Stereotaxis, Inc.
Q4 2020 Earnings Call Transcript

Published: 27 Feb 2021

[Operator:]

Good morning. Thank you for joining us for Stereotaxis Fourth Quarter and Full Year 2020 Earnings Conference Call. Certain statements during the conference call and question-and-answer period to follow may relate to future events. Expectations and as such constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the company in the future to be materially different from the statements that the company's executives make today. These risks are described in detail in our public filings with the Securities and Exchange Commission, including our latest periodic report on Form 10-K or 10-Q. We assume no duty to update these statements.

[David Fischel:]

Thank you, Operator, and good morning, everyone. I'm joined today by Kim Peery, our Chief Financial Officer. My prepared remarks today will be a bit longer than normal. I want to use the occasion of this being our annual call to provide a broader overview of Stereotaxis and our vision. I'll then review our accomplishments in 2020 and our focus and expectations for 2021. Stereotaxis is the global pioneer and leader of robotics for endovascular surgery. We have developed a highly innovative suite of robotic technologies that address the inherent limitations, risks and challenges posed by manual catheters. Our mission is to make minimally invasive endovascular surgery broadly available to improve its safety and outcomes and to modernize it with the benefits of digitization and robotics. Endovascular surgery is a broad class of procedures where a catheter is inserted into a blood vessel and navigated through the vascular system to an area requiring therapy. While millions of catheter-based surgeries are performed annually to treat a wide variety of conditions, the mechanism of action of manual handheld catheters has fundamental flaws. During a procedure, therapy takes place at the catheter tip, but a manual catheter is held and manipulated several feet away at the handle. Using a manual catheter is like writing in small font while holding a pencil from its eraser or holding on to a gardening hose several feet back from its end. The mechanism leads to limited precision, limited stability and limited reach. Manual catheters need to be rigid to allow for control to reach the tip, increasing the risk of patient injury. Procedures are complex and operator-dependent, and visualization of a catheter exposes patients and physicians to X-ray radiation. Stereotaxis' robotic platform is designed to address these inherent limitations, risks and challenges. It fundamentally transforms and improves catheter navigation by allowing for direct control of the catheter tip using precise computer-controlled magnetic fields. The magnetic fields can be viewed as invisible fingers holding on to the catheter tip. Direct control leads to enables reaching areas previously unreachable and enhances patient safety. Physicians operate with our robot from a computer cockpit seated and fully protected from radiation with full control over the procedure at their fingertips and with an ability to focus on the cognitive aspects of their profession rather than the mechanical efforts.

[Kim Peery:]

Thanks, David, and good morning, everyone. Revenue for the fourth quarter of 2020 totaled $6.8 million, consistent with the prior year fourth quarter. Recurring revenue for the quarter was $5.9 million, and system revenue was $0.7 million. Revenue for the full year 2020 totaled $26.6 million. Recurring revenue of $22 million for the full year 2020 declined 15% from the prior year, primarily due to the impact of the COVID-19 pandemic on procedure volumes. We continue to see a gradual recovery and procedure levels from the lows reached in the second quarter of 2020, but volume remains below pre-pandemic levels. System revenue of $3.6 million for the full year 2020 increased from $2.1 million in the prior year, reflecting the successful installation of our initial Genesis RMN system. Gross margin for the fourth quarter and full year 2020 were approximately 77% and 71% of revenue. Operating expenses in the fourth quarter were $6.4 million, consistent with the $6.3 million in the prior year quarter. Operating expenses for the full year 2020 totaled $25.7 million, down from $27.6 million in 2019. Operating loss and net loss in the fourth quarter were both $1.2 million. For the full year, operating loss was $6.7 million with a net loss of $6.6 million. Negative free cash flow for the full year 2020 was $3.3 million and including funding from the payroll protection program was $1.2 million compared to $4.6 million for the full year 2019. At December 31, we had cash and cash equivalents of $44.2 million. I will now hand the call back to David.

[David Fischel:]

Thank you, Kim. Despite the significant operational and commercial challenges thrust upon us in 2020, the year was one of significant progress. We have a clear strategy for transforming endovascular medicine with robotics, and I'm proud of the way our team responded with resilience, prudence and creativity to advance that strategy. 2021 is expected to be the start of a multiyear period of growth, and we reiterate our guidance of robust double-digit revenue growth in 2021 with Genesis system revenue of between $10 million to $20 million. We continue to invest in the team, infrastructure and projects that are critical for success but are proud that we are able to do so while maintaining financial discipline. A robust balance sheet allows us to reach profitability without the need for additional financings.

[Operator:]

And we'll take our first question, and that will come from Josh Jennings with Cowen.

[Josh Jennings:]

Good morning. Thanks, David and Kim. Congratulations on stoking up demand for Genesis and then the strong order number. I wanted to ask, just the five orders since your last earnings call that crushed – beat our expectations, clearly. I wanted to ask about the sales funnel. We don't want to get carried away and take that five order number that you just delivered and extrapolate it throughout the rest of 2021. And I know you're not providing order guidance. I was hoping you could give us some sense of the sales funnel. When we think about the pandemic in 2020, the Genesis launch just pushed out to 2021, have you? And I wanted to ask about the sales funnel in 2021 here versus where it was in 2020 and just thinking about launch dynamics. I mean our sense is that the demand funnel is exponential higher – I mean, a multiple higher in size than where it was this time last year, all the virtual visits that you were able to execute throughout the pandemic and ongoing in the third and fourth quarter. Sorry for the long-winded question. But really, just to get to it, I just wonder if you could comment on the sales funnel this year, where it stands versus where you were last year.

[David Fischel:]

Sure. Thanks a lot, Josh. So I think you're right that we don't want – we feel it's still premature to extrapolate kind of every subsequent quarter. We're still in the early stages of our launch and so we wanted to have a little bit of conservatism and then – and caution on just kind of extrapolating numbers out. Overall, there's multiple hospitals that we're talking with, both greenfield and replacement cycle hospitals, that are in various stages of the pipeline. We're still early in our history of having capital sales given that really, for many years, Stereotaxis had not had a robust capital sales effort at all. And so it's still kind of we are in our own learning mode of trying to be able to understand when a hospital is at a specific stage in a process, what's the probabilities that they will move to the next stage. We just don't have enough numbers yet. So I hope that over the coming quarters, we'll become smarter there and we'll be able to start giving kind of statistics. But we're still kind of a young company in that whole effort. So again, it kind of blends to a desire to be conservative. On the replacement side, if you kind of remember from my prepared remarks, I mentioned that we are seeing many of those still being delayed out. And so while historically we've talked about a $15 million a year replacement cycle revenue that would be very, very easy to rely on, I still very firmly believe that that's real. We don't see replacement cycles kind of slipping away from us, but we just see those being pushed out. I think given the macro environment, I think hospitals are trying to push out anything that they don't have to replace. And so that's been pushed out, and I would expect generally very little replacement cycle revenue this year. And then, hopefully, we get a bolus of that next year, some of the pent-up ones that have been delayed several years. There are multiple ones in discussions for next year. And then – and so, I guess, kind of that's how we're looking at things. I would expect kind of a steady pace of system orders to continue coming in, but I don't necessarily want to extrapolate from one quarter out to the future ones.

[Josh Jennings:]

That helps. That helps. Just a follow-up on just Genesis utilization trends. I know there's only a couple of installs out there, but I was hoping to get a sense of in these early days, the utilization levels of Genesis at centers with the elimination of latency – reduction in latency that are higher percentage of Genesis cases or for Genesis centers that are using Genesis in AFIB ablation cases. Is there – do you expect Genesis to drive deeper penetration in AFIB ablation versus BT or other arrhythmia indications?

[David Fischel:]

So I think on our last call, we talked about over 90] procedures having been performed at the first two hospitals since their installation. And I looked it up before this call, and it was still a little bit under 200. It would have been nice if it was 200 or more. We would have kind of called it out, but it was a little bit under 200. And so the utilization is definitely higher at those two sites than our typical average. Again, it's two hospitals, and there are various circumstances that can lead to that higher utilization, of which Genesis is one of them. But I don't want to yet with kind of small numbers to create kind of expectations there that every Genesis launch is going to necessarily be at a higher level. And we're being used at both sites for the broad range of arrhythmias from what are generally considered the simpler ones to the most complex.

[Josh Jennings:]

Great. And just my last question. I may be getting a little bit ahead of myself with the Genesis launch payment in the very early stages, free-standing, if you will. But the Tesla-like CEO compensation agreement that was announced yesterday, it implies – or just confirms that you believe the robotic navigation is a platform technology and then in a long runway. Some of those milestones, $1 million, $5.5 million valuations, that set off triggers in your compensation plan. I wanted to just do a direct question. Is – can you talk about how Genesis evolves from its current form? And then just anything high level in terms of – I know you had some comments here in your scripted remarks about it being a platform technology and moving out of just the EP indication. But just a Genesis technology as a whole and then the indication progression, any updates there?

[Josh Jennings:]

Excellent. Congrats again.

[David Fischel:]

Sure. Thanks. So – yes. So in terms of the compensation plan, kind of I think it reflects the fact that we are looking to build a long-term, very robust company that has a significant positive impact in medicine and then – and very much want to create the right alignment of interest to build that long-term, highly impactful company. And when we think about kind of Genesis, really, the role of Genesis as a medical device is to create very precise uniform magnetic fields that are controlled by a physician, where the patient's chest is or wherever the patient's anatomy is that requires therapy. And what you need to move to other indications is the right interventional devices that can be controlled by those magnetic fields. And right now, there's a cardiac ablation catheter that has the right kind of design so that it can be controlled by those magnetic fields. And in the future, you'll need a family of other devices to be able to do so. Again, I think there's kind of – every aspect of our technology can be improved significantly from where it is. But kind of in order to move into other clinical applications, it's that kind of suite of interventional devices that needs to be developed.

[Operator:]

Moving on, we'll go to Frank Takkinen with Lake Street Capital Markets.

[Frank Takkinen:]

Thanks for taking my questions and congrats on a good quarter.

[David Fischel:]

Thank you, Frank.

[Frank Takkinen:]

Absolutely. The first one from me is on the five purchase orders. Curious if you could talk a little bit more to the cadence of those installs potentially in 2021. Maybe if you could help us first half versus second half just to get a little better understanding of the sales cycle from purchase order to install would be fantastic.

[David Fischel:]

Sure. I would expect – we've already shipped the first of those, and I would expect that those installs all take place roughly in the second quarter or summertime.

[Frank Takkinen:]

Okay. Great. And then moving on to the catheters, speak about that a little bit. Could you talk to some of the milestones we should be looking for throughout the next couple of quarters to ensure we're on track for the EU launch in the second half or the back half of this year as well as the U.S. pivotal? And then maybe speak to the commercialization strategy and how that can change over the next couple of years with the launch of the catheter.

[David Fischel:]

Sure. So on the catheter side, and we've been going through a very, very intensive cycle of receiving batches of catheters, evaluating those batches to ensure that not just one catheter or a few catheters, but all catheters in a batch are performing according to specifications kind of across a wide range of things that you test and they continue to perform well despite some use, kind of some use and abuse. And then based on those learnings, you refine the manufacturing process to kind of to fix any areas or improve any aspect that kind of need improvement, and then you do another batch and you run the same cycle again. And so we've been running through that process multiple times now, and we're kind of getting to the point where now we're starting the manufacturing of hundreds of catheters to do formal testing that gets submitted to regulators. And so the real kind of next steps are running those formal testing and having, hopefully, successful results. Obviously, as we expect successful results from those testings, submitting that – a dossier that includes that testing to the EU notified body and then – and submitting an IDE application, which also rests on all of that testing to the FDA. And so kind of what you should see is kind of the next steps is us kind of completing that testing successfully and making submissions both in Europe and the U.S., and then receiving responses from both the European regulators and the FDA. And that's really kind of the next steps in the process. While we've been doing that, we have been obviously having discussions with the regulators in both geographies, and we've been planning for the commercialization in Europe. And so we are making very detailed business plans for every individual existing customer in Europe about what the dynamics are in order to launch a catheter in that hospital, whether there are kind of tenders that are necessary or what kind of purchasing processes take place at the hospital, what the kind of drivers might be for adoption, how pricing should look like. And so we're very much planning for that launch kind of concurrent with all of these activities.

[Frank Takkinen:]

Perfect. And then just last one for me. You guys have shown really good operating expense control this year. How should we think about operating expenses in fiscal year 2021 as revenues grow?

[David Fischel:]

Yes. We want to continue investing in the business. There's a lot of exciting things on the R&D side still to advance the technology further. And I think, again, we're still just in the earliest innings of what's possible with robotic magnetic navigation both in EP and obviously, in many other clinical applications. And so there's a lot kind of that we can invest in, and we will continue to build up the team and to invest in meaningful projects that drive long-term growth. Also on the commercial side, we are making efforts to really try to modernize across the in-house team and the field team various aspects of our commercial infrastructure, and we will be growing the team in the coming quarters. And so I think what you should expect is a gradual increase in operating expenses while still maintaining financial prudence. And so you – we should never have a burn rate, where some of you have concerns about us needing to raise capital or having any liability concerns. The fact that we have a very prudent business and a strong balance sheet, I think it's great for our customers. It's great for existing partners and potential partners. And it's just kind of – I think that's the right way to run the business.

[Frank Takkinen:]

Perfect. Thanks and congrats again on the quarter.

[Operator:]

Next, we'll go to Jason Wittes with Northland.

[Jason Wittes:]

Thanks for taking the questions. First off, you mentioned the China sale that you think will clear this year. Does that require an approval from the government, et cetera? Or what's required on the regulatory front to get that installed and revenue recognized?

[David Fischel:]

Jason, Good morning. So the sale to China was actually of the Niobe system. So because Genesis is not cleared in China, it was a sale of our Niobe system, which has regulatory clearance in China.

[Jason Wittes:]

I see, okay. That clarifies it. Also, can you kind of give some color in terms of how you're interacting with your partners, notably Acutus, which I believe you're partnered with? Are they helping with referrals? Or how is that relationship working in terms of promoting the system?

[David Fischel:]

So at its core, kind of we're great partners together because they have an elegant diagnostic technology and we have a very elegant robotics technology that navigates the therapeutic ablation catheter. And so we're delighted with our collaboration. We've started to see more and more hospitals use us together. We are seeing the initial use even this week of their contact mapping capability with our system. And so there's a positive kind of collaboration there and a natural benefit of seeing our two technologies used together and then try to support each other. But that's kind of not a big driver to the revenue growth. I think it's the broader aspect of our collaboration and the nice use of our technologies together which is really the positive effect.

[Jason Wittes:]

Okay. That makes sense. In terms of – you mentioned these systems, it sounds like there's about – there's a pretty wide range in terms of when these systems get installed, but it sounds like you're saying most of these are installed this summer. Is that – did I hear that correctly in terms of the five orders that you received this quarter? So that would roughly imply a 6-month time to installation. Maybe this has been asked before, but I just – how should we think about this? It sounds like given that's the time line by – basically, anything that you haven't had by the summer basically falls into next year for revenues. Is that the right way to think about it?

[David Fischel:]

I think generally, the time line will range anywhere from 3 months to 12 months or so. And then – and so some of these orders will be installed in the second quarter, some will be in the third quarter. It's somewhat dependent on the hospital itself. So we don't have full control over the installation time line if the hospital has its room ready for us and we can come in. But roughly, I think that 3- to 12-month time line is right. And what you see based on kind of the orders that we're talking about now, it ends up generally – it doesn't seem like any of these five will be 12-month time lines. It seems like it'll more be in the 6-month or sub-6-month time line.

[Jason Wittes:]

Okay. And then on the catheter, appreciated the update. Will you be ready to launch once you obtain CE mark? Or will there be some delay for manufacturing once you get it?

[David Fischel:]

We should be able to launch when we have CE mark.

[Jason Wittes:]

Okay. Well, thank you very much. Good quarter. Appreciate it.

[Operator:]

We'll take our next question from Christopher Hillary with Roubaix Capital.

[Christopher Hillary:]

Good morning. I wanted to ask just given the strong demand that you've been able to see, are there some things that you've been able to learn from your kind of virtual sales process? Or are there metrics that you're able to gather that maybe would have been harder to see from in-person? And then also, does this change at all how you expect to kind of go-to-market as the economy reopens?

[David Fischel:]

Great question. And I'd say from a metrics perspective, again, the numbers of orders and the numbers of customers is still – we're still in a relatively small and in an early stage, and so very hard to have statistics that you build modeling off of and that you can really rely on the probability. But in terms of these virtual test drives, TeleRobotic test drives that we've been performing, by now, we've had over 300 physicians, hospital administrators on these types of calls. I mean that has been an amazing, amazing experience for us and has allowed us to reach more of our existing customers and more potential customers than ever before. I'm hosting two physicians today, one from Europe, one from the U.S., on such calls after this earnings call. And the ability to do that kind of without the disruptions of travel and kind of to do it in a very nice fashion has really been one of the biggest positives from last year, and that's something that I think will maintain long after the COVID restrictions disappear. And so that does impact some of how we're thinking about commercialization. I think you can build a commercial team very much like all of our medical device companies, where you hire people, you give them territories. And that's a fair model. That's something that – we will do that type of building. But we also won't do – we won't build our commercial capability fully in just that way. If you look at some of the best companies out there, the Apples, the Teslas of the world, many of them have built great strength by having direct connections between the corporation and the customer and making sure that, that connection is a strong and very kind of customer-friendly connection. And so I think you'll see that we're going to do something, and we are doing kind of similar types of things. There's a lot of work still to do there. There's a lot of ways to make that better. But I think that you can also build a medical device company that doesn't necessarily have to rely purely on the old model of commercial teams. And so it will be a hybrid of those two approaches, and something like these TeleRobotic test drives is much more in the latter model than the former.

[Christopher Hillary:]

Okay. Great. Yes, and I'm sure I'll look forward to that year, an update on the new products and expansions that you see. Thanks so much.

[David Fischel:]

Thank you.

[Operator:]

Next, we'll go to Chris Basso, Private Investor.

[Unidentified Analyst:]

Good morning. Congrats on the quarter and the guidance moving forward. Just had a question. With respect to some of your robotic peers, learning about five orders on the call is great. Some of the previous or companies that are out there will announce the order via a press release when they get it. Are you still going down the path of potentially announcing these via press releases once they're installed? Or how do you think about how the shareholder base will learn about these new orders?

[David Fischel:]

We will make press release announcements in coordination with our hospital customers, and we want to use those also to the benefit of the hospitals in their regions so that they can showcase their leadership to their stakeholders. And so generally, I would expect for these quarterly earnings calls to be the primary source of hearing new orders. But you – but there's no reason for you not to know the names of the hospitals that have ordered the system that we described today. Just those will happen in coordination with the local hospitals.

[Unidentified Analyst:]

Okay. Great. And then you've talked about this expansion into multibillion-dollar adjacent markets. We're going to learn more later this year. I know you've been tight to divest on this with respect to divulging information. But if I could ask, on the regulatory requirement front, what's the picture? What's the outlook as you move into these new adjacent markets? Is that going to require new filings across the board? Or what's – once you announce something, can you go there immediately? Can you give us some color around that?

[David Fischel:]

Yes. There will be – I mean, whenever you develop new technologies, there is a regulatory process, and so I would expect us to have a regulatory process. I don't necessarily think that you're going to have a PMA process for some of these. And so again, I think kind of at the end of this year, we'll be in a position to give you much more color on the various technological components of that third wave and kind of the time lines that we think. We wouldn't talk about it if it was years off from commercialization. But there is – there will be also a regulatory aspect to the time line.

[Unidentified Analyst:]

Okay. Great. Well, I look forward to that future. Congrats on the compensation package. You should be commended for what you've done so far and not getting paid for it, and I hope you get the full 10% on the deal that was put forward.

[David Fischel:]

Thank you very much. I will work very hard to get the full 10%.

[Operator:]

And there are no further questions at this time. I'd like to turn it back to our presenters for any additional or closing comments.

[David Fischel:]

Okay. Thank you very much for your continued support and interest in Stereotaxis. We're excited for the year ahead of us and look forward to speaking again in a couple of months. Thank you.

[Operator:]

Thank you and that does conclude today's conference. We'd like to thank you for your participation. You may now disconnect.