Tim Wright
Analyst · FIN Capital. Your line is now open
Thank you, Hilary. Good morning everyone. Thank you for joining us this morning. The third quarter was a period of significant progress for Linux. As we continue to execute on our strategy. I'm pleased with many accomplishments in all areas of our business including R&D, supply chain and operations, and commercial operations. Moreover, we continue to make meaningful difference in the lives of patients and families suffering from chronic unhealed wounds. We remain at the forefront of patient care and treatment. Now with an established seasoned executive team in place, we are well-positioned to make deeper advancements in the large and expanding new care market. On today's call, I plan to recap key recent milestones, share highlights of our third quarter results and reiterate areas where we are investing in the business to drive near term and long term results. I do want to express my deep appreciation to our 700 plus employees and their families for their incredible ongoing commitment and dedication to MiMedx. I'm exceptionally proud of our team's performance in Q3. And for their perseverance over the last eight months as we weathered the unprecedented COVID pandemic together and with our customers. It must be noted, we're still in the pandemic, so we must remain vigilant. Some of our turnaround efforts have been complicated by COVID. But that has not deterred our focus on the fundamental business objectives to restore our financial integrity and our reputation. Build out are a cohesive and capable management team, maximize the core business and to continue to advance our musculoskeletal pipeline in strategically address any headwinds we may encounter. Our performance this quarter resulted in a strong rebound in sequential sales growth, with a 22% increase over the prior quarter. Since the onset of COVID in March, we mobilize to ensure continued access to our products for patients and their families, protect the health and safety of our own people, our most precious resource, maintain a product safety profile, that we must continue to remain vigilant on. This is an area that I'm very proud of. Since the inception, the company has distributed more than 2 million allografts. We've recovered more than 75,000 placentas. We've done all this and maintained a reported events, average of 0.1%. These are impressive statistics, and again, I'd like to thank the team for their commitment to quality and product integrity. Senior access to accounts improve has been a major hallmark of the business. And yet, we are looking at this as a potential rebound to begin to normalize our field personnel in their accounts. Overall, the business is operating efficiently. Over the past year, we build a capable and cohesive leadership team with industry domain expertise. We made two critical hires in the third quarter. Dr. Rohit Kashyap, who is our Chief Commercial Officer, and Dr. Bob Stein, who leads our Research and Development efforts. Approximately 90% of our senior leadership team is new. Others high performance individuals have been put in new leadership positions with increasing responsibility. We have a talented and dedicated employee base, I can say with confidence that we're working to systematically transform the business. I'd like to take a few minutes to recap some of the recent announcements that we've made. First, I'm exceptionally excited to reiterate that our common stock commenced trading yesterday, November 4. This is a momentous occasion for us and represents a significant transfer transformation to the business, not only for the business, our employees but also our shareholders. Obviously, this improves our trading liquidity allows us to have more interaction with the financial community and strengthens our ability to execute on our strategic objectives. I again want to congratulate the entire MiMedx organization and also thank our shareholders for their ongoing support. Second, earlier this week, we announced the addition of coverage for EpiFix. Now as many of you know, EpiFix our flagship Amnion/Chorion brand. This product was placed on the formulary of the largest U.S. Commercial payer as a proven and medically necessary option in the treatment of diabetic foot ulcers. Coverage will begin December 1. Recently, we outline key growth drivers for our core business and this additional coverage supports the tactics that we have outlined, including highlighting the clinical and economic value work of our core portfolio, and expanding patient and health care providers access to our products. We believe that EpiFix is the only amniotic membrane product to receive coverage under this payers updated commercial medical policy. We expect the payers decision will be an important competitive advantage over time for MiMedx, as it facilitates access to EpiFix in a growing market for diabetic foot ulcers. Important validation and demonstration of the strength of our clinical data in the skin substitute market. And it also recognizes the significant differentiated value of our portfolio. We'll continue to inform decision makers and payers and providers and help elevate the standard of care for millions of patients. Let me take a moment to just highlight the Agency for Healthcare Research and Quality data. As you know, this was published in February of 2020. As I noticed previously, this independent report was intended to healthcare decision makers, whether it be patients or clinicians, healthcare system leaders, policymakers, and among others, make well informed decisions and thereby improve the quality of health care services. I believe the report accomplish this objective and serve as a critical validation of our clinical evidence. It was one of the key factors leading to the attainment of the additional coverage by the U.S. as largest payer. The findings of the AHRQ report noted that in the MiMedx products review have statistically significant results in the way we conducted a randomized controlled trial way against many applications. Additionally, there was a head-to-head study that resulted in superiority play for us. These studies also demonstrated the world risk-of-bias. As indicated, this report serves to inform payers and key decision makers. There is no other amniotic product that has received coverage by this payer. It's important to note that more clinical evidence will be needed in the future. And we're very committed to this. This is clearly in line with our strategy to generating a body of evidence that could be payer reviewed. In mid September, we've launched the new EpiCord Expandable product line as the largest advancement in our portfolio of products. At the core of this technology is EpiCord, which has demonstrated clinical efficacy in the treatment of diabetic foot ulcers. This product has the ability to expand the tumor exercise and offers a cost effective way to treat larger wounds, and differentiated wound surfaces including uneven wound surfaces, and deeper wounds. The results of our internal product development efforts have been impressive. We're going to continue to develop meaningful products to provide our Salesforce the ability to sell these products in the areas of unmet need. Also, with this product, we're seeing utilization across a number of sizes, types of wounds. Once the wound has closed are starting to heal, the physician or the podiatrist can transition to our basic EpiCord or EpiFix products. This is a nice continuity of care that we've been able to take advantage of. This innovation importantly is open access to other customers it gives our Salesforce the opportunity to target new accounts and new care settings. Feedback from the launch has been very positive. We plan to highlight this at the Symposium on Advanced Wound Care this week through November 6. As a pioneer in the development of placental tissue technology, MiMedx is constantly improving our knowledge of placental science, and we're committed to continuous innovation. Now, earlier in this quarter, we outlined four key growth drivers. For adjusting core business, we expect to enhance the portfolio value by continuing to highlight our clinical and economic value of our portfolio. By this we can also expand our market into new applications. From an expansion standpoint, we're targeting new business opportunities, and in a controlled fashion, pursuing international expansion. The accomplishments as noted above, contribute to these growth factors and I'd like to highlight some specifics across three domains of value creation for our company. Number one, commercial, number two R&D, number three, supply chain and operations. In a commercial organization led by Dr. Kashyap. We, as we previously noted, we're starting to begin this key account stabilize. We're very conscientious that the pandemic isn't over, so we remain vigilant around this. I believe our recent accomplishments and our tactics to grow our business are working. We plan to leverage our commercial sales to operationalize the pull-through of the recent contract wins we've had and payer wins we've had. While we expect the impact of additional payer coverage will be modest as we first ramp up, our field reimbursement managers or medical affairs organization and our market access teams are well-positioned to support our Field Sales efforts in this effort. Growth will come from key initiatives including exceptional execution by our sales organization, investments in medical education, for example, key opinion speaker programs, as well science plays on in work on the buyer health policy team. Our Salesforce size and productivity are key elements in this strategy as well, and a pronounced engagement that important meetings will be important. Putting the right people in the right places will ensure that we have access to market demand. We will scale our efforts appropriately to address the clinical need across a variety of care settings in a wide range of applications. And let me transition to R&D. This is led by Dr. Stein. We're investing in medical education to support our current Salesforce growth objectives. We will highlight our clinical and economic evidence of our portfolio products which is substantial. We will drive disease state awareness across the care continuum and we'll continue to support our publication strategy, whether that be in the safety and efficacy of our product or their economic value. We will use these tactics to expand the leverage of the market. Our increasing our research efforts, our focused across our portfolio of currently marketed products today, as well as to support our BLA submissions in the future. As you know, we've recently announced we completed enrollment of PF Phase 3 trial and our osteoarthritis Phase 2b trial. We'll continue to update you on the progress of these important pipeline assets that we have. Now, in our manufacturing area. One thing where we do feel we have a competitive advantage is the vertical integration of our supply chain and our operations. We must use this to leverage our breath to maintain our business operations and our quality standards. Our vertical integration was particularly helpful in the beginning of our pandemic with COVID. Our ability to scale our donation network and our recovery network was absolutely essential during this process as some hospitals began to shut down. As you know, we had the largest civil network and recovery network in this industry. During the pandemic, and ongoing, we still continue to have a very high order fill rate. I'm pleased to share also, it's very important relative to our BLAs that we're on track for our GMP facility. This position us to benefit not only in support of our BLA products, but also benefits as long term with a favorable cost profile control over a manufacturing process, and allows us to ensure high quality controls. In summary, we're gaining momentum, we're seeing our access to accounts begin to stabilize with more normal looking financial and operational metrics, and feel we're in a position to run the business for growth. We continue to realize operating efficiencies as we streamline processes, align product strategies and focus on key priorities. And we're investing in the business. And we believe these initiatives that we've outlined position us well to leverage our recent wins, specifically with payer coverage and with our new product innovation, namely EpiCord Expandable. At this point, I'd like to turn the call over to Pete to review the specifics of our financial performance.