MiMedx Group Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
February 26, 2025

There are 8 speakers on the call.

Operator

Good afternoon, and thank you for standing by. Welcome to the MyMedx Fourth Quarter and Full Year twenty twenty four Operating Financial Results Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded.

Operator

I would now like to turn the call over to your host, Mr. Matt Notarani, Head of Investor Relations for Myabetics. Thank you. You may begin.

Speaker 1

Thank you, operator, and good afternoon, everyone. Welcome to the Mymedix fourth quarter and full year twenty twenty four operating and financial results conference call. With me on today's call are Chief Executive Officer, Joe Capper and Chief Financial Officer, Doug Rice. As part of today's webcast, we are simultaneously displaying slides that you can follow. You can access the slides from the Investor Relations website at mymedix.com.

Speaker 1

Joe will kick us off with some opening remarks and a summary of our operating highlights, and Doug will provide a review of our financial results for the quarter, and then Joe will conclude with some additional updates, including a discussion of our financial goals. We will then be available for your questions. Before we begin, I would like to remind you that our comments today will include forward looking statements, including statements regarding future sales, operating results and cash balance growth, future margins and expenses, our product portfolios and expected market sizes for our products. These expectations are subject to risks and uncertainties and actual results may differ materially from those anticipated due to many factors including competition, access to customers, the reimbursement environment, unforeseen circumstances and delays. Additional factors that could impact outcomes and our results include those described in the Risk Factors section of our annual report on Form 10 K and our quarterly reports on Form 10 Q.

Speaker 1

Also, our comments today include non GAAP financial measures and we provide a reconciliation to the most comparable GAAP measures in our press release, which is available on our website at www.mymedix.com. With that, I'm now pleased to turn the call over to Joe Capper. Joe?

Speaker 2

Thanks, Matt, and good afternoon, everyone. Thank you all for joining us on today's call. I am very pleased to report that we had an excellent 2024, culminating with another strong performance in Q4. Full year revenue grew by 9% and as you will hear today, our momentum remains strong and we expect 2025 to be another highly successful year for MiMedx. During Q4, we once again achieved solid year over year top line growth, maintained an excellent operating margin and continued to generate strong cash flow.

Speaker 2

We accomplished all of this in spite of challenges due to the much discussed Medicare reimbursement issue and the associated above average sales force turnover we experienced in select markets. I firmly believe our strong results would have been noticeably higher, but for these two issues. So let's take a few minutes to review the highlights of the fourth quarter and then I will update you on the progress we are making on our key priorities. Q4 net sales grew year over year by approximately 7% to $93,000,000 another excellent growth quarter. Full year sales closed at $349,000,000 up 9% over the prior year.

Speaker 2

Gross profit margin was 82% in the quarter. Adjusted EBITDA was $20,000,000 or 21 percent of sales in the fourth quarter and $76,000,000 or 22% of sales for the full year representing an increase of $18,000,000 over the prior year. We ended the year with $104,000,000 in cash, an increase of $16,000,000 during the quarter. We continued with the market release of Heliogen, our first xenograft which is targeted in the surgical market. We began enrollment for a randomized controlled trial for EpiFX and we continued our strong advocacy for regulatory and reimbursement reform.

Speaker 2

Turning now to our strategic priorities. On prior calls, we consistently discussed our market approach in terms of three primary areas of focus. Since this strategy has delivered excellent results, we will continue to allocate our time and resources around these three primary objectives. I would add an additional strategic priority to the list for this year, which is to capitalize on the opportunity presented through implementation of the pending LCDs. Make no mistake, we are poised to do just that and believe no other company in our space is as well positioned to grow share as MiMedx is based on the proposed guidelines.

Speaker 2

As a reminder, our top strategic priority is to continue to innovate and diversify our product portfolio. As discussed, the company has built a strong competitive advantage around our ability to develop and commercialize unique product configurations designed to meet explicit customer needs. We have introduced multiple new products in the last two years alone. First three received widespread market acceptance and Heliogen, which is an early market release is starting to gain traction. AmneoEfect continues to do well growing at close to 20% year over year in the surgical market.

Speaker 2

And EpiEffect, which we launched in late twenty twenty three continued to show significant strength in the private office. Both products have received excellent physician feedback as they have become integral parts

Speaker 3

of their quick care protocols.

Speaker 2

Additionally, we continue to make progress building our EpiFix business in Japan with sales nearly tripling in 2024. We now have most of the key opinion leaders and top decile customers routinely ordering and using our product. Building on the success of these product introductions, we expect a similar performance as we move toward full market release of Heliogen, our first xenograft. We're making good progress working through the mechanics of the early launch phase and expect Heliogen be a meaningful contributor in 2025. Our second priority is to develop and deploy programs intended to expand our footprint in the surgical market.

Speaker 2

As we've discussed, this objective calls for a significant commitment to the production of real world clinical evidence scientific research. We now have multiple studies in flight which are designed to support the use of our placental derived telegraphs in a variety of surgical procedures. On previous calls, we highlighted publications which demonstrated the incredible healing properties of our proprietary technology. This clinical research and general awareness pieces have appeared in publications such as Nature and The New York Times. The potential for reduced scarring or adhesion formation through the use of Vibetic's proprietary technology as demonstrated in this research could enable accelerated and improved quality of healing leading to enhanced surgical and economic outcomes.

Speaker 2

Again, coupling these potential benefits with the tens of millions of surgeries performed in The U. S. Each year, we believe the market opportunity could be massive over time. We firmly believe we are still in the very early market development phase for placental derived products. In addition to research and awareness, it is critical that we continue to expand our product and service offering in order to build a stronger presence in the surgical environment.

Speaker 2

Our third initiative is to introduce programs designed to enhance customer intimacy. As a reminder, the primary focus of this initiative is to develop programs which improve relationships and ultimately lower our customer turnover. To strengthen the connection with our customers, we have undertaken a variety of initiatives aimed at institutionalizing customer centric behavior. We continue to experience excellent adoption of MiMedx Connect, our new customer portal. Now over 1,000 customers using the platform to perform functions such as insurance, verification and product ordering.

Speaker 2

We are actively developing additional features designed to improve workflow and strengthen the bond between LiveMedics and their customers. We believe our commitment to this approach will lead to enhanced customer relationships, improve net promoter scores, higher margins and ultimately an increase in the average lifetime value of a customer. Now let me turn the call over to Doug for a more detailed review of our financial results. Doug?

Speaker 3

Thank you, Joe, and good afternoon to everyone on today's call. I'm pleased to review our results with you all today. As a reminder, many of the financial measures covered in today's call are on a non GAAP basis. So please refer to our earnings release for further information regarding our non GAAP reconciliations and disclosures, including the reconciliation tables in the back of our press release that provide more detail regarding the adjustments made to calculate our non GAAP metrics. I encourage you to review these materials alongside my comments today.

Speaker 3

As a reminder, unless otherwise noted, my discussion is on a continuing operations basis. For a full discussion of the impact of our discontinued operations, please refer to our most recent 10 ks filed today and 10 Q filings. Moving on to the results, our fourth quarter twenty twenty four net sales of $93,000,000 represented 7% growth compared to the prior year period. By product category, fourth quarter wound sales of $61,000,000 grew 10% versus the prior year, while surgical sales of $32,000,000 were up 2% as reported. Excluding the revenue impacts of Axiophill and of our dental product that was discontinued in late twenty twenty three, our surgical sales increased 6% in the fourth quarter.

Speaker 3

We saw significant contributions from many parts of the business in the fourth quarter, including solid double digit growth year over year from our effect product lines, Epi Effect and Amneo Effect, robust growth from international and modest but ramping contributions from our Xenograft Heliogen, which is our first five ten cleared product. Our fourth quarter twenty twenty four gross profit was about $76,000,000 compared to $73,000,000 last year. Our GAAP gross margin was 82% in the fourth quarter twenty twenty four compared to 84% last year. Excluding the incremental acquisition related amortization expense from intangible assets of roughly $2,200,000 in the quarter, our gross margins were 84% flat compared to the fourth quarter of twenty twenty three. Moving into 2025, with anticipated higher surgical sales and other sales mix changes, we expect our GAAP gross margin

Speaker 2

to be 81%

Speaker 3

to 82% and our non GAAP gross margin to be 82% to 83%. Turning to our operating expenses, selling, general and administrative expenses or SG and A were $61,000,000 in the fourth quarter compared to $54,000,000 in the prior year period. This increase was primarily related to higher commissions from increased sales and also reflects incremental spend associated with an adjustment we made to commission rates during the year, partially offset by certain spending efficiencies in G and A. Also please note that beginning this quarter and moving forward, we will be breaking up our sales and marketing or S and M expenses from our general and administrative or G and A expenses. Today's press release has a quarterly look back at these expenses for 2023 and 2024 to assist with modeling.

Speaker 3

We expect 2025 sales and marketing and G and A expenses to be relatively flat compared to 2024. Our fourth quarter R and D expenses were $3,000,000 or about 4% of net sales, up 38 compared to the prior year period, driven primarily by increased costs associated with our ongoing epi effect RCT as well as additional spend related to future products in our pipeline. Based on increased investments in clinical and economic evidence together with increased trial enrollment, we expect 2025 R and D to be approximately 5%. Income tax for Q4 twenty twenty four was about $4,000,000 reflecting a GAAP effective tax rate of 34%. Although slightly higher for the quarter due to timing, our full year GAAP effective tax rate came in at about 27% and we continue to expect our long term non GAAP effective tax rate to be about 25%.

Speaker 3

Our fourth quarter GAAP net income inclusive of the results of our discontinued operations was $7,000,000 or $0.05 per share compared to GAAP net income of $53,000,000 or $0.32 per share in the prior year period. Recall in the fourth quarter of twenty twenty three, we recognized a one time income tax provision benefit of over $37,000,000 which was the primary driver of GAAP net income in the prior year period. Adjusted net income for the quarter was $11,000,000 or $0.07 per share compared to $11,000,000 or $0.04 per share in the prior year period. Fourth quarter twenty twenty four adjusted EBITDA was $20,000,000 or 21% of net sales compared to $21,000,000 or 24% of net sales in the prior year period. Turning to our liquidity, our ability to continue to grow profitably and maintain a high EBITDA to cash flow conversion rate has dramatically improved the complexion of our balance sheet over the last two years.

Speaker 3

During the fourth quarter, we generated free cash flow of $19,000,000 a $9,000,000 increase over the same period in 2023. In turn, our net cash balance is now at about $86,000,000 up from $70,000,000 just last quarter and more than 150% increase in our net cash position compared to the end of twenty twenty three. Looking back on the full year, we are pleased with our 2024 results, which featured 9% top line growth and adjusted EBITDA margin of 22%, the refinancing of our balance sheet with incremental borrowing capacity and free cash flow generation of $65,000,000 Turning to our guidance for 2025, today we are introducing an outlook that assumes the LCDs are implemented as written and as currently scheduled on April 13. Under that scenario, we expect to be able to deliver net sales growth at least in the high single digits and an adjusted EBITDA margin above 20%. The fluidity of the situation around Medicare reimbursement over the last several months has required us to plan for numerous scenarios and could require us to be nimble in our approach and planning throughout the year.

Speaker 3

Obviously, we will continue to revisit expectations as the year unfolds. Longer term, we believe we can deliver top line growth in the low double digits, particularly as we continue to drive our business deeper into the surgical suite, while still generating robust profitability as measured by an adjusted EBITDA margin above 20%. We are not nor do we plan on providing quarterly guidance for the foreseeable future. However, for modeling purposes, I want to provide a few reminders about the nature of our business. Revenue is typically lowest in the first quarter of the year, highest in the fourth quarter with quarters two and three roughly similar.

Speaker 3

The same pacing holds true for our adjusted EBITDA as the first quarter exhibits a combination of lower revenue and elevated expenses, typically resulting in a lower adjusted EBITDA margin, which builds over the course of the year. I will now turn the call back to Joe. Joe?

Speaker 2

Thanks, Todd. As you have just heard, we had another solid quarter. Net sales were $93,000,000 up 7% in the quarter. Gross profit margin was 82%. Adjusted EBITDA was $20,000,000 or 21% of net sales in the quarter.

Speaker 2

We added another $16,000,000 to our cash balance, continued the market release of Heliogen, again the RCT for EpiFX, continued to invest in research designed to validate the use of our products in various applications and we advocated for much needed regulatory and reimbursement reform. Let me now turn to the latest on the proposed changes to the Medicare reimbursement system for the private office and adjacent care centers, a topic which we have discussed on numerous occasions. Shortly after our last call, Zenix announced their intent to implement the proposed LCDs on 02/12/2025. After the new administration took office, an executive order was signed which call for a sixty day delay on the implementation of any new policies. The new skin substitute LCDs were included in this order and the implementation date is now 04/13/2025.

Speaker 2

Based on feedback from our outside advisors and activity within the new administration, we deem any further delay as highly unlikely. As key members of the new team are named, not surprisingly, the LCDs are a priority topic on which they are being briefed. We also know that this topic has come to the attention of the newly formed and high profile Department of Government Efficiency, which was established in part to seek out and eradicate wasteful spending just like this. With the total Medicare spend in the private office and associated care settings running in excess of $1,000,000,000 per month, we can't imagine continued delays in the implementation of corrective solutions. We also believe it is highly likely CMS will take steps to modify the pricing methodology for skin substitutes within the physician fee schedule later this year.

Speaker 2

And of course the government has ramped up enforcement which we expect will continue to increase. We are prepared for the eventual implementation of the proposed LCDs and believe MiMedx is poised to gain share as a result. During this period of transition, we can expect potential confusion in the market as physicians change ordering patterns and practices and patients migrate to alternative sites of care. Given this potential for short term disruption, we are hesitant to project expectations with much specificity. However, we do not see a scenario in which the implementation of the LCDs does anything but bolster MiMedx business.

Speaker 2

For now, as Doug just outlined, we are comfortable with full year revenue growth rate guidance in the high single digits with higher growth rates in the back half of the year and with the obvious caveat that April 13 is to go live date for the LCDs. We also expect our full year adjusted EBITDA margin to be above 20%. We will continue to revisit expectations as we learn more. Importantly, our expectations about the long term prospects of the business are incredibly high. Post the implementation and enforcement of the new LCD guidelines, we anticipate resetting top line growth to the low double digits.

Speaker 2

Finally, I want to share a few closing thoughts. It's now been two years since I joined the company. As a practice at the end of each year, I'd like to take a look back on what we set out to accomplish and inventory on what we did accomplish and of course I just shared what we intend to accomplish moving forward. The company was on quite a different trajectory two years ago. And since then much has changed at MiMedx.

Speaker 2

I stated then that our mission was to transform the company into a highly focused growth oriented profitable medtech business. Since that time we've restructured parts of business, rationalized expenses and implemented productivity improvements which have dramatically enhanced our financial profile and significantly altered the course of the company in many positive ways. We have also spent a fair amount of time working with numerous stakeholders to reshape and modernize both the regulatory and reimbursement aspects of our industry. We believe these efforts are getting results. As our industry evolves to incorporate improved regulatory structure and fiscal accountability, products will need to demonstrate effectiveness in order to compete the market.

Speaker 2

I believe no other company is better positioned than MiMedx to excel in such an environment given our market leading technology which is supported by well powered clinical evidence. In short, our best days are right in front of us. In closing, I would like to sincerely thank our talented team of dedicated individuals for a great finish to 2024 and for all that you do for the thousands of people who rely on our products each and every day. With that, I would like to open the call to questions. Operator, we are now ready for our first question.

Speaker 2

Please proceed.

Operator

Thank you. We will now be conducting a question and answer session. Thank you. Our first question comes from the line of Chase Knickerbocker with Craig Hallum Capital Group. Please proceed.

Speaker 4

Good afternoon. Thanks for taking the questions. Just first for me, specific drivers in wound in Q4, that line item was quite a bit better than we were modeling. Was there kind of a recovery in epi effect growth? Was there faster kind of faster than anticipated recovery in those territories that had that sales turnover earlier in 2024?

Speaker 4

Maybe just a little bit of color there.

Speaker 3

Yes. Chase, good to talk to you. This is Doug. And yes, it was our highest quarter since 2018. Super proud of the way our sales team continues to execute and certainly feels better than our third quarter.

Speaker 3

But like Joe said, international was a big catalyst for us. The FX products that I mentioned in my script, AMNEEOFFECT and EPIffect were certainly factors in our growth during the quarter.

Speaker 4

And just specifically in wound, Doug, was there any drivers to call out in the quarter that kind of improved sequentially?

Speaker 3

No, I don't think so. I think we've touched on the ones that we mentioned in the script.

Speaker 4

Got it. And then just on 2025, as far as what guidance assumes, can you give us a little bit of a look into what your assumptions are for wound and surgical growth?

Speaker 2

Yes, as both Doug and I talked about right now, we're thinking at least tricent with digits across the board, not breaking out either one individually. With the potential to do better, but we'll see, right? The first question is, why would you do better if there's all this market share up for grabs with the implementation of the LCDs in April? The short answer is because we don't have a model to point to. Likely there is going to be a fair amount of disruption and dislocation in the marketplace.

Speaker 2

No one's better positioned than us to benefit from that. So we do believe we will benefit from it. However, we have to kind of wait and see as we work through it. But it should be interesting.

Speaker 4

Yes, agreed. And maybe on that front, there's certainly a lot of noise out there kind of around the LCDs. You noted that your guidance assumes implementation. Any more specifics you can give us just around conversations you've had kind of enforcing your confidence? And then second on that front for Doug, can you just help us quantify a little bit on what you kind of assume for impact from a benefit perspective from the LCD and kind of how you see that phasing into the year?

Speaker 2

You didn't like my answer on the upside. So probably first part of your question, Chase, we do not anticipate any further delay. A couple of things to point out. First of all, the delay that took place was not specific to SkinSub's LCDs. It was kind of a good housekeeping move on the part of the new administration and we're told that this is not uncommon when new administrations take office.

Speaker 2

They put a delay on any pending new policies until they have a chance to get folks in place to take a look at them. LCDs were included in that and not just the Skin Sub LCD, but other LCDs. So, we don't see any indication for further delay and based on input from our outside advisors, we are pretty confident that it will happen.

Speaker 3

And just from a flow through perspective with sort of the covered list a bit being typically lower ASP products, we expect higher volumes this year to support the products that we have that are on the covered list. And so as a result, I think the biggest financial impact will be on our gross margin line as we look at sales mix that largely has lower ASPs. We will benefit, however, from higher throughput and higher volumes to cover some of our fixed manufacturing costs, but generally that's the biggest line. But we continue to invest in our sales force and invest in evidence and the LCDs won't change that.

Speaker 4

Got it. Thanks, Joe. Thanks, Doug.

Speaker 5

Thank you.

Operator

Thank you. Our next question comes from the line of Ross Osborne with Cantor Fitzgerald. Please proceed.

Speaker 6

Hey, guys. Congrats on the quarter and thanks for taking our questions. Starting off with Heliogen, would you refresh us on how you're thinking about that revenue opportunity and the level of contribution to growth you're baking into the guide for this year?

Speaker 2

We have not broken out any numbers on Heliogen yet, simply because it's in its very early stage of launch and market prep. It takes quite some time to run through value analysis committees and get the product contracted and in place, and that's ongoing. So to date, the contribution has been nominal and we think it's going to be a much bigger contributor in 2025, but not something that's material enough to break out at this point. And so we'll see. As the Link Gains market acceptance, we might start start talking a little bit more about it numerically.

Speaker 6

Okay, got it. And then turning to your sales force, you caught up attrition. How have hiring plans gone since then? What are your thoughts on 2025?

Speaker 2

Yes. Look, I think with the commercial team did a nice job, it's best to recover from the above average turnover we experienced mid year twenty twenty four. And that had a lasting impact throughout the rest of the year. So I think they've done a really nice job getting the team back up to speed. And obviously turnover has come back to a more normalized rate.

Speaker 2

It's always disruptive when it happens, because as you know, this is non contracted business and it tends to follow some of the sales a portion of it will tend to follow the sales personnel, they can attend to another company. But we're in real good shape. We're at near full strength of where we need to be as we enter the New Year. So we feel pretty comfortable about it. Thanks for taking our questions.

Speaker 2

Sure.

Operator

Thank you. The next question comes from the line of Anthony Petrone with Lendlyco Securities. Please proceed.

Speaker 7

Hey, you've Brad Dowers on for Anthony. Thanks for taking our questions. Just wanted to double click on the LCD, obviously the two month delay kind of out of your hands. I just wanted to kind of hear what you expect to happen kind of on the day that there is this changeover that this is finalized, maybe assuming it is as proposed. It seems like you were probably ready to go for 2012, so you kind of have an idea of what the plan is.

Speaker 7

So just wanted to kind of hear about what you expect for business dynamics, obviously, some of the other competitors that are off the market, has there been stockpiling or are you guys now given preferential treatment?

Speaker 2

Yes. Obviously, we've been preparing from an inventory standpoint. So we're comfortable that we'll have product plenty of product to meet demand. The first team has a variety of tactical contingency plans in place depending on how these things are rolled out. There's still a few unanswered questions about specifically things like how our non DFU or BLU is going to be reimbursed.

Speaker 2

Are we just going to stick to the products on the list or are the products going to be allowed to be reimbursed. So there's a little bit of unknown still, but it doesn't matter how it's rolled out. We're prepared to excel in any scenario.

Speaker 5

That's helpful. And then maybe just

Speaker 7

to push on the Doge topic. As I understand it, this RTP would do a good job of cutting back on some of the waste, but maybe some of the actual building practices would still be ongoing, but this seems to fit right within the wheelhouse. So I wanted to kind of hear what your conversations are and maybe what the path is to pare down some of that excess spending and really let the good actors such as Mamedics kind of shine in this market? And again, thanks for

Speaker 2

the question. Yes, I think we've been pretty vocal about our advocacy for reform. It's just not healthy, A, from a taxpayer standpoint, from a patient perspective and just the healthcare industry in general. This is an issue that's past its time to be cleaned up. And I know that folks at Medicare and the Max have spent an awful lot of time trying to figure out the best way to address this.

Speaker 2

So if I were them, I would not let this ultimately get into the hands of those, I'd be out in front of it. And I think they have a plan to be out in front of it. But look, I think bringing up those is important because any further delays frankly run right in the face of what at least this administration has publicly said it's trying to do, and that is identify and root out fraud, waste and abuse. Now we can debate which one of those three words best describes what's been happening in the skin substitute market, but it's certainly one of those three areas and it's a wild overspend as we've outlined in the past. It's grown more than 20 fold at least a five year period.

Speaker 2

So it's again, it's past its time to be addressed. And I think there's a lot of good people inside that have been trying to figure this out.

Speaker 7

Appreciate it.

Operator

Thank you. Our next question comes from the line of Brooks O'Neil with Lake Street. Please proceed.

Speaker 5

Good afternoon, guys. Thanks for taking my questions. I'm curious just there's a variety of what I might call legal matters that are sort of outstanding. I put in that category, the axial fill matter with the FDA, the Surgenic suit related to employee turnover and IP related matters, sort of, I guess, we'd call it the plethora of knockoffs that are available in the marketplace as we speak. If you could just give us a sense for where you think you are in those three areas, that would be a great help.

Speaker 2

Yes. I appreciate you bringing it up. So let's just talk about legal matters in general for this company. Several years ago, this company was spent a lot of money on legal matters. We joked that it was a law firm that happened to be in the med tech business.

Speaker 2

But there was a lot of legacy legal issues that the company was spending an awful lot of its capital on from within a defense perspective. The three things you just talked about Axiobill, Surgenix and IP related issues, we're playing our offense on all of those. There are cases that we decided to proceed in all cases to protect our business. With Axiofil, again, as a reminder, we felt like the company was not being treated in a consistent fashion. There are three nearly identical products in the marketplace, Axiofil being one of them.

Speaker 2

One of those products has a designation as a three sixty one, one is a five ten, but we were told Axiofil has to be treated as a biologic drug and go through those drug light trials. It didn't make any sense to us, right? It wasn't the biggest revenue generator for us, but it's precedent setting and really frankly it's an opportunity to have the conversation with the agency about what is the best regulatory pathway for these products. And by the way, we're in favor of a more stringent regulatory burden like a five ten type of process versus three sixty one. I think it's better for the industry.

Speaker 2

I think the fact that these are categorized as three sixty one products is at least half the problem we're having with these skyrocketing prices in the private office. These products are just too easy to drop into the marketplace. The only thing new there is that that case has been reassigned to a new judge and that judge has already set a hearing date, which I believe is for the March. I'm not 100% sure on which it is, but I think it's the March. That's a good sign.

Speaker 2

It's a good sign that the process is moving. So, we'll get clarity on that at some point. And then hopefully, that will spur our conversation with

Speaker 7

the agency on what is

Speaker 2

the best way to handle these types of products. But certainly there has to be some level of consistency. With the Surgenix case that has to just play itself out. We're going through the process of depositions, etcetera, collecting evidence, but there's nothing really new to report on that case. But again, that was all about protecting our business.

Speaker 2

The company was rated in a very brazen fashion and we think it constitutes anti competitive behavior. So we're taking steps to protect the business. Not surprisingly, with the proliferation of so many skin substitutes in the marketplace, we've discovered cases, many cases where people are trampled on our intellectual property rights. So again, we need to protect our portfolio. We've already asserted one case in court and there has been several communications with other companies that are clearly violating our intellectual property.

Speaker 2

So we'll pick them up one by one and either it will serve as a royalty stream or these products will be removed from the market at some point in the future. That is our firm belief.

Speaker 5

Great. That's very helpful. I'll just say I'm looking forward to getting past this regulatory nonsense and moving to a more orderly situation in the marketplace. I think that will be later this year.

Speaker 2

I'm hoping Julien Stegazier is perfect. This is the first sector of healthcare that I've been in where there's no clinical level that's required to bring product to market. There's no premarket clearance and you get to set your own price. What in the hell could have gone wrong? Right.

Speaker 5

Well, it'll get better, I'm pretty sure.

Speaker 2

Yes, it will. And it'll be a really nice industry once we kind of migrate through these maturation phases.

Operator

Thank you. Our next question comes from the line of Karl Byrnes with Northland Capital Markets. Please proceed.

Speaker 2

Thanks for the question and congratulations on your progress. I'm wondering if you can comment a bit more on EPOSEX in Japan, which was up 3x year over year. What's driving that? Is it the number of docs trained? Can you walk that out a little bit or provide a little more detail on what's happening in Japan?

Speaker 2

All good. Thanks. Yes. As a reminder, we were the first human tissue in the marketplace in Japan, which meant it took a long time to prep that market to select the right distributor, get reimbursement for the product, train the doctors, have the doctors start to utilize product, see benefit from it and then begin to reorder process. So clearly, when you're in a new market like that, you're going to target the largest on care docs as key opinion leaders and the team did a very effective job of doing that.

Speaker 2

So you're seeing high growth off of a very low base, but it's a contributor. And originally, we had talked about this as being a fairly big TAM. Frankly, we don't know what TAM is yet. It depends on how well the market develops and whether or not there's pushback. Also as a reminder that pushback around reimbursement, also as a reminder, the product is priced in the market at a point that is much higher than their current standard of care.

Speaker 2

So they have to get sold in therapy and they have to really see the results. But we're definitely happy with the progress. We'll love to see it be a bigger contributor, but that's not a knock on the team, that's just a knock on the fact that it takes a while to prep a market like this when you're creating everything from ground zero.

Speaker 3

Carl, this is Doug. I would also add just from a grouping or categorization perspective that our other category that you're looking at includes does include international, but it also includes a few other care settings. So it wasn't just international that drove that growth.

Speaker 2

Got it. Thanks so much. Thank you.

Operator

Thank you. There are no further questions at this time. I'd like to pass the call back over to Joe for any closing remarks.

Speaker 2

Thanks, operator. Appreciate you guys being on the call today and your continued interest in the company. We will talk to you in a few months. That concludes today's call. Thank you.

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