Earnings Call Transcript - MDXG Q4 2022

Operator, Operator

Good afternoon, and thank you for standing by. Welcome to the MiMedx Fourth Quarter and Full Year 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, Mr. Matt Notarianni, Head of Investor Relations for MiMedx. Thank you. You may begin.

Matt Notarianni, Head of Investor Relations

Thank you, Shomali, and good afternoon, everyone. Welcome to the MiMedx fourth quarter and full year 2022 operating and financial results conference call. With me on today's call are Chief Executive Officer, Joe Capper; and Chief Financial Officer, Pete Carlson. As part of today's webcast, we are simultaneously displaying slides that you can follow. You can access the slides from the Investor Relations website at mimedx.com. Joe will kick us off with some opening remarks and Pete will provide a summary of our operating highlights and financial results for the quarter, and then Joe will conclude with some additional updates, including the 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, future margin, expected market sizes for our products 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, the reimbursement environment, 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.MiMedx.com. With that, I'm now pleased to turn the call over to Joe Capper. Joe?

Joe Capper, CEO

Thanks, Matt. Good afternoon, everyone. As you know, I joined MiMedx on January 30th. I spent the first month doing exactly what you would expect, meeting members of the team, learning more about our technology, product offerings, and associated opportunities, speaking with some of you in the investor community, and immediately taking a deep dive into the various parts of our business. While it's only been a month, I'm pleased to report that the Company has far surpassed the expectations I had walking in the front door. I knew MiMedx was a company with great potential or I would not have taken the job. What I've been learning in these early days is that the upside is significantly greater than I initially appreciated. Today, I will outline the approach I believe will unlock the vast potential I see at MiMedx. In prior leadership roles, my approach in maximizing the Company's potential has always been to streamline operations and add businesses or products that strategically benefit the growth profile. I see no reason why we can't do this with MiMedx. The Company is both financially and operationally strong and is poised to benefit from disciplined execution around a tight strategic plan. As we begin this journey, I want to state unequivocally that as a medtech tissue-based company, we have the foundation in place today to accomplish great things and create tremendous value. I know there is also considerable excitement about our clinical efforts in knee osteoarthritis. However, my near-term focus is to build a world-class wound care business that generates substantial EBITDA well before the knee OA program is commercially available in the U.S. To that end, we finished 2022 with a solid Q4, generating over 10% year-over-year net sales growth and an improving adjusted EBITDA. In fact, our fourth quarter net sales were our highest since the end of 2019. This strong finish of ‘22 has given us excellent momentum entering the New Year. I believe, with what we already have in place, the business can deliver consistent top line revenue growth for the foreseeable future. Not surprisingly, I've been asked several times what it was about MiMedx that attracted me to the opportunity, so I thought I would start by addressing that question, then we will dive into specifics about the business and our direction moving forward. While there were many positive aspects about this company, I will highlight the three that are most compelling for me. The first was the Company's best-in-class technology. MiMedx is a pioneer in the field of placental biologics with an unmatched product portfolio, and makes a positive difference in the lives of an increasing number of people. Second was the quality of people I met prior to joining the Company. And as I've gotten to know many of my new colleagues over the past few weeks, it is abundantly clear that we have a team of very knowledgeable and experienced people at every level of this organization. They understand the business and are as eager as I am to succeed. I am proud to be part of this team. And finally, it was important to me that the business was stable with significant opportunities for growth. MiMedx has a large growing revenue base, with opportunities to streamline operations and improve profitability. Some of that work, in fact, is already underway. Moreover, I believe this company has the ability to make opportunistic acquisitions or licensing deals that will enhance our growth profile. Let me shift gears to talk about the future and how we are focusing the efforts of the organization. Our success will be determined by how well we execute on three basic growth objectives. All company activity will stem from one of these three areas, with resources being allocated accordingly. Our first growth objective is to build on our leadership position in the Wound & Surgical markets by enhancing our product portfolio while concurrently expanding geographically. We operate a highly profitable business approaching $300 million of revenue, which we are confident we can grow annually at double digits with the proper focus. As such, the majority of our resources and focus will be invested in our Wound & Surgical business. We must execute well in this core business in order for MiMedx to be successful. On our last call, the Company reported on progress we have been making in these areas. Specifically in September, we introduced two new products to the U.S. market. As Pete will highlight, our fourth quarter results make evident that we are off to a fast start with these new products. During these early months of the launch, we have seen widespread market acceptance and we are exceeding our initial expectations. Additions like these to our already market-leading product portfolio will serve to strengthen our brand customer relationships and expand the use cases for our products into more areas where chronic and acute wounds are treated. We have also reported on the work being done in Japan in an effort to establish a presence in select markets outside of the U.S. While the requirements to get up and running in Japan have been a bit arduous, we have been making steady progress. We now have clearance and reimbursement for our product and several hundred physicians have recently been trained on its use. I'm also pleased to say that we have started generating initial sales with our partner, Gunze Medical. Our second growth objective is to develop opportunities in adjacent markets in addition to our development of a knee OA product. By way of update, after active engagement with the FDA over the last several months, we are pleased to announce that our registrational knee OA study is now underway. This is the result of a tremendous amount of work on the part of our Regenerative Medicine team and our partner CRO, Nordic. Thank you to all of those in the organization who got us to this exciting milestone. As a reminder, this is the first of two studies that will be needed in order for us to file our BLA. In this trial, we expect enrollment of approximately 470 patients with three arms, a six-month observation period and six additional months of monitoring. We are pleased to be underway and look forward to reporting on our progress as appropriate. While the knee OA project is our largest investment for the possible entry into a new market, it is also our intent to look for additional opportunities in areas that are complementary to our Wound & Surgical portfolio, both organically and inorganically. Last year's licensing of the Turn Therapeutics IP has stayed being a prime example. And finally, our third objective will be to build corporate discipline around expense control, rationalization and continuous process improvement in order to ensure our growth becomes more profitable over time. On our last call, my predecessor Todd detailed his objectives to drive operating leverage. Specifically, the Company has goals to improve the Wound & Surgical segment contribution margin to at least 30% of segment net sales and to get corporate expenses as a percentage of sales to below 20%. An important step in this process was to augment the team with the experience and leadership Ricci Whitlow brings as our new Chief Operating Officer. Ricci has an extensive background in the human tissue space and in her relatively short time here is already establishing disciplines within our operations team that will improve production yields and help transform the way we bring products to market. I've had success creating value at prior companies by establishing a process of consistently identifying growth drivers for the business, then executing on those that are the most strategically relevant. That is exactly what we will do at MiMedx. If we stay focused and execute well in these three areas of the business, I believe we will continue to build on this franchise, have the opportunity to create tremendous value, and once again, establish MiMedx as not only the leader in our space, but one of the most highly regarded healthcare companies in the market. I look forward to reporting on our progress in each of these areas. Hopefully, this gives you a sense of what drew me to MiMedx, and hopefully you too share my excitement for the future. Now, let me turn the call over to Pete, who will recap our fourth quarter and full year results. Pete?

Pete Carlson, CFO

Thank you, Joe, and good afternoon, everyone. As a reminder, unless otherwise specified, all results referenced in my prepared remarks are on a fourth quarter 2022 versus fourth quarter 2021 comparison basis. We ended 2022 with strong commercial and operational momentum and reported our highest level of quarterly net sales since the fourth quarter of 2019. On an adjusted net sales basis, our fourth quarter results represent the highest level we have seen since 2018. We are proud of these results and expect our momentum to continue going into 2023. For the fourth quarter, we reported $74.4 million in net sales compared to the $67.4 million. As you know, virtually all our net sales come from our Wound & Surgical segment, which delivered $73.6 million, reflecting growth of 10.6%. This strong performance is a testament to the dedication of our commercial team and our leading product offering, including our recently launched products. Further, this result is despite the continued unfavorable competitive environment in the private physician office setting. The quarter reflects strength across our Wound & Surgical end markets, and the team remains focused on bringing more new products to the market in support of future top-line growth, both organically and otherwise. Gross profit was $60 million compared to $56.7 million. Gross margin in 4Q was 80.7% compared to 84%. This margin level reflects production variances, primarily from lower production levels and is below our expectations going forward. We have several initiatives underway focused on improving our gross margins in Wound & Surgical. Selling, general and administrative expenses or SG&A were $50 million compared to $53.1 million. The current quarter included increased commissions on higher sales and the impact of severance associated with restructuring activities. These were more than offset by lower compensation, principally due to year-end incentive adjustments, and also reflect the impact of cost reductions taken during the quarter. As we previously noted, headcount reductions late last year are expected to reduce SG&A costs by more than $5 million on an annual basis. Our research and development expenses were $5.4 million compared to $4.6 million. We saw increased R&D expense in both of our segments. The higher spend came primarily in Regenerative Medicine related to preparation activities for our knee osteoarthritis clinical trial, which is now underway. Investigation, restatement and related results were an expense of $3.4 million compared to a benefit of $4.5 million. The prior year quarter included recoveries from our Directors and Officers insurance program. Net loss was $400,000 compared to net income of $2.2 million. Adjusted EBITDA was $7.3 million or 9.8% of net sales compared to $3.6 million or 5.4% of net sales. I want to now briefly discuss results for the full year, and will remind you that 2021 included sales of products impacted by the end of the FDA's period of enforcement discretion on May 31, 2021, impacting not only net sales but also our profitability metrics. Net sales for the full year 2022 were $267.8 million compared to $258.6 million in 2021, an increase of 3.6%. Excluding products impacted by the end of enforcement discretion, 2022 net sales growth was 10.5% compared to the $240 million in 2021. You could also see this growth in our Wound & Surgical segment, which had net sales growth of 10.9% for the full year 2022. Gross margin was 82% for the full year 2022, compared to 83.3% in 2021, again reflecting the impact of production variances. We had R&D expenses of $22.8 million in the full year 2022 compared to $17.3 million in 2021 as we increased our efforts on new product development and on our knee osteoarthritis program. SG&A for the year 2022 was $208.8 million compared to $198.4 million in 2021. Net loss for the year ended December 31, 2022 was $30.2 million compared to a loss of $10.3 million in 2021. Investigation, restatement and related expenses totaled $12.2 million in 2022 compared to $3.8 million in 2021, which included recoveries from our D&O program. Finally, adjusted EBITDA in full year 2022 was $3.9 million compared to $18.7 million in 2021. On a segment basis in 2022, Wound & Surgical had a segment contribution of $66.7 million or 25.2% of segment net sales and Regenerative Medicine had a segment loss of $15 million. Additionally, SG&A expenses in Corporate and Other were $62.9 million or 23.5% of net sales. As of December 31, 2022, the Company had $66 million of cash and cash equivalents compared to $73.2 million as of September 30, 2022, and to $87.1 million as of December 31, 2021. The sequential decline in our cash and cash equivalents was driven primarily by changes in working capital, including the annual payment of certain insurance premiums, along with the cash consideration associated with the Turn Therapeutics agreement we announced in December. Based upon our current position and expectations for the business, I want to reemphasize that we remain well-capitalized and do not foresee the need for external financing. Looking ahead, our goal is to deliver low-double-digit percentage growth in net sales. While we have seen solid demand for our products in the hospital outpatient, hospital inpatient and wound care clinic settings, the challenges associated with the reimbursement environment in the private physician office side of service have weighed on our business and we expect this to continue during 2023. Joe will touch on the latest developments as we see them in this segment of the market. From a profitability perspective, as you heard us say on our third quarter call in November and as Joe indicated earlier, we are focused on our goals and of improving our Wound & Surgical segment contribution margin to at least 30% of segment net sales, and reducing our corporate overhead, so that the corporate and other SG&A expenses as a percentage of sales is below 20%. In summary, our fourth quarter financial results were strong, led by commercial execution driving our top-line results and we are making progress to position the Company for sustainable profitability. I will now turn the call back to Joe.

Joe Capper, CEO

Thanks, Pete. As you have just heard, we finished the year with a strong fourth quarter, during which we reported quarterly revenue growth of over 10%, continued to roll out our two new products in the U.S. and set the Company on a course to drive greater efficiency and expense rationalization. Already in 2023, we have got our business up and running in Japan and an experienced leadership of our operations and initiated our registrational knee OA study. Before I open the call for questions, I wanted to comment on one additional item, reimbursement in the private physician office setting. As Pete mentioned, our business continues to face headwinds in this segment given the current reimbursement environment, which has created a very lopsided competitive landscape. Specifically, it appears some participants are using what I would describe as a loophole in the current system to provide sizable financial incentives to physicians who use their products, at the expense of the Medicare trust fund. Using financial incentives for physicians to differentiate a sale is expressly prohibited by Medicare regulations. It goes without saying, we do not engage in such practices. And as you can see on slide 16, all of our products are on the ASP list. Products that have historically not been on the ASP list are the ones being used to create financial incentives for physicians. Those of us who have been around healthcare for long enough know that eventually CMS closes these loopholes. To that end, we have been actively engaged with the agency highlighting this untoward behavior and offering our perspective and recommendations throughout this process. In mid-January, we participated in a CMS-hosted town hall meeting on the topic and provided subsequent written comments. We will keep you updated as we learn more. So, in summary, it is abundantly clear to me that MiMedx is an outstanding business with an incredible line of products that make a positive difference in the lives of thousands of people every day. We have a highly skilled team that is extremely passionate about delivering these life-changing solutions. We have a revenue base that is growing at a healthy clip, approaching $300 million with margin improvement efforts underway, and we have a product pipeline rich with opportunity. Given the solid foundation I have to work with, I am truly excited to be at MiMedx and enthusiastically embrace this opportunity. I look forward to working with the entire MiMedx team. I can tell, they genuinely share my belief and excitement about our path forward. I'd also like to thank Todd Newton who did all you could ask during his time as Interim CEO. As a result of Todd's efforts, I joined the company with positive momentum and a bright future ahead. With that, I would like to open the call to questions. Operator, we are now ready for our first question.

Operator, Operator

Thank you. Our first question comes from Anthony Petrone with Mizuho Group.

Anthony Petrone, Analyst

Thanks, and good afternoon. Joe, congratulations on your new role and to the team for a fresh start this year. To begin, you mentioned some high-level thoughts shortly after stepping into the CEO position. As you consider the overall strategy, particularly regarding the focus on wound care and expanding the surgical applications portfolio, how might the priorities evolve for these areas and in terms of market channels? Additionally, what is your perspective on the development pipeline? We have the knee OA initiative, but how do you see other pipeline projects for MiMedx? I have a few follow-up questions as well. Thanks.

Joe Capper, CEO

Thank you for the questions, Anthony. First, let me emphasize that my initial focus with the Company is to formalize our strategic planning process and enhance its structure. By doing this, we can encourage new ideas and begin to create a Corporate Development pipeline, both internally and externally. You are correct in highlighting the importance of the wound care and surgical business, which possesses a strong financial profile and significant growth potential, deserving our attention as it supports our operations. I see considerable opportunities here, and my main focus will be directed towards this area. In the future, we aim to transition from being solely a wound care company to one that manages wounds, allowing us to expand our product offerings with line extensions, new products, and other related capabilities. Regarding new development insights, I don’t have much to share at this moment. I'm still in my first month here, and it’s been quite a learning experience. However, I can share that everyone I've spoken to—both within and outside the Company—expresses deep passion for our entire product lineup. The feedback has been remarkable; people have shared how our products have significantly impacted their lives, calling them life-changing or miraculous. This indicates that we are on the right track. While the Company's past may not have been ideal, the team—especially at the executive and Board level—has done a commendable job guiding us through those challenges. We're now in a strong position with a growing revenue stream and an impressive margin profile that has plenty of room for improvement. It's hard not to feel incredibly enthusiastic about our current product portfolio.

Anthony Petrone, Analyst

No, that's very helpful. I have two quick questions. First, could you elaborate on the 10% outlook for 2023, particularly regarding the contribution of EPIFIX in Japan? Secondly, what can you share about reimbursement for wound care in physician offices, especially with regard to new literature from LCD Max since January? Thanks.

Joe Capper, CEO

Yes. I think Pete can provide more details on this. After EPIFIX in Japan, we anticipate some contribution, but it's not expected to be significant this year. We view this year as a developmental phase to establish that business. As I mentioned earlier, progress has been slower than anticipated, but we are making headway. We have made our first couple of sales to our local partner, and they have moved products to end users. Numerous physicians have been trained on the product's use. We are also allocating additional resources in the country to support our partner. We are taking all the necessary steps and are quite excited about it. However, it's difficult to predict where this will lead in 2023. In fact, we won't have a clearer outlook for 2024 until later this year.

Pete Carlson, CFO

Joe, that's correct. I think you've covered everything there. We're just excited about the reception we continue to see from practitioners on the market and are pleased that the product is getting into the market and applied on patients as we speak.

Joe Capper, CEO

Regarding your question about reimbursement, there hasn't been any new information since our January meeting. My best estimate is that we probably won't receive any updates until the proposed regulations are released mid-year, likely around July. I believe there will also be a comment period following that, and then final regulations will come by the end of the year. As I may have mentioned earlier, our company is in a favorable position in this context. Utilizing financial incentives to persuade physicians to use our products does not align with the intended guidance of the regulations. Therefore, I am very confident in our company's actions, and as this situation unfolds, we are positioned favorably.

Pete Carlson, CFO

This is Pete. It's important to remember that we are discussing revenue that constitutes about 28% of our business. While we are on the right side of this issue, it is merely a segment of our overall portfolio and not the largest portion.

Carl Byrnes, Analyst

Great. Thanks for the question and congratulations on the results and the progress. With respect to the gross profit margin, which I believe averaged 80.7% in the fourth quarter, was cited as being negatively affected by lower production levels. Can you be a little bit more specific on what was affecting the production levels, and when you might expect them to return to normalized levels? Thanks.

Pete Carlson, CFO

Carl, it's Pete. Good afternoon. We are anticipating a turnaround in 2023, starting in the first quarter. The extent of this turnaround, whether it happens quickly or later in the year, remains uncertain. Some of this is due to employee turnover and efficiency issues. We have experienced some turnover, and our production process has not achieved the efficiency we typically expect. As Joe mentioned, we have new leadership on the team, which has brought a renewed focus to these initiatives. The team has worked diligently in the fourth quarter and even after the year ended to identify ways to enhance our margins and production efforts, and we are excited about the progress.

Carl Byrnes, Analyst

And then just a follow-up, unrelated but on the physician segment. Are you seeing patients being displaced or warehouse in the physician segment? So, are they potentially going to other segments for treatment? Is that a factor here amid the reimbursement uncertainties? Thanks.

Pete Carlson, CFO

I don't think so. What’s difficult to determine is how much of this might be over-utilization due to financial incentives and how much is simply market share that we're not capturing because we're not involved in that area. As time goes on and this situation resolves, we’ll have a clearer understanding, and I believe we’ll start to capture more of that market share.

Swayampakula Ramakanth, Analyst

This is RK from H.C. Wainwright. I have a couple of quick questions regarding the Wound & Surgical business, specifically about building a portfolio of new products. First, how did the new products perform over the year? Second, what types of products should we expect in 2023?

Pete Carlson, CFO

RK, it's Pete. What I would be very happy to tell you is the new products did quite well in 2022 and really met our expectations for the year. The team did some great work even with some of the delay from what we might have thought the initial launch date was. So, we have a lot of good momentum on these products coming into 2023. As it relates to products for this year, I would certainly highlight the opportunity that the Turn transaction reflects for us. And as a reminder, there's two pieces to that. There's some frankly, intellectual property estate that we have access to now. We have a license in the antimicrobial aspect, as well as a product that they have in development and in front of the FDA that we would have a commercial license opportunity once that approval is in place. Joe, anything you'd add on the new product front?

Joe Capper, CEO

Yes. I would just say, RK, from my perspective, a new guy coming in, I'm trying to assess various parts of the business. When you have a commercial team that can take two new products and move them into the market as rapidly as this team did, you're in a pretty good spot. A lot of times, commercial teams that don't operate as effectively struggle with new products. So, what does that tell me? And I'm going to temper my own enthusiasm for you. It tells me that there's a lot more I can do with this commercial organization. And there's a lot more this sales and marketing team can do.

Swayampakula Ramakanth, Analyst

But talking about the ability to do a lot more, you also highlighted expansion geographically. So when you say that, are you talking more within domestic geographies, or are you also talking about international geographies?

Joe Capper, CEO

We have under-penetrated regions in the U.S. and will consider adding resources if the business justifies it. Our initial focus is on Japan, and as we enhance our strategic planning process, we may identify other countries as potential opportunities.

John Vandermosten, Analyst

Good evening, Matt, Pete. And welcome aboard, Joe. Let me start out with a question on Japan to kind of continue the theme on here. And as you said, that's one of the areas that you expect to grow in. Knowing now that you've got a foothold in the country, what other products might be appropriate for that market? And is that something that you'll think you might do now that you have the infrastructure in place?

Joe Capper, CEO

Yes. Really too early for me to answer that question, John. It's a good one. And again, I think as we go through the evaluation of various opportunities, we'll look at that, but I can't give you any more color on that today.

John Vandermosten, Analyst

I have a question for you, Pete, about R&D. Now that we have started the KOA trial, how should we consider the additional costs in 2023 compared to 2022 in the R&D segment?

Pete Carlson, CFO

When you look at R&D overall, there certainly will be an increase between the two years. The increase will be concentrated in the Regenerative Medicine segment. We've talked about those trials, individually, those trials being somewhere in the $20 million, maybe $25 million cost level. And that cost is going to be incurred over a multi-year period. For this first trial, it will be principally 2023 and 2024 with some of that front-loaded.

John Vandermosten, Analyst

Okay. I understand. Yes, that makes sense. Regarding the two trials you're going to conduct for KOA, will there be any overlap? Will you wait to analyze the results from the first trial before discussing with the FDA and starting the second one? How do you anticipate the timeline will work for both trials?

Pete Carlson, CFO

The second trial is expected to be our pivotal trial, and it is crucial that we have our final commercially ready product prepared by then. This is the main factor influencing the timing of that second trial, which will require collaboration with the FDA as well as our internal efforts. If we are ready before the first trial concludes, we will evaluate the situation, and it is possible that the timing of the two trials could overlap. However, the key consideration remains our interaction with the FDA and our readiness related to the chemistry, manufacturing, and controls process for the product.

John Vandermosten, Analyst

Okay. No, that's some good detail there. And last question for me is on the growth that you expect. There's a few different components of growth, organic product growth, international sales, and new products. How do you break that down among those three components?

Pete Carlson, CFO

Certainly, the predominant driver is our existing book of business. And now as you think about your existing book of business, that includes these two new products we launched in 2022. So that's going to be a predominant driver. New products are a driver as well as the growth in Japan and other countries. So they are all pieces of it. We're pleased with the way that the team has performed domestically, again, 10-plus percent growth year-over-year, driven by the new products, driven by our work in the surgical recovery application, and it's driven by the team's efforts working in some tough environments in that private office setting. So we're pleased with that and look for that to continue.

Anthony Petrone, Analyst

Appreciate that. Just a follow-up on some of the proposals MiMedx has out there as it relates to physician office reimbursement. Just kind of thinking of a scenario here. In other words, if there's acceptance on other products having to secure a tissue reference group letter from FDA and that all there should be uniformity that all of these skin products should be on the Medicare ASP list. If that sort of is accepted and plays out, what is the potential for some of these products to drop out of the market, A, and what would be the upside for EPIFIX if the MiMedx proposals are adopted?

Pete Carlson, CFO

Anthony, it's Pete. You raised a valid point, and I'd like to share some personal insights on this. Internally, we believe that as companies in this sector face regulatory requirements, such as obtaining a tissue reference group letter to clarify that their product is classified as 361 and undergoing related FDA inspections, some may not be willing to put in the effort to comply. Consequently, we anticipate that a few companies might exit the market. It's difficult to predict when this will occur. However, the TRG requirement is currently being addressed in proposals involving certain local coverage determinations. As you know, we have this requirement for our sheet products, particularly our core EPIFIX line, which constitutes 90% of our portfolio in private office settings. Therefore, we feel confident in that area. You've made a strong point about the increasing regulatory burden; as it becomes more established, we might see some products leave the market, which could create a potential advantage for us.

Joe Capper, CEO

So Pete, we do grow in this segment, right? We grow in this segment today. We just don't grow as fast as we do in other segments. So when price is not the issue, when we're competing on clinical efficacy, we win. And to the extent that we level this playing field, we will win more often. So to Pete's point, it will equate to some upside for us. It's hard to quantify that because, again, you have to take into account that some of this may affect the overutilization.

Pete Carlson, CFO

Yes, I agree with that.

Carl Byrnes, Analyst

Thanks again for the follow-up question. Pete, you touched on this with respect to the Turn and licensing program. Can you just remind us when the PDUFA action date is on FleX AM, which is the bovine collagen powder product? And then also unrelated but quasi related, any comments or thoughts in terms of potential tuck-under acquisitions that could augment the Wound & Surgical segment as well?

Pete Carlson, CFO

I'll begin with your first question and then let Joe address the second. There is no date to reference regarding the approval or receipt of approval from the FDA for the 510(k) submission from Turn for the Flex product. We are currently engaged in the usual back and forth with the regulator who is asking questions. Therefore, we do not have a time frame to provide.

Joe Capper, CEO

Yes. As far as adjacency, it's too soon to start talking publicly about. I think the most important message to you guys is it's a focus point. We've formalized the planning process, and we've put a core group together within the Company. So really, it's laying the groundwork.

Operator, Operator

And we have reached the end of the question-and-answer session. I'll now turn the call back over to the CEO, Joe Capper for closing remarks.

Joe Capper, CEO

Thanks, operator. Thank you, everybody, for your questions and for your interest in the Company. We look forward to talking to you in a few months. That concludes today's call. Thanks again.

Operator, Operator

And this concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.