VRAY (2021 - Q1)

Welcome to the Q1 2021 ViewRay Incorporated Earnings Conference Call. My name is Darryl and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] I will now turn the call over to Ashley Kluth. Ashley, you may begin. Ashley K

Thank you, operator. Good afternoon everyone and welcome to ViewRay's first quarter 2021 financial results conference call. Joining me today are Scott Drake, our President and Chief Executive Officer; and Zach Stassen, our Chief Financial Officer. Earlier today, ViewRay issued a press release and presentation for today's call. The presentation can be viewed live on our webcast or downloaded from the financial events and webinars portion of our site at www.investors.viewray.com. Today's call is being broadcast and webcast live and a replay will be available on our website for 14 days. Before we begin, I would like to caution listeners that comments made by management during this call may include forward-looking statements within the meaning of federal securities laws. These statements involve material risks and uncertainties and actual results could differ from those projected in any forward-looking statement due to numerous factors. For a description of these risks and uncertainties, please see ViewRay's Annual Report on Form 10-K for the fiscal year ended December 31, 2020. And its quarterly reports on Form 10-Q, as updated periodically with the company's other SEC filings. Furthermore, the content of this conference call contains time-sensitive information, accurate only as of today May 6, 2021. ViewRay undertakes no obligation to revise or otherwise update any statements to reflect events or circumstances after the date of this call. I will now turn the call over to Scott.

Thank you, Ashley. Good afternoon, everyone, and welcome to our Q1 call. Today we will begin with key patient metrics, we'll discuss our first quarter results, share how our clinical and innovation pipelines are driving commercial traction. Zach will cover our financials and then, we look forward to answering your questions. If you're not on the webcast, I'll be referring to slides from the presentation on our Investor Relations site. Turning to slide three. Our mission is to treat and prove what others can't. We have now surpassed 12,500 patients treated and have more than 3,000 patients with clinically reported outcomes. This growing body of clinical data is critical to our efforts to change and improve the paradigm of care. Slide four provides context on MRIdian's value to patients and customers. In 2020, we treated approximately 4,300 patients. Globally, about 80% of MRIdian patients were treated with five-fraction SBRT. That number in the US is nearly 90%. This stands in stark contrast to the overall market that delivers SBRT for only about 14% of patients. Consider the dramatic difference in patient experience. Generally speaking, treatment on MRIdian takes one week versus on average seven weeks with conventional therapy. That is five trips to the hospital versus about 35. The difference in time, energy, career disruption, life disruption and expense is profound. The 3,400 patients treated on MRIdian, we estimate, saved over 100,000 treatment days. This is priceless time given back to patients and their families and allows for a quicker return to normal life. This is the power of MRIdian. On slide five, patients treated on MRIdian have grown at a CAGR of about 85% since day one. We believe this growth to be a precursor to future business growth. Our customers are demonstrating that one successful MRIdian program can and increasingly does lead to another. Our clinical innovation and commercial pipelines continue to drive therapy adoption. Let's turn to our Q1 results on slide six. Performance in the quarter was broadly favorable to the same quarter in the prior year. We received seven MRIdian orders in the quarter, versus four in Q1 2020. Our backlog grew $33.5 million, about a 15% increase, bringing the balance to $264 million. Revenue grew nearly 9% over prior year, coming in at $15.5 million. Total gross margin improved by 1,700 basis points to 2.1%. And finally, from a cash perspective, we used approximately $28 million in the quarter, versus $36 million prior year or a reduction of about 22%. Cash used for this quarter was impacted by about $6 million of receivables that moved into Q2. These payments are now in hand. Our balance sheet is strong. We have $182 million of cash on hand and anticipate we will continue our multiyear trend of reducing cash use. Moving to slide seven. The number one thing our customers desire is meaningful clinical data. They have also been very clear about how they define clinical success. They want to deliver an ablative dose, with tight margins, no implants, five or fewer fractions and low to no grade three or higher toxicity. These elements represent the critical MRIdian 5. No hubris intended, but the only meaningful body of clinical work that meets these criteria belongs to ViewRay. Customer input has shaped our clinical pipeline and goals which are twofold: number one, to expand the utilization of MRIdian SMART and two, become frontline therapy. On slide eight, as mentioned, everything begins with and flows from our clinical value. We view the process of developing clinical evidence longitudinally. Phase I represents feasibility work that can result in an interesting signal that leads to Phase II confirmatory trials. When required, effort progresses to definitive Phase III. Currently our customers are conducting over 60 trials. The breadth and depth of this work reflects extraordinary clinical curiosity. Other than the SMART Pancreas trial our pipeline is predominantly investigator led. Turning to slide nine. We consistently hear from our customers that they buy MRIdian due to its clinical value. They used the system for a short period of time and realize there's even more clinical value than they anticipated. This clinical value translates into strategic value by attracting net new patients in the form of patients that wouldn't or couldn't be treated on any other system, patients who travel long distances for MRIdian therapy and an increase in in-network referrals. This strategic value translates into economic value. These three value propositions are why we see GenesisCare AUMC, Penn State, Henry Ford and many other customers evaluating or purchasing incremental MRIdian systems. On slide 10 customers' desire and patients demand shorter courses of effective treatment. Our technology allows clinicians to move along the continuum from IMRT to SBRT to MRIdian SMART. Our customers are now leading us in exploratory work with single fraction MRIdian therapy. The SMART ONE trial opens enrollment this year for single fraction therapy in both primary tumors and oligomets located in lung, pancreas, liver, kidney, adrenal and lymph nodes. Turning to slide 11. Our innovation in clinical pipelines accrue to commercial traction. On the innovation front, we are driving toward our goal of sub 20-minute treatment times and improving workflow and automation. In the future, you can expect enhanced MRI imaging, increase dosing, a brain treatment package and remote access. We are concurrently driving cost efficiencies to improve margin over time. We have solid traction in each of our three pipelines. Changing the paradigm of care is underway. With that, I'll turn it over to Zach to review our financials.

Thank you, Scott. Turning to slide 13. We will discuss some key financial highlights. We received seven MRIdian orders in the quarter totaling $40.9 million. This represents an 81% increase in total order value versus Q1 of 2020. The order ASP in the quarter is a solid reflection of the clinical strategic and economic value that MRIdian brings. We ended the quarter with a backlog of $264 million. On a sequential basis, this represents a $23 million or 10% increase. Compared to the same period last year, this is a $33.5 million or 15% increase. Revenue for the quarter increased 9% over the same period last year to $15.5 million, primarily from two revenue units. A 51% increase in service revenue was a key growth driver during the quarter. Gross margin for the quarter was a positive 2% and represented meaningful improvement over the same period last year. We saw improvement in our system margin on a year-over-year basis from negative 13% to a positive 7%. Service margin was impacted by some onetime costs in the period. Excluding the impact of the onetime costs, our service margin would have been breakeven. Related to service, we have seen positive movement in the average annual value of our service contracts. As our installed base grows and systems anniversary their respective warranty periods, we see customers signing up for our higher-end service offerings. We continue to focus on driving cost efficiencies and maximizing our cash saving initiatives. These efforts resulted in an 11% decrease in operating expenses, primarily in the form of decreased personnel and travel spend. Net loss for the quarter was $26.7 million, as compared to $27.5 million in the same period last year. We remain focused on maintaining operating efficiencies born over the programs we implemented during the pandemic. Turning to cash use. Excluding the net proceeds from our equity financing in January, we used $28 million during the quarter. This represents an $8 million decrease compared to Q1 of 2020. Q1 is our seasonally highest cash use quarter. In addition to some of the seasonal items, we saw approximately $6 million of receivables shift into Q2 and we have now collected on all those payments. We finished the quarter in a strong liquidity position with $182 million on the balance sheet. Due to lingering pandemic-related uncertainty, we will not be issuing guidance at this time. We are encouraged by the activity we are seeing for the remainder of the year. However, we need better line of sight to revenue conversion in several geographies most notably Europe, Middle East and Asia before providing guidance. Given the binary nature of our business, even one or two systems shifting into early next year has a material impact on our 2021 results. The combination of the strength of our clinical innovation and commercial pipelines coupled with our fortified balance sheet positions us well to capitalize on the opportunity in front of us. With that, operator we will now open the line for questions.

Thank you. [Operator Instructions] All right. And it looks like we have a question from Marie Thibault. Marie, go ahead.

Hi. Yes. Thank you for taking the question this evening and congrats on a very strong order result. I guess I'd like to start there and sort of hear your thoughts on what drove the order strength this quarter. I know that things can change from quarter-to-quarter and timing is always not certain, but I'd love to hear your thoughts on how sustainable some of the strength is and just general thoughts on the order environment at this point?

Yeah. Thanks so much, Marie. I think there's a couple of things that I would point out regarding orders in the quarter. The first is you're really seeing our strategy kind of unfold before our eyes. We have been focused for the past 2.5, nearly three years now on our clinical pipeline driving our business forward on our innovation pipeline targeted at exactly what our current and prospective customers are looking for. And those two pipelines accruing to commercial traction. So I think you're seeing that unfold before us as we speak. And the second thing I would say quite simply is our commercial team really has executed in a terrific way. My hats off to them. They have been very nimble during the pandemic in a travel-constrained environment. Fortunately, that's lifting in certain markets as we speak. But their creativity, how nimble they've been is really a credit to that team and the work that they're doing. As it relates to the sustainability of it, I would share with you my perspective that it feels like we're at a different level of both activity and productivity. Because of the things that I've already mentioned the three pipelines that we have and the traction that we have evidenced in each one of them. But I would tell you, what I shared with our team with frequency which is, this company is unrecognizable today to the company that we were 2, 3 years ago. And I anticipate that we'll be completely unrecognizable again in the next 1, 2, or 3 years going forward. So I think we've put up a solid quarter here. I love the prospects that our team has generated in the near term but frankly I'm more excited about the long-term of this business and the impact that we can have on cancer patients around the world.

Hey guys, thanks for that detailed start. And then maybe I can ask on the other side installation visibility and some of the revenue recognition trends. Maybe you can talk to us a little bit about what the different regions are looking like right now. It sounds like in EMEA you're looking for a little more clarity. So maybe you can talk through some of the dynamics that are happening over there? And thanks for taking the questions.

Yes. Absolutely. And thank you. It's a little bit spotty which is why we want to be very cautious here. We're able to move around the US market pretty freely as you would imagine. We are starting to travel, not only from an installation standpoint but commercially here in the United States. There are parts of Europe that are quite challenging at the moment. And certainly parts of the Middle East and Asia that we're having continued challenges getting visas for our travel to do the installation work. So we really want to be very careful in terms of the timing when we provide guidance and also be very prudent when we do to account for the uncertainties and risks associated with the pandemic and as Zach mentioned the binary nature of our business.

Thank you.

Thank you.

And our next question comes from Jason Bednar. Go ahead, Jason.

Hey, good afternoon guys. I'll share my congrats here on the order bookings here in the first quarter. Scott, I know you've had some success in booking orders from repeat customers. You mentioned some of those here today. But just out of the seven orders that are going into backlog this quarter, just wondering if you're willing to talk about how many of those are new versus repeat MRIdian customers?

Yes. Jason, Penn State is in this quarter for their second system. So that's a repeat order. But I would tell you, you bring up one of the things that we're most interested in and that is the proportion of our customers that are buying an incremental MRIdian system. It is a substantial number and it's quite gratifying. If this were just technology that were marketable obviously those customers would not need or probably want an incremental MRIdian system. And the activity on that front is very high. The other signals that we look at in our commercial pipeline include certainly the academic centers. But beyond that community hospitals freestanding market for profit chains and we like the level of activity and productivity there. So we're gratified by what we're seeing and we'll continue to keep you posted on those incremental MRIdian orders as we go forward.

All right. Great. Great. That's excellent to hear. And Zach, I'll throw in your way just on the gross margin side or Scott you feel free to weigh in as well. You guys are obviously making some nice progress. You had gross margin here that was positive in the quarter. I mean can it remain in positive territory? I know -- I'm sure there's plenty of kind of pushes and pulls here. But I guess what are the factors, we should be thinking about on that line on the margin line and product gross margin in particular as we go forward?

Yes Jason I would share a couple of things with you from a macro perspective and then I'll invite Zach to make any comments that he'd like to make. We have said and I'll repeat here that we see line of sight to getting to industry kind of norms from a gross margin perspective. It's going to take us a little time. And it is -- our gross margin profile is highly sensitive to the number of installations we do in any given quarter. So as that backlog builds and we're able post pandemic to really travel and install at the pace that our customers would like and we would like, I think you're going to see improvement there. And then we complement that with the work that we're doing to take cost out of the system. And increasingly, I think our commercial team is doing a better and better job selling our higher price service offering. So some macro comments and I'll invite Zach to chime in.

Yes. I think we do see our way to the industry gross margin profile on the system side. I think our demand at this stage is a little bit lumpy. So I think our margin, will bounce around a little bit just from an overhead absorption standpoint. But Jason we're going to work hard to keep that system margin positive going forward. So...

Got it. And if I can just squeeze one more in Scott I didn't hear you talk about M3 specifically here. I know you talked about a lot of the other -- a lot of the specific items in the commercial pipeline. But any update you can share here regarding that new platform? Have you had theoretical discussions with customers regarding M3? And is that at all influencing decision-making here as they pull the trigger on some orders?

Yes. Jason one of the norms in the space is to under NDA to share a bit of the pipeline given that you have a 10-year relationship with a customer and a system. So I do believe that on one hand our customers shape both our clinical and innovation pipeline. And on the other hand it's customary to give a bit of a peak into the pipeline in a noncommercial fashion. We're very careful about what we do and how we do it there. But I think we're going to be targeting that sub 20-minute treatment time brain treatment package remote access to the system are the things that we have shared publicly with investors and we think those things are targeted directly at what our current and prospective customers are looking for from us.

Great. Thanks so much guys.

Thanks,

Our next question comes from Andrew D'Silva. Go ahead Andrew.

Hey good afternoon. This is Cal on for Andy. And thanks for taking our question. So just a couple from us. You've started to invest in these Phase III studies. And obviously MRIdian can be used for these indications already. So I guess can you help us understand the commercial strategy with conducting these studies? And how many cancer types you think you'll need to run Phase II or Phase III trials for before you expect MRIdian's ability to improve outcomes is broadly accepted across all applicable cancer types?

Yes. Thank you for the question, Cal. I would tell you let's first zoom out for a second. And let me just kind of share that strategically from the time that we entered the door at ViewRay, we believe that it's critically important to lead with clinical data. It's a bit of a unique approach in this space in particular. But we believe leading clinical data and leading technology is a pretty tried and true recipe in the medical device space. And that's exactly what we're pursuing. The number one thing that our customers desire is meaningful clinical data. And they're also very clear about how they define clinical success. As I mentioned ablative dose very tight margins, no implants five or fewer fractions and low to no Grade III or higher toxicity. So we think it's critically important to keep our foot to the floor on our clinical pipeline. And I think it's also important to understand that of those over 60 studies that are going on out there those are investigator-led studies. The one trial that we are sponsoring is the SMART trial. And our strategy is to really prove MRIdian's value in the toughest to treat cancers and also prove value in more ubiquitous cancers. So I think it's difficult for me to say exactly how many studies we would need to run to drive faster and broader adoption, but I believe that's underway. Having 3,000 patients with very consistent clinically reported outcomes right in line with those five criteria that our customers state is compelling. So difficult to really tell you when it's actually going to take hold. But I would tell you in certain cancer types such as pancreas we have a customer down in Florida that prior to MRIdian was treating very few pancreatic cancer patients with radiation therapy. And now I believe that one customer is treating over 100 pancreatic cancer patients a year on MRIdian. So if you believe in that from a pancreatic standpoint, it's quite possible that you would believe in that from a central lung, ultra central lung and other cancer targets. But that work is ongoing in various cancer types led by our customers due to their clinical curiosity. So we think it's absolutely the bedrock of what we're doing. And I think it's having its effect and we're looking forward to just continuing to chop wood on that front.

Okay. That's helpful. And then as it relates to the episode based and alternative payer models is there any update on the timing there? Is it still set to be implemented next year? And then as a follow-up have the patients -- or have the percentage of total facilities expected in the APM test period and the number of cancer types that the APM covers is that still the same?

Yes. The start date we continue to believe is going to be January of next year of 2022. And to give you the statistics in terms of who's included it's 30% of all Medicare fee-for-service beneficiaries. That represents about 10% of all cancer patients when you look at Medicare, Medicare Advantage, private payer, Medicaid et cetera. So it is we believe pretty firm on that point. And we think we compete very well because of the clinical value that we have that accrues to strategic value. You hear that from our customers on the -- over a dozen webinars that we've had and they all talk about how that strategic value translates into economic value both top and bottom-line because of the net new patients that they're able to attract with MRIdian. If you think about that and the fact that the vast majority of patients treated on MRIdian are with five fraction SBRT then it's easy to consider that in the APM model we would compete even more favorably there. Shorter courses of treatment driving greater throughput and frankly I think the competition for patients increases in that model. So the strategic value of the system becomes something that more and more customers are going to seek.

Okay. Great. Thanks for taking the question.

Thank you.

And our next question comes from Anthony Petrone. Go ahead, Anthony.

Thanks and congratulations to a good quarter here. I hope everyone is doing well. Maybe Scott just on, sort of, environment out there as it relates to order flow matched to installations, right? So this quarter seven orders ahead of our expectation, seemingly looks like a robust start to the year. On numerous other calls in the past couple of weeks, we're actually getting the sense that hospital capital budgets actually fared better than feared I guess through the pandemic is the best way to put it. And there is an appetite for capital out there. So maybe just talk a little bit about hospital, capital purchases, the environment what you're hearing. On the flip side installations could still be a struggle. And so I'm just sort of -- when you sort of look at the geographies clearly Europe is still pressured. But what is the lead time that ViewRay will have on when it will get better visibility to installation cycles? And then I'll have one follow-up. Thanks.

Yes. Thank you, Anthony and hope you and your team are well also. I would agree with you. I think the environment from a customer standpoint is improving may not have been as bad as some feared. I think that's an accurate comment and our activity level with customers would reflect that. And I would also emphasize and agree with your point on just the uncertainty that we want to be careful about as it relates to installations, and therefore, revenue in the 2021 time frame. Very, very difficult for us to know when we're going to be able to clear visas and when parts of Europe and the Middle East are going to open up for us to be able to do the installation work that we and our customers want to do, and we want to be very cautious on that front. So that's how we're going to be going forward and we're going to be communicating with investors on our point of view on guidance at the earliest possible date. But we're not going to rush that because we want to give a meaningful number that we believe we can stand behind.

That's helpful. And my follow-up would be when you look at the data initiatives the Phase 1 programs investigator-initiated trials. And I think if I'm not mistaken the UCLA prostate study sort of falls in that category standard head-to-head in prostate, maybe just an update on the UCLA prostate study. So should we still be expecting data later this year? And Scott, maybe when you talk about the statistics where you get an increase in procedures after data is out there clearly prostate is a big category. How do you think that data will resonate after it's released? Thanks again and be well.

Thank you Anthony. Yes, we -- knock wood we're going to see some data out of UCLA here in 2021. That study the SCIMITAR study is fully enrolled. We're really excited about that. The other data that we anticipate that we could see in 2021. There's currently data from two large multi-center retrospective analysis one in pancreas and one in ligaments that we may see in 2021 as well. And then there's a whole bunch of clinical data readouts that we anticipate in the 2022 time frame and again in 2023. And these individual studies are interesting, Anthony, to your point but even more so the aggregate effect, when you look at MRIdian's capability post prostatectomy and when you look at some of the head-to-head studies out there, I think the individual studies are interesting. I think the aggregate effect is going to be even greater. And I think that's true in the really tough to treat cancers as well. So we feel like we're doing the right things here from a clinical product and commercial pipeline perspective and we're hopeful for cancer patients as we move forward.

Thank you.

Thank you.

Our next question comes from Mike Ott. Go ahead, Mike.

Good afternoon Scott and Zach. Thanks for taking my questions and congrats on a nice quarter. Have a couple of questions on competition, I guess, to start with Siemens Healthineers having now closed on Varian, how are the collaboration dynamics at play especially since I believe Siemens is providing the split magnet and on the other hand Varian competes with you?

Yes, Mike, thank you. Our collaboration with Siemens is very long-standing and very strong. We're gratified with the partnership that we have there. Our teams are in very close contact on a regular basis and we feel good on that front. Through the actual deal process we were able to strengthen what was already a pretty strong partnership agreement. So we feel good about that. And we see good things with our Siemens partnership that lie ahead.

That's great to hear. Thanks, Scott. And also would love to get your latest thoughts on Elekta's Unity platform and how any real or perceived competitive differences are playing out in the field today?

Yes. Mike, I'm going to shy away from that one a little bit. I think the advancement to MR guided radiation therapy is an important one. It took us about a dozen years as an industry to go from 2x2 X-rays to cone-beam CT what I call conventional linear accelerators. I believe we're in the early stages may be maturing a little bit now moving from conventional linear accelerators to MR-guided therapy. Key opinion leaders have been very clear in their language that they believe we will look back with the benefit of hindsight that MRIdian and MR-guided is a new paradigm of care that we will shift to. So I don't really want to get into any of the comparisons there. We want our performance to speak for itself. There are customers that have both the Unity system and MRIdian system. We'll see what they choose to do with future purchases and we'll let that speak for itself.

Okay. That makes a lot of sense. Thanks so much.

Thanks Mike. Last question.

And our next question comes from Brandon Folkes. Go ahead, Brandon.

Brandon, are you there?

Brandon, your line is open. Brandon, your line is open. All right maybe he stepped away from the phone. That is the last question we have. Do the speakers have any final comments?

Operator, I'd like to thank you and I'd like to thank everybody who joined us for our call today and we look forward to doing this again in about a quarter. Thanks so much.

Thank you. Ladies and gentlemen, this concludes today's conference. Thank you for participating. You may now disconnect.