Earnings Call Transcript

Axogen, Inc. (AXGN)

Earnings Call Transcript 2025-12-31 For: 2025-12-31
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Added on April 07, 2026

Earnings Call Transcript - AXGN Q4 2025

Operator, Operator

Good morning, everyone. 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 the fourth quarter and full year 2025 financial results and corporate highlights. Lindsey will then provide details on our 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, available on the Investors section of Axogen's website. Following the live call, a replay will be available on the Investors section of the company's website. Before we begin, I want to remind you that during this conference call, management will be making forward-looking statements, which are not historical facts and are based on current expectations and assumptions regarding future conditions, events, and results. Forward-looking statements include, among other things, statements about our financial guidance and outlook, clinical development activities and regulatory efforts, commercial growth initiatives, reimbursement and market access efforts, training and education initiatives, research and development activities, and our overall business strategy and operating performance. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, including risks and uncertainties reflected in our filings with the Securities and Exchange Commission, including our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, and other filings we make with the Securities and Exchange Commission. Forward-looking statements speak only as of the date made, and we undertake no obligation to update any forward-looking statements, except as required by law. In addition, please refer to today's press release for a reconciliation of non-GAAP measures and for a presentation with highlights from today's call and the corporate presentation on the Investors section of the company's website. Now I'll turn the call over to Michael. Michael, please go ahead.

Michael Dale, CEO

Thank you, operator, and welcome to everyone joining us this morning. Today, I'll walk through our fourth quarter and full year 2025 performance through the lens of the six priority areas of our strategic plan, highlighting how we executed against each in 2025 and how they frame our objectives for 2026. I'll then turn the call over to Lindsey to review the financials and outlook, after which we'll open the call for questions. 2025 was a year of significant achievement for Axogen, both financially and strategically, and one that positions us well for durable growth in the years ahead. The first strategic plan priority I will speak about is our growth target of 15% to 20% and the related financial operating leverage we expected for the business. We delivered strong top and bottom line performance in 2025, consistent with the upper end of the growth trajectory outlined in our strategic plan. Our Q4 revenue was $59.9 million, up 21.3% year-over-year with double-digit growth across all three target markets. Our full year revenue increased 20.2% to $225.2 million. Our adjusted EBITDA grew 41% to $27.9 million, and we increased our cash position by $6 million while fully funding our strategic initiatives. This performance reflects expanding adoption of Axogen's nerve repair algorithm across traumatic, iatrogenic, and chronic peripheral nerve injuries with Avance Nerve Graft remaining our primary growth driver, often complemented by our broader portfolio of repair, protection, connection and termination solutions. Importantly, we have now reached a financial inflection point enabling greater concentration of our market development efforts while generating positive cash flow and improving profitability. Regarding capital structure and balance sheet strength, in January, we completed an upsized public offering raising $133.3 million in net proceeds. We used $69.7 million to fully retire our term loan facility, leaving us with a clean capital structure and significantly enhanced financial flexibility. Eliminating the interest and revenue participation obligations improves our earnings quality over time, while the remaining proceeds provide capacity to fund continued execution of our strategic plan. As a result, we entered 2026 well capitalized and positioned to deliver disciplined, profitable growth. The second strategic plan priority I will speak about is our market development progress for elective and planned procedures in extremities, oral maxillofacial and head and neck, breast, and our prostate market development plans. Across our three core markets, momentum remains strong, as represented by continued double-digit growth in each market. In extremities, which continues to be our most mature market and where we are furthest along in achieving standard of care status supported by solid growth in both traumatic and chronic procedures. For Oral Maxillofacial and Head and Neck, we delivered high double-digit growth, driven by a surge in adoption of the Axogen algorithm and increasing recognition of nerve repair's impact on quality of life. Breast remains one of our fastest-growing opportunities with accelerating adoption of resensation techniques and increased implant-based reconstruction volumes. In Prostate, we made important foundational progress in 2025. More than 100 procedures were completed across 10 clinical sites, and in collaboration with our surgery partners, we established a standardized surgical technique. As we enter the second half of 2026, we expect to begin seeing meaningful clinical signals as nerve recovery data matures, an important step in what we believe is a highly underdeveloped and compelling market opportunity. The third strategic plan priority I will speak about is our commercial expansion progress concerning infrastructure and sales force growth. In 2025, we significantly expanded our commercial organization across all markets. In Breast, we added 10 sales representatives and 2 regional directors ending the year with 21 sales representatives and 2 regional directors. In Extremities, we added 12 sales representatives in high-potential geographies, ending with 117 reps and 15 regional directors. In Oral Maxillofacial and Head and Neck, we ended the year with 3 field-based market development managers. And in Prostate development, we added 3 clinical development managers and one director. Early productivity trends are tracking well with our assumptions. Across markets, new hires typically reach independence and breakeven within 6 to 9 months, after which they become accretive. In 2026, we plan to continue this expansion. We will grow the Breast team to approximately 30 sales representatives. We will grow Extremities to approximately 130 representatives and we will continue to evaluate further commercial investment to support Prostate market development in the second half of the year. The fourth strategic plan priority I will speak about is our commercial excellence performance specific to our high potential accounts, productivity in general, and education. Our high potential account strategy remains a cornerstone of our commercial model. In 2025, 61% of total revenue growth came from high potential accounts. Average high potential account productivity increased 21%, and active surgeons in high-potential accounts increased by 131. We ended the year with 679 active high-potential accounts out of an approximately 780 universe. While slightly below certain internal targets, fundamentals across both high potential and non-high potential accounts remain strong with double-digit growth and improving productivity across the broader base. For 2026, our high potential objectives include 60% of revenue growth from high potential accounts and 18% productivity growth in these accounts and activation of at least 100 surgeons. Surgeon education continues to be one of Axogen's core competencies and a critical driver of algorithm adoption. In 2025, we exceeded training targets across all markets. And in 2026, we plan to further expand education programs across Breast, Extremities, and Oral Maxillofacial, Head and Neck. In 2025, Extremities held 9 professional education programs and trained 170 surgeons. In Oral Maxillofacial and Head and Neck, we held 3 programs and trained 59 surgeons. In Breast, we held 5 professional education programs and trained 79 surgeon pairs. For 2026, our training objectives include holding and conducting 10 Extremities professional education programs and training 200 surgeons. In Oral Maxillofacial and Head and Neck, we will conduct 6 professional education programs and train 100 surgeons. And in Breast, we will conduct 5 professional education programs and train 75 surgeon pairs. The fifth strategic plan priority I will speak about is progress related to our standard of care objectives as related to evidence coverage in the FDA Biological License approval of Avance. In December, we achieved the most significant milestone in Axogen's history, which was the FDA approval of the biologics license application for Avance. Avance is now the first and only FDA-approved biologic therapeutic for treating peripheral nerve discontinuities with 12 years of market exclusivity. This establishes Avance as the standard of reference in nerve repair. We are acting on this milestone across four fronts: customer engagement to reinforce confidence in Avance's safety, efficacy and regulatory status; payer engagement to drive near universal U.S. coverage; clinical advancement by enabling prioritized studies under an approved regulatory framework; and lastly, manufacturing investments to support scalability and margin expansion by our ability now to manage our manufacturing operations under one quality system. In 2025, we also received strong validation of Avance from leading medical societies. The American Association of Hand Surgery and the American Society for Reconstructive Microsurgery issued position statements recognizing nerve allograft as a non-experimental medically necessary standard of care for peripheral nerve defects. Building on prior guidelines from the American Association of Oral Maxillofacial Surgeons, together, these endorsements represent an important step toward broader recognition of allograft nerve repair as a standard of care and support our efforts to expand coverage and payment in the future. On reimbursement, approximately 19.8 million additional lives gained coverage in 2025, bringing commercial coverage above 65%. With Biologics License approval, we believe we are well positioned to address the remaining payer objections. Additionally, CMS implemented a new outpatient payment classification for nerve procedures in January, improving the economic profile for outpatient settings and potentially expanding site of care flexibility over time. The sixth and last strategic plan priority I will speak about is our innovation progress. Our R&D investments, which are focused on improving benefit versus risk profiles for the treatment of nerve care, are concentrated on three strategic priorities. Firstly, making nerve coaptation faster, easier, and more consistent. Second, advancing solutions for non-transected and chronic nerve injuries through better protection. And thirdly, developing therapeutic reconstruction technologies to improve the fundamental ability for nerve regeneration. With the Biologics License approval in place, we are moving forward also with prioritized clinical studies, including in breast and mixed and motor nerve indications. We expect to provide more detailed updates on individual programs later this year. In each instance, these programs are progressing well and we plan to provide more detail on each of these programs in the second half of the year. In summary, 2025 was a year of execution and validation for Axogen. We delivered strong financial results, achieved a historic regulatory milestone, and continued building momentum across our markets, all while executing against the six priorities of our strategic plan. I am proud of the Axogen team and confident in our ability to deliver disciplined growth consistent with our guidance and long-term strategy. I'll now turn the call over to Lindsey to review the quarter's financials and our outlook for 2026.

Lindsey Hartley, CFO

Thanks, Mike. I'm pleased to report our 2025 financial results and provide 2026 guidance. We are excited about our results for the fourth quarter and the full year. Our focus on commercial execution and resource allocation have yielded top line growth and positive cash flows. For the fourth quarter, we reported strong growth with revenue of $59.9 million, reflecting 21.3% growth compared to the fourth quarter of 2024. For the full year, we reported revenue of $225.2 million, reflecting growth of 20.2% compared to 2024. As mentioned during our last earnings call, we estimated that our revenue was positively impacted by the discontinuation of the K stock sales program for Avance. We believe the pull-forward impact on our full year results to be minimal. Revenue growth continues to be fueled by strong sales of Avance and adoption of our comprehensive product algorithm across our target market with unit volume and mix serving as the primary driver of our revenue performance in addition to price. Our gross profit for the fourth quarter came in at $44.4 million, up from $37.6 million in the fourth quarter of 2024. This represents a gross margin of 74.1%, down from 76.1% in the same period last year. Gross profit for the full year came in at $167.4 million, up from $142 million in 2024. This represents a gross margin of 74.3%, 1.5 percentage points less than 75.8% in 2024. Gross profit was negatively impacted by $1.9 million or 3.3% for the fourth quarter and 0.9% for the full year from one-time costs related to the FDA BLA approval of Avance. Two-thirds of these costs or $1.3 million were non-cash and related to the vesting of certain stock-based compensation awards containing milestones tied to this event. Excluding these one-time costs, the year-over-year decreases of gross margin were primarily driven by approximately 2% higher product costs, offset by a reduction of inventory write-offs and reduced shipping costs on products sold. Product cost increased as a result of costs related to additional steps and tests required as we transition to and began processing Avance as a biologic. The reduction in inventory write-offs and shipping costs resulted from the discontinuation of the K stock sales program for Avance and process improvements implemented throughout the year. Operating expenses increased to $54.2 million in the fourth quarter, up from $35.6 million in the fourth quarter of 2024 and increased 18.3% as a percentage of revenue. Full year operating expenses increased to $175.2 million from $145.3 million in 2024 and increased 0.3% as a percentage of revenue. Included in operating expenses for the fourth quarter and full year was $7.2 million of non-cash one-time stock-based compensation expense related to the vesting of equity awards tied to the FDA BLA approval of Avance. This expense is reflected across operating expense categories, including $700,000 in sales and marketing, $4.6 million in research and development, and $1.9 million in general and administrative expenses. As a result, operating margin was negatively impacted by approximately 12.1% in the fourth quarter and 3.2% for the full year. Excluding this one-time cost, operating leverage improved by 3% as a result of top line growth and financial discipline year-over-year. Sales and marketing expenses as a percentage of total revenue increased nearly 5 percentage points to 45.4% in the fourth quarter compared to 40.6% in the fourth quarter of 2024. For the full year, sales and marketing expenses as a percentage of total revenue increased 1.5 percentage points to 43.4% from 41.9% in 2024. Research and development expenses increased 83.9% to $12.4 million in the fourth quarter compared to $6.7 million in the fourth quarter of 2024. And as a percentage, total revenue increased by approximately 7 percentage points to 20.7% from 13.6%. Full year research and development expenses increased 18.4% to $32.9 million from $27.8 million in 2024 and was flat at approximately 15% as a percentage of revenue. General and administrative expenses increased 64.6% to $14.6 million in the fourth quarter compared to $8.9 million in the fourth quarter of 2024. And as a percentage of total revenue increased 6.5 percentage points to 24.4% from 17.9%. Full year general and administrative expenses increased 14.2% to $44.6 million from $39 million in 2024 and as a percentage of revenue decreased 1 percentage point. Net loss for the fourth quarter was $13.2 million or $0.28 per share compared to net income of $500,000 or $0.01 per share in the fourth quarter of 2024. Full year net loss was $15.7 million or $0.34 per share compared to $10 million or $0.23 per share in 2024. Adjusted net income was $3.5 million or $0.07 per share for the fourth quarter of 2025 and 2024. Full year adjusted net income was $14.4 million or $0.29 per share compared to the $5.9 million or $0.13 per share in 2024. Adjusted EBITDA for the fourth quarter was $6.5 million compared to an adjusted EBITDA of $6.7 million in the same period last year. Fourth quarter adjusted EBITDA margin decreased 270 basis points to 10.9% from 13.6% in the same period last year. Full year adjusted EBITDA was $27.9 million, compared to an adjusted EBITDA of $19.8 million in 2024. Full year adjusted EBITDA margin improved 180 basis points to 12.4% from 10.6% in 2024, driven by revenue growth and increased operating leverage, excluding stock-based compensation expense. I am pleased to report for the full year, our balance of cash, cash equivalents, restricted cash, and investments increased $6 million to $45.5 million from $39.5 million as of December 31, 2024, demonstrating our ability to be cash flow positive for the year. Now turning to our full year financial guidance for 2026. We expect full year 2026 revenue growth to be at least 18% or total revenue of at least $265.7 million. We anticipate full year 2026 gross margin to be in the range of 74% to 76%. This range is consistent with 2025 and considers anticipated product cost pressure as we begin selling Avance Biologic product in the second quarter of 2026. In 2027, we expect to begin seeing improvement to gross margin as a result of implementing continuous improvement programs this year and increasing economies of scale. We expect to be free cash flow positive for the full year 2026. Similar to prior years, we anticipate higher cash burn in the first quarter. In summary, we are pleased with our fourth quarter and full year performance and entered 2026 with strong momentum. Looking ahead, we will continue to prioritize initiatives that strengthen our financial foundation including targeted investments in innovation and commercial infrastructure. By maintaining a disciplined approach to expense management and leveraging economies of scale, we are confident in our ability to further enhance operating margins and deliver consistent profitability. With that, I will now open the line for questions.

Operator, Operator

Our first question today is from Michael Sarcone at Jefferies.

Michael Sarcone, Analyst

Just to start on the guidance for the year, at least 18%. You exited 2025 at 21%. And maybe you could argue that's even higher when you adjust for the K stock discontinuation. But just wanted to get your take on how conservative or achievable do you view the guidance and maybe talk about some of the key assumptions that you've got in there?

Michael Dale, CEO

Thank you, Mike. We see it as a prudent approach. We're working from a larger foundation. We believe our commercial customer creation models are flexible, but they still require management. Each quarter presents new opportunities, and each year brings its own challenges. We are confident in our guidance of 18%. We aim to grow the business as quickly as possible. I hope that addresses your question. We believe we need to validate our progress on a quarterly basis because managing the customer creation processes is a diligent effort. While we're expanding our reach, we also need to be cautious not to overextend ourselves.

Michael Sarcone, Analyst

Understood. That's helpful. Could you elaborate on the CMS reimbursement and the healthy increase in the outpatient setting? How are you approaching pricing in that context? Additionally, could you provide a rough estimate of the business split between inpatient and outpatient procedures?

Rick Ditto, Team Member

Mike, thanks for the question. This is Rick. Just to start, we don't break out by care setting in terms of our revenue, but I do think this is a good derisking event. It's not a light switch. So it's not like all of a sudden, all these procedures are going to move to the outpatient setting. But I think it increases site of care flexibility over time, and it's something we'll continue to take a look at. One thing that's important to note is that facilities negotiate procedure payments with the commercial payers and that happens every 1 to 2 years. So CMS makes this decision and facilities will renegotiate their contracts accordingly. And so these things will just flow through the healthcare system over time, but it gives us a lot of belief in what we're doing. Jens, any color you want to add?

Jens Schroeder Kemp, Team Member

Yes, I would say it's definitely positive. The payments have increased, but the really important thing is coverage. As coverage expands, it will also give us more opportunities to expand into other care settings. There are two sides to this; the payment has increased, which is great, but we're still working hard to expand coverage as well.

Michael Dale, CEO

Mike, to give context of procedures that will likely move in the future where it's advantageous for the provider to do so are going to be more of the upper extremities, the hands and the arm, and then follow-up outpatient procedure opportunities. The other major significant procedures, particularly head and neck and breast, those are unlikely to move into that kind of setting. So it's all good for nerve care in the future, but it will be one that takes time to socialize as each hospital understands their own situation and then decides whether or not to deploy more resources to the setting.

Operator, Operator

Next question is coming from Larry Biegelsen with Wells Fargo.

Gursimran Kaur, Analyst

This is Simran, on for Larry. Maybe just to start out, Mike, since the BLA in December 2025, can you talk about the reaction to it so far from physicians in each segment of the market and payers as well? And then how are you thinking about major coverage wins in 2026 as you move towards full coverage from above 65% today?

Michael Dale, CEO

The response from the physician community has been mixed. The product has been available commercially for many years, and many individuals have taken it for granted, often unaware of the efforts to transition from a device classification to a biologic. This context is essential since it's a unique situation. The approval has enabled us to reconnect with our customers and reinforce their trust in Avance, which is quite encouraging. It allows us to revisit the fundamental product characteristics that make it an effective solution for treating nerve discontinuities, and this is all very positive. For those who were hesitant or have not yet adopted the product, it provides an opportunity to engage them again. Overall, this is a promising development, but it's important to note that this product has been accessible to the community for a considerable time. Regarding payers, this approval presents a chance to address one of their main concerns: that the device was experimental. We can now clarify that this is not the situation. The response process from payers is formal; it involves submitting documentation and navigating their required workflows to initiate discussions. Annually, payers review new information and reassess their decisions. There isn't a specific timeline we can provide for guaranteed feedback, but we expect to receive some responses from them in 2026. However, we cannot predict exactly which payer will respond or when those responses will come.

Gursimran Kaur, Analyst

Okay. That's helpful. And maybe just to follow up, yes, go ahead.

Michael Dale, CEO

One thing I would like to add is that while we can't predict the timing, we have predicted the timing in the context of the strategic plan. So I do want to be clear about that. It is our expectation that between now and 2028, we will overcome the negative coverage decisions that presently exist.

Gursimran Kaur, Analyst

Got it. Sorry, just a follow-up. So maybe just switching gears towards your sales force kind of adds for the year. I think if I'm doing my math right, you added about 22 reps across the business in 2025 and you're guiding to at least 12 repetitions in 2026. Maybe help me understand why is that the right number, especially as you're starting to sort of reach critical mass in some of your segments like extremities. And how are you thinking about the productivity ramp of the sales force today versus the historical ramp?

Michael Dale, CEO

Thank you for your question. To begin with your comment about reaching critical mass, it's important to note that to achieve full coverage for extremities, we would need around 400 to 600 sales representatives. The provider landscape for extremities is quite extensive. While 130 representatives may seem substantial, it doesn't offer complete coverage for the various patient cases related to trauma and similar injuries. We still have a significant distance to go for full coverage in this area. The same applies to breast services, where there are approximately 1,200 service sites. Our current team is growing quickly and performing well, but we aren't close to full coverage yet. That's why we've made a strategic choice not to tackle this all in one year. Instead, we'll gradually expand our team with incremental additions each year, continuing this approach through 2028.

Operator, Operator

Your next question is coming from Chris Pasquale from Nephron Research.

Christopher Pasquale, Analyst

Lindsey, I wanted to start with just the cadence of gross margin throughout the year. Could you just level set us on how we should think about it here? Is 2Q the low point and then you improve from there, and sort of magnitudes of the high and the low for the year would be helpful?

Lindsey Hartley, CFO

Yes. So as we progress through the year and we begin selling a new Biologics Avance product, it will carry a heavier cost. Now we will be selling both tissue and biologic products when we start selling Biologics. So we expect to see that pressure in Q2 and going into the remaining second half of the year.

Christopher Pasquale, Analyst

Okay. So it sounds like the pressure builds over time as that mix shifts and then we start to see improvement in '27. Is that fair?

Lindsey Hartley, CFO

That's correct.

Michael Dale, CEO

Mike, and then you talked about how having the BLA out of the way now frees you up to focus on other clinical priorities, including breast, I would assume, at some point, prostate as well. Can you give us any sense about how you're thinking about what's ultimately going to be required to establish the level of clinical evidence you want in those indications? Are we talking about randomized trials? Or can you get what you need just from documenting sort of single-site registry style study in more detail? Sure. It will be both. In every case, it doesn’t have to be randomized, but it must meet the FDA's guidelines, which align with what clinical evidence is considered adequate and controlled. There is a structural definition that goes with this. For mixed and motor, we will conduct randomized clinical trials. However, for breast, it's unlikely to be randomized due to significant resistance, as many believe it would be unethical. Nevertheless, there’s a strong demand for improved clarity regarding patient fit and response rates, so we will carry out adequate control studies in that area. Those are already planned and will begin this year. We will also consider additional studies. Regarding prostate, we will put in a significant effort, but we cannot specify the study details until the end of this year when we get clinical signals back from the ten sites we initiated last year. It's crucial to note that while individual single-center studies provide substantial evidence, there is a need for more evidence in randomized studies. RECON is the largest randomized clinical study ever conducted in nerve care, and although we are proud of it, it highlights the necessity for further evidence. We see this as an opportunity, and our customers are excited because we offer them a way to engage in nerve care similarly to other areas like cardiovascular health, which hasn't historically been the case in nerve care.

Operator, Operator

The next question is coming from Jayson Bedford from Raymond James.

Jayson Bedford, Analyst

Congrats on the progress. Just as it relates to the BLA, it doesn't look like it based on the physician training metrics you provided, but are you assuming any step-up in growth directly related to the BLA?

Michael Dale, CEO

Not explicitly. It was always assumed as part of the strategic plan that we would achieve Biologics License approval. And so the growth is implicit in our guidance. It's characterized based upon that assumption.

Jayson Bedford, Analyst

Okay. You mentioned there are 679 active high potential accounts out of a total of 780. Do you see a possibility that the number of high potential accounts could exceed 780?

Jens Schroeder Kemp, Team Member

Yes, definitely. As we increase our target indications and target procedures, that high potential algorithm will evolve. And so we do expect in the future that, that universe of high potential accounts will grow.

Operator, Operator

Next question today is coming from Caitlin Roberts from Canaccord Genuity.

Caitlin Roberts, Analyst

Just starting off with guidance. If you could provide some more color on the cadence of revenues throughout the year?

Michael Dale, CEO

From a calendarization standpoint, it should be very similar to what you've seen the last two years for Axogen. To generalize, first quarter is typically the most modest quarter for the business. And then the second and third quarter are stronger quarters based upon the dynamics that transpire across nerve care. So summertime is when you see a very significant trauma, people are out and active. And so that's a pronouncement. But it just basically builds throughout the year. And I would look to the last 24 months of history to give you a guide for the calendarization.

Caitlin Roberts, Analyst

Awesome. And then just for breast. I think you've talked in the past about addressing only a certain part of the market given the technique of the nerve size limitations. Are you working on expanding the technique to address further breast recon procedures?

Michael Dale, CEO

We have ongoing research and development as well as regulatory work to explore other options that could provide greater nerve length and different morphological representations of the nerve, which could enhance usability. There are no expectations for availability this year, but within the next 24 months, if we find we can successfully develop these options, we plan to introduce them to the market.

Operator, Operator

Our next question today is coming from Mike Kratky from Leerink Partners.

Michael Kratky, Analyst

So maybe just to jump in on prostate. You highlighted some really exciting milestones, over 100 procedures and some of the clinical activity we should be expecting in the latter part of this year. But how should we think about the potential revenue contribution in the commercial side ahead of that progression throughout the year? And any color there would be helpful.

Michael Dale, CEO

Sure. So we're trying to maintain discipline as we wait for the clinical signals from those 10 clinical sites. So prostate will not be a significant revenue contributor in 2026.

Michael Kratky, Analyst

Got it. Understood. And just to clarify, is there any contribution in the first half? Or will that be the determining factor for your ability to drive more commercial adoption as you receive more of that clinical signal?

Michael Dale, CEO

There is nothing new that we haven't already included in our guidance that we just shared. There are certainly expenditures and plans for potential development, but all of that is reflected in our current guidance. It is very unlikely that we will deviate from our existing plan. Essentially, we are waiting to see the clinical signals from the 100 patients in the various procedures we've conducted. If those results are positive, we will have much more information to discuss.

Michael Kratky, Analyst

Okay. Yes, I appreciate the color there. And then maybe just one last one, but some helpful color on the BLA expenses that you outlined in the fourth quarter. I'm curious if there was any G&A impact there? And then any BLA expenses that we should be building in for 2026?

Lindsey Hartley, CFO

Yes. As I mentioned on the call, there was the stock-based compensation expense directly tied to that event. In G&A, it was $1.9 million. Across all of OpEx, it was $7.2 million.

Operator, Operator

Next question today is coming from Anthony Petrone from Mizuho Group.

Anthony Petrone, Analyst

Congratulations on a strong end to the year here. Maybe I'll start just on the BLA transition, just something we touched on, Mike, previously, just around inventory or distributor channel shifts as you move from the tissue-based product to Avance BLA in 2Q? And anything we should be aware of over the next couple of months. And quick follow-up here would be on hospital outpatient, that new rate plus 40%. How does that play specifically on the breast side? Like how many breast reconstructions have done outpatient, and is that a driver for that segment in 2026. If I can, I have one quick one on just patient economics after as well.

Michael Dale, CEO

Sure. With regards to the transition from the tissue to the biologic, it will be invisible to the customer for the most part. There's no inventory obsolescence risk. So all the mechanics and logistics have been factored in and should be seamless at this point. So hopefully, that answers that question. With regards to the outpatient dynamics, despite the changes in reimbursement, as we presently understand the market opportunity in breast, it will not be a factor of any significance with regards to the outpatient setting. Most of those procedures will remain inpatient as we currently understand the situation.

Anthony Petrone, Analyst

Yes, a quick one would be just on patient economics. When you think of core extremity, oral maxillofacial, you're bringing in breast now and these 100 cases in prostate in 2027, presumably that will grow. When you think about revenue per patient between core extremity and oral, how does that stack up to breast and prostate? By our math, I think you used quite a bit more Avance graft in the latter two surgeries. Just trying to get an idea of how the different patient categories stack up from a revenue capture standpoint?

Michael Dale, CEO

Sure. Generally, from a product perspective, breast procedures typically utilize longer grafts, which are usually 1 to 2 millimeters in diameter and 7 millimeters long. The number of grafts used in these procedures will result in the highest average selling price. There are exceptions in extremities depending on the trauma or situation that could be comparable, but on average, extremity procedures will have a lower average selling price due to the number of grafts and products used. If we succeed in the prostate area, those will typically require grafts that are 4 to 5 millimeters in diameter and about 50 millimeters in length, resulting in a relatively higher average selling price as well. However, breast will likely continue to have the highest average selling price going forward.

Operator, Operator

Our final question today is coming from Frank Takkinen from Lake Street Capital Markets.

Frank Takkinen, Analyst

I was curious if I could follow up on breast. I think you outlined 1,200 potential accounts to target in that area. If you think about the 30 rep headcount, how much of that market can you pursue with that size headcount?

Michael Dale, CEO

Only a portion of it. And so as I've mentioned in the past, we don't have a firm number yet, but I think it should be expected that, that organization could as much as double between now and 2028 and '29 to ensure that we have full coverage based upon the number of accounts are representative to support the care pathway development. So we're still watching that and evolving that. Still a little too early to put a stake in the ground. But the bottom line is we currently have plans to continue to grow the breast organization for the next several years.

Frank Takkinen, Analyst

Got it. That's helpful. And then just as my last one. Curious if you could talk about any long-term gross margin targets once we get to a place where you're consistently manufacturing under the BLA and where that gross margin profile can go over a longer period of time?

Michael Dale, CEO

Our plan is to address that explicitly in the second half of the year. By then, we will have instituted many of the capital infrastructure investments and have those in place. And that's what's allowing us to guide that we expect improvements in 2027. And I know everyone is anxious to know what are we looking at. But until we really get that work behind us, we think it's appropriate that we hold off in terms of that guide. For this year, it's very similar to what we explained last year, that 74% to 76% range, people should feel good about.

Operator, Operator

We reached the end of our question-and-answer session. I'd like to turn the floor back over to Mr. Dale for any further closing 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 our plans for the business on our earnings call next quarter. So thank you very much.

Operator, Operator

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