Accuray Inc Q1 FY2020 Earnings Call

Thank you for joining us for the Q1 fiscal 2020 Accuray Incorporated Earnings Conference Call. I would now like to introduce your host for today's call, Mr. Doug Sherk. You may begin.

Thank you, Kevin, and good afternoon everyone. Welcome to Accuray's conference call to review financial results for the first quarter of fiscal year 2020, which ended September 30, 2019. In addition, during our call this afternoon, management will review recent corporate developments. Joining us today are Josh Levine, Accuray's President and Chief Executive Officer; and Shig Hamamatsu, Accuray's Senior Vice President and Chief Financial Officer. Before we begin, I'd like to remind you that our call today includes forward-looking statements that involve risks and uncertainties, including statements regarding our fiscal 2020 guidance, including factors that could affect such guidance, expectations regarding market conditions in China, expectations related to new product shipments and future business plans and strategies. There are a number of factors that could cause actual results to differ materially from our expectations, including, but not limited to, risks associated with the adoption of the CyberKnife, TomoTherapy and Radixact System's commercial execution; operationalizing the China joint venture and overall strategy in China; timing of China user license issuances and tenders, the company's ability to take advantage of the issuance of such licenses; future order growth; future revenue growth; profitability and macroeconomic factors outside of the company's control. These and other risks are more fully described in the news release we issued just after the market closed this afternoon as well as in our filings with the Securities and Exchange Commission. The forward-looking statements on this call are based on information available to us as of today's date, and we assume no obligation to update any forward-looking statements to reflect actual performance or results, changes in assumptions or changes and other factors affecting forward-looking information, except to the extent required by the applicable securities laws. Two housekeeping items for today's call. First, during the Q&A session, we request the participants limit themselves to two questions and then requeue with any follow-ups. Second, all references we make to specific quarters in the prepared remarks are to our fiscal year quarters. For example, statements regarding our first quarter refer to our fiscal first quarter ended September 30, 2019. Now I'd like to turn the call over to Accuray's President and Chief Executive Officer, Josh Levine.

Thank you, Doug. Good afternoon, everyone, and thank you for joining us on today's call. Accuray's Q1 performance represented a reasonably solid start to our fiscal 2020. As we shared with you during our year-end earnings release in late August, we expected fiscal 2020 to be characterized by revenue growth, primarily occurring in the second half of the year due to timing of China Type A license issuance and revenue recognition, and we believe that projected timing is still valid. First quarter gross orders exceeded our internal plan, and revenue was in line with our plan for the quarter. Gross orders were $78.5 million, representing a 28% growth over the prior year first quarter. Order growth was primarily driven by our CyberKnife System, while Radixact maintained strong momentum representing over 60% of the total orders for the quarter. Geographically, in fiscal Q1, our EMEA and AMS regions were meaningful contributors to gross orders, and we continue to see strong order growth from China, which contributed 11 new systems, 9 Type A and 2 Type B. On the revenue side, revenue for the quarter was $89.6 million, which was in line with our internal plan expectations. Turning to significant highlights. On October 9, the China National Health Commission announced the first round of Type A radiotherapy license awards for hospitals who had applications in the system for equipment. Of the 58 licenses that were awarded, 50 of them were for Accuray systems with TomoTherapy/Radixact Systems representing 60% of the awards, and CyberKnife Systems, the remaining 40%. We need to remember that the process identified by the Ministry of Health requires a tender process following the license awards for all participating end-user hospitals prior to being able to take receipt of a Type A device. This tender process has been put in place to define the transactional terms and conditions related to each hospital's equipment order and will not initiate a competitive bidding situation that would result in changes in the specific device that the hospital has received the Type A license for. We expect that based on the timelines required for this tendering process, we would not begin to see revenue impact related to the China Type A awards until sometime in our fiscal fourth quarter, and we remain excited about the China market opportunity as a significant growth catalyst for our business. Turning now to our product development roadmap. We introduced our Synchrony motion compensation and correction technology on the Radixact platform at the annual ASTRO meeting last month in Chicago and received strong customer interest over the course of the show for this exciting technology. As we indicated last quarter, we have our primary clinical product evaluation site for Synchrony on Radixact, currently underway at Froedtert Hospital in Milwaukee. Over the course of the next two quarters, we expect to ramp up additional commercial reference sites that will help drive full-scale commercialization going forward. Another highlight at the ASTRO meeting was the presentation of an abstract from the PACE study that was subsequently published in the September 17, 2019, online issue of The Lancet Oncology journal. The PACE study is an international multi-center Phase III randomized controlled study that compares three different prostate cancer treatment regimens across multiple safety and effectiveness metrics. This is the first study that we are aware of that allows for head-to-head comparative device data among both competitive products in the radiotherapy space and provides comparative data between radiotherapy and an alternative treatment modality; in this case, robotically-assisted prostatectomy. The first arm to reach target patient accrual and publish early toxicity results is referred to as the PACE-B arm of the study. The PACE-B trial is designed to determine whether ultra-hypofractionated SBRT offers therapeutic benefit over prostatectomy or conventionally fractionated or moderately-hypofractionated radiotherapy in the treatment of low and intermediate-risk prostate cancer patients. In this arm of the PACE study, patients are randomized to one of two treatment regimens, prostate SBRT treatment in five fractions utilizing accurate CyberKnife and conventional linacs, or IMRT treatment, involving conventional fractionation or moderate hyperfractionation in 20 or 39 fractions utilizing conventional linacs. There are a total of 845 patients enrolled in the PACE-B arm of the study, 431 of which were treated with SBRT and 414 who were treated with IMRT. Of these subsets, 41% of the SBRT group was treated on CyberKnife and roughly 59% was treated on conventional linacs. The results of the patient-reported and clinician-confirmed outcomes reported in the online September 17 issue of Lancet Oncology indicate two very important results: first, that there was no difference in acute toxicity between the SBRT and control arms indicating that patients can benefit from shorter treatment schedules without the risk of greater toxicity in the short term. The second result was that SBRT treatments on CyberKnife resulted in significantly fewer Grade 2 and higher acute urinary toxicity than treatments on conventional linacs. 12.4% versus 30.6%, a 2.5-fold difference, while maintaining equivalent levels of GI toxicity. CyberKnife's unique ability to deliver ultra-hypofractionated treatment allows patients to receive higher dose and shorter treatment regimens without the risk of greater toxicity or incidence of side effects. Before I turn the call over to Shig, I'd like to welcome the newest member of our leadership team, Suzanne Winter, who has joined us as Senior Vice President and Chief Commercial Officer. Suzanne comes to us from Medtronic, where she most recently served as Group Vice President for the Medtronic Diabetes business, overseeing annual revenues of $1.4 billion and more than 2,000 employees. Suzanne previously served as General Manager of GE Healthcare's Detection and Guidance Solutions business and has a strong and progressive track record of driving business growth across industry segments as diverse as radiology, neurology, and general surgery. I'm excited about having Suzanne on board, and I'm confident she'll become a key contributor to our future business growth. And now I'd like to turn the call over to Shig.

Thank you, Josh, and good afternoon, everyone. I will start with some detail on our gross order performance for the first quarter and then focus on certain highlights for the period. As Josh noted, gross orders for the first quarter were $78.5 million, up 28% over the prior year period. On a regional basis, orders in Americas approximately doubled compared to the prior year with South America being the largest contributor. The Japan and APAC each grew at healthy double-digit rates over the prior year period. Within APAC, orders in China were $24 million compared to $11 million during the first quarter of last year. Orders in EMEA were a meaningful contributor to our Q1 gross orders, but down compared to the prior year period due mostly to customer timing. From a product mix perspective, CyberKnife contributed approximately 40% of total gross orders in Q1, which was an increase from 15% of gross orders in the first quarter last year. The TomoTherapy platform led by Radixact accounted for approximately 60% of the gross orders during the quarter. Net age-outs for the quarter were $35.9 million, consistent with the forecast we provided during our fiscal 2019 fourth quarter call. As we expected, more than 40% of this total came from China. We continue to believe that a meaningful number of the orders from China that aged out during the past two years will eventually convert to revenue. The 50 Type A licenses recently awarded to hospitals for Accuray systems included several systems that were aged out of our backlog as of September 30, 2019. During the first quarter, we also recorded $3.6 million of cancellations and other adjustments. As a result, on a net basis, we generated $39 million of orders in the first quarter. We ended the first quarter with a backlog of $495 million, representing an increase of 7% from September 30, 2018. Turning now to our income statement. Total revenue for the first quarter was $89.6 million, down from $95.8 million in the prior year. During our fiscal 2019 fourth-quarter earnings call in August, we provided an outlook for revenue during the first half of fiscal 2020 to be below fiscal 2019 levels, and the 7% decline for the first quarter was in line with this expectation. Our product revenue of $37.6 million during the quarter declined 9% compared to the prior year. Service revenue in the first quarter was $52 million, down 4% from the prior year due to lower revenue from upgrades and purchases, service contracts, which as we discussed in prior calls, can fluctuate from quarter to quarter. From a product mix perspective, CyberKnife accounted for approximately 40% of the quarter's revenue, while the TomoTherapy platform accounted for the remaining 60%. Radixact revenue represented approximately 75% of the TomoTherapy revenue during the quarter. Turning now to gross margin. Our product gross margin was 42.6%, up from 40.9% in the prior year period due to a higher mix of CyberKnife revenue. Service gross margin in the quarter was 32.5% compared to 38.5% in the prior year. There were two primary drivers of lower-than-planned service margin for the quarter. First, parts consumption was higher than normal, which we believe was an isolated incident related to specific high-dollar parts. Second, we experienced delays in the renewal of certain service contracts that we expect to execute in the near future. Overall, we expect to see service margin return to near historical levels for the remainder of this fiscal year as we work through these items. Overall, gross margin for the first quarter was 36.8% compared to 39.5% in the prior year. Moving down to income statement. Operating expenses for the quarter were $37.2 million, a decrease of $5.4 million or 13% from the prior year. The prior year operating expenses of $42.6 million included $3.7 million from a one-time accounts receivable impairment charge during the first quarter. Excluding the impact of this charge, operating expenses decreased by $1.7 million or 4% during the quarter. We did not record any China joint-venture loss pickup during the first quarter due to the timing of Accuray's contractual obligations related to our equity contributions. We expect to report our share of the JV loss starting in the third fiscal quarter. Adjusted EBITDA was negative $1 million in the quarter compared to $4 million in the prior year period. The EBITDA decline was mainly the result of the year-over-year decline in revenue and commensurate decline of gross margin dollars during the quarter due to the lower service gross margin. We ended the first quarter with $87 million of cash and short-term restricted cash. Turning now to our guidance for fiscal 2020. We are reiterating our guidance provided back in August with revenue expected to range between $410 million and $420 million. We continue to believe in our ability to return to revenue growth during the second half of this fiscal year, while we continue to expect our total first-half revenue will be approximately 5% to 6% below fiscal 2019 levels. Our revenue forecast for the full fiscal year reiterated today does not include any incremental contribution from the 50 Type A licenses awarded in October because the hospitals awarded the licenses still need to complete the tender process before a shipment date can be arranged. Based on the timelines required for this tendering process, we do not expect to see revenue impact related to China Type A awards until sometime in our fiscal fourth quarter. We are reaffirming our expectations for gross order growth in the mid-single-digit range during fiscal 2020 with the Americas, EMEA, and Japan regions leading the way. During last year's second quarter, we received 16 orders from China as the government published the long-awaited quarters for Type A and B licenses in that quarter. While we expect solid gross orders from China during the second quarter, we do not believe we will match the 16 orders from the prior year period. Overall, our total second-quarter gross orders are expected to be approximately $10 million to $13 million below last year's level of $100 million. We continue to expect adjusted EBITDA for the full year to range between $19 million to $24 million, which includes approximately $2 million of our share of expected loss from the China joint venture operations. In terms of our gross margin outlook, we expect overall gross margin to be approximately flat to our fiscal 2019 levels of 39%. We expect operating expenses for fiscal 2020 to be down approximately 4% year-over-year as we see the benefit of the cost-reduction actions that we took in the prior year. Turning to Q2 net age-out forecasts, we anticipate Q2 net outs to be in the $18 million to $20 million range, which is approximately 50% less than the first quarter. And with that, I'd like to hand the call back to Josh.

Thank you, Shig. Operator, we're now ready to open the line for questions.

Our first question comes from Josh Jennings with Cowen.

Bryan here for Josh. With respect to being named in 50 out of the 58 Class A licenses, can you share how that compares to the level of participation you originally assumed?

Our original assumptions date back to about 2.5 to 3 years ago when the government was still issuing licenses for Type A radiotherapy products. At that time, we had a win rate in the low to mid-80s across both platforms. This win rate is consistent with where we were then, and we are very pleased to see license awards starting to come in. Additionally, having a balanced win rate across both platforms indicates how valuable our products are to academic medical centers and larger public hospitals in the local market.

Great. And with respect to the guidance, can you clarify what percentage of the total opportunity associated with these 50 Class A licenses that you expect to impact revenue in the fiscal fourth quarter?

Yes. This is Shig. I obviously can't be very specific about it, but I'll characterize that as a modest amount of Type A revenue in the fourth quarter in the guidance number based on awareness back in August when we provided original guidance, how many license applications for our system have been turned in. We obviously have a great news of the 50 licenses won, which is really higher than what we had expected, but we have not really built in any incremental units from that good news that we received into the guidance at this point because of the tender timing, which is still uncertain that you heard about. So all we want to do right now is, we want to see the pace of that tender process play out before we make any revenue forecast revision.

Okay. Great. And then just last one on the tender process itself. Just can you speak to Accuray's capacity to deal with multiple processes at once?

When discussing multiple processes, I'm not certain that the tender process involves much interaction beyond the end-user hospital and TomoKnife, our distributor. As we've mentioned previously, TomoKnife is currently in a transition phase while winding down operations as we ramp up the joint venture. Therefore, the main interactions during the tender process will occur directly between TomoKnife and the end-user hospitals. As noted in our year-end call in August, we have inventory ready and are well-prepared to respond promptly once the tender process concludes in a particular hospital and they are ready to receive our products. We can act swiftly from the start.

Our next question comes from Anthony Petrone with Jefferies.

Congratulations on the traction in China. And maybe to start there with a few questions, just on exactly how this process plays out. And so in terms of license awards, should we actually be looking at the license award as essentially a precursor to a booking? So is that a good way to look at it? And then you mentioned last quarter, Josh, just in terms of Class B licenses, that's going to take a bit longer and part of that had to do with just the infrastructure that was in the process of essentially being put together to handle the tender process. If you can provide an update there, that would be helpful.

Yes. So Anthony, our Type B activity accounts for about 10% of the total order activity we've been generating in China. As we've discussed previously, TomoKnife's primary focus as it ends its distribution relationship with us has been on Type A. The Type B products will primarily rely on the distribution network created by the joint venture and the long-term production at the Tianjin facility currently under construction with China Isotope & Radiation Corp. In the quarterly numbers, there were 9 orders for Type A and 2 for Type B. We expect to see significant growth in Type B as we progress. The established quotas for Type A and Type B highlight that we are only at the beginning. The orders from the first round of licenses represent just a third of the total Type A licenses in the quota, and there were nearly 1,300 licenses identified for Type B products. We are in the early stages, but we are generally pleased with our progress.

Yes, Josh, I want to clarify. The 50 licenses awarded for end users primarily reflect the orders that were previously booked into our backlog. As of June 30 last year, these 50 licenses were associated with applications submitted at the end of July this year. Most of the 50 licenses are linked to orders we had recorded in our books three to four months ago.

That's helpful. I have a quick follow-up regarding the American orders, which have nearly doubled. There was some concern about the CMS radiation oncology bundle, but from the reported results, it seems there was no disruption or effect on orders. Can you provide an update on what Accuray is hearing about the RO bundle and its lack of impact this quarter? What are the expectations for orders moving forward?

Yes. Anthony, it's a great question. I think you'll remember the conversation we had in Chicago during the IR event at ASTRO. And our view then and our view still today very consistently with what you heard from us already is that we actually think that we are, from a portfolio standpoint, very, very well positioned to deal with the alternative payment model situation. In general, from a directional standpoint, we believe that what will happen over time is you will see people that have been more predisposed to look at IMRT with greater number of fractions historically, they will be encouraged to move to SBRT-related treatments, probably using either moderately or ultra-hypofractionated treatment plans. And we think that favors our product portfolio, both platforms really strongly. So we've seen no negative overhang, if you will, or no negative feedback at all from customers relative to the APM announcement. And we're still bullish on longer term on our positioning from a portfolio standpoint related to that.

Our next question comes from Brooks O'Neil with Lake Street Capital Markets.

I want to just zone in on China a little bit more. I have really two questions. Obviously, we've been talking about your disproportionate market share of Class A licenses so far for a number of years, but if you could just remind us why your competitive position is so strong in China right now? And then obviously, the next phase is going to be this tendering process and I'm curious if you could shed any light on whether the joint venture you expect that to be a positive force in getting through the tendering process successfully? Or how do you view that right now?

So Brooks, the Type A discussion really goes back to the company's roots or the early days of both product platforms, both on the CyberKnife side and on the Tomo side. Both platforms had been very distinctly focused on larger academic medical centers. There was a significant amount of work in the early days done in building relationships with key opinion leaders across both of the technologies. If you remember some earlier conversations we've had, essentially we had in addition to academic medical centers with strong KOL endorsement, we had a very strong position in the PLA Military Hospital channel and the reason for that was that if you go back 10, 12 years ago, those hospitals were from a budgetary standpoint, essentially, they had open checkbooks. They had the best equipment you could find and the best technologies you could find across all the categories, and they were rarely, if ever, constrained from a budgetary standpoint. So you found a disproportionate number of the most important military hospitals and academic hospitals with both CyberKnife and TomoTherapy devices, really well represented in both of those customer profile types. We did some market research early on after I got to Accuray and one of the interesting things that we found was that, for a company of our size, given the market share we had, the brand awareness statistics and data from the market research that we did said that the awareness, both on the clinical side of the world, but also in a more general sense, population wise, was disproportionate. Awareness of our products and brands were disproportionate to our size relative to market share, which I thought was very interesting, and I think that, that has continued to play itself out. When you think about where high-ranking government officials in China where they go or where their families go for treatment, they end up in PLA military channel hospitals or they end up in the large academic centers. And so there's a high level of awareness across the MOH and the healthcare side of the government from a public health policy standpoint. High level of awareness about our products to this very day that we think is an important kind of foundational aspect or foundational advantage for us, given our positioning. So that I think is kind of the answer to the first part of your question. The second part concerns the tendering processes and the joint venture. The joint venture infrastructure will assist with the tender process, but I don't expect them to take the lead. Our current distributor, TomoKnife, is likely to lead because they have established relationships with the hospitals that received Type A licenses. They helped those customers apply for the licenses and enter the queue, giving them a stronger relationship and experience with these accounts. Consequently, they are better positioned to efficiently manage the tendering negotiations. While it may seem overwhelming with 50 different accounts, I am not overly concerned about potential challenges in the tendering process regarding infrastructure support and focus. The TomoKnife team is completely committed to ensuring the successful completion of these tenders so they can be first in line to receive a device. Yes, I would agree with that assessment.

Our next question comes from Tycho Peterson with JPMorgan.

This is Eleni filling in for Tycho. Regarding your questions about China, could you elaborate on why your timeline expectations for the tendering process have shifted, particularly with revenue recognition being delayed to your fiscal fourth quarter? Additionally, what initial pacing and cadence can we anticipate, considering the high demand and how quickly you could react once the tendering process is finalized?

So Eleni, let me start by saying that I don’t think our expectations regarding the timing of revenue impact in this discussion have really changed at all. If you look back at our prepared remarks and some of the feedback we've shared in Q&A over the last few quarters, one thing we've consistently noted is that whenever we've made bold predictions about timing related to China, we've been incorrect and disappointed. As such, we’ve taken a long-term perspective on this. We're being conservative, and if things occur more quickly, that's great, but as we mentioned in the previous earnings call, we expected the timing between the license awards announcement and the tendering process to impact revenue late in our fiscal year. It remains difficult to predict precisely how much revenue impact we will see, and that's where we currently stand. The good news is that before the end of the calendar year, we have license awards indicating that we have been a significant winner in the selection of Type A equipment. However, we still have some procedural activities to work through, particularly with the tendering. At this point, we have no reason to believe that we won't move through that process fairly quickly. However, I am not ready to make any definitive claims about exact completion dates for this process. I believe it's best to state that we don’t see any obstacles to completing the tendering process. We anticipate some revenue impact during our fiscal fourth quarter. If the tendering moves faster than expected, the revenue impact could be greater. As a reminder, our current backlog in China consists of about 59 units, roughly 60 devices, totaling around $130 million. Approximately $115 million is Type A and about $16 million is Type B. There’s a lot we can work with in that backlog once the tendering completes and the early end-user hospitals are ready to receive devices. As I noted in the last call, we have inventory ready and staged to respond to the completion of tendering, and we are prepared for installation and delivery of equipment. We are ready to proceed now. That's how I would characterize the situation.

Okay. And then can you talk about the give and take on guidance? Believe you previously included some assumption for tariffs on 150 basis points top line headwind and then also 150 basis points gross margin headwind. So just wondering how you're assuming given the tariff exemption.

Yes, we had an internal discussion and review about this topic, Eleni. We issued a press release in early to mid-September stating that we expect to benefit from the tariff exemption, and that has not changed. We still anticipate benefiting from the tariff exemption but are waiting for final clarification from the Chinese government regarding our exemption status. We have a high level of confidence regarding the Tomo-Radixact products. However, since the CyberKnife operates differently from a conventional linac, we want to ensure we receive full confirmation from the government that the CyberKnife will achieve the same exemption status we expect for the Tomo-Radixact products. Until we receive that clarification, we believe it is premature to adjust our guidance. Your estimate of about 150 basis points is in the range of the benefit we expect once we have clarification. Okay. Just want to thank everybody for participating today. Look forward to speaking with you again in January when we attend the JPMorgan Annual Healthcare Conference and report our fiscal 2020 second-quarter results later in that month. Thanks very much for your participation.

Ladies and gentlemen, this does conclude today's presentation. You may now disconnect, and have a wonderful day.