Good morning everyone. Joining me on today's call is Michael Dale, Axogen's Chief Executive Officer and Director; and Nir Naor, Chief Financial Officer; and Jens Kemp, Chief Marketing Officer. Michael will discuss fourth quarter 2024 financial results and Jens will provide a high-level introduction to Axogen's new strategic plan.

Nir will then provide an analysis of our financial performance and guidance and discuss our outlook for the year, followed by a question-and-answer session. Today's call is being broadcast live via webcast, which is available on the Investors section of Axogen's website.

Following the end of the live call, a replay will be available in the Investors section of the company's website at www.axogeninc.com. Before we get started, I'd like to remind you that during the conference call, the company will make projections and forward-looking statements.

Forward-looking statements which are usually identified by the use of words such as objectives, will, believe, expect, estimate, should, guidance, intend, projects or other similar phrases include, but are not limited to, statements relating to financial guidance, including revenue, margins, cash flow, future profitability, expectations for growth, estimated total addressable market opportunities, timing for future product and application launches, marketing opportunities within existing and new markets, and the company's expectations for approval of the biological license application of Avance Nerve Graft, including the anticipated timing of approval and the assumption that Avance Nerve Graft will be designated as a reference product for any future biosimilar nerve graft and that such designation will provide marketplace exclusivity.

Forward-looking statements are based on current beliefs and assumptions and are not guarantees of future performance and are subject to risks and uncertainties, including, without limitation, the risks and uncertainties reflected in the company's SEC filings, including its Form 10-K and 10-Q.

The forward-looking statements are representative only as of the date that they are made. And except as required by applicable law, the company assumes no responsibility to publicly update or revise any forward-looking statements.

In addition, for a reconciliation of non-GAAP measures, please refer to today's press release and the corporate presentation on the Investors section of the company's website. Now I'll turn the call over to Michael..

larger hospitals, including Level 1 trauma centers and/or academic affiliated hospitals with a high number of nerve repair procedures; and lastly, already trained microsurgeons.

We aim to drive growth in these types of accounts through targeted expansion of nerve repair indications by building on the existing experience in nerve repair in the account, the inherent potential of the account to grow based on size and procedure volume, and by expanding adoption of our nerve repair algorithm to other surgical specialties.

We believe our focus on these high potential accounts is the reason for our improvement in sales productivity. Next, I would like to address the status of the biologics license approval, also referred to as BLA, for Avance Nerve Graft.

As a reminder, a BLA approval will complete the regulatory transition of Avance Nerve Graft from a 361 tissue product to a 351 biological product. Importantly, we believe Avance will be designated as the reference product for potential biosimilars, providing 12 years of market exclusivity.

We submitted the BLA in the third quarter of 2024 and continue to engage regularly with the FDA, as part of the application review process. Consistent with prior guidance, we expect BLA approval in September.

I would now like to turn it over to our Chief Marketing Officer, Jens Kemp, so that he can share and highlight the key insights and priorities resulting from our strategic planning exercise. Our investments and market development priorities over the next four years will be guided by this plan, and the Axogen team is excited about our opportunities.

As mentioned, we will discuss the plan in detail during our Investor Day on March 4..

expand surgeon education and training programs to grow the number of trained surgeons and care sites that incorporate Axogen's nerve repair algorithm in targeted OMF and head and neck procedures.

We will increase field-based market development support to raise brand awareness and KOL engagement to drive advocacy, best practice and adoption in the head and neck market.

We'll leverage the societal support in OMF and inclusion in the AAOMS ParCare guidelines to drive societal support and standard of care designation for nerve repair in mandible reconstruction with key head and neck societies.

And finally, we'll drive increased patient and surgeon awareness of the quality of life impact from nerve damage in OMF and head and neck surgical procedures. Number five, there are numerous large underdeveloped markets for nerve repair, and addressing these is an important long-term growth driver for Axogen.

We will invest in the development of those with substantial market potential and opportunity to improve patient outcomes. Our initial focus will be for nerve repair and protection during prostatectomy.

Prostatectomy represents a large and attractive market opportunity due to a motivated patient population and a well-defined clinical problem that can be addressed with the Axogen nerve repair algorithm.

Number six, we will increase our investment in innovation programs that aim to improve the standard of care in nerve repair and in Level 1 clinical evidence generation that meets payer requirements for coverage, advances support for standard of care designation and drives consensus for incorporation of our nerve repair algorithm into clinical guidelines.

Number seven, we will drive operational efficiencies in manufacturing by investing in systems and processes to optimize gross margin in the upcoming years. And finally, we expect to maintain positive cash flows over the planning period sufficient to fund our organic growth initiatives, consistent with our strategic plan.

We look forward to providing more details on our upcoming Investor Day. Now I'll turn the call over to Nir to provide a review of our financial highlights and guidance.

Nir?.

Thank you, Jens. We're excited about our results for the quarter and the year. We have seen good progress in our commercial execution and resource allocation, both yielding results in terms of top-line growth, bottom-line profitability, as well as cash flow positivity for the year.

For this quarter, our revenue reached $49.4 million, representing 15.1% growth from the fourth quarter of 2023. This growth is attributed to an approximately 11% increase in unit volume and mix and a 4% increase in price. Our gross profit for the quarter was $37.6 million, an increase from the $32 million recorded in the fourth quarter of 2023.

This represents gross margin of 76.1%, up from 74.6% in the same period last year. Our total operating expenses for the quarter increased to $35.6 million, up slightly from $35.2 million in Q4 of 2023.

Sales and marketing expenses, as a percentage of total revenue decreased to 40.6% from 46.9% in the fourth quarter of 2023 as we saw an increase in our sales productivity and solid execution of our strategy focusing on high potential accounts.

Research and development expenses decreased by 6.2% to $6.7 million from $7.2 million in 2023, driven by the completion of the development of Axoguard HA+ at the end of Q2 of 2024. As a percentage of total revenues, total R&D expenses were 13.6%, down from 16.7% in the last quarter of the prior year.

General and administrative expenses were $8.8 million in Q4 of 2024, up 11.8% from the $7.9 million in Q4 of 2023, driven mainly by stock compensation expense reversals in Q4 last year due to the departure of some of our leadership team.

The quarter ended with net income of $0.4 million or $0.01 per share, compared to a net loss of $3.9 million or $0.09 per share in the fourth quarter of 2023. Adjusted net income for the quarter was $3.5 million or $0.07 per share, compared to an adjusted net loss of $2.6 million or $0.06 per share in the fourth quarter of 2023.

Adjusted fourth quarter EBITDA was $6.7 million compared to an adjusted EBITDA of $0.6 million in the prior year. As of December 31, our balance of cash, cash equivalents and investments was $39.5 million compared to $30.5 million at the end of the third quarter. Turning now to our guidance.

We expect full year 2025 revenue growth to be in the range of 15% to 17% versus the prior year. We also anticipate full-year 2025 gross margin to be in the range of 73% to 75%. This range includes approximately $2 million of one-time costs related to the BLA approval, which would impact full year gross margin by approximately 1 percentage point.

The timing of most of those costs would be around the anticipated BLA approval date, currently expected to be in September. Notably, we estimate that two-thirds of those costs are non-cash and pertain to the vesting of our BLA related stock compensation.

From a cash perspective, we expect to be net cash flow positive for the entire year and expect to self-fund our new strategic plan.

However, we expect similar seasonality of quarterly cash flows as we have seen historically, with Q1 expected to be a net cash outflow due to the yearly bonus payment and the national sales meeting, both of which take place during the first quarter, followed by positive cash flow for the remainder of the year.

In summary, we're pleased with our fourth quarter performance. We will continue to execute our strategies and invest in innovation, improve our resource allocation, while maintaining our full year cash flow positivity and striving towards greater bottom line profitability. And at this time, we'd like to open the line for questions.

Maria?.

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Our first question comes from Chris Pasquale with Nephron Research LLC. Please proceed with your question..

Thanks, good morning guys. A lot to ask about with the strategic plan you laid out. Looking forward to getting more details next week. Just as a starting point, I noticed the $5 billion U.S. TAM you called out. I believe that's about 2 times how the company had previously thought about their opportunity.

And frankly, even that prior estimate had gotten some pushback at various times from the Street in terms of whether that was real.

And so, I'm curious kind of what the difference is now as you look at a $5 billion opportunity? How much of that has to do with new opportunities like prostatectomy that you talked about that really weren't part of the calculus previously versus a rethinking of the core markets?.

Sure, Chris. No, I'm aware of the questions about the TAM historically. I can share with you that as part of the new planning process, those very basic and critical questions were evaluated, and we've looked at all the permutations on incidence presentation, the various promise -- problems, whether they be elective or emergent.

And we are very comfortable with the estimates of the overall TAM. In terms of the actual components of what makes up that TAM, we'll obviously, during the Investor Day, walk through that discreetly in terms of each part of the marketplace.

But there is -- pretty comfortable, based upon all the coding that's available to us to look at, the actual eligibility of who could use our products from a graph size standpoint versus simply reconnecting nerves. All of that was evaluated that allowed us to get to that.

I think the key question, as with almost any market, I don't care which market you are speaking to, is not so much even how big it is. Big is important because if you're off a little bit, obviously, you still have a target remaining, and that's why people are interested. But there is also addressability.

And so, while the markets are large, we do believe there are differences in addressability. We are simply sharing with you the facts as they exist, as we've been able to deduce..

That's helpful. And then, just as I think about that list that you laid out, a lot of investment in better market development, in driving adoption, in new opportunities. I'm curious whether you can do all those things that you guys laid out, while still continuing to improve profitability. The company has come a long way.

You are cash flow positive now, which is a great step relative to a couple of years ago.

Is top-line going to be the focus going forward? Or can you balance that with margin expansion?.

We can absolutely balance it. So that's what our plan reflects. Last thing we want to do is embarrass ourselves, as we go forward here. So the plans that we put in place, we think, are very practical. They are very doable.

The investments that we need to make, we've looked at top to bottom, and we've tied these to a cause and effect by a clinical application. So now, obviously, we need to prove it. We need to execute. But the plan is pretty straightforward in terms of that cause and effect relationship.

And unless there is something grossly off, we believe we'll be able to do what we just described..

Yes, Chris this is really the continuance of last year, as we have said. Yes, we're not just focusing, obviously, on top-line growth. It is a balanced growth with optimization of resource allocation. And as we mentioned, yes with those investments, we expect to be cash flow positive for the year for 2025..

The key thing I would share, Chris with everybody is that Axogen chronologically is a company that's, for all practical purposes, at least 15 years old. But from an actual market penetration, market development, this is still a very young company. It is very immature in terms of any individual marketplace.

And while we want to believe that we've done everything is possible, the truth of the matter is we still have customers who don't even know our name. And so, there is much opportunity left in terms of improving basic awareness, while we continue to also teach nerve care.

So the market opportunity is very large, but we still need to go out and develop that market..

Our next question comes from Michael Sarcone with Jefferies. Please proceed with your question..

Good morning and thanks for taking the questions. I guess just one on some of the strategic plans you laid out. You talked about your objective being a 15% to 20% CAGR for the planning period.

I know we're going to get into more details at the Investor Day, but any color you could provide on what are the assumptions at the low end versus the high end there? And how much of that is related to kind of penetrating your existing core markets versus newer markets?.

Well, we have obviously history in terms of the growth rate to look at. And so very simply, and we'll go into the detail on Monday and try to answer those questions more clearly. But fundamentally, we are expanding parts of our organization. So for example, breast, we will double that organization in terms of footprint.

We have a lot of history in terms of the business model. So we know -- at least we believe we know how extendable that business model is. So long as we execute that expansion on schedule, that should result clearly in new customer creation. We also have a lot of history with regards to training.

So for individual surgeons that we bring awareness to of these types of techniques who go through our programs, in some of these areas, we have more than an 80% probability that those individuals will go on to do cases, and we know how many cases they will do on average. So again, we've tied the math out.

You still have to execute, but there's nothing that's a hope pass where you're throwing the ball downfield and saying, gee, I hope someone catches it. So everything has a pretty simple math that we've tied to. If there's any errors, it's some sort of error in assumption that we didn't foresee, but we think this plan is eminently executable..

Got it. That's helpful. Thank you Michael. And maybe one for Nir. Maybe just comment around the key assumptions for the 15% to 17% sales guide for the year and then maybe some color on how you're thinking about sales cadence through the year..

Yes. So the key assumptions are basically counting on the existing organization and the existing momentum. And then, we have some investments -- some of the investments already started, obviously, in 2025. That said, they are staggered. And in addition to that, they will take time until they bear fruit.

So for instance, if we are hiring more sales reps, obviously, there's some time that it takes to train them and so on and so forth. So the key assumption is that some of those investments that are being carried out in 2025 will bear fruit already this year, leading up to the high-end of the guidance.

Obviously, we'd be happy to beat it, but this is the range that we feel confident with as of now.

And then, you asked also about the margin, Michael?.

No, just about how you are thinking about seasonality on the top-line through the year..

Right. So again, we -- as you know, we have -- we launched some products last year, and we have had an uneven year-over-year growth last year. So obviously, it is not going to be all smooth this year. There are all sorts of events, for instance Easter and others, which fall this year in different times of -- versus last year.

Overall, yes, we do expect to have some sort of upward trend in terms of our growth for this year that is led by the investments that will take time to bear fruit, more towards the latter half of this year..

Great. Thank you..

Our next question comes from Caitlin Cronin with Canaccord Genuity. Please proceed with your question..

Hi. Congrats on a great finish to the year. I guess, just starting with long-term margins, I appreciate the longer-term gross revenue guidance.

Any longer-term gross margin guidance, given your plan to drive operating efficiencies?.

Really more general. I think 2025 is all about getting through the BLA process. So it doesn't mean that we're not focused on continuous improvements. But the BLA and the plant approval inspection events, all of these are predicated on an existing quality system and expectation as part of the license approval.

And so, dramatic changes or improvements in that, while we're working through that process with FDA, mean that at some level, there's a governor, if you will, in terms of how quickly we could layer in process improvements. So a long-winded way of saying that the margin guidance that Nir shared with you is what we should all rely on this year.

Longer term, we expect to incrementally continue to improve as any operations situation would in terms of shortening cycle times, further improving waste yields, all the normal measures that you try to take advantage of. But in 2025, I think the range that we've shared with you is what's prudent to plan around..

That's great. Thanks.

And then, just any concerns or changes to your expectations with the new administration in regards to the BLA application?.

So far, no. The pace of the information requests that we are receiving from the FDA continue without a break. So that's a good sign. Everyone is working very hard on both sides, FDA in terms of their review and then request for information, and then our side in terms of responding. So there's literally activity weekly.

So far, I can't point to anything that suggests a delay..

Thank you so much..

Our next question comes from Mike Kratky with Leerink Partners. Please proceed with your question..

Hi everyone. Thanks for taking our question. Maybe first, can you help us understand to what extent you're going to increase sales and marketing as part of your growth strategy this year? I think you mentioned doubling the size of your footprint in breast.

So how large of a sales force expansion are you expecting to implement as part of this? And how should we see that play out in 2025?.

Sure. So breast, for example, is 12 people at the moment. And so, we'll double that to 24. And in addition, across various parts of the organization, while they are not direct salespeople, there is about another 10, I think.

Is that right, Jens?.

Yes..

Yes. And these are market development and professional education staff. They are required to also do the training. So you have the customer-facing headcount, which will increase in breast. And then, across both extremities as well as in breast, we'll have a fairly significant number of teachers and trainers.

And these are required to put people through those programs that we mentioned. So they have a significant impact on customer creation.

And then, finally, on the prostate side, there is not expected to be a lot of revenue this year as we are -- essentially what we're doing is we are developing with this small organization, which will involve physicians, professional education and market development managers to develop the business model that we intend to use to scale with a sales organization as we complete that development towards the end of the year.

In addition, we need to develop surgical techniques that we are willing to guide and teach to, and that's a process that's underway today where we are doing different evaluations, but we ultimately need to settle on a protocol. Just like we did for breast [resensation] (ph), we need to do the same thing for prostate.

We have a lot of early clinical data that makes us excited. That's part of why we've chosen this particular marketplace, but we still need to be able to teach it at scale. So hopefully that answers the question..

Great. Yes, that's very helpful.

And then, just separately, can you talk about some of the commonalities you've seen across the high potential accounts and how you've been able to identify some of those in advance?.

Jens, why don't you go ahead and speak to that?.

Yes. We look at -- as Mike mentioned on the call, we look for commonalities in terms of Level 1 trauma centers, a large body of microsurgically trained surgeons in the facility. We look at nerve repair cases, et cetera. So we have a whole algorithm that we use to identify high potential accounts. And that's really what we use for our targeting.

So all of these accounts, there's about 600 of high potential accounts we're focusing on right now, and they all share these common characteristics, which we believe have very high potential for expanding our nerve repair algorithm..

Understood, thanks very much..

Our next question comes from Jayson Bedford with Raymond James. Please proceed with your question..

Good morning. Maybe just a few here.

On nerve repair for prostatectomy, you have some data, but do you need additional data, like bigger studies here before you go into kind of a full launch? And is there a different regulatory dynamic to think about? Or does it fit within the BLA?.

To the latter question, it fits within the BLA. But in each case, there's virtually no part of our business where we will not have to continue to engage in development of additional data, so prostate, in particular. Breast, we will continue to develop data. We already have studies underway.

We are going to do more, and the same thing with regards to certain areas of extremities. So I just want to be very clear about that. So when we -- as part of our strategic plan, primary assumption is that significant high-quality data, in addition to quantity of data, is going to be required to fully develop the opportunities we're targeting..

That's helpful. Maybe for Nir. You did, what, 76% gross margin in '24. The '25 guide captures this kind of at the high-end if we back out the BLA expense.

But I guess, the question is, what needs to happen for gross margin to trend higher?.

Right. So, as we mentioned last year, gross margin is impacted by this growing proportion of Avance products sold that were manufactured at the new processing facility at a higher cost. So, as time goes by, this proportion grows, and that's one of the drivers for which the gross margin went down, absent of those BLA-related costs.

On the other hand, and as Mike mentioned before, yes, we have been working actually already as of 2024, and that will continue, especially after the BLA approval, on efficiency improvements. And regardless, we expect to capitalize more on higher capacity utilization. Those are the things that need to take place for the margin to continue to improve..

Okay. That's helpful. And then, maybe just a quick one for Mike. On the last call, you talked about implementing these different business models for different applications and the focus on high potential accounts.

Was that evident in the fourth quarter results? Or are these models and actions being implemented now?.

Yes, but they're still being implemented. So maybe to more discreetly describe this, so for example, in the small breast team, if you use the bell curve from an overview, it's extremely tight.

In other words, we know exactly what an individual will be able to produce, how many customers they can manage, how many they can create, and it's a very common distribution. And so, that business model, we can characterize and we can do the math on and say, okay, well, let's do that times two.

With regards to extremities, depending upon which part of extremities, it's much more varied. And because of some of the different changes in approach historically, that business model is less clear.

And so, the high potential focus, which is pretty basic when you think about it in terms of the strategy that we are trying to employ, just to go deep in places that you have a chance for the plants to grow, and to that end, we have about three quarters under our belt where I could say we have consistency and a stable organization.

Realistically, I think we need another quarter or more on the extremity side to get comfortable enough that we think that this particular strategy is sufficient. It's certainly showing progress. I wouldn't look anyone in the eye, including ourselves, when we talk internally to say that we have our arms fully around it on the extremities side.

Again, part of the challenges with extremities, as we've touched upon, is that there is more than 5,000 service providers potentially. And so, there's lots of activity.

But with a relatively small organization like ours of 100 people, you've got to be careful not to be everywhere because then essentially, you are not billing enduring recurring revenue based upon standard of care status.

And so, this strategy is, at the end of the day, pretty simple insofar as we're trying to develop more concentrated care approaches to nerve care by focusing on a small number of accounts with the people that we have.

We're seeing good results, but we're not ready to suggest that this is the last thing we need to do on the extremities side based upon our footprint..

Great. Helpful. Thank you..

Our next question comes from Ross Osborn with Cantor Fitzgerald. Please proceed with your question..

Hi guys. Congrats on the progress. And thanks for taking our question.

Starting off with the guide for '25, and apologies if I missed this, but can you parse out volume growth versus price baked into your 2025 revenue guidance?.

Yes, it's pretty much in line with past years. So price growth is around the CPI, and the rest is volume and mix..

Okay. Great.

And then, looking at your breast recon business, what is your comfort level with existing data? And what areas, economic, clinical, et cetera, do you need to generate more data to support incremental adoption?.

Sure. When we -- at the Investor Day, we'll make sure that we highlight that breast. But we're very comfortable -- no, comfortable is the wrong word. We're very confident that from a benefit-risk proposition, our breast Resensation technique is 100% justified. So zero safety risk, a very high probability of benefit to the patient.

Sadly, I can't recite off the top of my head, all of that data, but we, just literally this last couple of weeks, have prepared the updated executive summaries of exactly how breast looks. So we are very comfortable that the data is what it needs to be. What we need to do, however, in terms of breast, is we just need to do more data.

When you're establishing a new therapy and trying to pursue standard of care, there is a certain data quality type that's required, and we need to do more studies than we presently have. We have one underway that's almost complete, and we have one more that we believe we need to do over the next three to five years..

Great. Thanks for taking the questions..

Our next question comes from Dave Turkaly with Citizens. Please proceed with your question..

Hi, good morning guys. I think you had mentioned that your APC has 3 times the previous capacity that you had.

I was just curious, I don't think there's any issue with you, but as you look at your plans ahead, how comfortable are you that you have enough to kind of meet where you're going? And then, maybe any comment even on longer term?.

Over the planning period, we are comfortable that we have capacity. Now, beyond that, I can't speak to you definitively. But we would be able to plan for that. That would be obviously an exciting requirement in the near term, but we don't presently believe during the planning period that we have any kind of capacity constraints..

Got it. And then, maybe a follow-up for Nir. I know you're profitable in the quarter, so the share count went up a bit.

But I was just curious, is that a good level that we should use for '25? And then, any thoughts on sort of timing of any incremental sort of bump-ups that we might need to consider?.

Dave, could you repeat that question? Did you say -- did you ask about the share count?.

I did. I know you were profitable. Yes, I know you're profitable, so I think it bumped up a bit.

And I was just wondering if that's the number we should use sort of carrying forward through '25, and if there's anything else we should consider in terms of any other bump ups, as we look through the year?.

I think that share count is -- the one that was reported is what you can use for now..

Yes. No, I mean -- and as we mentioned, we expect to self-fund ourselves. So we don't expect to do a raise in the near future.

Does that answer the question?.

Yes, that's fine. Thank you..

There are no further questions at this time. I would now like to turn the floor back over to Mike Dale for closing comments..

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 a peripheral nerve function and expected standard of care.

We look forward to updating you on our continued progress and our plans for the future at our March Investor Day and our earnings call next quarter. Thank you..

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation..