I think we'll get started. Welcome again to the 47th annual Raymond James Institutional Investors Conference. My name is Jayson Bedford. I cover the med tech sector here, and it's really our privilege to have with us today the senior management team of AxoGen, AXGN. It's a name that we've liked for a little bit here, and they've done a good job of executing. With this, we have the company CEO, Mike Dale, the company CFO, Lindsey Hartley. With that, I'll pass it off to Mike, who will give a presentation, then we'll do some Q&A at the end.
Thank you, Jayson. And thanks for each of you for your time and attention this morning. I look forward to sharing with you a little bit about who is AxoGen, what do we do, why do we exist. The best place for me to start with that is this slide and this GIF. Our If you ask, "Well, what do we do every day? What's the source of our primary work?" The scope and purpose of why we exist is to make the restoration of peripheral nerve function an expected standard of care. You might assume that that would be something that already exists today, but in fact, it does not.
The opportunity for patients as well as for investors is the progress that we can make towards that. In this image, what you're looking at, and the reason why it was chosen, is it really captures the essence of what is peripheral nerve function. The mother and the child pushing on the bike, the ability to run behind the bike, to hold those handlebars, that's all dependent upon your motor function and your sensory function. Feeling that sunlight on your face, the warmth that creates, that's a sensory nerve function.
Your peripheral nerve function is something we all take for granted every single day, until you can no longer do so. And the things that affect peripheral nerve function in terms of a deleterious outcome, are typically two basic big buckets. One is trauma, you have an injury, and the second, is iatrogenic injury secondary to another type of intervention.
Might be an oncological intervention, might be some general surgery intervention. As a result of entering the body, you transect a nerve and you destroy its function. Nerves do not grow back on their own. They don't regenerate by themselves. They must be physically, organically repaired and reconstructed to give that a possibility. Our world is about making the restoration of peripheral nerve function an expected standard of care. It's not something we have to argue about. Most anyone that you speak to in the clinical pathways recognize that, of course, peripheral nerve function's important.
It's not top of mind because until more recently, there weren't recognized approaches and solutions that made this an adoptable effort to treat patients. This is what we do. The market is very large. What's represented in this are the areas of priority that have resulted from a strategic planning process that we entered into to decide "where are we going to spend our time to create and keep customers". Because the proliferation, the presentation of peripheral nerve injury is quite extensive but quite heterogeneous.
And so, while there's a lot of it, you have to stand back and say, "Where can I have the greatest effect in terms of fulfilling my mission purpose in an organized, efficient, yet effective way?" And so, what we've settled on in terms of our priorities for market development are these four basic areas. One is extremities. It's the largest, most numerous opportunity in terms of presentation. This is really trauma primarily. The second is breast reconstruction.
When you do a mastectomy, when you remove that tissue, you are severing all the nerves. While there's aesthetically a lot that can be done in terms of reconstructing the breast, that tissue is essentially numb. There's no sensation because the nerves have been removed as part of that procedure. What we offer is a chance to restore that function by the products that we sell. The third area is oral maxillofacial head and neck. This is served by our extremity sales organization. It's an oncological primarily, not exclusively, but in any event, an elective procedure.
A smaller number of practitioners who do this type of work, smaller number of centers who do this type of work, and is an area where we have a high opportunity to add value to an individual in terms of restoring them to what God gave them in terms of their functional capacity by including nerve repair as part of that reconstructive process. Then finally, the marketplace, which we will speak to in more detail towards the end of this year, and that will be the development of prostate care.
Right now, we're in the process of understanding whether or not we can teach this procedure so that the outcomes are more uniform and reproducible. On the assumption that we can, we will add this as our fourth area of market development for the company.
Today, for the purposes of context, the numbers in our formal strategic plan guidance of 15% to 20% growth over the next three to five years does not assume any activity with prostate. The growth is presently driven by the first three areas of market focus. Just to level set for anyone who's new to this, what is nerve injury? Most simply, it's cuts or lacerations, or any kind of damage, crushing, stretching, that results in damage to the nerve itself. This is as I described, caused by either trauma or iatrogenic injury, typically secondary to some other surgical procedure.
All of these result in the elimination or the minimization of nerve function capacity. The products that we use to address these problems are comprised of what you see in this portfolio. To the left is the AVANCE Nerve Graft. This is the first-ever approved biologic therapeutic solution for the treating of nerve discontinuities. It's got a generalized indication for any situation in the body for this particular application. It's what's distinctive. It's really what the foundation of the AxoGen house is built upon. It's a unique product exclusive only to AxoGen.
Its advantages are based upon benefit versus risk are superior to any other solutions or care that might exist. The other products are products used to facilitate the best possible surgical procedure utilizing products like this, but not exclusively also to protect, and/or enhance the reconstruction of a native nerve if that's possible to do. This is what comprises the sources of our revenue. About 60% of our revenue is driven on a routine basis by the Avance sales, and the AxoGuard, which complements that, represent the remainder.
What are the market development opportunities for us? As I just described, our mission purpose is to make the restoration of nerve function a standard of care. The barriers that exist to that are not those that normally come in the introduction of a new product where people argue about whether or not it's medically necessary.
That's not really the issue. The issue is one primarily of awareness, the lack of definitive care guidelines that establish the expectations of when and when you should consider and how you should treat nerve care, insufficient payer or referral networks across each of these various areas. Numbers of people just sometimes don't even know that there's an opportunity to deal with these types of problems. Finally, while it's becoming less and less of an issue, we still don't have complete coverage and payment.
These are the strategic work streams that we deal with on a regular basis as part of our organizational planning and our investments. This represents the summation at the highest level of what were the priorities that we set out for ourselves more than two years ago when we concluded our strategic planning effort. These of course remain unchanged. They're as viable today as when we first concluded on these.
Essentially for an investor watching our ability to develop and fulfill our mission purpose is represented by growth between at least 15% to 20% per annum over the course of the strategic planning period. Moving more and more to elective procedures as a priority area for development as opposed to emergent procedures. In particular, developing prostate on the assumption that we can figure out how to teach that procedure properly so that the outcomes are uniform. It would be a major strategic element of development. Finally, commercial expansion.
In all areas that we service, we do not presently have open all possible accounts, nor have we trained anywhere close to the number of surgeons who would need to be trained in order to fully deploy and practice nerve care on a routine basis. It's an area of constant work in terms of establishing that footprint, making sure they're ready, and then extending that business model accordingly. To that end, commercial excellence. I know it's a word that gets tossed around, but it's a very important part of playing good football.
You need to have pass plays for any type of customer creation process, and whoever practices those best usually wins. It's no different than sales and marketing. We spend a lot of time in figuring out what would be the best way to do that in extremities, oral maxillofacial and breast, and we'll be developing the same for prostate, and that would remain a focus for us throughout the period. While we have certain assumptions on elasticity, the timeliness and of managing to that math is critical to ensure that you have predictability and consistency of performance.
Finally, standard of care. A lot of the things that we're doing here are unnecessary once the therapy becomes an expected standard of care. Ultimately, that's how you win the total game, is establishing the expectation that when someone presents with a problem like this that is not an option to treat, but an expectation to treat.
You do this through accumulation of evidence, the socialization with physician societies, and establishing formal expectations and guidelines that say, "In this situation, you must also evaluate the nerve and treat that." When I say that, you might say, "Well, what is he talking about?"
Well, to give you an example, the simplest example is if I were to present to the emergency room with a trauma, terrible trauma, where I've torn up half my shoulder, it's completely flayed open, I've broken my bones and my shoulder and otherwise, I've cut my artery, I'm bleeding to death, what's going to happen is they're gonna stabilize me in the OR. They're gonna triage me. They're gonna call the cardiac surgeon, vascular surgeon. They're gonna stop my bleeding, so that they stabilize me.
They're gonna call in the orthopedic surgeon. They're gonna get those bones fixed. They'll probably also make sure they get the tendons, if they remember to do all of those. They may or they may not ever even think about the nerve. While I might leave the hospital alive, my function is obviously diminished because I don't really have the full use of that limb or my torso because my peripheral nerves were an afterthought. Not because people didn't care or the physicians were apathetic. It's just simply not part of the care continuum in all sites of service in the United States or anywhere in the world.
That is the substance of the work of AxoGen, is changing that paradigm because there are solutions now that can make this doable, and solutions that are demonstrably better than what presently exists today, which primarily is no care. That's the opportunity, that's what's driving our growth today is the progress we make towards that. Finally, investing in the future. What we're talking about here is making nerve care more adoptable by making it easier to do, and then further enhancing the effectiveness of these already good algorithms and products that we presently have.
There's both short-term catalysts that will translate over the strategic planning period as well as longer term elements. We're working all the normal fundamentals of good business, that's what's driving our growth and why we believe and have confidence in the guidance that we have. Payment is always a big factor. We've made great progress, but we still have about 35% of the gap in commercial lives to cover.
This is important because while Medicare provides full coverage for nerve care, today, the majority of the age at which you present with a nerve injury is primarily in the commercial coverage spectrum of healthcare. We have three significant payers who have not updated their coverage guidelines that we expect to complete in the near term. That will be a final barrier that we have resolved.
As I've mentioned, we're investing in the future. These are the various work streams. We will provide more granular guidance on some of this work towards the end of this year and then into the future. Today, for proprietary reasons, we keep the actual details of this still internal. In terms of quantity of investment, it's about 14% of our turnover is invested in R&D. Our guidance for this year is that we will grow at least 18% or $266 million in total revenues. Our gross margin guidance is that we will generate outcomes between 74% to 76%, and that we'll be net free cash flow positive for the year.
Big picture, just kind of round it out, telling you what I told you is that these are very large opportunities. There's a significant opportunity to improve and restore health and quality of life for individuals, and as a result of that, making for a great business. This is a big opportunity to do good, and it's one of these healthcare elements that no one argues about is not truly relevant. Not every problem in healthcare is worth investing time, capital, and people in. Your peripheral nerve function is one of those. This is a huge opportunity that we believe will drive growth and support growth for years ahead.
Clinical leadership. We are the experts in this space, if there is such a thing as an expert. People like to work with us because one of the elements we do have historically as a legacy is that we do good work in the professional education and the basic science side. As these products become more available and the guidelines get developed, we are the ones who are providing the support to grow that.
We have multiple catalysts, based upon the opportunities I described in terms of markets, and even not on that slide, there are significant opportunities in the future as the company grows and becomes larger, we have the ability to act upon and become leaders. Reimbursement-wise, we've made great progress over the last 24 months, added almost 20 million new lives, and we have a very, very high confidence that we will continue to make such progress here in the very near term as we close out the strategic plan period.
Our infrastructure is scalable. These business models should be elastic for years to come. We still have to manage to them, but we know what we need to manage and that's a controllable within our ability. Finally, we've reached that inflection point that all companies aspire to, which is we're able to create these customers and do the things that we just described with our own organic cash flows. With that, I'll open it up to you, Jayson, for any questions.
Great job, Mike. Thank you. Welcome up, Lindsey. Maybe Mike, start with the BLA. The path I'd say has been unconventional, right? You just received FDA approval for a device that you've been selling for 17 years, with over 120,000 implants. I guess what changes in your discussions with physicians, hospital administrators, payers now that you actually have the BLA?
You hear me?
Yep.
Yep. Okay. You are right, Jayson. It's very unconventional. In my career, I have never seen a unique situation like that from a regulatory framework where you operate for more than a decade under discretionary approval, while you're moving towards a new status of quantification of your benefit risk. It is now concluded. What's changed is that. Let me explain what is not going to happen. Normally, when you reach a such a significant milestone as a regulatory group like this, you have a massive commercial event that transpires, but that's because you're not yet commercial.
We've already been commercial. The product's already been accessible to our customers, there's not a light switch inflection point. That said, with the receipt of the BLA, we're able to approach our customers, and we're able to validate those who have been users of our products and supported our journey, by making clear to them that, "Hey, thank you. The FDA has just approved our Biologics License Application, and Avance is now the first of its kind, biologic therapeutic for the treatment of nerve discontinuities." It's a reference product now for the entire world for products of this kind. It's a big deal.
For those who might have been sitting on the fence who are still unsure whether or not the product was what it was purported to be, you can imagine that we revisit with those customers and make manifest the Biologics License Application's approval and its significance. It's certainly very supportive of our market development effort in that regard. Perhaps the most active elements is our ability to go back to payers, the remaining payers who don't provide coverage, who do so because they conclude that Avance is an experimental product.
Despite the fact it had discretionary approval and despite the fact it's been around for a while, some stakeholders did look at the product as if it was experimental. With the approval of the Biologics License Application, we are now able to reapproach these entities, and then formally make clear that it is not experimental. This is key to moving forward full coverage in the future with regards to that event. The third event is that, with now that we have an established codified benefit risk profile, we're able to enter into new clinical study work.
We don't need to do this for regulatory purposes necessarily, but we knew need to build evidence relative to our standard of care aspirations. All new markets are dependent upon the quantity and the quality of evidence, and there's more evidence work that we needed to do.
We couldn't really do that work in terms of controlled studies until such time that the Biologics License Application was completed and concluded. That's a big area. Then finally, and this I've spoken to about many times publicly, is because we were under a discretionary approval, we were managing our products under a quality system, which was adhered to device regulations for tissue. The biologics quality system is a different quality system with greater touch points, greater redundancies and different measures.
So we had to stand up two quality systems at the same time, we couldn't move conclusively to biologics because we weren't yet approved. It also made it difficult to invest as you would normally do in continuous improvements on the tissue side because you're new, you're moving to biologics. Extremely resource intensive as a result, because essentially you're doing two things at the same time that you would normally never do in a manufacturing process.
With the conclusion of the BLA, we now have one quality system that we can invest in, greater mind share and focus, less resource intensive strategically in the future. We're now allowed to implement into the manufacturing process, the kinds of things that would normally be associated with good practice, which is electronic batch records, continuous lean improvements. And all of this measures together is what allow you to, over the long term, reduce your costs, even further enhancing your gross margin
Okay. Very good answer. Maybe just to piggyback on a few of those, have you seen an increase in physician interest post-BLA?
Yes, more acknowledgment. Again, because it's already been available to them, it's an affirmation of what they were already doing. Not an inflection point, light switch.
Okay. That's fair. Fair enough. Just on the commercial coverage, I think you've talked about near universal coverage over the long-range plan. It sounds like there's some near-term milestones. What should investors expect for knocking down some of these reimbursement hurdles over the next 12 months?
Sure. As we've mentioned many times, we can't predict the timing explicitly. We can predict the levels of confidence over a period of time. That is that we believe we will gain full coverage by the end of the original strategic planning period, which is 2028. Does that mean something will or won't happen in 2026? We hope and believe it should, but we can't predict that. Why do we say this? A payer has their own requirements for coverage. They're published, they're transparent. You can literally go through their lists. They have a process by which you engage to interact in providing these kinds of proofs.
Some of people use independent evidentiary sources. Some people do all the work on their own. Some people have different advocacy requirements where their own physicians and their own networks need to make testament as to their advocacy. All this together goes into the calculus of do they provide coverage or do they not provide coverage. Where we are today is with each of the remaining payers, we have gone through all of the formal requirements, and we have submitted the information that makes clear that we meet or exceed any of the expectations.
We know objectively that technically there is no reason why any one of these individual payers should not, at this point in time, now provide at their next annual update approval and full coverage for Avance usage. What we now are waiting upon is as the first responses to these formal applications.
Okay. Very clear. Mike or Lindsey, you just completed a capital raise that allows you to pay off some high coupon debt. Can you just talk us through the opportunity that paying off that debt opens up, and where do you plan on allocating the remainder of the proceeds?
Yes. We just completed a upsized round of, $142 million. The net proceeds from that raise were $133 million. From that, we paid off our existing debt facility. That was about $68 million. We'll record a loss, from the extinguishment of that debt, about $17 million in first quarter here. What that money allows us to do, the excess funds, it's improving our balance sheet. It's also improving our cash flow and our profitability going forward. We're going to keep the cash opportunistically even though we are gonna be free cash flow positive, in 2027.
To be able to, if we see a need of a additional, a tuck-in that we want to do or to accelerate our innovation plans or just use it more opportunistically, as well as reduce the dilution impact of our employee stock-based compensation plan on our shareholders by approximately 30%.
Okay. Thanks. Very clear. Mike, prostate, what are the next steps after you get the initial clinical data in the second half of the year?
Sure. So, for those who may not have followed, we have a basic thesis, which is actually conditional to our approval of our product, that a nerve is a nerve is a nerve. In other words, whether it's in the arm, whether it's in a facial nerve, below the knee, that fundamentally, the potential for regeneration exists in a similar fashion. Prostate is another classic example of iatrogenic injury. You're doing a procedure that results in damage oftentimes to the nerves when they cannot be preserved wholly or completely. The result of that is dysfunction. It becomes a huge barrier to just diagnosis in general, much less interventional care.
When it is involved, it affects quality of life. At this age, we, particularly for someone like me, you all know somebody who's gone through that experience. Big health problem, no matter what, how hard people have worked, not been able to correct it. What we did this year was we identified 10 clinical sites, and we asked them to enroll together 100 patients with different approaches, but one primary approach with regards to the use of allograft.
Then what we are doing now is following and working with those individual centers to determine whether or not the procedures that we believe would be appropriate are teachable. Teachable is defined by everybody can technically do the procedure and that the outcomes reflect what we would expect to be appropriate in terms of nerve regeneration.
On the assumption that those outcomes are positive, and it's gonna take time for the healing process and enough patients to get through to really make that judgment call, on the assumption that those results are directionally positive, we will stand up commercial efforts accordingly to develop prostate just like we're doing for breast and just like we do for oral maxillofacial and extremities.
That time period in terms of where we'll have enough patient experience to speak to is going to be in the second half of the year. Towards the end of third quarter, and certainly by fourth quarter, we'll have enough data to draw a conclusion.
We've got a minute left, but I did wanna ask, gross margin. It was topical on the call. Business is generating a nice gross margin. There is a transition over to BLA manufacturing. What do you need to do, and what does it look like in 2027, when it snaps back?
Yes. As Mike kind of mentioned earlier, having that BLA approval is allowing us to be able to make more improvements in our manufacturing processes. We're implementing a manufacturing execution system, electronic batch records, a lab management system, and implementing a lot of lean programs. With that, we believe we'll be able to offset the additional costs that are related to processing as a biologic.
We haven't started talking about where we think we can be at the end, you know, where's the top? We plan on talking about that more towards the end of 2026, but we still view ourselves 75% plus gross margin business in the long term, and we'll have more details to come.
Lindsey, we're bumping up against our time here. Lindsey, Mike, thank you very much.
Thank you.
The breakout will be downstairs in Amarante I. Thank you.
Thank you.