a high-quality business, with $2.1 million in revenue 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.
Randy Mills: 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.
Randy Mills: 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 going to provide further updates on both processes as appropriate. Now, with that, I'd like to turn the call over to Matt.
Speaker #1: 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 a million dollars in revenue this quarter at an 85% gross margin and that's up from 300,000 just a year ago.
Speaker #1: 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 creation, which is NXT 41X.
Speaker #1: 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.
Randy Mills: Now, with that, I'd like to turn the call over to Matt.
Speaker #2: 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.
Matt Steinberg: Okay, thanks, Randy. I'll begin with a review of our Q1 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 Q1 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.
Matt Ferguson: Okay, thanks, Randy. I'll begin with a review of our Q1 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 Q1 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.
Speaker #2: 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.
Speaker #2: SimpleDerm revenue was 2.1 million dollars compared to 2.6 million a year ago. Cardiovascular revenue was 1.0 million compared to 300,000 in the prior year period.
Speaker #2: The increase in cardiovascular was primarily driven by our 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.
Speaker #2: 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.
Matt Steinberg: 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.
Matt Ferguson: 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.
Speaker #2: Total operating expenses were 8.2 million dollars, essentially flat year over year. Inside that number, we reallocated meaningfully. Litigation costs declined by approximately $2 million as we worked through legacy matters and we redeployed that capacity to achieve the substantial R&D progress and commercial readiness for NXT 41X.
Speaker #2: 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.
Matt Steinberg: 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 Q4 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.
Matt Ferguson: 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 Q4 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: Now, let's look ahead at the catalyst calendar. We continue to actively work towards our strategic transactions. The SimpleDerm and cardiovascular processes that Randy discussed.
Matt Steinberg: 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 Q4 2026, and in H1 2027, we anticipate FDA clearance of NXT-41x. In H2 2027, we anticipate commercialization and a focused NXT-41x soft launch. Overall, we believe Q1 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.
Matt Ferguson: 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 Q4 2026, and in H1 2027, we anticipate FDA clearance of NXT-41x. In H2 2027, we anticipate commercialization and a focused NXT-41x soft launch. Overall, we believe Q1 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: 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 Illusion today represents a unique combination of attributes.
Speaker #2: 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.
Matt Steinberg: 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 US, 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.
Matt Ferguson: 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 US, 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.
Speaker #2: We have existing GMP manufacturing infrastructure that is now online. We have growing regulatory clarity from our productive dialogue with the FDA. And we are pursuing a large market opportunity.
Speaker #2: 1.5 billion dollars in the US. 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.
Speaker #2: 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.
Speaker #1: Thank you. As a reminder to ask a question, you will need to press star 11 on your telephone to remove yourself from the queue.
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.
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.
Speaker #1: You may press star 11 again. Please stand by while we compile the Q&A roster. First question comes from the line. Frank Takinen. Lake Street Capital Markets, your line is open Frank.
Frank Takkinen: Great. Thank you for taking the questions. Congrats on all the progress. Was hoping to start with one on the follow-up. I know you said you wouldn't divulge too much detail on it, 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 41x. Is that a fair way to think about it and any other detail you would provide?
Frank Takkinen: Great. Thank you for taking the questions. Congrats on all the progress. Was hoping to start with one on the follow-up. I know you said you wouldn't divulge too much detail on it, 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 41x. Is that a fair way to think about it and any other detail you would provide?
Speaker #3: Great, thank you for taking the questions. 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.
Speaker #3: 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.
Speaker #3: Is that a fair way to think about it in any other detail you would provide?
Speaker #2: Yeah. The way I would describe it is, one, anytime that you submit something to FDA, you submit to a particular group. And so while it's the same regulatory pathway that we used with Elupro, we went from cardiovascular with Elupro over to plastic.
Matt Steinberg: 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.
Matt Ferguson: 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.
Speaker #2: 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.
Speaker #2: 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 at this stage, but real serious, meaningful conversations.
Matt Steinberg: 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 NXT-41, and NXT-41 is moving along, you know, the way we anticipated NXT-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 NXT-41x.
Matt Ferguson: 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 NXT-41, and NXT-41 is moving along, you know, the way we anticipated NXT-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 NXT-41x.
Speaker #2: And 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.
Speaker #2: But sort of keep in mind as we do, I would hope, Frank, that our eye is actually on the prize. And the prize is 41X.
Matt Steinberg: 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 it. The interactions we've had so far in the 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.
Speaker #2: 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 it.
Matt Ferguson: 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 it. The interactions we've had so far in the 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.
Speaker #2: And the interactions we've had so far in the 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.
Speaker #1: 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.
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 kinda internal as well as 1099s. Maybe talking about that split and when do you start to maybe bring on some of that early talent.
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 kinda internal as well as 1099s. Maybe talking about that split and when do you start to maybe bring on some of that early talent.
Speaker #1: 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.
Speaker #1: 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.
Speaker #1: Maybe talking about that split and when do you start to maybe bring on some of that early talent?
Speaker #2: Right. So, 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.
Matt Steinberg: Right. 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.
Matt Ferguson: Right. 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.
Randy Mills: Of comments on it. You know, 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, this is 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? You know, where are all the procedures done? 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?
Randy Mills: Of comments on it. You know, 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, this is 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? You know, where are all the procedures done? 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?
Speaker #2: So the first, one of the things Pete's doing is Pete's doing a really nice job of going out and assessing the market both qualitatively and quantitatively, Frank.
Speaker #2: And I mean, this is when you bring a sophisticated guy in-house, right? This is what they this is what they do. Quantitatively, it's great to know, "Hey, what's the actual infection rate?
Speaker #2: Where are all the procedures done? What are the times of infections and complications? Are they being seen 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, anyone that has spent any time with a surgeon knows their perception of the problem can oftentimes be very different than the actual problem.
Randy Mills: I mean, 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, 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, and then 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.
Randy Mills: I mean, 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, 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, and then 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.
Speaker #2: And the gap between those two 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.
Speaker #2: So I think it was 585. I count for 75% of the market. And then even that ends up being super concentrated where you have 300 million dollars of market opportunity.
Speaker #2: 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 nine months, they activated 193 VAC accounts, right?
Randy Mills: We took 12 direct reps with EluPro, paired them up with a handful of 1099s, and in nine months, they activated 193 VAC accounts, right? For 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. Then just to go on, I get really excited about this, as you can tell, Frank. 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, you know, the sort of the market size, you know, and this concentration effect that we're seeing, but also the severity.
Randy Mills: We took 12 direct reps with EluPro, paired them up with a handful of 1099s, and in nine months, they activated 193 VAC accounts, right? For 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. Then just to go on, I get really excited about this, as you can tell, Frank. 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, you know, the sort of the market size, you know, and this concentration effect that we're seeing, but also the severity.
Speaker #2: Through submission and 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.
Speaker #2: And then just to go on, I get really excited about this, as you can tell, Frank. But another thing that Pete's uncovered is, if you look at the post-operative complications that are happening—we mentioned in the press release that he's confirmed the market size and this concentration effect that we're seeing, but also the severity.
Speaker #2: It's really interesting because when you look at the complication rates at these high-volume centers, they're really high. You're looking easily at 30% complication rates at these high-volume centers.
Randy Mills: 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.
Randy Mills: 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 kind 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.
Speaker #2: 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.
Speaker #2: 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, that and all of those factors that lead to post-operative infection.
Speaker #2: But it's really, really gratifying to see 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.
Randy Mills: 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 next level with this. It's, 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.
Randy Mills: 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 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #1: Very helpful. Maybe just my last one. How do you think about maybe timelines around Simpleterm and cardiovascular understanding? It's always challenging to predict, but any wide gold posts you'd provide?
Frank Takkinen: Very helpful. Maybe on just my last one, how do you think about maybe timelines around SimpliDerm and cardiovascular understanding? It is always challenging to predict, but any wide goal, goalposts you would provide?
Frank Takkinen: Very helpful. Maybe on just my last one, how do you think about maybe timelines around SimpliDerm and cardiovascular understanding? It is always challenging to predict, but any wide goal, goalposts you would provide?
Speaker #2: Well, we started the Simpleterm process 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.
Randy Mills: 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, you know, it's like, it's like, you know, trying to, trying to pick the Final Four, or enrollment in a clinical trial, like trying to time, you know, when a deal like, 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.
Randy Mills: 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, you know, it's like, it's like, you know, trying to, trying to pick the Final Four, or enrollment in a clinical trial, like trying to time, you know, when a deal like, 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.
Speaker #2: 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 Four or enrollment in a clinical trial.
Speaker #2: 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 Simpleterm process is going.
Randy Mills: 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 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.
Speaker #2: 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, 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.
Randy Mills: 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 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.
Speaker #2: And as we think about strategic positioning of the company—and you could probably tell, right?—we're 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.
Randy Mills: 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 balance sheet and to our strategic focus. Did that help?
Randy Mills: 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 balance sheet and to our strategic focus. Did that help?
Speaker #2: These are two 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.
Speaker #2: And it will, I think both of these will have a meaningful impact on our balance sheet and on our strategic focus. So did that help?
Speaker #1: Yep. Very helpful. Thank you. I appreciate the color as always.
Frank Takkinen: Yep, very helpful. Thank you. I appreciate the color as always.
Frank Takkinen: Yep, very helpful. Thank you. I appreciate the color as always.
Speaker #2: All right then.
Randy Mills: All right then.
Randy Mills: 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.
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.
