Dave Demski
Analyst · Wells Fargo
Thank you, Brian, and good afternoon everyone. First Quarter sales were183 million, an increase of 4.9% as reported and 5.7% at constant currency compared to the first quarter of 2018. Non-GAAP EPS was $0.36 per share versus $0.41 a year ago. Our overall growth and profitability profile remains the best in our industry. For the quarter, the US spine business grew by over 8% adjusted for the impact of biologics disruption. The International spine business grew by almost 25% and Enabling Technologies delivered 7 million in revenue in the seasonally challenging first quarter. We also launched five new products during the quarter and shipped a record number of sets and both trauma and spine as our supply chain issues have been largely resolved. This year, we began reporting our sales in the categories of musculoskeletal solutions and enabling technologies to better reflect our business strategy. ExcelsiusGPS is currently the only product in the Enabling Technologies category. In the first quarter musculoskeletal solutions were up 8.7% and enabling technologies were off by 44%. The first quarter of the year is typically seasonally challenging for capital equipment. And our comfortable number from the first quarter of last year included a significant pent up demand for ExcelsiusGPS due to the delayed launch in late 2017. We are also experiencing an elongation of the decision cycle by hospital executives in purchasing robotic systems due to the increase in marketing initiatives by our competition. Deals are taking longer to get finalized as accounts evaluate potential alternatives. In fact, we have already closed several deals in Q2 that we had expected to close in Q1. We remain extremely bullish on the future of computer assisted surgery in spine and more importantly Globus ability to lead the industry in this transition. There are several reasons for our optimism. First and foremost, we are seeing consistent adoption of the technology backed by accounts who have purchased ExcelsiusGPS. And as a result, surgeons are able to perform less invasive techniques. Even the most challenging surgical approaches like single position lateral surgery are being performed routinely by surgeons with all levels of experience, something that was simply inconceivable before our technology. Second, surgeon interest in robotics continues to grow as evidenced by attendance at our MERC events, visits to our booth at society meetings, corporate tours and robotic road show presentations and labs. Third, we have one an overwhelming majority of head to head technology evaluations. While there may be a lot of noise in the market right now about various alternatives, we firmly believe that the best technology will lead the way. Fourth, our pipeline of innovation in this space is quickly coming to fruition. We recently filed a 510 (k) submission to the FDA for our ExcelsiusGPS interbody module, which we expect to launch in the third quarter. This fully integrated solution will enable surgeons to seamlessly navigate a variety of interbody spaces and utilize the Excelsius end effector to originally hold retractor supports. Both of these features are unmatched in the market. We also anticipate filing with the FDA on our cranial solution and our spine deformity planning solution that incorporates Surgimap technology during the third quarter with launches expected by year end. Finally, later this year, we will unveil three additional modular platform technologies that will complement and enhance the effectiveness of ExcelsiusGPS, and comprise an integrated suite of enabling technologies that we are calling the Smarter OR, focused on improving outcomes in spine surgery by enabling surgeons to effectively and efficiently deliver better care. While I would love to provide greater detail on these exciting developments, for competitive reasons we cannot at this time. We expect to provide more detailed information on the systems as well. As you know, we have been heavily investing in our imaging navigation and robotics business over the past several years with much of that investment going towards these new platforms. We are excited to be on the cusp of launching a series of innovations that we believe will accelerate the transformation of spine surgery into the digital age. Moving to musculoskeletal solutions, our US spine business grew by 6% over the first quarter of last year, significantly above the overall market. This result includes a negative impact we experienced in our biologics business due to the FDA warning letter we received late last year in our tissue processing facility in Texas. The run rate impact to Q1 revenues was about $3 million. Stripping out biologics would have resulted in a growth rate of 8.4% in the US spine business, consistent with the high single digit results we produced in the second half of 2018 and indicative of the continued strong momentum in the biggest segment of our business. Implant pull through from ExcelsiusGPS placements and contributions from competitive recruiting were the primary growth drivers. On the recruiting front, we are off to a tremendous start well in excess of the pace we saw in early 2018. Looking forward, we expect to have all tissue related issues resolved by the second half of this year, as well as launch a number of new spinal implant systems beginning in Q2 that we expect to further bolster the US spine business. Our international business grew by 19.7% in Q1 and 24.7% on a constant currency basis. The supply chain issues that constrained us in 2018 have been largely resolved and we were able to increase the number of sets shipped to international markets in late 2018 and into Q1. The Japan business produced record growth in the quarter driven by strong uptake of Globus technology there. Spain and Italy continue to be strong performers and the UK has begun its turn around. The growth rate we saw in Q1 is probably not sustainable for the full years as it included an investment cycle by distributors who now have full access to our technology. Dan will speak in more detail about it, but it is worth noting that the operational execution was offset by currency headwinds in the quarter. We made significant progress in our trauma business during the quarter as we shipped more sets in Q1 than we had shipped for the entire year of 2018. The pull through to sales will be somewhat delayed as we work through contracting and trial cycles. During the quarter, we launched our Tibial Nail System and the reports from the first several cases have been outstanding. Our focus remains on completing our initial ramp of set deployments and building sales momentum. We don't expect a meaningful revenue contribution from trauma until 2020. We are fully committed to this opportunity even though the EBITDA drag has been significant and the process has taken us longer than we had planned. In summary, we remain confident in our ability to achieve our growth and profitability targets for the year. The momentum in our US spine business, the uptick in our international spine business, the growing demand for robotic solutions, the improvements in our supply chain, and the robots lineup of product launches on tap of the spine, robotics and trauma all point to a strong year. I would like to take this opportunity to announce changes in our Board of Directors. Rob Liptak stepped down from the board effective May 1 after serving our company for nearly 12 years. Rob joined the board as part of Series E financing in 2007. He has been a valuable contributor to our success since then and we will miss him. Unfortunately Rob has assumed a role that precludes him from serving on public company Boards. We are also excited to announce the appointment of Steve Zarrilli to our board effective May 1. Steve is currently the President and CEO of University Science Center, Philadelphia, the oldest and largest urban research hub in the US. Prior to that Steve was the President and CEO of Safeguard Scientifics, a public company that provides growth equity capital to technology and healthcare enterprises. Steve has served as a member of the board of directors on six other public companies over the course of his career and is a graduate of La Salle University. We welcome Steve and look forward to working together with him to continue the success of our company. I will now turn the call over to Dan.