Tim Wright
Analyst · Northland Capital Markets. Please proceed
Thank you, Jack. Good afternoon, everyone and thank you for joining us on the call today. ‘21 was a defining year for MiMedx. In ‘21, we advanced our understanding of our PURION process placental tissue, both scientifically and clinically. We delivered above-market double-digit growth in our continuing tissue and core commercial portfolio despite COVID and the impact of the end of enforcement discretion. We are well positioned to execute against our goals and objectives for 2022. We are innovating by introducing new purpose-designed and developed products. We are expanding into areas of surgical recovery and across the globe with our anticipated launch of EPIFIX in Japan. And we are advancing the body of scientific evidence to support expanded applications of our placental biologics platform. The unmet clinical need across the markets we address today is significant. 10% of the U.S. population have diabetes, with calculated annual cost exceeding $300 billion. A key driver of cost for patients with diabetes is lower extremity diabetic ulcers, which present a substantial financial burden to payers and a significant burden to patients. Patients with these lower extremity ulcers-based challenges with mobility, the risk of infection, the risk of amputation, decreased quality of life and a shortened lifespan, many of which are exacerbated to an amputation actually be required. It is estimated that up to 85% of amputations are avoidable with the adoption of best practices of treatment. Results of our recent peer-reviewed study clearly demonstrate that MiMedx is proprietary PURION-processed EPIFIX, it should always be considered as part of a best practice treatment regimen. When following these guidelines, EPIFIX was shown to provide better clinical outcomes by reducing major amputations, emergency room visits, inpatient admissions and readmissions, all with statistically significant p-values less than 0.0001. Not only was EPIFIX noted as a dominant treatment strategy, it was also found to be cost effective, providing increased quality of life at a lower willingness to pay threshold. The results of this recent peer-reviewed study are meaningful for patients, physicians and payers. MiMedx will continue to pursue evident-based approaches to support the clinical use of our products. We can only do this by substantiating the clinical and economic attributes of our foundational placental biologics platform. We are advancing not only scientifically, but we are also delivering revenue growth. I’m extremely pleased to report another outstanding quarter of growth. Fourth quarter net sales from our tissue and cord products, also known as our 361 products, were $66.9 million, reflecting a 13% increase versus the same period 1 year ago. Net sales of the same portfolio of products increased an impressive 15% year-over-year for the full year 2021. We exceeded our stated ‘21 objective of greater than 10% growth as well as beat the market average growth, which is estimated to be between 6% and 8%. Despite the end of enforcement discretion this past May, total net sales in 2021 grew 4% versus the full year of 2020, and adjusted net sales grew 7%. These strong results are a direct reflection of our investment we’ve made to support our sales professionals and our medical science liaisons. In addition, our territories are designed to focus on high-growth areas. We are equipping our teams with meaningful clinical, scientific and economic evidence and reinforcing their efforts with medical education initiatives designed to amplify the important benefits of our products to patients, clinical decision makers and payers. Our commercial business is getting stronger, and we are expanding into new markets. Our strategic expansion into surgical recovery markets is one component that propels our continued growth. Here, our direct and agency sales professionals are laser-focused on identified areas where our tissue products can help reduce complications across several specialties such as most procedures, colorectal anastomoses, spinal decompressions, complex surgical reconstructions and lower extremity repairs where a patient may have an increased likelihood of complications. Complications such as dehiscence, adhesions, hypertrophic scarring and others may affect both the recovery of the patient and the outcome of the surgery. We are targeting certain procedures for use of our products based on an unmet clinical need, potential procedural complication rates, clinical relevance and economic factors plus overall business priorities. As in advanced wound care, we believe the surgical recovery market is expanding due to the demographic trends such as aging, obesity, diabetes and other comorbidities that can complicate healing and increase the patient’s susceptibility to non-healing chronic wounds. At our recent company Investor Day, we outlined our strategy for achieving sustainable annual growth of 11% to 14% in our continuing commercial portfolio. This above-market growth rate includes growth in our existing products, EPIFIX and EPICORD, along with an increase in our surgical recovery setting using our AmnioFix and AmnioCord products. I’d like to spend a moment on 2 additional contributors to our anticipated growth, our global expansion into Japan and our robust near-term organic product pipeline. First, Japan. As we had previously discussed, MiMedx received regulatory approval from the Japanese Ministry of Health, Labor and Welfare in June 2021 to market EPIFIX in Japan. As the first amniotic tissue approved for hard-to-heal chronic wounds, such as diabetic foot ulcers and venous leg ulcers, which do not respond to conventional therapy. We expect to secure reimbursement approval mid-2022, subject to the government’s ability to continue to progress our application in light of COVID constraints. Our commercial team is establishing the necessary structure, medical education programs and market development initiatives to operationalize our commercial strategy. As of today, we have already trained more than 200 Japanese clinicians on the use of EPIFIX, and we are working to build consensus on establishing a treatment practice guideline as well as leveraging the power of peer-to-peer education and partnerships with expert key opinion leaders. We believe these results could lead to the treatment of as many as 100,000 patients annually. Success in Japan is an important step in our aspirations to grow our business geographically outside the U.S. I’d like also to highlight an area I’m personally excited about. We are innovating. I’ve asked the organization to develop two substantial new products every year, and we are well on our way to achieving this goal. The native and multimodal therapeutic properties of our PURION process placental tissue provide an almost unlimited range of new organic product innovations, including 361 products as well as 510(k) products. We have outstanding scientists in our research and product development organization. We have the capital to invest in these important product development initiatives that broaden our portfolio and expand our addressable markets. The first 2 of these product innovations are planned to be introduced later this year, AMNIOEFFECT and our placental collagen matrix product. AMNIOEFFECT is a membrane product similar to EPIFIX and AmnioFix but is uniquely processed to produce a thicker, more robust graft. The initial feedback we have amassed through multiple focus groups: Customer preference, testing and key opinion leader dialogue indicates that this new platform has the applicability for operative procedures where a surgeon needs to anchor or suture the graft, such as in a rotator cuff pair or a complex wound reconstruction. Our placental collagen matrix product is made from the placental disc. It is a placental extracellular matrix in a particulate format. Its clinical utility will be in complex wounds that are deeper tunneling or simply difficult to reach with conventional products. We see this as an additional platform into which we can incorporate innovations and iterations that have the potential to improve the process of care and patient outcomes. Our commercial team will be well prepared to bring these new products to the market later this year, benefited by the armamentarium of evidence and medical education support designed to facilitate clinical adoption. Overall, we made great progress in 2021, and we’re putting the company in a solid position to achieve a number of significant milestones in 2022. Let me reiterate MiMedx’ commitment to developing new products, our commitment to expanding the market opportunities and our commitment to generating science-based evidence, these three things all position us to achieve 11% to 14% growth in our commercial business in 2022. Transitioning to another area I am excited about our late-stage musculoskeletal pipeline. We’re advancing in this area as well with our clinical operations team. We are confident in the therapeutic potential of micronized dHACM and are methodically focused on initiating our Phase 3 KOA program in order to demonstrate its effectiveness in the clinic and its potential to remodel soft tissue, demonstrating a demode characteristic or disease-modifying characteristic. We are diligently working on site selection, clinical trial protocols and design and the final analysis of the 12-month readout from our Phase 2b KOA study. This may provide an important look into the durability of patient response to micronized dHACM, and these studies will be considered as we advance our plans for Phase 3. We intend to hold confirmatory meetings with the FDA to review our statistical analysis plan as well as finalize our study protocol as soon as possible. Our Phase 2b study results provide an important insight into the properties and behavior of our AmnioFix injectable product. The number one thing we discovered from the first 190 patients was that our placental biologic is both safe and effective. The p-values for these 190 patients were statistically significant and clinically meaningful consistent with published retrospective studies and real-world experience amassed for more than 138,000 vials that have been used in the clinic prior to enforcement discretion. I would encourage you to read both our press releases on these results and also watch this segment of our Investor Day presentation available on our website for additional detail. The piece of the puzzle we had to solve is what went right in the first 190 patients and why that result wasn’t continued through the remaining 256 patients. Fortunately, after an extensive root cause analysis, we learned that the potency of the investigational product faded as it aged from time of manufacture and that our proprietary biochemical and biological test can detect this reduction in potency. Possibly the best news is that from what we have learned, this is fixable. The scientific and financial benefits from this root cause analysis are potentially enormous. And I believe the findings from our Phase 2b trial have increased our probability of technical and regulatory success as we commence our Phase 3 KOA clinical study program later this year. The cash we are generating from our growing commercial business is going back into advancing this important program, and I’m excited about the potential of these investments have to transform the treatment of KOA by providing rheumatologists and orthopedic surgeons a safe, effective and novel placental biologic modality. I will now turn the call over to Pete, who will take you through our fourth quarter and full financial results. Pete?