Karen Zaderej
Analyst · SVB Leerink
Thank you, Pete and good afternoon everyone. Our total revenue for the first quarter was $31 million, representing growth of 28% compared to the prior year. I'm pleased with our Q1 results, which continue to demonstrate our team's ability to execute our strategy despite ongoing COVID-19 challenges. The incidence of trauma and surgical procedures continue to be negatively impacted by new COVID resurgences. They began in late 2020 and continued into the first quarter. Additionally, the severe winter storms across the country in mid-February, further impacted the incidence of procedures. However, procedure volumes quickly recovered through March, resulting in increasing demand for our products. Our revenue volume and growth in the quarter continued to be driven by the repair of traumatic nerve injuries and by the use of Avance Nerve Graft across our nerve repair applications with more than 50,000 Avance implants since launch and 136 peer reviewed clinical publications featuring Avance. Surgeon adoption of our flagship product continues to lead our growth as surgeons adopt the AxoGen algorithm using our portfolio of nerve repair products. In the first quarter, our commercial team remains focused on our strategy of driving deeper penetration of existing accounts and surgeons and hospitals continue to place a high priority on nerve repair procedures with AxoGen products. Throughout the pandemic and despite access restrictions and limited surgical schedules, we've been able to effectively support our customers and remain close to surgeons as they continue their path of adoption. We believe that these efforts have positioned the business for improving growth as the incidence of trauma returns to normal levels, which we expect to occur over the course of the year with the continued roll out of vaccines and a gradual return to more normal activity levels across the country. We're pleased with the continued growth of our application for the surgical treatment of pain. Despite the reluctance of some patients suffering with chronic nerve pain to undergo a surgical procedure during the pandemic, an increasing number of our current surgeon customers are using AxoGen products with greater frequency to treat symptomatic neuromas as compared to a year ago. Our breast neurotization business slowed late last year and end of the first quarter of 2021 due to the increasing number of COVID-19 cases, which led many programs to suspend or limit breast reconstruction procedures. As the quarter progressed, several programs restarted these procedures and our breast business improved. Although, we anticipate that cancer diagnosis and reconstruction procedures may remain lower than normal in the near term as a result of pandemic-related delays and patients seeking care. We remain confident in the long-term growth potential of our breast neurotization business. Throughout the pandemic our oral maxillofacial nerve repair business has lagged the recovery seen in our other applications as mandibular reception procedures have remained below normal levels. OMF repair is a highly invasive procedure involving the head and neck area potentially increasing concerns associated with COVID-19. We're encouraged that our OMF business showed signs of improvement in the first quarter and we expect continued recovery throughout the year. Turning now to commercial execution and our sales team. We ended the quarter with 106 direct sales representatives in the US compared to 111 at year-end and 109 one year ago. The decline in sales reps is due largely to the timing of ordinary attrition and internal promotions and subsequent to the end of the quarter, we increased by two reps for current total of 108. We anticipate in the year with a 115 to 120 sales representatives as we plan to strategically expand our sales team in the second half of the year. Meanwhile, our sales rep productivity continues to improve and will be the primary driver of our revenue growth in 2021. Our direct sales channel continues to be supplemented by independent sales agencies that generally cover more remote geographies. Our independent agencies represented 11% of our total revenue in the first quarter compared to 12% in the prior quarter. We are having deeper penetration within our existing surgeon customers and accounts continues to be at the core of our strategy to increase revenue through improved sales productivity. In the first quarter, we had 919 active accounts out of the estimated 5,100 healthcare facilities, they may treat nerve injuries in the US. This represents an 11% increase compared to 825 in the first quarter of 2020. As a reminder, an active account is one that is purchased at least six times in the past 12 months. Active accounts have typically gone through their committee approval process and have at least one surgeon who has converted a portion of his or her nerve repair algorithm to AxoGen products. During the past few years, active accounts have consistently represented approximately 85% of our total revenue with the top 10% of our active accounts representing approximately 35% of our revenue each quarter. As our business continues to grow, we're adding a new account metric that we believe demonstrates the strength of adoption and the potential revenue growth in accounts that have developed a more consistent use of AxoGen products in the nerve repair algorithm. We refer to these as core accounts defined as accounts that have purchased at least $100,000 in the last 12 months. Our core accounts typically have at least one surgeon who has adopted the AxoGen nerve repair algorithm for the majority of his or her nerve injury patients and have other surgeons who are in earlier stages of AxoGen product adoption. In the first quarter, we had 274 core accounts, an increase of 13% from 243 one year ago. These core accounts represented approximately 60% of our revenue in the quarter. We see significant opportunity to drive increased revenue as more accounts reached this level of adoption and surgeons within these accounts, increase their adoption across our nerve repair applications including extremity trauma, breast, OMF and pain. Turning now to our continued focus on building market awareness. As mentioned in our previous earnings call, early in the quarter we participated in the virtual combined meeting of the American Association for Hand Surgery, American Society for Peripheral Nerve and American Society of Reconstructive Microsurgery. AxoGen's nerve repair portfolio was featured in several clinical and scientific presentations during these meetings, including data from the AxoGen-sponsored RANGER Registry. In the first quarter, we continue to utilize our digital marketing capabilities to supplement the efforts of our sales team to however important and timely nerve repair news and content to targeted surgeons. We were pleased with the continued high level of surgeon engagement with our email campaigns during the quarter and additionally our surgeon customers continue to participate in our Nerve Matters online surgeon community discussing their use of peripheral nerve injury solutions. In the first quarter alone, over 2,300 surgeons engaged with the Nerve Matters platform. During the last year, these platforms have been particularly helpful for surgeons given access limitations for sales and clinical support. We continue to drive awareness of Nerve Matters with patient audiences through our direct-to-patient marketing campaigns. Our awareness efforts are spearheaded by targeted digital and media strategies focused on driving awareness of the recent station surgical technique and nerve repair as a potential solution for chronic nerve pain. On www.resensation.com, we saw a 400% increase in organic traffic in Q1 versus one year ago. Surgeon education and advocacy development remains a high priority for our team as we continue to operate in a virtual environment. We continue to provide virtual surgeon education events led by surgeon experts in nerve repair targeting multiple constituencies including fellows, early career surgeons and all nerve repair surgeons. Building on the very positive response to our 2020 invitation-only mastermind of nerve program for early career upper extremity surgeons, we kicked off our second mastermind series in April providing education for emerging leaders in nerve repair. We also remain committed to providing education and training for each class of fellows despite the COVID-19 restrictions. As in prior years, we are training, more than three quarters of the hand and microsurgery fellows in the class of 2021 through a combination of local in-person hands on lab as well as virtual programs. We believe programs like these play an important role in providing future young attendings with the skills and knowledge to confidently incorporate nerve surgery early on in their practice. The majority of the new hand surgery attendance from the 2020 class has performed cases with our nerve repair portfolio since completing their fellowship training. We are encouraged by the early and positive adoption trend seen with this future generation of hand surgeons. Going forward, our surgeon education plans include a safe return to in-person programs in the back half of 2021 as we anticipate COVID-19 restrictions being lifted more of our surgeon customers being willing and able to travel to these events. We continue to expand the body of our clinical evidence in support of our product portfolio and increasing surgeon adoption. Our RANGER and MATCH registries continue to enroll with over 2,400 nerve repairs now enrolled in RANGER. In 2020 analysis of the MATCH registry data, which is the comparative population of conduit and autograft subjects for RANGER demonstrated that Avance Nerve Graft outcomes were statistically better than conduit and were similar to those for autograft. Data from these two clinical programs continues to play an important role in informing surgeons clinical decision-making. Our RECON study remains on schedule, after completing enrollment of 220 subjects in July of 2020. As a reminder RECON is our Phase 3 pivotal study supporting our biologics license application or BLA, which will transition our Avance Nerve Graft from a section 361 tissue product to a section 351 biological product. Our protocol includes a 12-month followup visit for all subjects, and given the impacted COVID-19, our plans allow for an additional three months for subjects to complete their final visits. We anticipate the final follow-up visit to occur in October of 2021 with the preliminary study data readout in the second quarter of 2022 and filing of our BLA in 2023. Earlier in the quarter, we announced positive results on the 15 subject pilot phase of the RECON study evaluating the use of AxoGuard Nerve Cap in the management of painful neuroma. Findings from the pilot phase demonstrated that subjects experienced a clinically significant reduction in pre-operative pain and experienced clinically meaningful improvements in secondary endpoints including fatigue, physical function, sleep disturbance, pain interference, pain intensity and pain behavior as measured by the validated promise questionnaires. Pain medication utilization data also shows positive indicators for reduction of pain medication burden including opioids following the procedure. There were no AxoGuard Nerve Cap safety issues reported and no observed recurrence of symptomatic neuroma. Enrollment in the comparative phase of repose is well underway and assuming a limited impact from COVID-19, we expect enrollment to be completed in Q1 2022 and a study data readout in Q2 of 2023. Additionally, we are pleased to report that our breast and pain clinical registries Sensation NOW and Rethink Pain have re-initiated enrollment efforts after a temporary COVID-19 related hold in 2020. These programs both play an important role in our development of these clinical applications and will provide procedure-specific data on the role of AxoGen's portfolio in the care of these nerve injuries. As we advance the science of nerve repair, we remain committed to investing the time and resources necessary to provide meaningful and impactful clinical evidence on the utility of our nerve repair portfolio. Nerves regenerate slowly, which often necessitates long follow-up times to assess treatment effects and to gather the meaningful clinical data that surgeons, payers and regulators have come to expect when making clinical care decisions. Our RECON and RANGER studies highlight the significant amount of time, effort and expertise required to conduct clinical research in peripheral nerve. The RECON study began enrolling approximately six years ago and the RANGER registry began enrollment more than 10 years ago. In RANGER, many of the nerve injuries have follow-up assessment periods of up to 36 months, to fully appreciate the impact of the repair. We are fortunate to have an established body of clinical evidence supporting Avance Nerve Graft and we remain committed to obtaining the clinical evidence to demonstrate the safety performance and utility of our nerve repair solutions. Before I turn the call over to Pete, I'd like to spend a moment discussing our outlook for 2021 including our re-initiation of financial guidance. We're encouraged by the trajectory of our business as we exited the first quarter. We expect the incidence of trauma will increase as communities relax pandemic related restrictions, which we believe will lead to increasing procedure volumes as we move through the year. As a result, we are re-initiating financial guidance and expect the full year 2021 revenue will be in the range of $133 million to $136 million and we expect full year gross margin will remain above 80%. We are confident that our commercial execution, combined with our substantial investments in clinical data over the past decade will continue to support surgeon adoption bolstering our confidence in our long-term growth potential as we continue our mission to revolutionize the science of nerve repair. Now I will turn the call over to Pete for a review of financial highlights. Pete?