Axogen (AXGN) Q4 2025 Earnings Call Transcript

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Date

Feb. 24, 2026 at 8 a.m. ET

Call participants

• Chief Executive Officer and Director — Michael Dale
• Chief Financial Officer — Lindsey Hartley
• Vice President, Commercial Operations — Rick Ditto
• Vice President, Marketing and Strategic Development — Jens Schroeder Kemp

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Risks

• Gross margin and operating margin for Q4 and full year were negatively impacted by onetime stock-based compensation expenses linked to FDA BLA approval, totaling $1.9 million for gross profit and $7.2 million for operating expenses, reducing Q4 operating margin by 12.1%.
• Net loss widened to $13.2 million in Q4 and $15.7 million for the year, primarily due to the aforementioned onetime expenses and increased R&D, sales, and G&A spending.
• Guidance concedes that gross margin will face pressure during 2026 as the company transitions to higher cost Biologics Avance product beginning in Q2, with improvement not expected until 2027 following continuous improvement initiatives.

Takeaways

• Revenue -- $59.9 million for the quarter, up 21.3% year over year, and $225.2 million for the year, representing 20.2% annual growth.
• Gross profit -- $44.4 million for the quarter (gross margin: 74.1%, down 2 percentage points); $167.4 million for the year (gross margin: 74.3%, a 1.5 percentage point decline), both affected by onetime costs from FDA Biologics License Application (BLA) approval.
• Onetime expenses -- $1.9 million in Q4 gross profit (3.3%) and $7.2 million in Q4 operating expenses (12.1% of revenue) were directly tied to stock-based compensation related to the Avance BLA milestone, with $4.6 million allocated to R&D, $1.9 million to G&A, and $700,000 to sales and marketing.
• Adjusted EBITDA -- $6.5 million for the quarter (margin: 10.9%, down 2.7 percentage points) and $27.9 million for the year (margin: 12.4%, up 1.8 percentage points), reflecting margin leverage and revenue growth after adjustment for onetime costs.
• Net loss -- $13.2 million ($0.28 per share) in Q4; $15.7 million ($0.34 per share) for the year, as compared to net profit of $500,000 in Q4 2024 and net loss of $10 million in 2024.
• Adjusted net income -- $3.5 million ($0.07 per share) for the quarter; $14.4 million ($0.29 per share) for the year, a marked increase from $5.9 million ($0.13 per share) in 2024.
• R&D and commercial spending -- Full-year R&D expense grew 18.4% to $32.9 million (flat at ~15% of revenue), while sales and marketing expense reached 43.4% of revenue (up 1.5 percentage points).
• Cash & capital -- Cash, equivalents, and investments increased $6 million to $45.5 million; $133.3 million raised via public offering in January, with $69.7 million used to retire all debt, leaving a debt-free capital structure.
• FDA BLA approval -- Avance Nerve Graft received FDA BLA approval with 12 years of market exclusivity, positioning it as the only approved biologic for peripheral nerve discontinuity repair and immediate standard of care reference.
• Commercial coverage -- Over 19.8 million additional U.S. lives gained coverage, moving commercial insurance coverage above 65% for the portfolio.
• Sales force expansion -- Year-end count: 21 Breast sales reps (targeting ~30 in 2026), 117 Extremities reps (expanding to ~130), 3 Oral Maxillofacial/Head and Neck market managers, and 3 Prostate clinical development managers added.
• High potential accounts -- 61% of total revenue growth attributed to high potential accounts; year-end universe consisted of 679 active high potential accounts from a universe of ~780, with 131 new active surgeons added in 2025.
• Professional education -- 9 Extremities programs trained 170 surgeons, 3 Oral Maxillofacial/Head and Neck programs trained 59 surgeons, and 5 Breast programs trained 79 surgeon pairs; 2026 targets aim to increase programs and surgical trainees.
• 2026 guidance -- Revenue growth of at least 18%, total revenue of at least $265.7 million, gross margin expected in 74%-76% range (matching 2025), and guidance to be free cash flow positive; seasonally higher cash burn anticipated in Q1.

Summary

Axogen (NASDAQ:AXGN) reported a 21.3% increase in quarterly revenue and significant annual growth, underpinned by higher adoption in all three commercial segments and culminating in a milestone FDA BLA approval for Avance Nerve Graft, which now enjoys 12 years of market exclusivity. The company used its recent $133.3 million equity raise to repay all outstanding debt, entering 2026 with a clean balance sheet and enhanced financial flexibility. Management outlined 2026 revenue guidance of at least 18% growth and a maintained gross margin range, while cautioning of temporary margin pressure due to higher biologics costs until operational improvements in 2027. The BLA approval led to significant onetime stock-based compensation expenses, which factored heavily into a quarterly and annual net loss, despite underlying adjusted EBITDA and net income improvements. The company’s commercial strategy focuses on expanding its sales force, accelerating high potential account productivity, and pursuing broad insurance coverage for its core graft platform.

• Company leaders indicated that BLA approval status serves as a lever to re-engage non-adopter physicians and address payer concerns regarding experimental use, though payer response timelines are formally regulated and unpredictable.
• Surgeon education efforts surpassed internal targets in all markets, targeting additional growth in trained surgeons and professional programs in 2026 for improved adoption curves.
• CMS implemented a new outpatient payment classification for nerve procedures in January, potentially expanding care site flexibility but expected to impact primarily upper extremity procedures, not breast or head and neck cases.
• Prostate is not forecast as a material revenue contributor in 2026, as the company awaits clinical signals from over 100 completed procedures before scaling further commercial investment.
• Management projects the overall universe of high potential accounts and sales force coverage will continue to expand through 2028 as new indications and procedures are developed and commercialized.

Industry glossary

• BLA (Biologics License Application): Submission to the FDA requesting approval to market a biologic product; approval confers regulatory exclusivity and can shift market positioning for products like Avance Nerve Graft.
• High potential accounts: Designation for hospitals or physician practices identified as likely to drive a disproportionate share of revenue growth and targeted for prioritized commercial engagement and support.
• K stock sales program: Company-specific sales channel for Avance prior to its discontinuation, previously used for inventory management and distribution, ended in 2025.
• ASP (Average Selling Price): The average revenue attained by the company per procedure or product unit, varying by surgical segment based on graft volume and length.

Full Conference Call Transcript

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 fourth quarter and full year 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 on the Investors section of the company's website at www.axogeninc.com.

Before we begin, I'd like to remind you that during this conference call, management will be making forward-looking statements, which are statements that 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 regarding 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, without limitation of 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 may make -- we undertake no obligation to update any forward-looking statements, except as required by law.

In addition, for a reconciliation of non-GAAP measures, please refer to today's press release 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: 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 6 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 3 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 3 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 repairs 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 in regards to 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 events.

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 4 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 focused on 3 strategic priorities. Firstly, making nerve coaptation faster and easier and more consistent. Second is 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 6 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: 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 onetime costs related to the FDA BLA approval of Avance. 2/3 of these costs or $1.3 million were noncash and related to the vesting of certain stock-based compensation awards containing milestones tied to this event. Excluding these onetime costs, the year-over-year decreases of gross margin were primarily driven by approximately 2% higher product cost, 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 noncash onetime 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 onetime 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: [Operator Instructions] Our first question today is coming from Michael Sarcone from Jefferies.

Michael Sarcone: 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: Thanks, Mike. We would characterize it as prudent. We're building off of a larger base. We believe that our commercial customer creation models are elastic, but they still need to be managed. And so each quarter is a new quarter, each year is a new year. And we feel very confident in the guidance of 18%. Obviously, we aspire to growing the business as fast as possible. But hopefully, that answers the question.

It's a situation that we still believe that we need to prove out quarter-to-quarter because the management of those -- of the customer creation processes is one of diligence, and then we're expanding the footprint, and we still need to be careful about getting out ahead of ourselves.

Michael Sarcone: Understood. That's helpful. And then maybe just -- you touched on the CMS reimbursement, a healthy increase in the outpatient setting. Can you maybe just help us think about how you're thinking about pricing in that context? And any help on -- can you give us a rough sense of the split of the business between inpatient versus outpatient procedures?

Michael Dale: Why don't I ask my colleagues, Jens and Rick to weigh in on answering that question.

Rick Ditto: 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 health care 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: Yes. I would say it's definitely positive. The payments have increased, but the really important thing is coverage. And so as coverage expands, that also will give us more opportunities to expand the footprint into other care settings. But it's really -- there's 2 sides of the coin. You've got the payment, which is great, has been increased, but we're still working hard to expand coverage as well.

Michael Dale: 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: Next question is coming from Larry Biegelsen with Wells Fargo.

Gursimran Kaur: 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: Sure. The reception from the physician community is varied. So the product has been commercially available to the community for many years now. So for a lot of individuals, they more or less took for granted that this is the case and we're in many instances, only modestly aware of the work going on behind the scenes to move from a device classification to a biologic. So I think that context is important because it's an unusual circumstance. That said, what we have done is with the approval, it has allowed us to go back to the customers, the people we serve and to affirm with them their trust and confidence in Avance. So that is very positive.

It gives us a chance to revisit the basic product characteristics of why it's a suitable solution for treating nerve discontinuities. So all very positive in that regard. And as you might appreciate, for those individuals who are sitting on the fence or who were not adopters, it's given us a new vehicle to go back and revisit the question with those individuals. So in all regards, it's very positive, but it's something that also is important to understand it has been a product that's already been available to the community for quite a while.

Now as for payers, it's a vehicle that allows us to go back and revisit any of the payers whereby their -- one of their primary objections was that the device was experimental and has allowed us to make clear that, that is not the case. As to their response, it's a formal process. You make the submissions, you work through their various work streams that they require in order to even have a conversation. And then periodically, on an annual basis, they review that information that's new and then revisit their decisions. So there is not a schedule that we can point to that will guarantee us a feedback.

But other than what we can say is that we hope and expect to see some sort of responses from these entities in 2026, but we have no prediction per se as to which one or exactly when they will respond.

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

Michael Dale: 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: 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: Thanks for the question. I think maybe to start with the one comment you made that reaching critical mass. To put it in context, if you wanted to provide full coverage for extremities, you probably need somewhere between 400 to 600 sales representatives. So there's a very, very large provider universe in extremities. And so -- and point of fact, while 130 sounds like a lot, it does not provide full coverage of that particular patient presentation stream in terms of trauma and related injuries. So we're a long way from full coverage in extremities. With regards to breast, the same thing. So we are -- there's about 1,200 sites of service in breast.

And to that end, the current organization, while growing rapidly and doing good work is a long way from full coverage. So that's why we have made the strategic decision. We're not going to try to do all of this in a single year, but we're going to grow into it through incremental additions throughout the year and in the succeeding years through 2028.

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

Christopher Pasquale: 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: 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: 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: That's correct.

Christopher Pasquale: Okay. 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?

Michael Dale: Sure. It will be both. So in every instance, it does not need to be randomized, but it needs to fit the bill of what the FDA refers to -- and it's really not an FDA requirement, but needs to fit the clinical evidence expectations of what's considered adequate and controlled. And so there's a structural definition that accompanies that. So with regards to mixed and motor, that's going to be randomized clinical trials. With regards to breast, unlikely to be randomized. There's great resistance to that given the current belief that it's unethical to do such. But nonetheless, there's a desire for greater clarity in terms of patient fit and response rates.

And so there will be adequate control studies that will run there. So those 2, for example, are already planned. Those will all initiate this year. And then we will consider doing additional studies. Prostate, as you raised, will be certainly a significant effort, but we are not in a position to describe what that study will be until really before the end of this year once we see the clinical signals back from 10 clinical sites that we initiated last year.

So most important thing to understand is while evidence is significant in so far as individual single-center studies, in terms of randomized studies, to put it in context, RECON is the largest randomized clinical study ever done in nerve care. And while we're very proud of that, it also speaks to the fact that there does need to be more evidence, and so we look at this as an opportunity. Our customers are actually very excited because we provide for those individuals an opportunity, essentially a vehicle by which to engage in nerve care in a way that's very common, say, for example, cardiovascular or some other health care domains, but not historically the situation in nerve care.

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

Jayson Bedford: 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: 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: Okay. And then just you mentioned the active 679 high potential accounts within a universe of, like you said, 780. So my question is, you see scenarios where there's -- the potential universe of high potential accounts grows beyond the 780?

Jens Schroeder Kemp: 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: Next question today is coming from Caitlin Roberts from Canaccord Genuity.

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

Michael Dale: From a calendarization standpoint, it should be very similar to what you've seen the last 2 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 Cronin: 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: We are. So we have ongoing R&D and regulatory work to understand what other permutations could be offered that includes greater nerve length, greater -- different morphology representations on the nerve, all things that could make it easier. There's nothing expected this year that would be available. But certainly, within the next 24 months, if we decide and determine that we can successfully develop such, we will be bringing those to the marketplace.

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

Michael Kratky: 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: 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: Got it. Understood. And just to clarify there, is there any then contribution in the first half? Or is it really -- that will be kind of the gating factor for your ability to drive more commercial adoption there just as you get more of that clinical signal?

Michael Dale: Nothing that we haven't already forecasted implicit in the guidance, which we just shared. So certainly, there's spend and there's things being planned for potential development. But that's all captured in the guidance at present. And it would be very unlikely -- it's very unlikely that we would depart from the current plan. It really boils down to what we've been describing is that we want to see the clinical signals from those 100 patients in the various procedures that we conducted. And again, on the presumption that those are positive, then we'll have a lot more to talk about.

Michael Kratky: 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: 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: Next question today is coming from Anthony Petrone from Mizuho Group.

Anthony Petrone: 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: 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: 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 2 surgeries. Just trying to get an idea of how the different patient categories stack up from a revenue capture standpoint?

Michael Dale: Sure. In general, from a pure product standpoint, breast because of the longer grafts, these are typically 1 to 2-millimeter diameter grafts, 7 millimeter in length and the number of those grafts that are used, those will -- those procedures will represent the highest average selling price. There are exceptions in extremities based upon the trauma or the situation where it could be similar. But on average, extremities will have a lower ASP point based upon the number of grafts and products utilized. Prostate, should we succeed there and move forward, we'll employ grafts that are typically 4 to 5 millimeters in diameter and about 50 millimeters in length.

And so it will also have a relatively higher ASP, but breast will remain into the future, the highest ASP procedure.

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

Frank Takkinen: 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: 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: 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: 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: 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: 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: 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.

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