Karen Zaderej
Analyst · Leerink Partners. Please proceed
Thanks, Brian, and good afternoon, everyone. Welcome to our fourth quarter and full year 2017 conference call. Joining me today is AxoGen's Chief Financial Officer, Pete Mariani. I'd like to begin today's call with a review of our fourth quarter and full year highlight, a brief company overview and an update on our key strategic initiatives. Pete will then provide a review of our fourth quarter and full year financial results and review financial guidance, after which time, we'll open up the call for Q&A. We are pleased report another successful quarter. Fourth quarter revenue grew 49% to a record $17 million. Our full year annual growth is 47%, with revenue of $60.4 million. It's gratifying to see expanded use of the AxoGen product portfolio in our core markets of hand surgery, trauma and oral and maxillofacial surgery. We're seeing increased adoption by surgeons across these applications. We're pleased with increased data in mixed and motor nerve repair, as well as in long gap nerve repair. And we're excited to announce the launch of our expanded application in breast reconstruction neurotization in Q4. We believe new application in breast reconstruction neurotization, along with the expanded use of the AxoGen product portfolio in oral and maxillofacial procedures, changes our addressable market to $2.2 billion across our current target applications. As in prior quarters, our revenue growth is continuing from both active and new accounts as we continue to build and strengthen our commercial team. We're pleased with 2017 results and believe we're demonstrating our ability to successfully execute our strategy and continue to drive awareness and growth in the emerging peripheral nerve repair market. For those of you who are new to our story, AxoGen is a global leader in developing and marketing innovative surgical solutions for peripheral nerves. We're passionate about helping to restore nerve function and quality of life to patients with physical damage or discontinuity to peripheral nerves by providing innovative, clinically proven and economically effective repair solutions for surgeons and health care providers. Peripheral nerves provide pathways for both motor and sensory signals throughout the body. Every day, people suffered traumatic injuries or undergo surgical procedures that impact the function of their nerves. Physical damage to a nerve or the inability to properly reconnect nerves can result in the loss of muscle or organ function, the loss of sensory feeling or the initiation of pain. We currently have four surgical implants in our portfolio. Avance Nerve Graft is the only commercially available process nerve allograft used for the bridging of nerve gaps of 5 millimeters to 70 millimeters. AxoGuard Nerve Connector is a minimally processed porcine extracellular matrix implant for connector-assisted repair of transected nerves with gaps of 5 millimeters or less. AxoGuard Nerve Protector is a minimally processed porcine extracellular matrix implant for wrapping and protecting damage peripheral nerves. And Avive Soft Tissue Membrane is minimally processed human umbilical cord that may be used as a resorbable soft tissue covering to separate tissue layers and modulate inflammation in the surgical bed. Along with these core surgical products, we also offer the AcroVal Neurosensory & Motor Testing System. AcroVal and our AxoTouch Two-Point Discriminator are evaluation and measurement tools. Health care professionals use these tools in detecting changes in sensation, assessing return of sensory grip and pinch functions, evaluating effective treatment interventions and providing feedback to patients on nerve function prior to and following nerve repair. Our products are used primarily by reconstructive plastic surgeons, hand surgeons and oral and maxillofacial surgeons in a wide variety of nerve repair surgeries, including upper extremity trauma, iatrogenic injuries from dental procedures such as third molar extraction, nerve repair during mandible reconstruction, nerve compression surgeries, including recurrent carpal tunnel syndrome, and now breast reconstruction neurotization. We are building awareness of peripheral nerve repair and expanding usage of our products with innovator and early-adopter surgeons, and we're excited to be moving toward the developing market of the middle adopters who are the majority segment of the nerve repair market. We find surgeons are initially cautious adopters for nerve repair products. They typically start with a few cases and then wait to see their results. Active accounts are usually past this wait period and have developed some level of product reorder. These accounts have typically gone through the committee approval process, have at least one surgeon who has converted a portion of his or her treatment algorithm of nerve repair to the AxoGen portfolio and have ordered AxoGen products at least 6 times in the last 12 months. In the fourth quarter, the number of active accounts increased 31% to 591, up from 452 in Q4 of 2016. The growing number and penetration of active accounts is driven by increased adoption of our nerve repair products across the surgeons' treatment algorithms. Accounts ordering Avance Nerve Graft, AxoGuard Nerve Connector and AxoGuard Nerve Protector now generate greater than 6 times the revenue of an account ordering just one of the products. Our objective is to continue expanding the treatment algorithms of surgeons to include all four of our surgical implants across their full continuum of nerve repair. AxoGen is generating strong and consistent revenue growth in a nerve repair market that remains largely untapped. There are more than 900,000 nerve repair surgeries annually in the U.S., pointing to a market opportunity of over $2.2 billion for AxoGen's products. The majority of these procedures are being performed in approximately 5,100 centers. Most of our 591 active accounts are still at an early stage of penetration and provide additional opportunities for growth. As a result, we believe we're just scratching the surface of our available market potential. We continue to develop this market through the execution of our strategic initiatives, which we believe will allow us to build long-term sustainable growth. We refer to these strategic initiatives as our five pillars of growth, building market awareness, educating surgeons and developing advocates, growing the body of clinical evidence, executing on our sales plan and introducing new products and expanded applications in nerve repair. I will now comment on our progress over the quarter in each of these areas. First, we continue to build market awareness of AxoGen and our products by engaging with surgeons at hospitals, clinical conferences and promotional events. We've developed strong relationships with many well-known surgeons who are innovators and early adopters of our platform. They've been extremely helpful sharing their experiences using our products with the clinical community and publishing the outcomes they've achieved around peripheral nerve repair solutions. In Q4, we participated in the 99th Annual Meeting of the American Association of Oral and Maxillofacial Surgeons, where we hosted key thought leaders at our exhibit booth who demonstrated surgical techniques for OMF nerve repair and discussed the importance of timely referral pathways. These demonstrations, several presentations and a nerve repair symposium helped increase OMF surgeon awareness of the AxoGen's comprehensive platform for nerve repair, including solutions to address nerve damage in the jaw, resulting from either surgical injuries or reconstruction following benign tumor removal or similar procedures. We hosted our Second Annual Analyst and Investor Day in November, including guest surgeon presenters who shared their experiences using the AxoGen platform for nerve repair. They reviewed current clinical techniques, data and the development of expanded procedures for peripheral nerve repair. We appreciate that many of you on this call joined us for our Analyst Day event. And while we worked to increase awareness of tissue donation year-round, our support of the Donate Life Rose Parade float each New Year's day helps us educate millions of parade viewers about the importance of tissue donation and nerve repair. Each year, we select a patient ambassador to ride on the float, representing patients who have received donated peripheral nerve tissue. Our 2018 patient ambassador, Dylan, is an active young man from Phoenix who was critically injured in a serious motorcycle accident. Once stabilized, Dylan discovered he was unable to move most of his left arm as a result of significant nerve damage. Several physicians told Dylan and his family that he might never regain use of his arm and suggested they consider amputation. His family searched for options and found a surgeon who could help. Dylan underwent several surgeries, including an Avance Nerve Graft implanted in his left arm. Today, Dylan is back to an active lifestyle and has sensation and movement in his previously damaged left arm. He rebuilds cars, helps his father run an electronics business and is pursuing active - acting and film classes. Our second pillar of growth is focused on surgeon education and the development of surgeon advocates. We conducted four national education events in the fourth quarter and a total of 15 for the year. These surgeon-led programs focus on advances and best practices in nerve repair. They allow surgeons to gain additional confidence in nerve repair techniques, and they drive adoption and increased utilization of our products. On average, we see the utilization from surgeon attendees more than double 6 months after they attend the program. Fourth quarter educational events included two fellows programs, where we train the next generation of nerve repair surgeons. We conducted a total of four fellows programs in 2017, training more than two thirds of all hand and microsurgery fellows for the year. And we plan to conduct five fellows programs in 2018. Our third pillar is to grow the body of clinical evidence. In 2017, there were 21 clinical and scientific presentations of our surgical portfolio. In addition, we now have a library of 53 peer-reviewed clinical publications. We're particularly pleased that seven of the 53 clinical publications focus on the use of our surgical portfolio in oral and maxillofacial procedures. This increase in presentations and publications reinforces both the importance of peripheral nerve repair and the growing body of evidence for AxoGen's products in nerve repair. Our RANGER Registry has enrolled more than 1,300 nerve repairs and continues to provide significant new evidence in the management of nerve injuries. Surgeons are using this data to better understand nerve repair outcomes and to expand their treatment algorithms. A presentation by Dr. Bauback Safa from the Buncke Clinic during the September meeting of the American Society for Surgery of the Hand provided further focus and clarity on a new subset of the RANGER database. This subset is the largest sample size and the longest follow-up presented to date on Avance Nerve Graft in mixed and motor injuries. Historically, these upper extremity nerve injuries have been repaired with nerve autograft. In the published literature, nerve autograft has achieved an average meaningful recovery rate of 68%, with a range of 57% to 80%. We were pleased to see that in the RANGER Study, 75% of the patients with mixed and motor injuries achieved meaningful recovery, which compares favorably to nerve autograft without the downside, morbidity and costs of an autograft. Also during his presentation, Dr. Safa discussed another subset of RANGER data that evaluated long gap nerve repair. Nerve autograft is typically believed to have an inverse relationship between gap length and meaningful recovery rate. In other words, the longer the gap, the fewer patients who achieve meaningful recovery. Contrary to historical belief, the data from this subset of the RANGER Study found consistent levels of meaningful outcomes in both long gaps and short gaps when repaired with Avance Nerve Graft. We believe this data provides additional opportunity for Avance Nerve Graft to continue challenging the norms of historical repair options and evolving the practice of nerve repair. RECON, our Phase III pivotal study comparing Avance Nerve Graft to manufactured conduits in digital nerve injuries, continues to enroll. We anticipate enrollment to be completed in Q4 of this year. These studies continue to produce important data that assist in clinical decision-making and support the adoption of our platform for nerve repair. In addition to the adoption we're experiencing with hand and reconstructive plastic surgeons, we continue to see increased adoption of our portfolio in oral and maxillofacial surgery. As these surgeons become confident with AxoGen's portfolio, we see expanded use of multiunit repairs in iatrogenic nerve injuries and the application of our products to more complex injuries, such as mandible reconstruction due to benign tumor resection. Clinical data showed that repair of these injuries with the AxoGen portfolio of products can provide meaningful recovery in 87% to 94% of these patients. The data and techniques presented at the October AAOMS annual meeting demonstrated the role of our platform for nerve repair in both simple iatrogenic injury repairs as well as large reconstructions with nerve gaps up to 70 millimeters. Surgeons now have an option to reconstruct these nerves, giving patients the opportunity to see return of function and avoid the social stigma associated with numbness of the lip, mouth and chin. The company's launch in breast reconstruction neurotization includes partnering with 20 to 25 breast neurotization centers by the end of 2018. At AxoGen, we believe the ideal breast reconstruction restores size, shape, symmetry, softness and now sensation, without the potential risk and comorbidity associated with autograft nerve harvest. We have developed the ReSensation surgical technique, which includes this - which incorporates this vision into a reproducible and efficient solution for reconstructive plastic surgeon. We began surgeon training on the ReSensation technique for breast reconstruction neurotization as a part of the application launch. Breast reconstruction neurotization provides an important new opportunity for women who choose autologous lap reconstruction following a mastectomy. Using AxoGen's nerve repair portfolio, surgeons can now connect peripheral nerves in the autologous lap to nerves in the chest wall, enabling sensory nerve regeneration. Historically, the sensory nerves were not repaired in these procedures, leaving the women with no sensory restoration. AxoGen believes that the restoration of sensory function is an important advancement for women facing the challenges of mastectomy and reconstruction. We have initiated the Sensation-NOW outcomes for women. Let me say that again. We have initiated the Sensation Neurotization Outcomes for Women or Sensation-NOW clinical registry. Sensation-NOW will study the physical and quality-of-life outcomes of breast neurotization. We believe that data from this registry will demonstrate that the ReSensation technique provides meaningful recovery in sensation and quality-of-life outcomes for women who choose reconstruction following a mastectomy. Our fourth pillar is sales execution. Our expanded sales organization is solidly executing and driving strong revenue growth. We ended the year with 60 direct sales reps, 36 of whom have been - who have been with us for at least 12 months. We expect to end this year with at least 75 direct reps. And in fact, we estimate we will end the first quarter with 68 direct sales reps. In addition to our direct sales force in the U.S., we have 20 independent distribution partners supporting the execution of our sales strategy. During the past 2 years, we've increased the number of direct sales reps by nearly 50%, and we had invested in and expanded our sales leadership, sales training, marketing and support structures. We have a world-class commercial team that will continue to scale and enable us to drive growth in current and expanded applications in our platform for peripheral nerve repair. Our fifth pillar of growth is the introduction of new products and expanded applications in nerve repair. AxoGen believes there are many unmet needs in the surgical repair of peripheral nerves. And we, as the leading company in this space, are positioned to develop new solutions for these needs. Although our existing products in the upper extremity, trauma, oral and maxillofacial and breast reconstruction markets are our prime revenue sources today, expanded applications in lower extremity surgery, head and neck surgery, urology and the surgical management of pain offer AxoGen expanded revenue opportunities in the future. We believe that surgical management of pain may provide an effective, nonpharmacologic resolution for many causes of recurrent and chronic pain. The pain universe is large, and the potential to apply surgical nerve repair and nerve management techniques to address issues such as neuropathy, migraine headache, pain associated with hernia repair or nerve injuries resulting from total joint replacement creates a single opportunity for us to introduce new products and expanded applications for our product portfolio. In November, AxoGen announced FDA clearance for AxoGuard Nerve Cap. In certain situations, AxoGuard Nerve Cap provides surgeons with a new option to protect the peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of asymptomatic or painful neuroma. It may be used in both the surgical management of symptomatic neuromas and as a preventative measure at the time of initial surgery to help reduce painful neuroma formation. We will initiate clinical evaluations to explore specific procedures and techniques using AxoGuard Nerve Cap in anticipation of a potential launch as a part of an expanded application in the surgical management of pain. Before I turn the call over to Pete, I want to highlight again that Q4 was a great quarter for AxoGen. We continued to execute against our strategic initiatives. And by doing so, we increased revenue by 49% to $17 million, with gross margins over 84%. We closed 2017 with $60.4 million, representing 47% year-over-year growth. We continued our focus on nerve repair education and awareness, experienced successful interactions at professional society meetings and at educational programs for surgeons. Surgeons are demonstrating an increasing awareness and adoption of the AxoGen portfolio and our core applications and are applying our portfolio of surgical solutions in new areas. We are making investments to grow expansion markets in breast reconstruction neurotization, and we're exploring the surgical management of pain. We're pleased with our progress and with our opportunity to continue developing the emerging nerve repair market and driving long-term sustainable growth for AxoGen. Now I'll turn the call over to Pete. Pete?