Suzanne Winter
Analyst · Lake Street Capital Markets. Please go ahead
Thank you, Josh. We delivered solid top line performance for the quarter and our Q3 results represent our sixth consecutive quarter of delivering of above expectations in both orders and revenue. Looking at our first nine months of FY2022, we have delivered 14% growth in orders and 12% growth in revenue versus last year. We continue to see the strength of customer demand for both CyberKnife S7 and Radixact TomoTherapy platforms and the growing recognition by customers that Accuray technology provides a new standard of accuracy and precision compared with conventional C-Arm Linux systems. The market is adopting the use of ultra-hypofractionated stereotactic body radiation and stereotactic radiosurgery, or SBRT SRS treatments. We estimate that currently less than 20% of worldwide radiation therapy procedures are using ultra-hypofractionated treatments, but that number is expected to grow significantly over the next several years. These treatments are changing the way radiation therapy is delivered to patient, as it delivers a more powerful dose of radiotherapy and only one to five treatment sessions versus 35 to 40 treatment sessions with conventional radiation therapy. This represents a paradigm change offering significant patient benefits and additional treatment options for providers and reduces overall healthcare costs with a focus on value over volume. As discussed in previous earnings calls, the ability to deliver ultra-precise SBRT treatments vary substantially across commercially available radiation therapy platforms. Any error in the precision or accuracy of the treatment plan or delivery can have a significant impact on long-term patient outcomes and their quality of life, especially given the higher dose delivered over fewer treatments. The ability to see more, to distinguish tumor from healthy tissue enabled through superior ClearRT helical CT imaging, in addition to the ability to adjust the treatment beam to the tumor or patient motion continuously and in real time is only accomplished with Synchrony technology. These are two capabilities that differentiate Accuray technology from the rest of competitive radiation therapy platforms. And in combination with our latest product introduction for the Radixact platform, VoLO Ultra treatment planning, we are being recognized with these tools as critical to providing clinicians with the ability to deliver the highest precision and accuracy required for SBRT and SRS treatment planning and delivery. The growing body of clinical evidence shows that Accuray technology is making a difference in long-term patient outcomes. As we have seen in the results PACE-B trial for prostate cancer, which showed 50% less bladder side effects for men treated with a CyberKnife. The Tomo breast trial also demonstrated a reduction in secondary effect on lung and cardiac function for women treated on the TomoTherapy platform for breast cancer, versus those treated with conventional treatment. And most recently the results of ten-year follow-up data from the CyberKnife center in Milan Professor Romanelli at all showed durable pain relief after ten years, post-treatment for patients suffering from trigeminal neuralgia. With over 20 years of clinical evidence of growing body of studies now show the impact of Accuray’s ultra-precision technology and what it has on patient outcomes, years after treatment. And we continue to execute on our innovation roadmap that provides additional tools for clinicians to provide safe and effective therapy. During the quarter, we introduce the Neuro package at the Radiosurgery Society meeting in March. The new Neuro package for the CyberKnife S7 platform provides enhanced treatment planning capabilities for both the precision treatment planning as well provides access to the Brainlab Elements software, further expanding the capabilities for neuro-oncology customers. A key performance metric we are using to gauge our performance in the market is our ability to win competitive bunkers. In the developed markets, including U.S., Europe and Japan, which is a replacement market and highly competitive, we continue to be successful un-ceding the incumbent Linac manufacturers installed base. While this may vary from quarter-to-quarter, in Q3 21% of our unit orders we're replacing a competitive system. Year-to-date our competitive replacement performance for the first three quarters of FY’22 has improved by six percentage points year-over-year for the same time period, demonstrating that winning in competitive bunkers is a growing contributor to our order performance. In emerging markets like China and in Kenya, where we sold our first CyberKnife S7 system, the majority of system orders were to new radiation therapy customers, allowing us to further our vision of expanding patient access to advanced radiotherapy care, where it was previously unavailable. Looking at our regional order performance, the America's region delivered 239% orders year-over-year growth. And the APAC region delivered 30% year-over-year order growth with China, the major contributor offset by the EIMEA region, which decreased 27% year-over-year, mostly due to market uncertainty, which lengthened the sales cycle. In regional revenue performance demand for customer installation remains very strong with the expected supply chain constraints, tempering our ability to fulfill demand. However, I could not be more proud of our operations and sourcing team and their ability to navigate the challenges and execute a strong quarter and fulfill balanced regional revenue performance across our major regions with year-over-year growth in both the Americas region and non-China APAC region. China, again, delivered solid results with $26 million in orders and $21 million in revenue, despite the zero COVID policy, which is driving challenges for this region. We expect stringent central government policies that restrict travel will slow our regulatory submission of our JV developed type-B product. However, we remain on track for market introduction at the main conferences in the fall and are optimistic about the market reaction to the product features and the ability to gain share in type-B segment pending regulatory clearance. In summary, we are advancing each of our strategic initiatives forward and our business fundamentals are strong. Our teams are executing despite the extremely challenging supply chain conditions in Q3. And while we cannot predict with full visibility, when macroeconomic trends will improve, we are mitigating the impact of inflation headwinds with increased pricing on our high value, new product introductions like ClearRT and Radixact, and increasing service contract pricing to partially mitigate the impact of increased inflation and logistics costs. We have been very effective at expediting product supply pivoting to alternate sources of supply and designing in alternate components to ensure availability. On the logistics activity with the assistance of our strategic partner DHL, we have instated process controls to ensure better on shipment costs while maintaining quality and responsiveness to customer needs. We believe early visibility to component shortages and proactively mitigating risk associated with long lead time parts or key sub-assembly is a key success factor. As a result, I am confident that the actions we are taking to successfully navigate these supply chain and logistic headwinds will provide operational productivity once the macroeconomic environment improves. In summary, we are advancing our innovation driven growth plan forward in all areas and expect continued customer demand for installations. Product revenue is growing from an increased investment, in R&D growth initiatives with increased customer adoption of our unique platforms that provide providers with the mission critical tools that are needed to provide ULTRA-PRECISE, SRS and SBRT and advanced patient care. Looking into the remainder of the year we are maintaining our guidance for the full year at the revenue range of $420 million to $430 million and adjusted EBITDA of $15 million to $20 million with the range defined by our ability to fulfill customer demand impacted by the ongoing macroeconomic and supply chain environment. And now I'd like to turn the call over to Brandy for her review of the financial details. Brandy?