Earnings Call Transcript - AXGN Q4 2024

Operator, Operator

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. 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.

Michael Dale, CEO

Thank you, operator and thank you to everyone who is joining us today as we discuss our 2024 fourth quarter and full year financial results. 2024 was a solid year of key accomplishments for Axogen. We are pleased with our progress as a team. And while we have work ahead of us to realize Axogen's full potential, we are entering 2025 with increased confidence across all parts of the business. On my first call as CEO last November, we established three near-term priorities for the business: number one, successfully complete the submission of our BLA application; number two, meet our established revenue guidance for the year; and lastly develop a new strategic plan for the business, engaging all employees and key external stakeholders in the process. These were, in each case highly relevant commitments we made to all stakeholders, and the successful completion of these commitments explains in part our increased confidence as we enter the new year. Regarding future expectations for Axogen, I am excited to introduce our new strategic priorities today and look forward to providing details about our new plans during our March 4 Investor Day event. The insights and opportunities identified from our strategic planning exercise explain the other part of why we are entering 2025 with increased confidence. Before I address financial results, I’d like to provide background for anyone who might be new to our story. Whenever we reference Axogen's nerve repair algorithm, we are referring to a broad product portfolio designed to address the needs of common nerve injuries, including bridging the gap, resulting from transected nerves, nerve protection for non-transected but injured nerves, and termination of nerves when there is no opportunity for reconnection or reconstruction. Depending on the clinical situation, one or many permutations of Axogen's nerve algorithm may be necessary to ensure the best possible patient outcome. Now to our financial results. Our full year 2024 revenue was $187.3 million, a 17.8% increase compared to 2023. In 2024, we saw broad-based growth across all of the markets we serve, which comprises extremities, oral, maxillofacial, and head and neck, and breast. For each market, positive performance was driven by improved commercial execution of our growth strategy focused on driving adoption of our nerve repair algorithm and development of high potential accounts. EBITDA was similarly positively impacted by our improved sales productivity and resource allocation. Now turning to our fourth quarter results. Revenue increased to $49.4 million, up 15.1% compared to the prior year. Like the year, fourth quarter performance reflected broad-based growth, driven by adoption of our nerve repair algorithm across all clinical applications. We continue to execute our strategy to focus and deepen our presence in high potential accounts, which are primarily characterized by the following criteria: 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.

Jens Kemp, CMO

Thank you, Mike. To start we believe Axogen's planned peripheral nerve repair market development priorities represents a $5 billion total addressable market opportunity with significant potential to improve patients' health and quality of life based on a superior benefit to risk value proposition. We believe Axogen's nerve repair product portfolio and expertise remain significant advantages which we can build upon over the next four years. Axogen's international presence is limited today, but we believe the market opportunity for nerve care outside the U.S. is just as large and attractive, and we look forward to taking concrete steps towards developing these markets in the coming years. Our objective for the full year planning period will be to achieve a compound annual growth rate of 15% to 20% by executing on the following strategic priorities, which include: number one, we will prioritize investments towards markets with elective and planned procedures, which are characterized by a more efficient market development and customer creation process, resulting in more predictable and consistent revenue growth. Number two, we will advance the Axogen algorithm towards standard of care in extremities. Our extremities business, which consists of traumatic and chronic nerve injuries in the upper and lower extremities, represents more than half of our business today. We have a large customer base, Level 1 clinical evidence and strong key opinion leader relationships. Growth in this market has been impacted by commercial payer coverage policies, a challenging customer creation process and a complex patient journey. To address these challenges and accelerate growth, we will execute on the following strategies, which include; we will continue to drive advocacy for Avance Nerve Graft as a standard of care option in extremity nerve reconstruction and work to expand coverage by leveraging the BLA approval, Level 1 clinical evidence and societal support. Next, we will optimize the patient journey through education and therapy awareness of the referral base to drive more patients to our nerve surgeon customers. We'll continue to develop the market for nerve protection and expand our market development efforts to lower extremities. And finally, we'll continue to drive commercial excellence with higher sales productivity by execution of our high potential account strategy with a dedicated sales organization to drive focus and adoption of the Axogen nerve repair algorithm. Number three, we will establish leadership in the breast neurotization market and drive our Resensation technique towards standard of care in breast reconstruction procedures. Axogen's Resensation surgical technique is designed to address post-mastectomy numbness, a significant consequence of breast cancer surgery, by restoring sensation to the breast as part of the reconstructive surgery. Breast neurotization represents a significant market opportunity and is Axogen's fastest-growing business with a consistent, predictable and scalable business model. To accelerate growth, we will focus on the following strategies, including significantly increasing investments in our breast commercial infrastructure to support growth. This includes growing our dedicated sales and marketing organization, as well as expanding our professional education capacity. We will expand surgeon education and training programs to increase surgeon activation and Resensation procedure adoption. We will accelerate patient awareness and activation by increasing the quantity and reach of our campaigns, while growing relationships with advocacy groups and healthcare providers. And finally, we will advance Level 1 clinical evidence generation to expand coverage and drive societal support for standard of care. Number four, our oral, maxillofacial and head and neck business represents a large and attractive market opportunity for Axogen with high procedural concentration in about 900 hospitals with strong overlap with our extremities high potential accounts. Iatrogenic nerve injuries are common in OMF and head and neck surgical procedures, but are often not treated due to lack of surgeon education on available nerve repair options, as well as awareness of the quality of life impact for patients. To accelerate adoption of the Axogen nerve repair algorithm in OMF and head and neck and drive towards standard-of-care, we will execute on the following strategies: 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 key opinion leader 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 Naor, CFO

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.

Operator, Operator

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

Chris Pasquale, Analyst

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?

Michael Dale, CEO

Sure, Chris. I'm aware of the questions regarding the total addressable market historically. As part of our new planning process, we evaluated those fundamental questions and examined all the variations in incidence presentation and the different issues, whether elective or emergent. We feel very confident about our estimates of the overall total addressable market. During the Investor Day, we will go through the specific components that make up that market in detail. Based on the coding available to us, we assessed the actual eligibility of potential users of our products in terms of size versus merely reconnecting nerves. All of this analysis helped us reach our conclusions. The key point, as with nearly any market, is not only its size. Size is important, and even a small miscalculation still leaves a target, which is why people are interested. However, there are also differences in addressability within the markets. We are simply presenting the facts as we have been able to determine them.

Chris Pasquale, Analyst

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?

Michael Dale, CEO

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.

Nir Naor, CFO

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 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.

Michael Dale, CEO

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.

Operator, Operator

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

Michael Sarcone, Analyst

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?

Michael Dale, CEO

We have a track record of growth to reference. We'll delve deeper into the details on Monday to clarify these points, but essentially, we're expanding parts of our organization. For instance, we plan to double our footprint in the breast segment. Our experience with the business model gives us confidence in its potential for scalability. As long as we execute the expansion on time, we expect it will lead to new customer creation. We also have extensive experience with training individual surgeons. In certain areas, we have over an 80% likelihood that trained surgeons will perform procedures, and we know the average number of cases they will conduct. We have done the calculations, and while execution is crucial, we have a solid plan backed by straightforward metrics. If there are any miscalculations, they would stem from unforeseen assumptions. However, we believe our plan is highly feasible.

Michael Sarcone, Analyst

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.

Nir Naor, CFO

Yes. The key assumptions rely on our current organization and the existing momentum. Some investments have already started in 2025, but they are staggered and will require time to show results. For example, hiring more sales representatives takes time for training. We anticipate that some of the investments made in 2025 will yield results this year, helping us reach the high end of our guidance. While we would be pleased to exceed this range, this is the level of confidence we have at the moment. You also asked about the margin, Michael?

Michael Sarcone, Analyst

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

Nir Naor, CFO

We launched some products last year, and experienced uneven year-over-year growth. This year will not be entirely smooth either, as various events, including Easter, occur at different times compared to last year. However, we do anticipate some upward trend in our growth this year, driven by investments that we expect will start yielding results later in the year.

Michael Sarcone, Analyst

Great. Thank you.

Operator, Operator

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

Caitlin Cronin, Analyst

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?

Michael Dale, CEO

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 the 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.

Caitlin Cronin, Analyst

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

Michael Dale, CEO

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.

Caitlin Cronin, Analyst

Thank you so much.

Operator, Operator

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

Mike Kratky, Analyst

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?

Michael Dale, CEO

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?

Jens Kemp, CMO

Yes.

Michael Dale, CEO

Yes. The market development and professional education staff are required to conduct training as well. This will lead to an increase in customer-facing headcount, particularly in breast procedures. Additionally, across both extremities and breast, we will have a significant number of teachers and trainers essential for the programs we discussed. Their work greatly influences customer creation. On the prostate side, however, we do not expect significant revenue this year. We are in the process of developing a business model with a small team that includes physicians and education and development managers, aiming to scale with our sales organization as we finalize this development by the end of the year. We also need to establish surgical techniques that we are prepared to guide and teach, which is currently in progress as we conduct various evaluations; ultimately, we need to finalize a protocol. Just as we did for breast, we'll apply the same approach for prostate. We are encouraged by the early clinical data we've gathered, which is a reason we've targeted this market, but we still must ensure we can teach it effectively on a larger scale. I hope that clarifies your question.

Mike Kratky, Analyst

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?

Michael Dale, CEO

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

Jens Kemp, CMO

Yes. As Mike mentioned, we look for commonalities among Level 1 trauma centers, a significant number of microsurgically trained surgeons at the facility, nerve repair cases, and more. We use an algorithm to identify high potential accounts, which is our targeting method. Currently, we are focusing on about 600 high potential accounts that all possess these shared characteristics, which we believe could greatly enhance our nerve repair capabilities.

Mike Kratky, Analyst

Understood, thanks very much.

Operator, Operator

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

Jayson Bedford, Analyst

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?

Michael Dale, CEO

To the latter question, it fits within the BLA. However, there's almost no part of our business where we won't need to continue developing additional data, particularly for prostate and breast cancers. We have studies already underway and plan to conduct more, as well as in specific areas of extremities. I want to emphasize this point. As part of our strategic plan, our primary assumption is that high-quality data, alongside a substantial amount of data, will be necessary to fully develop the opportunities we are targeting.

Jayson Bedford, Analyst

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?

Nir Naor, CFO

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.

Jayson Bedford, Analyst

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?

Michael Dale, CEO

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.

Jayson Bedford, Analyst

Great. Helpful. Thank you.

Operator, Operator

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

Ross Osborn, Analyst

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?

Nir Naor, CFO

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

Ross Osborn, Analyst

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?

Michael Dale, CEO

Sure. At Investor Day, we will highlight breast. We are very confident that our breast Resensation technique is completely justified from a benefit-risk perspective, with zero safety risk and a high probability of patient benefit. Unfortunately, I cannot recall all the data right now, but we have recently prepared updated executive summaries regarding breast. We believe the data is solid. However, we need to conduct more studies to meet the necessary data quality for establishing a new therapy and pursuing standard of care. We have one study almost completed and plan to conduct another in the next three to five years.

Ross Osborn, Analyst

Great. Thanks for taking the questions.

Operator, Operator

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

Dave Turkaly, Analyst

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?

Michael Dale, CEO

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.

Dave Turkaly, Analyst

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?

Michael Dale, CEO

Dave, can you please repeat your question? Were you asking about the share count?

Dave Turkaly, Analyst

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?

Michael Dale, CEO

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

Nir Naor, CFO

Yes, as we mentioned, we expect to self-fund ourselves. Therefore, we do not anticipate any fundraising in the near future. Does that answer your question?

Operator, Operator

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

Michael Dale, CEO

Thank you, operator. On behalf of the Axogen team, I want to thank everyone for their time and interest in our work to fulfill the promise and potential for all stakeholders in our business purpose to restore health and improve quality of life by making restoration 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.

Operator, Operator

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