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MiMedx Group, Inc
2/28/2023
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.
Thank you, Shamali, 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 a discussion of our financial goals. We will then be available for your questions. Before we begin, I would like to remind you that our comments today will include forward-looking statements, including statements regarding future sales growth, future margins, expected market sizes for our products, 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.mymedics.com. With that, I'm now pleased to turn the call over to Joe Kaplan. Joe?
Thanks, Matt, and 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 offering, 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 an 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 have 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 EVDOT well before the knee OA program is commercially available in the US. 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 to 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 are 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 potential biologics. With an unmatched product portfolio, It 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... And finally, it was important to me that the business was stable with significant opportunities for growth. MyMedx has a large and 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 profiles. Let me shift gears and 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 and surgical markets by enhancing our product portfolio while concurrently expanding geographically. We operate a highly profitable business approaching $300 million in revenue, which we're 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 and 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've 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 and customer relationships and expand the use cases for our products into more areas where chronic and acute wounds are treated. We've 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've 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 am 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 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 NEOA 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 and surgical portfolio, both organically and inorganically. Last year's licensing of the Tern Therapeutics IP estate being a prime example. And finally, our third objective will be to build a 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 and surgical segment contribution margin to at least 30 percent of segment net sales and to get corporate expenses as a percentage of sales to below 20 percent. An important step in this process was to augment the team with the experience and leadership Ricky Whitlow brings as our new Chief Operating Officer. Ricky 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 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?
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