4/28/2026

speaker
Operator
Conference Call Operator

Good morning, everyone. Joining me on today's call is Michael Dale, Axiogen's President and Chief Executive Officer, Lindsay Hartley, Chief Financial Officer. Michael will discuss first quarter 2026 financial results and corporate highlights. Lindsay will then provide details on financial performance and overall outlook for the year. This will be followed by a question and answer session. Today's call and presentation is being broadcast live via webcast, which is available on the investor section of Axogen's website. Following the end of the live call, a replay will be available on the investor section of the company's website at www.axogeninc.com. Before we begin, I would like to remind you that during this conference call, management will be making forward-looking statements. Forward-looking statements include statements regarding financial guidance and outlook, clinical development and regulatory efforts, commercial growth initiatives, reimbursement and market access efforts, training and education initiatives, research and development activities, and overall business strategy and performance. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, including, without limitation, the risks and uncertainties reflected in the company's filings with the Securities and Exchange Commissions. including the most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, and other filings made with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the company undertakes no obligation to update any forward-looking statements except as required by law. In addition, for a reconciliation of non-GAAP measures, please refer to today's press release, presentation with highlights from today's call, and the corporate presentation on the investor section of the company's website. Now, I will turn the call over to Michael. Michael, please go ahead.

speaker
Michael Dale
President and Chief Executive Officer

Thank you, operator, and welcome to everyone joining us this morning. What I would like to do today is walk through our first quarter 2026 performance through the lens of the six priority areas of our strategic plan, sharing with you how we executed against each one of those during the quarter. I will then turn the call over to Lindsay to review the financials, after which we will open the call for your questions. To begin, we are delighted with our first quarter revenue performance and the progress we're making across each of Accigen's strategic plan priorities. As noted in our earnings release, we delivered strong growth across all of our target markets, reinforcing the relevance of our market development strategies and the strength of our commercial executions. We believe we are well positioned to achieve our financial guidance and continue advancing our strategic priority objectives for 2026. Key first quarter results that underpin our confidence in the remainder of 2026 include revenue of $61.5 million, representing over 26% growth year-over-year, double-digit growth across each of our three target markets, continued progress expanding commercial insurance coverage and payment for advance, and the on-schedule expansion of our commercial organization. Combined with our well-capitalized balance sheet, these achievements reinforce our confidence in our plans to make restoration, a peripheral nerve function, and expected standard of care. So, let's review in order the progress during the quarter for each of our six strategic priorities. Starting with our first priority, revenue growth and financial operating leverage, we delivered a strong start to 2026. First quarter revenue was $61.5 million, representing 26.6% growth versus the first quarter of 2025. Growth was broad-based with all three target markets contributing to our year-over-year performance. Adjusted EBITDA was $5.7 million for the quarter, and we ended the period with $103.6 million in cash, cash equivalents, restricted cash, and investments. Performance was driven by strong demand for events and continued adoption of our broader product algorithm across all three target markets. Salesforce productivity was ahead of plan, and our active surgeon count increased meaningfully during the quarter, an indicator we monitor closely because it reflects broader adoption of nerve care within an institution. We are also beginning to see the benefit of the Salesforce additions we made in 2025, as those representatives progress through their ramp and approach full productivity within our target market development model. Overall, these results reflect execution across our full commercial system, account activation, surgeon education, rep productivity, coverage expansion, and patient awareness, and working together in alignment with our strategic plan. Moving on to our second priority, market development across extremities, oral, maxillofacial, and head, neck, and breast. Extremities delivered strong double-digit year-over-year growth in the first quarter, reflecting continued adoption of the actogen nerve repair algorithm across both traumatic and chronic peripheral nerve injury presentations. Momentum in our OMF and head and neck market continued in Q1, delivering strong double-digit year-over-year growth Increased investments in professional education and a stronger focus and presence in head and neck helped drive surgeon activation and algorithm adoption in these procedures. Breast was our fastest growing market in the first quarter, delivering strong double-digit year-over-year growth. We are seeing momentum in resensation adoption overall and implant-based reconstruction volumes specifically. We also believe we are beginning to see the productivity contribution of the sales representatives we added to the breast organization in the summer of 2025, as those reps ramp and become more productive in their accounts. Before I move on, I want to take a moment to revisit how we think about the size and nature of each of these markets, because it is directly relevant to understanding what we are doing and what we believe is possible. When we introduced our total addressable market framework, at the March 2025 Analyst Day. We were deliberate in how we estimated our market opportunities. Our TAM estimates are based on procedure volumes captured from CMS, QDMD, clinical literature, and the ASPS data. For each segment, we apply a discounting algorithm to remove procedures where an oxygen product would not realistically be indicated. We then apply expected algorithm usage based on historical utilization data and apply a procedure, ASP. The resulting TAMs, we believe, are genuinely addressable. In extremities, that is $2.9 billion including traumatic and chronic nerve injuries segmented by gap length across sensory, mixed, motor, and protection applications. In breast, the TAM is segmented by autologous and implant-based reconstruction and represents approximately one-third of the more than 150,000 reconstructive procedures performed annually in the United States. In OMF and head and neck, the TAM includes nerve reconstruction and protection across mandible reconstructions, iatrogenic injuries, neck dissections, peridectomies, and thyroidectomies. Roughly 90% of targeted OMAP head and neck procedures occur in approximately 900 accounts in the United States, most of which already overlap with our high potential account universe. And in prostate, TAM includes approximately 110,000 annual robotic-assisted radical prostatectomy cases with a well-defined, well-documented clinical problem. While we believe the patient numbers reflected in our TAM represent genuinely addressable treatment opportunities, it's important to be clear that these are markets still in development. We are building them in real time, and our strategic plan reflects the work required to establish standards of care, and in doing so, to develop these markets. As we said about a year ago, the question for action is not whether the problems are large and whether our products work. It's what business models are required to connect patients with providers. Each market has a different patient journey, variance in microsurgical knowledge and training, different referral dynamics, and a different reimbursement environment. In extremities, while we've made strong progress developing the market and advancing our standard of care objectives, we remain significantly underpenetrated relative to the size of the opportunity. There's still meaningful work to do to ensure NERF care is reflected in care guidelines across the full range of treatment presentations. In breast, most women are not aware that numbness and loss of sensation can be a consequence of a mastectomy. Even when patients understand this risk, they are often unaware our procedure is an option until after numbness has already occurred. In OMF and head and neck, we're still below 1% penetrated with an account universe that our current sales organization already covers. In prostate, we continue to refine the clinical techniques This work has been underway throughout 2025, and we believe we are making good progress. Across all of these markets, the work is about creating the conditions under which peripheral nerve repair becomes an expected standard of care. While there is still significant work ahead, this development runway is a key reason we believe Axigen has the opportunity to deliver double-digit growth for many years, as the potential to restore health and improve quality of life is enormous. With regards to our third priority, commercial expansion, we ended the first quarter with a total commercial organization of 146 sales representatives across all markets, reflecting continued disciplined expansion in line with our four-year plan. Salesforce productivity was ahead of plan in both our breast and non-breast organizations in the first quarter, which is an encouraging early data point as 2025 hires continue to ramp. Representatives hired in 2025 are progressing toward independence and break even within our six to nine month target window. And we expect them to be increasingly accretive through the remainder of the year. Now, just to give you some context for why this matters in terms of our historical trajectory, Action has not expanded its sales organization for more than three years prior to us beginning this process. So we're just now beginning to see contributions of this build. and we believe it will be a meaningful driver of our growth going forward. The fourth priority is commercial excellence, specific to our emphasis on high-potential accounts, productivity, and education. High-potential accounts continue to be a primary engine of our revenue growth, representing 60% of total revenue for the first quarter. Growth from high-potential accounts represented 48% of total revenue growth in the quarter, below our four-year target of 60%. This difference reflects strong performance in breast accounts, which are not always designated as high potential accounts. We use this as a mixed dynamic rather than a structural concern, and it simply reflects that we are seeing high growth across all accounts and market segments. Our active surgeon count in high potential accounts increased by more than 70 in the quarter, reflecting continued progress in our efforts to make nerve care awareness and skills part of more surgeons' repertoires and their practices. In the first quarter, we conducted four professional education programs, two in breast, one in extremities, and one in OMF and head and neck, consistent with our market development plans. We remain on track toward our four-year targets of 10 extremities programs training 200 surgeons, six oral maxillofacial and head and neck programs training 100 surgeons, and five breast programs training 75 surgeon pairs. As I have often mentioned, education is truly one of AXGEN's core competencies. I have been consistently impressed by what Accutane has built and the trust it has earned within the clinical community. As a reminder, we support the training of the majority of hand fellows in the United States in nerve care and are increasing our investments in fellows training in our other markets as this is key to establishing nerve care as part of their clinical practice in the future. We are regularly sought out to lead and support these educational programs. As awareness of nerve care continues to build, and with more than 70% of the clinical literature on the subject published in just the last five years, we expect demand for education and for training associated with our algorithm to continue to grow. Our fifth priority relates to our standard care objectives specific to evidence, coverage, and the FDA biologic license approval of advance. We continue to make progress expanding commercial coverage. Since receiving biologics license approval for AVANCE in December of 2025, we have been actively reengaging payers where prior objections to coverage and payments were centered on the perception that AVANCE was experimental. I'll share two recent updates. First, Cigna. In mid-April, Cigna extended explicit broad coverage to AVANCE nerve graft for peripheral nerve repair in extremities and post-mastectomy breast reconstruction for its approximately 16 million members. Cigna's breast-related coverage criteria states, quote, advanced nerve graft is considered medically necessary when used in association with mastectomy or breast reconstruction procedures when nerves cannot be preserved. We believe this medical policy update means surgeons and patients will no longer face denials for extremity, breast, and head and neck NOMAP procedures. Second, Elements, also known as Anthem. In early April, LVANCE removed ANTS from its experimental investigational list, which is an important first step. However, LVANCE also implemented utilization management criteria limiting the ANTS usage to 5 to 25 nanometer nerve gaps, consistent with what we studied in the RECON pivotal trial. It is common for medical policy teams to initially adopt the inclusion and exclusion criteria from the pivotal trial for a newly approved drug or biologic. And we believe that is what drove Elevance's decision. As we have said before, Advance is unique. While the BLA approval makes Advance still quote-unquote new to payers, the product has 17 years of clinical experience and well over 100 peer-reviewed publications. Our health, economics, and university team is currently partnered with more than 15 surgeons to educate Elevance and resolve this gap-linked criterion collaboratively. As we communicated at ERAD, advanced biologic product will begin entering commercial channels in the second quarter of 2026. From a customer and physician standpoint, this transition will be largely invisible. Surgeons order advance for its clinical profile, not its regulatory designation, and the product going into their hands performs the same function. There is no inventory obsolescence risk, and we have managed the logistics carefully to support a smooth transition. The primary effect of the biologic launch on our financials will be at the gross margin line, where we have guided to a 74% to 76% full-year range that anticipates the incremental product cost that comes with manufacturing under a biologic quality system. On the clinical study front, we have programs in active development in breast and in mixed and motor nerve educations with initiations expected this year. we will provide more detail on individual programs in the second half of the year, consistent with our prior guidance. In prostate, we remain focused on gathering clinical signals from the procedures completed at our 10 clinical sites in 2025, before making any decisions about commercial or clinical study expansion. That data is expected to mature in the second half of the year, and we will update investors accordingly when we have something meaningful to share. And finally, our sixth priority, which is about innovation, research and development, therapeutic reconstruction. As a reminder, our R&D work has three primary focus areas. First, making nerve coaptation faster, easier, and more consistent. Second, advancing solutions for non-transsected and chronic nerve injuries to better protection. And third, developing therapeutic reconstruction technologies to improve the fundamental biology of nerve regeneration. These are not abstract objectives. They are line of sight improvements to advance and to our broader algorithm that we believe will further extend our clinical and competitive position. In closing, the first quarter of 2026 was a strong start, reflecting disciplined execution of our strategic plan and total commitment to our business purpose of restoring health and improving quality of life by making restoration of peripheral nerve function an expected standard of care. Like Wadi Piper's story about the little engine that could, We think we can fulfill our mission and purpose and look forward to reporting continued progress across the priorities outlined in our strategic plan. We are raising our four-year guidance accordingly. I will now turn the call over to Lindsay to review the quarter's financials and our updated outlook for 2026. Thanks, Mike.

speaker
Lindsay Hartley
Chief Financial Officer

I am pleased to report our first quarter 2026 financial results. For the first quarter, we reported revenue of $61.5 million, reflecting growth of 26.6% compared to the first quarter of 2025. Revenue growth continues to be fueled by strong demand for advance and adoption of our product algorithm across target markets, with unit volume serving as the primary driver. Our gross profit for the quarter came in at $46.2 million, This represents a gross margin of 75.2%. Gross margin in the first quarter reflects our pre-biologic launch cost structure, as advanced biologic product has not yet entered commercial channels. Beginning in the second quarter, as biologic advance enters the channel, we expect to see incremental product cost pressure. Our full year gross margin guidance of 74% to 76% accounts for this transition, and we continue to target improvement in 2027 as we implement continuous improvement programs and benefit from increasing economies of scale. Operating expenses increased to 49 million in the quarter, up from 36.6 million in the first quarter of 2025. and increased 4.5% as a percentage of revenue. The increase as a percentage of revenue was driven primarily by an increase of compensation costs, including stock-based compensation, expense tied to certain PFUs anticipated to achieve above target on revenue growth components. Sales and marketing expenses as a percentage of total revenue increased 3.3 percentage points to 46.6% in the first quarter, compared to 43.3% in the first quarter of 2025. This increase reflects investments in our commercial strategy to support our market development initiatives and long-term growth plan. Research and development expenses increased 23.4% to 7.5 million in the first quarter. compared to 6.1 million in the first quarter of 2025. And as a percentage of total revenue decreased slightly to 12.2% from 12.5%. Our continued investment in research and development is essential to our mission of making peripheral nerve repair a standard of care through the development of clinical evidence and innovation. General and administrative expenses increased 36.1% to 12.9 million in the first quarter, compared to 9.5 million in the first quarter of 2025, and as a percentage of total revenue, increased 1.5 percentage points to 21% from 19.5%. Net loss for the first quarter was 19.6 million or $0.38 per share compared to net loss of $3.8 million, or $0.08 per share in the first quarter of 2025. Included in net income is one-time loss of $16.8 million, which was incurred upon the extinguishment of our debt facility in January. Adjusted net income was $4.1 million, or $0.07 per share for the first quarter compared to an adjusted net loss of 900,000 or two cents per share for the first quarter of 2025. Adjusted EBITDA for the first quarter was 5.7 million compared to an adjusted EBITDA of 2.9 million in the same period last year. And as a percentage of revenue increased 3.4 percentage points to 9.3% from 5.9%. demonstrating our ability to improve our financial performance. Adjusted net income and adjusted EBITDA are calculated as net income or EBITDA adjusted for stock-based compensation and the loss on the extinguishment of the debt. As of March 31, 2026, cash equivalents, restricted cash, and investments totaled $103.6 million. As expected, we experienced higher cash burn in the first quarter, consistent with prior year seasonal patterns, and we remain on track to be free cash flow positive for the full year. As a reminder, in January we completed an upsized public offering, raising $133.3 million in net proceeds, and used $69.7 million to fully retire our term loan. We continue to operate with a clean capital structure and no debt obligation. Based on our first quarter performance and visibility into the remainder of the year, we are raising our full year 2026 financial guidance. We now expect full year 2026 revenue growth of at least 20% or total revenue of at least $270 million. full-year 2026 gross margin is expected to remain in the range of 74% to 76%, and we continue to expect to be free cash flow positive for the full year 2026. This guidance reflects continued confidence in commercial execution across all three core markets and the ongoing Salesforce productivity improvements. It does not include material benefit from payer coverage decisions beyond what is already known. With that, we will now open the line for questions. Operator?

speaker
Operator
Conference Call Operator

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. We ask that analysts limit themselves to one question and a follow-up so that others have the opportunity to do so as well. One moment, please, while we poll for questions. Our first question comes from Michael Sarcone with Jefferies. Please proceed with your question.

speaker
Michael Sarcone
Analyst, Jefferies

Good morning, and thanks for taking the questions. So just two for me on guidance to start. Really nice quarter with the 27% growth, and you're expecting at least 20% for the full year, which implies a decel as we make our way through the year. Just wanted to kind of hear you elaborate on what's driving that, the moving pieces there, and how much of the guide continues to reflect prudence.

speaker
Michael Dale
President and Chief Executive Officer

Thanks, Mike. So to your question, As we look at the comparables on a going-forward basis, there are sort of sequential increases that we're going to be comparing against. And this is a commercial execution story, as we've advised continuously. And so our guide, in part, reflects that reality. So very confident about the future, very confident about the guidance we've just raised, but mindful of the fact that each quarter is a productivity quarter. growth expectation that we need to continue to execute against.

speaker
Michael Sarcone
Analyst, Jefferies

Got it. Thanks, Mike. And then just to follow up there, you know, I believe Lindsay mentioned, you know, the guide is about continued execution here. And I think she also finished with on the reimbursement coverage side, you know, nothing beyond what we already know. I know the prior guide didn't have any of the potential coverage wins baked in. We've seen Anthem and Cigna. We may see an Aetna update soon. I guess, can you talk about if there's anything in the guide related to progress there, even modestly? And then the follow-up to that is, how do you view timelines for seeing more of a contribution from some of the recent commercial coverage wins? Thank you.

speaker
Michael Dale
President and Chief Executive Officer

Sure, Mike. We're digesting realities of that impact in real time. As we often mention, these are not events when you enjoy achievement that immediately translate into activity. These need to be socialized within the relative providers across the country. They then need to negotiate their individual contracts as part of that. So we know it's all going to be a net positive. in a significant way, but it is not an event that happens immediately. And so I think really as the next quarter rolls out, we'll start to get some insights into that and speak more to it. But again, it's just not an instantaneous benefit.

speaker
Michael Sarcone
Analyst, Jefferies

Great. Thanks a lot, Mike. Sure thing, Mike.

speaker
Operator
Conference Call Operator

Our next question comes from Larry Beelson with Wells Fargo. Please proceed with your question.

speaker
Larry Beelson
Analyst, Wells Fargo

Good morning. Thanks for taking the question and congrats on a really nice quarter here. Mike, you know, growth obviously accelerated here in Q1. Maybe a little bit more color on what drove the acceleration here. And with the new, you know, 20% plus, you know, guidance here, how are you thinking about the LRP of 15 to 20%?

speaker
Michael Dale
President and Chief Executive Officer

Sure. With regards to first quarter, really what we're seeing is cumulative effects of all the things we've been discussing now for quite some time. The ramp of the physical footprint, those individuals coming into play, the continuing benefits of the market development activities in terms of positioning, awareness. Each part of the business is getting just a little bit better each quarter. And so it's no one single thing, no one single part of the business. That's the most comforting thing to the team is that we're not dependent upon any one part of the business. They're all doing well. And it just reflects the fact that these are real needs from a health standpoint, grossly undertreated, and we're making a little progress each quarter towards that. So that's really what's driving the growth. There's really no magic to it. It's all of the... all of the things underlined in our strategic plan descriptions. And so we're benefiting from that. In terms of the LRP, we have not made any adjustments to our long-range plan. We still think that 15, 20% stands. As this year plays out and as we start to digest more about payment and coverage progress, that may change. But for now, we have not adjusted.

speaker
Larry Beelson
Analyst, Wells Fargo

That's helpful. Mike, for my follow-up on prostate, What are the early signals you're seeing from the 100-patient cohort ahead of the second half readout? And can you put a finer point, please, on the timing of the readout? Thank you.

speaker
Michael Dale
President and Chief Executive Officer

In terms of the timing of the readout, in terms of substance to where we could really begin to make judgments, that's still on schedule as previously described, which is the end, really getting into third quarter. and the reason why we'll have a body of patients that we can draw conclusions from as that happens. At present, what we have in terms of feedback is best described as anecdotal individual experiences, and those are all positive, but I need to emphasize those are anecdotes, not data body. of significance that you can truly base decisions upon. All right. Thanks for taking the question. Sure thing.

speaker
Operator
Conference Call Operator

Our next question comes from Mike Kratky with LeRinc Partners. Please proceed with your question.

speaker
Mike Kratky
Analyst, LeRinc Partners

Hi, everyone. Thanks for taking our questions and congrats on the really nice quarter and recent progress. You know, maybe just to follow up on Prossy quickly. In terms of the specific updates or that clinical activity signal that you're looking for, what are going to be the specific metrics that you're focused on that will influence your commercial outlook there?

speaker
Michael Dale
President and Chief Executive Officer

Sure. Jens, why don't you address that question?

speaker
Jens
Director, Clinical Operations

Yeah. I mean, we're looking at how Basically, we're following these patients very closely, or the sites that we're working with are following patients very closely, and we're looking for clinical signs for potency and continence. The other objective with working with the clinical sites was to see how incorporating nerve grafting into robotic procedures influenced the workflow, and what we've seen is it's very easy for these highly trained surgeons to incorporate, advance into robotic procedures. So that's another key learning that we've gotten so far. So overall, very positive, but as Mike said, we'll report further on kind of the clinical science in the second half of the year.

speaker
Mike Kratky
Analyst, LeRinc Partners

Understood. Appreciate the color there. And maybe just as a follow-up, it looks like in the latest corporate deck, you mentioned that 14% of commercial lives remain uncovered. So, you know, curious not to... get ahead of any updates. But if you do see an update from Aetna, you know, how close to full coverage could that get you? And how widespread is the coverage within those different plans today?

speaker
Michael Dale
President and Chief Executive Officer

Rick, why don't you take that question?

speaker
Rick
Vice President, Market Access and Reimbursement

Yeah, happy to do it. Good question. It would put us in the mid-90s if Aetna extended coverage. And there are a couple of regional payers out there that we certainly communicated with in our target markets. We feel really good about that. The term we like to use instead of saying full coverage is near universal, but I wake up every day feeling pretty good if we have Aetna making a coverage decision. And then timing on that, because you guys are probably curious. You know, we expect something by the end of June, but that's based on historical updates. So trust that I wake up every day and refresh that webpage and try to see what the news is.

speaker
Mike Kratky
Analyst, LeRinc Partners

Thanks very much. Appreciate the call. Thanks, Mike.

speaker
Operator
Conference Call Operator

Our next question comes from Jason Bedford with Raymond James. Please proceed with your question.

speaker
Jason Bedford
Analyst, Raymond James

Hi, good morning, and congrats on the progress here. I guess just are you selling BLA product today? And if not, when will it be launched? And then just as my follow-on, I'll ask it up front. Is there a different launch strategy specifically around price, area of focus? Any detail there would be great.

speaker
Michael Dale
President and Chief Executive Officer

We are now selling a BLA-produced product. There is no change in the pricing structure. And in terms of general positioning, effectively no change beyond the presentation to customers that the product is now the first biologically approved therapeutic solution for providing physical scaffolds for treating nerve discontinuities. We remind people of the criteria that was required of that process, and oftentimes thank particularly the existing customers for their support and confidence in the product over the years. But effectively, it's business as usual for the surgeon doing that kind of work.

speaker
Jason Bedford
Analyst, Raymond James

Thank you.

speaker
Michael Dale
President and Chief Executive Officer

Thank you, Jason.

speaker
Operator
Conference Call Operator

Our next question comes from Kaitlyn Roberts with Canaccord Genuity. Please proceed with your question.

speaker
Kaitlyn Roberts
Analyst, Canaccord Genuity

Hi, thanks. Congrats on Great Corps and thanks so much for taking the questions. You know, just to ask again on the biologic product transition, does that change really the method or the regulatory procedures by which a new hospital or the VAC committees within the new hospital would approve advance or did that really occur with the BLA approval?

speaker
Michael Dale
President and Chief Executive Officer

there's no change whatsoever in the activities that you asked about. The transition is effectively invisible to the customer.

speaker
Kaitlyn Roberts
Analyst, Canaccord Genuity

Got it. Understood. And then just thinking about the commercial coverage currently, how many, if any, of the current payers have any restrictions on the length of the type of nerve based on you know, the recon study or, you know, what was approved under the BLA and then conditionally approved under the BLA.

speaker
Rick
Vice President, Market Access and Reimbursement

Rick, why don't you go ahead and address the question? Yeah. Hey, Caitlin, good question. So, Elevance, first is good news, right? Elevance removed us from the investigational experimental list. We were surprised that they chose the recon gap length and put that criteria on there. We've actually already engaged them and have consistent communication. We feel it's inappropriate for a few reasons. First is to preauthorize on gap length is just surgically inappropriate because you don't know the gap length until you get into the operating room. So we educated them on that. And if you go read the medical policy update, there are three key omissions. One of them is there's no mention of the VLA. Second is there's no mention of the biggest systematic review and meta-analysis on nerve repair, which shows that Avance is as effective as Autograph in long gaps. And the third is they don't mention either of the specialty society position statements that were issued last year. So we've submitted this to them. We expect there will be an update sometime hopefully by the end of this year or early next year to correct this. But we think it's just an honest error on their part. They've been collaborative, and we look forward to addressing it here in the near future.

speaker
Lindsay Hartley
Chief Financial Officer

Great. Thank you so much.

speaker
Michael Dale
President and Chief Executive Officer

Thanks, Caitlin.

speaker
Operator
Conference Call Operator

Our next question comes from Anthony Patron with MZUHU Group. Please proceed with your question.

speaker
Anthony Patron
Analyst, Mizuho Group

Thanks, and congrats on the quarter here. Strong execution. Maybe to go back to breast resensation, Mike, you mentioned five programs. You have 75 surgeons in there, and each of these end markets are a little bit different. So maybe when you have a program that's ongoing, you're training surgeons, what has been the average conversion rate to an active implanter, and how does that stack up to breast? Is it similar in extremities to breast, or does the conversion curve look a little bit different? And I'll have one follow-up.

speaker
Michael Dale
President and Chief Executive Officer

With regards to breast, and I'm generalizing here, but the historical conversion rate has been above 75%.

speaker
Anthony Patron
Analyst, Mizuho Group

That's helpful. And is that across all end markets or that's breast specifically?

speaker
Michael Dale
President and Chief Executive Officer

It's breast specifically.

speaker
Anthony Patron
Analyst, Mizuho Group

Okay. And then maybe just to recap, when we think about pushing into these new markets, breast and prostate, just a recap of The amount of graft per case, what does it look like in breast and potentially prostate if we get there relative to core extremities? Thanks. Vince, why don't you address that?

speaker
Jens
Director, Clinical Operations

Yeah, so in breast reconstruction procedures, we typically see bilateral reconstructions, which means two grafts per procedure. In prostate, it depends whether or not it's unilateral nerve sparing or bilateral. bilateral, or sorry, or a non-nurse-bearing procedure. So, it could be one graft if it's just one side or two grafts if it's both sides that needs the prostate that needs reconstruction. So, it depends on the mix.

speaker
Michael Dale
President and Chief Executive Officer

Thank you. Thanks, Anthony.

speaker
Operator
Conference Call Operator

Our next question comes from Frank Tikinen with Lake Street Capital Markets. Please proceed with your question.

speaker
Frank Tikinen
Analyst, Lake Street Capital Markets

Great. Thank you for taking the questions. Congrats on the quarter. I was hoping to start on sales reps. Mike, I think I heard you call out 146 reps. Could you parse out between the different units that you have in the past between extremities and breast? And then as a second part to that, I think you previously guided for 130 extremities and 30 breast reps by year end. With some of the positive developments and momentum so far in 2026, could you see yourself potentially hiring ahead of that plan?

speaker
Michael Dale
President and Chief Executive Officer

The answer to the last question is yes, we're always looking at that. The key element is making sure we maintain quality control and logistically. So, yes, constantly monitoring that. But the primary expectation is to stay on schedule at minimum. In terms of the breakouts, we have 26 rest reps now in place, and we have three regional sales directors. And then extremities, we have 120 reps in place and 15 regional sales directors. And in OMF head and neck, we have four field-based market managers who support that effort. And in prostate, we have three clinical development managers and one director who manages the program.

speaker
Frank Tikinen
Analyst, Lake Street Capital Markets

Great. That's helpful. And then just as a follow-up on some of the gross margin commentary, any other details you can provide on cadencing of margins should we expect that Q2 impact, given it's the first quarter of BLA products, to be more pronounced? Or will it actually be less pronounced as it is transitioning and then through the back of the year? You could see it either go up or down. Any color on that would be helpful.

speaker
Lindsay Hartley
Chief Financial Officer

Yes. Hi, Frank. This is Lindsay. For this quarter Q2 that we're in right now, we expect to be at the lower end of that range where we should see the most pressure from transitioning to the BLA. And then for each quarter, we should expect to be within that range and here as well.

speaker
Frank Tikinen
Analyst, Lake Street Capital Markets

Perfect. Thank you. Thanks, Frank.

speaker
Operator
Conference Call Operator

Our next question comes from Dave with Citizens. Please proceed with your question.

speaker
Dave
Analyst, Citizens

Hey, good morning, guys, and congrats. I'd follow up one for Rick. You know, looking at some of the decisions from the insurance companies and noting that, you know, they called out some of the specific indications like breast, is that common? Do you expect that you might need to go back to some of these payers? to get, like, a broader coverage, or was that expected for some of these, you know, insurers to kind of call out specific target areas like that?

speaker
Rick
Vice President, Market Access and Reimbursement

Thanks for the question, Dave. Our label on the BLA is quite broad, and we expected the coverage criteria that the payers set to continue to be broad, and you can see it in the growth in all of our markets. So I don't think we're going to have to go back to the well too much, but I look, we stay pretty well connected with our sales force, with surgeons out there. If we hear denials, we're pretty engaged. And as you can tell, we've got pretty consistent communication with medical policy teams out there. So we don't expect any big hiccups. If we run into any hurdles, we'll go collaborate with the payers and try to knock those down in due time. But look, the product's been on the market 17 years. We got well over 100 publications, and we have society position statements and a BLA approval. So we've got a pretty strong case for coverage and a really good evidence package.

speaker
Dave
Analyst, Citizens

Thank you for that. And then maybe, Mike, just, you know, it doesn't seem like you need to do anything but invest kind of organically here, but $100 million on the balance sheet now. Just thoughts on the world you're operating in. Are there M&A opportunities specifically in nerve repair that you're looking at?

speaker
Michael Dale
President and Chief Executive Officer

Sure. With regards to the cash, as we've mentioned in the past, We have significant infrastructure development underway from a capital allocation standpoint in terms of systems, so we'll continue to deploy cash for those purposes. And then if we opportunistically see assets that would further burnish our business purpose, we'll absolutely pay attention to deploying cash for that purpose. But that's kind of a day-to-day hygiene, you might say, as an expectation from our viewpoint.

speaker
Dave
Analyst, Citizens

Thank you.

speaker
Michael Dale
President and Chief Executive Officer

Thanks, Dave.

speaker
Operator
Conference Call Operator

Our next question comes from Yi Chen with HC Wainwright. Please proceed with your question.

speaker
Katie
Analyst, HC Wainwright

Hi, good morning. This is Katie on for Yi. I was hoping we could get a little bit more color on maybe percentages or how the breakdown is working out in your percentages of growth. So it's like new surgeons versus existing account expansion. I know you said you were getting more people on board at existing facilities, but are you getting more locations? And are you seeing more new indications versus those core trauma? Just trying to get a feel for if growth is becoming, is kind of concentrated or if it's getting more diversified as you go along.

speaker
Michael Dale
President and Chief Executive Officer

Well, I'll ask you to weigh in on this as well, but this is a general statement. So the key driver in terms of overall growth is numbers of surgeons and the relative productivity of individual surgeon practitioners. So both are key elements. The third in that line would be adding the number of accounts, primarily driven by oral, maxillofacial, and breast. the number of accounts on the extremities is also growing, but only incrementally as compared to the others. So that, from a source standpoint, that's the hierarchy in terms of contribution.

speaker
Jens
Director, Clinical Operations

Yeah, I think Mike, you said it well. I think the key takeaway is that this is thought-based growth. We're seeing surgeon activation across all of our markets, and the same for new accounts. So it's really broad-based. We continue to have a strong focus in our high-potential accounts. Saw strong growth here as well in this quarter, but it really is broad-based. We're seeing growth across all of our markets.

speaker
Katie
Analyst, HC Wainwright

Great. Thank you guys so much.

speaker
Michael Dale
President and Chief Executive Officer

Thank you.

speaker
Operator
Conference Call Operator

Ladies and gentlemen, that concludes our question and answer session. I'll turn the floor back over to Mr. Dell for any final comments.

speaker
Michael Dale
President and Chief Executive Officer

Thank you, operator. On behalf of the action team, I want to thank everyone for their time and interest in our work to fulfill the promise and potential for all stakeholders of our business purpose, which is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We look forward to updating you on our continued progress on our earnings call next quarter. Thank you very much.

speaker
Operator
Conference Call Operator

Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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