David Bailey
Analyst · Piper Sandler
Thanks Matt. Good morning everyone and thank you for joining us. We hope you are safe and well. As we start all earnings call, I'd like to highlight that we helped over 9,300 children in the first quarter of 2022. Since inception, OrthoPediatrics has now helped more than 540,000 children in total, when including the accomplishments of MD Orthopedics, which I'll provide more detail on shortly. Doing the right thing for children is an always will remain our top priority. In the first quarter of 2022, we generated revenues of $23.4 million, representing growth of 9% compared to the first quarter 2021. Despite meaningful COVID headwinds in January and February, we rebounded in March, which allowed us to generate solid revenue growth given the extremely challenging environment. Moving to our revenue segments. In the first quarter of 2022, we generated quarterly trauma and deformity revenue of $16.5 million, representing growth of 13% compared to the prior year period. Despite increasing Omicron impact in January and February, our non-elective trauma business delivered strong growth led by high rate of surgeon adoption of our PNP Femur System, as well as our new Cannulated Screws and SCFE Systems. Specifically PNP Femur and Cannulated Screws continued to benefit from positive customer preference and record set deployment. In the United States, we expect this trend to continue throughout the balance of 2022 and beyond, supported by additional set deployment and continued surgeon adoption. Internationally, we expect to see strong growth from PNP Femur and Orthex specifically. After showcasing both surgical systems at the 40th Annual European Pediatric Orthopedic Society in Denmark in early April, we saw noticeable increases in interest from key agency and stocking distributors. Additionally, we are planning a more robust launch of the PNP Femur and external fixation systems in key international markets, which should contribute nicely to growth in the balance of 2022 and beyond. In the first quarter of 2022, we generated scoliosis revenue of $6 million, representing growth 1% compared to the prior year period. Given the elective nature of surgical procedures within our scoliosis franchise, we experienced more meaningful headwinds in the early part of the first quarter. From a geographic perspective, domestic scoliosis revenue increased modestly compared to the same prior year period, while international revenue declined slightly due to international stocking distributors reacting unfavorably to the Omicron variant. That said our core scoliosis business continues to be driven by our flagship RESPONSE fusion system and the continued onboarding of new users of our ApiFix non-fusion system. Given the number of new surgeon users added in 2021, we view consistent adoption of response and growing the growing ApiFix franchise as combined tailwinds to growth in 2022. Next, I want to speak to some of the macro trends experienced in the first quarter that have impacted the entire healthcare system and specifically, the medical device industry, the first being COVID. As stated on our previous earnings call on early March, we entered the first quarter of 2022 experiencing meaningful headwinds associated with the Omicron variant, which negatively impacted elective procedure volume in January and February. Although the operating environment is improving, we continue to see pockets of COVID cancellations and elective case scheduling disruptions due to staffing challenges, albeit, at a much lower level compared to January and February. While delta and Omicron have deferred elective surgeries, it's important to note that this situation is temporary and that these elective cases do not permanently go away. This brings me to my second point. While the backlog of cases has increased since September 2021, we believe the recapture of deferred cases will be flattered in 2022 compared to 2021, due to continued hospital staffing shortage issues. That said, we believe the underlying demand for our products remain strong and we expect a more favorable elective procedure environment as we progress through the second quarter and the balance of 2022, which gives us tremendous confidence to deliver mid-20% growth for the full year. Lastly is the disruption associated with a global supply chain and increasing inflationary risk. While we are starting to see small pockets of inflation and extended lead-times, it is mostly isolated to instrument sets. Based on the current environment, we anticipate any supply chain disruptions will be in small quantities that may delay certain set deployments by several weeks. Since we're not seeing major inflation from our suppliers regarding our surgical implants or systems, we do not expect gross margins to be impacted in 2022. Furthermore, if inflation worsens, we have a high degree of confidence to offset increased costs with modest price increases to our customers, which we have historically been able to do. Regarding specific raw materials, the vast majority of our products are made from stainless steel, limiting our exposure to titanium. We are also proud to say we source approximately 90% of all materials and inventory domestically, which significantly reduces our exposure to global supply contracts. I'll now provide an update on a few of our key strategic initiatives, starting with the acquisition of MD Orthopedics. MD Orthopedics is a pediatric specialty bracing company focused exclusively on the treatment of children with clubfoot. Based in Wayland, Iowa, MD Orthopedics was founded through a partnership with Mr. John Mitchell and Dr. Ignacio Ponseti, a globally renowned pediatric orthopedic surgeon. MDO developed a custom-fit bracing system to correct congenital clubfoot deformity, which they sell in over 90 countries globally. In fact, this unique bracing system supported the dissemination of the Ponseti technique, which has become the gold standard treatment to correct clubfoot. Once fully integrated, we'll take advantage of our globally recognized brand and distribution network, combined with the strength and scale of our surgeon relationships to increase adoption of MDO's innovative clubfoot solution. While this unique non-operative solution will maintain its focus on the treatment of clubfoot, we also plan to leverage the capabilities of the MDO organization to develop several new innovative products that address large unmet needs for specialty bracing within the pediatric orthopedic market. Specifically, MDO will serve as a specialty bracing platform company within OrthoPediatrics' trauma and deformity correction business, allowing for rapid development and launch of several new products. Lastly, the pediatric orthopedic specialty bracing market has very attractive financial characteristics for OP, and then it requires minimal capital deployment for consignment inventory. Qith an estimated 80% of pediatric orthopedic care involving non-surgical treatment, MD Orthopedics expands OrthoPediatrics' total addressable market by an estimated $600 million. Speaking of rapid new product development, in late March, we announced a limited U.S. launch of our new PediFlex Advanced Interlocking Clamp System with a full global launch planned for later this year. This new system provides surgeons with additional options when using flexible intramedullary nails to treat fractures in children. While traditional flexible nailing has existed in pediatric orthopedic fracture care for over 40 years, this innovation evolves the use of flexible nailing in pediatrics. The clamps are offered in multiple sizes, ranging from three millimeters to four and a half millimeters, and are specifically designed to prevent problems associated with unwanted nail instability and migration. In April, we received an additional FDA clearance for Drive Rail, our new external fixation system. Unlike Orthex, which is a multi-plainer system, Drive Rail is a unilateral external fixation system with components designed to manage lower extremity fractures and corrective procedures. Unique to Drive Rail, this system contains integrated and customizable features that simplify the number of parts and steps needed to perform these complex surgical cases. In addition, the Drive Rail system can be utilized with the Orthex system serving multiple indications at the same time. We believe that Drive Rail will be a welcomed addition and complement to our entire external fixation portfolio. Accelerating new product development is one of our top priorities in 2022 and 2023 and we continue to make substantial progress in several key areas. Specifically, we're expanding our iron nailing platform, including extensions to our rapidly growing PNP Femur brand, developing the first ever pediatric specific tibia nail and a system to dedicate it to treat rare bone disease. We're building out a software development competency and plan to launch pre-op and inter-operative planning software for pediatric deformity correction surgery. As mentioned previously, in connection with MD Orthopedics, we plan to accelerate the development of other key non-surgical systems, which will provide more detail in the future. Regarding our scoliosis franchise, we're increasing focus on multiple unique solutions to address early onset scoliosis and the addition of several key instrument updates within the response Spine Fusion system. Turning to ApiFix, we've made great progress enrolling patients in our registry and continue to add commercial sites with IRB approvals. As of April, there were approximately 50 U.S. ApiFix patients with greater than 12 months follow-up with our first ever patient reaching two-year follow-up this June. Preliminary results remain very encouraging. Given the early clinical success of ApiFix, we continue to receive positive inbound inquiries from key hospital customers, leading to an accelerated onboarding of new surgeons in recent quarters. Additionally, ApiFix was awarded the Gold Medal from the 2022 Medical Design Excellence Award Program. Being judged by an impartial panel of medical device experts, this award embodies the dedication and passion of our company, along with our surgeon partners who are committed to providing children with a new treatment path for adolescent idiopathic scoliosis. Transitioning to strategic partnerships, we're seeing strong demand for the 7D Surgical Navigation platform. Specifically, we've performed numerous evaluations in the fourth quarter of 2021 and the first quarter of this year. Multiple customers, including many that are new, are currently going through value analysis committees and working through capital purchasing agreements. In the coming months, we look forward to providing more details regarding our first unit placements. We continue to view 7D as a transformative platform that will improve patient outcomes, drive increased surgeon engagement, and allow us to leverage our entire product portfolio to pull-through sales of our other products. Lastly, we're particularly proud of our execution and helping train the next generation of pediatric orthopedic surgeons. Year-to-date through March 31st, we carried out more than 70 training events for health care professionals. In April, we were the only diamond sponsor at the 40th Annual EPOS Meeting in Denmark, where we hosted a Surgeon Symposium led by OP's Medical Director, Dr. Scott Hoffinger. This was a particularly exciting event, as it was the first time since 2019, where we were able to meet with hundreds of European surgeons. Additionally, we're a Gold Sponsor at the International Meeting of Advanced Spine Techniques, or IMAS, in Miami, Florida, where we held an ApiFix surgeon training meeting. Our commitment to non-commercial clinical education keeps us true to our cause and signals our dedication to advancing the entire field of pediatric orthopedics. In summary, we believe the fundamentals of our business have never been stronger and we are proactively making the necessary investments to ensure our long-term success as the market leader in pediatric orthopedics. As a management team, we've adopted the mantra of controlling what we can control. We've been operating in this dynamic environment for over two years and are taking the steps to neutralize these periodic headwinds by you utilizing and deploying creative approaches to execute our strategy. We recognize the continued challenges that affect the healthcare environment. However, as a company, we are moving forward and tackling the challenges in stride. Circumstances won't dictate our success. The word our customers, and we do is too important. We have kids to help. With that, I'll turn the call over to Fred to provide more detail on our financial results. Fred?