AxoGen, Inc. (AXGN) 2026 Q3 法說會逐字稿

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  • Operator

  • Good morning, everyone. Joining me on today's call is Michael Dale, Axogen's President and Chief Executive Officer, and Lindsey Hartley, Chief Financial Officer.

  • Michael will discuss third quarter 2026 financial results and corporate highlights.

  • Lindsey 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 Investors section of Axogen's website.

  • Following the end of the live call, a replay will be available on the Investors 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, including anticipated benefits and integration activities related to the BioCircuit acquisition.

  • 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 Commission, 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 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 investors section of the company's website.

  • Now I'll turn the call over to Michael. Michael, please go ahead.

  • Michael Dale - Chief Executive Officer, Director

  • Thank you, operator, and good morning, everyone.

  • Today, I will walk you through our third quarter performance using the same lens we've used all year, which are the six priorities that comprise our strategic plan.

  • Once I've concluded my commentary, Lindsey will review our financials in detail, after which we'll open the call for questions.

  • Before reviewing performance against each strategic priority, I would like to make clear how delighted we are with our third quarter and year-to-date results. We are meeting or exceeding our customer creation objectives as Ralph the board and remain confident in our ability to execute our strategic plan.

  • Starting with our first priority, which is revenue growth and financial operating leverage.

  • Third quarter revenue was $75.8 million, up 26.2% from third quarter 2025, with growth in all of our markets.

  • Breast grew more than 50% year-over-year and extremities, OMF, head and neck combined grew 10.7%.

  • Advance made-up 64% of revenue in the quarter and year-to-date.

  • Versus about 60% for 2025.

  • GAAP net income was $2.3 million, adjusted net income was $13.1 million and adjusted EBITDA was $13.4 million with adjusted EBITDA margin of 2.3 percentage points from a year ago.

  • We ended the quarter with $350 million in cash equivalents. Restricted cash and investments, including proceeds from our September equity offering.

  • GRalph margin was 74.8%, up from 72.7% in the second quarter and down from 76.6% a year ago.

  • Moving to our second priority, market development.

  • Consistent with prior quarters, all three target markets contributed positively to third quarter results.

  • We continue to see momentum in the breast as nerve reconstruction becomes a larger part of the breast reconstruction conversation.

  • Growth is coming from expansion within existing accounts, new surgeon adoption, and new account development, supported by rising patient awareness and interest in breast sensation.

  • Because this market remains early in its development, we see significant long-term growth potential from expanding our commercial footprint, developing new accounts, and training new surgeons.

  • In third quarter, we held our final two surgeon training programs planned for 2026, training more than 50 plastic surgeons in the resensation technique.

  • We also continued investing in patient awareness and completed significant market development work to prepare for Breast Cancer Awareness Month in October.

  • We now have roughly 485 active breast accounts, up more than 95 year-over-year, and roughly 590 active surgeons, up more than 140 year-over-year.

  • Turning to extremities and OMF and head and neck markets. Growth was double-digit in the third quarter, continuing the steady progress described on prior calls, supported by account expansion and increased surgeon activation as driven by our high potential account strategy.

  • Extremities grew acRalph key indications in both upper and lower extremities.

  • In OMF, head and neck growth was driven by adoption of our algorithm in mandible reconstruction and continued momentum in oncologic procedures such as neck dissections.

  • With regards to priority three, commercial expansion, breast now has 31 representatives and three regional directors, 10 more representatives than at the start of the year.

  • Extremities in OMF and head and neck has 132 representatives and 15 regional directors, 15 more than at the start of the year.

  • We also have three field-based market development managers supporting OMF and head and neck and three clinical development managers supporting prostate.

  • The fourth priority of our strategic plan is commercial excellence.

  • Our primary strategy over the past several years. Focusing on high potential accounts to build enduring nerve care practices continues to deliver results.

  • In these accounts, our goal is to develop new surgeons and drive adoption of best practices and the full treatment algorithm, making the restoration of peripheral nerve function a standard of care acRalph the hospital.

  • Year-to-date, high potential accounts generated 61% of revenue and 55% of growth.

  • With productivity increasing 22%. Productivity in non-hypertensive counts rose 25%, while productivity acRalph all accounts increased 22%. These results point to broader adoption in nerve care as more surgeons practice acRalph multiple sites, supported by expanded coverage.

  • Next, I'd like to update everyone on our fifth priority, standard of care, evidence, and coverage.

  • Today, we have two national payer updates to provide.

  • Let's start with Elevance.

  • In April, Elevance removed Advance from its experimental and investigational list, but included a utilization management criterion based on the nerve gap length from the recon trial.

  • After a collaborative meeting with Elevance and a few world leading surgeons in the second quarter, Elevance removed the gap length criteria in August.

  • This timing beat our internal expectations.

  • Now Aetna.

  • In early October, Aetna extended coverage to events for short to medium sensory nerve gaps of 30 millimeters or less in the upper extremity.

  • As we've stated before, it is common for medical policy teams to initially adopt strict utilization management criteria for a new coverage position, and we believe that is what drove Aetna's decision.

  • Similar to how we've handled the prior Elevance situation, our health economics and reimbursement team will partner with surgeons to educate Aetna and resolve this situation collaboratively.

  • With the updates from Elevance and Aetna, the commercial payer coverage for Evance is approximately 96% of covered lives in the United States.

  • This satisfies the milestone in our strategic plan for near universal coverage.

  • Since the second quarter of 2025, we have added an estimated 87.6 million commercial and Medicare Advantage lives acRalph Cigna, Elevance, Aetna, and the 12 Blue CRalph Blue Shield regional plans.

  • Beyond expanding coverage, we continue to invest in the clinical evidence needed to advance nerve repair as an expected standard of care.

  • This quarter, we made progress acRalph that evidence strategy, including. New peer-reviewed evidence in advancement of two important clinical studies.

  • Recently, results from our MATCH study were published providing direct comparative evidence for advanced nerve graft and nerve autograft in mixed and motor nerve reconstruction. The study demonstrated that motor recovery with advanced was comparable with autograft, further strengthening the body of clinical evidence supporting advanced and mixed and motor nerve repair.

  • Nerve restore, which we described last quarter, builds upon this evidence through a randomized assessor-blinded comparison of advanced nerve graft and seral nerve autograft and mixed in motor nerve repair.

  • We are pleased to report that the first patient has now been enrolled, marking an important milestone in this study.

  • Additional site activations are planned for the fourth quarter as enrollment continues.

  • We are also advancing EMBRACE. Our prospective multi-sensor study evaluating sensory recovery following breast reconstruction with and without nipple areolar complex nerve reconstruction.

  • The study is designed to generate comparative evidence on restoration of nipple areolar complex sensation, including patient-reported outcomes.

  • Study startup is underway with the first site initiation planned for the fourth quarter.

  • And finally, our sixth priority, which is about innovation, R&D, and therapeutic reconstruction.

  • On October 1, we completed our acquisition of Biocircuit, adding nerve tape as the sixth product in our nerve repair algorithm.

  • We see significant potential to scale nerve tape as a faster, easier coaptation date.

  • In large gap repairs, nerve tape can be used with advance to connect the proximal and distal nerve ends.

  • Nerve tape also expands our reach into direct repair, an underdeveloped and effectively new opportunity for accident that represents approximately 40% to 50% of transected nerve procedures.

  • In these procedures, nerve tape enables surgeons to reconnect a transected native nerve more simply and effectively than with microsuturing, the predominant method used today.

  • Biocircuit historically sold through approximately 50 independent distributed representatives and served roughly 400 accounts.

  • As of today, Actugen's direct sales organization has assumed all sales and distribution responsibilities.

  • We expect the transaction to contribute to revenue growth and adjusted EBITDA margin in the 1st year, while Actugen remains free cash flow positive.

  • Looking ahead, we are confident that leveraging nerve tape acRalph Oxygen's direct commercial platform and demonstrating its ability to enable simpler, faster and more effective repairs will accelerate the adoption of nerve repair and strengthen our overall growth strategy.

  • Turning to prostate, as announced in this morning's earnings release, we will initiate prostate nerve reconstruction market development in 2027.

  • Based on collaboration with global experts in urology and men's sexual health, we validated the clinical need, which is substantial, developed a scalable technique that is efficient and reproducible and see positive clinical outcome signals from our clinical development sites.

  • To date, over 220 patients have received prostate nerve reconstruction with Advance acRalph 15 clinical development sites.

  • Of these, 117 patients have at least six months of follow-up, 86 grafted on one side unilaterally and 31 grafted on both sides bilaterally.

  • No graft or grafting procedure-related complications were reported.

  • Historically, men undergoing traditional non-nerve-sparing radical prostatectomy have a high risk of severe erectile dysfunction, with unilateral non-nerve-sparing patients reporting recovery of erectile function in only 33 to 56% of men.

  • And those undergoing bilaterally non-nerve sparing procedures having a less than 13% chance of recovering useful erections.

  • When preparing the nerves with AVANCE, we see that among patients with at least six months of post-operative follow-up, surgeons report that approximately 80% have achieved better than expected recovery of erectile function.

  • Defined as a Sexual Health Inventory for Men or otherwise known as SHIM score of 15 or higher.

  • On this validated 25-point scale, a score of 15 or higher is generally associated with erections sufficient for sexual activity.

  • For reference, a score of 7 or lower indicates severe erectile dysfunction.

  • These early results suggest that meaningful erectile function may return as early as six months after surgery when following post-operative penile rehabilitation protocols as prescribed with or without PDE5 inhibitors.

  • In addition, over 95% of patients achieved pad-free urinary continence at or above expected levels.

  • These results demonstrate an exceptional benefit-to-risk ratio and have established the foundation to initiate prostate nerve reconstruction market development in 2027.

  • We look forward to sharing a detailed overview of the clinical outcomes and market research underlying our decision to move forward on November 9th.

  • Dr. David Lee. Professor of Urology at the UC Irvine School of Medicine and Director of the University of California Irvine Health Comprehensive Prostate Cancer Program and Dr. Zayed Xuan, Assistant Professor of Urologic Surgery at Cleveland Clinic will join us to provide clinical and patient perspectives.

  • Regarding the financials and logistics of our prostate nerve reconstruction market development plan, we will share details during our March 2027 Investor Day.

  • We believe nerve reconstruction in prostatectomy can become a meaningful long-term growth driver for Axigen and more importantly, a new standard of care for men facing prostate cancer.

  • Lastly, as a reminder, prostate is not included in our current or long-range guidance. We will provide an update on guidance in the first quarter of 2027.

  • To close, we are delighted with our overall business performance and have high confidence in our ability to continue executing our near and longer-term plans.

  • With that, I will now turn the call over to Lindsey to review our financials.

  • Lindsey Hartley - Chief Financial Officer

  • Thanks, Mike. I'm pleased to report our third quarter 2026 financial results.

  • For the third quarter, we reported revenue of $75.8 million, reflecting growth of 26.2% year-over-year.

  • Revenue growth continues to be driven by strong demand for Advance and adoption of our product algorithm acRalph target markets, with unit volume serving as the primary driver then price.

  • Our gRalph profit for the quarter came in at $56.7 million. This represents a gRalph margin of 74.8%. GRalph margin decreased 180 basis points year-over-year, driven by 3% higher product cost, partially offset by 1.2% lower write-off.

  • We continue to expect gRalph margin to decline in the fourth quarter sequentially and to be slightly less than our second quarter as a result of adjusting our production plans beginning in the third quarter to better align production with the increased demand for long-length advance largely stemming from the growth of our breast business.

  • Yield improvements and pricing actions are underway, but their impact on gRalph margin will lag as they move through cost of goods sold. We expect full year 2027 to be more in line with full year 2026 and will provide formal 2027 guidance in the first quarter.

  • Operating expenses increased to $55.8 million in the third quarter, up from $44.1 million in the third quarter of 2025, an increased 0.1% of revenue.

  • The increase year-over-year was driven primarily by compensation costs. Stock-based compensation expense tied to certain PSU anticipated to achieve above target on revenue growth components and costs related to the acquisition of BioCircuit.

  • Sequentially, as a percentage of revenue, operating expenses decreased 2.3 percentage points.

  • Sales and marketing expenses as a percentage of total revenue decreased. 2.7 percentage points to 40% in the third quarter compared to 42.7% in the third quarter of 2025.

  • Sequentially, as a percentage of revenue, sales and marketing expenses decreased 4.2 percentage points.

  • Research and development expenses increased 18.3% to $9 million in the third quarter compared to $7.6 million in the third quarter of 2025 and as a percentage of total revenue decreased to 11.8% from 12.6%.

  • Sequentially, as a percentage of revenue, research and development expenses decreased. 0.5 percentage points.

  • General and administrative expenses increased 51.9% to $16.5 million in the third quarter compared to $10.8 million in the third quarter of 2025 and as a percentage of total revenue increased 3.6 percentage points to 21.7% from 18.1%.

  • Sequentially, as a percentage of revenue, general and administrative expenses increased 2.4 percentage points.

  • During the quarter, we incurred $2 million of costs related to our acquisition of BioCircuit, contributing to the year-over-year and sequential increases.

  • Net income for the third quarter was $2.3 million or $0.04 per share compared to $700,000 or $0.01 per share in the third quarter of 2025. Sequentially, net income improved $3.9 million.

  • Adjusted net income was $13.1 million or $0.21 per share. For the third quarter compared to $6.1 million or $0.12 per share for the third quarter of 2025.

  • Sequentially adjusted net income improved $5.8 million.

  • Adjusted EBITDA for the third quarter was $13.4 million compared to an adjusted EBITDA of $9.2 million in the same period last year and as a percentage of revenue increased 2.3 percentage points to 17.7% from 15.4%. Sequentially adjusted EBITDA improved $5 million.

  • Adjusted net income and adjusted EBITDA are calculated as net income or EBITDA adjusted for stock-based compensation, the loss on the extinguishment of debt, and the transaction and integration cost incurred in connection with the acquisition of BioCircuit.

  • The improved bottom line performance demonstrates our continued ability to drive both top-line growth and profitability.

  • As of September 30, 2026, cash equivalents, restricted cash and investments totaled $350.1 million.

  • Through the first nine months of 2026, we generated $18.9 million of free cash flow.

  • On October 1, we completed the acquisition of BioCircuit and funded the purchase price of $200 million plus transaction expenses. Integration and purchase accounting activities are underway and progressing well.

  • In connection with our purchase accounting for the transaction, we expect to adjust the value of the acquired BioCircuit inventory and recognize goodwill and intangible assets on our balance sheet.

  • Amortization of these intangible assets over their respective lives will significantly increase our amortization expense and general and administration expenses going forward.

  • Our preliminary purchase price allocation and required disclosures, including pro forma, historical, revenue and earnings related to the Biosypha acquisition will be included in our 2026 Form 10-K.

  • Based on our year-to-date performance, acquisition of BioCircuit and visibility into the remainder of the year, we are revising our full year 2026 financial guidance.

  • We now expect full year 2026 revenue growth of at least 29% or revenue of at least $290 million, including at least $7 million of revenue from BioCircuit.

  • Excluding BioCircuit, we expect organic revenue to be at least $283 million, representing organic growth of at least 26%. We continue to expect gRalph margin to be at least 73% and positive free cash flow for the full year.

  • This guidance does not assume material benefits from payer coverage decisions beyond what's already known, nor from our decision to begin market development activities for Prostate.

  • While not expected, our biocircuit revenue guidance does contemplate some level of integration or disruption risk associated with the acquisition.

  • The expected impact resulting from the overlap of BioCircuits nerve tape with our AxaGuard connector and AxaGuard protector products is included in our organic revenue growth guidance of at least 26%.

  • Our gRalph margin guidance is presented on a GAAP basis, but does not include the potential impact from the purchase accounting adjustment to Biocircuits inventory value as of the acquisition date, which is currently underway.

  • The resulting step-up in value of the acquired inventory could negatively impact gRalph margin in the fourth quarter and for the full year relative to our current expectation.

  • To close, I am pleased with the quarter's results and progress we continue to make improving our profitability. With that, we'll now open the line for questions. Operator.

  • Operator

  • Thank you. We will now begin the question-and-answer session.(Event Instructions)

  • One moment, please, while we poll for questions.

  • Thank you. The first question today comes from the line of Ray Tan with Bank of America.

  • Please proceed with your questions.

  • Ray Tan - Analyst

  • Hi. Thanks for taking our question.

  • My first question is related to breast, which continues to be a strong driver of growth. We saw comps increase year-over-year.

  • And was just curious what share of eligible reconstructions now include recent station with accidents portfolio and how much of this growth is coming from new account activation versus increased utilization within existing accounts?

  • Michael Dale - Chief Executive Officer, Director

  • Sure.

  • With regards to penetration, it's probably around 11%, we don't know exactly, but it's within that range.

  • In terms of the drivers, it's the basic mechanics of increased same-store sales, i.e. The counts are becoming more productive as they adopt re-sensation as a true standard of care.

  • Most surgeons who go through the initial training and then start eventually reach a point whereby it's considered part of any kind of reconstructive procedure.

  • And as that happens, their referral networks otherwise reflect that.

  • The other element is adding new surgeons within an existing account. So once one surgeon begins to practice resensation as part of their repertoire as a standard of care, invariably, other surgeons within the same account will.

  • Ultimately adopt the same practice and then in addition, adding new accounts. And so these are the drivers, both elements are contributing to the double-digit growth.

  • And that's why our priority is expanding footprint so that we can competently and appropriately support the education process and then obviously working through the process of opening all accounts. And I guess to put a fine point on it. Why we continuously say that we expect growth in this area to continue for years as this basic infrastructure and process plays out.

  • Ray Tan - Analyst

  • Great. Thanks.

  • And then appreciate that we probably will get more information on the November 9th call. But just on prostate, of the 110,000 robotic prostatectomies a year, how many procedures are you planning to target at launch or can be targeted at launch? And what determines which procedures can be initially targeted?

  • Michael Dale - Chief Executive Officer, Director

  • Jens will take that question.

  • Jens Kemp - Chief Marketing Officer

  • Our estimated TAN procedure volume is around 110,000 procedures. So obviously, we're not going to target all centers initially. So we're developing the targeting algorithm. We'll be focusing on academic centers, high volume centers.

  • And centers that do a mix of both unilateral, bilateral reconstructions and their spring procedures.

  • Operator

  • Thank you.

  • The next question is in the line of Lawrence Butelsen with Wells Fargo.

  • Please proceed with your questions.

  • Ralph Osborne - Analyst

  • Hi. Good morning, Mike and Lindsey. This is Ralph Osborne off for Larry. Thanks for taking our questions.

  • So to start off, there's been some confusion around how much Nerve Tape is incremental versus cannibalistic to your business and we heard Lindsey's comments on 26% organic growth this year, but how should we think about a $34 million in Nerve Tape sales next year, how much is incremental versus cannibalistic?

  • Lindsey Hartley - Chief Financial Officer

  • Hi, Ralph, this is Lindsey.

  • We for next year, the $34 million that I put out in the press release at closing is incremental, that is net of cannibalization, we'll provide more guidance in the first quarter on 2027.

  • Ralph Osborne - Analyst

  • Okay, great. And then regarding your Aetna coverage update, what share of your Aetna insured advanced procedures falls inside the policy of shorter than 30 millimeters today? And then are Aetna breast cases being paid under WHCRA today or are you seeing denials?

  • Jens Kemp - Chief Marketing Officer

  • Yeah, great question, Ralph. On the second point, which I'll answer first.

  • In the Aetna policy, they have a footnote that says that federal and state mandates apply, and it's been our experience that Aetna, CVS Health intend to comply with WICRA, and so they pay these claims. On the first point, we don't break out our procedures by gap length, and whether it's sensory or mixed motor, but it's a fair number of procedures, and Mike talked about in the prepared remarks.

  • Our match publication, and we just believe the evidence body supports the coverage criteria that we see from the other payers. So, again, we're confident we can resolve this with surgeons and at this team, and it's probably in line with next year's annual update, but that work's already underway.

  • Ralph Osborne - Analyst

  • Great.

  • Thank you for taking our questions.

  • Michael Dale - Chief Executive Officer, Director

  • Thanks, Ralph.

  • Operator

  • Our next question is from the line of Michael Sarcoin with Jefferies.

  • Please proceed with your question.

  • Michael Sarcoin - Analyst

  • Good morning, and thanks for taking the questions, and congrats on a nice quarter. I guess just to start, the updated guide when you exclude the bio-circuit contribution, I think that implies 4Q growth of around 27% year-over-year, and that's about a 1-point acceleration from 3Q. So just wanted to get your take on what you're seeing so far in 4Q in your core markets. And where that expected growth acceleration is coming from in 4Q?

  • Michael Dale - Chief Executive Officer, Director

  • Sure, Mike. The growth that we're seeing is really driven by the fundamentals we mentioned each quarter, which is expand the footprint that allows you to support more surgeons, open more accounts and then go deeper within those. And so those basic sales fundamentals are what applies in our opportunity.

  • As we've long discussed, the opportunity to add value from a benefit versus risk value proposition acRalph the spectrum of nerve dysfunction presentation is huge. And so that question is really what drives and underlies the whole opportunity. And so our job as we see it is making sure that we have people present in each of the areas where we have the ability to develop the education process.

  • To drive that process through new surgeon development education and the addition of new counts that you have to practicing or repair. And so there's nothing really new under the sun, I guess is the best way to summarize it is that the math on this in terms of the footprint just becomes a multiplier effect as that situation expands.

  • Lindsey Hartley - Chief Financial Officer

  • And to add a little color on the guidance.

  • Sequentially from Q3 to Q4, we don't see a large step-up, so we just went based on our normal historical seasonality and our planning and our guide.

  • Michael Sarcoin - Analyst

  • Got it. That's helpful.

  • Thank you both. And then second question is a two-parter. I guess first, can you talk about what you're seeing and your experience so far with your sales force selling nerve tape, particularly around how doctors may be transitioning.

  • From using Connector to Nerve Tape. And then the second part of that is, Lindsey, I believe you mentioned that 26% growth guide for this year includes your cannibalization estimate. I was wondering how you were thinking about that quantitatively and what's baked into the guide for the full year.

  • Michael Dale - Chief Executive Officer, Director

  • With regards to the process of our sales organization.

  • Representing nerve tape, that's all just underway. All I can really speak to at the moment is great enthusiasm. People are very excited.

  • And the reasons why we thought that this would be a good fit for organization, there's nothing that we've experienced thus far to suggest that that original sentiment wasn't well placed and built on a good foundation.

  • As for the issues or the question about the cannibalization, nerve tape is far broader than just connector. And I think that's very important to emphasize and appreciate is that there's many different permutations on a technical nerve repair, whether it be direct or otherwise. And so while the product mix naturally in favor of nerve tape versus connector will still continue to be used for specific procedures.

  • Their tape will obviously be adopted more for large gaps, but then in particular, the application towards direct repair where we can eliminate the requirement for microsuturing in a more effective way in a simpler and faster manner.

  • So nothing's changed in terms of the thesis here and people will be able to, of course, measure.

  • What we've just expressed in terms of explaining Biocircuit on a quarter-to-quarter basis, we'll publish those results from a pro forma standpoint.

  • But we have high confidence that this will be highly synergistic and appropriately accretive to the business.

  • Lindsey Hartley - Chief Financial Officer

  • And when setting the guide for the organic growth. We, through our research, we modeled just an assumption of what the cannibalization will look like. And so as we move forward with integrating trial circuit, we'll continue to challenge those assumptions and see how close we are and adjust as needed. But they are baked in. We're not going to guide to the exact amount of cannibalization that we are anticipating, but we're just going to disclose the organic growth.

  • Michael Sarcoin - Analyst

  • Okay, great.

  • Thank you.

  • Operator

  • The next question comes from the line of Christopher Pasquale with Barclays. Please proceed with your question.

  • Michael - Analyst

  • Hi, this is Michael on for Chris.

  • Thank you for taking the question and congrats on a nice quarter. I wanted to ask just one question on the nerve tape opportunity. It seems like there are several different levers you could pull on here to drive growth moving forward and I just want to understand what you think is the biggest opportunity. Is it under the direct nerve repair procedures, increasing nerve tape utilization in existing advanced cases, or are you even expanding the population of surgeons willing to use advanced because of the easier procedure? And how soon do you think you could capitalize on each of those opportunities and at which pace?

  • Thank you.

  • Michael Dale - Chief Executive Officer, Director

  • To be very Honest, I know this might be unsatisfying, but it's all of the above.

  • Anytime you can make any procedure more adoptable through ease of use without sacrificing effectiveness, that this basically removes burdens and barriers, so we think it will be enabling of nerve repair in general over time to include people taking on practicing certain elements of nerve repair. That otherwise might not have been able to do so or wouldn't do so because of the micro-suturing requirements. So that won't happen overnight, but that is part of the strategic rationale.

  • In terms of its adoption, I think in the procedures where it's currently gotten its start, OMF amendable procedures.

  • And then you add into that breast that will continue to grow for the reasons that it started, which it simply makes the procedures more accessible and easier and faster.

  • And then finally, strategically direct repair, which is an area that we haven't really had tools that would provide a superior value proposition when you're simply taking the nerve that's been that that suffered a simple transaction and you put it back together.

  • Now with nerve tape, we have the ability to bring a real value there in terms of, again, effectiveness, simplicity and speed. And so all of these are going to contribute to the incremental growth, and we've seen nothing in our early experience to suggest otherwise. And again, as a reminder, we've been following this aspect for quite a while, so it's not as if we don't have familiarity with it.

  • Operator

  • The next question is from the line of Mike Kratky with Leerink Partners.

  • Mike Kratky - Analyst

  • Hi, everyone. Thanks for taking our questions and congrats on another great quarter. Maybe to start and apologize if I missed that.

  • Can you help quantify what your growth looked like in Breast during the third quarter after the 47% growth in the first half?

  • Lindsey Hartley - Chief Financial Officer

  • In the third quarter, the Breast growth is over 60%.

  • Mike Kratky - Analyst

  • Just in terms of a follow-up, can you help quantify to what extent you've seen incremental growth coming from your recent commercial wins? And is it fair to think that those commercial wins are having an outsized impact in extremities and OMF or is breast also benefiting from that equally?

  • Michael Dale - Chief Executive Officer, Director

  • It's very difficult to quantify it, Mike, and part of the reason is kind of a bias analysis and so far as you know when you have an issue because everyone brings it to your attention. Well, when it's no longer an issue, no one tells you, hey, it's no longer an issue.

  • So we don't really have the ability to quantify other than to generalize and say clearly our work is enabled in terms of customer curation simply because there's fewer and fewer coverage and reimbursement issues.

  • Mike Kratky - Analyst

  • Understood. Thanks very much.

  • Operator

  • Our next question is from the line of Caitlin Roberts with Canaccord Genuity. Please proceed with your questions.

  • Caitlin Roberts - Analyst

  • Hi, congrats on the reporter and thanks for taking the questions. Good morning.

  • Maybe just some more color on the over 4,000 surgeons. I think you noted on the last call that are potentially users of nerve tape. So how many of those would be market expansionary to oxygen and what kinds of surgeons are you adding there and what's the medical education strategy over the longer-term for you guys there?

  • Michael Dale - Chief Executive Officer, Director

  • Sure.

  • With regard -- well, first of all, we've only just begun, so can't report any differences in terms of adoption yet. It's just too early. But in terms of medical education strategy, the actual technical use of the product is extremely simple. There are very low levels of required education.

  • Where most of the consultative selling and market development will take place will be in best use case scenarios and development. So for example, direct nerve repair, what I mentioned earlier, OMEP procedures, we have individuals who are not necessarily microsurgical training, but have very difficult procedures. Where you're trying to reconnect a nerve to a nerve stump in the mandible, those are very difficult and sometimes becomes a barrier to actually doing the nerve part of the procedure. So nerve tape.

  • Enables that to making it much simpler by virtue of its form factor. So that's where most of the training will come back. The actual use, literally, of the tape is like in the movies that we've provided in the links. It's that simple.

  • So hopefully that answers your question.

  • Jens Kemp - Chief Marketing Officer

  • Great.

  • Jens has some additional color on the actual penetration. If you combine the AxiGuard connector and nerve tape penetration of the overall TAM procedure TAM that we see, it's around 5% today. So there's a significant opportunity to grow nerve tape in procedures acRalph all of our as we see both in graft repair and in direct repair as Mark.

  • Caitlin Roberts - Analyst

  • Understood. And then you also touched briefly on this on your last call relative to Axagard, but maybe just speak to, again, the economics and the reimbursement landscape for nerve tape?

  • Jens Kemp - Chief Marketing Officer

  • Yes. So the proper code for a nerve tape procedure is 64,910. That's a nerve repair with a conduit.

  • So I think we updated the corporate deck with also a. The CMS payments for a direct repair code as well. So you can see that there's adequate facility payment to cover the implantables in any procedure like that.

  • Caitlin Roberts - Analyst

  • Great. Thanks so much.

  • Jens Kemp - Chief Marketing Officer

  • Thanks, Caitlin.

  • Operator

  • The next question is from the line of Ravi Misra with Truist Securities. Please proceed with your question.

  • Ravi Misra - Analyst

  • Hi, good morning. Thanks for taking the question. So just one.

  • My first question, just on the Salesforce kind of productivity and headcount additions, you've pretty much achieved your full year guidance here in the third quarter, at least exiting 3Q.

  • How should we think about the pace of rep adds for the remainder of the year? And productivity took a pretty nice step up even ahead of the nerve tape being layered into the bag.

  • Do we just kind of assume similar run rate and kind of layer on nerve tape or do you see further increases, I guess, at least in 4Q on that front?

  • Lindsey Hartley - Chief Financial Officer

  • Yes, we're going to continue to add headcount. We'll come out in Q1 with our guidance for 2027.

  • As we go into '27, we will be posting for more positions and continue to hire into these roles.

  • Michael Dale - Chief Executive Officer, Director

  • The constraints mentioned before in terms of our pace of ad will be that we don't affect profitability. So but that said, we see footprint expansion as to be one of the most important levers in the business.

  • Ravi Misra - Analyst

  • And then just strategically on the nerve tape integration.

  • And biocircuit integration. Our checks have at least suggested pretty robust enthusiasm for this product that the company might not have been able to kind of get through hospitals on their own.

  • How do we think about the VAC process with existing Axigen contracts or just the kind of logistics of getting this into doctors' hands now that you own it, could you maybe provide a little bit of color how you plan on accelerating that?

  • Jens Kemp - Chief Marketing Officer

  • That's a great question. So Fire Circuit had around 400 accounts, active accounts. We have a footprint of close to 3,000 accounts. And given our presence in these accounts and the presence of our portfolio connections within the facilities, we do believe that we'll be able to accelerate approval.

  • In the back process for nerve tape. So we definitely believe that we will continue to expand the presence of nerve tape throughout our accounts in the coming months and that process is already started.

  • Operator

  • The next question is from the line of Jason Bedford with Raymond James. Please proceed with your question.

  • Zack Gold - Analyst

  • Good morning, Lindsey. Hope you guys are doing well. Zack Gold on for Jason here.

  • I'll just take a step away from nerve tape for a second here, so I got a couple of questions on that. I think Lindsey made a comment that '27 margins will be similar to '26. I don't want to kind of ask for '27 guidance before you're ready. Maybe can you walk us through some of the puts and takes. What helps, what hurts '27 margins, does this include any impact from selling prostate or how did you get to '27 similar to '26 margins?

  • Lindsey Hartley - Chief Financial Officer

  • Yes, so we're going through right now some pricing initiatives as well as yield initiatives. And as we put those into place, they're just going to take time to be able to go through COGS.

  • And so we don't predict right now.

  • That we'll see a big uplift in '27 from that. So that's why I've guided the way that I have informally until we get to Q1 and we have pricing fixed.

  • With prostate, it does help with our initiatives in production in terms of just getting more from each donor.

  • And we do see that as being helpful, but again, we won't probably see that in '27.

  • Zack Gold - Analyst

  • Got it. That makes sense. And then on profit, just a follow-up there.

  • I know breast has been a source of margin softness just given the length of the breast and I think Mike has talked about this last quarter with the COGS proportional.

  • Will you guys see sort of a similar margin dynamic from prostate? Is it also sort of a disproportionate COGS versus revenue dynamic?

  • Michael Dale - Chief Executive Officer, Director

  • Generally speaking, prostate should be helpful. The graphs are shorter in length.

  • So therefore, your productivity per donor is better.

  • So the answer to the question is we don't see the same pressure.

  • Zack Gold - Analyst

  • Got it.

  • Thank you, guys.

  • Operator

  • The next question is from the line of Anthony Petrone with Mizuho.

  • Please proceed with your question.

  • Anthony Petrone - Analyst

  • Thanks, and congrats on a solid quarter, maybe one on core extremities and then.

  • I'll a follow-up on prostate. On core extremities, Mike, maybe could we just kind of go back to those numbers and maybe put an estimate out there of where penetration in that core peripheral market is. And I know in the quarter just leading in, there was a little noise in some of the data that was out there. There was some tough comps, I think, in the September month. But it certainly seems like we're still relatively early in terms of penetration into core extremities. So just.

  • A revisit on those numbers would be helpful and I'll one on prostate.

  • Michael Dale - Chief Executive Officer, Director

  • That's correct, Anthony. So we still view that market as underpenetrated. If you make an adjustment for the case stock from third quarter prior year, growth in extremities is about 15%. And as we look at the business on a going-forward basis, we still believe that extremities will be a business that will range from very high single-digit to low double-digit growth quarter-to-quarter year in year out just by virtue of the logistics of the selling process.

  • And until we see other dynamics to change that, that's the best way to model the business.

  • Anthony Petrone - Analyst

  • Very helpful. And on prostate, the initial studies here on da Vinci prostatectomy, 110,000 a year, but you have a pretty big active surveillance prostate population out there of nearly a million patients and there's certainly intermediate risk patients out there as well. So when you just think of prostate more broadly beyond DVP.

  • Are you going to go after active surveillance, intermediate patients or should we be thinking about this as exclusive to DVPs at least for the first few years?

  • Thank you, Anthony.

  • Michael Dale - Chief Executive Officer, Director

  • First things first, I mean, the value proposition. That we can speak to with high confidence is the unilateral or bilateral non-nerve sparing patients. So in those situations we unequivocally bring to bear value without risk that there's simply no alternative or comparison to.

  • Now what we expect and what we've heard from market research and from surgeons is that as the potential risk of.

  • Of cancer intervention itself shows promise of mitigation that they expect that more patients will be more willing to, first of all, enter into the screening process itself, which is one of the biggest issues is most men just don't even want to know the answer, much less an intervention.

  • And so these things will take time, awareness will have to build, but everyone believes that this will be a. A tide that will raise everybody's boats in terms of better cancer care and better screening.

  • Operator

  • Thanks.

  • Thank you.

  • Our final question is from the line of Frank Takkinen with Lake Street Capital. Please proceed with your questions.

  • Frank Takkinen - Senior Research Analyst

  • Great.

  • Thank you for taking the questions. Just one for me, a little bit broader question.

  • Any guideline updates we should be looking for over the next, we'll call it 12 months or so? I know you've gotten a few this year already, but any other major ones outstanding that are in the relative near term?

  • Jens Kemp - Chief Marketing Officer

  • Are you referring to clinical guidelines or coverage updates?

  • Frank Takkinen - Senior Research Analyst

  • Clinical guidelines.

  • Jens Kemp - Chief Marketing Officer

  • Okay.

  • We don't see any changes to clinical guidelines in 12 months.

  • Frank Takkinen - Senior Research Analyst

  • Okay. Fair enough. Thanks for the questions.

  • Michael Dale - Chief Executive Officer, Director

  • Thanks, Frank.

  • Operator

  • Thank you.

  • Ladies and gentlemen, this concludes our question-and-answer session. I now turn the floor back to Mr. Dale for any final comments.

  • Michael Dale - Chief Executive Officer, Director

  • 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 expected standard of care.

  • We look forward to updating you on our continued progress on our earnings call next quarter.

  • Thank you very much.

  • Operator

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