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spk01: Good afternoon, and thank you for standing by. Welcome to the MiMedx Third Quarter 2022 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 today, Mr. Matt Notarayani, Head of Investor Relations for MiMedx. Thank you. You may begin.
spk04: Thank you, LaTanya, and good afternoon, everyone. Welcome to the Mimetics Third Quarter 2022 Operating and Financial Results Conference Call. With me on today's call are Interim Chief Executive Officer Todd Newton, Chief Financial Officer Pete Carlson, President Wound and Surgical Dr. Rohit Kashyap, and President Regenerative Medicine Dr. Robert Stein. 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 memedics.com. Todd and Pete will provide a summary of our operating highlights and financial results for the quarter, and Todd will conclude with some remarks about our micronized D-HACM knee osteoarthritis clinical program. At the conclusion of these remarks, Todd, Pete, Dr. Kashyap, and Dr. Stein will 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, future margins, expected market sizes for our product, and potential timelines for clinical trials and FDA submissions and reviews. These expectations are subject to risks and uncertainties, and actual results may differ materially from those anticipated due to many factors. Actual results, market sizes, timing, and FDA review will depend on a number of factors, including competition, access to customers, unforeseen circumstances and delays, the results of our clinical trials, our interpretation of those results, 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, and we provide a reconciliation to GAAP measures in our press release, which is available on our website at www.memetics.com. With that, I'm now pleased to turn the call over to Todd Newton. Todd?
spk07: Thanks, Matt, and good afternoon to everyone. With this being my first call with you, I will begin with my observations and assessment of our company, and then we'll move through our third quarter performance. On my first day in my current executive capacity, which was now 57 days ago, I told our team we needed to combine the strength of this company, which is its products and people, with a renewed focus on four key fundamentals. One, to deliver year-over-year top-line growth that exceeds the underlying growth rate in the markets where we elect to operate. Next, to focus on profitability. and improve our operating margin year over year so that we have the means to invest further in growth. Then to ensure our R&D activities are prioritized, productive, and pursued with a sense of urgency because the innovations from these efforts are the lifeblood of future growth. And last, manage our balance sheet with an attitude and mindset that cash and equity capital are both precious commodities. And look, these are the basics of success. These aren't complicated, but admittedly, they're not easy to achieve. Now, let me tell you how I see our business. Our commercial stage placenta-derived products business, which we call wound and surgical, has successfully transitioned from being historically a single vertical wound care business to a two vertical business by expanding the use of our technology and products to meet the healing needs within the surgical recovery settings. Wound and Surgical has a good future growth potential, very attractive gross margins, and the potential to generate strong operating margins and cash flow. Additionally, Wound and Surgical has historically been a domestic business, and this is soon changing with the upcoming launch of EpiFix in Japan. However, in terms of our corporate expenses, our level of spend is simply too high for the size of our business. The profitability goal I have set for the management team is pretty straightforward. We need to gain more operating leverage. And I have put in front of our leadership team two challenges that they have embraced and are now underway working to realize. One is to improve our wound and surgical segment contribution margin to 30% of segment sales. If we are able to do this, combined with our targeted long-term revenue growth rate, This business unit could be generating annual cash approaching $100 million by the end of 2023. The second challenge goes back to corporate overhead. We need to push our corporate expense as a percentage of sales down below 20%. As a first step in bringing corporate overhead expense down, in early October, we restructured certain corporate support functions, which resulted in a reduction in our executive headcount. This initial small step will reduce annual corporate expense by nearly $3 million on an annual basis. We will be implementing further improvements as we continue to evaluate our cost structure and profitability. We currently have two research and development priorities. The first is to continue to introduce innovative products into wound and surgical, such as the two new products we introduced in September. And the second is to start as soon as practical a well-designed and well-controlled registrational clinical study for the use of our micronized product in the treatment of knee osteoarthritis, or what I'll refer to today as knee OA. I will speak more about the knee OA program status shortly. As I review our balance sheet, there is one very important aspect to stress. Our R&D pipeline, including the knee OA program, and other growth initiatives such as Japan do not require us to write any checks or make commitments that we aren't comfortable funding from existing cash and the anticipated cash flow resulting from our wound and surgical business. Therefore, today, we do not foresee the need to raise capital to achieve our goals. We feel fortunate to have this financial stability at a time when the capital markets are volatile. and many other companies are facing looming overhangs because of their need for additional capital. Let's transition now to the third quarter. We launched two new products in September, AmnioEffect and AxioFill, which we anticipate will bolster our momentum in the surgical recovery market. With AmnioEffect, we've added a thicker tri-layer placental allograft to offer surgeons superior handling characteristics including the capability to suture the allograft in place with sutures, which is often a need seen in a wide variety of surgical procedures. AmnioEffect offers users many of the same attractive handling properties as our cord-based products, but can come in many different sizes, including larger sizes. For AxioFill, early user feedback has confirmed that the product is very versatile. It can be applied as a particulate or as a paste. which makes it attractive for a wide range of complex surgical wounds of varying shapes, depth, or size. And it's compatible with negative pressure wound therapy as well as hyperbaric oxygen therapy. Also in September, we received a positive reimbursement approval decision for our EpiFix product in Japan for the treatment of refractory or hard-to-heal lower extremity diabetic or venous ulcers. The posted reimbursement rate is very attractive and should support clinician adoption and use. Since the reimbursement decision, physicians in Japan have treated the first patients with FB6. Over the next couple of months, our focus will be on generating physician awareness and education, as well as complete in-country distributor contracting. Japan represents a new and attractive addressable market that we estimate to be around $500 million in size. EpiFix is the first and only amniotic tissue product cleared for use in Japan, and we anticipate this market will be a good source of top-line revenue growth starting in 2023 and a profitable standalone market accreted to our overall operating margins by 2024. And now turning to our third quarter financial results, revenues were softer in July and August as the easing of COVID-19 travel restrictions resulted in higher than normal seasonal vacation activity and a higher than normal seasonal impact then on procedure volumes. These combined to negatively impact our product sales during the summer months. But in September, demand rebounded very well, indicating to us that the July and August growth pause was temporary. Overall, third quarter sales grew by 7.3% over the third quarter last year, while wounds in surgical cells grew by 7.6%. So I'm going to turn now to call over to Pete to further discuss the quarterly results along with specifics of our segment reporting being introduced this quarter. Pete?
spk05: Thank you, Todd, and good afternoon, everyone. As a reminder, unless otherwise specified, all results referenced in my prepared remarks are on a third quarter 2022 versus third quarter 2021 comparison basis. Beginning this quarter, we are reporting financial results by specific business unit, wound and surgical, regenerative medicine, and corporate and other. This reporting methodology enables us to transparently isolate the profit and cash flow generation of the wound and surgical business, more clearly demonstrate the investments we are making in regenerative medicine to advance the knee osteoarthritis clinical program toward BLA registration, and highlight the opportunity Todd has outlined for the company to reduce overall corporate expenses. We are using operating income excluding investigation, restatement and related expenses as a consistent segment performance metric. I believe our financial results and related trends are now easier to understand for two key reasons. First, the impact of the end of the FDA's period of enforcement discretion for our section 351 products is behind us and no longer affects our year over year comparisons. Second, The new reporting structure provides greater visibility into our financial information, costs, and investments by our defined business units as we look to improve profitability of the company moving forward. Let me take a moment to walk through some of the specific details for what is included within each segment. I'll start with wound and surgical. This reflects virtually all current product sales. Additionally, Sales generated from the upcoming launch of EpiFix in Japan will be reflected here. I will note that revenue and related costs from the domestic sales of Section 351 products sold prior to the end of enforcement discretion in 2021 are reflected within prior year results for the regenerative medicine segment. Wound and surgical operating expenses include the cost of our commercial operations, as well as research and development expenses related to new product development initiatives to support this business. Next, moving to our regenerative medicine segment. This reflects all costs associated with progressing our knee osteoarthritis program towards BLA registration. Lastly, Corporate and another is essentially everything else. I will highlight that the net sales reflected here are dental products sold to a single distributor. We have canceled that contract and expect to meet our final delivery requirements sometime in the second quarter of next year. Transitioning now to our third quarter results. As Todd mentioned earlier, we recorded net sales for the third quarter of $67.7 million, a 7.3% increase. This increase reflects growth of our wound and surgical products in the surgical recovery market, including early results from the recent launches of AmnioFX and Axiophil. Gross profit of $55.5 million increased by $2.6 million. Gross margin was 82.0% compared to 83.9%, reflecting lower production levels. Selling general and administrative expenses were $53.5 million compared to $46.3 million. This change reflects increased commissions on higher sales through sales agents and increased compared to the COVID-related travel restrictions in place throughout 2021, higher travel expenses in the current quarter. Additionally, the current quarter includes net severance expense associated with our former CEO and consulting expenses related to market assessments conducted as part of the company's strategic planning process. Our research and development expenses were $6 million, an increase of 36%. This increase spans both our wound and surgical and regenerative medicine business units, with investments in clinical research efforts connected to our knee osteoarthritis clinical trial program, along with higher development and testing costs primarily related to the launches of amnio effect and axiophil. Investigation, restatement, and related expenses decreased slightly to $3.0 million compared to $3.2 million. Net loss was $8.4 million compared to a net loss of $2.3 million. Adjusted EBITDA was a loss of $724,000 compared to a gain of $7 million. As of September 30, 2022, the company had $73.2 million of cash and cash equivalents, compared to $87.1 million as of December 31st, 2021, and to $72.5 million as of June 30th, 2022. We continue to expect to be free cash flow neutral for the full year 2022. And importantly, I want to reemphasize that we remain well capitalized to invest across the business both in wound and surgical and in regenerative medicine, without the need for external financing. Looking to revenue outlook, we expect fourth quarter net sales to be between $73 million and $76 million, which reflects year-over-year growth in a range of 8% to 15%. For the full year 2022, This would result in net sales between $266 million and $269 million, or growth of 11% to 12% over 2021 net sales of our continuing portfolio of products. In closing, we believe this financial reporting by business unit underscores the company's cash flow generation potential provides visibility into the investments we are making in the business, and highlights the potential opportunities we have to achieve the profitability objectives Todd outlined. I will now turn the call back to Todd. Todd?
spk07: Thanks, Pete. On our NEOA program, we are currently actively engaged with the FDA soliciting their input. Recent activity has included the following. First, the Type B RMAT meeting to seek FDA input on some important protocol questions we had for our upcoming registrational trial, particularly around patient dosage. We also submitted the clinical protocol for our next registrational study for FDA review. And we filed two chemistry manufacturing and control, or otherwise called CMC amendments, with the FDA that further described in detail the root cause related to the Phase IIb study readouts. and our proposed corrective actions to prevent the issue of potency loss over time that was experienced in the 2B study from recurring in this next proposed clinical study. So where are we currently? We're at this moment addressing FDA comments on the registrational study protocol. In parallel, our team is also working through several other readying activities such as study site selection and preparing investigational product data. all with the aim to begin patient enrollment as quickly as possible. It is certainly our desire to have the study's first patient enrolled and treated this calendar year, but that may not be feasible. The timing is subject to the FDA's review of our responses to their comments, and as we work through this dialogue, we'll have a better sense of when enrollment can start. In any event, priority number one for us is to lock down the study protocol. Management and our board continue to believe our NeoAid program is worthy of this continued focus and investment. Our micronized DeHacken product has shown clear signals of efficacy in the treatment of NeoAid. And while our Phase IIb study did not meet its primary endpoints, we saw this signal of efficacy in the first 190 patients treated, and we saw this signal in real-world clinical practice from back when the product was on the market. Over a quarter million vials were sold over a period of more than a decade prior to the end of enforcement discretion. And a number of satisfied physicians who used the product in their daily practices liked it enough to publish their clinical results. With the benefit of ongoing FDA interaction on our path forward, a leading clinical research organization helping navigate our registrational trial, and an increased scientific understanding of our product, We believe our micronized product from EOA will prove to be a significantly undervalued asset, but it will also take us time to prove this. We just need to run a well-controlled study. Our micronized DHACM product has the potential to address a significant unmet need and help a large and growing patient population, and also has the potential to produce substantial value for our shareholders. I'll close in a moment for Q&A, but first a final comment about our wound and surgical business. We believe this business has strong fundamentals, and we are developing a pipeline of ideas to further grow our product offering, and we have a dedicated commercial organization helping expand the use of MiMedx products in various settings across the country. And soon, this will include Japan. However, for over two years, especially in the wound care private office setting, we have seen a reimbursement environment characterized by for rulemaking, and for enforcement that has allowed competitors to aggressively promote financial incentives to physicians in return for using their products, especially when the competitor's products are not on the CMS price list. This lax reimbursement environment has had an impact on our market share in the private office setting since our products are on the CMS price list. CMS had previously put forth proposed rules to change private office reimbursement to take effect at the beginning of 2024. And just yesterday, CMS announced plans to hold a town hall meeting in early 2023 to further discuss these proposed rules and the feedback from the community. At this point, we still expect new rules will take effect in 2024 for the private office. And look, there are aspects of the CMS proposal we were not in favor of. We were pleased to learn yesterday that CMS was still considering feedback. However, we have strongly advocated that CMS needs to take steps to promote fair competition and reimbursement, including the immediate publishing of all skin substitute products on their price list. We are hopeful the new rules, when published, will address this. If so, it would re-level the private office playing field and positively impact our competitive position in this important private office side of service. Of course, as with any new rule, there's always uncertainty. We have been and will continue to be engaged with CMS in order to ensure our feedback is considered as part of any final rule. In closing, we believe our wound and surgical business has strong fundamentals and are a noteworthy reason to own MiMedx stock today. This is a growing, profitable, and cash generating business. We recognize the work we have to do to reduce corporate expenses as a percentage of sales, and those efforts are already underway. And lastly, we have sufficient capital, human and financial, to execute our business plans. With today's results and changes in our financial reporting structure, we hope investors will be able to more transparently understand and evaluate our business now and in the future. With that, operator, would you like to open the call up for questions?
spk01: Thank you. We will now conduct a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that's star 1 at this time. One moment while we pull for our first question. Our first question comes from Anthony Patron with Mizuho Group. Please proceed.
spk00: Thanks, and I hope everyone's doing well. I think maybe I'll start with the 4Q implied guidance and shift over to Pete, and then I'll have a couple of follow-up questions on reimbursement and the announcement last night from CMS. Now, Pete, on the guidance for 4Q, 9% to 15% is wider. you know, than we've seen in the past, and obviously a number of puts and takes implied there. Several new products launched, inclusive of EpiFix now having reimbursement approval in Japan. Axiophil and Amni Effect are out there. On the other hand, there's, you know, headwinds we've been hearing about all quarter in the way of staffing, headwinds in particular, both in the inpatient and outpatient settings, certainly in the physician office setting as well. So how should we be thinking about what gets you to the high end of the range at 15% versus the low end of the range? And I'll have a follow-up question again on reimbursement.
spk05: Hi, Anthony. Good to hear from you. You cited the factors really that drive us through the range. Certainly the ramp up and start in Japan and how successful we can be here in the remainder of the fourth quarter once we've launched is going to be one of those factors. We have seen the product in use and that's great. We have some uncertainty to it as to how high it could put us up in the range. We have the continued opportunity with the two new products. And then you've got a holiday period. And traditionally, the fourth quarter has higher volumes, particularly given people trying to get procedures done as their deductibles or before their reimbursement and deductibles get reset in January. We think that trend is going to continue this year, so we're comfortable certainly within the range. I think the new products and then any reimbursement noise that could come through are the top and the bottom factors relative to the range.
spk00: Thanks. Appreciate that. And then to follow up on reimbursement, Todd, you mentioned the update from CMS last night, published last night, that they're not going to finalize their proposal on their terminology for skin substitutes, specifically in the physician office setting. Maybe just to level set Can you sort of, A, recap what percentage of wound care is physician office as a percent of that total number for my medics? And then the follow-up would be, you know, just recapping if the proposal went through, what does that represent in the way of a headwind? And, you know, where do you think ultimately we can settle out? Because it does look like CMS is acquiescing here to an extent. So any additional color there would be helpful. Thanks.
spk07: Yeah, Anthony, I'll answer your first question, and then the second part I'll let Dr. Kashyap address. The private office business for MiMedx today is roughly a third of the wound and surgical business. I'd call it a small third, probably more like 30% versus 33%. But anyway, it's about a third of our business. And Dr. Kashyap, you can take the other part.
spk08: I think with the... Thanks, Anthony. And with the unknowns around reimbursement, it's hard to quantify the impact on the business going forward. As Todd mentioned, in the current environment and with our strengths of evidence, with our strengths of the product portfolio, we feel confident that in a new reimbursement environment, we would be able to navigate it effectively based on where we have been in the past. So we continue to work on those elements in there. We continue to work with CMS to give them our feedback around the current reimbursement and how it's impacting the business today and how it should be in the future. But we are confident of being able to adjust our strategy. Obviously, part of the market, which is the outpatient, but the wound care clinic side is reimbursed under a similar type of format and the proposal calls for right now in the private market. And we are able to continue to grow that business in that space. So we expect that should there be no big surprises in the absolute amount of reimbursements, we should be able to navigate that space effectively.
spk00: That's helpful. And just a quick follow-up there, and I'll hop back in. It seemed to be pretty vague in terms of the comment period and when they're going to open that up. Is there anything more you can share there? Is this sort of a 1Q event where they begin the comment period and end it in 1Q and we get an update into 2Q? Or is that window perhaps a little bit wider?
spk08: We know almost as much as you do in terms of that. There hasn't been any more clarification All we know is that they plan to have that comment period in town hall in early 2023. And subsequent to that, they would give us more feedback. I would expect that any rule changes would still fall into the next calendar year as a result of that. But what is the next milestone date in terms of communication to the broader community? industry and the physician community, as a result of the town hall and comments, we don't have much clarity on that as well in terms of timing. Okay, thank you.
spk01: Our next question comes from RK with HC Wainwright. Please proceed.
spk09: Thank you. Thanks, Todd, Pete, and Dr. Gushup for the updates. Todd, As you take charge of Mammarix and you look at the ongoing operations, you made a statement saying that you put a mandate to the management asking them to improve the operating margins of the wounded surgical business. I think about 30%. I don't know if that's right or not, but... So from where you stand, at a higher level, what are the areas where you think that real improvement can come to get to your mandate?
spk07: Okay, thank you for the question. I would say this, I'm really thinking about this And in terms of execution, I'm thinking about this all in terms of making decisions to advance the business with a sense of urgency. And so, you know, I was always told that if you want to make $2, you've got to make $1 first. And I know that sounds like it doesn't, it stays the obvious. As Dr. Kashuk and I have talked about the wound and surgical business, We think it can become more profitable than 30%, but we need to start with 30%. And so the four priorities that we laid out today are all about growth and also about improving profitability and capital discipline. And that's really what I'm focused on here in these first 60 days or so and what I think I'll continue to be focused on for the next while.
spk09: Thanks for that. And then on the Epifix launch in Japan, obviously this launch was being worked on for quite a bit of time as we were waiting for the reimbursement to come through. And now that we have the reimbursement and you are executing the launch, even though we may not have meaningful revenues to talk about, how is it working through in terms of getting the launch itself? And also, what's the sort of operational way that you do it in Japan? Is it a similar system that we offer here in the U.S. in terms of rebates and whatnot, or is it a little bit different? And I'm trying to understand, you know, how fast can you get to the stage where you can actually start predicting future quarter sales?
spk07: Yeah, good question. I think I'll turn that over to Dr. Kashyap.
spk08: Good afternoon, Mark, and that's a great question. Again, we're very pleased with the reimbursement The way it was established and the absolute yen value for the reimbursement as well. In the true sense, that kick-started our approach of how we can commercialize in Japan because in the absence of reimbursement, we weren't able to make progress in terms of having our sales channel in place, which is in the form of a distributor. So we are in the stages of finalizing that before we can commercialize our product. In the meantime, we have been very focused in trying to develop the market. And what I mean by that is we are working with significant KOLs over there. We have several physicians who have used the product both for VLU and DFU cases. The feedback from those cases has been positive, so that gives us confidence that both the profile of patients, the profile of wounds that we are targeting, and the outcomes we expect will be positive and drive good adoption of a product once we are ready to launch it fully in the marketplace. And our approach to launching it is collaborative. In some ways, it's basic, but not too complicated. In Japan, the key element, as we have just spoken, is that this is the first of its kind biologic amniotic product to be launched in Japan. As a result of it, we have an obligation as well as a responsibility to make sure that we can educate the market. And as a result, we are heavily focused on that for the first few quarters, both through sales channel but also through medical education in terms of doing that, generating some local evidence that cases can be shared in the marketplace as well. That will be a heavy emphasis. So while the revenue guidance that Pete just outlined includes some contribution from Japan in there, as we expect to be commercial in Q4, we do expect that the revenue impact in 2023 will be meaningful to the overall corporate growth. I won't be able to exactly quantify the amplitude of that, but we expect that to be a good contributor to growth in subsequent years after that as well.
spk09: Perfect. Thank you very much. Thanks for taking my questions. I'll step back and get back in the queue.
spk01: Our next question calls from Carl Burns with Northland Capital. Please proceed. Thanks for the question.
spk03: Turning to slide seven and understanding that the procedure volumes were lower in July and August, due to vacations and probably some scheduling issues with providers, but then sales demand rather increased in September. Would you characterize the environment now as being more normalized, or do you believe that there's still a bit of a warehousing of procedures that would reflect pent-up demand that might fall into the fourth quarter, bolster the fourth quarter, and possibly even spill over into the first half of next year? Thanks.
spk07: Yeah, and I'll let Dr. Keshav comment about what he's been seeing or hearing anecdotally, but I think we will talk about the fourth quarter, of course, when we get there, but what we have so far, I believe, been experiencing in October is more a continuation of what we saw in September, and that was more a return to normalcy. You know, July and August are always vacation months but this year the vacation impact was greater than normal i think in september we saw a more of a return to normalcy and we were already on a good growth trajectory before we got to july and august as reflected in prior reporting on the basis of just the advanced wound care product portfolio so september it will return to normalcy, and I think we continue to see that here early in Q4. But Dr. Kashyap, do you have anything else anecdotally you want to add?
spk08: No, I think, Todd, you answered Carl's question. Good afternoon, Carl. Q4 typically is our strongest quarter, but it's very hard to... differentiate the growth coming from Q3 to Q4 between what's as a result of the pent-up demand or patients that have gone unseen in Q3 versus what's just the normal cyclic nature of growth in there. So we continue to monitor that, continue to do our market checks as we see that growth. But we are seeing what I would call and what Todd just described as a return to what is a normal pace in Q4. Not necessarily able to break apart whether that's pent-up demand or that's just the normal trajectory. Q4, as Pete mentioned, is driven a lot by procedure growth as a result of deductibles being met and people wanting to get their procedures done in this period before they either go on a new insurance plan or new deductibles kick in starting January 1st.
spk03: Thanks. That's very helpful.
spk01: Our next question comes from John Vander Molsten with ZACS. Please proceed.
spk02: Good evening, everyone. Can I follow up on 4Q guidance questions? I was wondering how you break down the increase over the prior year when you look at products that have been around since 2021 and then the new product launches that recently went out. How do you break it down into those different components?
spk05: John, it's Pete. We haven't provided that. It's all included in those pieces. If you go back to some things we talked about over the last year or so, we've given people a view of over a multi-year period how the existing portfolio contributes to our growth pattern versus the new products and versus the the growth external, the outside the US, our geographic expansion. So, you know, in that 11 to 14% range over a recurring number of years, the two to 3% was focused on these new products and two to 3% on the international expansion. Um, again, that's over a multi-year period. So within a quarter or a year, the, those numbers will move around, but, um, That's the only thing we've said relative to that. And as Rohit indicated, what we've talked about here, the $73 million to $76 million incorporates everything, our existing portfolio, the two new products here in the U.S., and the launch in Japan.
spk02: Okay. Thank you. And I also wanted to follow up. Thank you, Pete. Yeah, Pete. And also, I wanted to follow up on the comment you made about free cash flow. I think I heard you say it might be neutral for the year, and it looks like we're already down over 10 million. Did I hear that correctly?
spk05: You did, free cash flow neutral. It's what we've talked about really over the last, coming out of the third quarter of last year, that was what we talked about, kind of through the end of 2022 being free cash flow neutral. Remember, the fourth quarter does have higher volumes. You're right, but when you look at the trailing 12 months or the nine months of a pre-cash flow number, which as we define it is adjusted EBITDA less the capital expenditures and patent costs. And really, it was just a way to say, you know, we're going to be sort of break even in that kind of proxy for cash flow. So, yes, that's what we've said, and you're thinking about it correctly.
spk02: Okay, great. Well, that's impressive based on where you are today for the cash flow. I also wanted to see if you could share any of the details of the clinical protocol for us for the knee osteoarthritis efforts. Maybe top line, kind of big picture details on that.
spk07: Yeah, I think we can give you a little bit of color on that. Why don't I turn that over to Dr. Stein to give an overview of those.
spk06: Hello. For the anticipated registrational trial that we're working hard to get started, we're looking at dosing patients with either saline or 40 or 100 milligrams of micronized DeHackam. And we will be looking at the impact that has on their level of pain and then put it in function at six months. Other aspects of the protocol, we're still in discussion with the FDA to make sure we have an agreed upon protocol that we think will demonstrate the utility and safety of our product.
spk02: Okay, great. Thank you.
spk01: Thank you. At this time, I would like to turn the call back over to Mr. Newton for closing comments.
spk07: Well, thank you, operator. In closing, I just want to reiterate that this quarter, We accomplished a lot of achievements that I think we can build upon. The two new products had good showing in the couple of weeks in September when they were in the market. I think we feel optimistic about these moving forward as well as our ability to continue to innovate with new products. Japan represents a really important opportunity for us and an exciting opportunity as the first amniotic product into this market, as Dr. Cash has talked about. And we are close to being ready to start our registrational study for NEOA, and that's going to be an exciting time. We have to work through some open comments, of course, with the FDA. There's no denying, though, that we need to be more profitable, and we're working on that. We have goals in place. We now have to develop the detailed plans to realize those goals, and that process is in progress. place right now to be able to do that. And then we look forward to reporting back to you, our shareholders and investors, in the near future as we take on these initiatives. And with that, I just would thank you for your interest in MiMedx. And if you have any questions about today's call or the information that we released, please contact Matt Notoriani at the contact information as described in the press release today. Thank you very much. Thank you, operator.
spk01: Thank you. This does conclude today's teleconference and webcast. You may disconnect your lines at this time and have a great day.
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