Hello, and welcome to the AxoGen, Inc. 2023 Fourth Quarter and Full Year Financial Results Conference Call and Webcast. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Harold Tamayo, Vice President, Finance and Investor Relations. Harold, you may now begin.

Thank you, Kevin, and good morning, everyone. Joining me on today's call is Karen Zaderej, AxoGen's Chairman, Chief Executive Officer and President, and Nir Naor, Chief Financial Officer. Karen will discuss the quarter and full year 2023, and Nir will provide an analysis of our financial performance, 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 the AxoGen 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 this conference call, the company will make projections and forward-looking statements, including our expectations regarding our ability to expand our footprint, expand core accounts, anticipate growth for revenue categories, penetration of core accounts, marketing opportunities with nerve applications associated with emerging trauma, breast, oral and maxillofacial and surgical treatment of pain and new products, our expectations regarding the timing of our launch for Avive+, our statement regarding the timing of the complete biologics license application submission for Avance Nerve Graft, as well as statements of the timing of the approved BLA. Our expectation is that, assuming approval of the BLA, Avance Nerve Graft will be designated as the reference product and expected market exclusivity of such designation. Our belief that our balance sheet will continue to be sufficient to bridge through to cash flow breakeven and longer-term profitability. Our expectation is that we will continue trending towards cash flow breakeven, and our belief that trends towards operating leverage will allow us to maintain a strong balance sheet position and provide ample support as we work towards profitability. 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 not limited to, the risks and uncertainties reflected in the company's annual and periodic reports such as hospital staffing issues, regulatory processes and approvals, surgeon and product adoption, and market awareness of our products. The forward-looking statements are representative only as of the date they are made and except as required by applicable law. We assume no responsibility to publicly update or revise any forward-looking statements. In addition, for a reconciliation of non-GAAP measures, please reference today's press release and our corporate presentation. Now I would like to turn the call over to Karen. Karen?

Thank you, Harold. And thank you all for joining us today as we discuss our 2023 Fourth Quarter and Full Year financial results. 2023 was a solid year of key accomplishments, and we entered 2024 with a strong commercialization strategy, fueled by innovation and focused execution by our sales team. Full year 2023 revenue was $159 million, a 14.7% increase compared to 2022. In the back half of 2023, we saw improved commercial execution, and during this period, we estimate that revenue from our emerging trauma procedures grew in the mid-single digits, and revenue from scheduled procedures grew above 25% as compared to the same period in 2022. As a reminder, these estimates of procedure categories are based on available data received from hospitals and sales reps and assumptions regarding specific surgeon practices and account information, and as such, are subject to the limitations of the data received and our assumptions. We're pleased with our progress and execution as we drive long-term growth, leveraging innovation, clinical data, surgeon education and patient activation. We're appreciative of our ongoing surgeon engagement and feedback as they continue to integrate AxoGuard HA+ into their nerve protection algorithm, finding differentiated applications compared to AxoGuard Classic. We're confident that AxoGuard HA+ will expand the adoption of nerve protection products and will help more patients with nerve injuries. Additionally, we're continuing to expand our offering for nerve protection with Avive+ Soft Tissue Matrix, which we anticipate will be commercially available in the second quarter of 2024. Avive+ is the resorbable nerve protection product that functions as a barrier, providing temporary protection and tissue separation during the critical phase of healing for nerve injuries. We believe Avive+ will be regulated as a Section 361 tissue product and will further strengthen our position in nerve protection, supporting emergent trauma and the surgical treatment of pain. In 2023, we also launched our Resensation breast neurotization technique for women who choose an implant-based reconstruction. We believe this innovative technique could apply to an additional 10% to 15% of all breast reconstruction patients. We're pleased with the surgeon engagement, positive feedback from our educational programs, and the early adoption of this new technique. This approach will allow more patients to have the opportunity for sensory restoration following their mastectomy and reconstruction. In August, the RECON study was published in the Journal of Hand Surgery. The publication includes the authors' analysis of the results, which found that Avance returned a greater degree of functional recoveries than conduits, and superiority was demonstrated as GAAP length increased. We believe that this addition of Level 1 evidence supporting the efficacy of Avance Nerve Graft in published literature continues to play an important role in surgeon clinical decision-making, especially with middle adopter surgeons. This study adds to a strong pool of clinical evidence supporting Avance Nerve Graft. In combination with the recent publications of the Meta-Analysis, the premier all payers cost comparison study and the US cost-effectiveness analysis, these four studies provide a package of compelling evidence for both clinicians and payers. During the year, we completed the validation and transitioned into our new processing facility near Dayton, Ohio. This facility was designed for long-term growth and expansion, providing three times our previous capacity. This new facility will also support our BLA for Avance Nerve Graft. Now turning to our fourth quarter results. We're pleased with our performance during the quarter. Revenue from the quarter increased by 18.7% to $42.9 million compared to last year. We estimate that revenue from emergent trauma represented approximately half of total revenue and grew mid-single digits compared to last year. As a reminder, emergent trauma generally results from injuries that initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury. We believe scheduled procedures also represented approximately half of total revenue. During the quarter, we estimate that this category grew more than 25% versus the prior year. As a reminder, scheduled procedures are generally characterized as procedures where a patient is seeking relief of a nerve condition caused by a nerve defect or surgical procedure. These include breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of a painful neuroma, nerve decompression, and oral and maxillofacial procedures such as a mandible reconstruction. Strength in this category reflects the opportunity to provide improved quality of life outcomes for patients, compelling clinical data, effective surgeon education and implementation of patient activation programs. As mentioned in today's press release, our growth strategy continues to be focused on going deeper into core accounts where we see significant opportunity to expand our footprint. As a reminder, core accounts are defined as those generating more than $100,000 in revenue over the trailing 12 months. Revenues from core accounts represent approximately 65% of total revenue. Growth was primarily driven by increased productivity of our direct sales force as they gain deeper surgeon adoption and expanded use cases of our products within these core accounts. We ended the fourth quarter with 116 direct sales representatives, up 1 from a year ago and flat sequentially. We will continue to evaluate and add sales reps as their territories approach targeted levels. Our direct sales force is supplemented by independent sales agencies that represent approximately 10% of our total revenue. In Q4, growth was broad-based across all applications and products. We were pleased by the contributions from innovations in new products and new applications. We continue to raise awareness of the need for nerve protection and saw expanded use of AxoGuard HA+ across both emergent and scheduled procedures. We also saw strong surgeon and patient interest in neurotization and implant-based breast reconstruction and expanded the number of surgical teams trained in this important new application. Moving on to updates on our growing body of clinical evidence. Over the years, we've made significant investments to develop quality clinical evidence to demonstrate the safety, performance, economics and utility of our nerve repair solutions. Our active clinical programs are progressing as expected. At the end of the quarter, we have 245 peer-reviewed publications, including trauma, breast, oral and maxillofacial and pain. This January, we announced positive top line results from the REPOSE clinical study, comparing the standard-of-care neurectomy of symptomatic neuroma to neurectomy and protection of the terminated nerve end with AxoGuard Nerve Cap. This post-marketing study met its primary endpoint for reduction of pain as measured by the visual analog scale. In addition, the study investigators found that over the full 12-month course of follow-up, AxoGuard Nerve Cap demonstrated statistical superiority for reduction in total pain reported by the subjects compared to the standard of care neurectomy. We believe that these findings will play an important role in surgeon clinical decision making. Now turning to the BLA for Avance Nerve Graft. We've recently completed our productive pre-BLA meeting with the FDA. We're encouraged by the positive interactions and have aligned with the FDA on a rolling submission process and the content of the modules for submission. We now anticipate the filing to be completed in Q3 of 2024, with potential approval in mid-2025. 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. With over 100,000 Avance Nerve Grafts implanted since launch, we are well positioned to continue to lead and innovate in the large and developing peripheral nerve repair market. I'm proud of our team, and I look forward to continuing our mission of revolutionizing the science of nerve repair. Now I'll turn the call over to Nir to provide a review of our financial highlights and guidance. Nir?

Thank you, Karen. I'm very happy to participate in my first call. It's been great three months ramping up and meeting people on the team. I'm very excited about the AxoGen story and the potential of the company. And moving to the financial results. For this quarter, our revenue reached $42.9 million, an 18.7% growth from the fourth quarter of 2022. This growth is attributed to a 10.5% increase in unit volume, coupled with a 4.9% mix favorability, and a 3.3% increase in price. We estimate that revenue for emergent trauma represented approximately half of total revenue and grew mid-single digits compared to last year. We estimate that revenue from scheduled procedures represented approximately half of total revenue. During the quarter, we estimate that this category grew more than 25% versus the prior year. Our gross profit for the quarter was $33.8 million, an increase from the $30 million recorded in the fourth quarter of 2022. This represents gross margin of 78.7%, down from 83% in the same period last year. This change is mainly driven by the costs associated with starting tissue processing at our new facility. Our total operating expenses for the quarter increased by 3.7% to $37 million, up from $35.6 million in Q4 of 2022. Specifically, our sales and marketing expenses for the fourth quarter grew by 11.6% to $22.2 million. Sales and marketing expenses, as a percentage of total revenue, decreased to 51.7% from 55% in the fourth quarter of 2022 as we saw improved sales force productivity. Research and development expenses increased by 7.2% to $7.3 million from $6.8 million in 2022, driven by costs related to the BLA. As a percentage of total revenues, total R&D expenses reduced to 17%, down from 18.8% in the last quarter of the previous year. General and administrative expenses decreased by 16.3% to $7.5 million in Q4 of 2023 from $8.9 million in Q4 of 2022, driven mainly by stock forfeitures due to the departure of executives from our company. The quarter ended with a net loss of $3.9 million or $0.09 per share, compared to a net loss of $5.4 million or $0.13 per share in the fourth quarter of 2022. However, we recorded an adjusted net loss of $2.6 million for the quarter, translating to roughly $0.06 per share, a shift from an adjusted net loss of $1.1 million or $0.03 per share in the same period last year, driven in part by one-time severance costs. Adjusted fourth quarter EBITDA was $0.6 million compared to an adjusted EBITDA loss of $0.7 million in the prior year. As of December 31, our balance of cash, cash equivalents and investments was $37 million compared to $38.6 million at the end of the third quarter. Turning now to our guidance. As outlined in today's press release, we are issuing our full year guidance for 2024. We expect revenue to be in the range of $177 million to $181 million, which represents an annual growth rate of approximately 11% to 14%. Additionally, we anticipate gross margin for the full year to be in the range of 76% to 79%. In the future, we expect our gross margin to benefit from improved capacity utilization of our new processing facility as our sales volume of Avance increases. And in summary, we're pleased with our fourth quarter performance. We will continue to execute our strategies, invest in innovation, improve our productivity and drive towards cash flow breakeven and profitability. At this time, we'd like to open the line for questions. Kevin?

Our first question today is coming from Chris Pasquale from Nephron. Your line is now live.

Thanks. Karen, Avive was annualizing at close to $8 million in sales before you pulled it off the market. Is there any reason to think that Avive+ won't ramp to that same level relatively quickly? And how do you think about how much of that is incremental versus cannibalistic to your existing portfolio?

Just to remind everyone, we previously launched a product called Avive, which we had to withdraw due to changes in FDA regulatory classifications. We've introduced Avive+ to re-enter that temporary protection segment, which we believe is a valuable tool for surgeons. However, I don't expect an immediate increase in sales, so I want to temper expectations about its performance in the coming quarters. There are surgeons eager to use this product since they relied on the previous Avive product in their nerve treatment protocols. I want to be cautious and suggest it will mainly complement our existing protection business and contribute to overall growth, but it won't quickly generate substantial revenue. Some cannibalization is expected, as surgeons had to switch to alternative tools when Avive was removed from the market. While there will be some impact from that, we believe much of the Avive business will come from new customers, so despite some cannibalization, it should primarily represent new business for us.

Thanks. And then Nir, just a question about the cadence of gross margin during 2024. The guidance is a little bit lower than what we were thinking. I'm assuming that's related to the new facility. Can you give us some sense of what the first half looks like versus the second? And whether you see a pathway back to the 82%, 83% margins the company enjoyed a year ago?

Yeah. Thank you for the question. So yeah, indeed, as we mentioned, we fully transitioned to the new processing facility at the end of last year. It is an important milestone for BLA. It is designed for long-term growth and basically has capacity, which is three times our previous one, which is very good for long-term potential and the margin. That said, in the short term, it's running at a fraction of its total capacity. And this is one of the drivers for the lower margin. And we're ramping it up, learning about the various benefits of capacity and other efficiencies. That said, we wanted to give guidance that we feel fully confident with. We expect the margin probably in the later half of the year to be on the lower side versus the first half of the year. Nonetheless, this is our average. And then long term, definitely, we expect the margin to benefit from higher sales, higher production and higher capacity utilization.

Sorry. So just to confirm, we should expect sequential decreases in gross margin through the year? Not a first half dip and then a second half rebound?

We're selling old inventory that was produced at the previous facility, which is why the second year may be slightly lower. However, we are gaining insights from the new facility's impacts. For the overall year, we provided guidance of 76% to 79%, with a strong expectation for improvement in the long run.

Great. Thank you.

Thank you. Next question is coming from Mike Sarcone from Jefferies. Your line is now live.

Good morning and thanks for taking the question. I guess just to start on the guidance, the 11% to 14%, can you just talk about what's baked in, in terms of scenarios in healthcare utilization environment at the low and high ends of the range?

Yeah. So we're looking at continuing to see measured growth through the year, driven predominantly by productivity improvements with our existing sales team. So think of it as about the same number of reps, maybe up or down a few, but not a big expansion of the sales team, so it's driven by productivity, and a real focus on driving that growth in our core accounts. So that's our strategy. That's how we think we're continuing to build this out. And we’ve drawn that out and have taken what we think is a measured approach in thinking about our overall growth.

Okay. And I guess, can you provide any color on how you're thinking of the growth differential in 2024 between emergent trauma and scheduled non-trauma? Can you break that out for us or help us think about that?

Well, as we've talked about before, we think the conversion process in trauma, well, it's a very large market, it's just hampered by the very nature of the fact that it's an unscheduled procedure, and surgeons don't take trauma call every day in a given month. And so we think that the trauma growth will continue to be paced through continued growth but having to reach those surgeons in a longer time frame with a greater number of adoption steps. In scheduled procedures, by the very nature of the fact that they're scheduled, you can plan to be with the surgeon as they adopt a new technology, work with them in those cases and help change their practice patterns over a more discrete amount of time. So we think the adoption process and scheduled cases can be more rapid than what you see in trauma. So it's a blend of those two that is what made up our overall guidance.

Okay. Thanks, Karen. And maybe if I could just squeeze one last one in. Can you maybe just elaborate on how you're thinking about seasonality and sales cadence through the year?

Yeah. Great question. So as we've talked about in the past, trauma has a peak during the time periods where people are more active. And so as our business was originally trauma, you saw a cadence where first quarter to second quarter, there was a big jump up. Second quarter to third quarter, there was another jump up. And then it was basically flat to down in the fourth quarter, and then sequentially, again, flat to down into the first quarter of the next year. Scheduled cases don't follow that cadence. So you're seeing some shifts in our cadence and seasonality, where scheduled cases will be driven, like most other elective scheduled procedures, they tend to be heavy towards the end of the year. A little slight nuance difference for breast reconstruction where many women prefer not to have their breast reconstruction during that holiday period. But in most scheduled elective procedures, you'll see a push towards the end of the year and it will be a little bit lighter at the beginning of the year and then more of a steady slope throughout the year. So again, we're going to see some shifts over time in the cadence quarter-to-quarter as we balance between trauma and scheduled cases.

Okay. Thanks, Karen.

Thank you. Next question today is coming from Mike Kratky from Leerink Partners. Your line is now live.

Hi, everyone. Thanks for taking our questions. Great to see the agency alignment on the Avance BLA. What's the latest you've been hearing from KOLs and physicians on the extent to which having that ultimate BLA approval could really drive higher utilization? And what are the key factors that are driving that?

We're really excited about continuing to move forward and getting to the final stage of our submission on the BLA. It's been a long process for us. So we had a very productive meeting with the FDA that we think laid out a clear path for us as we go forward. So yeah, we are turning our sights not just to the submission, but to our commercialization post-BLA. Look, from a surgeon standpoint, the surgeons really care more about the data and that RECON publication than they care about the regulatory classification of a particular product. But we do think it will be helpful to continue to drive standardization, especially with middle adopters and accounts as again, becoming a premium standard product that they use in their nerve protection algorithm. We also think that having the BLA, and again, the data will be helpful as we continue to work with payers to make sure that Avance is listed as non-experimental on their - on payers' algorithms. So we think that it will continue to be helpful as we continue to grow. But the first step actually was getting this recent publication of the RECON data, which we're wanting to make sure that surgeons see so they can make an informed choice in their clinical decision-making.

Got it. Yeah, that makes sense. And then maybe just one separate one. You saw a great growth in the scheduled procedures in Q4. Would be curious if you could provide some additional color on which procedures within that category were driving some of that growth? And whether you've seen some of that momentum continue so far in early 2024?

I mentioned in the script that all of our application areas experienced growth. We were very pleased with the performance across all areas and products. This growth is not just a one-time event; it represents our ongoing effort to develop and expand in this market. We've noticed sustained enthusiasm for this growth and expansion as we entered Q1.

Thank you. Next question is coming from Caitlin Cronin from Canaccord Genuity. Your line is now live.

Hi, thanks for taking the questions and congrats on a great quarter.

Thanks, Caitlin.

Yeah. Just to start with 2024 guidance, it seems to imply a deceleration year-over-year at the midpoint, even though it seems like scheduled procedure growth has seemed to tick up. Any kind of reason for that? And where do you think the mix between scheduled and emerging trauma could trend really over time?

Well, again, I think we're taking a measured approach. We looked at this not just on them, we had great momentum coming out of the year, but we really looked at the total year to take a measured approach and think about our overall guidance. And so that was the thinking behind it. Again, so far, we've been pleased with how we saw the beginning of the year, but we're wanting not to get out over our skis on this.

Okay. Makes sense. And where did active accounts end for the year?

Can somebody pull up the active account number for me? So we generally are focusing and it will be in the deck that we'll get out. But we're generally focusing on the core accounts because that's where the majority of our revenue comes from, it's from those core accounts. But of course active accounts grow into core accounts. So it's important to make sure that we have that feeder pool of active accounts. But our real focus is on thinking about how can we take these accounts to be $100,000 or bigger so that we can continue to go deeper and become a standard of care in those core accounts. If you remember, an active account is a pretty low threshold. It means that we had only six orders in the past 12 months. Basically what it says is you're through the back committee, and you've got a surgeon who has started to use the product in some small way, but it may not be a focus or target account for us. So we had 1,006 active accounts. So we have a very good pool to continue to build from as we drive those core accounts and build a bigger base.

Understood. Thanks so much.

Thank you. Next question today is coming from Dave Turkaly from Citizens JMP. Your line is now live.

Hey, good morning.

Good morning.

I was wondering if you could provide us with a bit more detail. Regarding the 367 core accounts, how many of them are using more than one AxoGen product? Are there accounts that are conducting both trauma procedures and scheduled ones, and how common is that?

It's challenging to provide a definitive answer because it's a combination of various factors. Most of our core accounts utilize more than one product, yet they haven't fully adopted all of our offerings in every application and algorithm. When it comes to trauma, it's important to note that while we refer to trauma as a single category, there are actually many different types. A surgeon may start by using our products for minor digital nerve injuries and gradually move on to more complex mixed and motor injuries in a step-by-step adoption process. Currently, many of our accounts are still in the early stages of this adoption. That's why we aim to focus on our core accounts and strive to become the standard of care within those accounts. Some of these core accounts deal exclusively with trauma, while others may only focus on scheduled procedures. Typically, establishing a foothold with just one surgeon is what enables us to consider it a core account, as that surgeon can generate around $100,000 in revenue. Then, the representative's role is to expand our presence to other surgeons and applications. Given that the threshold for defining a core account is only $100,000, a single surgeon who handles trauma cases can represent a core account, indicating that there is significant potential for growth from that point.

Thank you for that. And then maybe one for Nir. Congratulations on your progress on the bottom line. As we look ahead to next year, I assume we might not see adjusted EBITDA positive for the full year, but perhaps it's trending in that direction. I was wondering if you could provide any insights on what you anticipate the EBITDA loss might be, or how it might compare directionally to 2023. Any assistance there would be appreciated.

I think it's essential to focus on revenue growth and the benefits of operational leverage and economies of scale. Additionally, we are prioritizing better resource allocation and improving sales force productivity. There are also a couple of tailwinds to consider, one of which is impacting EBITDA and the other affecting our cash balance. Specifically, the royalties on Avance that we've been paying for the last couple of years increased by over $3 million in 2023 and will phase out at the end of the year. These factors are important when assessing the improvement from last year to this year regarding our bottom line.

Thank you.

Our next question is coming from Ross Osborn from Cantor Fitzgerald. Your line is now live.

Hey guys. Good morning, and thanks for taking our question.

Good morning.

In your prepared remarks, you mentioned seeing AxoGuard HA+ being used in new types of cases versus classic offering. Could you maybe just walk us through some of those use cases?

Sure. One of the things we're really excited about AxoGuard HA+ is the HA layers provide a slippery gliding surface. So when you think about your extremities and where you need to bend or move, that slippery layer helps when a nerve is going around a large joint. So elbows, knees, hips, those are all areas where that gliding surface can be important to make sure that the nerve remains free from attachments and can move smoothly across and through that joint. And so, that’s one of the big areas that we see surgeons really seeing a great application for the AxoGuard HA+. So we continue to see interest in how they're using it, seeing some great applications in those areas where they want to have that gliding surface and getting some very positive feedback about the product.

Okay. Great. And then maybe lastly for us, just on OpEx. So it sounds like hiring maybe minimal this year in terms of sales reps. But would you walk us through any new or expanded marketing initiatives? And also remind us puts and takes on the R&D line, please? Thank you.

We believe the number of sales representatives will remain close to 116, possibly fluctuating slightly above or below that figure. Regarding new developments, we've mentioned Avive+, which will be launching soon. We will continue to emphasize various aspects of nerve protection. In the short term, we are not planning a significant new application launch, but we are actively working on the development in multiple application areas. The potential for nerve repair is quite large since nerves are present throughout the body and can be damaged in many procedures. Our medical affairs team is dedicated to exploring Avance techniques in nerve repair and identifying new areas for growth. While I cannot confirm any specific expansion areas at this time, our R&D team is actively pursuing promising new opportunities.

Great. Thank you.

Thank you. We've reached the end of our question-and-answer session. I'd like to turn the floor back over to Karen for any further or closing comments.

Well, thank you. As we conclude today's earnings call, I want to express my appreciation to our team for their exceptional efforts, and all the participants for your attention and contributions. The dedication of our staff has been pivotal in achieving the milestones we discussed today, and we look forward to sharing our continued progress with you in the future.

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