MiMedx Group Q3 2025 Earnings Call Transcript

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Provided by Quartr
October 29, 2025

Key Takeaways

  • Positive Sentiment: MiMedx reported record Q3 results — $114 million revenue (up 35% YoY), adjusted EBITDA of $35 million (31% margin), and ended Q3 with $124 million net cash (expects >$150 million by year-end).
  • Positive Sentiment: Management raised full‑year 2025 guidance to mid‑to‑high‑teens revenue growth and now expects adjusted EBITDA margin of at least the mid‑20s%, reflecting stronger-than-expected momentum.
  • Positive Sentiment: The EPIEFFECT randomized controlled trial produced a favorable interim analysis with >50% enrollment completed, and the company submitted a manuscript and will present results to support reimbursement requests.
  • Negative Sentiment: Regulatory uncertainty from impending CMS reforms — including a proposed fixed payment of $125.38 per cm² and new LCDs effective Jan 1, 2026 — could cause early‑2026 choppiness and disrupt current pricing/volume dynamics.
  • Neutral Sentiment: Surgical franchise strength (26% Q3 growth), multiple new product rollouts (EPIEXPRESS, HELIOGEN, CELERA, EMERGE), active co‑marketing pilots, and available cash create M&A and commercialization optionality, though legal (Axiophil) and reimbursement risks remain.
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Earnings Conference Call
MiMedx Group Q3 2025
00:00 / 00:00

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Operator

Good afternoon and thank you for standing by. Welcome to the MiMedx Third Quarter 2025 Operating and Financial Results Conference Call. At this time, all participants are in listen-only mode. The 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 over to your host, Mr. Matt Notarianni, Head of Investor Relations for MiMedx. Thank you. You may now begin.

Matt Notarianni
Head of Investor Relations at MiMedx

Thank you, Operator, and good afternoon, everyone. Welcome to the MiMedx Group Inc. Third Quarter 2025 Operating and Financial Results Conference Call. With me on today's call are Chief Executive Officer, Joseph Capper, and Chief Financial Officer, Douglas 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.

Matt Notarianni
Head of Investor Relations at MiMedx

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 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 Joe Capper.

Matt Notarianni
Head of Investor Relations at MiMedx

Joe?

Joseph Capper
Joseph Capper
CEO at MiMedx

Thanks, Matt, and good afternoon, everyone. Thank you all for joining us for today's call. I'm very pleased to report that our third quarter performance was outstanding across the enterprise, generating strong top-line growth in both our wound and surgical franchises. We set new company highs for quarterly revenue, adjusted EBITDA, and adjusted EBITDA margin, which added $23 million of cash in the quarter. I am extremely proud of the team's focus, which drove these superior results. We continue to prove we can adjust to challenges and advance on opportunities whenever they arise. As such, we are once again raising our full-year 2025 revenue growth guidance and our expectations for adjusted EBITDA margin. Our goal for the remainder of the year is to maximize near-term opportunities to ensure a strong finish and usher in the pending Medicare reimbursement reforms from a position of strength.

Joseph Capper
Joseph Capper
CEO at MiMedx

The final rules are likely to be implemented at the start of 2026, and we are well prepared for a range of potential scenarios, especially given the dramatic financial improvements we've made to the business over the last few years. I will touch on some of the highlights of the quarter and then provide an update on our strategic focus, which I'm confident will help you understand why we are so bullish about the future for MiMedx. For the third quarter, year-over-year net sales growth was an exceptional 35%, finishing at a record $114 million. Our adjusted gross profit margin was 88% in the quarter. Adjusted EBITDA was $35 million, or 31% of net sales.

Joseph Capper
Joseph Capper
CEO at MiMedx

We continued to build cash ending Q3 with $124 million in net cash, a sequential increase of $23 million for the quarter, and we expect to end the year with a net cash balance of more than $150 million. Our surgical business was an important contributor, growing 26% this quarter, driven by the continued growth across the portfolio. We now have over half of the target patients enrolled in our EPIEFFECT randomized controlled trial, and we have recently completed an interim analysis with favorable results. We launched a few strategic collaborations with companies offering complementary solutions in the wound care market, and we continue to evaluate additional products to expand our portfolio for both our wound and surgical businesses. In terms of our strategic focus, we continue to make excellent progress in the three areas we have consistently highlighted as the most important for our long-term growth.

Joseph Capper
Joseph Capper
CEO at MiMedx

Our top strategic priority is to continue to innovate and diversify our product portfolio. As you have witnessed, one of the ways we have been able to maintain strong momentum in the business has been with the introduction of products designed to address the numerous unmet needs in both the wound care and surgical markets. In this year alone, we continued with the full market release of EPIEFFECT licensed, and introduced HELIOGEN, CELERA, and EMERGE, and we have just begun the rollout of EPIXPRESS. A randomized controlled trial for EPIEFFECT continues to progress on schedule. As mentioned, we have over half of the target number of patients enrolled in randomized, which provided sufficient data for interim analysis and manuscript submission. These favorable results will be presented tomorrow at the Tissue Repair Evidence Summit.

Joseph Capper
Joseph Capper
CEO at MiMedx

This is excellent news, as we will then have completed all the necessary steps to request reimbursement coverage for EPIEFFECT as required by the pending LCDs. On our last call, I mentioned that we had received a TRG letter for EPIXPRESS, which confirmed its status as an FDA Section 361 product. EPIXPRESS is a fenestrated allograft designed to be used in post-acute cases where the flow or extraction of fluid is of critical importance to the healing process. The full market release of EPIXPRESS is now underway, and the early feedback is extremely positive. CELERA and EMERGE, allografts we license to remain competitive in the private office marketplace until Medicare reform is enacted, both performed well in the quarter, contributing to our growth in wound care. We also continued executing on the previously announced co-marketing pilot with Vaporox Inc.

Joseph Capper
Joseph Capper
CEO at MiMedx

As a reminder, the Vaporox Inc system, named VHT device, or Vaporous Hyperoxia Therapy, is a 510K 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. We are receiving excellent early feedback about this solution. Our second priority is to develop and deploy programs intended to expand our footprint in the surgical market. To achieve our continued success in this area, exemplified by our 26% surgical revenue growth in Q3, we have committed significant resources toward the introduction of products like our xenograft particulate HELIOGEN, additional commercial resources, and development of robust real-world evidence demonstrating the potential clinical benefits for patients, the healthcare economic payoff, and the immense business opportunity for MiMedx.

Joseph Capper
Joseph Capper
CEO at MiMedx

By way of example, we've mentioned the use of our technology in anastomosis procedures a few times in the past. One of the most common complications from those procedures are leaks, which occur in upwards of 9% of patients who undergo colorectal surgery, and are associated with statistically significant increases in morbidity, mortality, length of stay, and rehospitalization. The cost associated with these complications is estimated to be approximately $28 million for 1,000 patients, making anastomotic leaks a nearly $14 billion challenge for the healthcare system. As we have demonstrated in peer-reviewed publications, the application of AMNIOFIX as a protective barrier at the surgical closure site has proven to help reduce anastomotic leaks by nearly 50% and readmissions by approximately 40%, which would provide massive savings.

Joseph Capper
Joseph Capper
CEO at MiMedx

Given there are over 500,000 colorectal surgeries per year in the U.S., our TAM is in excess of $500 million for AMNIOFIX just in colorectal procedures. We will continue to make these critical investments and expect to generate evidence across a variety of procedures. Our third initiative is to introduce programs designed to enhance customer intimacy. As we have mentioned, we believe the way we interact with our customers and our company's comprehensive value offering will help drive engagement and retention, especially as we transition to a reimbursement environment where profit potential is no longer a primary driver in product selection. We continue to invest in ways to enhance these relationships, including increasing improved customer interaction at various levels within the company. We also continue to experience excellent adoption of MiMedx Connect, our proprietary customer portal.

Joseph Capper
Joseph Capper
CEO at MiMedx

In the third quarter, we saw sequential sales growth of nearly 60% for orders managed within MiMedx Connect. We also recently added bill pay functionality within MiMedx Connect for online payments and invoicing, and we are actively developing additional features to this system 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 a customer. On last quarter's call, we discussed the reforms CMS plans to implement to address the runaway fraud, waste, and abuse plaguing the skin substitute market. As a reminder, CMS announced the following initiatives.

Joseph Capper
Joseph Capper
CEO at MiMedx

First, at the end of June, CMS introduced 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, through December 31, 2031, in five states and will examine several product categories, including skin substitutes. Next, in July, CMS posted the proposed Physician Fee Schedule, or PFS, and the Outpatient Prospective Payment System, or OPPS, for calendar year 2026. These proposed rules move away from the ASP methodology in the private office and the bundle in wound care centers in favor of 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.

Joseph Capper
Joseph Capper
CEO at MiMedx

We submitted our comments to the proposed rules in September, recommending CMS consider setting a higher application fee for providers covered by the PFS, reimbursing skin substitutes as pass-through items, setting the fixed price using other reasonable inputs we highlighted, resulting in a relatively modest increase to the price per square centimeter, applying an inflationary index moving forward, and phasing in a price change over time. We believe these suggestions, taken together, would compensate providers appropriately for the important work they do, eliminate perverse incentives to overutilize skin substitutes, and ensure product developers continue to invest in cutting-edge technologies and solutions, all while saving U.S. taxpayers, the Medicare trust fund, and beneficiaries billions of dollars. Final rules are expected to be published in November to take effect at the start of the new year. Lastly, the much-discussed LCDs are scheduled to go into effect on January 1.

Joseph Capper
Joseph Capper
CEO at MiMedx

It remains to be seen if they will be modified and/or delayed once again, but as I said earlier, we are well positioned for any scenario. As we've stated in the past, we are extremely confident about the company's position post-Medicare reimbursement reform. When product performance is once again the primary factor driving product selection, our best-in-class technology will carry the day. Let me offer three facts in support of this statement. First, in 2023, we grew our business by 20% with constant pricing. It was all volume-related growth, driven in part by the introduction of a few new products and commercial execution. This was just about the time we started to see a rapid uptick of new high-priced skin substitutes entering the market, which subsequently caused our growth to slow.

Joseph Capper
Joseph Capper
CEO at MiMedx

Second, in the surgical market, where profit potential does not so overwhelmingly drive product selection, we have been outperforming in the market, as evidenced by our 26% growth in the third quarter. Third, we've recently introduced a few wound products that are, quote unquote, "more competitively priced." While these products are priced below the mean of other available products on the market, they have been enough to stem the attrition of customers in search of these opportunities. These three points illustrate that when profit potential is not such an outside motivator in product selection and performance and outcomes are of greater importance, MiMedx grows faster than the market. We also expect to see a number of competitors decrease in the wound care market when the reimbursement reform goes into effect, as certain business models will become significantly less attractive.

Joseph Capper
Joseph Capper
CEO at MiMedx

We therefore see this as an excellent opportunity to pick up market share. Before I turn the call over to Doug for a detailed financial review of the quarter, I want to share some of my thoughts on guidance. First, we had a great third quarter, and we expect to finish the year in a similar fashion. As such, we are increasing our full-year 2025 revenue growth rate outlook from the low teens to the mid to high teens. We also now expect our full-year adjusted EBITDA margin to be at least in the mid-20% as a percentage of net sales. Second, you are no doubt trying to determine how to model the business for 2026 post the implementation of the proposed reforms. We are somewhat in the same boat.

Joseph Capper
Joseph Capper
CEO at MiMedx

However, it would not be prudent to project the base case from the proposed numbers and current volumes, given the other factors which will no doubt benefit our business. Until we have clarity on the CMS final rules for the PFS and OPPS, which have yet to be published, we do not want to overspeculate. At a higher level, we do expect some choppiness in the early part of the year as the industry navigates the changes. Still, we welcome these reforms and expect the change will bring much-needed stability and predictability to the market. We firmly believe that the change is an opportunity for MiMedx to pick up share due to our numerous competitive advantages. We have a fully vertically integrated business, from product development to manufacturing to commercialization, including donor recovery. We have an excellent, robust, and defensible intellectual property portfolio.

Joseph Capper
Joseph Capper
CEO at MiMedx

We have arguably the most comprehensive and effective commercial organization in the space. Over the past two and a half years, we have dramatically improved our financial position to include an anticipated net cash balance of more than $150 million by year-end. I've been running medtech companies for decades, and I can tell you that these types of events have a way of shaking out the marginal players. Our fundamentals are solid, and we are going to leverage our competitive advantages to ensure continued success in this new area. That is why I am incredibly bullish regarding the prospects for MiMedx. Now let me turn the call over to Doug for a more detailed review of our financial results. Doug?

Douglas Rice
CFO at MiMedx

Thank you, Joe, and good afternoon to everyone on today's call. I'm pleased to review our results with you all today. As a quick reminder, as Matt mentioned at the top, 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, our third quarter 2025 net sales of $114 million represented 35% growth compared to the prior year period. By product category, third quarter wound sales of $77 million increased 40% versus the prior year period, while surgical sales of $37 million were up 26%, reflecting strong results across both of our franchises. We saw significant contributions across our business in the third quarter. In wound, our third quarter performance was driven by new product sales of CELERA and EMERGE.

Douglas Rice
CFO at MiMedx

In our surgical franchise, AMNIOFIX and AMNIOEFFECT once again delivered strong double-digit year-over-year increases in sales, and our particular products also demonstrated strong growth on a year-over-year and sequential basis. Our third quarter 2025 GAAP gross profit was about $95 million, a 38% increase compared to the prior year period. Our GAAP gross margin was 84% in the third quarter 2025 compared to 82% last year. Excluding the incremental acquisition-related amortization expense in the quarter, our non-GAAP adjusted gross margin was 88%, up about 540 basis points compared to the third quarter of 2024. This increase was primarily a result of product mix as well as the timing of positive production variances. In light of the strong year-to-date results, we now expect our full-year non-GAAP gross margin to be around 85%.

Douglas Rice
CFO at MiMedx

Turning to our operating expenses, GAAP sales and marketing expenses were $54 million, or 47% of net sales in the third quarter, compared to $42 million, or 50% of net sales in the prior year period. The dollar increase was due to a combination of increased sales costs, including higher commissions associated with both higher sales as well as the changes we made to our sales commission plans in the middle of 2024. As a result of our year-to-date results, we now expect full-year 2025 sales and marketing expenses to be between 49% and 50% of net sales, which would be a modest improvement on a percentage of sales basis compared to 2024, albeit up in absolute dollars.

Douglas Rice
CFO at MiMedx

GAAP general and administrative expenses, or G&A, were $15 million, or 13% of net sales in the third quarter, compared to $12 million, or 14% of net sales in the prior year period. The dollar increase was driven by incremental spend from legal and regulatory disputes in the current period, including our ongoing litigation with certain competitors and former employees. As with other OpEx lines, we expect GAAP G&A to grow in absolute dollars for the full year 2025 and to be about 14%-15% of net sales. Our third quarter R&D expenses of $4 million, or 3% of net sales, were up $800,000 compared to the prior year period. Our R&D expenses are primarily comprised of the costs associated with our EPIEFFECT randomized controlled trial, as well as additional spend related to the development of future products in our pipeline.

Douglas Rice
CFO at MiMedx

As Joe mentioned, we have prepared an interim analysis of the EPIEFFECT randomized controlled trial and have submitted it for publication and presentation later this year in support of any potential Medicare coverage requirements. As we think about the full year, we expect R&D expenses to be about 3% of net sales. GAAP income tax expense for Q3 2025 was around $6 million, reflecting an effective GAAP tax rate of 27%. We continue to expect our long-term non-GAAP effective tax rate to be 25%. Our third quarter GAAP net income was $17 million, or $0.11 per share on a diluted basis, compared to GAAP net income of $8 million, or $0.05 per share in the prior year period. Adjusted net income for the third quarter was $23 million, or $0.15 per share, compared to $10 million, or $0.07 per share in the prior year period.

Douglas Rice
CFO at MiMedx

Third quarter adjusted EBITDA was $35 million, or 31% of net sales, compared to $18 million, or 22% of net sales in the prior year period. Sequentially, our third quarter adjusted EBITDA grew by nearly $11 million, as we focus on expense management that enables our sales increases to drop to the bottom line. Turning to our liquidity, we continue to bolster our balance sheet and position the company to make growth investments. In the third quarter, the business generated $29 million in free cash flow, a record for the company, and our net cash position rose to $124 million. The steady improvement in our balance sheet provides us with the ability to evaluate a range of organic and inorganic investments, and we believe we have a healthy amount of combined firepower between cash on hand and borrowing capacity to help continue to grow and diversify our business.

Douglas Rice
CFO at MiMedx

I will now turn the call back to Joe. Joe?

Joseph Capper
Joseph Capper
CEO at MiMedx

Thanks, Doug. As you just heard, we had an outstanding quarter and expect a strong finish to the year. We set record highs for revenue and adjusted EBITDA, with strong growth in both the wound care and surgical businesses. We continue to generate excellent cash flow. We launched EPIXPRESS. We advanced a few pilot programs to co-market complementary solutions in the wound care market, and we increased our 2025 guidance meaningfully to reflect our strong momentum. As far as the upcoming wound care reimbursement reform is concerned, it is a matter of when, not if, this is going to happen. The current trends are not sustainable. We hope these much-needed reforms incorporate our recommendations. We believe they would be beneficial to all stakeholders. As I said, we are confident in our ability to excel when the industry resets to the proposed guidelines.

Joseph Capper
Joseph Capper
CEO at MiMedx

In closing, I would like to once again thank the MiMedx team for a tremendous quarterly performance and for your unwavering commitment to our mission and the many individuals we have the good fortune to serve. Let's now shift to Q&A and open the call to questions. Operator, we are ready for our first question. Please proceed.

Operator

Thank you. At this time, we'll be conducting the question and answer session. If you'd like to ask a question at this time, you may press star one on your telephone keypad, and the confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to withdraw your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, for our first question. Thank you. Our first question comes from the line of Frank Takkinen with Lake Street Capital Markets. Please proceed with your questions.

Frank Takkinen
Senior Research Analyst at Lake Street Capital Markets

Great. Thanks for taking the questions. Congrats on a really nice quarter. I was hoping to start with the guide for the rest of the year. How should we be thinking about kind of contribution from wound versus surgical? Obviously, we still have the wound policy in place through year-end, and that might change at the beginning or likely will change at the beginning. Should we continue to expect that that grows really heavily, and should we continue to expect that surgical business too as well? Just trying to kind of get a little bit more of the variables behind the Q4 guide.

Douglas Rice
CFO at MiMedx

Thanks, Frank. This is Doug. Good question. We're obviously super happy with record revenue for the quarter led by 40% growth in our wound franchise and 26% in surgical. With regards to the guide and how that looks going forward, we continue to expect strong uptake in the surgical suite. I would think that momentum continues into Q4, and the wound business and franchise is certainly going to continue to grow at a healthy clip. 40% is, you have to also recall that Q3 last year was sort of the nadir of our impact from the sales turnover that we experienced in Q2. The comps are going to get a little tougher there in Q4. I'll leave it at that.

Joseph Capper
Joseph Capper
CEO at MiMedx

The only caveat to Q4 growth is Doug mentioned that it's going to be a tougher comp in Q3. As the rules, once the rules are announced and adjustments start to take place, there's probably some folks who will make those adjustments a little bit earlier. Backing up to 10th of December, these will be a little bit more difficult to prepare. You know we've got great momentum going there. Obviously, the first month is over, so we know we're in good shape.

Frank Takkinen
Senior Research Analyst at Lake Street Capital Markets

Got it. That's helpful. Maybe just thinking a little bit about kind of post-January 1. I know you've mentioned you're doing a number of things to prepare for that. Maybe call out some of those things that you're doing today to prepare for different reform options. Maybe if you can extend to what you feel like would be the best outcome for your company, is it kind of how your comments were structured and proposed, or is there anything else you think would be kind of the best outcome for MiMedx?

Joseph Capper
Joseph Capper
CEO at MiMedx

I think how our comments were structured and proposed would be the best outcome for the industry and for MiMedx. What we have been advocating for for some time is level the playing field and take this price variability out of the equation. Take its unhealthy variability. We don't need to revisit that. It looks like that is going to happen. We clearly welcome the reform. Given our experience in competing on a level playing field, we're really comfortable that we're going to outperform the market. I don't want to go into details in terms of what types of scenario planning we have done. You can imagine an environment that's less attractive from a profitability perspective. Some participants are not going to be in the market. They're probably not going to find it as attractive as it did over the last couple of years.

Joseph Capper
Joseph Capper
CEO at MiMedx

I think there's going to be ample opportunity for market share growth in a number of different ways. We have plenty of evidence to that, right? We've done it in the past. You see it today in our surgical market, how we're growing there, where it's much more of a level playing field. The last thing I would leave you with is we have a great balance sheet. There's opportunities to do things to kind of aggregate a little bit of share that way. We'll look at those opportunities.

Frank Takkinen
Senior Research Analyst at Lake Street Capital Markets

Got it. If I can squeak one more quick one in, cash ending at $142 million. I know you guided to greater than $150 million in cash. That obviously leaves the door open above $150 million. How should we maybe think about cash generation if you just put up $20 million this quarter and at $150 million is out there?

Joseph Capper
Joseph Capper
CEO at MiMedx

Yeah. We probably confuse people because sometimes we talk gross cash and net cash. We still have about $18 million drawn on our line. When we say $150 million by year-end, think of that as net. You're probably in the high $160 million range from a gross standpoint. The question is, why haven't you paid that line down? It's just Doug yells at me every quarter. It's because we've, frankly, been looking at so many different opportunities that we thought it made sense to do it all at the same time.

Frank Takkinen
Senior Research Analyst at Lake Street Capital Markets

Got it. Okay, that's helpful. Thanks for taking the questions.

Operator

Our next questions are from the line of Chase Knickerbocker with Craig-Hallum. Please proceed with your question.

Chase Knickerbocker
Chase Knickerbocker
Analyst at Craig-Hallum

Good afternoon. Congrats on the quarter, and thanks for taking the questions. Maybe just first, Joe, was hoping you'd be willing to share in your wound business on an overall square centimeters basis what volume growth was, either sequentially or year-over-year. Respect your comments on the uncertainties as it relates to 2026, but you know, just trying to get some sort of kind of guidepost for us as we think about Q4 and then 2026 as it relates to volumes.

Joseph Capper
Joseph Capper
CEO at MiMedx

As you know, we have not been public about that because there's puts and takes and ups and downs. When you launch new products, some products need less tissue, and so your volume per square centimeter may go down, may go up. There are so many factors that go into that. We tend to stay away from that. We certainly stay away from it by segment. I think the way I answered the previous question, we feel very comfortable about pending changes. We feel that we're in great, we're in a pole position to pick up share, depending on what the ultimate price is. The other thing, too, is depending on what other factors are associated with the new rules. Is there pass-through pricing? Is there opportunity to continue to discount? How much discounting is going to be permitted?

Joseph Capper
Joseph Capper
CEO at MiMedx

There are several other mechanics, I would say, about how these rules are going to go into effect that could affect the way people market products. It's just too soon. We'll know the final rules in a couple of weeks, I'd say. I know we always want the answer today, so do we, but it's right around the corner. I have to stress, I don't see another company that is in a better position than us to compete once these rules are in effect.

Chase Knickerbocker
Chase Knickerbocker
Analyst at Craig-Hallum

Understood. Maybe just on that, have you had a chance to get any feedback on the Hill or from any sort of constituents on some of those suggestions that you made? I think particularly around kind of a potential pass-through mechanism or, you know, like a CPI adjustment, for example, instead of a recalculation annually. I mean, have you gotten any feedback from that?

Joseph Capper
Joseph Capper
CEO at MiMedx

Nothing that we could publicly comment on. You know, we work through third-party advisors who communicate directly with, as much as possible, obviously, we're in a shutdown, but as much as possible, directly with CMS and the MACs. We try to put together as much information on it as we can, but there's nothing that we can share publicly that we can stand behind 100% at this point today.

Chase Knickerbocker
Chase Knickerbocker
Analyst at Craig-Hallum

Just last, maybe just on the LCDs, you know, that submission as far as when the clinical data was supposed to be submitted is obviously coming up here very quickly. Have you heard from the MACs as far as, you know, get your data in, as in, you know, LCDs could likely be moving forward? On that front, I know you mentioned that presentation tomorrow, but just kind of, can you speak any more additional detail to that data or, you know, I guess your confidence that it'll be sufficient to support inclusion on the LCD as it relates to EPIEFFECT?

Joseph Capper
Joseph Capper
CEO at MiMedx

I'm going to frustrate you for the third time, Chase. I apologize. There's really not a whole lot more I can offer in terms of LCD, go/no-go, whether they're going to be implemented, whether they're going to be modified. All that's kind of rumor in the industry. Everybody's got their opinion. The second part of your question is whether or not we feel that we've got sufficient evidence relative to EPIEFFECT to justify reimbursement. The answer to that is yes. The analysis was very strong, and then there are steps we have to go through. Either it has to be a presentation, and there has to be a manuscript submission, and then you can apply for reimbursement. We have those steps completed as of tomorrow. We feel comfortable that our submission is in good shape.

Joseph Capper
Joseph Capper
CEO at MiMedx

Whether or not they stick to that protocol is yet to be seen, or that, I would say, requirement is yet to be seen. That will tie back to whether or not the LCDs are, once again, postponed and/or modified. We're in pretty good shape with that product.

Chase Knickerbocker
Chase Knickerbocker
Analyst at Craig-Hallum

Got it. Thanks, Joe.

Operator

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

Carl Byrnes
Carl Byrnes
Managing Director and Senior Equity Research Analyst at Northland Capital

Congratulations on the quarter, and thanks for the questions. Considering the foreseeable shakeup, obviously, rising from reimbursement changes, which are long overdue, and your cash buildup, are you seeing any compelling so-called low-hanging fruit with respect to M&A prospects or business development opportunities that would fit nicely? Thanks.

Joseph Capper
Joseph Capper
CEO at MiMedx

Yeah. The answer is yes. There are compelling assets. We have leaned a little bit more into the surgical side of our business in terms of scouring the landscape for opportunities to license and/or acquire technologies or products or companies. That does not mean that we're dismissive of the wound care business. It's just that if assets have any exposure to pending changes, they're much more difficult to value at this juncture. I think there's ample opportunity to kind of leverage or use our balance sheet to accelerate the strategic growth plan. We've said this in the past. We're not buying for the sake of buying. If it fits our strategic plan, if it augments our current product portfolio in the wound care business, if it adds assets that are a strategic fit for us in the surgical business, they're the types of assets that we're looking at.

Carl Byrnes
Carl Byrnes
Managing Director and Senior Equity Research Analyst at Northland Capital

Great, thanks so much. Congrats again.

Joseph Capper
Joseph Capper
CEO at MiMedx

Thank you.

Operator

Our next question is coming from the line of Ross Osborn with Cantor Fitzgerald. Please proceed with your question.

Ross Osborn
Ross Osborn
Director and Lead Research Analyst at Cantor Fitzgerald

Hey, guys. Congrats on the strong quarter. Would you walk through where you're seeing adoption of HELIOGEN and where you stand on evidence generation there?

Joseph Capper
Joseph Capper
CEO at MiMedx

We haven't put out a number on that, you know.

Ross Osborn
Ross Osborn
Director and Lead Research Analyst at Cantor Fitzgerald

It's increasing quarter to quarter, sequentially?

Joseph Capper
Joseph Capper
CEO at MiMedx

It's increasing month to month, quarter to quarter. It takes a while, right? You have to get the product on contract. You have to get it through batch. You have to do a value analysis, committees, I should say. You have to prove efficacy at the surgical level. Feedback is great. We are building evidence around it in various cases. I would expect it to be, I don't, we haven't put out a growth number on that, but let's just say it's becoming a meaningful contributor to our surgical business. I can't stress enough how important it is for us to point out the fact that the surgical business continues to grow well. When we decided to shut down the KOA business about two years ago, we did that with the intention of pivoting more and focusing more on the surgical business. We've done that.

Joseph Capper
Joseph Capper
CEO at MiMedx

We've added human resources to that group. We've added products, as you know, we've launched a few new products, including HELIOGEN, which we just started talking about. We spent a lot of time on the evidence. I walked through one example of that in our comments. That's about a third of our business today. The surgical business is about a third of our total business. You could do the math on that. It's growing at 15%, 20% plus all year long. If that was a standalone surgical company with that kind of growth rate, I think we would all agree that it would be traded at a much higher multiple than MiMedx is trading at today. We're super excited about continuing to invest in that business.

Ross Osborn
Ross Osborn
Director and Lead Research Analyst at Cantor Fitzgerald

Great. Turning to AXIOFILL, what's the path forward there following the September court ruling?

Joseph Capper
Joseph Capper
CEO at MiMedx

We have to kind of resubmit our arguments and likely have another hearing with the judge. We're sort of back to the beginning, which is, and you know, in the meantime, AXIOFILL continues to do well in the marketplace. As you remember, when we brought HELIOGEN into the portfolio, part of that was mitigation in the event that AXIOFILL went away. We have not overtly tried to change out that product, and it has stabilized and even, in some cases, grown. If we looked at our particulate business, which would be AXIOFILL and HELIOGEN together, that's a really strong business. It continues to grow. You know, we'll see. We'll get through that. We have some mitigation plans in place, including AXIOFILL, if for some reason that does not go our way. We think our case is really strong. The arguments are really, really strong.

Joseph Capper
Joseph Capper
CEO at MiMedx

I wouldn't read anything into that delay other than it was a little bit long in the tooth from a scheduling standpoint, and that may have motivated the judge to kind of do a reset.

Ross Osborn
Ross Osborn
Director and Lead Research Analyst at Cantor Fitzgerald

Okay, got it. Thanks for taking our questions.

Joseph Capper
Joseph Capper
CEO at MiMedx

Sure.

Operator

Thank you. The next question is from the line of Anthony Petrone with Mizuho Group. Please proceed with your question.

Anthony Petrone
Managing Director, Senior Medical Devices, Diagnostics, and Therapeutics Equity Research Analyst at Mizuho Group

Congrats here on a great quarter, you know, very, very bullish results all around. Maybe on the 40% wound growth in the quarter, and obviously, you mentioned the final CMS LCD outcome here coming in November. Do you think there was pull forward of demand in the physician channel specifically just ahead of that ruling? Did you notice any of that taking place? When you think of underlying volumes on the surgical side, we've heard from others in the medical device space that there's some pull forward of just surgeries generally, on the notion that potentially ACA policies may not renew just with the government shutdown happening here. Did you notice any pull-through on the surgical side from any Medicaid or ACA dynamics? I'll have one quick follow-up.

Joseph Capper
Joseph Capper
CEO at MiMedx

We didn't notice pull-through on either side of the business. We certainly didn't notice pull forward, I should say, on the surgical side of the business. Frankly, I wouldn't expect it in the types of procedures where our product is being utilized. These are not elective surgeries, so I doubt we would be impacted by that. You might see it more in the orthopedic space or something like that, but you're not going to see it really where our products are being used for the most part.

Anthony Petrone
Managing Director, Senior Medical Devices, Diagnostics, and Therapeutics Equity Research Analyst at Mizuho Group

Okay. Great. Just to follow up again on looking at the final rule here, I know there's a debate out there on potentially how skin substitute products could settle on a per centimeter squared basis, but also on the allotment for how many applications could be decided on in the LCD. Is there any way to set expectations on what the range of scenarios could be on a per centimeter squared basis, as well as a total application basis? Thanks again.

Joseph Capper
Joseph Capper
CEO at MiMedx

Yeah. I think it's a good point you bring up about limitations because there are things that we still need clarity on, which is one of the reasons why I'm staying away from speculating. I'm going to frustrate you as much as I frustrated Chase. I just can't give you that range right now. I certainly am not going to speculate on what the final price is going to be because there's all kinds of rumors running around in the marketplace, and they are just that. We're really close to this thing being public. If I were a betting person, I'd say we're going to see it sooner in November rather than later in November. We're going to know real soon, Anthony. Then we'll be able to kind of, you know, plug these inputs into the way we've been modeling potential scenarios, and we'll have more clarity.

Joseph Capper
Joseph Capper
CEO at MiMedx

Again, I have to stress that regardless of the rules, the industry will be more stable. It will be more predictable. If it resets somewhat, that's okay because this company will outperform the market as it has done in the past when the playing field is even. When everybody's playing by the same rules, especially relative to price and profitability, we will outperform the market. We welcome it.

Anthony Petrone
Managing Director, Senior Medical Devices, Diagnostics, and Therapeutics Equity Research Analyst at Mizuho Group

Appreciate that. Thank you.

Operator

Thank you. At this time, this concludes our question and answer session. I'll hand the floor back to Joseph Capper for closing comments.

Joseph Capper
Joseph Capper
CEO at MiMedx

Thanks, Operator, and appreciate you guys being on the call today and the interest in the company. That concludes today's call, and we will speak to you after our next quarter. Thanks, everybody.

Operator

Thank you. Today's conference has concluded. You may now disconnect your lines at this time and have a wonderful day.

Executives
Analysts
    • Ross Osborn
      Director and Lead Research Analyst at Cantor Fitzgerald
    • Douglas Rice
      CFO at MiMedx
    • Anthony Petrone
      Managing Director, Senior Medical Devices, Diagnostics, and Therapeutics Equity Research Analyst at Mizuho Group
    • Frank Takkinen
      Senior Research Analyst at Lake Street Capital Markets
    • Carl Byrnes
      Managing Director and Senior Equity Research Analyst at Northland Capital
    • Chase Knickerbocker
      Analyst at Craig-Hallum
    • Matt Notarianni
      Head of Investor Relations at MiMedx
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