Earnings Call Transcript - MDXG Q1 2021

Operator, Operator

Thank you, operator, and good morning, everyone. Welcome to the MiMedx first quarter 2021 operating and financial results conference call. With me on today's call are Chief Executive Officer, Tim Wright; Chief Financial Officer, Pete Carlson; and Executive Vice President and Chief Commercial Officer, Rohit Kashyap. Tim and Pete will provide a summary of the operating and financial results for the first quarter 2021. And at the conclusion of their remarks, Tim, Pete, and Dr. Kashyap will be available for your questions. Before we begin, I would like to remind you that comments made during today's call include non-GAAP financial measures, and we provide a reconciliation to GAAP in our press release, which is available on our website at www.mimedx.com. Also, our comments today will include forward-looking statements. While we discuss some reasons why we are optimistic, actual outcomes and results are subject to risks and uncertainties and may differ materially from those anticipated due to many factors. Listeners are directed to the cautionary notes in the press release issued today as well as the risk factors set forth in the MiMedx 2020 annual report on Form 10-K for factors that could cause actual outcomes and results to differ materially from those reflected in the forward-looking statements. The company assumes no obligation to update or supplement any forward-looking statements, except as required by law. In particular, Tim will mention expected clinical trial, FDA submission, and approval and product launch timelines for both plantar fasciitis and knee osteoarthritis. Obviously, there can be no assurance that our clinical trials will produce favorable results and the actual timing of trials, BLA submissions to the FDA, and approval will depend on a number of factors, including COVID, the results of our clinical trials, and other factors that may be outlined in our meetings with the FDA. Today's prepared remarks will be followed by our typical question-and-answer session, during which time you will have the opportunity to ask management about our most recent quarter. As a reminder, the purpose of the call is to discuss our financial and operating results and we appreciate you keeping your questions focused on that topic. Please be advised that the company, its directors, and certain of its executive officers are participants in the solicitation of proxies from the company's shareholders in connection with the 2021 annual meeting. The company intends to file a definitive proxy statement with the SEC in connection with any such solicitation of proxies. Shareholders are strongly encouraged to read such proxy statement once available, and all other documents filed with the SEC carefully and in their entirety as they contain important information. Information regarding the identity of the company's participants and their direct or indirect interests by securities, holdings, or otherwise can be found in the company's annual report on Form 10-K for the fiscal year ended December 31, 2020, and the company's definitive proxy statement for the 2020 annual meeting and other materials filed with the SEC, and updated information will be included in the company's definitive proxy statement for the 2021 annual meeting and other materials to be filed with the SEC. These materials can be obtained free through the company's website in the section titled investors or through the SEC's website at www.sec.gov. With that, I'm now pleased to turn the call over to Tim Wright. Tim?

Tim Wright, CEO

Thank you, Jack. Good morning, everyone, and thank you for joining us on today's call. Yesterday afternoon, we issued a press release reporting our first quarter '21 operating and financial results. I'd like to start today's call with a review of our commercial business and then move right into an overview of our progress to date on our promising late-stage pipeline. After I complete my opening remarks, Pete Carlson, our CFO, will take you through a full discussion of our first quarter results. MiMedx reported 4% growth in adjusted net sales in the first quarter, driven by our Wound Care business. This included the positive impact from sales of our recently launched EpiCord Expandable product. We further attribute the recent growth in our business to a number of strategic changes and investments we've made with our commercial organization. These fundamental changes, coupled with the addition of talented representatives are designed to accelerate our top line growth. Not only are we making the right changes in investments within our core business, we are retaining the right people to keep our transformation and momentum going. We continue to recruit highly skilled individuals with experience in biotechnology and tissue segments of the health care industry. Supplementing these hires by focusing on supplying them with a refreshed training model and clinically-oriented selling tools. The people we are onboarding are focused on selling our current portfolio of products and understand the fundamental science that differentiates our products and believe in our core mission, vision, and values. I'm pleased to report that our sales representative headcount stands at 284 people strong. To further supplement our sales representatives with the right tools, our market access group continues to expand the availability of MiMedx products to the wound care patients through increased coverage by leading payers around the country. As you recall, in November of last year, the largest commercial payer in the United States added EpiFix to their list of covered products. As a reminder, EpiFix is the only amniotic tissue-based product to receive coverage for diabetic foot ulcers by this payer. Following this big market access win, we were pleased to announce that on April 1, Premier awarded MiMedx an amniotic tissue supplier agreement under their Surpass purchasing program. The agreement allows Surpass to take advantage of special pricing and terms prenegotiated by Premier for MiMedx's amniotic tissue product. We believe that this agreement strengthens our position as an industry leader in amniotic tissue-based products backed by the best class clinical evidence, along with broad coverage and reimbursement. We're excited about these new partnerships and remain committed to increasing patient access to our amniotic tissue products to heal intractable wounds. I'm also pleased to share with you, we had just received notification that another large national commercial payer added coverage for EpiCord as a medically necessary option in the treatment of diabetic foot ulcers. This, in addition to the previously existing EpiFix coverage, marked another win for the MiMedx team. I want to shift gears now and provide some important updates on our late-stage pipeline. Last week, we announced the final patient visits for our novel therapeutic biologic AmnioFix injectable in the Phase III plantar fasciitis and Achilles tendonitis studies, as well as the final blinded efficacy visits for the Phase IIb knee osteoarthritis trial. The achievement of these milestones represents a pivotal advancement to bring amniotic tissue platform technology to market as a treatment option for a range of musculoskeletal conditions with substantial unmet patient need. As we previously discussed, existing treatments for knee osteoarthritis and plantar fasciitis are suboptimal. There is significant patient interest for alternative options that relieve pain and improve functionality. Today, there continues to be a lack of approved and efficacious treatment, particularly in knee OA, which is a widespread debilitating and chronic disease. The MiMedx studies were initially designed to prove clinical efficacy and safety of AmnioFix injectable in reducing pain and improving function of these chronic conditions. With the last patient visits now complete, we will lock the databases and conduct the appropriate statistical analysis and prepare for meetings with the FDA. We anticipate announcing top line results from all 3 studies this summer. As you may recall, our long-standing hypothesis and the feedback from interested physicians is that AmnioFix injectable certainly has the potential to work in Achilles tendonitis. However, the original study design, including patient selection criteria, may not have been sufficiently designed or powered to demonstrate statistical significance and capture all elements of a clinical response. For these reasons, this is why we do not anticipate filing a BLA for Achilles tendonitis at this time. We continue to believe that the safety results from this study could add valuable information to the AmnioFix injectable database, and we intend to include them. Turning now to AmnioFix Injectable for plantar fasciitis. The Phase III study was designed following promising results from our large Phase IIb prospective trial, which was a single blinded randomized controlled trial of 145 patients. We have previously shared that this trial demonstrated a statistically significant reduction in visual analog score, or VAS score, for pain and improvement in the Foot Function Index score. The Phase III trial enrolled 277 patients with an investigator-confirmed diagnosis of plantar fasciitis. The primary endpoints are: change in VAS for pain at 90 days and incident-related adverse events at 180 days, serious adverse events and unanticipated events during the first 12 months post-injection. The secondary endpoints include: self-reported responses to the Foot Function Index at 90 days. In this case, the BLA filing will require gathering data from 2 adequate and well-controlled clinical trials. Development of these tests to demonstrate consistency and reliability of our manufacturing process, along with satisfactory completion of an FDA inspection of our manufacturing facilities to comply with the agency's good manufacturing practice regulations. At this point, we believe we are on target to meet all these criteria in the coming months and remain on track to file our first BLA in the first half of 2022. Another potentially significant opportunity coming out of our pipeline is the initiation of a Phase III study in knee osteoarthritis. We are currently exploring ways to accelerate the timeline for this clinical study, assuming a positive outcome from our Phase IIb results, with our announced plan to initiate Phase III in the first half of '22. Osteoarthritis, or OA, is by far the most common joint disease and millions of adults experience pain and decreased quality of life every day because of joint destruction caused by OA. According to published data, osteoarthritis is responsible for a staggering public health and economic impact. More than 242 million people worldwide currently suffer from symptomatic OA of the knee and hip, and 45% of all people have a lifetime risk of developing OA of the knee. OA is responsible for $71 billion in lost earnings in the United States. Although knee replacement is an option for those with advanced knee arthritis, it carries significant risk, and current treatments, including oral anti-inflammatory medications, cortisone injections, and hyaluronic acid injections are all limited in the amount of relief they can provide. Additionally, anti-inflammatories have negative cardiovascular effects, and injectable steroids may cause further joint deterioration with chronic use. Current projections indicate that nearly 18 million Americans suffer from osteoarthritis annually. Today, we estimate the injectable size of the market for our products to range from 1 million to 1.5 million patients per year. And that is only based upon 1 injection in 1 knee per year. The opportunity for MiMedx is potentially significant. And our goal is to file a BLA in the second half of 2024 or early 2025, with an emphasis in 2021 to accelerate timelines. I'll pause here to provide a comment on our thinking with respect to the ability of our PURION processed amniotic tissue AmnioFix Injectable to slow the progression of knee OA. Based on our ongoing research, we have uncovered a novel mechanism that may indeed support our PURION processed amniotic tissue as a candidate for disease-modifying osteoarthritic therapy. This is very early research, yet very, very encouraging. In addition to these exciting therapeutic biologics, we are working towards filing 2 INDs for our injectable product in the treatment of chronic cutaneous ulcers and surgical incisions, and an IDE or investigational device application for AmnioFill in the treatment of soft tissue defects. Last Friday, we received notice from the FDA that the first of 3 of our 3 investigational new drug applications were accepted and now in effect. This IND was filed for chronic cutaneous ulcers, and we'll keep you apprised as to the progress towards filing the additional applications once they have been successfully accepted by the FDA as submitted. Finally, I'm pleased to announce the appointment of Dirk Stevens, PhD, as a Senior Vice President, Quality Assurance and Regulatory Affairs. Dr. Stevens brings more than 35 years of strategic leadership experience in quality management and regulatory compliance across multiple device and pharmaceutical companies. The addition of Dr. Stevens exemplifies our ongoing commitment to advancing the quality standards for both science and manufacturing in our industry; his extensive operational insight, relevant experience and regulatory review and submission processes and proficiency in the quality system assurance will be instrumental as we continue to advance our late-stage pipeline under good manufacturing practices. Dr. Stevens joins us from Smith & Nephew, where he was accountable for regulatory submissions, compliance and commercial quality assurance. Before we get into the first quarter results, I'd like to spend a minute putting into perspective our business development thinking. Consistent with our fiduciary responsibility to all shareholders, we continuously evaluate the most productive choices for investments and capital deployment. Several months ago, we stated that we would consider inorganic growth as an option with the goal of potentially adding to top line growth in 2021 and support other aspects of our BLA filings. As a company, we intend to adhere to a stringent criteria whenever we consider and evaluate potential business development opportunities, and we'll continue to leverage valuable input and oversight from our highly experienced Board of Directors. I will underscore that, in general, we employ a rigorous process in evaluating any business development opportunity, and steadfastly adhere to our commitment to build shareholders' value in all that we do. The evaluation of business development opportunities is no exception. In 2021, we began the year evaluating opportunities that could particularly mitigate any risk from change in our business environment, such as the end of enforcement discretion, and our thinking proved correct in this matter. We also employ a process where we look for products with low regulatory risk in the field of regenerative medicine. That can be integrated easily into our portfolio, predominantly through a licensing agreement. As a general rule, we require that any transaction enhance our competitive position by expanding either our intellectual property estate, operating margins, or international footprint. Lastly, it is critical that any transaction be accretive to adjusted EBITDA within 2 years of acquisition. While we have a clear set of standards for inorganic growth, our focus today is on organic growth rather than inorganic growth. We are on the verge of some very important data readouts that are likely to change the future of MiMedx going forward, and we look forward to providing you those updates at the appropriate time. Now I'd like to turn the call over to Pete to take you through our financial results in Q1.

Pete Carlson, CFO

Thank you, Tim, and good morning, everyone. I will provide an overview of our first quarter 2021 financial results, starting with an update on some of the underlying trends in our business. Overall, we saw growth in demand across our core portfolio as patients return to the hospital for treatment of their wounds and hospitals return to a more normal operational workflow. Additionally, as Tim noted, our new EpiCord expandable product line launched this past September drove additional increased demand during the first quarter. Net sales for the first quarter ended March 31, 2021, were $60.0 million compared to $61.7 million for the same period in 2020. Net sales for the first quarter of 2021 and 2020 included the benefit of $0.3 million and $4.5 million, respectively, resulting from the change in revenue recognition methodology. Adjusted net sales, which excludes impacts of the company's transition in revenue recognition, were $59.7 million in the first quarter of 2021, an increase of 4.2% from the same period a year ago. Gross margin in the first quarter of 2021 was 83.9% compared to 83.8% in the first quarter of 2020. Selling, general, and administrative expenses, or SG&A, for the first quarter of 2021 were $45.2 million or a decrease of 3.8% compared to the first quarter of 2020. The year-over-year decrease was driven by lower travel expenses due to government and company-imposed restrictions on travel to mitigate the effects of the COVID-19 pandemic. Research and development expenses were $4.3 million for the first quarter of 2021 compared to $2.8 million for the same period last year. The increase reflects our planned investments to support the company's clinical research efforts and includes increased consulting fees, headcount additions, and additional activity in our preclinical studies. We continue to expect that these costs will increase over time as we plan to file the additional INDs and continue working towards the filing of our BLAs, as Tim discussed. Investigation, restatement and related expenses for the quarter were significantly lower at $7.2 million compared to $15.6 million in the first quarter of 2020. As a reminder, we do not anticipate incurring any more costs related to the Audit committee investigation or restatement of our prior period financial information as both of these are complete. Other decreases were driven by fewer expenses incurred relative to obligations to advance litigation defense costs to former members of management. The company is no longer advancing costs to certain former members subsequent to their sentencing in late February. Turning to the bottom line, the net loss in the first quarter of 2021 was $8.4 million compared to a net loss of $4.8 million in the first quarter of 2020. Adjusted EBITDA was $4.7 million in the first quarter of 2021 compared to $3.1 million in the first quarter of 2020, reflecting the factors I've just discussed. Now let me review our cash position. As of March 31, 2021, the company had $84.7 million of cash and cash equivalents compared to $95.8 million as of December 31, 2020. Our healthy cash position continues to provide us the flexibility to invest in our key initiatives for both our core business and R&D pipeline. Moving now to an update on enforcement discretion. On April 21, 2021, the FDA reaffirmed that the period of enforcement discretion would not be extended and would therefore end on May 31, 2021. As you know, this applies across the industry to products that do not meet the criteria for minimal manipulation and homologous use as outlined in Section 361 of the Public Health Service Act. Our understanding is that the FDA intends to take action regarding unlawfully marketed products that do not have an IND in effect or an approved biologics license. We believe without the approval of such a license, this means companies are no longer able to actively market the Section 351 products to health care providers and patients after May 31, 2021. To put things in proper perspective, sales of marginized and particulate products have represented approximately 14% of the company's net sales for the 3 months ended March 31, 2021, and 13% for the year ended December 31, 2020. Given the FDA's reaffirmation of the end of enforcement discretion, the company now expects adjusted net sales for 2021 to be consistent with that amount in the prior year. This is in line with the expected impact previously disclosed in our 2021 outlook within the company's annual report on Form 10-K for the year ended December 31, 2020. It's important to understand that we regularly engage with representatives at the FDA and are committed to adhering to their standards and requirements. We agree with and welcome the rigor to ensure quality, and we continue to align our plans with theirs in an effort to remain fully compliant with their guidance and direction on enforcement discretion.

Tim Wright, CEO

Thanks, Pete. In summary, we made significant progress on our transformation strategy in a compressed period of time and are starting to see tangible results stemming from our efforts and initiatives. We continue to meet with and take calls from a variety of investors interested in our business and our pipeline. Significant financial investments in R&D and commercial are now possible with most accounting and legal issues resolved. We have several priorities and milestones ahead for 2021: pipeline acceleration, improving our understanding of the full potential of our products based on their mechanism of action, sales force expansion, successful registration of EpiFix in Japan, CGMP compliance and building a world-class regulatory, quality and medical affairs team, just to name a few. We're building on a strong foundation we created in 2020, and are committed to delivering operational excellence across all functions for all stakeholders, increasing the value of our PURION amniotic tissue-based platform. Expanding the body of scientific evidence for our product portfolio of products, increasing patient access to the best possible wound care through an expanded coverage, and advancing our innovative pipeline of musculoskeletal therapies are 4 key priorities that we will unlock the value for shareholders, and our entire company is ready to deliver. Now before we open the call for questions, I'd like to briefly address Precious Point, nomination of 4 Director candidates to stand for reelection at our 21st Annual Meeting. The MiMedx Board is made up of 9 experienced and highly engaged directors who are committed to acting in the best interest of all MiMedx shareholders. As part of this commitment, the company maintains a consistent and open dialogue with shareholders, including Precious Point. It's unfortunate that Precious Point is pursuing a potentially costly and distracting proxy contest instead of working constructively with the company. Among the 4 directors, Precious Point is seeking to replace 2 of their own nominees from 2019, our Board Chair, Dr. Kathy Behrens; and our Audit Committee Chair, Mr. Todd Newton. Both have been outstanding leaders and made significant contributions to our successful turnaround and to the creation of additional shareholder value. Under this Board's stewardship, the MiMedx management team is executing on its strategy and driving enhanced shareholder value and patient value. Over the course of 2020, MiMedx successfully implemented a number of governance, operational and financial initiatives that were critical to the company's future success and potential. Our significant progress has created a strong foundation for growth in '21 and beyond. With that, I'd like to underscore that the purpose of today's call is to talk about our financial results. We will not be commenting further on Precious Point on this call. We appreciate you keeping your questions focused on our results.

Operator, Operator

Our first question comes from Swayampakula Ramakanth with H.C. Wainwright.

Swayampakula Ramakanth, Analyst

A few questions from me. So starting off on the top line. In the press release, you stated there was a decline in year-over-year sales due to a decrease in recognition of contracts, which is not quite a bit, it's just $0.3 million, but compared to $4.5 million from the previous time period. I'm just trying to understand what this statement means. Does this mean that you did not receive contracts of similar or increasing value in '21? Or you are ending up some existing contracts, and they were not renewed for 2021? I'm just trying to understand how to think about this number going forward.

Pete Carlson, CFO

It's Pete. The remaining contracts refer to our change in the way we recognize revenue. When we switched from cash receipts to the as-shipped method on October 1, 2019, we had several contracts for shipments that had already been made, bills processed, and cash not yet received. We've separated these out, which explains the difference between reported net sales and adjusted net sales. There was a fixed amount of about $40 million at that time, and by the end of 2020, there was $1.2 million still to be collected, with $0.3 million collected this year. We anticipated that amount would decrease as we collected on it. These sales occurred prior to the fourth quarter of 2019. This disclosure aims to clarify the numbers to show more comparable adjusted net sales. These are not lost contracts; they simply reflect the remaining balance we are collecting from, which has been declining over the past quarters.

Swayampakula Ramakanth, Analyst

Regarding the April '21 announcement from the FDA, which indicated that enforcement discretion would begin by the end of May, and the subsequent impact, which accounted for about 13% of your 2020 revenues. I understand that, but what steps is your commercial team and management taking to address that loss moving forward? Are there plans to expand other revenue streams or introduce new revenue sources to prevent it from becoming a larger issue in the future? My question specifically pertains to sales and the top line, noting that you have significant R&D expenditures, which is a separate matter.

Rohit Kashyap, CCO

This is Rohit. That's an excellent question about what we are aiming to achieve regarding our products and their application in clinical practice. We are assessing the areas where alternative therapies can be utilized, particularly with our sheet products that can replace micronized products that will no longer be available due to the 361 path. This will enable us to retain some existing business. Additionally, we are placing greater emphasis on our sheet products to tap into their potential for growth. We are also mobilizing our medical education team to effectively communicate our value proposition, and we recently released health economics data on the sheet side, which will help us offset some of the impacts. While we cannot promote those products directly and have not been doing so in compliance with enforcement discretion, we will continue to seek opportunities to expand and grow our business while mitigating the impact. We remain optimistic and confident that we can maintain an above-market growth rate of over 10% as we move past the enforcement discretion period.

Tim Wright, CEO

Thank you, Rohit. This is Tim. Regarding business development, as we mentioned earlier, we've been approached by several companies about licensing deals that potentially meet our scientific and clinical criteria. We are always on the lookout to incorporate suitable opportunities into our representatives' offerings. However, at this time, we are not interested in mergers and acquisitions to offset sales losses. I believe Rohit's team is making a good effort in transitioning from our injectable products to our tissue products in certain contexts, and I am confident that we will be successful in this transition.

Swayampakula Ramakanth, Analyst

I have one last question for Bob regarding the AmnioFix injectable for the PF indication. I understand that the data will be released in the summer. What do you need to show to obtain FDA approval? Additionally, what other tasks need to be completed between this summer and the middle of 2022 when you plan to file the BLA?

Tim Wright, CEO

Yes, that's a good question. We have successfully completed our last patient out for the PF. Now we are in the process of cleaning up the database, finalizing it, implementing our statistical analysis plan, and engaging with the FDA. The significant steps have been completed: the analysis of the Phase III trial and discussions with the FDA. Another critical aspect is ensuring that our manufacturing facility meets GMP standards. A major component of the BLA filing will involve the chemistry manufacturing control section, which we have been working on for two years to ensure we meet the essential quality metrics expected by the FDA. This area is very important to us, and I am confident in our ability to file our BLA in the second half of 2022. I have outlined the three major steps involved, although there are numerous smaller steps as well. What is encouraging is our ongoing communication with the FDA on this matter. This isn't a typical route, and the level of cooperation we have received from the agency has been excellent, both in manufacturing and clinical development. These are the primary areas of focus for us. The recent addition of Dirk Stevens to our team has also been significant, especially regarding quality and GMP in chemistry, manufacturing, and control. We are well positioned to complete everything needed and file our BLA.

Swayampakula Ramakanth, Analyst

So a quick follow-up, Tim. On the GMP facility, once you have this audited and validated, what all products will be produced through this facility so that you don't have to kind of answer this question to the FDA in the future on any of your products?

Tim Wright, CEO

Yes, I believe we won't need prior approval inspections for knee osteoarthritis. This is advantageous as we prepare our biologic license application for PF, even though it is still early in that process. Having an approved facility and comprehensive data on purity, potency, and stability included in our BLA package for PF will be very beneficial. Our intention is to manufacture all products under Good Manufacturing Practices (GMP), which is crucial for the industry and highlights our commitment to producing high-quality products in the future. GMP is a vital component of our strategy to ensure consistent production of our products every day. I'm confident in our approach to GMP, and it will influence our entire portfolio.

Operator, Operator

Our next question will come from John Vandermosten with Zacks.

John Vandermosten, Analyst

I would like to expand on the earlier questions regarding the implications of enforcement discretion over the coming year. First, can you describe what the channel will look like as of May 31? Will everything that was already requisitioned continue to go through, or could you explain how that might function?

Pete Carlson, CFO

John, it's Pete. The end of enforcement discretion, what happens that day is we are no longer able to sell after that day. So sales up until that day will continue. At this point, some of the details are still being worked through. But at this point, there is no product recall aspect of this. So sales up through that day. And then after that, we don't ship the product out without the biologic license application approved. Obviously, we'll have some production going on and some product will be out and about related to our clinical trials, and there might be an opportunity to expand those trials to continue to get product into patients' hands. There's a lot of guidelines around that. But as far as normal sales, they stop as of May 31.

Tim Wright, CEO

John, you raised an excellent question. I want to provide some context for our patients and physicians. We have had many discussions with the FDA about patient access. If you're a patient who has been using our product for the last five years or two years, you would want to maintain continuity in your care. We have emphasized to the FDA that it's important to continue providing patient access to our product. There is potential within the FDA's guidelines for expanded access under a cost recovery model, and we are actively working on that with the FDA. This is in the best interest of both the physicians and patients we serve. Once we have more details, we will share that information with our investors. It is also crucial to communicate this with our physicians and other healthcare workers who have been using these products safely and effectively. From our viewpoint, we have a duty to ensure that patients have access to our products, and I believe we can achieve this through expanded access.

John Vandermosten, Analyst

Okay. I know it's only been about a week, which may not be enough time to gather feedback, but what have you heard from the doctors and users of micronized products so far regarding the upcoming cutoff in about 4 weeks?

Tim Wright, CEO

I think there's some misunderstanding. Each company has its own unique situation regarding what they can and cannot do. Some companies believe that if they have an IND on file, they can still sell their products. However, that hasn't been our discussion with the FDA. In April 21, Dr. Mark outlined all the work that has been done since 2017, providing companies with the chance to file INDs and pursue BLAs. They also emphasized the end of enforcement discretion. There seems to be considerable confusion on this matter. I can confirm that I have had conversations with Dr. Mark and his team about it. We intend to clarify this for our patients, physicians, and healthcare systems through continuous dialogue with them, which will be backed by the FDA.

John Vandermosten, Analyst

Okay. Okay. Yes, complex issue. And I guess we'll find out how it comes out in another couple of months. I want to move on to the IND that was cleared chronic cutaneous ulcers. So how does this indication expand where the product is already used?

Tim Wright, CEO

Yes. All the clinical work for our products has been done in the DFU, VLU, there are other indications that we'd like to pursue. And if you see where the regulatory environment is heading, it makes sense to have discrete indications that can be reimbursed in the future. Look, the beauty of our amniotic tissue platform, I think, is important to stay here. If you think about it, MiMedx was a pioneer in reducing to clinical practice, their amniotic tissue membrane that was produced by a proprietary system engineering system called PURION. Okay. I do not believe that all amniotic tissue is created the same. Our PURION process is a unique process. It's pristine in how it delivers a finished product. The first application was in Advanced Wound Care. This company grew dramatically during that period. It was very disruptive to wound care. It's going to be disruptive in the musculoskeletal space as well. The flexibility, the strength of our amniotic tissue platform is rare to be able to expand into other indications. This whole musculoskeletal space has an enormous amount of unmet need. We're tackling knee osteoarthritis. If we're successful there, we changed the complexion, not only in this company but as an industry, and it would be well welcomed by patients and physicians. Other indications like Achilles tendinitis or plantar fasciitis, it's just the start with this platform. We feel we can extend that into other areas and we're exploring those other areas. We're just not ready to initiate and pull the trigger on an IND. But if you think about it or partial thickness tears of rotator cuff, very important area here. If you can avoid surgery in that area and avoid the recuperation of the rehab process, it's very significant for that patient. So I think this amniotic tissue membrane platform is very unique. It's supported by an outstanding product that's been engineered very successfully here. We need to build on the clinical data, and we need to produce these products in a GMP environment. So that's the cool thing about this company. It's very rare where you have a company that has the potential to keep adding indications based on their underlying amniotic tissue platform technology.

Rohit Kashyap, CCO

I'd just say the chronic cutaneous includes all the pressure ulcers along with venous and the diabetic foot ulcers and almost the pressure ulcers are almost as big in market opportunity as the other 2 combined. So there's a huge potential that it allows us to access. But as Tim mentioned, where exactly that product with the IND is applicable and how big that opportunity is, we're still quantifying it to give you more precise aspects of that as we go forward.

Operator, Operator

Ladies and gentlemen, thank you for participating in today's question-and-answer session as well as today's conference call. You may now disconnect, and have a wonderful day.