Ronald Lloyd
Analyst · Joshua Jennings from Cowen. You may begin
Thanks, Leigh. Good afternoon everyone and thank you for joining us. Since our last call, we've continued to execute on our business strategies, and achieved $11.5 million in revenue for Q3. Year-to-date, we have generated over $36 million in total revenues, a 21% increase over the corresponding period in 2020. More importantly, we're preparing for a seminal year in 2022. As we look to next year, we see several catalysts for growth. With CanGaroo, we'll be scaling our commercial organization, generating clinical data and advancing CanGaroo RM, our next generation product with antibiotics. We remain on track to file CanGaroo RM in Q1 and planned for approval in the second half of next year. We believe CanGaroo RM has potential to exceed a $100 million in revenues and be the core driver of value creation for Aziyo over the next few years. Second, with SimpliDerm, we’re expecting new clinical data, greater market access, and continued growth. For both CanGaroo and SimpliDerm, we're building off strong momentum that's been created over the second half of this year. And third within our orthopedic and spine business, we anticipate bringing on board additional partners and launching new viable bone matrices as we return to growth mode. In addition to further support the safety of these products, we will have in place new screening and testing procedures, which we believe will set a new standard in the industry. Finally, we are participating in a patient support program for those impacted by our single donor lot recall of FiberCel. While it's very early in the litigation, we feel confident we have our arms around the legal challenges of this recall, and believe it will be manageable within the company's resources. Now I'm going a bit deeper in each of the main areas of our business. I'll start with CanGaroo. CanGaroo is the only commercially available biological envelope that forms a natural, healthy pocket for holding implantable electronic devices. We are making exciting progress on the commercial and medical fronts that showcase the remodeling benefits of this product. Despite the headwinds of COVID that negatively impacted CRM device placements in August and September, sales of CanGaroo improved during the quarter. There were several factors that drove this growth, including: growing awareness within the electrophysiology medical community for CanGaroo's remodeling benefits; the impact of peer-to-peer programs, which have been very influential in developing new users; opening up new accounts by leveraging our recently signed contracts with healthcare delivery systems and our Breakthrough designation within Premier; as well as continued contributions from our partnerships with Boston Scientific and Biotronik. More specifically, during the quarter, we saw increased productivity from our U.S. direct sales force, as our newer reps gained tenure throughout the year and access to our customers reemerged. And we are very encouraged by this increased momentum, both in higher utilization within existing accounts, as well as the opening of new accounts, and we see significant opportunity for additional expansion. Also encouraging was the traction we saw with our partners in Q3, with Boston and Biotronik places of CanGaroo reaching their highest levels for the year. In parallel, we've been successful in mining opportunity through our Premier Breakthrough Technology designation, as well as with other healthcare system partners. These relationships have been key to driving CanGaroo sales, and we expect that to further leverage through these relationships going forward. We are also confident in our opportunity to add additional healthcare systems in the future. Outside the U.S., we saw increased sales of our CanGaroo Envelope in Europe due to the launch of our new expanded label. As a reminder, Aziyo received approval in January that now permits CanGaroo Envelope to be hydrated in a gentamicin solution prior to implantation. This new label was launched in Q3 through our partnership with Biotronik, leveraging clinical data that was presented at the European Society of Cardiology Annual Meeting this summer. As an update on the clinical front, both the HEAL study and the de novo study are progressing as expected. We look forward to this clinical data for CanGaroo and we're confident results will further validate the unique clinical benefits derived from our biological envelope. On the product development front, as mentioned earlier, CanGaroo RM remains on-track for FDA submission in the first quarter 2022, and we are planning for clearance and launch in the second half of the year. The new envelope will be enhanced by adding the antibiotics rifampin and minocycline. Our team continues to execute against these key milestones for this biological product. And again, we're confident in its potential to create substantial, long-term growth for Aziyo. In the soft tissue reconstruction area, we continue to make progress in our SimpliDerm business. Our goal with this product is to generate clinical data, expand access through payers and hospital systems and drive product sales through our national distributor network. We are completing a clinical study comparing SimpliDerm to a market-leading product and plan to submit the results this quarter for publication early next year. We'll leverage this data in our prior publications to expand market access. Finally, we are pleased with the progress our distributor network is making in opening new accounts and further penetrating existing accounts, which is driving sequential, quarterly sales growth. Turning to our products for the orthopedic and spine repair market. Starting with an update on the recall of a single donor lot of our FiberCel product. While this was an unfortunate back, we conducted a thorough review of our procedures for screening donors and producing FiberCel. We found no deviations from established industry and regulatory protocols. The FDA also completed inspection of our Richmond, California facility in June, and issued Form 483 observations, meaning that they also found no deviations from accepted protocols and standards. Nonetheless, we remain committed to supporting patients that were impacted by this event. They've agreed to find a patient support program in which we'll participate as a limited sponsor with Medtronic. Under this program, qualifying patients may receive reimbursement for out-of-pocket medical and incidental expenses related directly to seeking testing or treatment or treatment related to the recall. This program is designed to support patients and ensure that they are not delaying any necessary treatment. We remain committed to providing high quality, safe and effective products. As such, we've developed and implemented measures that further enhance the safety of future production launch for our Viable Bone Matrix products. These measures include implementing heightened donor screening procedures and developing additional methodologies to test tissue products. We believe these safeguards exceed applicable FDA and industry standards for donor screening and testing. Despite these actions, we were obviously disappointed to receive notice from Medtronic of the company's decision to discontinue distribution of any cellular bone matrix products, which includes an existing agreement for Aziyo’s FiberCel product. As mentioned in previous communications, our agreement with Medtronic for our fiber-based Viable Bone Matrix product was non-exclusive. And we continued to sell this fiber-based product through our other partners. We remain confident that the quality performance of our products will enable us to expand business through our existing partners as well as secure additional distribution partners for our products that we have on the market that day, as well as pipeline products we plan on launching in 2022. Turning to our non-core contract manufacturing business. We saw upside in the quarter, largely due to fulfilling the supply requests from a new customer, building inventory in advance of their product launch. Going forward into Q4, we anticipate that this segment of our business return to levels more in line with the first half of this year. Finally, I'll mention that we recently welcomed Peter Edwards to the company as a General Counsel. His extensive legal and business experience in the healthcare space has already proven valuable in numerous aspects of our business. His addition makes our strong team stronger. And together, we believe we're poised for great accomplishments in the years ahead. With that update, I'd like to turn the call over to Matt.