Earnings Call Transcript
Axogen, Inc. (AXGN)
Earnings Call Transcript - AXGN Q3 2025
Operator, Operator
Good morning. 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 third 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 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 in the Investors 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 include, but are not limited to, statements relating to financial guidance, 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 in December 2025, 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 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 most recent Form 10-K and 10-Q. The forward-looking statements are representative only as of the date 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, short presentation with highlights from today's call and the corporate presentation on the Investors section of the company's website. I'll now turn the call over to Michael.
Michael Dale, CEO
Thank you, operator, and welcome to everyone joining us this morning as we discuss our 2025 third quarter financial results. I'll begin today's call with a financial and corporate overview, highlighting our progress through the third 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 the quarter's financials and outlook for the remainder of 2025, and then we will open the lines for a question-and-answer session. As remarked in this morning's earnings release, we are delighted with our third quarter performance and progress year-to-date for the business. Our strong revenue growth and notable milestone achievements during the quarter further validate our strategic plan objectives and market development strategies and importantly, AxoGen's ability to operationally execute our plans. Indeed, I am proud of our executive team in each of the respective operating functions at AxoGen for the performance year-to-date that is at or above plan. Looking ahead, we will continue to optimize our business models based on experience and have confidence in our ability to continue delivering growth consistent with the guidance we have provided for our strategic plan in both the near and longer term. Regarding the quarter, Q3 sales increased to $60.1 million, growing 23.5% 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 breast. Consistent with prior quarters, our growth is driven by expanding adoption of nerve care using AxoGen's nerve 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 OMF and head and neck, surgeon adoption of the AxoGen algorithm during the quarter was strong across all products and procedures, particularly in mandible reconstruction procedures. And likewise, in breast, we continue to see strong adoption of our breast resensation techniques, 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 in 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 total revenue growth from high potential accounts and average account productivity of 21%. Through the first three quarters, approximately 64% of revenue growth was driven by high potential accounts based on an average account productivity of 19%. These results are slightly below our planned target, but notably, the result of the fact that we are also seeing double-digit revenue growth and account productivity growth year-to-date in our non-high potential designated accounts as well. Growth in all account types was amplified in the quarter by the discontinuation of our case stock sales program for Avance Nerve Graft in preparation for the anticipated BLA approval. This sales program previously allowed for Avance Nerve Grafts to be shipped for a case for an unused product to return to AxoGen. With the discontinuation of the case stock program, previous case stock customers are transitioning to either order by direct sale or consignment. This shift in purchasing behavior contributed to our top line performance and reduced revenue growth from high potential accounts by an estimated 4%. To be clear, high potential account growth was actually quite strong on an absolute basis, while it appears lower than last quarter, it's really just a function of the denominator getting larger because of the benign high potential base performing better as well. The underlying fundamentals in all account types remain very positive. And after accounting for the case stock impact in the third quarter, we continue to realize 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 three quarters of 2025, there were 668 active high potential accounts out of the approximately 780 accounts that meet our high potential criteria, which represents an increase of 8 accounts or 1.2% as compared to the first three quarters of 2024. Regarding our 2025 commercial infrastructure expansion goals, as of the end of the third quarter, we are now at or ahead of our hiring plan for each target market. In breast, we ended the quarter with 22 breast resensation sales specialists and 2 regional sales directors. We have met our goal to double the breast sales force in 2025 by the end of the year. To support broader adoption in non-breast markets, we ended the quarter with 125 sales professionals, including 15 regional sales directors. In OMF and head and neck, we ended the quarter with 4 field-based market development managers. Surgeon training remains a core component of our customer creation and nerve repair algorithm adoption. Execution of our 2025 professional education programs are on track, and we fully expect to meet our 2025 surgeon training targets. In breast, we have trained 62 surgeon pairs year-to-date with one program planned in the fourth quarter. We are confident we will meet our 2025 target of 75 surgeon pairs trained. Active breast resensation programs increased 7% from the third quarter of 2024 from 113 to 121. We estimate 281 surgeons performed a breast resensation procedure in the third quarter, which represents a 20% increase versus the third quarter of 2024. In Extremities, we have trained 97 surgeons year-to-date, of which 30 were trained in the third quarter with three additional programs planned in the fourth quarter. We expect to meet our 2025 target of 105 surgeons trained. In OMF and head and neck, we have trained 57 surgeons year-to-date, up 16 from the second quarter 2025, exceeding 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 1 study protocol for implant-based neurotization, a clinical evidence plan for Avance versus autograft and a motor nerves and clinical evidence plan for oral maxillofacial and head and neck. Regarding research and development, as we have outlined in our strategic plan, innovation remains critical to our long-term growth. Through the first three quarters of the year, we continue to progress and advance our innovation platform across three pillars. Those include therapeutic reconstruction, ease of coaptation, and protection expansion. Consistent with our clinical research objectives to build evidence in support of nerve care, in the third quarter, we received meaningful external validation of AxoGen's differentiated technologies and leadership in peripheral nerve repair. 10 new peer-reviewed publications cited clinical use for discussion of our products, bringing our total nerve repair related literature body to 339 publications. This growing body of evidence underscores the clinical relevance and impact of our solutions. Notably, there has been a 70% increase in the number of nerve repair publications in the last 5 years, reflecting in part the growing experience and interest in nerve repair. For those interested, all peer-reviewed studies are available on our website. During the third quarter, we also saw significant validation from medical societies. Both the American Association of Hand Surgery and the American Society for Reconstructive Microsurgery released official position statements recognizing nerve allograft as a nonexperimental and medically necessary standard medical practice option for the treatment of peripheral nerve defects. These position statements add to the previously released clinical practice guidelines from the American Association of Oral and Maxillofacial Surgeons. Together, these endorsements mark a critical step towards establishing peripheral nerve repair with allograft as a recognized standard of care, and we believe this support will be helpful in our efforts to expand coverage. On the coverage and reimbursement front, we continue to see noncoverage policies removed within the Blue Cross Blue Shield network and within Medicare Advantage for Nerve Care, resulting in an estimated 1.1 million newly covered lives in the third quarter. Year-to-date, we estimate 18.1 million additional lives are now covered for nerve repair for peripheral nerve injuries using synthetic conduits or allografts. This expansion brings coverage amongst commercial payers to more than 64%, reflecting continued momentum and expanding access. And finally, I will provide an update on our prostate clinical and market development plan. We remain enthusiastic about the opportunity to improve nerve function outcomes in robotic-assisted radical prostatectomy and are actively collaborating with key opinion leaders to advance surgical technique development. During the third quarter, our clinical development team provided field-based support to surgeons and clinical sites incorporating nerve repair into the robotic-assisted prostatectomy cases. We added four new clinical sites during the third quarter, bringing our total to 10 active sites meeting our year-end goal. Procedures are ongoing, and we remain on track to complete 100 cases by year-end. Before I hand it over to Lindsey, I would like to address the status of our biologics license application for Avance Nerve Graft. In August, the FDA extended the PDUFA goal date from September to December 5, 2025. In the communication from the FDA, it stated that a recent submission by AxoGen, a facility and manufacturing information provided in response to an FDA information request constituted a major amendment to our BLA for the Avance Nerve Graft submission, which resulted in the three-month extension. Since our last public update, interactions with the FDA have expanded to all elements of the BLA application. Based on these interactions, we remain confident we will successfully complete the application process, consistent with the new December 5 PDUFA date. 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 this, I will now turn it over to Lindsey.
Lindsey Hartley, CFO
Thanks, Mike. I'm happy to share our third quarter results. We achieved strong growth with revenue of $60.1 million, which is a 23.5% increase compared to the third quarter of 2024 and a 6% increase from the second quarter of 2025. This revenue growth was driven by robust sales of Avance Nerve Graft and the adoption of our comprehensive product algorithm in our target markets, with unit volume and mix being key contributors to our performance. As Mike mentioned, we successfully concluded our case stock sales program for Avance Nerve Graft in preparation for the expected BLA approval. We estimate our revenue for the third quarter benefited by $1.6 million or 3% due to customers shifting from the case stock program to direct sales. Our gross profit for the quarter was $46 million, up from $36.4 million in the third quarter of 2024 and $42 million in the second quarter of 2025. This translates to a gross margin of 76.6%, compared to 74.9% last year and 74.2% in the previous quarter. The growth in gross margin year-over-year and sequentially was mainly due to lower inventory write-offs and reduced shipping costs, though these gains were slightly offset by modestly increased product costs, which had a minimal effect on gross margin. For the first three quarters of 2025, our gross margin stood at 74.4%, down by 1.3% from the same period in 2024, primarily caused by a 1.9% rise in product costs. The increase was linked to the transition of processing Avance Nerve Graft to our AxoGen processing center and the additional requirements as we prepare for the switch to biologic processing anticipated in December. We foresee that costs for our advanced product will decrease as we achieve economies of scale at the processing center, and once the BLA is approved, we can begin implementing more substantial continuous improvement programs. Operating expenses rose to $44.1 million from $36.8 million in the third quarter of 2024, but as a percentage of revenue, they decreased by 2.2%, showcasing our ability to improve operating leverage. Sales and marketing expenses as a percentage of total revenue increased nearly 4% to 42.7% from 38.9% in the third quarter of 2024. Research and development expenses grew by 8.1% to $7.6 million from $7 million a year prior, but as a percentage of total revenue, they decreased to 12.6% from 14.4%. General and administrative expenses stayed consistent at $10.8 million quarter-over-quarter, and as a percentage of total revenues, they fell to 18.1% from 22.3% in the same quarter last year. Our net income for the quarter was $0.7 million or $0.01 per share, compared to a net loss of $1.9 million or $0.04 per share in the same quarter last year. Adjusted net income was $6.1 million or $0.12 per share versus adjusted net income of $3.1 million or $0.07 per share in the prior year’s third quarter. Adjusted EBITDA for the quarter reached $9.2 million compared to $6.5 million last year, with the adjusted EBITDA margin improving to 15.4% from 13.3%, driven by revenue growth and enhanced operating leverage. As of September 30, our balance of cash, cash equivalents, restricted cash, and investments rose by $3.9 million to $39.8 million, up from $35.9 million at the end of the second quarter of 2025. Additionally, for the first three quarters of 2025, our balances increased by $0.3 million from $39.5 million at the end of December 2024, reflecting our capacity to maintain positive free cash flow for the year. Moving on to our full-year financial guidance for 2025, we are raising our revenue growth expectations to at least 19%, projecting revenue of at least $222.8 million. We maintain our gross margin guidance between 73% and 75%, which includes one-time costs related to the BLA approval for Avance Nerve Graft, estimated to impact gross margin by about 1% or $2 million. These costs are anticipated to incur around the expected BLA approval date in December, with a significant portion linked to non-cash stock compensation awards due to vesting milestones. We continue to anticipate being net cash flow positive for the year. In conclusion, we are very pleased with our third quarter performance and the advancements we have made. We remain committed to executing our strategy, investing in innovation, optimizing resource allocation, and striving for profitability. Now, we will open the line for questions.
Operator, Operator
Our first question comes from Chris Pasquale with Nephron Research.
Christopher Pasquale, Analyst
Congrats on the nice quarter. If I look back at the last few years, your fourth quarter revenue tends to be up slightly compared to 3Q. I know guidance is for at least 19% growth. So you're leaving the door open for something better than that. But at 19, it would imply a 4% sequential decline. So I want to make sure we understand how to think about this case stock program transition and whether that $1.6 million was in effect kind of pulled forward from 4Q into 3Q? And then there's anything else about the dynamics this year that we should be keeping in mind as we're updating our models, especially related to the BLA decision date. I would love to sort of flesh that out.
Lindsey Hartley, CFO
Thanks, Chris. For our fourth quarter, we are expecting our typical seasonality. But in giving our guidance, we have been prudent as because of the case stock program. During the third quarter, we saw an increase of $1.6 million related to these customers transitioning mostly to direct sales. We discontinued that program September 1, so we're just one month in. So we're still trying to get a grasp on what that full potential impact could be and if that was a one-time pickup as a result of a shift to direct sales. So in modeling, I would exclude the $1.6 million that we saw from the case stock program in Q3.
Christopher Pasquale, Analyst
Okay. That's helpful. And then looking ahead to consensus is right now embedding about 16% revenue growth. You've actually done better than that now 3 quarters in a row, but that's obviously going to create some tougher comps as well. I know you guys will give formal guidance in February, but just curious if there's any directional comments you'd like to make now about how you're thinking about next year and maybe some of the key puts and takes across the business.
Michael Dale, CEO
Chris, we're not prepared at this point to give any color on 2026 beyond the general statement that we remain very positive about the business and have full confidence in the strategic plan. I realize you guys are looking for more granularity than that, but not ready to provide that.
Operator, Operator
Our next question comes from the line of Michael Sarcone with Jefferies.
Michael Sarcone, Analyst
I guess just to start on the BLA, thanks for all the color, Mike. In the press release you had put out in late August, you mentioned the FDA was targeting November to maybe start talks around the label. Is this still the expectation? And then I guess just a follow-up, I'll throw out there. Just on the labeling front, can you comment on how you're thinking about the label in terms of being broad versus narrow? And you've made some good progress with the medical societies. Does the FDA take that into account when kind of thinking about the label?
Michael Dale, CEO
Sure. With regards to the last part of your question, we do not know explicitly whether the FDA takes that information into account. So I can't comment definitively. With regards to the label, as I mentioned in my comments a moment ago, we have expanded already into all parts of the BLA application to include scope of label and hence, why I was able to provide some color that based upon those interactions, we believe that we will continue to serve the full scope of patient indications that we have been serving historically. So no dimidiation of our ability to provide support and service for mixed and motor nerve patients as we have historically.
Operator, Operator
Our next question comes from the line of Caitlin Cronin with Canaccord.
Caitlin Cronin, Analyst
On an awesome quarter. I guess just to start off in terms of the commercial coverage, I mean, pretty impressive move up from last quarter. I mean, do you see this plateauing at a certain point prior to the BLA? Or can you give any more color in terms of the trajectory going forward?
Michael Dale, CEO
Well, I think it's best if Rick answers that question.
Rick Ditto, CMO
All right. Caitlin, great question. So the increase in our percentage of commercially covered lives primarily reflects the refinement in our data. So we acquired a data set that tracks health plan enrollment by state and metro area. And so that is the main driver of the uplift from 55% coverage to 64% coverage. We're really excited with the progress we've made, and we're a few weeks away from engaging the national payers. There are three big national payers that currently list us investigational experimental. And so that work is ongoing. I've been here seven months, and I would say we're probably five or six months ahead of the initial plans on when we would engage them. So the society support is helpful. We're not going to speculate on when those payers will flip medical policy to cover us. But we're marching forward in our pursuit of making nerve repair an expected standard of care, and we're happy with the progress.
Michael Dale, CEO
The way we look at it in our strategic plan over time, Caitlin, is use that phrase I often use, like little engine it could. It's going to become fits and starts, but it's going to keep going up and to the right, simply because factually and objectively, we have the information to justify these asks. What what's happening over the last 12 months and going forward is that we are methodically engaging with the payers with regard to the information they need and the processes they utilize so that we can make these asks. And when you do, when you have a high ground objectively to make the ask, most of the time, you're going to win. And so that's really what's underway and the effort that Rick and his team is leading. And all we can say is so far, so good.
Caitlin Cronin, Analyst
That's awesome. And then just as a follow-up, Lindsey, I don't think I heard the breakdown in revenue growth this quarter between price and volume and mix. Do you have that available?
Lindsey Hartley, CFO
Yes. We're seeing about the typical increase from price. Our mix is the same as what we see historically.
Operator, Operator
Our next question comes from the line of Jayson Bedford with Raymond James.
Jayson Bedford, Analyst
Congratulations on the progress. I have a quick financial question regarding the case stock program. Was there any impact on gross margin in the third quarter or an expected impact in the fourth quarter?
Michael Dale, CEO
From case stock specifically?
Lindsey Hartley, CFO
We're not seeing it yet. In the future, we do anticipate some savings just from the nature of that program. It required a lot of additional resources shipping back and forth. With one month in right now, it's hard to say what that total impact is going to be, but we hope to see in the next quarter or two.
Michael Dale, CEO
But there will be no negative impact. The only question is to what degree positive. The case stock program was not a very efficient program.
Jayson Bedford, Analyst
Okay. Okay. Internationally, I think historically, you've talked about addressing the international market. I'm just wondering what the timing is? And is it somewhat dependent on the BLA at all?
Michael Dale, CEO
Completely connected to the BLA in terms of any formative efforts going forward. So until we actually have that and can then reengage with competent authorities overseas, we're not going to make any significant investment changes. So bottom line, at some point during the first half of 2026, we'll come to a conclusion as to what we will do and where we will do it, and then we'll be providing updates at that point.
Operator, Operator
Our next question comes from the line of Mike Kratky with Leerink Partners.
Mike Kratky, Analyst
Congrats on the strong quarter. You provided some really helpful color on the dynamics between high productivity accounts and other accounts. So what seems to be driving some of the adoption in the non-high productivity accounts? And then have you seen any signs of utilization growth in those or how you could convert some of those to high productivity accounts over time?
Michael Dale, CEO
Sure. Jens, are you on the call still?
Jens Schroeder Kemp, Director of Sales
I am. So yes, so our strategy continues to be really focusing the majority of our efforts in the high potential cohort, which is about 800 accounts. The reason for focusing in that segment is because that's where the majority of the nerve repair takes place in the hospital segment. Now we do have, of course, a lot of other accounts. And the progress that we've been making and the support that we're getting from societies and the increased awareness of the AxoGen nerve repair algorithm also basically means that you have more procedures adopting the AxoGen algorithm outside of our high potential focus. So in some ways, the progress that we're making within these academic institutions also has a spillover effect in the other non-high potential accounts.
Operator, Operator
Our next question comes from the line of Ross Osborn with Cantor Fitzgerald.
Ross Osborn, Analyst
So what are the next steps for targeting the prostate market following the completion of your targeted 100 procedures by year-end?
Michael Dale, CEO
At the conclusion of the initial clinical trials that we're running and development of the procedure guides, we will follow those patients, and we will evaluate those outcomes. And based upon those outcomes, that will determine the velocity that we invest thereafter. So we're assuming it will be positive, but we are watching. And realistically, we won't see the clinical feedback on that initial 100 patients that we are enrolling in this trial until sometime towards the middle part of 2026 at the earliest. In the meantime, what we are doing in terms of work product is we are further characterizing the market, refining the support plans and beginning the process to think through what would be required in terms of a controlled study, Level 1 type studies. So that's what's underway with prostate.
Ross Osborn, Analyst
Perfect. And then outside of prostate, would you provide some more color on where you stand on generating Level 1 evidence across your portfolio?
Michael Dale, CEO
We are currently developing protocols related to breast and, similarly, for each of the prioritized segments, we will initiate one or more studies formally in 2026. The exact dates and timing have not yet been confirmed, but we will provide a public update as soon as we have that information.
Operator, Operator
Our next question comes from the line of Dave Turkaly with Citizens JMP.
David Turkaly, Analyst
Mike, I know the society updates are positive, and I know you've been working on them for a while, but I was curious if you could just comment on sort of the process there and maybe why you think this happened kind of right in front of the BLA? Is there anything to read into that?
Michael Dale, CEO
Well, fortunately, it's serendipitously coincidental, but this is really a process of socialization of clinical evidence and the society's understanding that for nerve care to go forward, they, as the leaders of their membership need to take an effort formally to provide the guidelines and the expectations because that's part of their duties and roles as a society. And for any novel therapies until societies do that, it's very difficult for these types of new therapies to be adopted to go forward. And furthermore, it directly impacts coverage and payment as coverage and payment is really driven by medical care and clinical guidelines.
David Turkaly, Analyst
And then just as a quick follow-up. Is there any thoughts on sort of your other products, maybe the AxoGuard lines and such in terms of the societies maybe looking at them and maybe having a policy at some point down the line that may include them or incorporate them as well?
Michael Dale, CEO
There is nothing immediate regarding that. Ultimately, it will rely on future evidence for them to take on the responsibility or something similar, and that work still needs to be done. Some of the algorithms being adopted are based on people's belief from their clinical practice and experience. However, we also need to generate the evidence to support them in the same way that is necessary to include them in the guidelines. That process is currently in motion, but it is unlikely to be completed this year or even next year, more realistically targeting a 2027 timeline.
Operator, Operator
Our next question comes from the line of Anthony Petrone with Mizuho Group. Sorry. disconnected. Our next question comes from the line of Frank Takkinen with Lake Street Capital Markets.
Frank Takkinen, Analyst
Congrats on a nice quarter. I was hoping to start with some more guideline commentary as well. How should we think about impacts commercially? Can you do anything differently? Would you maybe pull hiring forward even more? It sounds like you've already been hiring a little faster than anticipated. But with some of these positive guideline wins, do you change strategy and get a little bit more aggressive in any of those areas?
Michael Dale, CEO
No, we won't change strategy. Although I think maybe to provide open clarity on this, what we have decided is with respect to the strategic plan is we will incrementally hire on a quarterly basis across all target markets. So we believe that we do not touch every customer and every opportunity and that the most important thing we can do for our therapies to ensure that we have coverage in order to develop use of nerve care in all locations of service. So to that end, and we'll continue to update everybody, but we will be incrementally expanding the sales footprint for several years going forward on an incremental basis. But we will also do that within the constraints we previously described in terms of financials. So we'll do this with our operating cash flow, and we'll do this only as we can maintain positive leverage.
Frank Takkinen, Analyst
Got it. That's helpful. I know there was previously some street perception that the government shutdown could impact the BLA process. Based on your commentary today, that feels like those conversations are going well and potentially ahead of expectations in some areas. I assume it's fair to think that the government shutdown is not having an impact on any of your FDA interactions at this point?
Michael Dale, CEO
That is fair. So to date, we've maintained productive discussions. And as I've just described, we've already extended our discussions to future labeling and scope and expectations. So these things are not finalized yet. But directionally, we are already receiving positive feedback.
Operator, Operator
Our final question this morning comes from the line of Yi Chen with H.C. Wainwright.
Yi Chen, Analyst
This is Eduardo on for Yi. I guess to follow up a little bit on the segment growth. I'm curious about if you're seeing particular profitability. I know you have different fragmentations of each of these markets in breast and extremity and OMF. I'm curious if you see anyone to be more specifically profitable and if that's guiding any of your strategic decisions and investing.
Michael Dale, CEO
Good question. The simple answer is all the segments are from a profitability standpoint, very positive. The markets that we have established were part of a process to determine what would be the most efficient as well as effective ways to further our business purpose. And so in that sense, we love all of our children to use that expression. So they were selected explicitly because we thought they were addressable in different ways. So I know it's a little bit of a non-answer, but it's because they're all positive in that we make progress in is accretive to the business.
Yi Chen, Analyst
Got it. Following up, you mentioned that the BLA could unlock better coverage potentially. I'm curious if you could quantify that. You have strong support within the medical groups and societies, and reimbursement is largely driven by these medical guidelines. Can you quantify the impact of the BLA? You mentioned international markets, but I'm focusing on the local market in the U.S.
Rick Ditto, CMO
This is Rick. I'm happy to chime in and answer that. Sorry. In terms of the BLA unlocking incremental coverage and quantifying the impact, I think the way to think about it is that it helps unlock portions of the TAM that may have not been accessible prior rather than thinking about it in terms of a direct impact to revenue in 2026 in the way Mike said it, this isn't a light switch, and so that's how I would think about it.
Operator, Operator
Ladies and gentlemen, that concludes our question-and-answer session. I'll turn the floor back to Mr. Dale for any final comments.
Michael Dale, CEO
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 plans on our earnings call next quarter. Thank you.
Operator, Operator
Thank you. This concludes our call.