Keith Valentine
Analyst · Ryan Zimmerman of BTIG. Your line is open
Thank you, Leigh. Good afternoon, and thank you all for joining us. 2019 was another year of solid execution for the SeaSpine team. We delivered on our commitment to pivot to double-digit revenue growth by posting 11% growth for the full year and more than 13% growth in the second half of 2019. We accomplished this through an aggressive cadence of new product introductions, including 10 new products or line extensions; and two full commercial launches. We also expanded our distribution footprint, both in the U.S. and internationally, with the addition of even more committed and exclusive distribution partners. Armed with the robust product pipeline, the opportunity to leverage 7D Surgical’s Machine-Vision Image Guided enabling technology and $92 million in net proceeds raised from an equity offering last month, we have never been better positioned to continue the momentum and gain additional market share. We remain laser-focused on our vision to develop surgeon-centric, cost-effective solutions that combine innovative spinal implant systems with industry-leading orthobiologics, which together, will drive improved procedural solutions and deliver clinical value to the surgeon, hospital and patient. As our recent global sales meeting demonstrated this month, the entire SeaSpine organization is steadfast in executing this vision, and we look forward to achieving even greater results in 2020. Turning to our top line performance. In the fourth quarter of 2019, we delivered the highest quarterly revenue in our history as a stand-alone company, posting total revenue of $43.7 million, an increase of 15% versus the year ago period. I’m especially proud of the 21% growth we posted for U.S. Spinal Implants in the fourth quarter of 2019, which is by far the highest growth rate in that portfolio to date. Total U.S. revenue increased 16% to $39.3 million, and international revenue grew 10% to $4.4 million. In the U.S., growth was once again led by higher sales by our core distributors of recently launched products and line extensions. New and recently launched products contributed more than 50% of U.S. Spinal Implant revenue and more than 25% of U.S. orthobiologics revenue in the fourth quarter. From a distribution perspective, we have continued to add more committed and increasingly exclusive distributors in the U.S. For the fourth quarter and full year 2019, these core distributors collectively generated nearly 58% and 54%, respectively, of our total U.S. revenue. Core distributors, collective revenue mix is roughly 60% spinal implants and 40% orthobiologics, which is approaching the average revenue breakdown per procedure for spinal Implants versus orthobiologics. Turning to our product launches. 2019 was another exciting year for innovation and execution. Highlights included alpha launches of three line extensions to our Mariner platform for MIS, midline cortical and more complex revision surgery; and our full launch of the midline cortical system in December. We also alpha launched the incorporation of the innovative new Reef Topography into our Shoreline Anterior Cervical System. We continue to invest in the scientific work to evidence the value of Reef. We recently completed a large animal study that demonstrated significant benefits in fusion performance and early biomechanical strength. Within the orthobiologics portfolio, we introduced a new integrated hydration system for the Osteostrand and Osteostrand Plus, demineralized bone fibers products that allows the surgeon to seamlessly hydrate the DBM fibers with blood, saline or bone marrow aspirate in a convenient open bore syringe system. During the fourth quarter of 2019, we also launched a minimally invasive pedicle based TLIF retractor that is compatible with our Mariner system and a bulleted interbody featuring NanoMetalene with Reef Topography for PLIF and TLIF approaches that accommodates both straight impaction and inset and rotate techniques. In 2019, we also completed the full launch of our Regatta Lateral System, featuring our proprietary NanoMetalene surface technology. Looking ahead for the next 12 months, from a product development perspective, SeaSpine enters 2020 with our most ambitious launch schedule in our history. Starting with our interbody franchise, where we have the most new product introductions planned, we expect to alpha launch three new implants featuring NanoMetalene with Reef Topography and articulating TLIF implant and – a hinged TLIF implant and a new no-profile anterior lumbar interbody implant that includes both a screw and an optional modular locking plate. We also plan to alpha launch in the first half of this year a newly designed comprehensive anterior decompression and disc preparation instrument system to better support this next-generation ALIF and our existing implant systems. Our plans are on track for our lordotic and parallel expanding interbody implants to launch under the EXPLORE [ph] brand name during the first quarter. We also expect to launch a line extension of our NanoMetalene Regatta lateral implant to include a modular locking plate in the first half of 2020. We are perhaps most excited to begin alpha commercialization of a suite of 3D-printed interbody devices under the agreement we announced with restor3D late last year. These 3D-printed implants, which will ultimately span cervical, TLIF, anterior and lateral approaches, allow us to be more efficient with capital expenditures because they are designed to utilize the existing instrumentation from their NanoMetalene counterpart systems. In our cervical franchise, we expect to alpha launch our Northstar [ph] posterior cervical OCT system in the first half of 2020 and a next-generation anterior cervical plating system in the second half of the year. We are particularly excited about the launch of the Northstar system as it will address the last big product gap in our cervical franchise and will ultimately replace two aging systems that were launched almost 10 years ago. We also expect to transition our Mariner MIS revision system and the Shoreline ACS system with Reef Topography to full commercial launch in 2020, and to launch a line extension of our Daytona Small Stature Deformity System in the first half of the year to capitalize on summer deformity season. Finally, I want to highlight our enthusiasm around our recently announced strategic alliance with 7D Surgical to co-market their flagship, Machine-Vision Image Guided Surgery platform and to develop SeaSpine specific instrumentation optimized to work with their platform. This agreement allows us to offer a best-in-class navigational solution to our hospital and surgeon customers, which combined with our innovated and differentiated spinal implant systems and orthobiologics products, collectively provide for a complete integrated and seamless procedural solution in spine. This enabling technology uses only visible light, eliminating patient and staff exposure to interoperative radiation, which is common with other technologies. Perhaps most importantly, we have been extremely impressed by the system’s ability to improve surgical workflow by registering the patient in just seconds and by allowing the surgeon to control the system from the sterile field, which is a great value-added benefit for this navigational platform. Continued investments in product innovation and in the deployment of more of our highly utilized foundational spinal implant systems, combined with the increasingly efficient and full- scale production of our advanced DBM products, gives our larger and increasingly exclusive distribution network confidence that we can support the growth of their businesses. These investments are further enhanced by our expanded surgeon and distributor training and educational programs, which underscore our commitment to providing a world-class customer experience to our surgeons and distributor partners. We believe that our greatest strength is our focus on marrying our best-in-class and cost-effective DBMs with a differentiated spinal implant portfolio built upon a solid foundation of advanced surface technologies, including NanoMetalene and 3D-printed implants and modularity features that provide surgeons with the interoperative flexibility to meet their patients needs. As mentioned earlier, this message was on full display at our global sales meeting, which was held in La Jolla, California, earlier this month. It was also a venue to recognize and celebrate our most successful sales leaders and distributor partners, and how we have transformed SeaSpine into a company focused on designing procedural solutions for spine fusion. We shared aggressive product launch plans for 2020 with all of our employees and our most committed distributors, and you could sense the excitement and positive energy that we generated throughout the meeting. We all are ready to translate that energy into even greater commercial momentum and success for everyone in 2020. I’ll now turn the call over to John to provide more detail on our financials and our financial outlook. Then I will wrap up. John?