Mark Throdahl
Analyst · Stifel. Your line is now open
Good morning, everyone, and thank you for joining us today on our second quarter 2018 earnings conference call. I'll begin with an overview of our second quarter's financial and operating results, followed by Fred, who will provide a detailed financial review. Afterwards, I'll make some closing remarks before opening the call for questions. For the second quarter of 2018, we are proud to report record quarterly revenues of $15.1 million, representing a 28% year-over-year increase. This robust performance results from strong execution in all areas of our business. Domestic sales up 25%, international sales up 39%, worldwide trauma and deformity up 25%, and scoliosis up 43%. It demonstrates that we are strengthening our competitive position in all segments of our business so that we can achieve sustainable growth at industry leading levels. During the first half year, we increased investments in consigned sets, sales representatives, and research and development by levels that are in line or have exceeded our expectations. Specifically, we deployed an additional $2.8 million of consigned sets in the quarter and have increased our target to $11 million for the full year 2018 to help satisfy the strong demand for our products. Concurrently, we continued to expand our domestic salesforce that supports the increased consigned sets and drives the utilization of our surgical systems. The significant increase in R&D investment is reflected in the recent FDA clearance of our 25th surgical system and the expected system launches and line extensions by yearend. These demonstrate our commitment to new product development that will sustain the future growth of an ever-bigger company. All in all, we continue to build traction through our first full year as a public company while further expanding our lead as the domestic player and the dominant player in pediatric orthopedics. With that overview, let me highlight the 4 primary initiatives that support our ongoing success and position the company for future growth. The first is consigned set deployments. During the quarter we invested an additional $2.8 million in consigned sets and realized the initial benefits from the $5.5 million deployed in the first quarter of this year. The combined $8.3 million in new consigned sets during the first half of 2018 significantly exceeds our historical annual investment of $3.5 million. We have thus removed a constraint to our growth. We continue to address broad pent up demand for our products as we track an updated target of $11 million for the full year 2018 and we expect to recognize the contribution from these additional consigned sets in upcoming quarters. The second initiative is salesforce expansion. To support the placement of these consigned sets and broaden their overall utilization, we supplemented our best in class pediatric sales team with four additional sales reps in the second quarter. This keeps us on track to add 18 reps during the year. Our 88 US sales reps today compare to 69 reps in June, 2017, an increase of 28% that mirrors the growth of sales revenue over the same time period. These reps are fully dedicated to selling our products and in conjunction with our 37 international stocking distributors and two international sales agencies, they are the driving force behind the expansion of our market position. We remain committed to providing outstanding service and consistent sales execution everywhere in the world in order to support our market leading position in pediatric orthopedics. The third initiative is new products. In addition to supporting our existing products, the expansion of our salesforce will drive adoption of our 25th surgical system, the Pediatric Nailing Platform, FEMUR, that was launched in July following FDA clearance in May. This system features two distinct implant offerings, one for children and another for adolescents, both of which are optimized for pediatric specific anatomy and can be used to treat both traumatic injuries and deformity corrections. This new system represents substantial improvements on the first ever pediatric nailing platform, our PediNail system, as well as the next step in the expansion of our intermedullary nailing franchise. The early feedback we have received is uniformly positive and suggests the significant sales potential of this new product. It also demonstrates how 11 years of pediatric orthopedic experience enables us to meet the needs of pediatric orthopedic surgeons and their patients. We remain on track to launch additional systems and line extensions in the second half of this year, including our small stature RESPONSE scoliosis system for which we have submitted the 510(k) to the FDA, and an additional BandLoc, sublaminar polyester banding system. These two product introductions will expand our ability to treat the unique challenges of pediatric spinal deformities. We are progressing development of our osteogenesis imperfecta nail system which will provide surgeons with dramatically improved options to treat the difficult pediatric condition known as brittle bone disease. In addition, we are also working on the first ever pediatric foot system. As we continue our aggressive cadence of new product introductions that fill in the grid of unmet needs in trauma and deformity in scoliosis surgery, we believe that OrthoPediatrics will achieve an insurmountable lead relative to any company that might try to follow us into the pediatric market. The consistent growth of virtually every system we have ever launched confirms our ability to provide customers with innovative surgical solutions as well as continuous improvements in existing products. A word about our two longer term development projects. We are making very satisfactory progress on active growing implants and have seen impressive results from our partnership with the company that has deep technical capabilities in this area. The spinal tethering program has also produced tangible results. While it's too early to say when these new systems might reach the market, we are confident that they will significantly contribute to the company's growth, even as our sales approach the $100 million mark. The fourth initiative is clinical education and surgical society support. Our commitment to advancing the entire field of pediatric orthopedics is demonstrated by our continued highest level of support for surgical societies including the European Paediatric Orthopaedic Society whose annual meeting we attended in April, and the Pediatric Orthopaedic Society of North America whose meeting we attended in May. We recently strengthened our relationship with the World Pediatric Project to provide surgical implants, instruments and financial support to increase access by children in developing countries to pediatric orthopedic care. We look forward to continuing our clinical education programs through our association with the OrthoPediatrics Foundation for Education & Research which received public charity status in March. Finally, we are the only orthopedic company to have a social media platform that allows surgeons to post cases and pose questions to their colleagues around the world. During the second quarter, the number of surgeons who follow OrthoPediatrics DocMatter platform exceeded 700. Before I turn the call over to Fred, I'd like to provide an update on the K2M litigation and our vigorous defense in this matter. In late June, 2018, the United States Patent & Trademark Office's Patent Trial & Appeal Board, or PTAB, instituted both Inter Partes Review petitions or IPRs, that we filed earlier this year to contest the patentability of one of the two patents at issue in the federal lawsuit. The PTAB has set a trial date of February 20, 2019 for both of these IPRs. Accordingly, in early July, 2018, OrthoPediatrics and K2M moved to stay the federal lawsuit pending the outcome of the subject IPR proceedings. The court order the stay on July 10, 2018 Moreover, later this month, we expect to file additional IPR petitions with the PTAB to challenge the patentability of the second patented issue in the federal lawsuit. For these reasons, among others, we view our case as particularly strong. Although we believe that the K2M lawsuit is without merit and we'll continue to vigorously defend the claims asserted against us, we welcome constructive discussions on a negotiated settlement. I'll now turn the call over to Fred for a review of our financial results. Fred?