Axogen, Inc.

Greetings and welcome to the AxiGEN Incorporated Fourth Quarter 2020 Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Pete Mariani, AxiGEN's Chief Financial Officer. Please begin, Mr. Mariani.

Thank you, Victor, and good afternoon, everyone. Joining me on today's call is Karen Zatteray, Hexagen's Chairman, Chief Executive Officer, and President. Karen will begin today's call with an overview of our fourth quarter performance and an update on our operational highlights. I will then provide an analysis of our fourth quarter and full year financial performance, followed by closing remarks from Karen and a question and answer session. Today's call is being broadcast live by webcast. which is available on the investor section of the Axigen website. Within an hour following the end of the live call, a replay will be available in the investor section of the company's website at www.axigeninc.com. Before we get started, I'd like to remind you that during this conference call, the company will make projections and forward-looking statements regarding future events. We encourage you to review the company's past and future filings with the SEC including, without limitation, the company's forms 10-K and 10-Q which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include, without limitation, statements related to the expected impact of COVID-19 on our business, statements regarding product acquisition and or development, product potential, the regulatory environment, Sales and Marketing Strategies, Capital Resources, or Operating Performance. And with that, I'd like to turn the call over to Karen. Karen?

Thank you, Pete. And good afternoon, everyone. Our total revenue for the fourth quarter was $32.5 million, representing growth of 15% compared to the prior year. I'm pleased with our Q4 results, which reflect our team's continued focus on commercial execution, are customers' ability to successfully navigate the ongoing challenges of COVID-19, and surgeons and hospitals continuing to prioritize nerve repair. At the same time, COVID-19 continued to dampen our revenue in Q4 as trauma remained below normal levels, access for sales representatives to customer facilities remained restricted, and the resurgence in COVID cases further reduced elective procedure volumes particularly late in the quarter. We're also pleased with the pace of our overall recovery in the second half of 2020, with mid-teens growth each quarter allowing us to deliver total revenue of $112.3 million for the year, representing growth of 5% compared to 2019. In addition to achieving year-over-year growth in 2020, We reached a noteworthy milestone during the year, surpassing 50,000 advanced nerve grafts implanted since launch. AVANCE has been featured in more than 125 peer-reviewed clinical publications and has demonstrated clinical outcomes that exceed those reported for conduits and are comparable to those for autograft. The challenges of COVID-19 have further highlighted the benefits of advanced nerve grafts as an off-the-shelf alternative to the surgical harvesting of an autograft for the repair of transected nerves. Along with avoiding the risk of complications from a second surgical site, the desire to shorten procedure time to increase patient and healthcare worker safety and to minimize resource utilization favors the use of our advanced nerve graft. Reviewing our first quarter, We believe revenue that can be attributed to the catch-up of previously deferred procedures decreased considerably compared to the prior quarter and represented approximately $1 million, primarily in our breast, pain, and OMS applications. Our trauma business continued to be the key driver of volume and revenue growth in the fourth quarter, although we believe our growth continued to be dampened by a below-normal incidence of traumatic injuries. At the same time, our trauma business has proven resilient during the pandemic, with surgeons and hospitals continuing to prioritize nerve repair procedures. More importantly, we believe that our efforts to refocus on the core trauma opportunity beginning in late 2019 have led to sustainable improvements in our ability to drive growth and have positioned us well as the market continues to recover and the incidence of trauma returns to normal levels. The recovery of our breast neurotization business continued in the fourth quarter, including meaningful contribution from the onboarding of new surgeons at targeted programs during the year. Despite the ongoing recovery in this application during the second half of 2020, we remain cautious in the near term as several programs again suspended breast reconstruction procedures late in the fourth quarter and into Q1 due to local COVID-19 resurgence. Additionally, new cancer screenings were significantly reduced for several months during 2020 due to the pandemic, which may impact breast reconstruction procedure volumes in the short term. Although cancer diagnosis and reconstruction procedure scheduling may continue to be lower than normal, we are confident in the long term and our growth potential of our breast neurotization business. Our emerging business in the surgical treatment of pain improved during the fourth quarter and remains an exciting opportunity for the company. Prior to Q4, patients with chronic pain due to neuroma formation were particularly reluctant to undergo a surgical procedure, choosing to live with the pain and often relying on pain medications. The recovery and growth of oral maxillofacial nerve repair continued to lag our other applications as procedures remained below normal levels. OMF repair is a highly invasive procedure involving the head and neck area. potentially increasing the risk associated with COVID-19. We expect our OMF application to return to growth during 2021 as COVID cases eventually decline and procedure volume recovers. Turning now to commercial execution. While the pandemic presented many challenges throughout the year, the rebalance of our commercial organization around extremity trauma, our largest market opportunity, and driving deeper penetration with our existing surgeon customers was a meaningful catalyst to our growth during the second half of 2020. The time we invested in extensive sales training during the second quarter strengthened our sales team and improved our ability to support surgeons and their patients and to drive continued growth going forward. We ended the fourth quarter with 111 direct sales representatives in the U.S., an increase of one representative during the quarter. Our direct sales channel was supplemented by 23 independent sales agencies that generally cover more remote geographies. Our independent agencies represented 12% of our total revenue in the fourth quarter compared to 13% in the prior quarter. In recent months, we've selectively added new independent agencies to cover largely untapped remote accounts to reduce travel time of our direct sales team which allows our direct reps to focus on going deeper in the highest potential accounts. Although we are increasing our number of independent agencies, we expect the portion of our revenue covered by the independent agencies to remain similar to recent levels. Throughout the pandemic, we kept our sales team and the broader commercial organization intact and benefited from the stability of our sales territories, customer relationships, and support. as well as from the increasing tenure and experience of our sales team. In 2021, we plan to achieve revenue growth primarily by driving sales productivity while strategically adding up to 10 sales representatives in the second half of the year. To increase sales productivity, our team remains focused on our largest market opportunity, Extremity Trauma, and on driving deeper penetration with our existing surge in customers and accounts. In fourth quarter, we had 893 active accounts, an increase of 12% from 797 one year ago. The increase in active accounts is primarily due to the impact of existing surgeon customers expanding their use of oxygen nerve repair algorithm across multiple facilities, including alternate sites of care. The top 10% of our active accounts continue to represent approximately 35% of our revenue, further demonstrating the meaningful growth opportunity within our existing accounts. Turning now to our continued focus on building market awareness, we participated in the American Society for Surgery of the Hand Conference in October, which was held virtually. In January, we participated in the virtual combined meeting of the American Association for Hand Surgery, American Society for Peripheral Nerve, and the American Society for Reconstructive Microsurgery. AXIGEN's Neurorecare Portfolio was featured in several clinical and scientific presentations during these meetings, including data from the AXIGEN-sponsored Ranger Registry. During 2020, in response to the pandemic and resulting access restrictions to healthcare facilities, we accelerated the development of our digital marketing capabilities, which enabled continued engagement with our surgeon customers. In the second half of the year, We launched a series of email marketing campaigns delivering important and timely nerve repair news and content to targeted surgeons. Monitoring of these activities has showed a high level of engagement, and we're confident that our newly developed digital marketing capabilities have improved our ability to support our sales and market development efforts in 2021 and beyond. Additionally, our surgeon customers continue to participate in our Nerve Matters online surgeon community. discussing their use of peripheral nerve injury solutions. In Q4 alone, over 2,200 surgeons engaged with the platform. We have also continued to increase awareness of the resensation technique. Our efforts to raise awareness around breast neurotization were spearheaded by a media strategy targeting both regional and national news outlets. In 2020, More than 35 million people had the opportunity to learn about resensation through news media coverage. As a result, we've seen a significant increase in organic traffic to resensation.com and a marked increase in visits to the Surgeon Locator tool on the website. I'd like to take a moment to highlight the impact of changes in CMS reimbursements for nerve repair in the outpatient setting. Over the last two years, Reimbursement of direct repairs, or repairs where no implant is used, has been reduced by approximately 60% in both the hospital outpatient and ambulatory surgery centers, while reimbursement for procedures using a van increased 25% in hospital outpatient centers and 97% in ambulatory surgery centers. During the same timeframe, Reimbursement rates for procedures involving conduits and connectors were also increased 25% in hospital outpatient centers and 45% in ambulatory surgery centers. While Medicare patients represent a relatively small percentage of trauma cases, 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 using oxygen products in ambulatory surgery centers. Surgeon education and advocate development continued as a high priority during the fourth quarter and year. Our transition to virtual education, which occurred during the second quarter, has included several events led by surgeon experts in nerve repair and involves multiple constituencies, including fellows, early career surgeons, and all nerve repair surgeons. In particular, We've seen a very positive response from our invitation-only program for early career upper extremity surgeons. And despite COVID-19 restrictions, we were able to train more than three-quarters of the hand and microsurgery fellows in the class of 2020. To highlight our commitment to training fellows, During the fourth quarter, we partnered with an academic center on an educational event that featured a cadaveric session, which was live-streamed to an at-capacity audience of approximately 100 surgeons in academic centers across the country. The event featured a hybrid learning experience with virtual education, interactive clinical decision-making, and hands-on skills labs. Experts in hand surgery and nerve repair were able to broadcast dissections and nerve repair skills in real time, as well as conduct interactive clinical decision-making sessions. The event was a resounding success, and according to the host surgeon, sets the standard for what a virtual course should look like. In addition, in anticipation of continued restrictions on in-person programs, we've created over 20 nerve repair technique videos as valuable teaching tools to help educate residents and fellows during the years ahead. We continue to expand our body of clinical evidence in support of our product portfolio and increasing surgeon adoption. As announced last Thursday, we've completed analysis of the 15 subject pilot stage of the REPOSE study, evaluating the use of Astragard nerve cap in the management of painful neuroma. Findings from the pilot phase demonstrated that subjects experienced a clinically significant reduction in pain from baseline at each of the 3, 6, 9, and 12-month time points following surgical excision of the neuroma and placement of Axigard nerve cap. Specifically, the study observed a statistically significant mean reduction in pain of 69 points at 3 months and 80 points at 12 months as measured on the 100-point visual analog scale. Additionally, subjects experienced clinically meaningful improvements in secondary endpoints evaluating quality of life, including fatigue, physical function, sleep disturbance, pain interference, pain intensity, and pain behavior as measured by the validated PROMIS questionnaires. Pain medication utilization data showed positive indicators for a reduction of pain medication burden, including opioids, following the procedure. There were no AxiGuard NerveCap safety issues reported and no observed recurrence of symptomatic neuroma. Although a small sample, we're encouraged by the promising results of the proposed pilot phase supporting the ongoing safety and performance of AxiGuard NerveCap in the management of painful neuromas. Enrollment in the comparative phase of repose is well underway, and assuming limited impact from COVID-19, the company expects enrollment to be completed in Q1 of 2022 with a data readout in Q2 of 2023. Our RECON study remains on schedule. As a reminder, RECON is our phase three pivotal study supporting our biologics license application, or BLA, which will transition our advanced nerve graft from a section Our last subject was enrolled in July of 2020. Our protocol includes a 12-month follow-up visit for all subjects, and given the impact of COVID-19, our plans allow for an additional three months for subjects to complete their final visit. We anticipate the final follow-up visit to occur no later than October of 2021. A study report in the second quarter of 2022 and filing of our BLA in 2023. Our ranger and match registries continue to enroll, with over 2,300 nerve repairs now enrolled in ranger. In 2020, the match registry, which is a comparative population of conduit and autographed repairs, provided a publication on the comparison of conduit and advanced outcomes, and a presentation on the preliminary findings of autografts and advanced outcomes. Findings from these analyses demonstrate that the outcomes of advanced nerve grafts were statistically better than conduit and were comparable to those for autograft. Data from these two clinical programs continue to play an important role in informing surgeons' clinical decision making. Additionally, during the clinical and scientific sessions at the American Association for Hand Surgery annual meeting in January, a group of independent investigators presented on the comparative clinical outcomes for nerve autografts, conduits, and allografts, of which all allografts were advanced nerve grafts. The study was a large, systematic review of the available literature, including 35 clinical studies and over 1,500 nerve repairs. Similar to the findings from our match studies, this large review found that outcomes for nerve allografts were statistically better than those for nerve conduits and comparable to those for autografts. Investigators also analyzed procedure cost data from 340 Medicare claims and found that hospital facility procedure costs, both inpatient and outpatient, were also comparable. These findings further highlight the growing body of clinical evidence on the role of advanced nerve graft as an alternative to nerve autograft. Current data suggests advanced nerve graft provides both comparable outcomes and similar procedure costs compared to nerve autograft without the donor site morbidity and potential complications associated with the harvest of nerve autograft. In January, a new publication with the first clinical outcomes data from the resensation procedure published in the Plastic and Reconstructive Surgery Global Open Journal. The publication from Stanford University reported on 36 breast reconstructions that included 22 breast reconstructions utilizing the resensation neurotization technique and 14 standard non-neurotized breast reconstructions. The study found that neurotization using the re-sensation technique allowed for attention-free co-optation to sensory nerves. Return of protective sensation was reported in 73% of the neurotized subjects as compared to 36% of the non-neurotized group. Although an early time point, the subjects who underwent neurotization were more likely to see a return of sensation to the reconstructed breast and also more likely to have sensation in the majority of the breasts. This single center study is part of our larger Sensation Now registry, and we look forward to providing additional long-term sensory and quality of life data on the role of resensation for women undergoing breast reconstruction following mastectomy. As we advance the science of nerve repair, we remain committed to providing meaningful and impactful clinical evidence on the utility of our nerve repair portfolio. Reflecting on 2020, I'm extremely proud of the results delivered by our Axigen team and the creativity, resilience, and grit required to navigate the unprecedented market challenges that occurred throughout the year. Despite the pandemic, we entered the new year a stronger company, positioned well to drive meaningful growth in a more normalized environment. Before I turn the call over to Pete, I'd like to spend a moment discussing our outlook for 2021 and the first quarter. As mentioned previously, overall procedure volumes were further impacted late in the fourth quarter by increased COVID-19 cases, and this impact has continued into the first quarter. Given the uncertainty around the ongoing impact of COVID-19, including the timing of vaccine rollout to a larger portion of the population and the potential for new, more contagious variants of the virus, We believe it's appropriate to remain measured in our near-term outlook for the business. Accordingly, we are not providing full-year guidance at this time. Now, I'll turn the call over to Pete for a review of financial highlights. Pete?