AxoGen - Earnings Call - Q1 2025

Executive Summary

• Solid top-line, mixed margin quarter: revenue grew 17.4% year over year to $48.6M; gross margin compressed to 71.9% on higher product costs and inventory write-offs.
• Clear beat vs Street on EPS and slight beat on revenue: Adjusted EPS was -$0.02 vs S&P Global consensus of -$0.07*, and revenue was $48.56M vs $48.35M consensus*; EBITDA came in well below consensus as reported by S&P Global (see Estimates Context).
• Guidance maintained: FY25 revenue growth 15–17%, gross margin 73–75% (≈1 ppt one-time BLA cost impact), and net cash flow positive for the year.
• Regulatory trajectory on track; BLA milestones completed (mid-cycle, site and sponsor inspections), late-cycle meeting scheduled; management reiterated expectation of Avance BLA approval in September 2025.
• CFO transition: Lindsey Hartley appointed CFO (effective May 12) with outgoing CFO staying through July 1 in advisory role; transition framed as orderly.

What Went Well and What Went Wrong

• What Went Well

  • Broad-based growth across portfolio and markets (Extremities, OMF/Head & Neck, Breast) with double‑digit performance; CEO: “Our revenue growth remains robust across our full range of nerve repair and protection solutions”.
  • Commercial execution exceeded internal goals in high‑potential accounts: 566 active HPAs in Q1 (+5% y/y) and average account productivity +24% vs 21% plan.
  • BLA milestones: mid‑cycle meeting completed, clinical site and Bioresearch Monitoring sponsor inspections successful; confidence in September approval reiterated.

• What Went Wrong

  • Gross margin pressure: down to 71.9% from 78.8% y/y on increased product costs tied to new facility and inventory reserves/write‑offs; management expects improvement post‑BLA when process changes can be implemented.
  • EBITDA below S&P consensus; while Adjusted EBITDA improved y/y to $2.9M, Street had modeled higher EBITDA (see Estimates Context).
  • Breast sales hiring lagged plan in Q1; management expects to catch up by end of Q2, but flagged it could affect cadence if delays persisted.

Transcript

Operator (participant)

Good morning, everyone. Joining me on today's call is Michael Dale, Axogen's Chief Executive Officer and Director, Nir Naor, Chief Financial Officer, and Jens Kemp, Chief Marketing Officer. Michael will discuss first quarter 2025 financial results and corporate highlights. Nir will then provide an analysis of our financial performance and guidance and discuss our outlook for the year, followed by a question and answer session. Today's call is being broadcast live via webcast, which is available on the Investor's section of Axogen's website. Following the end of the live call, a replay will be available in the Investor's section of the company's website at www.axogencompany.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, 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 assumption that Avance Nerve Graft will be designated as a reference product for any future biosimilar nerve graft, and that such designation will provide marketplace 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 risks 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 reconciliation of non-GAAP measures, please refer to today's press release and the corporate presentation on the Investor's section of the company's website. Now, I'll turn the call over to Michael.

Michael Dale (President, CEO and Board Director)

2025 first quarter financial results. As you know, we announced a leadership transition this morning with Nir Naor stepping down as Chief Financial Officer. I want to thank Nir for his contributions to the company and wish him all the best in his future endeavors. I'm delighted to announce that succeeding Nir will be Lindsey Hartley. Lindsey will formally assume her new responsibilities as Chief Financial Officer on May 12th. Lindsey has served as Vice President and Corporate Controller at Axogen since 2021 and brings a wealth of experience, and we are confident in her ability to lead our financial operations. Nir will remain in an advisory capacity through July 1st, 2025, to ensure a smooth transition of responsibilities.

I will begin today's call with a financial and corporate overview, highlighting our progress to date against plans for the business through the quarter, which will include the quarterly key performance indicators relevant to our growth strategies for each of the four markets as identified at our March 4th Investor Day. In addition, I will provide an update on the biologic license approval, often referred to as BLA process, for our Avance Nerve Graft. I will then turn the call to Nir, who will provide a summary of the quarter's financials and update on full-year 2025 guidance for the business. How did we do for the quarter? I'm pleased to report we kicked off the year with broad-based growth across our entire portfolio to include double-digit growth performance in all markets.

This growth was driven, in each instance, by good overall execution of the customer creation initiatives we described during our March Investor Day, generating continued adoption of our nerve repair algorithm and the high-potential accounts central to our growth strategies. Said another way, perhaps more simply, we are focusing our customer-facing sales and clinical resources on the highest potential hospital providers and physicians to maximize our ability to teach and establish nerve care as an expectation as part of their patient care. This basic strategy continues to show promise in the form of increasing productivity for headcount and account. Progress with our strategic work to develop additional clinical evidence, societal support, coverage and payment, and new product research and development will naturally leverage and further improve our objective to make nerve care standard of care for all patients.

Revenue in our first quarter increased to $48.6 million, up 17.4% compared to last year, driven by continued adoption of Axogen's nerve repair algorithm across each of our target markets and applications, including extremities, oral-maxillofacial, and head and neck and breast. Per our plan for 2025, we started the work to expand our commercial infrastructure during the quarter, completing multiple strategic hires across our sales, marketing, and market access teams to strengthen our capabilities and capacity. As we mentioned at our Investor Day last quarter, we will begin disclosing specific key performance indicators to help everyone better understand and measure our progress against plans and their relationships to growth. We will begin providing updates on these KPIs during each quarterly earnings release starting today. These KPIs describe performance or progress across the following areas: high-potential accounts, commercial infrastructure, professional education and societal support, and prostate market development preparations.

I'll begin with an update on our performance and growth in high-potential accounts. As a reminder, high-potential accounts are primarily characterized by the following criteria: larger hospitals, including level one trauma centers and/or academic-affiliated hospitals with a high number of nerve repair procedures, and lastly, already trained microsurgeons. As of the end of first quarter, we are on track relative to our productivity targets in high-potential accounts. As we said during our Investor Day, we are targeting to generate approximately 66% of our growth in 2025 from high-potential accounts. In first quarter, we exceeded this target, driven by an increase in average account productivity of 24% versus our plan of 21%. As a reminder, we have identified approximately 780 accounts that meet high-potential criteria. Average account productivity is the average revenue generated per high-potential account.

The first quarter had 566 active high-potential accounts, which represents an increase of 5% versus first quarter of 2024. Next, I will provide updates on the expansion of our commercial infrastructure and professional education initiatives by market. Beginning with extremities, we enjoyed double-digit growth during the quarter and continued adoption of our nerve protection portfolio in both trauma and chronic nerve injury procedures. Our plans to expand our customer-facing field footprint in extremities and raise the awareness of the need to treat non-transected nerve injuries include adding five additional sales representatives in high-potential territories in 2025. We intend to add these territories before the end of the third quarter. Key extremities market development activity during the quarter included the completion of one upper extremity professional education fellows program involving 30 surgeons.

For 2025, we intend to conduct at least four upper extremity fellows programs, three attending physician-level programs, and training at least 105 surgeons. We also completed one international extremity-focused professional education program in Spain involving 22 surgeons. In breast, we continue to experience double-digit growth and new customer creation from adoption of our ReSensation technique and implant-based reconstruction procedures. Regarding our plans to expand our customer-facing footprint from 12 to 22 sales specialists in 2025, we have initiated the recruitment and hiring process and expect to complete the expansion of the sales team before the end of third quarter. We ended first quarter with one regional sales director and 13 breast ReSensation sales specialists trained in in-territories.

Although we made good progress generating a significant talent pool for expansion of the sales team, we are running behind our original hiring and training plan but believe we will be on track by the end of the second quarter. We also executed on two professional education programs and trained 35 surgeon pairs and are on track to complete five national programs and train 75 surgical pairs by year-end. We finished the first quarter with 119 active breast re-sensation programs, which represents an increase of 4% versus first quarter of 2024. Each program has multiple hospital accounts, and we are working to increase adoption in these accounts. In first quarter, we had 229 active accounts, which represents an increase of 6% over 2024. We had an estimated 254 surgeons who performed a breast re-sensation procedure in the first quarter, which represents a 16% increase versus the first quarter of 2024.

In our oral-maxillofacial and head and neck markets, we saw strong continued momentum and growth from adoption of our nerve algorithm and mandible reconstruction procedures, as well as other head and neck procedures. To accelerate growth in mandible reconstruction, increase our brand awareness, and key opinion leader engagement in head and neck, we have started the hiring process to add the planned five field-based market development managers and expect to complete hiring by the end of the second quarter. We also conducted one professional education fellows training program where we trained 26 surgeons, and we are on track to conduct two more professional education programs and train at least 45 surgeons by year-end. Finally, an update on prostate. Our prostate clinical and market development plan is on track, and we are excited about the opportunity to improve nerve function outcomes in robotic-assisted radical prostatectomies.

In first quarter, we hired a new Director of Marketing and are in the process of hiring a clinical support team. Our initial focus is on surgical technique development and onboarding sites for our clinical development pilot. The clinical pilot will support the development of a scalable training and education program by the end of the third quarter. We expect to be able to meet the goal of having 10 pilot sites running by the end of the year. We have confirmed three clinical pilot sites and are in advanced discussions with other sites. We have already started support cases in our pilot sites. We recently attended the American Urological Association Conference in Las Vegas, where we had an opportunity to get an update on the latest developments in robotic-assisted radical prostatectomy and unmet clinical needs.

Nerve injury-related outcomes continue to be a significant challenge, and we believe Axogen is well-positioned to address these challenges in a clinical, meaningful way with our portfolio. We also had an opportunity to engage with multiple globally recognized key opinion leaders during the quarter and can report there is high interest to partner with Axogen to address the challenge of nerve-related injuries in prostatectomy. As a reminder, we have KPIs related to advancing our clinical research priorities. For breast nerveization, we are advancing efforts on the design of our level one study protocol and are in detailed discussions with health economics and outcomes research and surgeon advisors on the study design and expect to complete the protocol design by year-end. In extremities, we are on track to complete the study design for a comparative level one study of Avance Nerve Graft versus autograft in mixed and motor nerves by year-end.

In addition, we are on track to develop our clinical evidence plan for oral-maxillofacial and head and neck by year-end. In the first quarter, we continue to see strong external validation of Axogen's differentiated technologies in leadership and peripheral nerve repair, with eight new peer-reviewed publications citing clinical use or discussion of our products. For those interested, these peer-reviewed studies are available on our website. This growing body of literature supports surgeon confidence in adopting our technologies and aligns with our strategic objective of becoming a standard of care option. Consistent with our Investor Day comments and aligned with our product development strategy, we continue to make meaningful progress across our three core innovation pillars. We advanced our therapeutic reconstruction program, focused on enhancing overall functional recovery following nerve repair. Our easy coaptation initiatives progressed towards developing milestones aimed at simplifying nerve coaptation and making it more predictable for surgeons.

Finally, as part of our protection expansion efforts, we initiated early-stage preclinical design work, exploring our next-generation new applications for our protection technologies. From a development perspective, we're actively progressing all product and application initiatives outlined in our 2025 innovation roadmap. Finally, I would like to address the status of our biologics license approval, often referred to as BLA, for Avance Nerve Graft. The BLA remains on track and continues to progress as planned. We held a mid-cycle meeting with the FDA in March and have our late-cycle meeting with the agency scheduled for later this month. We are pleased to report successful clinical trial site inspections, as well as a successful sponsor inspection of Axogen under the FDA's Bioresearch Monitoring, also known as BIMO, program.

These important regulatory milestones further reinforce our confidence in the strength and completeness of our BLA submission and align with prior guidance that we expect BLA approval in September. Overall, Axogen is excited to reach this next milestone with BLA approval, securing 12 years of market exclusivity with respect to biosimilar nerve allografts and establishing Avance Nerve Graft as the only implantable biologic indicated for the repair of functional deficits in peripheral nerves. I will now hand over the call to Nir to discuss the financials and our guidance. Nir?

Nir Naor (CFO)

Thanks, Mike. For this quarter, our revenue reached $48.6 million, representing 17.4% growth from the first quarter of 2024. This growth is attributed to an approximately 14% in unit volume and mix and a 3% increase in price. Our gross profit for the quarter was $34.9 million, an increase from the $32.6 million recorded in the first quarter of 2024.

This represents a gross margin of approximately 71.9%, down from 78.8% in the same period last year. The year over year decline was driven by two factors. The first was the year over year impact from a growing proportion of Avance sold, which was processed at a higher cost at our new facility in Dayton, Ohio. We expect that Avance cost of goods will reduce over time as capacity utilization increases and as we start recognizing additional efficiencies following planned process improvements. The second impact on the gross margin this quarter was due to increased inventory reserves and related write-offs. Looking beyond this quarter, as we progress through the BLA process, which is not expected to conclude before September, our ability to make significant improvements to our processes and procedures is limited.

Once we receive approval, we will be able to implement continuous process and quality system improvement, which we expect to positively impact our gross margin. Our total operating expenses for the quarter decreased to $36.6 million, down slightly from $37.2 million in the first quarter of 2024. As the marketing expenses, the percentage of total revenue decreased to 43.3% from 47.9% in the first quarter of 2024, as we saw an increase in our sales productivity and solid execution of our strategy, focusing on high-potential accounts. Research and development expenses decreased by 17.8% to $6.1 million from $7.4 million in 2024, driven primarily by the completion of the development of a 5-plus cm soft tissue matrix in Q1 of 2024, as well as by reduction of clinical trial expenses.

As a percentage of total revenues, total R&D expenses were 12.5%, down from 17.9% in the first quarter of the prior year. General and administrative expenses were $9.5 million in Q1 of 2025, down 5% from the $10 million in Q1 of 2024. This quarter ended with a net loss of $3.8 million, or $0.08 per share, compared to a net loss of $6.6 million, or $0.15 per share in the first quarter of 2024. Adjusted net loss for the quarter was $0.9 million, or $0.02 per share, compared to an adjusted net loss of $2.7 million, or $0.06 per share in the first quarter of 2024. Adjusted first quarter EBITDA was $2.9 million, compared to an adjusted EBITDA of $1 million in the prior year. As a reminder, Axogen's definition for adjusted EBITDA is EBITDA excluding stock-based compensation.

As of March 31, our balance of cash, cash equivalents, and investments was $28.1 million, compared with $39.5 million at the end of the fourth quarter. Turning now to our guidance, we are maintaining our full year 2025 revenue growth guidance in the range of 15% to 17%. In addition, we continue to expect full year 2025 gross margin to be in the range of 73% to 75%. As a reminder, this includes approximately $2 million one-off costs related to the BLA approval, which would impact full year gross margin by approximately 1 percentage point. The timing of most of those costs would be around the anticipated BLA approval date, currently expected to be in September. Notably, we estimate that two-thirds of those costs are non-cash related and pertain to the vesting of our BLA-related stock compensation.

From a cash perspective, we continue to expect to be cash flow positive for the entire year and expect to self-fund our new strategic plan with cash from operations. In summary, we're pleased with our first quarter performance. We will continue to execute our strategies, invest in innovation, improve our resource allocation, and strive towards greater bottom line profitability. We would now like to open the line for questions. Operator?

Operator (participant)

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 your line is in the question queue. You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. One moment, please, while we pull for questions. Our first question comes from the line of Michael Sarcone with Jefferies. Please proceed with your question.

Michael Sarcone (Analyst)

Good morning, and thanks for taking our questions. Also, Nir, it's been great working with you, and best of luck on your new opportunity.

Nir Naor (CFO)

Thank you.

Michael Sarcone (Analyst)

Just wanted to start maybe around Avance and the BLA approval. Great to hear that everything is tracking to plan. I did want to know, right now, I guess you sell that product as regulated as a tissue-based product, but you're working to get this Biologics License Application. Was wondering if you had any insight for the different customer accounts. Once this product gets approved as a biologic, do accounts have to go through another VAC process or a recertification to kind of recertify the product as a new category before they can continue to use it? Would love to get any sense of what you've found there and what you're expecting.

Michael Dale (President, CEO and Board Director)

Sure. Mike, I'm going to ask Jens to respond to that. It's clearly a question that we've anticipated and think we're ready for. Jens, go ahead.

Jens Kemp (CMO)

Yes. Thanks, Mike. So based on our research to date and conversations with customers, we do not expect any major changes to ordering or shipment for Avance, storage of Avance, or the reimbursement pathway. As an implantable biologic with an already established CPT 1 code, the reimbursement pathway will remain unchanged, and we will continue to be reimbursed as an implant using CPT code 64912. While some institutions may require approval from P&T committees, Axogen does not anticipate any major disruptions to hospital access or product availability.

Michael Sarcone (Analyst)

Got it. That's very helpful. Thank you. Maybe one for Nir. Just on the gross margin, kind of well below what we were expecting, just wanted to get a sense for how severe were the kind of one-time inventory write-offs, and then you are maintaining your gross margin guidance. Just wanted to get a sense for do we see a full rebound in Q2? Just kind of would love to get a sense for the cadence of gross margin through the rest of the year.

Nir Naor (CFO)

Yeah. So yeah, we do not break out the exact impact of those write-offs, but yeah, they were significant for Q1. They were also driven by various process improvements that we were making to allow us better and earlier detection of the need for such write-offs. We definitely expect to improve in the course of the year. In addition to that, as we mentioned, gross margin also is supposed to be impacted by process improvements, which we intend to put in place after the BLA. Regarding cadence, yeah, we do expect it to improve, subject to what we said before regarding the BLA-related expenses to be hit in Q3. That is basically the guidance. Yeah, we do expect to improve with those around $2 million of one-off BLA approval-related expenses in Q3.

Michael Sarcone (Analyst)

Got it. Sorry, just to sneak one more follow-up in there, Nir. I mean, how quickly do you think those process improvements could take place following the BLA approval? Just really trying to get a sense for how much of a step-up we could see in Q4 after the BLA approval.

Michael Dale (President, CEO and Board Director)

It won't be a stepwise improvement, Michael. It'll be through the next 12 months thereafter. More or less, I'm oversimplifying a complex situation, but the BLA is moving from one quality and operation systems to another. It's the same product the day before and the day after this event transpires, but the quality systems are different. We are in a position now where we're navigating to an approval of an existing quality system. Significant changes in operations and systems and quality systems can't change as part of normal course of continuous improvement between now and then. Anything we want to do based upon looking at workflow and natural efficiency improvements, unfortunately, can't really take place until after we close the chapter on the approval of the plant.

Michael Sarcone (Analyst)

Got it. Thanks, Mike. Thanks, all.

Michael Dale (President, CEO and Board Director)

Our part of the guidance of gross margin for this year is that we knew it would be noisy as we ramped production and went through the inventories that we initially started the plant with, as well as identified work process improvements.

Michael Sarcone (Analyst)

Great. Thank you.

Michael Dale (President, CEO and Board Director)

Sure.

Operator (participant)

Thank you. Our next question comes from the line of Caitlin Cronin with Canaccord Genuity. Please proceed with your question.

Caitlin Cronin (Analyst)

Hi. Thanks for taking the questions, and Nir, I wish you the best. I'm just to jump off that last question, talking about the process for validation changing with the BLA. If Avance is approved, can you still sell through current inventory levels if that inventory did not necessarily go through that specific new validation process?

Michael Dale (President, CEO and Board Director)

Yes, we can. The simple answer is yes. We have, as part of the approval process, the existing inventories that were produced under the tissue designation will still be available for sale.

Caitlin Cronin (Analyst)

That's great. And then just with the moving parts of the BLA and also the new segment initiatives, just the cadence of OPEX for this year.

Michael Dale (President, CEO and Board Director)

Yeah. I would say two trends. Number one, as we mentioned, as part of our strategic plan, we are, or it's already started, to invest in hiring and other investments throughout the year. OPEX is expected to grow gradually, pursuant to that. That said, again, as we mentioned in the past, once we pass the BLA, there are some costs that are expected to roll off. Again, BLA as of September of this year.

Caitlin Cronin (Analyst)

Great. And then just one more. Appreciate the team-specific updates. Just an update overall on where you are now from a sales team standpoint in terms of count and then where you plan to be by the end of the year, just broadly across all different call points and segments.

Jens Kemp (CMO)

In terms of true salespeople in territories, by the end of the year, we should have approximately net 20. In addition to that, there are various marketing support staff, clinical staff that will be added during that timeframe. In terms of true actual sales territory expansions, it'll be approximately 20 by the end of the year.

Caitlin Cronin (Analyst)

Great. Where did you begin the year with?

Jens Kemp (CMO)

I have to confess, Caitlin, I don't have that number off the top of my head.

Caitlin Cronin (Analyst)

Okay. No problem. That's it for me. Thanks so much.

Michael Dale (President, CEO and Board Director)

Thanks, Caitlin.

Operator (participant)

Thank you. Our next question comes from the line of Chris Pasquale with Nephron Research LLC. Please proceed with your question.

Chris Pasquale (Senior Analyst)

Thanks. I wanted to ask about the high-potential accounts initiative. If I heard correctly, you think there are about 780 of those nationwide and 566 were active in one queue. We'd just love to know kind of where you stand with the other 215 or so. Are those accounts that you don't have a relationship with today, or are they just ordering sporadically? Part of the goal here is to get them to a consistent cadence of reordering where they would be considered active in each period.

Jens Kemp (CMO)

Great question. It is actually a mix. We do have accounts that have different ordering patterns. Not all of our high-potential accounts order each month or each quarter. We do have, on an annual basis, more active high-potential accounts than the 566. We also have accounts that we are not currently present in. We see that as a great opportunity to continue to expand our presence in this cohort. There is plenty of opportunity to expand within our existing customer base. There are still high-potential accounts where we need to establish a footprint.

Chris Pasquale (Senior Analyst)

Great. I think the leaning in on clinical data is a really interesting and, I think, important part of the strategy here. You talked about wanting to run another comparative study of Avance to autograft in the core extremity segment. The trial to support the BLA submission took a long time to enroll. I'm curious, one, sort of your view on the need for a second randomized study in that indication, or is this trial answering a different question? The feasibility of completing that work in a timely fashion, given the history here.

Michael Dale (President, CEO and Board Director)

Yeah. Fair questions, Chris. The mixed motor trial against autograft, that's different than what was done with RECON specifically. So it's intended to answer narrowly that question. From a planning standpoint, we don't believe that it would take as long to enroll as some of the historic studies. We look at this in terms of trial recruitment and in terms of patient recruitment and enrollment, something that should transpire over a period of a year, then followed by the follow-up. These are still two- to three-year programs at minimum in terms of activity. That's what's required to complete these Class 1 evidence data sets. I hope that answers your question. We feel pretty good that we can do this.

Michael Sarcone (Analyst)

Yeah, that's great. Thanks, Mike.

Operator (participant)

Thank you. Our next question comes from the line of David Turkaly with Citizens. Please proceed with your question.

David Turkaly (Analyst)

Hey, good morning. Yeah, good luck, Nir. Mike, I know you've had some track record with some really differentiated technologies in the space. And Axogen's got a history of sort of nice price increases. I think you called out 3%. I was curious, how sustainable do you think that is? Looking back at some of your prior companies and then comparing it to this, do you think that's a consistent factor moving forward?

Michael Dale (President, CEO and Board Director)

It's a fair question. I don't have a specific answer. What I can tell you, we evaluate it on an annual basis. To your question, I think there will be a point at which that may not be, but we don't have a date for that. There's not a specific plan assumption at the moment. Regardless, I don't have a perfect answer for you.

David Turkaly (Analyst)

That's fine. No worries. You did say a lot, so thanks for all the detail. When you look at all the clinical efforts you have ongoing, I guess, I don't know, outside of obviously your BLA and maybe this new mixed nerve, would you look at any of them to call out that could have maybe the most near-term impact on, let's say, maybe even your financial results?

Michael Dale (President, CEO and Board Director)

Fortunately, these studies do not incur costs like that, for example, purposes like that of structural heart, for example. It is one of the reasons why we are able to guide that we believe over the course of the strategic plan that we'll be able to fund all of our operations. Hopefully, that answers if your question is about cost, can we actually afford to do this? The simple answer is yes. We believe we can. Strategically, we believe this evidence generation is necessary. We have a lot of clinical experience, a lot of individual paper publications, a lot of individual surgeon hospital experience. At a fundamental level, level one evidence needs to be increased because outside of RECON and one other study over the years, we haven't engaged in other studies. With our new plan, what we identified as gaps and opportunities was to do that.

That is what we are going to do. We think it will be exciting for our customers. These are partnerships. Many of these individuals are physician scientists. While they may believe in something, the more evidence we can add to that equation, the better. Finally, of course, as everyone can appreciate in our world, it goes directly to the heart of coverage and payment. If we do not start this stuff, it never gets done. Bottom line, we are going to get it done.

David Turkaly (Analyst)

Thank you.

Michael Dale (President, CEO and Board Director)

You're welcome.

Operator (participant)

Thank you. Our next question comes from the line of Mike Kratky with Leerink Partners. Please proceed with your questions.

Brett Gasaway (VP of Equity Research)

Hey, guys. This is Brett on for Mike. Thanks for taking the questions. And Nir, best of luck to you in your next role. It's been great working with you so far. I want to go back to Brett's. You obviously mentioned that the hiring and sales specialist is running a bit behind plan. Obviously, this is one of your fastest-growing segments. I just want to get a sense for if there's anything contemplated within the original guide for Brett's and if that was reliant on the pacing of that hiring, and then obviously, if anything has shifted with the delay.

Michael Dale (President, CEO and Board Director)

We still believe that we will be able to catch up on time in terms of that footprint. Now, to be very blunt, if we do not, which I do not expect to be the case, but if we did not, yeah, that would affect absolutely the cadence of the market development. I hope that answers the question. Bottom line, we will be on track by the end of this quarter.

Brett Gasaway (VP of Equity Research)

Understood. Yeah, that's helpful. And just one more on prostate. Obviously, you said the pilot they're launching in 3Q, but it seems to imply that a lot of that pilot will be in 4Q, at least the ramp to 10. So is there anything, again, similar line of questioning implied within the guide for 4Q that is factoring that in? Obviously, probably a smaller portion of revenue, but just the extent to which the guide relies on that pilot.

Michael Dale (President, CEO and Board Director)

Yeah. The guide does not rely on prostate market development from a revenue standpoint. We're doing our best to go slow with prostate just to make sure that we, I mean, there's tremendous enthusiasm, but we want to make sure that that enthusiasm is channeled into a standardized surgical approach so that the outcomes that we generate, we can make and draw conclusions from in terms of how to go forward with market development. Because we also intend to run clinical studies in prostate as well next year. Hopefully, that answers the question. There's lots of interest. That's the easy part. The hard part, the real work, is making sure that we develop surgical approaches that are teachable so that we can draw conclusions from the clinical outcomes and then, very importantly, engage in level one evidence.

Brett Gasaway (VP of Equity Research)

Understood. Thanks, guys.

Michael Dale (President, CEO and Board Director)

Sure.

Operator (participant)

Thank you. Our next question comes from the line of Ross Osborne with Cantor Fitzgerald. Please proceed with your question.

Matthew Park (Equity Research Associate)

Hey, guys. This is Matt Park on for Ross today. Thanks for taking questions. Going back to a question asked earlier on reimbursement, I guess outside of continued evidence generation, are there specific commercial payer targets or policy barriers you're looking to address this year?

Michael Dale (President, CEO and Board Director)

Sure. I will ask Rick Ditto, who now leads that part of our program, and he can speak to his impressions.

Rick Ditto (VP, Global Health Economics, Reimbursement and Policy)

Thanks for the question. Yeah. Following the BLA, we're working with evidence intermediaries. These are the health benefit managers and groups that summarize evidence for payers. We'll start in Q4 tackling some of the regional non-coverage policies that are out there for Avance Nerve Graft. As we develop a winning formula, we'll start tackling the national payers next year.

Matthew Park (Equity Research Associate)

Got it. That's helpful. Just one more for me on OMF and head and neck. You cited continued strong momentum here. Are there specific referral pathways or procedure types that are helping drive the strong performance? How do you see this growth in this segment trending relative to extremities and breasts as you continue to penetrate the market here? Thanks.

Jens Kemp (CMO)

Yeah. Thanks for the question. Yes. The focus is on driving growth in mandible reconstruction procedures. We have a very good position in benign mandible reconstruction procedures and are making inroads with malignant pathology as well. The primary growth driver is mandible reconstruction. As we start engaging more with head and neck surgeons, there are multiple other procedures that we're targeting, including radical neck dissections and parotidectomies. There is a lot of opportunity in the head and neck space, and that's why we're adding five field-based market development managers to really accelerate brand awareness and adoption with that surgeon group.

Michael Dale (President, CEO and Board Director)

Yeah. I know we've talked about it in the past, but just to build upon Jens' comments, it's still a not uncommon, not infrequent situation where we meet these specialists within these various centers who are either unaware of Axogen and, as a result, don't appreciate that the alternatives even exist. This is still very immature market development, and therein lies the opportunity.

Matthew Park (Equity Research Associate)

Got it. Super helpful color. Thanks for taking the questions.

Operator (participant)

Thank you. Our next question comes from the line of Jason Bedford with Raymond James. Please proceed with your question.

Jayson Bedford (Managing Director and Equity Research)

Good morning. So a few questions. On gross margin, you came in a bit below our estimate for the quarter. I'm guessing you came in a bit lower than your internal, maybe not. You still have the one-time cost related to the BLA that will hit in the third quarter. So by maintaining the guide, it kind of implies a higher exit rate. Is it fair to assume that you exit 2025 north of 75% on the gross margin line?

Nir Naor (CFO)

You mean in Q4, Jason?

Jayson Bedford (Managing Director and Equity Research)

Correct.

Nir Naor (CFO)

Yeah. One, we do not give quarter-to-quarter guidance, and I do not want to do that. No, I would think that would be too high.

Rick Ditto (VP, Global Health Economics, Reimbursement and Policy)

Yeah. I would say, Jason, in general, yes, we do expect, as I think I answered to one of the other analysts, the other quarters to be higher than Q1, again, subject to those one-off BLA approval-related costs in Q3.

Jayson Bedford (Managing Director and Equity Research)

Okay. Okay. Maybe just on the top line, I'll ask the high-potential account question a little differently. Have you seen much of a drop-off in those accounts that are not high-potential? Meaning, I think there's a few hundred accounts out there that aren't necessarily a focus. Have you seen the business with those accounts fall off at all?

Michael Dale (President, CEO and Board Director)

Our focus is on these accounts. By definition, yes, because technically, we have been in, we have touched more than 3,000 accounts over recent years. I use the word touch because you're in and out, and you're not maintaining constant market development and physician development in those accounts. Yes, we have some accounts which have done nothing beyond that original experience. It's because we've moved all of our resources towards these accounts. That does not mean we never step outside of a high-potential account. Fundamentally, the focus has been reframed, and the expectations are to build recurring and enduring revenue in these accounts. It's a long-winded way of saying, yes, some places have not done an action procedure because we do not go there any longer.

It's really just a resource allocation question, and this is the decision that we believe is best for driving growth in standard of care.

Jayson Bedford (Managing Director and Equity Research)

Okay. Okay. That's helpful. Thank you.

Michael Dale (President, CEO and Board Director)

If you had 600 people, it'd be a very different equation. That is literally why, just to be clear about why are we doing this, is those individuals, in terms of time and duration working with a physician, have to make choices. The high-potential account is what we think is most practical.

Jayson Bedford (Managing Director and Equity Research)

No, the strategy makes sense. I'm just looking at it. You grew well, right? 17% is quite strong. Either it's the high-potential accounts doing really, really well or the non-high-potential actually hanging in there a bit better than maybe expected. That was kind of the genesis of the question.

Michael Dale (President, CEO and Board Director)

Got it.

Jayson Bedford (Managing Director and Equity Research)

Thank you.

Michael Dale (President, CEO and Board Director)

Thanks, Jason.

Operator (participant)

Thank you. Our next question comes from the line of Frank Takkinen with Lake Street Capital Markets. Please proceed with your questions.

Frank Takkinen (Senior Research Analyst)

Great. Thanks for taking the questions. Congrats on the first quarter. I was hoping to start with one, just kind of growth rates across businesses. I know you're not going to disclose too much specifics, but my assumption is some of the businesses grew faster than 17%, and then maybe some were still in the double digits, but below that 17% rate. Any kind of goalposts you can provide on growth rates between breast, OMF, and extremities?

Michael Dale (President, CEO and Board Director)

Yeah. A fair question, Frank, but we do not want to get into that level of detail at this point. In the future, perhaps, but not today.

Frank Takkinen (Senior Research Analyst)

Okay. Fair enough. I was going to follow up on the breast comment you made. I think you said 254 active surgeons plus 16% year over year. I was curious where you feel you currently stand in those active accounts from a percent of surgeons currently offering re-sensation. Any approximation of how much growth you still have to just inside of your same accounts with new surgeons?

Jens Kemp (CMO)

I think if you look at kind of the growth in programs and accounts versus the growth in number of surgeons doing breast re-sensation, we can see that we are still activating new surgeons within those accounts, and we believe there is still a lot of surgeons within our existing programs that we can continue to develop. We do believe there is still significant opportunity within existing programs.

Frank Takkinen (Senior Research Analyst)

Okay. And then maybe just the last one. On the BLA process, what's left between now and September? Any major checkpoints that you feel that are most important to successfully receiving the BLA?

Michael Dale (President, CEO and Board Director)

Sure. The most important thing is to keep answering the questions that we receive timely. I think the number is when they answer questions, it's called an IR, an information request, and it's a very formal process. We've fielded, I think, 200 of these thus far through the process once they accepted our application. That's gone very well. We've been able to answer it timely. The intercourse between FDA and our staff is very professional and very cordial. The work is going well. The next major milestone will be the late-cycle meeting, and that's where we all sit down to kind of review and kind of take stock of where we are. We'll learn more there.

All we can say at this stage is there's lots of work going on, and so far, we're getting the work done, but it's just part of the process.

Frank Takkinen (Senior Research Analyst)

Perfect. That's helpful. Thanks for taking the questions.

Michael Dale (President, CEO and Board Director)

Sure. Thanks, Frank.

Operator (participant)

Thank you. We have reached the end of the question and answer session. I would like to turn the floor back to Michael Dale for closing remarks.

Michael Dale (President, CEO and Board Director)

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 for the earnings call next quarter. Thank you very much.

Operator (participant)

Thank you. This concludes today's conference, and you may disconnect your line at this time. Thank you for your participation.