NASDAQ:MDXG MiMedx Group Q2 2025 Earnings Report $3.60 -0.09 (-2.44%) Closing price 05/8/2026 04:00 PM EasternExtended Trading$3.63 +0.03 (+0.83%) As of 05/8/2026 07:59 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. ProfileEarnings HistoryForecast MiMedx Group EPS ResultsActual EPS$0.10Consensus EPS $0.06Beat/MissBeat by +$0.04One Year Ago EPSN/AMiMedx Group Revenue ResultsActual Revenue$98.61 millionExpected Revenue$90.79 millionBeat/MissBeat by +$7.81 millionYoY Revenue GrowthN/AMiMedx Group Announcement DetailsQuarterQ2 2025Date7/30/2025TimeAfter Market ClosesConference Call DateWednesday, July 30, 2025Conference Call Time4:30PM ETConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by MiMedx Group Q2 2025 Earnings Call TranscriptProvided by QuartrJuly 30, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: Revenue grew 13% year-over-year to a record $99 million in Q2, delivering the highest quarterly adjusted EBITDA of $24 million (25% margin). Positive Sentiment: Both core franchises posted double-digit growth, with surgical up 15% (led by HelioGen adoption) and wound care up 12% (driven by Solara and Emerge). Positive Sentiment: Management raised full-year revenue outlook to low double-digit growth and expects adjusted EBITDA margin to exceed 20% in 2025. Positive Sentiment: Company is preparing for the proposed January 1, 2026 Medicare reform—$125.38 per cm² fixed payment—and plans to submit comments, citing its robust evidence base and integrated model as competitive advantages. Neutral Sentiment: Ongoing product innovation includes an interim RCT readout for EpiEffect by year-end, FDA clearance of EpiExpress, and a pilot collaboration to co-market Vaprox’s VHT device. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallMiMedx Group Q2 202500:00 / 00:00Speed:1x1.25x1.5x2xThere are 7 speakers on the call. Speaker 300:00:00Good afternoon and thank you for standing by. Welcome to the MiMedx Second Quarter 2025 Operating and Financial Results Conference Call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I will now turn the conference over to Mr. Matthew M. Notarianni, Head of Investor Relations for MiMedx. Thank you, Matt. You may begin. Operator00:00:25Thank you, Operator. Good afternoon, everyone. Welcome to the MiMedx Second Quarter 2025 Operating and Financial Results Conference call. With me on today's call are Chief Executive Officer Joseph H. Capper and Chief Financial Officer Douglas C. 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. Joseph will kick us off with some opening remarks and a summary of our operating highlights, as well as a discussion of our financial goals. Douglas will provide a review of our financial results for the quarter. Joseph will conclude before we make ourselves available for your questions. Operator00:01:04Before 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 report on Form 10-Q. 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 mimedx.com. With that, I'm now pleased to turn the call over to Joseph Capper. Operator00:02:01Joseph? Speaker 300:02:03Thanks, Matt. Good afternoon, everyone. We appreciate you all joining us for today's call. I am pleased to report that we had an excellent, and as you will hear today, action-packed second quarter. We grew our top line by 13%, generating the highest quarterly revenue and highest adjusted EBITDA in the history of the company. Both our wound and surgical franchises rose by double digits. We also posted improved margins and generated solid cash flow. Naturally, we are very happy with this exceptional performance and expect it to continue. Therefore, we are raising top-line guidance today to reflect the strong momentum we anticipate in the second half of 2025. We are also preparing the company to operate under the long-overdue reform to the Medicare reimbursement system, which is now set to take effect January 1, 2026. Speaker 300:02:56I will discuss these steps in more detail shortly, but first, let me touch on some of the highlights of the quarter, as well as an update on our strategic priorities. During the second quarter, net sales grew year over year by 13% to a record $99 million, representing another excellent performance by the team. Our adjusted gross profit margin was 84% in the quarter. Adjusted EBITDA was $24 million, or 25% of net sales. We continued to build cash, ending the quarter with $119 million, an increase of $12 million over the period, and we expect to end the year with a cash balance of more than $150 million. Our surgical business grew by 15% with contributions across the portfolio, including another uptick in Heliogen sales as adoption gains traction. We continued enrollment in our randomized controlled trial for EpiEffect. Speaker 300:03:56We began collaborations to offer a few complementary wound care solutions, and we continued to evaluate additional products to expand our portfolio for both our wound and surgical businesses. Turning to a quick update on our strategic priorities. As articulated on prior calls, we have our team's collective efforts organized and focused on three primary areas. Our top strategic priority is to continue to innovate and diversify our product portfolio. As a reminder, this objective stems from our belief that there remain numerous unmet needs in both the wound care and surgical markets for which placental-derived allografts are uniquely capable of assisting. We are confident we can continue to strengthen our market position by adding complementary skin substitutes and other adjacent products and services. This was the thinking that led us to add Heliogen to the portfolio and that continues to guide our evaluation of additional solutions. Speaker 300:04:58To that end, we have made recent progress worth mentioning. Starting with EpiEffect. As a reminder, we launched this product at the end of 2023 and began a randomized controlled trial late last year. We are still in the enrollment phase and expect to soon be positioned for an interim report out. This is a critical milestone given the reliance the Local Coverage Determinations (LCDs) place on randomized controlled trials. Next, we received a TRG letter, which confirms the product is regulated under Section 361 by the FDA for another product line extension named EpiExpress, clearing the way for its launch later this year. EpiExpress is a fenestrated allograft designed to be used in cases where the flow or extraction of fluid is of critical importance to the healing process. Speaker 300:05:47As mentioned on our last call, to remain competitive in the private office marketplace until reform is enacted, we began marketing AmnioEffect, a higher-priced amnion chorion allograft. During the quarter, we also began selling another iteration of this product called Emerge. Naturally, we expect these products will be de-emphasized next year as Medicare reimbursement reform takes hold. Last, we were excited to begin pilot programs for a few non-skin substitute complementary wound care solutions, the most notable being the collaboration we began with Vaporox Inc to co-market their Vaporous Hyperoxia Therapy, or VHT, device. At the same time, we made an investment in Vaporox, providing us with certain limited acquisition rights. VHT is a 510(k) cleared device that delivers ultrasonic mist and concentrated oxygen for the treatment of nine types of hard-to-heal chronic wounds, including diabetic foot ulcers, venous leg ulcers, and pressure ulcers. Speaker 300:06:48Vaporox's VHT has been researched in three IRB clinical studies, demonstrating wound healing rates exceeding 80% at 20 weeks when combined with standard wound care. Additionally, VHT is an adjunct therapy that has shown promising signs of efficacy in real-world use cases with MiMedx's advanced wound care products, such as EpiFix. Together with our leading placental allografts, VHT provides clinicians across numerous care settings another innovative option to treat chronic hard-to-heal wounds. We view VHT as highly complementary to our portfolio. Our second priority is to develop and deploy programs intended to expand our footprint in the surgical market. In addition to seeking opportunities to expand our offering, this objective requires significant commitment to the production of real-world clinical and scientific research. As such, we continue to fund work to produce tangible evidence in support of our technology for a variety of surgical procedures. Speaker 300:07:55The May 2025 issue of the Journal of Drugs and Dermatology included a study on the cost-effectiveness of using MiMedx placental allografts following Mohs surgeries. We also had the opportunity to highlight the growing body of evidence that supports the use of our products in certain surgical procedures while attending high-profile conferences during the spring months. These efforts and the expansion of other commercial activities continue to pay dividends, as evidenced by our Q2 top-line surgical growth of 15%, led by AmnioEffect. As stated in the past, we believe we are in the early innings as it pertains to the use of placental-derived products in many surgical applications. The development of these markets will take time and perseverance, but the potential clinical benefits for patients, the healthcare economic payoff, and the immense business opportunity for years to come make it well worth the investment. Speaker 300:08:54Our third initiative is to introduce programs designed to enhance customer intimacy. As we prepare for the transition to a reimbursement environment where profit potential is no longer a primary driver in product selection, we believe a company's comprehensive value offering will heavily influence vendor selection. As such, we have been focused on developing programs which improve customer relationships and ultimately lower turnover. We have several initiatives underway aimed at institutionalizing customer-centric behavior throughout the organization. We continue to experience excellent adoption of MiMedx Connect, our proprietary customer portal, and we are actively developing additional features designed to improve workflow and strengthen the bond between MiMedx and our customers. We believe our commitment to this approach will lead to enhanced customer relationships, improved net promoter scores, higher margins, and ultimately an increase in the average lifetime value of the customer. Speaker 300:09:54In addition to our superb performance in the quarter, the other big news of the day relates to recent announcements by the federal government on the steps they are taking to finally address the wildly inappropriate Medicare reimbursement for skin substitutes in private office and associated care settings. As you know, we have spoken about this issue at length on numerous occasions and have been long-time ardent advocates for action necessary to address the obvious fraud, waste, and abuse that have plagued this industry and taxpayers. We have met with or spoken to nearly every relevant three-letter agency which could enact reform, and we enthusiastically welcome these recent developments. Speaker 300:10:34First, at the end of June, CMS announced the introduction of the Wasteful and Inappropriate Service Reduction, or WISR, model, which is focused on leveraging artificial intelligence and machine learning in concert with human clinical review to curb fraud, waste, and abuse in healthcare. This voluntary model, which aims to encourage safe and evidence-supported best practices for treating Medicare beneficiaries, will run from January 1, 2026, to December 31, 2031, in five states and will examine several product categories, including skin substitutes. Next, several weeks ago, CMS posted the proposed Physician Fee Schedule, or PFS, and the Outpatient Prospective Payment System, or OPPS, for calendar year 2026. CMS will accept comments until September 12, and the final rules are expected to be published in November to take effect at the start of the new year. Speaker 300:11:32According to the proposed schedule, CMS is moving away from the ASP methodology at the private office and away from the bundle in the wound care centers. Instead, CMS will move to a fixed payment for skin substitutes of $125.38 per square centimeter in all outpatient sites of care, private offices and wound care centers alike. We plan to submit comments in support of the new reimbursement methodology with certain recommendations regarding payment levels and requests for clarification. Before I turn the call over to Doug for his detailed financial review of the quarter, I want to share with you a few comments regarding our updated guidance. As a result of our strong performance year to date and the current momentum in the business, we increased our full-year revenue growth outlook from the high single digits to the low double digits. Speaker 300:12:25We also expect our full-year adjusted EBITDA margin to be above 20%. Importantly, our expectations regarding long-term prospects for the business are even more positive given the changes pending to the Medicare reimbursement methodology. Now, let me turn the call over to Doug for a more detailed review of our financial results. Doug? Speaker 100:12:46Thank you, Joe, and good afternoon to everyone on today's call. I'm excited 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. Moving on to the results, as Joe mentioned, our second quarter 2025 net sales of $99 million represented 13% growth compared to the prior year period. By product category, second quarter wound sales of $64 million increased 12% versus the prior year period, while surgical sales of $34 million were up 15%, which marks the second consecutive quarter of mid-teens growth for surgical. We saw significant contributions across our business in the second quarter. In wound, our second quarter sales faced a tough comparable due to solid EpiFix sales last year. Speaker 100:13:41However, this was overcome by strong sales of EpiExpress and, to a lesser extent, initial contributions from Emerge. In our surgical franchise, AmnioEffect and AmnioFix once again delivered strong year-over-year increases in sales, and uptake of Heliogen accelerated in the quarter as well. Our second quarter 2025 GAAP gross profit was about $80 million, up nearly $8 million compared to the prior year period. Our GAAP gross margin was 81% in the second quarter 2025 compared to 83% last year. Excluding the incremental acquisition-related amortization expense from intangible assets of roughly $2.5 million in this quarter, our non-GAAP adjusted gross margin was 84%, roughly flat compared to the second quarter of 2024. We continue to expect our full-year non-GAAP gross margin to be around 82% to 83%. Speaker 100:14:37Turning to our operating expenses, sales and marketing expenses were $48 million in the second quarter compared to $42 million in the prior year period. The increase was due to a combination of increased sales costs, including higher commissions associated with higher sales, as well as the changes we made to our sales commission plans in the middle of 2024. Looking ahead, we continue to expect our full-year 2025 sales and marketing expenses to be between 50% and 51% of net sales, which would be a flat 1 percentage point increase on a percentage of sales basis to 2024 and up in absolute dollars. General and administrative expenses, or G&A, were $16 million in the second quarter compared to $14 million in the prior year period. Speaker 100:15:25Over the balance of the year, we continue to expect G&A expenses to be around 13% of sales on an adjusted basis, which would be a decrease of around 1 percentage point on a percentage of sales basis to 2024 and up in absolute dollars. Our second quarter R&D expenses were $3 million, just up slightly compared to the prior year period. Our R&D expenses are primarily comprised of the costs associated with our ongoing EpiEffect randomized controlled trial, as well as additional spend related to the development of future products in our pipeline. As we continue to ramp enrollment in the trial this year and prepare for an interim readout, we now expect our full-year R&D expenses to be about 4% of net sales. GAAP income tax expense for Q2 2025 was around $3 million, reflecting an effective tax rate of 26%. Speaker 100:16:20Please note that this tax expense number does not reflect the third quarter tax reform that was enacted earlier this month. As a result of this bill, we expect modest impacts in our effective tax rate. We also expect the new tax reform to significantly decrease our cash tax payments in the near term as a result of immediate expensing of domestic R&D expense. We continue to expect our long-term non-GAAP effective tax rate to be 25%. Our second quarter GAAP net income was $10 million, or $0.06 per share on a diluted basis compared to GAAP net income of $18 million, or $0.12 per share in the prior year period. Adjusted net income for the second quarter was $15 million, or $0.10 per share compared to $11 million, or $0.08 per share in the prior year period. Speaker 100:17:11Second quarter adjusted EBITDA was $24 million, or 25% of net sales compared to $20 million, or 23% of net sales in the prior year period. In addition to the highest ever quarterly sales in this company's history, our second quarter adjusted EBITDA was also a new record and a testament to the work our team has done to scale our business as we continue to grow our wound and surgical footprints. Turning to our liquidity, we had $119 million of cash and cash equivalents on June 30, 2025, a sequential increase of over $12 million. During the second quarter, we generated free cash flow of $14 million, representing a sequential step up of $9 million compared to the first quarter. Speaker 100:17:56In turn, our net cash balance now sits at about $100 million, up from $88 million just last quarter and also double our $50 million net cash balance from just a year ago. We continue to pursue several opportunities to deploy our strong balance sheet and borrowing capacity on growth opportunities that support our strategic priorities. I will now turn the call back to Joe. Joe? Speaker 300:18:21Thanks, Doug. As you have just heard, we had an outstanding quarter, and MiMedx is well positioned to have a terrific second half. Importantly, we are in an even better position to excel once the industry resets to the proposed more orderly reimbursement guidelines. We set record highs for revenue and adjusted EBITDA with strong growth in both wound care and surgical businesses. We continue to generate strong cash flow. We kicked off a few pilot programs to co-market complementary solutions in the wound care market and increased our guidance meaningfully to reflect our strong momentum. In closing, I would like to sincerely thank the MiMedx team for an outstanding quarterly performance and for your unwavering commitment to the company and to the many individuals who rely on our products each and every day. With that, I would like to open the call to questions. Speaker 300:19:16Operator, we are now ready for our first question. Please proceed. Speaker 400:19:21Thank you. We're now conducting a question and answer session. If you'd like to be placed in the question queue, please press star one on the telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove a question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star one. Our first question today is coming from Chase Richard Knickerbocker from Crest Hallam. Your line is now live. Speaker 600:19:49Good afternoon, guys. Congrats on the nice quarter here. Joe, maybe first, we'd love to get your thoughts on how you see this market post-reimbursement change. It's certainly going to come down a bit as that $12 billion of spend is reduced. If we assume the $125 sticks and there's, call it, limited product discounting, do you guys have a first-blush estimate on the skin sub-market size across physician office and HOPD together that you'd be willing to share? Speaker 300:20:22Chase, first of all, let me start with a couple of high-level comments. I think, as I stated in the prepared remarks, we welcome this change and we firmly believe it will be better for MiMedx long term. Number two, reform was inevitable. We can all agree, hopefully, we can all agree that things have gotten completely out of control and reform is a good thing for not just U.S. taxpayers, but our industry and for Medicare beneficiaries. Number three, the fee schedules aren't the proper mechanism to address pricing. Number four, fixed pricing is a better way to reimburse for skin substitutes than either the ASP methodology or bundling. We can debate the most appropriate price point, but the fixed price method is a better methodology. Number five, the future state is certainly better for MiMedx in the long run. Why am I so confident about that? Speaker 300:21:15We have the most robust evidence in support of our technology. When we are back to competing on product efficacy, we feel very confident in our ability to prevail. When the market is acting rationally, we win, as evidenced by our double-digit growth in the surgical market where we do not compete primarily on price. Instead, product performance typically drives the decision. Next, we're a fully integrated company. We have our own donor network, our own manufacturing, again, the best evidence and the most evidence, and our own high-performing direct commercial organization. While there may be some short-term choppiness in the industry as things adjust, we're well positioned to compete relative to our peer growth, and certainly in the long term. We have full access to all care settings. We have the most private insurance coverage, which is important for Medicare co-pays. Speaker 300:22:06You know, we're certainly going to be in a position to pick up share, and we have the capacity to handle any ramp of share. We're certainly going to advocate for clarification on some of the rules, as well as certain modifications. When the market's acting rationally, it's better for us. We're going to win. It's certainly better for the industry. The industry becomes more investable. Last, we also have an excellent balance sheet, which provides us maximum flexibility as the industry goes through some change. Your second part of your question in terms of market size, it's just too early to tell, right? Obviously, we've done a lot of internal sensitivity modeling at this price and at a range of prices and certainly a range of volume levels. We're pretty confident we're going to pick up a fair amount of share. Speaker 300:22:55Suffice to say, we feel very comfortable that we're going to be able to compete regardless of how these rules ultimately shake out. Speaker 600:23:03That's helpful. Maybe kind of another one along those lines, just as it relates to kind of your model specifically. You know, based off your ASP today, is there a way that we can think about, if we assume the sticks again, how we should think about the dollar impact that you'll need to make up with volume? Can you speak to your confidence level that, with all those points you just made, that you can take enough share next year to counteract any headwind that would be there and then grow and to be able to grow wound in 2026? I'm just trying to get some initial thoughts on our model next year. Thanks. Speaker 300:23:43Yeah, we're super confident we can do it. Again, clearly, we're doing a lot of modeling around this, but I would say kind of high levels, we would have to pick up some share, but not a ton, right? If we, these price levels are not foreign to us. If you go back and look at what our average pricing was a few years ago, we're not that far off. Obviously, ASPs crept up a little bit with the introduction of some new products, but we're in really good shape. Speaker 600:24:16Got it. Just last for me, just on EpiEffect, is there a timeline that we can kind of think of for that readout as we, you know, have the LCD, you know, potentially still going into effect next year? Just kind of a little bit more specific on that readout, if you would. Speaker 300:24:34Yeah, hopefully maybe this year we're going to have some good data to take a look at. The RCT is going a little bit slower than we had hoped for, probably because there's a million of these things being run at the same time, and there's capacity issues to run RCTs in the marketplace. There are only so many patients, only so many doctors that are qualified to participate in studies like this. We're moving forward, we're making traction, but knock wood, hopefully we'll have something to report out by the end of the year. The good news is we have two really high-performing products that are already on the list if the LCDs go through as proposed. Speaker 600:25:10Great. Thanks, Joe. Speaker 400:25:13Thank you. Next question today is coming from Carl Edward Byrnes from Northland Capital Markets. Your line is now live. Speaker 500:25:20Thanks for the question. Congratulations on the results. I'm wondering if you have any feel for CMS's flexibility in the comment period on the single fixed rate of $125.38. In other words, I mean, I would expect that that might and should migrate higher, but sort of what is your anticipation with that process? I have a follow-up as well. Speaker 300:25:43Yeah, Carl can't handicap it. Have they done it in the past? Yes, they've made modifications throughout, or I would say as a result of comments, but can't handicap it, right? I'm sure there's a lot of logic that went into the price point that they selected. There's a lot of pricing available in the market that would, you know, direct them to kind of settle in on a price like this. We'll provide our comments and some recommendations on other ways to look at it, as I'm sure a lot of other stakeholders in the market will. I'm not going to handicap whether or not it's this price or at some price point higher or how much higher. I think it's impossible for any of us to know at this point. Speaker 500:26:25Fair enough. A follow-up, you know, considering the potential for the LCDs to become effective in January 2026, would you foresee any anomalies in stocking, you know, given that you've got two of the 15 products that will be eligible? Speaker 300:26:46Yeah, it's a good question, right? That's something that we're going to stay on really close to as we start to close out the calendar year. We'll monitor inventory levels very, very closely. Clearly, we're going to have more clarity as we get closer to the end of the year whether or not Local Coverage Determinations are going to take effect and what the final price point is and the final rules associated with OPPS and the physician fee schedule. We'll just watch it as tight as we can. As far as pre-stocking, etc., I don't know yet. We'll have to wait and see. I would just say, look, we've been managing inventory closely as we rotate products in and off the market for years, so we know how to do this. Speaker 300:27:29We've had to do it for a long term because we're operating under the ASP methodology, which requires you to manage inventory a whole lot tighter. I wouldn't say I'm that concerned about it, but it is something that we will watch incredibly closely as we close out the year. Speaker 100:27:47Carl, this is Doug. I would also add, we've already done this a couple of times as we're gearing up for the February Local Coverage Determinations to take effect. They got delayed until April. We were prepared at that time. You've seen us with our balance sheet and our capital wherewithal. We've been able to invest in carrying a little bit more inventory. With our capacity and the strength of our donor recovery network and the other items that Joe articulated a second ago, we feel like we're in a good position to be prepared. Speaker 300:28:19Great. Thank you. That's very helpful. I'll hop back in the queue. Thanks. Speaker 400:28:25Thank you. Our next question is coming from Ross Everett Osborn from Canterfish Shoals. Your line is now live. Speaker 200:28:30Hey, guys. Congrats on the strong quarter. Thanks for taking our questions. Maybe you wanted to put a finer point on the market next year, assuming the PFS goes through as proposed. Where's the low-hanging fruit for you guys to take share? As a follow-up to that, curious to hear your thoughts on the opportunity on the mobile side of things. Speaker 300:28:51What was the last part of that? Opportunity where? Speaker 200:28:55On the mobile wound care market, with the proposed price, assuming a lot of those players will go away, curious to hear if that's an attractive market opportunity for you all. Speaker 300:29:06Yeah, I don't really want to speak for the mobile wound care sites. Let me just put it this way. In comment, we're going to support providers as much as possible. One of the things that we will advocate strongly for is a higher application fee for providers. We would like to see them get paid more for what they're doing. I do think that the circumstances we are in now are partly created because they weren't getting paid properly for what they were doing. Frankly, they were living off margin that they could get on skin subs, which is not a healthy way to pay physicians for what they're doing. We will advocate strongly for that. I think it's a much better way to go. Speaker 300:29:52In terms of what, I think the mobile health market will be affected or will be impacted a bit more as a result of that. Hopefully, they could be compensated properly for the work that they're doing. I think it's a very important segment that's developed over the years and likely reaching more patients. Patients that frankly wouldn't get the care necessary, short of having that site of service available. What was the first part of the question? Speaker 200:30:19We hear you for it. Speaker 300:30:20Yeah, I'm not going to talk about that. We think we could pick up market share in a variety of different ways. I think we're in every site of care you can imagine. Some are stronger than others. I think there's going to be migration from one care setting to another. We're going to make sure that we're well positioned in every one of those care settings. In terms of tactically where we think we'll compete best, I'd rather keep that to ourselves. Speaker 200:30:45Fair enough. Lastly, regarding the LCD, any feedback or conversations with the MACs? Curious to hear probability that that ends up going through. Speaker 300:30:59Yeah, I think that's been a little quieter as, you know, naturally. Last official word was they were delayed for a Gen 1 implementation. You know, we still have all the same advocates and advisors, and we'll try to get our position heard. I think it's important to note that even if the LCDs went into effect back in February or in April, we still would have needed this action by CMS. Again, the proper way to regulate pricing is through the fee schedules. This step would have had to happen. As far as putting requirements in to prove clinical efficacy like randomized controlled trials, it's fun to argue that that's not a good thing for healthcare, right? To prove that your products are clinically viable to be marketed. How that requirement comes into play remains to be seen, whether it's through the MACs, whether it's through FDA. Speaker 300:31:57It's hard to argue that that's not a good thing for healthcare. Speaker 200:32:02Thanks for taking our questions. Speaker 300:32:05Thanks, Russ. Speaker 500:32:06Thank you. Next question today is coming from Anthony Charles Petrone from Azuho Group. Your line is now live. Speaker 200:32:14Thanks, and congrats on a strong quarter. Maybe I'll stick on physician fee schedule and hospital outpatient. I just have a follow-up on core wound care. Maybe one of the nuances in there, Joe, was on, you know, the distinction of level one, two, and three classification of wounds. I think there was basically a linkage into, or at least a read-through there on max utilization based on that classification. Maybe walk us through that a little bit and bridge that to what is the actual mix of patients that are getting treated according to those classifications? Does that present any risk, you know, to volumes and LF1 quick flow? Speaker 300:33:01As far as impact on volumes, etc., it's too early to tell. We need more clarification on that. I think what they attempt to do is recognize that there's different regulatory pathways that are established and potentially setting tiers or categories, however you want to look at it. At least at first pass, they recognize it, but set the price per square centimeter to be the same for all three. We're working closely with, or I would say advocating strongly on the regulatory side as well. We think some changes need to take place on the regulatory side. Speaker 200:33:40Okay. The broader question is, and Joe, you've been great in just calling out the expansion of billing category to, you know, $1 billion a month. Obviously, a lot of players in here, there's still the 17 approved products on the LCD side. Just any updated thoughts on the shakeout as we finalize potentially physician fee schedule and outpatient to a final rule, but also these LCDs come in. How much of that $1 billion per month do you think goes away? Ultimately, where can MiMedx, you know, kind of land in terms of share here? Thanks again. Speaker 300:34:24Yeah, I think we're speculating, right? It's safe to say that a fair amount of that goes away. First of all, even if all the current volume was at the lower price point, by definition, the math changes and the market is smaller in terms of total dollars in the market. I think it's also safe to say that some of that volume is going to disappear because there was probably a fair amount of overutilization, right? You don't have to take my word for that. There have been numerous enforcement actions that were announced already. I think there was another one announced today. I think this is going to be on the DOJ work list for probably the next decade. We're going to be reading about these things. There was a ton of bad behavior, and typically that means overutilization. Speaker 300:35:09My guess is some of the volume goes away, and certainly the price gets adjusted down. We know that it's a sizable market because we competed in this market very effectively before we saw this run-up. Even if we adjust back to, and you can kind of adjust those old volume levels just for demographics, it's going to be a pretty sizable market, right? We're very comfortable. I've said it numerous times, in a rational marketplace where providers are selecting product based on product performance, safety, and efficacy, we're going to win those battles. Have in the past, and we will continue to win those. Speaker 200:35:57Thank you. Speaker 400:35:59Thank you. Our next question is coming from Carl Edward Byrnes, a follow-up from Northland Capital Markets. Your line is now live. Speaker 500:36:05Thanks for the follow-up. With respect to the partnership, when would it be realistic to see a material contribution? Speaker 300:36:20Not anywhere in the near term, Carl. I mean, it's a collaboration. We still have to work out some of the details in terms of how we'll work together. If something's hitting our numbers, that won't be for a while. You won't see anything until next year. Speaker 500:36:40Great. Thanks. Speaker 400:36:42Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over for any further or closing comments. Speaker 500:36:49Thanks, Robert. Thanks, everybody, for joining today's call. I appreciate your interest in the company. We'll talk to you next quarter.Read morePowered by Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) MiMedx Group Earnings HeadlinesMiMedx: The Hard Math Behind My Downgrade To Hold4 hours ago | seekingalpha.comMIMEDX Announces Launch of G4Derm® PlusMay 8 at 8:00 AM | globenewswire.comElon Musk’s $1 Quadrillion AI IPO$1 quadrillion would be enough to send a $2.8 million check to every man, woman, and child in America. That is the scale of what analysts are calling the biggest AI IPO in history.And right now, you can claim a stake before the company goes public, starting with just $500.Elon Musk is predicting this investment could climb 1,000x from here. Early access is available today.May 9 at 1:00 AM | Brownstone Research (Ad)Some May Be Optimistic About MiMedx Group's (NASDAQ:MDXG) EarningsMay 7 at 11:57 PM | finance.yahoo.comINVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of MiMedx Group, Inc. - MDXGMay 7 at 10:00 AM | prnewswire.comHow Reimbursement Shifts Are Rewriting The MiMedx Group (MDXG) Investment NarrativeMay 5, 2026 | uk.finance.yahoo.comSee More MiMedx Group Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like MiMedx Group? Sign up for Earnings360's daily newsletter to receive timely earnings updates on MiMedx Group and other key companies, straight to your email. Email Address About MiMedx GroupMiMedx Group (NASDAQ:MDXG). is a biopharmaceutical company focused on the development, manufacture and marketing of regenerative biomaterial products derived from human placental tissues. The company’s core mission centers on harnessing the extracellular matrix and growth factors within amniotic and chorionic membranes to support wound healing and surgical applications. MiMedx’s product line leverages proprietary purification processes designed to retain native tissue properties while ensuring sterility and safety. MiMedx’s principal offerings include amnion/chorion allografts branded under names such as EpiFix® and AmnioFix®, which are indicated for the treatment of acute and chronic wounds—including diabetic foot ulcers, venous leg ulcers and surgical site repair. The company also supplies specialized bioimplants for orthopedic and spine procedures, supporting soft-tissue repair through its PURION® Plus technology platform. These products are used by wound care centers, hospitals, long-term care facilities and physician offices. Headquartered in Marietta, Georgia, MiMedx serves a primarily U.S. customer base, with a growing international presence through distributors and strategic partnerships in Europe, Asia and Latin America. The company’s direct sales force works alongside a network of third-party distributors to educate clinicians on the clinical and economic benefits of its regenerative therapies. MiMedx continues to invest in clinical research and educational programs to expand awareness of placental-derived tissue allografts across multiple therapeutic areas. Founded in 2008, MiMedx has grown from a niche tissue processor to an established player in the regenerative medicine sector. Over its history, the company has received approvals from the U.S. Food and Drug Administration for tissue donor eligibility and manufacturing practices governed by FDA and American Association of Tissue Banks (AATB) standards. Leadership includes experienced professionals in biotechnology and medical device commercialization, supported by a board with backgrounds in healthcare investment and corporate governance.View MiMedx Group ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles MarketBeat Week in Review – 05/04 - 05/08Rocket Lab Posts Record Q1 Revenue, Raises Q2 GuidanceHims & Hers Earnings Preview: The Novo Nordisk Shift Puts GLP-1 Strategy in FocusWater Infrastructure: Why This Boring Sector Could Get ExcitingAppLovin Pops After Earnings With Growth Catalysts in SightDutch Bros Q1 Earnings: The Newest Starbucks Rival Faces Its First Big Reality CheckThe AI Fear Around Datadog Stock May Have Been Completely Wrong Upcoming Earnings Constellation Energy (5/11/2026)Barrick Mining (5/11/2026)Petroleo Brasileiro S.A.- Petrobras (5/11/2026)Simon Property Group (5/11/2026)SEA (5/12/2026)Cisco Systems (5/13/2026)Alibaba Group (5/13/2026)Manulife Financial (5/13/2026)Sumitomo Mitsui Financial Group (5/13/2026)Takeda Pharmaceutical (5/13/2026) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 7 speakers on the call. Speaker 300:00:00Good afternoon and thank you for standing by. Welcome to the MiMedx Second Quarter 2025 Operating and Financial Results Conference Call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I will now turn the conference over to Mr. Matthew M. Notarianni, Head of Investor Relations for MiMedx. Thank you, Matt. You may begin. Operator00:00:25Thank you, Operator. Good afternoon, everyone. Welcome to the MiMedx Second Quarter 2025 Operating and Financial Results Conference call. With me on today's call are Chief Executive Officer Joseph H. Capper and Chief Financial Officer Douglas C. 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. Joseph will kick us off with some opening remarks and a summary of our operating highlights, as well as a discussion of our financial goals. Douglas will provide a review of our financial results for the quarter. Joseph will conclude before we make ourselves available for your questions. Operator00:01:04Before 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 report on Form 10-Q. 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 mimedx.com. With that, I'm now pleased to turn the call over to Joseph Capper. Operator00:02:01Joseph? Speaker 300:02:03Thanks, Matt. Good afternoon, everyone. We appreciate you all joining us for today's call. I am pleased to report that we had an excellent, and as you will hear today, action-packed second quarter. We grew our top line by 13%, generating the highest quarterly revenue and highest adjusted EBITDA in the history of the company. Both our wound and surgical franchises rose by double digits. We also posted improved margins and generated solid cash flow. Naturally, we are very happy with this exceptional performance and expect it to continue. Therefore, we are raising top-line guidance today to reflect the strong momentum we anticipate in the second half of 2025. We are also preparing the company to operate under the long-overdue reform to the Medicare reimbursement system, which is now set to take effect January 1, 2026. Speaker 300:02:56I will discuss these steps in more detail shortly, but first, let me touch on some of the highlights of the quarter, as well as an update on our strategic priorities. During the second quarter, net sales grew year over year by 13% to a record $99 million, representing another excellent performance by the team. Our adjusted gross profit margin was 84% in the quarter. Adjusted EBITDA was $24 million, or 25% of net sales. We continued to build cash, ending the quarter with $119 million, an increase of $12 million over the period, and we expect to end the year with a cash balance of more than $150 million. Our surgical business grew by 15% with contributions across the portfolio, including another uptick in Heliogen sales as adoption gains traction. We continued enrollment in our randomized controlled trial for EpiEffect. Speaker 300:03:56We began collaborations to offer a few complementary wound care solutions, and we continued to evaluate additional products to expand our portfolio for both our wound and surgical businesses. Turning to a quick update on our strategic priorities. As articulated on prior calls, we have our team's collective efforts organized and focused on three primary areas. Our top strategic priority is to continue to innovate and diversify our product portfolio. As a reminder, this objective stems from our belief that there remain numerous unmet needs in both the wound care and surgical markets for which placental-derived allografts are uniquely capable of assisting. We are confident we can continue to strengthen our market position by adding complementary skin substitutes and other adjacent products and services. This was the thinking that led us to add Heliogen to the portfolio and that continues to guide our evaluation of additional solutions. Speaker 300:04:58To that end, we have made recent progress worth mentioning. Starting with EpiEffect. As a reminder, we launched this product at the end of 2023 and began a randomized controlled trial late last year. We are still in the enrollment phase and expect to soon be positioned for an interim report out. This is a critical milestone given the reliance the Local Coverage Determinations (LCDs) place on randomized controlled trials. Next, we received a TRG letter, which confirms the product is regulated under Section 361 by the FDA for another product line extension named EpiExpress, clearing the way for its launch later this year. EpiExpress is a fenestrated allograft designed to be used in cases where the flow or extraction of fluid is of critical importance to the healing process. Speaker 300:05:47As mentioned on our last call, to remain competitive in the private office marketplace until reform is enacted, we began marketing AmnioEffect, a higher-priced amnion chorion allograft. During the quarter, we also began selling another iteration of this product called Emerge. Naturally, we expect these products will be de-emphasized next year as Medicare reimbursement reform takes hold. Last, we were excited to begin pilot programs for a few non-skin substitute complementary wound care solutions, the most notable being the collaboration we began with Vaporox Inc to co-market their Vaporous Hyperoxia Therapy, or VHT, device. At the same time, we made an investment in Vaporox, providing us with certain limited acquisition rights. VHT is a 510(k) cleared device that delivers ultrasonic mist and concentrated oxygen for the treatment of nine types of hard-to-heal chronic wounds, including diabetic foot ulcers, venous leg ulcers, and pressure ulcers. Speaker 300:06:48Vaporox's VHT has been researched in three IRB clinical studies, demonstrating wound healing rates exceeding 80% at 20 weeks when combined with standard wound care. Additionally, VHT is an adjunct therapy that has shown promising signs of efficacy in real-world use cases with MiMedx's advanced wound care products, such as EpiFix. Together with our leading placental allografts, VHT provides clinicians across numerous care settings another innovative option to treat chronic hard-to-heal wounds. We view VHT as highly complementary to our portfolio. Our second priority is to develop and deploy programs intended to expand our footprint in the surgical market. In addition to seeking opportunities to expand our offering, this objective requires significant commitment to the production of real-world clinical and scientific research. As such, we continue to fund work to produce tangible evidence in support of our technology for a variety of surgical procedures. Speaker 300:07:55The May 2025 issue of the Journal of Drugs and Dermatology included a study on the cost-effectiveness of using MiMedx placental allografts following Mohs surgeries. We also had the opportunity to highlight the growing body of evidence that supports the use of our products in certain surgical procedures while attending high-profile conferences during the spring months. These efforts and the expansion of other commercial activities continue to pay dividends, as evidenced by our Q2 top-line surgical growth of 15%, led by AmnioEffect. As stated in the past, we believe we are in the early innings as it pertains to the use of placental-derived products in many surgical applications. The development of these markets will take time and perseverance, but the potential clinical benefits for patients, the healthcare economic payoff, and the immense business opportunity for years to come make it well worth the investment. Speaker 300:08:54Our third initiative is to introduce programs designed to enhance customer intimacy. As we prepare for the transition to a reimbursement environment where profit potential is no longer a primary driver in product selection, we believe a company's comprehensive value offering will heavily influence vendor selection. As such, we have been focused on developing programs which improve customer relationships and ultimately lower turnover. We have several initiatives underway aimed at institutionalizing customer-centric behavior throughout the organization. We continue to experience excellent adoption of MiMedx Connect, our proprietary customer portal, and we are actively developing additional features designed to improve workflow and strengthen the bond between MiMedx and our customers. We believe our commitment to this approach will lead to enhanced customer relationships, improved net promoter scores, higher margins, and ultimately an increase in the average lifetime value of the customer. Speaker 300:09:54In addition to our superb performance in the quarter, the other big news of the day relates to recent announcements by the federal government on the steps they are taking to finally address the wildly inappropriate Medicare reimbursement for skin substitutes in private office and associated care settings. As you know, we have spoken about this issue at length on numerous occasions and have been long-time ardent advocates for action necessary to address the obvious fraud, waste, and abuse that have plagued this industry and taxpayers. We have met with or spoken to nearly every relevant three-letter agency which could enact reform, and we enthusiastically welcome these recent developments. Speaker 300:10:34First, at the end of June, CMS announced the introduction of the Wasteful and Inappropriate Service Reduction, or WISR, model, which is focused on leveraging artificial intelligence and machine learning in concert with human clinical review to curb fraud, waste, and abuse in healthcare. This voluntary model, which aims to encourage safe and evidence-supported best practices for treating Medicare beneficiaries, will run from January 1, 2026, to December 31, 2031, in five states and will examine several product categories, including skin substitutes. Next, several weeks ago, CMS posted the proposed Physician Fee Schedule, or PFS, and the Outpatient Prospective Payment System, or OPPS, for calendar year 2026. CMS will accept comments until September 12, and the final rules are expected to be published in November to take effect at the start of the new year. Speaker 300:11:32According to the proposed schedule, CMS is moving away from the ASP methodology at the private office and away from the bundle in the wound care centers. Instead, CMS will move to a fixed payment for skin substitutes of $125.38 per square centimeter in all outpatient sites of care, private offices and wound care centers alike. We plan to submit comments in support of the new reimbursement methodology with certain recommendations regarding payment levels and requests for clarification. Before I turn the call over to Doug for his detailed financial review of the quarter, I want to share with you a few comments regarding our updated guidance. As a result of our strong performance year to date and the current momentum in the business, we increased our full-year revenue growth outlook from the high single digits to the low double digits. Speaker 300:12:25We also expect our full-year adjusted EBITDA margin to be above 20%. Importantly, our expectations regarding long-term prospects for the business are even more positive given the changes pending to the Medicare reimbursement methodology. Now, let me turn the call over to Doug for a more detailed review of our financial results. Doug? Speaker 100:12:46Thank you, Joe, and good afternoon to everyone on today's call. I'm excited 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. Moving on to the results, as Joe mentioned, our second quarter 2025 net sales of $99 million represented 13% growth compared to the prior year period. By product category, second quarter wound sales of $64 million increased 12% versus the prior year period, while surgical sales of $34 million were up 15%, which marks the second consecutive quarter of mid-teens growth for surgical. We saw significant contributions across our business in the second quarter. In wound, our second quarter sales faced a tough comparable due to solid EpiFix sales last year. Speaker 100:13:41However, this was overcome by strong sales of EpiExpress and, to a lesser extent, initial contributions from Emerge. In our surgical franchise, AmnioEffect and AmnioFix once again delivered strong year-over-year increases in sales, and uptake of Heliogen accelerated in the quarter as well. Our second quarter 2025 GAAP gross profit was about $80 million, up nearly $8 million compared to the prior year period. Our GAAP gross margin was 81% in the second quarter 2025 compared to 83% last year. Excluding the incremental acquisition-related amortization expense from intangible assets of roughly $2.5 million in this quarter, our non-GAAP adjusted gross margin was 84%, roughly flat compared to the second quarter of 2024. We continue to expect our full-year non-GAAP gross margin to be around 82% to 83%. Speaker 100:14:37Turning to our operating expenses, sales and marketing expenses were $48 million in the second quarter compared to $42 million in the prior year period. The increase was due to a combination of increased sales costs, including higher commissions associated with higher sales, as well as the changes we made to our sales commission plans in the middle of 2024. Looking ahead, we continue to expect our full-year 2025 sales and marketing expenses to be between 50% and 51% of net sales, which would be a flat 1 percentage point increase on a percentage of sales basis to 2024 and up in absolute dollars. General and administrative expenses, or G&A, were $16 million in the second quarter compared to $14 million in the prior year period. Speaker 100:15:25Over the balance of the year, we continue to expect G&A expenses to be around 13% of sales on an adjusted basis, which would be a decrease of around 1 percentage point on a percentage of sales basis to 2024 and up in absolute dollars. Our second quarter R&D expenses were $3 million, just up slightly compared to the prior year period. Our R&D expenses are primarily comprised of the costs associated with our ongoing EpiEffect randomized controlled trial, as well as additional spend related to the development of future products in our pipeline. As we continue to ramp enrollment in the trial this year and prepare for an interim readout, we now expect our full-year R&D expenses to be about 4% of net sales. GAAP income tax expense for Q2 2025 was around $3 million, reflecting an effective tax rate of 26%. Speaker 100:16:20Please note that this tax expense number does not reflect the third quarter tax reform that was enacted earlier this month. As a result of this bill, we expect modest impacts in our effective tax rate. We also expect the new tax reform to significantly decrease our cash tax payments in the near term as a result of immediate expensing of domestic R&D expense. We continue to expect our long-term non-GAAP effective tax rate to be 25%. Our second quarter GAAP net income was $10 million, or $0.06 per share on a diluted basis compared to GAAP net income of $18 million, or $0.12 per share in the prior year period. Adjusted net income for the second quarter was $15 million, or $0.10 per share compared to $11 million, or $0.08 per share in the prior year period. Speaker 100:17:11Second quarter adjusted EBITDA was $24 million, or 25% of net sales compared to $20 million, or 23% of net sales in the prior year period. In addition to the highest ever quarterly sales in this company's history, our second quarter adjusted EBITDA was also a new record and a testament to the work our team has done to scale our business as we continue to grow our wound and surgical footprints. Turning to our liquidity, we had $119 million of cash and cash equivalents on June 30, 2025, a sequential increase of over $12 million. During the second quarter, we generated free cash flow of $14 million, representing a sequential step up of $9 million compared to the first quarter. Speaker 100:17:56In turn, our net cash balance now sits at about $100 million, up from $88 million just last quarter and also double our $50 million net cash balance from just a year ago. We continue to pursue several opportunities to deploy our strong balance sheet and borrowing capacity on growth opportunities that support our strategic priorities. I will now turn the call back to Joe. Joe? Speaker 300:18:21Thanks, Doug. As you have just heard, we had an outstanding quarter, and MiMedx is well positioned to have a terrific second half. Importantly, we are in an even better position to excel once the industry resets to the proposed more orderly reimbursement guidelines. We set record highs for revenue and adjusted EBITDA with strong growth in both wound care and surgical businesses. We continue to generate strong cash flow. We kicked off a few pilot programs to co-market complementary solutions in the wound care market and increased our guidance meaningfully to reflect our strong momentum. In closing, I would like to sincerely thank the MiMedx team for an outstanding quarterly performance and for your unwavering commitment to the company and to the many individuals who rely on our products each and every day. With that, I would like to open the call to questions. Speaker 300:19:16Operator, we are now ready for our first question. Please proceed. Speaker 400:19:21Thank you. We're now conducting a question and answer session. If you'd like to be placed in the question queue, please press star one on the telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove a question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star one. Our first question today is coming from Chase Richard Knickerbocker from Crest Hallam. Your line is now live. Speaker 600:19:49Good afternoon, guys. Congrats on the nice quarter here. Joe, maybe first, we'd love to get your thoughts on how you see this market post-reimbursement change. It's certainly going to come down a bit as that $12 billion of spend is reduced. If we assume the $125 sticks and there's, call it, limited product discounting, do you guys have a first-blush estimate on the skin sub-market size across physician office and HOPD together that you'd be willing to share? Speaker 300:20:22Chase, first of all, let me start with a couple of high-level comments. I think, as I stated in the prepared remarks, we welcome this change and we firmly believe it will be better for MiMedx long term. Number two, reform was inevitable. We can all agree, hopefully, we can all agree that things have gotten completely out of control and reform is a good thing for not just U.S. taxpayers, but our industry and for Medicare beneficiaries. Number three, the fee schedules aren't the proper mechanism to address pricing. Number four, fixed pricing is a better way to reimburse for skin substitutes than either the ASP methodology or bundling. We can debate the most appropriate price point, but the fixed price method is a better methodology. Number five, the future state is certainly better for MiMedx in the long run. Why am I so confident about that? Speaker 300:21:15We have the most robust evidence in support of our technology. When we are back to competing on product efficacy, we feel very confident in our ability to prevail. When the market is acting rationally, we win, as evidenced by our double-digit growth in the surgical market where we do not compete primarily on price. Instead, product performance typically drives the decision. Next, we're a fully integrated company. We have our own donor network, our own manufacturing, again, the best evidence and the most evidence, and our own high-performing direct commercial organization. While there may be some short-term choppiness in the industry as things adjust, we're well positioned to compete relative to our peer growth, and certainly in the long term. We have full access to all care settings. We have the most private insurance coverage, which is important for Medicare co-pays. Speaker 300:22:06You know, we're certainly going to be in a position to pick up share, and we have the capacity to handle any ramp of share. We're certainly going to advocate for clarification on some of the rules, as well as certain modifications. When the market's acting rationally, it's better for us. We're going to win. It's certainly better for the industry. The industry becomes more investable. Last, we also have an excellent balance sheet, which provides us maximum flexibility as the industry goes through some change. Your second part of your question in terms of market size, it's just too early to tell, right? Obviously, we've done a lot of internal sensitivity modeling at this price and at a range of prices and certainly a range of volume levels. We're pretty confident we're going to pick up a fair amount of share. Speaker 300:22:55Suffice to say, we feel very comfortable that we're going to be able to compete regardless of how these rules ultimately shake out. Speaker 600:23:03That's helpful. Maybe kind of another one along those lines, just as it relates to kind of your model specifically. You know, based off your ASP today, is there a way that we can think about, if we assume the sticks again, how we should think about the dollar impact that you'll need to make up with volume? Can you speak to your confidence level that, with all those points you just made, that you can take enough share next year to counteract any headwind that would be there and then grow and to be able to grow wound in 2026? I'm just trying to get some initial thoughts on our model next year. Thanks. Speaker 300:23:43Yeah, we're super confident we can do it. Again, clearly, we're doing a lot of modeling around this, but I would say kind of high levels, we would have to pick up some share, but not a ton, right? If we, these price levels are not foreign to us. If you go back and look at what our average pricing was a few years ago, we're not that far off. Obviously, ASPs crept up a little bit with the introduction of some new products, but we're in really good shape. Speaker 600:24:16Got it. Just last for me, just on EpiEffect, is there a timeline that we can kind of think of for that readout as we, you know, have the LCD, you know, potentially still going into effect next year? Just kind of a little bit more specific on that readout, if you would. Speaker 300:24:34Yeah, hopefully maybe this year we're going to have some good data to take a look at. The RCT is going a little bit slower than we had hoped for, probably because there's a million of these things being run at the same time, and there's capacity issues to run RCTs in the marketplace. There are only so many patients, only so many doctors that are qualified to participate in studies like this. We're moving forward, we're making traction, but knock wood, hopefully we'll have something to report out by the end of the year. The good news is we have two really high-performing products that are already on the list if the LCDs go through as proposed. Speaker 600:25:10Great. Thanks, Joe. Speaker 400:25:13Thank you. Next question today is coming from Carl Edward Byrnes from Northland Capital Markets. Your line is now live. Speaker 500:25:20Thanks for the question. Congratulations on the results. I'm wondering if you have any feel for CMS's flexibility in the comment period on the single fixed rate of $125.38. In other words, I mean, I would expect that that might and should migrate higher, but sort of what is your anticipation with that process? I have a follow-up as well. Speaker 300:25:43Yeah, Carl can't handicap it. Have they done it in the past? Yes, they've made modifications throughout, or I would say as a result of comments, but can't handicap it, right? I'm sure there's a lot of logic that went into the price point that they selected. There's a lot of pricing available in the market that would, you know, direct them to kind of settle in on a price like this. We'll provide our comments and some recommendations on other ways to look at it, as I'm sure a lot of other stakeholders in the market will. I'm not going to handicap whether or not it's this price or at some price point higher or how much higher. I think it's impossible for any of us to know at this point. Speaker 500:26:25Fair enough. A follow-up, you know, considering the potential for the LCDs to become effective in January 2026, would you foresee any anomalies in stocking, you know, given that you've got two of the 15 products that will be eligible? Speaker 300:26:46Yeah, it's a good question, right? That's something that we're going to stay on really close to as we start to close out the calendar year. We'll monitor inventory levels very, very closely. Clearly, we're going to have more clarity as we get closer to the end of the year whether or not Local Coverage Determinations are going to take effect and what the final price point is and the final rules associated with OPPS and the physician fee schedule. We'll just watch it as tight as we can. As far as pre-stocking, etc., I don't know yet. We'll have to wait and see. I would just say, look, we've been managing inventory closely as we rotate products in and off the market for years, so we know how to do this. Speaker 300:27:29We've had to do it for a long term because we're operating under the ASP methodology, which requires you to manage inventory a whole lot tighter. I wouldn't say I'm that concerned about it, but it is something that we will watch incredibly closely as we close out the year. Speaker 100:27:47Carl, this is Doug. I would also add, we've already done this a couple of times as we're gearing up for the February Local Coverage Determinations to take effect. They got delayed until April. We were prepared at that time. You've seen us with our balance sheet and our capital wherewithal. We've been able to invest in carrying a little bit more inventory. With our capacity and the strength of our donor recovery network and the other items that Joe articulated a second ago, we feel like we're in a good position to be prepared. Speaker 300:28:19Great. Thank you. That's very helpful. I'll hop back in the queue. Thanks. Speaker 400:28:25Thank you. Our next question is coming from Ross Everett Osborn from Canterfish Shoals. Your line is now live. Speaker 200:28:30Hey, guys. Congrats on the strong quarter. Thanks for taking our questions. Maybe you wanted to put a finer point on the market next year, assuming the PFS goes through as proposed. Where's the low-hanging fruit for you guys to take share? As a follow-up to that, curious to hear your thoughts on the opportunity on the mobile side of things. Speaker 300:28:51What was the last part of that? Opportunity where? Speaker 200:28:55On the mobile wound care market, with the proposed price, assuming a lot of those players will go away, curious to hear if that's an attractive market opportunity for you all. Speaker 300:29:06Yeah, I don't really want to speak for the mobile wound care sites. Let me just put it this way. In comment, we're going to support providers as much as possible. One of the things that we will advocate strongly for is a higher application fee for providers. We would like to see them get paid more for what they're doing. I do think that the circumstances we are in now are partly created because they weren't getting paid properly for what they were doing. Frankly, they were living off margin that they could get on skin subs, which is not a healthy way to pay physicians for what they're doing. We will advocate strongly for that. I think it's a much better way to go. Speaker 300:29:52In terms of what, I think the mobile health market will be affected or will be impacted a bit more as a result of that. Hopefully, they could be compensated properly for the work that they're doing. I think it's a very important segment that's developed over the years and likely reaching more patients. Patients that frankly wouldn't get the care necessary, short of having that site of service available. What was the first part of the question? Speaker 200:30:19We hear you for it. Speaker 300:30:20Yeah, I'm not going to talk about that. We think we could pick up market share in a variety of different ways. I think we're in every site of care you can imagine. Some are stronger than others. I think there's going to be migration from one care setting to another. We're going to make sure that we're well positioned in every one of those care settings. In terms of tactically where we think we'll compete best, I'd rather keep that to ourselves. Speaker 200:30:45Fair enough. Lastly, regarding the LCD, any feedback or conversations with the MACs? Curious to hear probability that that ends up going through. Speaker 300:30:59Yeah, I think that's been a little quieter as, you know, naturally. Last official word was they were delayed for a Gen 1 implementation. You know, we still have all the same advocates and advisors, and we'll try to get our position heard. I think it's important to note that even if the LCDs went into effect back in February or in April, we still would have needed this action by CMS. Again, the proper way to regulate pricing is through the fee schedules. This step would have had to happen. As far as putting requirements in to prove clinical efficacy like randomized controlled trials, it's fun to argue that that's not a good thing for healthcare, right? To prove that your products are clinically viable to be marketed. How that requirement comes into play remains to be seen, whether it's through the MACs, whether it's through FDA. Speaker 300:31:57It's hard to argue that that's not a good thing for healthcare. Speaker 200:32:02Thanks for taking our questions. Speaker 300:32:05Thanks, Russ. Speaker 500:32:06Thank you. Next question today is coming from Anthony Charles Petrone from Azuho Group. Your line is now live. Speaker 200:32:14Thanks, and congrats on a strong quarter. Maybe I'll stick on physician fee schedule and hospital outpatient. I just have a follow-up on core wound care. Maybe one of the nuances in there, Joe, was on, you know, the distinction of level one, two, and three classification of wounds. I think there was basically a linkage into, or at least a read-through there on max utilization based on that classification. Maybe walk us through that a little bit and bridge that to what is the actual mix of patients that are getting treated according to those classifications? Does that present any risk, you know, to volumes and LF1 quick flow? Speaker 300:33:01As far as impact on volumes, etc., it's too early to tell. We need more clarification on that. I think what they attempt to do is recognize that there's different regulatory pathways that are established and potentially setting tiers or categories, however you want to look at it. At least at first pass, they recognize it, but set the price per square centimeter to be the same for all three. We're working closely with, or I would say advocating strongly on the regulatory side as well. We think some changes need to take place on the regulatory side. Speaker 200:33:40Okay. The broader question is, and Joe, you've been great in just calling out the expansion of billing category to, you know, $1 billion a month. Obviously, a lot of players in here, there's still the 17 approved products on the LCD side. Just any updated thoughts on the shakeout as we finalize potentially physician fee schedule and outpatient to a final rule, but also these LCDs come in. How much of that $1 billion per month do you think goes away? Ultimately, where can MiMedx, you know, kind of land in terms of share here? Thanks again. Speaker 300:34:24Yeah, I think we're speculating, right? It's safe to say that a fair amount of that goes away. First of all, even if all the current volume was at the lower price point, by definition, the math changes and the market is smaller in terms of total dollars in the market. I think it's also safe to say that some of that volume is going to disappear because there was probably a fair amount of overutilization, right? You don't have to take my word for that. There have been numerous enforcement actions that were announced already. I think there was another one announced today. I think this is going to be on the DOJ work list for probably the next decade. We're going to be reading about these things. There was a ton of bad behavior, and typically that means overutilization. Speaker 300:35:09My guess is some of the volume goes away, and certainly the price gets adjusted down. We know that it's a sizable market because we competed in this market very effectively before we saw this run-up. Even if we adjust back to, and you can kind of adjust those old volume levels just for demographics, it's going to be a pretty sizable market, right? We're very comfortable. I've said it numerous times, in a rational marketplace where providers are selecting product based on product performance, safety, and efficacy, we're going to win those battles. Have in the past, and we will continue to win those. Speaker 200:35:57Thank you. Speaker 400:35:59Thank you. Our next question is coming from Carl Edward Byrnes, a follow-up from Northland Capital Markets. Your line is now live. Speaker 500:36:05Thanks for the follow-up. With respect to the partnership, when would it be realistic to see a material contribution? Speaker 300:36:20Not anywhere in the near term, Carl. I mean, it's a collaboration. We still have to work out some of the details in terms of how we'll work together. If something's hitting our numbers, that won't be for a while. You won't see anything until next year. Speaker 500:36:40Great. Thanks. Speaker 400:36:42Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over for any further or closing comments. Speaker 500:36:49Thanks, Robert. Thanks, everybody, for joining today's call. I appreciate your interest in the company. We'll talk to you next quarter.Read morePowered by