Joshua Levine
Analyst · Lake Street Capital Markets. Your line is now open
Thank you, Todd. Good afternoon, everyone, and thank you for joining us on today's call. Before we begin, I would like to introduce Shig Hamamatsu, our interim CFO was is joining me on the call today. Shig was our VP of Finance and Chief Accounting Officer before assuming the role of interim CFO on October 1. Shig has done a great job as the Interim CFO during this transition. With regards to Q1 performance, we had a solid start to our fiscal year 2019. First quarter gross orders of $61.4 million were up 10% year-over-year with a specially strong demand for our Radixact System. Gross orders for our Radixact System were more than doubled year-over-year receiving approximately 25 system orders, highlighting the growing market interest and adoption of our newest generation treatment offering. The strength in Radixact orders also highlights our expanding customer base with more orders coming from community and regional-based hospitals. Breaking down gross orders by type, approximately half of our Q1 orders were for new vaults. We also had a strong quarter for competitive replacements, which more than doubled year-over-year and represented approximately 40% of our gross orders for the quarter. Again, this activity was driven by our Radixact product line. It is important to note that these orders from both new and competitive vaults represent positive indications for future installed base growth. Lastly, 10% of our gross orders were replacement sales for existing Accuray systems. We believe that the success we're seeing with Radixact in new vaults as well as with competitive replacements is because of improved performance characteristics related to treatment speed and overall throughput. These characteristics have positioned Radixact as a highly efficient and versatile platform exceedingly capable of treating routine cases with great speed and efficiency, while allowing for complex case treatment capability. Radixact's functional performance and efficiency improvements early positive customer feedback and our upgrade roadmap have all contributed to a much stronger product position for Radixact across all customer profiles. Gross orders for our CyberKnife platform were down year-over-year primarily due to quarterly variability in order timing. As a reminder, we reported historically high CyberKnife orders in the fourth quarter of fiscal year 2018. Regardless of the quarter-to-quarter variability, given the positive -- positively receive launch of our CyberKnife mobile optimizer software last week at the ASTRO meeting which substantially improved system productivity with both increased patient throughput and reduced treatment planning time, we still expect to see full order growth on the CyberKnife platform. Turning to our regional performance, we saw continued growth from our EMEA region which accounted for almost half of our gross order dollars for the quarter with a significant contribution from our distributor managed markets. While we continue to gain traction in our distributed markets, we also continue to see successes in India where we’re selling direct. Overall, the EMEA region grew 10% last fiscal year and continues to perform very well for us, generating double-digit order growth again in the first quarter of fiscal 2019 relative to the prior fiscal year. In our Asia Pacific region, while we continue to generate orders in China in Q1, the big China related news is the long-awaited announcement regarding Type A and Type B radiotherapy quotas and licenses which were released by the Chinese Ministry of Health last evening at roughly 7:30 PM Pacific Standard Time. The announcement confirmed that there will be licenses issued between now and the end of calendar 2020 for 188 Type A radiotherapy systems and 1,208 licenses issued for Type B radiotherapy systems. While we are very pleased that we’ve final confirmation on this topic based on both the timing of this late breaking news and the depth of analysis required, we will not be giving any details on this call regarding estimates or guidance adjustments for FY '19 related to last evenings announcement from China. We expect that when our analysis is complete, we will be communicating in great detail about the potential benefits to Accuray from the release of Type A and B radiotherapy licenses. Additionally, nothing related to last night's announcement regarding quotas and licenses has changed our strategy regarding establishing the joint venture in China with a local partner and we're continuing to advance our efforts related to this objective. As we continue to work towards achieving this goal, we will provide updates as developments merit. Regarding tariffs in China, we saw a modest pricing impact based on orders received in the first quarter, but generally we don't expect significant margin erosion from a system standpoint given historically high end-user pricing levels. In our Japan region, we continue to see solid order generation for our Radixact System is in Q1 with a strong contribution this quarter from competitive replacements representing half of the orders we received in Japan. We were down a few orders in Japan year-over-year primarily due to quarterly variability and timing and we expect our orders will increase from this region for the remainder of the year. Since receiving Shonin approval last year for our integrated data management system and our precision treatment planning software, our funnel in this region has continued to expand. In our Americas region, our initiatives to improve our growth in the U.S market yielded positive results in fiscal 2018. We continue to focus on key initiatives including increased attention on replacement of Accuray systems, existing Accuray systems, multisystem opportunities and competitive wins. While Shig will provide a detailed review of the P&L in his prepared remarks, I wanted to provide a few financial highlights for the quarter. Total revenue for the fiscal first quarter increased 5% year-over-year to $96 million. Product revenue for the first fiscal quarter increased 7% year-over-year driven primarily by the increased adoption of our Radixact System. In the first quarter, we also generated adjusted EBITDA of $4 million. As noted in today's earnings press release, we announced that we’ve initiated a strategic organizational restructuring that will reduce the overall cost structure of the company, while preserving our ability to continue our product innovation objectives and generate higher levels of sales growth going forward. The workforce reduction actions taken which were focused primarily across noncommercial functions will make Accuray a leaner and more market responsive organization. We estimate that these actions will result in annual savings of approximately $15 million. We expect the full benefit of these cost reductions will be realized in the current year fiscal fourth quarter and we believe these actions will give us a clear path to GAAP net income while we continue to focus on top line growth. We believe that achieving a positive GAAP net income position will allow Accuray to generate improved levels of cash, continue to pay down debt, and unlock business development and investment opportunities that were previously unavailable to us. Before I turn the call over to Shig, I want to touch briefly on the innovation and product advancements we highlighted at the annual ASTRO meeting last week in San Antonio. As I mentioned last quarter, one of the most important development programs for our Radixact System is the launch of our motion tracking, correction and beam synchronization capability, which is similar to the Synchrony System on the CyberKnife platform. We are pleased to announce that during the quarter, we submitted our 510(k) application for similar functionality on our Radixact System. Last week at ASTRO, we previewed how this proprietary technology will work in our Radixact System and the reception from existing and prospective customers was outstanding. Similar to our CyberKnife platform, our proprietary Synchrony Target Tracking and Motion Correction Capability for Radixact corrects the target during respiration and ensures the beam is synchronized with movement of the target. Based on the projected turnaround timing on our 510(k) submission, we estimate that the first customer installation of Radixact with motion tracking correction and beam synchronization capability will be treating patients by the end of our fiscal year. As mentioned earlier in my remarks, at last week's ASTRO meeting we also previewed the CyberKnife VOLO Optimizer. Those who had a chance to see -- use the software have been very impressed. The CyberKnife VOLO Optimizer reduces treatment delivery time by as much as 50% and reduces plan -- treatment planning development time by as much as 90%. Plans created using the CyberKnife VOLO Optimizer are also reported to improve plan quality even further than observed in earlier generations. In conjunction with our precision treatment planning software, we believe that CyberKnife VOLO Optimizer is the latest in a long line of next-generation functionality and performance improvements that position the CyberKnife as a fast, efficient and remarkably precise full body treatment platform for stereotactic radiosurgery and stereotactic body radiotherapy. We expect these improvements will be catalysts in driving continued installed base upgrades and full-year order growth for our CyberKnife platform. Lastly, on the topic of products and innovation, we recently announced the published data from two of the largest multicenter studies we referenced in the past, focused on SBRT prostate treatment utilizing CyberKnife. The published data reinforces the CyberKnife System provides excellent prostate cancer survival rates in five or fewer treatment sessions. In fact, for low-risk patients, the disease-free survival rates were between 97% and 100%, which was superior to the 92% to 94% from historical conventional radiotherapy data. These studies also reported superior survival rates for intermediate risk patients. We believe that the results of these studies further validate the superior clinical utility and efficacy of our CyberKnife Systems in treating prostate cancer patients. I will now turn the call over to Shig to provide more details regarding our fiscal first quarter results as well as update our fiscal 2019 annual guidance in light of the cost reductions I just discussed. With that said, I will turn the call over to Shig.