Good afternoon, and thank you for standing by. Welcome to the MiMedx Third Quarter ‘23 Operating and Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Matt Notarianni, Head of Investor Relations for MiMedx. Thank you. You may begin.

Thank you, operator, and good afternoon, everyone. Welcome to the MiMedx third quarter 2023 operating and financial results conference call. With me on today's call are Chief Executive Officer, Joe Capper; and Chief Financial Officer, Doug Rice. As part of today's webcast, we are simultaneously displaying slides that you can follow. You can access the slides from our Investor Relations website at mimedx.com. Joe will kick us off with some opening remarks, and Doug will provide a summary of our operating highlights and financial results for the quarter, and then Joe will conclude with some additional updates, including a discussion of our financial goals. We will then be available for your questions. Before we begin, I would like to remind you that our comments today will include forward-looking statements, including statements regarding future sales growth, EBITDA, free cash flow and cash balance costs, future margin and expenses 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. Actual results and market sizes will depend on a number of factors, including competition, access to customers, the reimbursement environment, unforeseen circumstances and delays, and other factors. Additional factors that could impact outcomes and our results include those described in the Risk Factors section of our annual report on Form 10-K, and our quarterly reports on Form 10-Q. Also, our comments today include non-GAAP financial measures, which we provide a reconciliation to 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. Joe?

Thanks, Matt, and good afternoon, everyone. Thank you all for joining us on today's call. It is my pleasure to report on another excellent quarter. As you will hear today, the Company is executing across the board commercially, operationally and financially. In addition to delivering outstanding results for the period, we continued to improve the operational effectiveness of the Company and prepared for the launch of another new product. I will detail these positive developments one-by-one, starting with our strong financial performance. Q3 marked the third consecutive quarter, during which we grew revenue by plus 20%. This type of consistent sales performance with above market growth rates is a testament in the team's stellar execution and our sound strategic plan. We've also been clear in our messaging that expect to generate greater profitability as the business close. In fact, on our last call, we've guided to an adjusted EBITDA margin of above 20% for the second half of 2023, demonstrating excellent leverage as the business scales. We are happy to report that we did indeed achieve this objective in Q3. We have a powerful combination of highly talented individuals, innovative solutions that help people heal and industry leading sales and operations infrastructure. Our multifaceted approach in the Wound & Surgical Markets is generating the impressive results we were targeting when we repositioned the business this past summer. As importantly, the organization is well-situated to continue our momentum and significant growth for the foreseeable future. More on our long-term growth plan in a minute. First, I'd like to touch on some of the noteworthy accomplishments from the quarter. Q3 year-over-year net sales grew by approximately 21% to $81.7 million, another outstanding growth quarter. Gross profit margin was 82% and would have been even higher, but for contractually committed last time by…

Thank you, Joe. Good afternoon, everyone, and thanks for joining us today. I'm pleased to once again be presenting these strong quarterly results to you all today. Before diving in, I wanted to note that many of the financial measures covered in today's call are on a non-GAAP basis. So please refer to today's earnings release for further information regarding our non-GAAP reconciliations and disclosures. First, as Joe mentioned, our third quarter 2023 was the third consecutive quarter in which our net sales growth exceeded 20% year-over-year, despite having one fewer shipping day than the prior year period. Third quarter net sales of $81.7 million also represented modest sequential growth compared to the second quarter of 2023, which is all the more impressive given the traditional Q3 dip in healthcare seasonality as well as the broad based strengthen we have seen across all of our sites and service during the first half of the year. The commercial team has once again executed across all of sites and services with strong double-digit growth in each segment, despite some of the confusion Joe mentioned related to the on and off reimbursement changes during the quarter. Moving to gross profit and gross margin. Our third quarter gross profit was about $67 million an $11 million improvement compared to $56 million last year and our gross margin was roughly flat on a year-over-year basis at around 82%. In the third quarter, our quality operations and regulatory team continue to make progress on its yield improvement plans, which we expect will benefit us moving forward. These efforts include the introduction of certain automation enhancements that are designed to help us realize additional scale as we grow. As Joe mentioned, gross margin was negatively impacted in the quarter by a contractual last time buy for a…

Thanks, Doug. As you have just heard, we had another outstanding quarter, once again exceeding expectations. Quarterly revenue was up 21% year-over-year. Gross profit margin was 82%. Adjusted EBITDA was $17.6 million. We increased our cash balance to over $81 million, ready EPIEFFECT for launch and continue to realize margin improvement by driving expense rationalization throughout the organization. For the first three quarters of the year, we have delivered consistently improving performance. With Q3 having our highest quarterly sales and an adjusted EBITDA margin of over 20%. As you may recall, after exceeding expectations last quarter, we raised full-year guidance for revenue percentage growth to be in the mid-to-high teens. Following a similar performance in Q3, we are now again raising full-year revenue percentage growth outlook to be in the high-teens, nearing 20%. As a reminder, sales for the fourth quarter of 2022 were by far our highest quarterly sales of 2022, at $74.4 million, naturally making it our toughest comp for the year. That being said, given the current strength of the business, and with the help of the EPIEFFECT launch, we do expect to close 2023 with another strong performance and ride that momentum into the New Year. As we’ve stated on our last call, we also expect at least a 20% adjusted EBITDA margin for second half 2023 and with the recent Hayfin transaction complete, we now expect to end the year with over $80 million of cash. Additionally all fundamentals continue to point to a double-digit percentage annual revenue growth rate for the foreseeable future. Those of you who have been following the Company for the past three quarters have witnessed a meaningful business transformation, driven by excellent commercial execution, decisive strategic action to reposition the Company and expense reduction initiatives all resulting in a much improved financial profile for the Company. I fully expect that we will continue to execute our plan, close the year up strong and set the business up or sustain long-term growth. In closing, I would like to thank the entire MiMedx team for their outstanding performance throughout the first three quarters of the year. Your enthusiasm and continued dedication to the Company and to people in need of care have been a source of personal inspiration during my short tenure. I look forward to working with you as we seek to maximize the potential of this incredible Company and take it to new heights. With that, I'd like to open the call to questions. Operator, we are now ready for our first question. Please proceed.

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

Hi, Joe. Hi, Doug. Thanks for the question guys, and congrats on a good quarter. Maybe starting on the physician office segment first. Maybe a little bit of additional color on how kind of customers reacted to that LCD, you know, during the quarter, obviously, still good growth there. Maybe talk as to why you being listed on that LCD would still lead to some pausing. And then in, if we look at kind of what we've seen so far in Q4, have we seen kind of normal ordering behavior kind of come back now that LCD has been pulled? Just some additional color there.

Yes. Chase, thank you. That’s Joe. Yeah, we saw some confusion in ordering patterns in the third quarter in particular, in the regions that were impacted, the 15 states were covered by those three LCDs. And it was -- and we could compare that against the other MACs. So there was definitely some confusion and kind of feedback from the field was that docs for to figure out, what they had to do, how they might have to modify care protocols to adhere to the full application restriction. And then there was a lot of noise as to what products would have will go into the coverage and which ones were not. So we saw the impact, good news for us is overall, that site of service continued to grow at a very healthy rate. Second part of your question is what are we seeing, in October so far? It looks like within those three MACs, that order behavior started to revert back to normal.

Got it. That's helpful. And maybe stay in the position office segment. If we look at kind of EPIEFFECT, kind of growth and initial kind of launch here. Do you expect it to, cannibalize some EPICORD and EPIFIX users, or is this going to be more de-novo uptake or maybe some people who are using your products for commercial patients using something else for Medicare patients. How should we think about the customer set for EPIEFFECT earlier?

I think earlier, I'm thinking about it primarily in the private office setting and it will be used in applications that is not being used in today or used for a procedure just not being used in today. So it should expand the market a bit, and then there will be some cannibal situation of the EPIFIX product.

Got it. And then just last for me. I think it's fair to say that your stock may have gotten caught up in, the recent GLP-1 craze we've seen in the markets lately. Maybe just some general kind of high level thoughts there from you guys, any sort of impact that you expect from proliferation of these drugs, in the mid-to-long-term in the markets that you compete in?

Yeah. Chase, yes, I think you're right. The word in the property is a bit of a craze in the marketplace. So here's my thought on it. I worked for three different companies that had some business in the diabetes space. And I would tell you that so I've been in that space, I was in that space for almost 20 years. And I can't remember back 15, 20 years ago when we were appalled at the increase in the rate of diabetes in the United States when it surpassed 8%. And since that time, there has been numerous drugs, products like continuous glucose sensors, automated insulin delivery systems, all kinds of education to help drive down against this supply of diabetes in this country, a lot of diabetic, a lot of diet products. And unfortunately, the epidemic continues to expand in the U.S. So I don't know that it's a product that's going to cure the problem. By all indications, everything that I could tell, these GLP-1 drugs do work. People are losing weight with them, which is wonderful if at some point in the future, these would expand with minimal adverse effects and it had some potential impact on the rate of diabetes, that would be wonderful. Do I think it's going to happen? I would say that historical evidence would suggest otherwise. So I think it's great. I think, the more people can use these drugs it has a weight loss impact. Wonderful, so I think it's going to translate into a decrease in the rate of diabetes the United States. I think that is a bridge too far. Evidence would suggest otherwise. But even if it did, let's talk for a second about potential impact on diabetic foot ulcer DFUs like ulcer indications for use of our product. The evidence would suggest that there is not a strong correlation between obesity and lower extremity ulcers. In fact, I think you cited this in your very thoughtful initiation that you published last week. The evidence would suggest the opposite. If in fact, DFUs are often associated with people, have low BMI, but are just generally unhealthy smokers, hypertension, poor diet, etcetera, etcetera. I just don't think that's, that behavior is going to change much, because we've lost a new drug. And, I think Ozempic has been out since 2016. And that was, you know, the one of the first GLP drug in this category. At the time it was launched, the incidence of diabetes was somewhere around 9.1%. Two or three years after it's launched, the incidence of diabetes in the U.S. was at 11.3%. That was the number that was published pre-COVID. I can't imagine that COVID did anything positive for that number. So, maybe it will at some point have an impact on the incidence of diabetes in the U.S., but it certainly is not doing so right now. So, I just don't see the correlation at this point.

Got it. Thanks for those thoughts and thanks for the questions, guys.

Thanks, Chase.

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

Hi, thanks, and good afternoon. Congrats on a strong quarter here set up into 2024. Maybe I'll pivot back to the LCD, Joe, if I can for a moment. I'm just wondering when you look at sort of the verbiage in late September, there was references to just -- the implementation timeframe that there wasn't enough time to sort of transition practices over and that potentially could impact patient care. But, you also saw just a certain amount of advocacy from the various different medical societies out there in favor of sort of taking a second look here. So maybe just a little bit behind the scenes. What do you think was the tipping point on putting the brakes here? And as we look at the new sort of just common periods, I mean, what are the next big updates here that we should be thinking about from these you know, local MACs and as well as other MACs that potentially may look to change their policies heading into 2024 and 2025. And then I'll have a couple of follow ups.

Thanks, Anthony. Well, first of all, we really don't know because they never pulled back curtain and let you know why they made the decision that they made. If you're asking me for my personal opinion, I never thought I had a chance of being implemented. Because I thought it was arbitrary and completion, quite frankly. And, there was no good evidence to support the four application cap, and it was I think the flimsy evidence to support the restriction on some of the products and organizations that were eliminated for participating. But, you asked me, I think we're maybe trying to make up since for the past. But any case, I’ll just – we’ll never really know. I think it was probably more the, uproar across the industry, both clinically and from, industry that this was, not a great way to approach the problem that they're trying to solve. And they indicated that they would continue to analyze and collect more evidence and try to see if there's a better way to approach these LCDs in the future. So, as I indicated in my commentary, we continue to work with various stakeholders who have an influence on this. We would -- we continue to advocate for policy that would, eliminate some of the gamesmanship that's permitted around reimbursement of these products at the same time maintaining access for, products like ours that have tremendous evidence that show effectiveness. So I do I think something will change at some point in the future? Yes. Do I know what it is? Absolutely not. I would say though that of all the companies in the category, we are -- I believe, far and away best positioned to continue to support the private office setting regardless of the change. If it moved, into some sort of, restricted utilization, we have evidence to support use of our product. If, for some reason, it moves towards a bundle, we have probably less impact than some of our other large competitors in category. So look, we're going to continue to support this sector. We think it makes a lot of sense. It's great access for patients that can't necessarily be treated in the hospital, and it continues to grow as a result. So, again, I think we're just really well positioned regardless of the outcome, but we'll continue to try to influence it.

That's very helpful. And then maybe just two nuances in there. I mean, one was the, you know, advocacy and push from my medics that all of these products be, sort of, disclosed on the Medicare B pricing list as opposed to wholesale acquisition cost. And then there was another, decision in these LCDs where they actually wanted to limit applications to four for ulcer, which was below the 10 applications previously. So maybe just on those two specifically, I mean, is there anything that my medics is aware of on those two levers versus certainly going to Medicare Part B is positive for EPIFIX and other products that were included in the 58. On the other hand limiting the applications per ulcer just seemed like perhaps too limiting. Is there anything on those two levers you can share?

No, not really. Again we continue to work with them and hopefully this gets clouds part over time. We get more clarity. We've always -- we thought that the application restriction was somewhat arbitrary. There was a good point of some evidence, but it was misconstrued in the way that it's being applied. So hopefully that goes away because that could be disruptive for patients that need more than four applications or they, they end up going into a more expensive care setting, excuse me, care setting frankly to get treated. So it's not really good for Medicare long term. As far as continuing influence the use of the ASP versus the WACC, we think that's the easiest way to go in the near term, its kind of the low hanging fruit. And to their credit, the CMS has been pressuring people to move in that direction. As you know, the OIG published a letter earlier in the year, pretty much directing them to adhere to these guidelines. And we have seen a lot of products move on the ASP price cuts. If you looked at the list a couple of years ago, there was maybe 12 products on the list, and now it's probably up to around 75. So the market is moving in the right direction. And quite frankly, that could be one of the reasons we performed so well, in that site of service for the first three quarters of the year, because the fine field is starting to level a bit.

Last one, and I'll hop in real quick. Just on EBITDA, second half, all three, to exceed 20%. Maybe just high level, there was restructuring program earlier this year to help in achieving that 20%. As you as you look forward next couple of years, how much of the EBITDA expansion will just be from organic growth as opposed to a follow on restructuring program. Congratulations again. Thanks.

Thanks, Anthony. This is Doug. I'll take your question. We're excited exiting the year with a lot of momentum. We had a really solid strong Q3. We saw improved execution that will continue into Q4, and now with the new product introduction, we're going to have a lot of upside and growth it'll help us scale. We expect our gross margin stands back up from an EBITDA perspective. We also expect to scale in sales and marketing and realize efficiencies all along our P&L. So, as our crew focus, as you mentioned, from the suspension of our [DOA] (ph) program, helps going into next year. We feel like we have a lot of momentum and ability to continue to grow into the double digits.

Thanks again.

And Anthony, the only other thing I might add, is just some of those legacy expenses kind of across the board. There's focus. There's SG&A leverage. There's obviously, kind of get a sense of where the R&D trend line looks and then obviously not having any other ancillary pieces hitting us, whether we adjust them or not should show a really nice kind of leveraged P&L.

Thanks again.

Thank you.

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

Thanks for the question and congratulations on your quarter and the progress here. I think most of my questions have been addressed. But as a bit curious, if you see an opportunity for further purchases in the Series B preferred, such that it's done and organized in orderly fashion. And then I have a follow-up to that. Thank you.

Yeah. So just a little more clarity on that. And I think I mentioned my commentary that not my first, but not my highest priority for use of capital at this stage of the company's evolution. However, it was kind of opportunistic. We got real close to the mandatory conversion, few months ago. In fact, we were above the $7.70 mark for several days. As you may recall, it requires us to stay above that for 20 out of any 30 consecutive trading days. So it did not trigger, but it prompted us to start having conversations with Hayfin as to what is your long term intent with the common once it converts. So they were pretty transparent that, it's typically not their approach to hold that stock for a long period of time and would look to probably exit it in some organized way. So it was really, that's how conversations evolve. It was very opportunistic. Why we didn't buy all of it. We only bought half of it. Frankly, it was just to keep some dry powder because we are looking to do other things with the business. And they also agreed to a 12 month lockup on the other half of the of the equity, whether it converts or not. So we felt like any potential disruption as they exited the position was limited, quite a bit because of our repurchase of [Hayfin] (ph) agreements to lock up the other half for the time being.

Great. Thanks. That's very helpful. And then segueing to EPIFIX in Japan. Do you have any updates with respect to the number of docs that have been trained to use product?

Well into the hundreds, I think several 100, I think about one point you may still have number of 500, it continues to grow. We're getting nice feedback from the physicians. There are several physicians have used the product in various procedures. They have reordered the product they have gotten paid on the product. All these are very important steps when you're talking about developing a new business in a new market. Want to remind everybody that this is a first of its kind in the Japanese market. So this will take time to develop and get positions comfortable with how to use it and as importantly whether or not they're getting paid for it. So we're seeing pretty significant percentage growth on utilization, but off of a very low base, right? So, we're pretty optimistic about what this could look like a few years down the road, but again it's very early on.

Understood and congratulations again. Thanks.

Thanks, Carl.

Thank you. Our next question comes from the line of RK with H.C. Wainwright. Please proceed with your question.

Thank you. Thanks for taking my question. This is RK from H.C. Wainwright. So a couple of quick questions. And looking at what the total revenues for this quarter and comparing it against last quarter, it's kind of similar numbers. And I see that the guidance you gave is higher teens. So what's the push hard pull on these numbers just on at a high level on the business? And also trying to see what's the probability that it'll get into lower twenties, based on what you're seeing?

I think that the first part of your question was what happened from Q2 to Q3. Your comment was relatively flat sequentially, which is a home run for this business, right? As you know these types of businesses typically have a seasonal decline in Q3 which we did not experience this year. On the contrary, we were able to tick the business up a little bit. We also had one less work day so seasonal decline, one less workday and flat to up is a home run, in my opinion, in this business. I think the second part of your question was, why would we not continue to see something in the low 20s as we move through the rest of the year and into next year. The comp for Q4 2022 is by far our toughest comp for the year. The revenue was, clear in a way the highest revenue that the business experienced last year. As you recall, that was the quarter in which we launched two new products in the surgical setting, and revenue was somewhere around $74.5 million. So, double-digit growth off of that would be a meaningful number. We think we're well positioned to do that. We think the business will close out in the high teens, if not 20%, but still a pretty good hill to climb to get those numbers. And as you know, fourth quarter can be disruptive depending on how holidays fall, etcetera, etcetera. We think this year we have great momentum going into the fourth quarter. Clearly, our sales organization is executing better than other organizations in the market. We have the strongest leadership team than any other company in the marketplace. So I think we're well positioned to continue to drive that momentum. We're launching another product, in EPIEFFECT into the private office segment now takes time to ramp up any new product. So that rollout will happen over the next two, three quarters before we see full effect of it, but we could get nice impact from that in Q4. So, look, could we get there? Maybe. But these numbers are pretty darn good numbers.

Yes. I agree with you. I'm not -- I was not negative on it. My comments are not supposed to be negative. I was actually trying to see what else is there that can actually push this higher. Anyway thank you very much for that answer. The other question I have is regarding seeking opportunities outside of just introducing another product in the fourth quarter as you have previously said and just -- and you also just made some comments on it. But in addition to that, given what you're doing in terms of trying to do this buyback and keep some powder ready. What sort of opportunities would you be looking for as you go into the 2024 and even into 2025?

I think you're referencing potential inorganic, opportunities. And as I've indicated on a couple of calls now, strategically, we have determined that expanding our skin substitute product line to include non-human skin subs, xenografts and synthetics make a lot of sense. If we add those products to our portfolio, we double our total available market just in the US, because unfortunately, amniotic history is restricted from use in certain market segments. So that's a priority for us. And it also gives us, more opportunity within the hospital -- within the surgical suite, which is another focus area for us. So products that allow us to move in that direction at an accelerated rate are ones that we would prioritize. And then after that, anything within the wound care continuum that will allow us to, a, broaden our offering, but b, leverage our current, operational infrastructure, both commercial and internal infrastructure. So you can imagine what those products might look like, but I think our highest priority would be the expanded skin sub line. Now, I'll also tell you that there's internal developments as well, right? We continue to develop, placental derived allografts and we have a rich pipeline for those, as well as a potentially internal development of xenografts. But we're also looking externally because as you know, that could accelerate the plan. And in my opinion, that's the only time you do acquisitions like this if it will accelerate your strategic plan. Can't just be done for the sake of doing them.

Thanks for taking all my questions.

Thanks, RK.

Thank you. Our next question comes from the line of John Vandermosten with Zacks. Please proceed with your question.

Thank you and good afternoon, Joe, Doug and Matt. I wanted to understand the medical collaboration a little more. That sounds like a great opportunity to get involved with clinical trials, you know, more further proof that the FDA has recognized a new product. Are there any other opportunities like this in with MediWound does that guarantee that your product will be used with their device, what if it's approved?

Yeah. First, yeah, we're excited about it and we're glad to be supporting that trial we think important. It's probably going to be the largest [DFU] (ph) trial in at least a decade, and the product looks very promising. With EPIFIX was selected because it has more evidence and more around its clinical efficacy than any other product in the category. So they know it works. They want to ensure closure, throughout the trial so they get the best results. And I think they said that in their press release when they announced. As far as other opportunities, we're always looking to work with people who have complimentary products. I don't have anything to talk about today. But certainly, working with other people in and around our product category makes a lot of sense.

Okay. And then thinking about free cash flow, should we expect a sequential expansion in that in the fourth quarter?

Yes. John, we're really pleased with where our free cash flow ended up in the quarter, sequentially an increase versus Q2 $7 million. I would expect Q4 to look similar. I think there's a lot of puts and takes in Q4. But, we signaled in our prepared remarks that we expected adjusted EBITDA to be north of 20%. That's what it was in Q3. We would expect the same in Q4. And I would expect, that our free cash flow would look similar.

Okay. Good. And I wanted to expand on the earlier, analyst question about EPIEFFECT. Do you feel that having more products in the wound product portfolio will actually provide some kind of synergistic benefit there or might there be, you know, cannibalization in the group of product?

Yeah. I think a little bit of both. Clearly, EPIEFFECT can be used in other procedures, which we talked about specifically when suturing is required. So it's going to expand utilization, but there effective it might be some cannibalization of EPIFIX as well.

Okay. Great. Thank you for taking my questions.

Thanks, John.

Thank you. There are no further questions at this time. I would like to turn the floor back over to Joe for closing remarks.

Thanks, operator, and thanks your questions after your continued interest and support in the company. That concludes today's call and we will talk to you after our next quarterly report. Thank you.

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