Greetings. Welcome to the AxoGen, Incorporated Fourth Quarter 2021 Conference Call. At this time, all participants are in listen-only mode. A brief question-and-answer session will follow the formal of presentation. As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Ed Joyce, AxoGen's Director of Investor Relations. Please begin, Mr. Joyce..

Thank you, Hillary, and good afternoon, everyone. Joining me on today's call is Karen Zaderej, AxoGen's Chairman, Chief Executive Officer and President; and Peter Mariani, Executive Vice President and Chief Financial Officer.

Karen will begin today's call with an overview of our fourth quarter and update on our operational highlights and our guidance for the year. Pete will then provide an analysis of our financial performance, followed by closing remarks from Karen and a question-and-answer session.

Today's call is being broadcast live via webcast, which is available on the Investors section of AxoGen website. Within an hour of the end of this call, a replay will be available on the Investors section of the company's website at www.axogeninc.com.

Before we get started, I'd like to remind you that during this conference call, the company will be making projections and forward-looking statements regarding future events.

We encourage you to review the company's past and future filings with the SEC, including, without limitation, the company's Forms 10-K and 10-Q, which identify the specific factors which may cause actual results or events to differ materially from those described in the forward-looking statements.

These factors may include, without limitation, statements related to the expected impact of COVID-19 and hospital staffing on our business, statements regarding our growth, our financial guidance, product development, product potential, expected clinical enrollment timing and outcomes regulatory process and approvals, APC renovation timing and expense, financial performance, sales growth, product adoption, market awareness and our products, data validation, our assessment of our internal controls over financial reporting, our visibility and sponsorship of conferences and educational events and other matters not within our control.

And with that, I'd like to turn the call over to Karen.

Karen?.

Thank you, Ed, and good afternoon, everyone. Our total revenue for the fourth quarter was $31.5 million, representing a 3% decline versus the prior year period. Excluding the impact of revenues from Avive Soft Tissue Membrane in both years, revenue for the quarter was approximately flat year-over-year.

Although we saw a sequential improvement in revenue in November, the Omicron variant negatively impacted procedure volumes and hospital staffing in December, which negatively impacted our revenues for the quarter. For the year, we achieved revenue of $127.4 million, an increase of 13% over the last year.

Excluding the impact of Avive, revenue increased 15% year-over-year. I'm proud of the growth we were able to achieve despite the ongoing challenges of COVID and hospital staffing shortages, and we believe more surgeons and accounts recognize the value AxoGen provides.

We had an excellent year engaging and educating surgeons using a combination of in-person and virtual programs, and we again met our annual goal of training more than 75% of hand and microsurgery fellows.

We are confident that we've built the right organization and a solid foundation of clinical evidence that will allow us to deliver sustainable long-term growth as the impact of COVID wanes and hospital operating environments improve. The Omicron-related challenges we faced late in the fourth quarter continued through the early part of Q1.

Like all of you, we're encouraged by reports of declining COVID rates in the recent weeks. However, we believe it will take longer for hospital staffing challenges to improve and for surgical schedules to normalize.

As a result, we are measured in our outlook of the pace of procedure volume improvement in the first half of the year compared to 2021 and anticipate a return to more normalized growth rates in the second half. Commercially, we remain focused on driving deeper penetration into customer accounts while also continuing to add new accounts.

We've achieved success with this strategy as demonstrated by the growth in our active and core accounts, which helps us frame and monitor our growth. As a reminder, active accounts have ordered at least 6 times in the last 12 months and may still be in the early stages of adoption.

Core accounts represent more penetrated accounts, defined as those that have greater than $100,000 in revenue in the trailing 12 months. We ended the year with 951 active accounts, up 6% over the last year and 294 core accounts, up 9% over the last year.

Active accounts typically represent about 85% of our total revenue, with the top 10% contributing about 35% of revenue. Our core accounts continue to represent about 60% of our revenue and typically contain at least one surgeon who's adopted the AxoGen nerve repair algorithm for a significant portion of his or her nerve injury patients.

Leveraging this surgeon's success with our products, we focus on going deeper with that first surgeon and gaining adoption by additional surgeons.

We have significant opportunity for growth within our core accounts by more deeply penetrating the treatment of traumatic injuries and continuing to expand into other nerve repair applications, including breast, OMF, and the surgical treatment of pain.

We ended the year with 115 direct sales representatives, an increase of 6% during the quarter and up from 111 a year ago. We believe we have an established and well-trained sales footprint and expect that our growth can be delivered primarily by improving sales rep productivity.

At the same time, we will continue to monitor and evaluate our sales territories for capacity and growth opportunities and anticipate increasing our sales team by 5 to 10 sales reps this year.

Our direct sales force continues to be supplemented by independent sales agencies that represented approximately 10% of our total revenue in the fourth quarter. We continue to build market awareness through numerous initiatives across our applications.

For example, we're employing direct-to-patient educational campaigns to increase awareness of the potential for nerve repair procedures to improve outcomes for patients with breast cancer and those suffering from chronic neuropathic pain.

Over the last few years, we've been very successful growing the number of patients visiting our re-sensation website to learn more about the problem of breast numbness, post-mastectomy and the potential for nerve repair to restore sensation.

In the fourth quarter, we launched an educational animation to help illustrate the problem with post-mastectomy numbness and its impact on quality of life as well as how re-sensation may be a potential solution.

Through these awareness efforts, surgeons report that an increasing number of their patients are expressing interest in returning sensation for a more complete breast reconstruction.

Leveraging our success with direct-to-patient educational campaigns for re-sensation we're following a similar strategy to increase visitors to our re-think pain website to raise awareness of the surgical treatment of pain as a potential solution for patients suffering from chronic neuropathic pain.

In 2021, we initiated a partnership with the US Pain Foundation. Each November, the foundation runs a campaign called November to explore and educate on a unique area of pain management through webinars, social media content and more.

In November of 2021, the foundation focused its campaign to raise awareness of neuropathic pain and its treatment options resulting in a significant community response. Direct-to-patient educational campaigns will continue to be important in our market development efforts for the breast and pain applications.

In terms of our progress with our clinical endeavors, we continue to expect top line results of our RECON study in the second quarter. RECON is our Phase III pivotal study supporting our Biologics License Application, or BLA, which will transition our Avance Nerve Graft from a Section 361 tissue product to a Section 351 biological product.

We look forward to the readout of our RECON topline results. The study was designed to test for noninferiority of the primary endpoint, static 2-point discrimination as compared to conduit nerve repairs.

In addition to the RECON data, our teams are continuing to work on other BLA, CMC, and documentation requirements for our facilities, operations, quality systems and validation as a part of our preparations for a successful application. We expect to submit our BLA to the FDA in 2023. Our RANGER and MATCH registries continue to enroll.

Now with over 2,600 nerve repairs enrolled in RANGER. MATCH is a subset of the RANGER registry, which is the comparative population of conduits and autograft subjects for RANGER. Readouts from this data have demonstrated that advanced nerve graft outcomes were statistically significantly better than conduit and were similar to those for autograft.

Data from these 2 clinical registries continues to play an important role informing surgeons in their clinical decision process. Enrollment in the comparative phase of REPOSE, our study of Axoguard Nerve Cap compared to standard treatment for symptomatic neuroma is ongoing.

Surgery delays have led to slower-than-expected enrollment, and we're now anticipating completing enrollment in Q2 of this year, with a topline data readout from the comparative phase in Q3 of 2023.

We've always made clinical evidence generation, an important priority and believe that our collection of meaningful data publications is the most comprehensive in the area of peripheral nerve repairs. This unparalleled amount of evidence in nerve repair is expected by our surgeons and payers when making clinical care decisions.

As of the end of the year, we have 181 peer-reviewed papers, including growing numbers among all of our nerve repair applications, namely trauma, breast, OMF, and the surgical treatment of pain.

We remain committed to developing the clinical evidence to demonstrate the safety, performance and utility of our nerve repair solutions to support the continued adoption of the AxoGen algorithm across our full portfolio of nerve repair products. I'd now like to spend a moment discussing our outlook for this year.

We expect that full year revenue in 2022 will be in the range of $135 million to $142 million. This revenue guidance represents about 10% to 15% growth over 2021, excluding the $4.1 million of Avive revenue from last year. Full year gross margin is expected to be above 80%.

As I noted earlier, we're being measured in our outlook for procedure volume improvement and revenue growth in the first half of the year compared to 2021, but we anticipate a return to more normalized growth rates in the second half of the year.

We're confident that we've built the right organization with a solid foundation of clinical evidence that will allow us to deliver sustainable long-term growth as the impact of the COVID pandemic wanes and hospital operating environments improve.

We continue to view AxoGen as a long-term growth company, delivering sustainable annual revenue growth in the high teens to low 20% range. Now I'll turn the call over to Pete for a review of financial highlights.

Pete?.

Thank you, Karen. Fourth-quarter revenue was $31.5 million, a 3% decrease compared to Q4 of 2021. Fourth-quarter revenue was negatively impacted by COVID and related hospital staffing challenges, particularly in the final weeks of the quarter.

Fourth-quarter revenue includes $500,000 from the reversal of a sales return reserve recorded in the second quarter of 2021 for Avive soft tissue membrane for which we voluntarily suspended from market availability on June 1, 2021. Avive revenue in the fourth quarter of 2020 was $1.6 million.

Gross profit for the fourth quarter was $26.1 million compared to $27 million in Q4 of 2020. Gross margin was 82.8% for Q4 compared to 83.2% in the prior year fourth quarter. Total operating expense in the fourth quarter decreased 3% to $31.5 million compared to $32.4 million in the prior year.

The decrease is primarily due to a reduction in employee compensation where decreases in incentive and stock compensation, bonus and commissions were partially offset by increases in salaries.

The net decrease in operating expense was partially offset by increases in professional and consulting fees, marketing programs and travel, and research and development projects. Sales and marketing expense in the fourth quarter decreased 11% to $17.7 million compared to $19.8 million in the prior year.

The decrease is primarily related to lower employee compensation, partially offset by an increase in marketing programs and travel. As a percent of total revenue, sales and marketing expenses decreased to 56% for the 3 months ended December 31 compared to 61% in the prior year.

Research and development expenses increased 28% to $6.3 million compared to $4.9 million in the prior year. Product development expenses represented approximately 73% of total research and development expenses for the current quarter as compared to 55% in the prior year.

The increase in product development expense reflects increased spending and specific programs, including our efforts related to the BLA for Avance nerve graft and a next-generation Avance product. Clinical trial expenses represented approximately 27% of research and development expenses in the fourth quarter compared to 45% in the prior year.

As a percentage of total revenue, Research and development expenses were 20% in Q4 compared to 15% in the prior year. General and administrative expense in the fourth quarter decreased 3% to $7.4 million compared to $7.7 million in the prior year. G&A as a percent of revenue was 24% in both periods.

The net decrease is due primarily to decreases in employee compensation, partially offset by increased professional and consulting fees. Adjusted net loss and net loss per share was 3.3 and $0.08 per share in both fourth quarters of 2021 and 2020.

Adjusted net loss in the quarter was $1.7 million compared to an adjusted EBITDA loss of $1.3 million in the prior year. The company has updated its definition of EBITDA and adjusted EBITDA to now include amortization of the right-of-use assets and debt discount and deferred financing fees.

The reconciliation of these non-GAAP financial measures to GAAP can be found in today's earnings release and on our website. The balance of all cash, cash equivalents and investments on December 31, 2021, was $90.3 million compared to a balance of $98.1 million on September 30 of '21.

The net change includes capital expenditures of $5.8 million related to the construction of our new processing facility in Dayton, Ohio and $1.9 million of operating cash burn in the quarter. we typically see elevated operating cash burn in the first half of the year, and we expect this to be the case again in 2022.

We expect this to improve in the second half of the year.

Additionally, we anticipate capital expense to be up to $14 million over the course of the year for the physical completion equipment and validation of the Dayton facility, along with up to $6 million in capitalized interest through the end of the year, and we expect to convert production to the new facility in early 2023.

With $90 million in cash, our balance sheet is strong, and we expect to end the year well-positioned to continue funding our growth while maintaining an appropriate level of cash. As Karen mentioned, our guidance for full year 2022 will be in the range of $135 million to $142 million.

and this represents about 10% growth year-over-year, excluding the impact of $4.1 million of Avive revenue from 2021. We're being measured in our outlook for procedure volume improvement and revenue growth in the first half of the year compared to 2021, but we anticipate a return to more normalized growth rates in the second half of the year.

And as a matter of corporate housekeeping, we will be providing an update to our expiring shelf registration along with the filing of our 10-K in the coming days. And with that, I'd like to hand the call back over to Karen..

Thank you, Pete. I'm proud of our achievements this year and of the entire AxoGen team in the face of pandemic headwinds. We remain committed to delivering our innovative nerve repair solutions to patients, surgeons and hospitals, and I believe we're well positioned for long-term success. At this point, I'd like to open up the line for questions.

Hillary?.

[Operator Instructions]. Our first question is from Dave Turkaly of JMP Securities. Please proceed with your question..

Pete, maybe just following up on the commentary on the spend you expect in 2022 if your adjusted EBITDA loss was close to $7 million this year, it sounds like you still have some initiatives that you're anticipating spending on.

Directionally, I mean, you're almost breakeven and you have plenty of cash, but that EBITDA losses if you were just commenting up or down.

Is it up a little bit this year and then when the new facility is on in '23, would you expect it to be -- would you expect to breakeven?.

Look, we're headed in the right direction. I mean, I think your point is right. As we get the building up and running and as we continue to drive revenue growth, I think we're certainly on the path towards breakeven across the line, but I'm not going to call that in in 2022. We're not going to give that type of outlook.

But certainly, we're in a good position from a spend perspective. We can -- we've got some initiatives that we're continuing to invest in around the BLA product development and other items. And we think we're in a good position to manage spend well through next year and into '23..

Yes. And I don't think anyone would be super surprised about the measured sales outlook as a lot of companies are kind of forecasting that at least in the first half of the year.

Could you just remind us the RECON readout, like what are we anticipating there? I know you said in the second quarter, is it just -- will it just be a PR are you going to do a call or like what are the plans right now?.

Yes, we'll do -- we're going to do a press release and we'll schedule a call. As soon as we have the information available, we'll be excited to talk about that..

Our next question is from Danielle Antalffy of SVB Leerink. Please proceed with your question..

This is Erin on for Danielle.

I was just hoping you guys could talk about some of the trends that you saw in the fourth quarter related to Omicron and hospital staffing shortages and maybe how that's trended starting heading into the first quarter?.

Sure. I think we're on a pretty good trend of what we measure as daily sales in November and then certainly in December, started to see some substantial drop off of that, especially towards the back end.

As Omicron started to ramp up, hospitals had the double whammy of both capacity constraints because of patients in the hospital because of COVID patients testing positive when they were showing they're asymptomatic and showing up for procedures, but not able to have procedures because they were positive with COVID and being sent home and then constraints in terms of staffing.

And that continued into January. Now as COVID has -- the incidence rate has come down and to some extent, has come down of hospital beds as well. We start to see things loosening up and getting -- trending much better, and we hope to see that continue to trend..

Okay. Great. And then if you could just -- regarding the 2022 guidance, just if you could walk us through kind of some of the assumptions baked in regarding COVID and hospital staffing shortages and kind of what we would expect to see maybe at the upper and the lower end of the range..

Yes. I think our observation is that even though COVID is certainly coming down -- COVID is coming down, hospitals are still dealing with a census that includes a lot of COVID patients, and we expect that to improve. But what we also are recognizing is that the hospitals still have challenges with staffing.

And we think that will take some additional time for them to work through. Look, we see hospitals as being very resilient. They will figure this out. We think that in time, this will move back towards what we all hope to be a more normalized situation where surgical schedules are keeping up with the current pace.

But I think in our outlook, we wanted to just be fairly measured in assuming when that's going to happen and not get out in front of it. We'll see how things go over the rest of this quarter. And we certainly think that back half of the year, this is back to more normalized growth rates for us..

Our next question is from Frank Pennal [ph] of Jefferies. Please proceed with your question..

Hope everyone is doing well. A bit of a follow-up to the last question. I was hoping you can maybe provide some color on rep access sort of exiting last year and so far, what you're seeing this year? And I have a follow-up to that..

Well, through the year, we've seen rep access actually get better. Obviously, when things were shut down completely, it went down completely as we've seen hospitals become more comfortable with operating in a COVID environment, they've allowed rep access to occur.

It does go up and down depending on what's happening with the hospital in terms of their COVID constraints at a moment if they move into crisis management, then where their extreme capacity, they don't want reps in there. But they're also limited in the number of procedures that they can do.

Having said that, I think that some of the tools that we learned in remote case coverage during the COVID pandemic will continue to be important to us, it both helps our productivity as these are unscheduled cases.

And many hospitals have put in place restrictions that I think are going to be durable post all of this and that they don't want -- they will ask reps in for a specific case, but not allow reps to just visit the OR on a daily basis and check out the Board. And I think those changes are going to be more durable for the long term.

So we've been very successful with the resources that we provide to surgeons to be able to have the access that we need in most cases. And where we can't do that, we can do the remote case coverage..

Great. I guess, a follow-up to a prior question as well on RECON. What sort of the significance in your view, how are you thinking about the significance of a positive top line readout? I'm sure you're expecting that at this point, but I guess, really on growth penetration.

And will the BLA -- will BLA approval in 2023 allow you to charge a premium for Avance? I guess, in addition to what seems like already favorable CMS reimbursement trends at least on the JPM presentation..

Sure. Well, I'll start with the pricing piece. Being a BLA, actually, we don't believe we'll adjust the reimbursement of Avance. So we don't see that as impacting our pricing strategy.

We think that we've done a good job of looking at this and pricing this to be comparable to autograft so that from an economic standpoint to hospitals, it is a good choice for their patients to switch from autografting to Avance. In terms of the data readout, we're getting very excited about that.

I think that there's an opportunity -- there's an opportunity for us to, in fact, showcase this with a lot of surgeons. Our PIs are pretty enthusiastic about getting a chance to announce this information. We will be looking to present it later in some conferences.

Obviously, we'll do the short-term presentation here when we -- when we have the data in second quarter, but we're looking for more extended review with surgeons and some presentations at scientific conferences later this year and think that it's going to create some buzz among our surgeon friends as they continue to think about changing their treatment algorithms.

This is important -- really for middle adopters, our early adopters and innovators they were willing to try Avance and actually help us build this data. But middle adopters are looking for this type of level 1 evidence to be confident in changing their treatment algorithms.

And we think it will be helpful as we continue to drive penetration in some of our core accounts to help convert those middle adopters. I do want to go back real quick. One thing I thought I heard you say with BLA approval in 2023, we actually plan to do the submission in 2023.

And while we have an expedited review with the FDA, I think we should assume right now that it will be a year approval, just they're running a little slower given some of the other things going on. So we're assuming a 2024 approval..

[Operator Instructions]. Our next question is from Jubran Amed [ph] of Canaccord. Please proceed with your question..

This is Jubran on for Kyle. I guess one question from us. In terms of backlog, sort of a follow-up from the Omicron dynamics seen at the end of the Q4.

Did the backlog grow this quarter? Maybe has there been any sort of shift in terms of how the 2022 guide is assuming working through that backlog? Obviously, less of a factor on the trauma side of the business, but curious if any sort of dynamics have shifted on that front..

Yes. Thank you for the question. We do believe that there are some deferred cases in certainly all of our segments. But in trauma, we no longer have visibility to what those are. It really has to do with the staffing issues that they have.

In the first round, if you go back to 2020, when hospitals were turned back on, they were able to run with significant overtime and pulled back these nerve repair patients very quickly.

And we could see a very clear spike in their business as they worked off all of their deferred patients in about a 2- to 4-week period, they no longer have that flexibility. They can't work them off that quickly. We do think that they'll be bringing patients back in. And as a reminder, you can do nerve repair.

It's always better when it's done sooner in terms of the outcomes expected, but you can still get good meaningful recovery up to a year post the injury. So it isn't something that has to be done in days or weeks. It's better if it's sooner, but we think it's going to be a little bit longer tail for any deferred patients.

In our more elective procedures like in particular, breast neurotization we do have a fair number of patients who are -- have been deferred on their breast reconstructions. These deep flat procedures are pretty resource-intensive in the hospital. They're a long surgical procedure, and they're an inpatient stay.

And so from a resource standpoint in a hospital, they are actually some of the first ones we see deferred every time that there's been a hospital constraint.

And so at this point, we are having surgeons tell us that they have substantial deferred waiting lists and deferred patients, but they don't have enough block time in the OR to work them off quickly. So they are telling us that it may take them as much as a year or more to work through their deferred patients.

So while we thought about that in our guidance, it's also something that's going to trickle in. It's not going to be a big spike..

That's helpful. Appreciate the color there, Karen. And then maybe if I could just squeeze a second one in. The active account, core account numbers have held relatively sort of steady now for a couple of quarters in terms of percentages of revenue.

I guess what do you need to see to start maybe getting more pull-through from those active accounts into core accounts? Does that direct-to-patient marketing efforts that you alluded to? Does that help sort of drive that? Or maybe what are some other factors to consider there?.

Yes. So first of all, we expect the percent of our revenue to remain approximately the same. Now we expect our revenue to grow up, but to go up -- but for example, approximately 60% of our revenue coming from these core accounts as our revenue goes up, it's going to be primarily driven by increased penetration in core accounts.

And so we think that 60% number will hold approximately the same. The drivers of that are really increasing the usage of surgeons within the accounts. So it is really that first surgeon. I've described this as almost a stair step of adoption.

That first surgeon who's kind of our anchor surgeon in the core account has some significant adoption, but it's not fully adopted. We want to continue to drive full adoption with that surgeon so that they become a champion across the full algorithm that we teach and start to move to the second and third surgeon at those accounts.

In addition, at our biggest accounts, we can be bringing in the breast business and the surgical treatment of pain.

Those are the segments that are driven more on the patient education segment to help patients start to show up and ask the right questions to say, I think sensation is important to me in my breast reconstruction and I want to understand where I can get that done.

And we're more and more seeing patients showing up understanding that, that is a problem and looking to have the repair done in a site that will do the re-sensation technique..

We have reached the end of the question-and-answer session. I will now turn the call back over to Karen Zaderej for closing remarks..

Thank you, Hillary. I just want to thank everyone for joining us on today's call, and we look forward to speaking with you in the near future..

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation, and have a great day..