AxoGen - Earnings Call - Q2 2025

Executive Summary

• Q2 2025 delivered broad-based strength: revenue $56.7M (+18.3% YoY, +16.7% QoQ), gross margin 74.2% (+40 bps YoY, +230 bps QoQ), GAAP diluted EPS $0.01, and adjusted EPS $0.12; adjusted EBITDA rose to $9.3M.
• Results exceeded S&P Global consensus: revenue beat by ~$4.0M ($52.6M* est) and EPS beat by $0.16 (-$0.04* est vs $0.12 actual, Primary EPS basis)*. Values retrieved from S&P Global.
• Guidance raised: FY25 revenue to at least 17% growth or $219M; gross margin reiterated at 73–75% (including ~1% one-time BLA-related impact); net cash flow positive reiterated.
• Key catalysts: advancing Avance BLA (late-cycle meeting, inspections completed in Q2) and expanding commercial coverage (+~10M lives in Q2; ~17M YTD; >55% of commercial lives now covered). Note: post-quarter, FDA extended PDUFA goal date to December 5, 2025 (from September 5) following a Major Amendment submission, potentially shifting expected labeling feedback to November.

What Went Well and What Went Wrong

What Went Well

• Double-digit growth in all target markets (Extremities, OMF/H&N, Breast) drove revenue to $56.7M and GM to 74.2%. CEO: “strong revenue growth across the full range of our nerve repair solutions reflects the soundness of our market development strategies”.
• Sales execution and HiPo account focus: ~70% of YTD revenue growth from high potential accounts vs 66% goal; average HiPo account productivity +21% YoY; 641 active HiPo accounts (+3% YoY).
• Coverage tailwinds: BCBS policy changes added ~10M covered lives in Q2 and ~17M YTD; >55% of commercial lives now covered; management expects acceleration post-BLA approval.

What Went Wrong

• Cost headwinds from Avance processing transition: product costs increased YoY given added steps/tests ahead of biologic transition; Q1 gross margin was pressured (71.9% vs 78.8% in Q1’24), though Q2 improved to 74.2%.
• EBITDA vs consensus mixed: S&P Global consensus EBITDA for Q2 was ~$6.5M*, while actual (Primary/GAAP EBITDA basis per S&P data) was ~$3.4M*, despite strong adjusted EBITDA of $9.3M. Values retrieved from S&P Global.
• Near-term logistics uncertainty tied to BLA: trunk stock likely curtailed post-approval, requiring supply model changes; management is prudently conservative on H2 cadence pending final FDA mechanics.

Transcript

Speaker 2

Joining me on today's call is Michael Dale, Axogen's Chief Executive Officer and Director, and Lindsey Hartley, Chief Financial Officer. Michael will discuss second quarter 2025 financial results and corporate highlights. Lindsey will then provide details on financial performance, guidance, and overall outlook for the year. This will be followed by a question and answer session. Today's call 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 in the Investor section of the company's website at www.axogeninc.com. Before we get started, I'd like to remind you that during the conference call, the company will make projections and forward-looking statements.

Forward-looking statements, which are usually identified by the use of words such as objectives, targets, will, believe, expect, estimate, should, guidance, intend, projects, or other similar phrases, include but are not limited to statements relating to financial guidance, including revenue, margins, cash flow, future profitability, expectations for growth, market development priorities, estimated market opportunities, timing for future product and application launches, and the company's expectations for approval of the Biologics License Application for Avance Nerve Graft, including the anticipated timing of approval and the assumption that Avance Nerve Graft will be designated as a reference product for any future biosimilar nerve graft, and that such designation will provide market exclusivity.

Forward-looking statements are based on current beliefs and assumptions and are not guarantees of future performance and are subject to risks and uncertainties, including without limitation the risk and uncertainties reflected in the company's SEC filings, including its Form 10-K and 10-Q. The forward-looking statements are representative only as of the date that they are made and except as required by applicable law, the company assumes no responsibility to publicly update or revise any forward-looking statements. In addition, for a reconciliation of non-GAAP measures, please refer to today's press release and the corporate presentation on the Investor section of the company's website. Now, I'll turn the call over to Michael.

Speaker 4

Thank you, Operator, and welcome to everyone joining us this morning as we discuss our 2025 second quarter financial results. I'll begin today's call with a financial and corporate overview highlighting our progress through the second quarter and year to date implementing our strategic plan, followed by an update on the Biologics License Application, or BLA, for our Avance Nerve Graft. I will then pass the call to Lindsey to review second quarter's financials and outlook for the remainder of 2025, and then we will open the lines for a question and answer session. As we marked in this morning's earnings release, we are delighted with our second quarter performance and progress year to date for the business. We believe our strong revenue growth and related business milestone achievements reflect the soundness of both our market development strategies and commercial execution capabilities.

I have mentioned publicly on various occasions that I felt our performance through mid-year would be an important measure of our progress optimizing our business model. While there will always be opportunity for further optimization, as a leadership team, we believe based on the measures we use for our customer creation business models, we are managing our market opportunities the way we had planned and have high confidence in our ability to grow the business consistent with the guidance we have previously provided for our strategic plan. Regarding the quarter, Q2 sales increased to $56.7 million, growing 18.3% compared to the same period last year. This performance reflects double-digit growth across all of our nerve repair target markets, including extremities, oral maxillofacial and head and neck, and breasts.

Consistent with prior quarters, our growth is driven by expanding adoption of nerve care using Axogen's nerve repair algorithm for the treatment of all types of peripheral nerve injuries, including traumatic, iatrogenic, and chronic nerve injuries. The Avance Nerve Graft is the primary growth driver, often complemented based on the clinical situation by one or more of our nerve repair connection, protection, or termination products. In extremities, we continue to execute our high-potential account strategy with solid growth in both traumatic and chronic nerve injury procedures in the quarter. In oral maxillofacial and head and neck, surgeon adoption of the Axogen nerve repair algorithm during the quarter was strong across all procedures, particularly in mandible reconstruction procedures. Likewise, in breast, we continue to see strong adoption of our breast ReSensation technique, supported by new surgeon activation, increased procedure volume in implant-based reconstruction cases, and the expansion of our commercial infrastructure.

In summary, we are encouraged by the broad-based adoption of our nerve care portfolio and momentum across each of our three target markets. To assess our progress, we continue to monitor key metrics tied to our plan and 2025 strategic priorities, including high-potential accounts, commercial expansion, professional education, new product development, clinical research, and prostate market development. I'll begin with an update on our performance and growth in high-potential accounts. We continue to focus on expanding our presence in these accounts to drive more consistent customer creation, algorithm adoption, and improvements in sales force productivity. Our goal for 2025 is to generate at least 66% of revenue from high-potential accounts. Through the first half of the year, we continue to exceed our target with approximately 70% of revenue growth driven by high-potential accounts.

Furthermore, through the first half of the year, average high-potential account productivity is up 21% year over year, tracking in line with our full-year target. These results reinforce our belief that our focus on high-potential accounts is enabling broader and more enduring adoption of nerve care and, as such, more predictable growth. During the first half of 2025, there were 641 active high-potential accounts, out of the approximately 780 accounts that meet our high-potential criteria, which represents an increase of 19 accounts or 3% as compared to the first half of 2024. Regarding our 2025 commercial infrastructure expansion goals, as of end of second quarter, we are now at or ahead of our hiring plan for each target market. In breast, we ended the quarter with 19 breast ReSensation sales specialists and one Regional Sales Director.

We are on track to double the breast sales force in 2025 by the end of the year, targeting 22 reps and two Regional Sales Directors. To support broader adoption in non-breast markets, we added five additional sales representatives in high-potential territories in the second quarter, ending with 124 sales professionals, including 12 Regional Sales Directors. In oral maxillofacial and head and neck, consistent with our plan, we added five field-based Market Development Managers year to date. Surgeon training remains a core component of our customer creation and nerve repair algorithm adoption. Execution of our 2025 professional education programs is on track, and we fully expect to meet our 2025 surgeon training targets. In breast, we have trained 35 surgeon pairs year to date, and with three programs planned in the second half of the year, we are confident we will meet our 2025 target of 75 surgeon pairs trained.

Active breast ReSensation programs increased 9% from the second quarter of 2024, from 116 to 126. We estimate 280 surgeons performed a breast ReSensation procedure in the second quarter, which represents a 17% increase versus the second quarter of 2024. In extremities, we have trained 67 surgeons year to date, up 37 from first quarter 2025, with six additional programs planned in the second half of the year. We expect to meet our 2025 target of 105 surgeons trained. In oral maxillofacial and head and neck, we have trained 41 surgeons year to date, up 15 from first quarter 2025. We are on track to meet our 2025 target of 45 surgeons trained. Next, I will provide an update on our clinical research priorities.

We continue to advance our 2025 initiatives and are on track to complete a level one study protocol for implant-based neurotization, a level one clinical evidence plan for Avance versus autograft and mixed and motor nerves, and a clinical evidence plan for oral maxillofacial and head and neck. Regarding research and development, as we have outlined in our strategic plan, innovation is critical to our long-term growth. Through mid-year, we continue to progress and advance our innovation platform across three core pillars: therapeutic reconstruction, ease of coaptation, and protection expansion. Regarding coverage and payment, during the quarter, multiple non-coverage policies were removed within the Blue Cross Blue Shield network for nerve care, adding an estimated 10 million additional covered lives.

Year to date, we estimate 17 million additional lives are now covered for nerve repair for peripheral nerve injuries using synthetic conduits or allografts, which brings coverage amongst commercial payers to more than 55%. Adding to our progress during the second quarter, we enjoyed significant external validation of Axogen's differentiated technologies and leadership in peripheral nerve repair, with 17 new peer-reviewed publications citing clinical use or discussion of our products. For those interested, these peer-reviewed studies are available on our website. Finally, I will provide an update on our prostate clinical and market development plan. We are excited about the opportunity to improve nerve function outcomes in robotic-assisted radical prostatectomy and continue to work closely with key opinion leaders to advance surgical technique development.

During the second quarter, we completed the hiring of our clinical development team, which will provide field-based support to surgeons in pilot sites incorporating nerve repair into their robotic-assisted prostatectomy cases. We added three additional clinical pilot sites and now have six active sites. We expect to meet the goal of having 10 pilot sites running by year-end. Procedures are ongoing, and we aim to complete 100 cases by year-end. Before I hand it over to Lindsey, I would like to address the status of the Biologics License Application, or BLA, for Avance Nerve Graft. The BLA remains on track and continues to progress as planned. During the second quarter, we completed several key regulatory milestones to support our anticipated approval in September of 2025: the late cycle meeting with the FDA, pre-licensing inspection, and sponsor inspection under the FDA's bioresearch monitoring program.

These milestones follow the successful clinical trial inspections we spoke about on our last call, further reinforcing our confidence in the strength and completeness of our Biologics License Application submission for Avance Nerve Graft. We reiterate prior guidance that we expect BLA approval in September. The BLA approval will secure 12 years of market exclusivity from biosimilar nerve allografts and establish Avance Nerve Graft as the only implantable biologic indicated for the repair of functional deficits in peripheral nerves. With that, I will turn it over to Lindsey, who is off to a great start as Chief Financial Officer and is adding a great deal of clarity to our operating performance.

Speaker 0

Thanks, Mike. I'm pleased to report our second quarter results. We reported revenue of $56.7 million, reflecting an 18.3% growth compared to the second quarter of 2024 and a 16.7% sequential increase over the first quarter of 2025. The year-over-year performance was driven by an increase of approximately 3% in price and 15% in unit volume and mix. Our gross profit for the quarter came in at $42 million, up from $35.3 million in the second quarter of 2024 and $34.9 million in the first quarter of 2025. This represents a gross margin of 74.2%, up from 73.8% in the same period last year and up from 71.9% in the first quarter of 2025. The year-over-year increase is primarily due to lower inventory write-offs and shipping costs on products sold, partially offset by slightly higher product cost.

Gross margin for the first half of 2025 was 73.1%, 3% less than the first half of 2024. The decrease of gross margin for the first half of 2025 was driven by a 2.8% increase in year-over-year product cost. Product cost increased as a result of the transition of processing Avance Nerve Graft to our Axogen processing center and cost related to the additional steps and tests required as we approach the transition to processing as a biologic in September. We expect the cost of our Avance product to decrease over time as we gain economies of scale at the Axogen processing center, and once the BLA is approved, we can begin implementing a continuous improvement program. Our operating expenses increased to $40.3 million, up from $35.8 million in the second quarter of 2024, and as a percentage of revenue decreased 3.5%, highlighting our ability to increase our operating leverage.

Sales and marketing expenses as a percentage of total revenue were up less than one percentage point to 42% from 43.1% in the second quarter of 2024. Research and development expenses increased 2.9% to $6.8 million from $6.7 million in the second quarter of 2024. As a percentage of total revenue, research and development expenses were down 1.8% to 12.1% from 13.9% in the second quarter of 2024. General and administrative expenses increased 2.9% to $9.7 million from $9.4 million in the second quarter of 2024. As a percentage of total revenues, general and administrative expenses were down 2.6% to 17.1% from 19.7% in the second quarter of 2024. Net income for the quarter was $0.6 million or $0.01 per share, compared to a net loss of $1.9 million or $0.04 per share in the second quarter of 2024.

Adjusted net income for the quarter was $5.7 million or $0.12 per share, compared to an adjusted net income of $2 million or $0.05 per share in the second quarter of 2024. Adjusted EBITDA for the quarter was $9.3 million, compared to an adjusted EBITDA of $5.6 million in the same period last year. As of June 30, our balance of cash, cash equivalents, and investments increased $7.8 million to $35.9 million from $28.1 million at the end of the first quarter of 2025. Now, turning to our full-year financial guidance for 2025, we are raising our revenue growth guidance to at least 17%, a revenue of at least $219 million. We reiterate our gross margin guidance in the range of 73% to 75%, inclusive of one-time costs related to the BLA approval for Avance Nerve Graft, which are expected to impact gross margin by approximately 1%.

As a reminder, these costs will be incurred around the anticipated BLA approval date, currently expected in September. Also, we estimate that two-thirds of those costs relate to the vesting of our BLA milestone-related stock compensation awards and our non-cash. We continue to expect to be net cash flow positive for the year, and we also expect to self-fund our strategic plan with growing cash from operations. In summary, we are pleased with our second quarter performance and the progress we have made. We remain focused on executing strategy, investing in innovation, optimizing our resource allocation, and driving towards profitability. With that, we will now open the lines for questions. Operator?

Speaker 2

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two 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. One moment, please, while we pull for questions. Our first question comes from Christopher Thomas Pasquale with Nephron Research. Please proceed with your question.

Thanks. Congrats on a nice result. Mike, I wanted to dig in a little bit more on the progress you've seen in the business through the first six months of the year. The 18% growth this quarter was similar to what you posted in Q1, but it came against a much tougher comp. I think arguably it shows some acceleration in underlying trends. We'd just love to know where you think that the changes you've implemented are bearing the most fruit here early on, and then maybe juxtapose that with the full-year outlook, which does imply a bit of a deceleration in the back half.

Speaker 4

Certainly. In terms of the reasons for the growth, it's consistent with what we've described from the very beginning. This is sales management in terms of the application of specific strategies that we think are necessary to grow adoption of nerve care within each of these various clinical application areas. The basic product value proposition, of course, is Avance Nerve Graft, and then in conjunction with the products that complement that make up what we call the nerve repair algorithm. Just the focus on that in accounts that have the greatest potential is the result. There's really no magic. There's nothing new here. It's exactly what we described going back to our strategic plan in early March, is how do you create a customer and what do you need to manage and measure to ensure that you're making progress? We're doing that in each area.

There's nothing particularly different from what was previously described. It really boils down to good solid execution. The bell curve is pretty tight in terms of the performance, and we expect that to continue to come. The opportunity, which we continue to try to make manifest to everybody, is that the actual treatment and penetration of nerve care across all various disease and presentation scenarios is very, very low. As you provide people in front of these physicians who deal with these patients, the opportunities are significant. What we've simply done is try to organize accordingly. I would say in terms of which area is maybe a pleasant surprise, I don't know if surprise is maybe the wrong word, but exceeding expectations is that we're growing faster in our extremities business than was even part of our original internal plan. All other parts of the business are growing as expected.

Bottom line, all parts of the business are growing. Even outside of high-potential accounts, all of our accounts are enjoying significant growth. The business is moving in the right direction. Our job is obviously to keep it in that direction, but hope that answers your question.

Yeah, that's helpful. I know the updated guidance calls for at least 17% growth, but anything you'd call out in terms of back half of the year dynamics versus first half?

Sure. As part of the BLA process, until it's final, it's not. We're trying to maintain a level of conservatism given that there may be some sort of change in terms of how we employ our logistics in providing our product. We planned accordingly, but we think it's prudent until that's completely settled and that we understand exactly what the mechanics will be, that we don't get ahead of ourselves.

Great. Thank you.

Thank you, Chris.

Speaker 2

Our next question comes from Michael Sarcone with Jefferies. Please proceed with your question.

Hey, good morning, and thanks for taking our questions. I guess just a follow-up there on Chris's. You have this ramping sales rep productivity factor that's playing out through the year. When we think about kind of historical seasonality or quarterly cadence, do we expect it to be similar to years past, or we typically see a slight bump in the third quarter? Could that be exacerbated by productivity improvements as you're growing the rep days?

Speaker 4

In general, the prior history would be something that I don't think will change. You know, if we kind of go through our various segments, on the extremity side, we typically see an increase in procedures when the weather is good and people are outside and active, which is primarily summer. On the chronic nerve injury side, these are elective procedures, and we typically see an increase in those kinds of procedures in the last quarter of the year as patients have maximized their co-pays. On the oral maxillofacial and head and neck, I mean, these are malignant pathologies typically, so we don't see much in the way of seasonality. On the breast, we typically see a slowdown in breast reconstructive procedures during the summer as many women are caretakers for the kids, and when they're off from school in the summer, they generally prioritize time with family.

You mix it all together, and I think just given the expansion of the business, I would say that we're still looking at our own seasonality, but those are the key elements that I would describe by clinical application area.

Got it. Thanks, Mike. Just one, calling out the commercial coverage wins, it seems like you're making pretty good progress there, and that's prior to the BLA approval. Maybe you could dig in a little and just tell us what's helping to drive that progress now, and is it fair to assume that those coverage expansion wins can accelerate even more post-BLA approval?

Yes, to the latter point, I think you can absolutely expect that. I'll allow Rick to build on here to my answer, but one of the things that even took me a while to actually appreciate is that the recon study, while done some years ago, was only published a little more than two years ago. The database, the dossiers, the value dossiers that support our products have only recently been updated and then made available to payers and all the third parties who provide opinion and/or clarification on our product status from an evidence standpoint and regulatory standpoint. As this information is digested and as we engage with those payers, you basically are able to make clear to people that this is the therapy that should be covered. It starts to build upon itself, and it's kind of like the snowball effect.

This isn't going to happen overnight, but the long story short, it's why we've basically said that over the period of our strategic plan, we fully expect to get to nearly complete commercial coverage. It won't happen in one year, but you know, 5%, 6%, 7%, and it builds on itself. Rick, do you want to add anything to that?

Speaker 1

The thing I'd add to what Mike said is that I've been pleasantly surprised in my first four months is the healthcare climate in the U.S. is sort of changing, and I think practitioners acknowledge that they need to stand up and let their voice be heard. As we've gone out across some of these regional plans and we're developing ways to engage national payers toward the back end of this year and early next year, clinicians are activated. They're willing to sign letters, they're willing to reach out to payers, and they're willing to advocate for patient access and coverage. We expect to see the number of patient appeals and surgeon appeals climb over time. When you break down the coverage landscape in the United States, you know, we report at least 55% of commercially covered lives have access. You guys know this.

If three payers flip, that looks pretty good. We've got really concrete plans in place, and we look forward to moving the mission forward. We think over time, our benefits and risk value prop is there. This is a really good opportunity for the company, and as patient access improves, you know, it's really going to open up one of the main bottlenecks in our business.

Speaker 4

Great. Thank you.

Speaker 1

Thanks, Mike.

Speaker 2

Our next question comes from Caitlin Cronin with Canaccord Genuity. Please proceed with your question.

Hi, Caitlin.

Speaker 0

Congrats on a great quarter. Hi, how's it going?

Good.

Just to start off, how was the interaction during the late cycle BLA meeting? Any more color on that, and if there were any processes that you've had to implement as you near the expected approval?

Speaker 4

Sure. First of all, as it has been throughout the whole process, it's been professional, cooperative, highly interactive, although it does go in waves. It might be almost every other day. Sometimes you might go a week at a time between interactions. For example, in my experience on class three devices, you don't have these finite gates that you go through. You go through the same processes, but you don't receive immediate clarity that, okay, this is now done. That all comes together towards the end. I can't say that we know with certainty exactly yet, as part of the process, exactly what will be required, other than we fully expect there will be modifications to our quality system as in the discussions that we've had with the FDA today.

Speaker 0

Got it. Okay. As you work through your hiring process for the year, any change to the cadence and level of OpEx spend expected in the back half?

Speaker 4

No, not yet, although we are looking at what might be possible in terms of incrementally accelerating our hiring plans. It's not that this is a surprise to us, but it's more and more evident that one of the greatest opportunities we have is simply to scale this footprint. There are lots of needs for nerve care. While we have a good-sized sales force in terms of some comparisons in the context of nerve repair, it still remains a pretty small footprint. Our ability to scale that within the context of our ability to fund our operations is what we're looking to do. We are very encouraged by the progress that we have with the commercial footprint, and that's on the table. At the moment, there's no change in our guidance.

Speaker 0

Got it. Thanks so much.

Speaker 4

Thank you.

Speaker 2

Our next question comes from Mike Kratky with Canaccord Genuity. Please proceed with your question.

Hi, everyone. This is Sam on for Mike. Thanks for taking our questions. I just wanted to dig in on the BLA process a little bit more. You know, are there any specific major milestones to call out remaining in your back and forth with the FDA prior to the expected approval in September? I have one follow-up.

Speaker 4

Sure. There's no, as I already mentioned, there's no explicit milestones beyond what we've already shared where you basically get a checkbox, you have an impression. The final stages that we'll work with the FDA upon is regards to labeling and then final requirements as part of the quality systems. Those conversations will be ongoing for the next 30 days, and it will be a process that upon complete, obviously, we will update everybody.

Got it. Can you provide a little bit more detail on the specific manufacturing improvements that you're planning on implementing following the BLA approval in September? How quickly can you implement these improvements and drive meaningful operating leverage? Is this something that we might see a good deal of in fourth year?

Sure. Much of the improvements that we expect to introduce are our classic continuous improvement processes. By virtue of if it takes five steps and you can do it in three, you start to do it in three. These need to be qualified and verified, but they all basically reduce inefficiencies. Those are the types of things that we'll be doing. Those will be complemented by electronic systems that we'll be introducing also that, by virtue of those, will reduce a lot of the manual record keeping that accompanies the current process. There's nothing particularly remarkable about what we're going to be doing. It's just that we're going to be doing them once we have one system upon which we can run our day-to-day operations. We continuously refine our processes even as they exist, even under the current situation. We enjoy greater yields as a result of that.

There's a tremendous opportunity for very basic improvements that will ensue upon the completion of the BLA.

Understood. Thanks, guys.

Sure.

Speaker 2

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

Good morning, and congrats on the progress. Just a few, I guess maybe start with gross margin. What was the biggest change in the Q2 gross margin versus Q1?

Speaker 0

The biggest change was really just savings from our product costs year over year, the quarter over quarter, and the lack of the write-off reduction.

Okay. Helpful. It looked like there was a fairly big sequential jump in high-potential accounts. I think previously you had identified about 780 high-potential accounts. I guess first, is this still the right number? Second, can you reach the 780 by year end?

Speaker 4

We don't have a specific goal to do that this year, Jayson. A lot of some of this is footprint-related. Probably as we enter into the next year, we'll codify more goals specific to how we expand that. The way it works today is that each individual rep was, as part of the planning process, required to pick within the survey of high-potential accounts which accounts that they believe they had the greatest opportunity. They have also accounts that they manage, which are not high-potential accounts. I want to be clear about that. A good part of compensation and our focus from both a marketing and a sales management standpoint is on those. We did not pick all 780 this year, but we will certainly be working towards expanding that target pie as we look into the next year, but not this year.

Okay. Maybe just lastly, I think when you were responding to an earlier question from Chris in the second half cadence, you mentioned leaving some variability for, I forget the exact language, but some sort of change in logistics and mechanics. Can you just elaborate on that comment? I think it was tied to the BLA.

Sure. It primarily involves a trunk stock, so a product that we would have as a component of supply when an unplanned or unscheduled procedure is available. As we look forward to post-BLA, it's very unlikely that that will be part of our repertoire. This requires us logistically to look at supplying that product differently for some customers. It's not a majority in any way of our business, but it's also not an insignificant element. While we have plans in place for that, we're also, until that's truly codified and finalized with FDA, trying to be prudent to make sure we don't have any disruptions.

Okay. Thank you.

Sure.

Speaker 2

Our next question comes from Ross Everett Osborn with Cantor Fitzgerald. Please proceed with your question.

Hi, good morning, and congrats on the quarter. I was hoping you could provide some more color on where you're seeing above expectation growth within the extremities business.

Speaker 4

Basically, it's broad-based. We have internal growth targets that we had for the business, and what I can speak to is that we're exceeding those, and we have been consistently. We're very pleased with that. If you ask, why? It's a lot of things. For more than a year now, once we stabilized the organization, we've slowly and incrementally added to that. In terms of tenure, that's deepening even over the last year. The focus of the business, the clarity of purpose that everyone has, they're excited to wake up and go to work. We have commitments to the future. All of this together is adding to a more productive, more focused effort on the part of the teams. Also, the focus on high-potential accounts can't be overemphasized. There's a lot of opportunity in nerve care.

If you want to create enduring repeatable revenue, you need to build nerve care as part of an expectation of care within an individual institution and within the individual physician to practice in that institution. All those things combined are what's leading to a greater overall productivity.

Got it. That's helpful. Would you remind us of how we should be thinking about the time from training a new doc to the company to getting to scale?

I'll ask Lindsey Hartley to comment on that.

Speaker 1

Yes. One of the things that we've done this year is really continue to expand our surgeon education and training programs, which is a critical component in activating new surgeons. Once they go through a training, let's pick a breast training program, it typically takes about three quarters for them to get fully productive after they attend a training program. There is some ramp-up time.

Thank you. Congrats again on the quarter.

Speaker 4

Thank you.

Speaker 2

Our next question comes from David Louis Turkaly with Citizens JMP Securities. Please proceed with your question.

Hey, good morning. Congrats on the results and the clinical progress. Mike, I just want to clarify one thing. I know you've gone through a bunch of inspections, and I just wanted to ask explicitly, were there any issues raised or any observations from the FDA?

Speaker 4

No, I mean, one, we don't provide that level of discrete detail, but no, it's so far so good is the phrase that I utilize. I think it's important to just continue to emphasize that the BLA process we believe is on track, and we'll report out on that once it's concluded. Most of the work involved at this point is revolving around the quality systems, which is fully expected. We're moving from a device regulatory scheme quality system to a biologic, and we are the first of its kind. Where the work mostly comes into play is that we're dealing with human tissue, and that quality system needs to be adapted to literally what an injectable drug would utilize. As you might imagine, it's not a natural change in process. That said, we've worked together with the agency, and we think we've got our hands around it.

Speaker 1

Thanks for that. I'm just curious also if you've had any sort of discussions around the labeling. I know I think you're expecting a pretty broad label, but have they made any comments about either like injury type or type of nerve or physical location or anything like that? Any discussions about anything that might be less broad in the label?

Speaker 4

We're just.

Sorry.

Sorry to interrupt you, David. We're just engaging in that process, and we fully expect that will ensue over the next 30 days. We will not be in a position to provide any kind of guidance until this is completed.

Okay, thank you.

Speaker 2

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

Great. Thanks for taking the questions. Congrats on the good quarter. I was hoping to start with a little bit more color on breast. Sounds like you had a good quarter of hiring. Can you talk about rep ramp-up, the quality of the reps you've been able to retain through the hiring process, and then maybe any other underlying trends just in breast in general throughout the quarter would be great to hear.

Speaker 4

Sure. In terms of the ramp-up, obviously, we got behind the eight ball early in the year, but we've fully caught up and expect to maintain that cadence going forward. In terms of quality, obviously, it's in the eyes of the beholder, but we have no problems attracting talent. We have multitudes of candidates who seek the jobs once we post them across the organization, not just in breast. We're very, very pleased. It's an exciting space right now, and it's very encouraging in that regard. In terms of the ramp-up, we have a multi-stage program that we bring the reps, each representative, through for extremities as well as breast. In total, it's a program that transpires over about nine months before the rep is finished with their formal training. They're engaged in working before that period is complete, but it is a process that takes time.

Got it. That's helpful. I just wanted one more.

In terms of trends.

I'm sorry. Go ahead, Frank. I was just going to ask you the second half of the breast trends question I had.

Yeah. Really, nothing new in trends other than as more breast ReSensation is done, more physicians basically look at it really from an ethical standpoint that they believe they have the obligation to provide this as an option to their patients. Once you are introduced to it, that becomes the desire and the expectation based upon the fact that the data that's available and the experience that's available clearly suggests that you can add value to those patients. That's a dynamic. That's not a new dynamic, but it's one that continues to grow as our footprint grows and as we train more surgeons and establish more sites.

Got it. That's helpful. Maybe just one last one on gross margin. Lindsey, I appreciate the comments of the step-down and write-downs quarter over quarter that drove that snapback in gross margins in the quarter. We're just curious how you guys are thinking about that dynamic. Are we kind of through write-downs, or is there any other future cleanup that you think may occur in future quarters related to write-downs?

Speaker 0

Yeah. We are going through a process of identifying processes for them, and as we transition through the BLA, identifying things. If we identify additional write-offs, we'll take them as we deem necessary. At this moment, I don't see any, but you never know what will come up. We are thinking that we will be impacted in Q3 by the BLA PSUs we've disclosed. In Q4, we expect to return back to a little bit normal and then implement those process changes and hopefully get some upside on that as we move forward in 2026.

Okay, that's helpful. Thanks for taking the questions.

Speaker 4

Thank you.

Speaker 2

There are no further questions at this time. I would now like to turn the floor back over to Michael Dale, CEO, for closing comments.

Speaker 4

Thank you, Operator. On behalf of the Axogen team, I want to thank everyone for their time and interest in our work to fulfill the promise and potential for all stakeholders in our business purpose 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 and our plans on our earnings call next quarter. Thank you.

Speaker 2

You may disconnect your lines at this time. Thank you for your participation.