Joshua Levine
Analyst · Cowen. Go ahead
Thanks, Joe, and thank you to everyone joining us today. Joining Shig and I on today’s call is also Suzanne Winter, our Chief Commercial Officer and Head of R&D, who will be joining us during the Q&A session. Despite the challenging environment caused by COVID-19, we concluded the fiscal year on a strong note and feel good about our full year fiscal 2020 performance. We generated 10% year-on-year order growth, aggressively managed expenses and working capital and positioned the business for future growth. With that said, it's clear that the macro environment is requiring our team to find new and creative ways to engage customers and manage the business. The intensity of the COVID-19 situation is highly variable by region and local markets, continuing travel and customer access restrictions in certain markets, and the resulting logistics and bunker construction schedules related to installation project timelines have been impacted at both our distributor and end user levels. As a result, we expect continued uncertainty of revenue conversion timing for at least the first half of fiscal 2021. Despite these headwinds, we're demonstrating a high degree of adaptability. Our commercial team continues to successfully respond to customer specific conditions and requirements. Sales, clinical application support, and even some service related diagnostics and troubleshooting interactions are being conducted through videoconference platforms that enable customer communication and support in real time. On balance, we believe we are operating very effectively within the constraints of the COVID environment. And I'm proud of our commercial team's ability to adapt and the dedication of our entire organization during these challenging times. From an internal focus perspective, we've been taking actions across an array of operational and financial areas to help ensure the continuity of our business. Operationally, we are continuing to work aggressively with critical supply chain and logistics partners to ensure that we can support our production and service activities globally, while maintaining maximum flexibility related to production schedule changes tied to revenue conversion timing. We exercise great financial discipline in fiscal 2020 and maintained our focus on cash flow management, with minimal compromise to commercial activities and advancing future innovation. While Shig will discuss our balance sheet position in greater detail in his prepared remarks, these actions allowed us to finish fiscal 2020 with a stronger cash position than our initial internal forecast anticipated. As we exited the fourth quarter, we were able to prepay $10 million of our term loan and renegotiate the covenants related to the remaining debt with the lender in the first week of the fiscal 2021 first quarter. Thinking about our strategic growth opportunities, we are still awaiting final completion of the tender process for the China Type A licenses, awarded to end user facilities for Accuray devices. While the timing of Type A shipments remains uncertain, our belief is that we will begin to see initial revenue impact sometime in the first half of fiscal ‘21. Turning to the Type B segment of the China market, we continue to advance our plan to produce a made in China product for the Type B segment. Operationally, we have made significant progress in readying our production capability in Tianjin. The JV manufacturing facility there is now complete, with manufacturing qualification, and in-country required testing, finishing sometime in the first calendar quarter of 2021. Based on estimates of the product registration process timelines, we expect that we will begin shipping the Tianjin produced version of Radixact in the fourth quarter of calendar ‘21, or roughly 15 months from now. Additionally, the Tianjin training center is also now complete and devices and equipment to support training are scheduled to be installed and in place by the end of this month, in order to support a grand opening of that facility by mid-September. Turning to one of our more important R&D development projects. During the fourth quarter of fiscal 20, we achieved full commercial release of the Synchrony Motion management upgrade on Radixact. And we are very encouraged by the strong interest in Synchrony from existing Radixact customers who are treating complex SBRT cases. During fiscal Q4, we shipped a total of nine Synchrony upgrades and installed three of these upgrades in the Japan market alone. We now have five customer locations that are actively treating patients with Synchrony-equipped Radixact’s, and our expectation is that we will have an additional 10 customer sites going live by the end of our current quarter. We believe the added clinical value that Synchrony can bring to Radixact will be a strong driver of trade-in, trade-up opportunities for existing Tomo-installed base replacement sales.. The importance of the Synchrony introduction on Radixact cannot be overstated in terms of clinical impact. In order to share with you how truly unique Synchrony’s motion management capability is, and the significance of the clinical impact it will have on the Radixact platform. We have some visuals to share with you, as I walked through my prepared remarks. As background, Synchrony uses artificial intelligence, employing predictive algorithms to automatically adapt to the known position of treatment targets, as they move during the rhythmic motion associated with the patient's respiratory cycle, and adjust when necessary, if the patient's breathing pattern changes. Synchrony also has the ability to adjust to targets that move intermittently as can often occurred during treatment of prostate cases. This unique ability to adapt the treatment delivery beam in real-time to a moving target enables clinicians to reduce margins, resulting in significantly less radiation dose to healthy tissue, which can lead to better outcomes when treating lesions in the lung, liver and other anatomical sites that move with respiration. It also allows for improved clinical confidence in utilizing hyperfractionated treatment plans to deliver SBRT cases. Going to our first slide, we have provided a comparative example of a lung case with and without Synchrony. Prior to Synchrony, the two conventional approaches of treating tumors or lesions that are affected by target motion are gating, and the ITV or internal target volume method, both of which require clinicians to utilize larger treatment margins. In gating, the radiation beam is turned off except when the target moves into a narrowly defined target window. Because beam-off time associated with gating results in less efficiency and overall treatment time, typically, during gating, the target window is widened, but in doing so that means that more healthy tissue is exposed to unwanted dose. With the ITV method, the beam targets the entire envelope or range of target motion, delivering a large amount of dose to healthy tissue. While this approach is more time efficient than gating, this method creates significantly greater radiation exposure to healthy tissue. Looking at the highlighted treatment locations in the side-by-side comparison in the slide, it's striking to see how much smaller the treatment margins are on the left side of the slide, utilizing Synchrony versus the gating or ITV approach. Because Synchrony enables clinicians to deliver larger doses, with smaller treatment margins, and faster treatment times, clinicians experienced with Synchrony report, greater clinical confidence in using hyperfractionated treatment plans for their more challenging SBRT cases. Turning to our second slide. We have provided a case study for a recent case performed at Froedtert Medical Center in the Medical College of Wisconsin of a 45-year old male patient with lung metastases. This is a great example of how small changes in margins can have an overly large impact on the amount of healthy tissue receiving radiation. This patient was treated fiducial-free, utilizing SBRT in three fractions with 30% less treatment volume. Beam-on time for this case was only nine minutes. Because the beam synchronization takes place automatically, and in real-time treatment delivery remains highly efficient, from a timing and workflow standpoint, with no need to ever pause the treatment beam, mechanically restrain the patient to ensure proper positioning or requiring the patient to hold their breath for uncomfortably long periods to interrupt the respiration cycle. Customer sites in Japan, Italy and the US have successfully delivered fiducial-free SBRT treatments for lung patients using hyperfractionated SBRT treatment plans with beam-on time of less than 10 minutes. Synchrony on the Radixact platform is driving clinical confidence and expanding the universe of patients who historically might not have been treated with hyperfractionated SBRT because of already compromised pulmonary or respiratory function. Looking forward in fiscal ‘21, we believe the COVID environment will continue to be a catalyst for radiotherapy treatments, utilizing high dose, shorter duration treatment timelines. Both of Accuray's treatment platforms are uniquely capable of supporting these requirements. Going forward, we expect the accelerated use of hyperfractionated treatments driven first, by changes in US-based reimbursement with the proposed alternative payment model. Second, the growing body of clinical data that demonstrates clinical safety and efficacy of hypofractionation versus conventional treatment. And lastly, the benefit of shorter treatment regimens for both the patient and the provider in terms of user experience. Covering both short and long term horizons, we believe Accuray's portfolio is very well positioned to meet the clinical needs of our customers and their patients. In closing, while the COVID-19 environment continues to be challenging, we are focused on managing the activities that we can control, ensuring the health and safety of our employees, ensuring continued support for our customers and their patients and focusing on those elements both operationally and financially that will drive Accuray's business continuity. Now, I'd like to turn the call over to Shig for his review of the financial details. Shig?