Good afternoon, and thank you for standing by. Welcome to the MiMedx Third Quarter 2024 Operating and 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. I would now like to turn the conference call over to your host, Mr. Matt Notarianni, Head of Investor Relations of MiMedx. Thank you. You may begin.

Thank you, operator, and good afternoon, everyone. Welcome to the MiMedx third quarter 2024 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 mimedx.com. 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. Also, our comments today include non-GAAP financial measures, and we provide a reconciliation to GAAP measures in our press release, which is available on our website at www.mimedx.com. With that, I'm now pleased to turn the call over to Joe Capper. Joe?

Thanks, Matt, and good afternoon, everyone. It is my pleasure to welcome you to today's call as we provide an update on our business, which continues to move in a very positive direction. For the third quarter, we once again achieved year-over-year top line growth and maintained an excellent operating margin in spite of the challenges in the private office and associated care settings due to the massive abuse of the Medicare reimbursement system being perpetrated in those sectors. We generate approximately 25% of our revenue from Medicare fee-for-service patients in the areas being impacted by this fraudulent activity. Based on feedback we have received during numerous recent interactions with relevant governing bodies, we are confident that corrective action is on the near-term horizon, which we expect will restore good fiscal governance to this market. I will talk more later in the call about why we are optimistic that our tireless efforts to affect change are gaining traction. Importantly, despite these headwinds, our business continues to flourish. As you will recall, we achieved a significant structural transformation of the company in 2023, which is now not only safeguarding the business as we navigate the current disruptive reimbursement environment, but allowing us to execute our strategy from a position of financial strength. Based on our results, it is clear we have the right strategy in place. We grew the top line and generated a solid operating margin in the quarter in which our business was under duress. That makes us very optimistic about our future as we expect such headwinds to dissipate in the coming year. I'll take a few minutes to discuss the highlights of the third quarter and then update you on the progress we are making regarding our strategic priorities. For the third quarter, net sales grew year-over-year…

Thank you, Joe, and good afternoon to everyone on today's call. Thank you for joining us. I'm pleased to once again share our results with you all today. As Matt mentioned, many of the financial measures covered in today's call are on a non-GAAP basis, so please refer to today's earnings release for further information regarding our non-GAAP reconciliations and disclosures 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. 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-K and 10-Q filings. Moving on to the results. Our third quarter 2024 net sales of $84 million represented 3% growth compared to the prior year period. As Joe mentioned in his remarks, this performance against a tough growth comparison in the prior year was marked by exceptional resilience and execution of our commercial team. By product category, third quarter wound sales of $55 million grew 8% versus the prior year period, while surgical sales of $29 million were down 5% as reported. Excluding the impacts of AXIOFILL and the sales of our dental product that were discontinued in the prior year period, our surgical sales increased 5%. Across these product categories, two of the standout contributors in the quarter were our AMNIOEFFECT and EPIEFFECT products, along with initial, albeit modest contributions from HELIOGEN, our new xenograft product for surgical. And finally, turning to our results by site of service. Net sales growth in the private office grew 11% to about $25 million compared to the prior year quarter. Despite the ongoing challenges in the environment related to high-priced skin substitutes for Medicare fee-for-service…

Thanks, Doug. As you have just heard, we had another solid quarter. Net sales were $84 million, up 3% in the quarter and in line with the expectations we highlighted last quarter. Gross profit margin was 82%. Adjusted EBITDA was $18 million or 22% of net sales in the quarter. We added another $20 million of cash. We continued limited market release of HELIOGEN, our first xenograft product, and we continue to invest in and support research designed to validate the use of our products in various applications. Let me now revisit the reimbursement saga [ph] in the private office and adjacent care settings, a topic which has dominated the chatter in the industry and has caused massive abuse of the Medicare trust fund as well as disruption and dislocation in the market. If you have been following the story, you know that multiple bad actors are using intricate schemes and unethical business practices to exploit a relatively loose regulatory and reimbursement environment for Medicare claimant [ph] of placental-derived advanced skin substitutes. While I remain frustrated that this behavior has been allowed to persist for so long, I now have renewed hope that a fix is on the horizon based on our recent interactions with CMS, the MACs and congressional staff. Last quarter, I shared that CMS payments for skin substitutes increased from approximately $1.5 billion in 2022 to $4 billion in 2023 and that we were anticipating the spend to climb even higher given the rate at which these improper business practices have been metastasizing. It turns out that our concern was spot on. We recently learned that the CMS spend for skin substitutes in the private office and associated care settings is now running at a rate north of $1 billion per month. Let that number sink in…

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

Good afternoon, guys. Thanks for taking the questions. I'm going to start, I guess, unsurprisingly on kind of the reimbursement dynamics here. So you kind of spoke to the confidence that you guys have that change is indeed coming, which I think really is kind of a change in tone from a standpoint of - of kind of that confidence level. And I think just my question is specifically on the LCDs. Kind of in those conversations that have given you incremental confidence, kind of what's that confidence level that the LCDs, you had said slightly changed, are still in a format of a certain structure that does solve this high ASP kind of loophole problem that is in the market in the near term where this isn't something where we're waiting until January 1, 2026, for a solution. Thanks.

Yeah. Chase, the big difference is what we learned over the quarter. That's kind of what's driving our change in tone and our more bullish attitude towards a pending correction. We've met with CMS on multiple occasions. We met with MACs. We've met with multiple congressional staffers. And even throughout the quarter, we could see the storyline evolving, and we met with various stakeholders. There is an incredible sense of urgency to get some correction in place given the spend level and the rate at which the spend is escalating. As you know, they can't tell us specifically as industry participants what they're going to do and when they're going to do it. But our read on the situation is it is, they're spending an awful lot of time on it, and it has gotten everybody's attention. So yes, I am more confident as I sit here this quarter versus last quarter that there is change coming. I don't know exactly how the LCDs will be modified, but I do believe that they will be implemented in some way, shape or form. And the reason I believe that is not because anyone is telling me it's coming is because it's the mechanism they have at their disposal to address this problem and everybody agrees that they need to address the problem.

Got it. Thanks. Maybe shifting gears over to the surgical business. Can you kind of help us quantify the majority of kind of that impact year-over-year, the shortfall from dental and AXIOFILL? Was it AXIOFILL? And then how quickly do you think you can fill that hole with HELIOGEN from here? And kind of do you have any kind of early kind of - how are you monitoring success early in the launch of HELIOGEN there with your reps?

Chase, this is Doug. Just from a numerical perspective, pro forma without last year's dental and without - neutralizing for AXIOFILL is about a 10-point swing. So we go from surgical being around negative 5% to a grower of 5% in Q3. That's the relative impact of those items. And with regards to HELIOGEN, we're - we launched in Q3, and it's off to a really good start. I'll let Joe provide more color there.

Yeah. We're on track where we expected to be at this point. I think it's an important point, working through the early phase mechanics like getting through value analysis, which could take quite some time depending on the institution. You have to get a sponsor within the organization to represent you as you go to value analysis and then you have to get yourself on the agenda and then you have to get it through value analysis. So those things could take a while. And so you have to work through cycles. The good news there is we're getting very positive feedback as we work through that process. Also, clinicians who are using the product in various case studies we're getting great outcomes and tremendous feedback. So it will take a little while to soften the beach and build momentum for the product. But we're pretty confident that this thing is going to be a well-received product like the other products we launched over the last 2 years. The other thing I would just add to what Doug said about the AXIOFILL number. We highlighted, excuse me, the surgical number. We highlighted the fact that we no longer have dental, and we were sort of neutralizing the AXIOFILL portion of this. But there was some disruption in the business with turnover that we had highlighted on the last call. So I don't want to kind of be dismissive of that. There was disruption in certain parts of our commercial organization in certain parts of the country, and we're addressing that. And the good news is those positions have been filled rapidly. We did - I think the commercial team did an excellent job recruiting very experienced people from all different parts of health care. And we're already starting to see those new folks get in and gain some traction. So I didn't want to leave that part out.

Yeah. Chase, one other thing just as you're kind of ticking in time, we talked about the dental impact. You'll recall last Q3 was the sort of last time buy for that product. So it was about $1.4 million in the quarter. So that hopefully helps you with the math.

Yeah. Great. And you had said, Joe, you expect material contribution from HELIOGEN in 2025. I mean do you think it can fully kind of - do you think HELIOGEN can be at, say, 2023 kind of AXIOFILL levels next year, kind of filling the gap in that product? And then just last for me. I would have also expected that sales rep turnover to really impact the physician office as well and much better growth there than we had anticipated. Can you just give us some additional detail? Is that largely driven from EPIEFFECT? Just kind of how you kind of outperformed our expectations in that market segment this quarter? Thanks.

Yeah, definitely EPIEFFECT, especially in regions that weren't impacted by the churn in the sales organization. So much - doing very well with that product. What was the other part of your question? I forgot already.

Just on - like you had said material, you expect HELIOGEN to be a material contributor in 2025. Can it be at the '23 level of AXIOFILL, for example, to kind of fill that hole in '25?

Yeah, tough to say right now. As you may recall, when we had a negative designation on AXIOFILL from FDA, we had kind of a multipronged approach to how we would counter that. One would be we would dispute the finding that AXIOFILL is not a Section 361 product. We would launch a product like HELIOGEN, that's a xenograft 510(k) regulatory pathway, which we have done. And then third, we would pursue a 510(k) on an AXIOFIL-like product. And we have started that process. We just completed our pre-sub meeting with the agency. So that will continue. I think - I think the HELIOGEN from what we're hearing, definitely can be a backfill for a portion of the AXIOFILL usage, probably not 100% of it. So it's hard for me to say, yes, gee, we're going to do everything that AXIOFILL did. It might just take a little bit of time. But the good news is we're getting excellent feedback on the product.

Great. Thanks, guys.

Thank you. Our next question comes from the line of Ross Osborn with Cantor Fitzgerald. Ross Osborn.

Hi, guys. Thanks for taking our questions. Starting off, you had a decent cut to SG&A sequentially. Is this a new base to grow off of? Or should we expect some more cuts in the fourth quarter and start to '25?

Ross, this is Doug. Our SG&A remained fairly consistent from Q2 to Q3, and I would expect it to sort of stay in that ZIP code in the near term.

Okay. Got it. And then could you just remind us of some of your manufacturing initiatives and where those stand?

Well, I don't know that we're highlighting any specific manufacturing initiatives. We've talked about just general expense discipline across the board, and we spent a lot of time talking about that last year. There was a fair amount of process improvement work that was implemented in operations. We cut in some laser technology. The majority of that has been implemented. But I would say that the team has kind of a more of a culture of ongoing process improvement that will always be looking to lean out the cost structure where there are opportunities to do so. I can't point to any major initiative that I would want to highlight with you. But I would just say, in general, the institutionalizing the discipline of operational cost control, I think the team has done a very good job of achieving that.

Okay. Got it. Congrats on the progress and thanks for taking our questions.

Thank you. Our next question comes from the line of Anthony Petrone with Mizuho Securities. Please proceed with your question.

Hi there guys. You have Brad Bowers on for Anthony today. I appreciate you taking our questions. I'm going to jump on a few topics here, but just kind of, I guess, staying on the P&L. I kind of expected an R&D step-up maybe in the back half of the year. It sounded like there was some RCT initiatives. I just wanted to kind of hear if there were any projects that were either pushed out or canceled or how we should think about R&D progression here? And maybe just extrapolating a bit, is there anything that you had heard from CMS that some of the additional studies weren't needed? I just know that some of the data was - that was kind of why some of the products were taken off some of the CMS list. So I just want to make sure that everything is kind of being taken care of to what CMS wants to kind of stay on their good side.

We're not hearing anything from CMS that studies like this are not going to be needed, and we do have a major RCT in flight for EPIEFFECT. I think it's fair to say that, that's sliding a little bit. There's competition to get these studies enrolled. We feel really good about where we are. Enrollment is underway. We have all sites selected. But probably fair to say that some of that spend will manifest itself more in the fourth quarter and first quarter of next year. But we don't expect R&D as a percent of revenue to materially change over time. Yes, we have to run these studies. But frankly, we've always run studies. And we have multiple studies in flight at any given time, maybe not to the magnitude of spend that is required for an RCT. But I don't think it's going to materially change. Doug, do you want to add anything?

I would say just over the next several quarters, you could expect some of these things to ramp up from 0.5 point maybe all the way up to 1.5 points by the end of next year is the relative level of increased investment in the R&D line.

Great. And maybe touching on kind of margin outlook. I appreciate you guys given some of the puts and takes here for 2025 and totally understand not guiding there yet. But I just thought it was interesting that your outlook for this year as well as your outlook for out years, both call for adjusted EBITDA margin above 20%. Obviously, already there right now, which is impressive in and of itself. I just wanted to kind of hear about how we should think about cadence and further progression and kind of what are the drivers of that? Is it something like a revenue uplift that will get maybe the next leg or if there's other maybe low-hanging fruit?

It's a good question. I think we're built to scale. I think the more we sell, the more we're going to leverage the bottom line and that with the way our gross margin as well as our EBITDA margin is structured, it gives us a lot of optionality on kind of when and how and where to invest in the business versus drive leverage. And so we're always looking for the right places to invest. But at 20-plus percent, we feel good about our cash flow and liquidity and ability to invest both organically and inorganically. My experience running medtech businesses of this size, I'm always pleasantly surprised at the amount of margin accretion or leverage you get the scale. And so the fact that we started to see it so soon is a really positive sign. So I can't peg a number for you, but I would expect margin accretion with scale.

That's great. And if I could get a last one in here. You mentioned inorganic. I know HELIOGEN was one of those inorganic opportunities. So I just wanted to maybe give you an opportunity to hear about just what the sales force experience has been with HELIOGEN kind of the first foray into xenograft. I know that we had talked in the past about this may have been a product that was - the customers were kind of asking for. So I just wanted to kind of hear about how this product has maybe opened any doors or if there's any flow through to some of the other products and really just how the launch is going. And thanks again for the question.

Yeah, absolutely. I think it will open up doors, right? It's a product that's used in slightly different procedures. I was personally with customers a few weeks ago, and I know this is anecdotal, but had several physicians just raving about the effectiveness of the product and how they're starting to use the product. So I think it's just working through the process, getting through value analysis, getting the product through pricing and then having more awareness built in various parts of the market. But we're pretty pleased with where we are with it.

Thank you.

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

Thanks for the question and congratulations on the results. Just out of curiosity going back to reimbursement and given the sense of urgency around CMS and the LCDs, do you think that there's any potential that there would be an adoption of reimbursement on a square centimeter basis? And then I have a follow-up as well. Thanks,

Yeah. I don't know. I can tell you that several industry participants, including us, have recommended a new pricing methodology very similar to what you just stated, price per square centimeter. And I'm hopeful that CMS is taking that under consideration. Likely that would not manifest itself until next year's new proposed physician fee schedule. As you may recall, these are typically proposed in July and the final schedules are published around about now, early November is the typical time frame, implemented in January. So because we're mid-cycle and nothing has been proposed, which means people didn't have a chance to comment on it, we're likely not going to see anything in the final rule. So a change like that would probably at earliest, take place sometime next year. We have recommended. We're hopeful. We think it's a more sound way to price these products. One thing is for sure, they have to come off this ASP methodology. The fact that these products are too easy to bring to market under Section 361, Q codes are way too easy to get issued and then you get to set your own price. They are the factors that have contributed to the mayhem that we're now experiencing in the marketplace. I don't know bizarre set of circumstances, super low barrier to entry to get to set your own price. So what could possibly have gone wrong. We're looking at it. But I am very hopeful, Carl, that, that is the case.

Great. That's helpful. And then just a quick follow-up. Out of curiosity, how does the HELOGEN launch differ from other product launches in the segment or similar? I mean, whatever you can add there would be very helpful. Thanks so much.

I would say it's very similar to the way we've rolled out products in the surgical environment in the past, right? This process takes time to work your way through.

Yeah, Carl, the only thing I'd maybe add is that relative to going into, say, a wound care center or a physician office setting, right, you do have to go through by analysis committee and data does maybe hold a bit of a higher bar. So you got to go through that process on a hospital-by-hospital basis. So as Joe said, the early results are super positive and encouraging with the clinicians who can then hopefully, some of them become champions of the product to help us really start to see that inflection point in adoption.

Yeah. Another nice benefit to that acquisition was we were able to establish a relationship with Regenity [ph] the manufacturer of the product. So we already have a development agreement in place for them and have already identified additional products we would like them to develop that we would ultimately commercialize. So a lot of benefits coming from that, albeit relatively small acquisition.

Great. Thanks and congratulations again.

Thank you.

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

Good afternoon, guys. This is Aaron on the line for Brooks. Thanks for taking our questions. Most of them have been addressed already. I'm just sort of curious on how MIMEDX Connect has sort of developed since last quarter. I know you sort of mentioned a little bit in your prepared remarks, but maybe any additional details there or just anything additional that you're planning in the future would be very helpful. Thanks, guys.

Yeah. I would just say adoption continues to increase at a rate above what we had anticipated and feedback from customers are that it is a major enhancement to workflow within their practices. So that's excellent to hear. And then based on customer feedback, we are developing additional capabilities to integrate into the platform. Concept here being the more we can do for them, the more we become part of their workflow, the more difficult it is to replace us, right? That's just logical that we're trying to create more value with our overall service offering. Nothing specific in terms of capabilities that I could highlight for you today. But just in general, we have a lot in the queue.

Great. No, that's super helpful. That's going to do it for me. Congrats on the strong quarter guys.

Thank you.

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

Thanks, operator. I appreciate you all being on the call today. I appreciate your interest in the company. We're going to go ahead and call that a wrap. That concludes today's call, and we will talk to you at the end of our next quarter. Thank you.

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