MiMedx Group, Inc

Ladies and gentlemen, thank you for standing by. And welcome to the memetics first quarter of 2022 operating and financial results conference call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone today should require operator assistance during the conference, please press star zero from your telephone keypad. Please note this conference is being recorded. I would now like to turn the conference over to your speaker. Mr. Chad Comer, Senior Vice President of Investor Relations. Please go ahead, sir.

Thank you, Operator, and good morning, everyone. Welcome to the MiMedx First 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 Wound Care and Surgical Dr. Rohit Keshav, and President Regenerative Medicine and Biologics Innovation Dr. Robert Stein. Tim and Pete will provide a summary of our operating and financial results for the quarter, and at the conclusion of their remarks, Tim, Pete, and Drs. Keshav 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 size for these 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 timelines, 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, as we provide a reconciliation to GAAP 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. On today's call, I will highlight some of the key drivers behind our consistent top line growth and provide an update on significant initiatives we have underway to streamline operations, expand our reach, and enhance shareholder value. Yesterday afternoon, we reported the third straight quarter of double digit top line growth in our continuing portfolio of tissue and cord products. First quarter net sales of this portfolio grew 13% year over year. We are executing on the fundamentals of our growth strategy and driving strong performance. Last year, we completely reorganized the sales and marketing teams, taking a major step in improving our ability to execute commercially. We focused on geographic Salesforce optimization and enhanced educational resources to assist our sales force. Additionally, we align the compensation plan to reward revenue growth. I believe we have the most highly trained memetic sales professionals and agency sales colleagues to communicate the clinical and economic value of our market-leading products. In short, the changes we have made to date are working. We are gaining traction in the under-penetrated surgical recovery market by expanding our reach in procedures where our customers are looking for new clinical solutions to address complex cases and where patients are seeking a better outcome. Our commercial research and product development teams are collaborating and executing, allowing us to make significant progress toward our targeted objectives. The initiatives we implemented over the past year are coming to fruition as we continue to execute toward our objective of sustainable double-digit growth. Following the end of enforcement discretion, we faced a 13% shortfall as our Section 351 products came off the market. With this quarter's strong top-line performance in our continuing portfolio, we have essentially closed that gap. A major expected near-term contributor is the launch of EpiFix in Japan following the approval of reimbursement for this product. As a reminder, EpiFix received regulatory approval to be marketed in Japan last June. And since then, we have been in constant dialogue with the Ministry of Health regarding reimbursement and timelines. The reimbursement review process typically takes 9 to 12 months to complete following regulatory approval. Though COVID has slowed down this process for many companies seeking reimbursement decisions in Japan, we will remain vigilant in our efforts to gain full reimbursement approval. In the meantime, we are focused on our launch readiness plans. We have gained the support of local key opinion leaders and prominent medical societies. And I would like to take a moment to acknowledge our marketing, operations, clinical and regulatory teams, all of whom have been instrumental to our progress to date. Thanks to their efforts, we have identified clinical sites for the initial product evaluations and have selected our local distributor as a key part of our go-to market strategy. This distributor will help supplement our direct resources on the ground in Japan, and we are well on our way to putting in place the necessary supporting infrastructure. We remain confident in our ability to secure reimbursement and we stand ready to officially launch the product shortly thereafter. Japan is a very attractive market for us. EpiFix will be the first and only amniotic product approved use, giving memetics a first mover advantage. Our regulatory and clinical operations groups negotiated the labeling for EpiFix in Japan to include coverage for all hard to heal wounds. which is considerably broader than our coverage here in the U.S. We estimate that the total addressable market in Japan is just over 600,000 patients, and we anticipate we can access approximately 100,000 of those patients with our product. Turning now to the planned launch of our two new products in the U.S., AmnioEffect and our Placental Collagen Matrix product, or PCM. We are bullish about these innovative product introductions, both of which we expect to launch in the back half of this year. First, AmnioFix. This is a membrane product similar to EpiFix and AmnioFix, but is thicker and can hold a suture. At launch, our direct and agency sales teams will target surgical procedures where a surgeon needs to anchor or suture the graft, such as in a rotator cuff repair or a complex wound reconstruction. Customers with experience using our amnio cord portfolio have been asking for a larger size offering, and we believe amnio effect can address that market need. We are on track for a limited market release next month and have more than 20 unique sites identified for the first clinical evaluations. Our second product introduction, PCM, is made from the placental disc. and will be available in a particular format for use primarily in complex wounds that are deep tunneling or difficult to reach with conventional products. Advisory panels that evaluated PCM provided positive feedback and shared excitement about its features and benefits. We know the target market for this product and our sales representatives and medical liaisons will be ready to engage those customers when the product is ready to launch. Transitioning to our novel late-stage drug biologics pipeline, we view our micronized DHACM injectable platform as an outstanding opportunity, and we are taking meaningful steps to accelerate the start of trial enrollment in our planned NEOA clinical trial program. Our clinical operations team, under the leadership of Dr. Bob Stein, is preparing for the initiation of our next studies in knee osteoarthritis. And consistent with the industry best practices we're lining up industry leading clinical and scientific resources to augment our own efforts, along with world class experts in the field of osteoarthritis. We have been big rigorously assessing third party collaborators who can help oversee clinical trial site monitoring data management statistical analysis and reporting activities and I look forward. to updating you on our progress in the very near future. Furthermore, I'm excited to share that we are well on our way towards the formation of an exceptional scientific advisory board charged with providing both external expert and clinical perspectives and high-level counsel on the company's micronized de-hackam injectable pipeline and EOA, as well as other indications in musculoskeletal disease and in sports medicine. These individuals share our enthusiasm about memetics' micronized DHACM placental biologic injectable and are eager to be engaged with us to help drive our registrational studies forward. In addition, I've asked our R&D teams to accelerate our publication strategy. It is imperative we fast track these research initiatives to build on the data derived from our Phase IIb KOA study and further educate the market on the potential impact of micronized DHACM on the underlying disease process. If approved, we see blockbuster revenue generation potential in these programs and we are working to accelerate our path to serving these patients suffering from a gaping void in safe and effective treatment options for patients suffering from knee osteoarthritis and other diseases where our underlying mechanism of action can be clinically beneficial. Now, turning to strategic initiatives, in April, we created two defined cohesive internal business units within the company. The first is focused on wound care and surgical recovery markets, our existing product portfolio, and near-term innovation. This team is charged with growing our existing business, and an important part of that is the development and launch of two new products each year. we are focused on significantly improving our overall product vitality index. The second business unit is focused on regenerative medicine technologies, specifically progressing our placental biologics platform towards registration as an FDA-approved biological drug in the treatment for knee osteoarthritis. This organizational structure allows for each business unit to focus on areas where they can create the most value for our patients and our shareholders. The senior leadership team we have assembled at Memetics is talented, experienced, and well-equipped to accomplish these strategic initiatives that we have outlined. And I'm confident that this realignment best positions our collective abilities to innovate, execute, and achieve the next phase of growth and R&D milestone achievements for Memetics. These are exciting times for your company. The commercial business is consistently performing and growing at double-digit rates. Moreover, it provides the funds necessary to drive innovation in our research programs. Now I'd like to turn the call over to Pete for a review of our first quarter results. Pete?