MiMedx Group, Inc

Greetings and welcome to the MiMedx Group second quarter 2022 operational 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. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Jack Hallworth, Senior Vice President, Investor Relations for MiMedx Group. Thank you. You may begin.

Thank you, operator, and good morning, everyone. Welcome to the Memetics Second Quarter 2022 Operating and Financial Results Conference Call. With me on today's call are Chief Executive Officer Tim Wright, Chief Financial Officer Pete Carlson, President of Wound Care and Surgical, Dr. Rohan Kashyap, and President of Regenerative Medicine and Biologics Innovation, Dr. Robert Stein. Tim and Pete will provide a summary of our operating highlights and financial results for the quarter, And at the conclusion of their remarks, Tim, Pete, and Doctors Keship and 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 potential timelines for our ongoing clinical trials and FDA submissions and approvals, and expected market sizes for products. These expectations are subject to risks and uncertainties, and actual results may differ materially from those anticipated due to many factors. Actual timing and FDA approval will depend on a number of factors, including the results of our clinical trials, our interpretation of those results, the impact of COVID-19, actions by others that affect our timeline, and other factors that the FDA deems important. Additional factors that could impact outcomes and our results include those described in the risk factor 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 Tim Wright. Tim?

Thank you, Jack, and good morning, everyone. I appreciate you calling in. I'm going to start off today with five very important news items. Number one, I want you to know how excited I am about the strong commercial momentum. This momentum has led to four sequential quarters of double-digit revenue growth in our continuing portfolio of products. I'm energized about the performance of our commercial team. We are on strategies. and more patients are being treated with better outcomes. Number two, the memetics expanded research and product development team is creating new and novel products to meet the unmet clinical needs of our surgical community. I am very pleased to share that two new launches are on track for September. Number three, we are preparing for the launch of Perion engineered EpiFix in Japan later this year, as early as September. Perion Engineered EpiFix is the first and only amniotic tissue product approved in Japan. And it's important to note that we have first mover advantage in this large and underserved market. Number four, I want you to know that we are on track to enroll the first patient in our knee osteoarthritis clinical trial by year end. I'm confident. that the important recent progress by our clinical, regulatory, and manufacturing teams increases our overall probability of a successful drug registration. And number five, I think it's worth repeating that our business is generating the cash needed to fuel future investments. And I'm bullish about what can be accomplished in the second half of the year. Starting with our second quarter growth, I'm pleased to report fourth consecutive quarter of double-digit revenue growth in our continuing portfolio of products. Tissue and cord revenue grew 11.6% over last year, with a strong performance in our surgical recovery business. Surgeons are incorporating our products to biologically enhance procedures where patients are at risk of potential complications. This can be in surgeries where there are wound-adjacent, for example, podiatric surgical wounds or orthopedic lower extremity procedures, or in areas where we are leveraging our direct and agency relationships to expand our reach and our customer base. We have strong momentum here. I would like to share with you that our two upcoming product launches are on track for full release in September. Innovation is an important part of our near and long-term growth potential. And I'm excited that our research and product development engine is developing new and novel products that meet specific unmet patient needs. In June, we initiated a limited market release of AmbioEffect. And surgeon feedback has been positive. AmbioEffect offers a thicker graft with broad size availability and complements our leading AmbioFix products. and amniocord brands in the surgical suite. Axiophil is a placental collagen matrix product. It offers a flexible form factor that can be easily applied to deep, tunneling wounds or conform to a large, uneven surface. Axiophil has impressive clinical utility and serves as an outstanding platform for further iterations of new products. What I'd like you to remember is that AmnioEffect and Axiophil are the first new important products we have internally developed for use in the surgical recovery market. The importance of these innovative products cannot be understated, as they not only support our revenue growth goals, but they act as important foundations for future product development. I'd like to turn your attention to the upcoming launch of EpiFix in Japan. We are on track for this launch, as I stated. We plan to launch this as early as September. As I mentioned, EpiFix is the first and only amniotic tissue product approved in the large underserved market, and Memetics has first mover advantage in this market. Our dialogue with the Ministry of Health has been productive, and we believe we're in the final stages of the approval process, nearing in on a specific reimbursement rate. We hired a general manager for this market, and last month, an additional 100 physicians in Japan were trained on the proper use and application of EpiFix. The product is in-country and ready for use, and I'm pleased to share that we will anticipate treating the first patient in Japan later this month. Momedics' commitment to engineering new products, expanding our market and customer base, and generating robust clinical, scientific, and economic evidence all position us to achieve our double-digit growth objective in our commercial business in 2022 and beyond. Transitioning to our regenerative medicine and biologics innovation efforts, I think you'll be impressed with our recent progress. We have an upcoming Type B RMAT meeting scheduled with the FDA to review the results from our Phase IIb knee osteoarthritis clinical trial and our protocol for the next knee OH study. We plan to use WOMAC pain and WOMAC function as co-primary endpoints that are on track to enroll the first patient before the end of the year. We selected and engaged a world-class contract research organization, Nordic Biosciences Clinical Development, an image analysis group, an expert imaging company. With their operational support, we can greatly streamline patient recruitment and accelerate study initiation and enrollment in our upcoming knee outlay trials. And I'm honored to have an exceptional industry and academic experts join Memetics, Regenerative Medicine Scientific Advisory Board. These multidisciplinary leaders will provide guidance on our pipeline initiatives and can help us optimize the overall value of our placental-based biologics pipeline. We view our micronized DHACM platform as a significant future year growth opportunity and want to stress how important it is to do things right. These products are one of a kind and I'd like to reinforce that Memetics has more than a decade of experience with these products. I am confident these recent milestones increase our overall probability of successful drug registration. Memetics is growing, creating value and innovating. The commercial business has strong momentum and is growing at double digit rates. I think it's worth repeating that the business is generating the cash we need to fuel investments in our future. I will now turn the call over to Pete.