Karen Zaderej
Analyst · Jefferies. Please state your question
Thanks, Pete, and good afternoon, everyone. We delivered solid revenue growth in both the fourth quarter and the full-year. Total revenue in the fourth quarter grew 20.2% to $28.1 million, driven by the strength in our core trauma business. For the full-year, revenue grew 27.1% to $106.7 million. At AxoGen, our mission is to restore nerve function and quality of life to patients with peripheral nerve injuries. We are advancing this mission through the pursuit of our five pillars of growth, which are building market awareness, educating surgeons and developing advocates, growing the body of clinical evidence, sales execution, and introducing new products and expanded applications in nerve repair. Turning first to sales execution. As we discussed on last quarter's earnings call, we have rebalanced and refocused our commercial efforts towards extremity trauma, our largest market opportunity and most efficient path to sustainable long-term growth. Specifically, we have increased our sales representatives focus on going deeper within our current surgeon customers to support achievement of optimal clinical outcomes for all their nerve injury patients. This deeper use is anchored by our flagship, Avance Nerve Graft, and supported by the expanded use of our full nerve repair algorithm. We believe this increased sales rep focus will result in deeper penetration and improved development of active accounts. We are pleased with our progress executing this refocused approach, while also recognizing that new market development requires persistence at both the account and surgeon level. Developing surgeons should consistently use our nerve repair portfolio requires us to raise awareness of the clinical data that supports the use of our products and to provide peer-to-peer education programs and interactions that teach and endorse optimal nerve repair algorithms and techniques. We work closely with each surgeon as they build their own nerve repair experience and positive patient outcomes to support their continued use of our technology. Our sales representatives are highly involved, supporting each surgeon's journey to become a consistent long-term user of AxoGen's products and nerve repair algorithm. We are confident that we have the right strategy and team in place to continue driving surgeon adoption over the next several years. As we focus on extremity trauma, we do continue to invest in and grow the breast reconstruction neurotization, and oral and maxillofacial markets, but are doing so with an improved balance of commercial resources as these nascent markets continue to develop. To increase our market penetration, we continue to build our sales footprint and ended the quarter with 109 direct sales representatives and 19 independent sales agencies. As we discussed throughout 2019, by thoughtfully splitting sales territories and strategically converting agency territories to direct reps, we are gaining improved account coverage, which allows our sales reps to spend more time developing surgeons and accounts within tighter geographies. As a result, approximately 90% of our fourth quarter revenues came through the direct sales channel versus 85% a year-ago. It is important to know that our agency channel will continue to be an essential part of our strategy as these agencies are able to more efficiently and effectively cover target accounts in geographically remote locations. In the fourth quarter, we increased our number of active accounts to 797, up 12% from 712 at the end of 2018. We continued to observe year-over-year increases in revenue for active accounts and expect this trend to continue as we focus on increasing surgeon adoption in these and other targeted accounts. We also expect that our focus on surgeons and accounts in extremity trauma will lead to further development of our pipeline of developing accounts, leading to continued increases in active accounts over the course of the year and beyond. For the quarter, the top 10% of our active accounts continue to represent approximately 35% of our revenue, suggesting that there is a significant runway for growth within our current account base. In other words, increasing our penetration of our existing accounts, represents a significant growth opportunity as more accounts moved towards the utilization rate of our top 10%. Additionally, revenue from our top 10% of accounts continues to come primarily from a small number of early adopter surgeons within each account, which provides additional growth opportunities even in our strongest accounts. We are encouraged by the early results of our commercial improvements and we remained firmly focused on execution as our sales force matures and our commercial organization continues to develop throughout 2020. Our leadership team will continue to review and analyze our commercial strategy and allocate resources to those areas that provides the greatest long-term growth. I am pleased with the progress we have made on sales execution, and I am confident we will continue to see these efforts payoff throughout the year. Turning to our pillar of building market awareness. Our platform for nerve repair was well represented at the recent combined 2020 meetings of the American Association for Hand Surgery, American Society for Peripheral Nerve and the American Society for Reconstructive Microsurgery. AxoGen hosted an educational symposium that explore peripheral nerve repair advancements made in the last decade as well as AxoGen's role in supporting improved procedures and techniques that are on the horizon. In addition to our symposium, there were several clinical and scientific presentations throughout the meetings that highlighted AxoGen's full product portfolio, including data from the AxoGen-Sponsored RANGER Registry. I also like to take a moment to highlight the new 2020 CMS reimbursement rates for nerve repair in the outpatient setting that went into effect on January 1. With these new rules, CMS has effectively unbundled direct repair from gap repair, significantly lowering the reimbursement for direct repairs and increasing the reimbursement for repairs requiring an implant to bridge the injured nerve gap. Specifically, reimbursement of direct repairs was reduced by approximately 60% in both hospital outpatient and ambulatory surgery centers, while reimbursement for procedures using Avance increased 21% at hospital outpatient centers and 78% in ambulatory surgery centers. Reimbursement rates for procedures involving conduits and connectors also increased 21% in hospital outpatient centers and 20% in ambulatory surgery centers. While Medicare patients represent a relatively small percentage of trauma cases, we are encouraged by the new CMS direction as it reflects the evolution of nerve repair adoption. Commercial payers often follow the lead of CMS, which we believe bodes well for future reimbursement for nerve repair and could lead to increased procedure volume of short gap nerve repairs in ambulatory surgery centers. Our efforts to educate surgeons and develop advocates continued in the fourth quarter and we conducted a total of 26 national education programs in 2019, including six Fellows programs. These surgeon-led events focused on Advances and Best Practices in nerve repair with participating surgeons gaining additional confidence in nerve repair techniques. We trained three-quarters of all hand and microsurgery fellows in 2019 and expect to train three-quarters of incoming fellows in 2020 as we remain committed to educating the next-generation of surgeons. The structure and format of our educational programs will continue to evolve in 2020. We plan to shift resources more towards targeted regional and advanced education program to compliment our core national education programs. Increasing surgeon adoption of our product portfolio continues to be supported by a large and expanding body of clinical data. In January, we announced that our RANGER Registry has achieved a significant milestone, enrolling more than 2,000 Avance Nerve Graft repairs. The ongoing registry study allows for the evaluation of nerve injury and repair techniques and outcomes in sensory, mixed and motor nerves across short and long gap repairs and has supported several peer-reviewed clinical publications and surgeon presentations at scientific meetings. For example, at the September meeting of the American Society for Surgery of the Hand, data was presented from 511 upper extremity nerve repairs with an average follow-up of 14 months, demonstrating a consistent meaningful recovery rate of 84% for Avance Nerve Graft with no graft-related adverse events. Findings from the MATCH cohort of the major study show Avance Nerve Graft had statistically significant improvements as compared to synthetic conduits in three essential areas: the rate of recovery, the overall degree of recovery, and the average recovery of static two-point discrimination, a key sensory measure in the hand. The study founded in digital nerve gap less than or equal to 14 millimeter, Avance demonstrated a meaningful recovery rate of 92% as compared to 67% for conduits and gaps between 15 and 25 millimeter, Avance demonstrated a meaningful recovery rate of 85% while conduits were found to be 45%. These outcomes are consistent with previously published literature for synthetic conduits and Avance. The MATCH arm of RANGER serves as a contemporary cohort control providing conduits and autograft data from participating centers. Surgeons are using this clinical data to better understand nerve repair outcomes and to expand the treatment algorithm. Our RECON Study continues to enroll, and we recently updated our expectation to reach the target enrollment of a total of 220 subjects to the end of second quarter. We anticipate the data report out for RECON will occur in Q3 of 2022. Our Sensation-NOW clinical registry continues to enroll. Sensation-NOW studies the sensory and quality of life outcomes of breast neurotization after reconstruction using the ReSensation surgical technique. We completed the pilot phase of REPOSE Study and are currently enrolling in the comparative phase. REPOSE is a prospective, randomized-controlled study, evaluating the use of Axoguard Nerve Cap in the management of painful neuroma as compared to a standard neurectomy procedure. We are making significant advancements in both the depth and breadth of clinical studies and we will continue to invest in new studies that provide surgeons with confidence in Avance nerve repair techniques with the AxoGen portfolio. One example is our newly initiated RETHINK PAIN Registry Study, evaluating the surgical treatment of pain. This study is designed to capture the patient's pain journey, beginning at the onset of chronic pain, following patients through the referral networks, including the prior therapy attempted and then onto the surgeon that performs nerve repair using AxoGen technology. Following the surgery, the study will ultimately collect data on patient outcomes. This study recently initiated at its first center and we believe once complete, it will provide meaningful data to aid in the clinical management of patients with chronic nerve pain. The first module of this study will target approximately 200 subjects across up to 10 centers. We had previously discussed several foundational initiatives to introduce new products and expand the application of our portfolio into the surgical treatment of pain. We believe symptomatic neuromas are a common source of chronic pain following traumatic injuries or orthopedic surgeries. Surgeons can surgically remove the neuroma and repair the resulting nerve injury using our products. We see significant interest among surgeons in treating this underserved patient population. In 2019, we initiated market development efforts with a limited number of our current hand and plastic surgeon customers to increase the identification and referral of symptomatic neuroma patients for their evaluation and treatment. This month, we initiated an expansion of these efforts, including the launch of Axoguard Nerve Cap, an important addition to our solutions portfolio to address neuromas. Axoguard Nerve Cap is designed to separate the nerve and from the surrounding environment to protect it from mechanical stimulation and reduce painful neuroma formation. Before I hand the call over to Pete, I want to reiterate how pleased I am with the progress we've made as we continue to executing against our strategic initiatives in this large and developing market. 2019 was a year of significant change in our commercial organization and we believe the steps we've taken will support long-term sustainable growth for AxoGen. We will continue to invest in our commercial organization to drive future revenue growth, but will do so at a measured pace in order to allow our current sales – field sales capability to continue to mature and develop. Now I'll turn the call over to Pete for a review of financial highlights. Pete?