Stereotaxis, Inc. (STXS) CEO David Fischel on Q2 2022 Results - Earnings Call Transcript

Aug. 09, 2022 3:39 PM ETStereotaxis, Inc. (STXS)
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Stereotaxis, Inc. (NYSE:STXS) Q2 2022 Earnings Conference Call August 9, 2022 10:00 AM ET

Company Representatives

David Fischel - Chairman, Chief Executive Officer

Kim Peery - Chief Financial Officer

Conference Call Participants

Josh Jennings - Cowen

Adam Maeder - Piper Sandler

Neil Chatterji - B. Riley

Alex Nowak - Craig-Hallum Capital Group

Frank Takkinen - Lake Street Capital Markets

Nathan Weinstein - Aegis Capital

Javier Fonseca - Spartan Capital


Good morning! Thank you for joining us for Stereotaxis’ Second Quarter 2022 Earnings Conference Call.

Certain statements during the conference call and question-and-answer session 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 may 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.

At this time all participants have been placed on a listen-only-mode. The floor will be open for questions and comments following the presentation. As a reminder, today’s call is being recorded.

It is now my pleasure to turn the floor over to your host, David Fischel, Chairman and CEO of Stereotaxis.

David Fischel

Thank you, operator and good morning everyone. I'm joined today by Kim Peery our Chief Financial Officer.

We are operating in an environment that remains very similar to what I described on our last call in May. It is both a challenging and exciting period for Stereotaxis. The macro business environment remains littered with a host of pandemic related supply chain, regulatory, personnel and economic disruptions.

We saw nearly 70% reduction in China procedure volumes during the second quarter, continued to see delays to hospital purchasing decisions, and construction projects, have not yet observed an improvement in supply chain reliability, and seen inflationary pressures on various expenses. The optics of our financial results in the quarter reflect these challenges, particularly the delays in hospital construction, with negligible system revenue recognized in the quarter, contributing to reduced revenue compared to last year's second quarter.

Despite these pressures and the poor optics of our financial results, Stereotaxis is making significant progress commercially and technologically. I am pleased with our progress and confident in where we stand and the path ahead of us. We have continued demand for our technology; we are advancing a transformative innovation pipeline. We are assembling an all-star commercial team and we're doing all this while maintaining financial stability and strength.

Let me first touch upon our return commercial performance. During the second quarter we received three orders for Genesis systems, two of which we received since four last call. All three of the orders came from the United States. Two order are replacement cycle systems where Genesis will replace aged Niobes at existing hospitals.

The third order is unique and exciting. An existing hospital customer who already operates a successful robotic EP program, decided to establish a second robotic lab at the same hospital. This is a prestigious hospital led by a key opinion leader in the field, and will be the first EP program in the U.S. with two of our robotic systems.

Our continued pace of Genesis orders bodes well for future financial results, as we now have over $12 million in backlog of system orders waiting to be shipped, installed and converted into revenue. While timing of revenue recognition is often outside of our control and dependent on hospital construction, orders in our backlog are essentially guaranteed with an over 99% conversion rate and significant non-refundable down-payments, providing confidence in their realization.

Our efforts to grow capital sales are performed alongside a continued commitment to the success of existing robotic practices and the development of the holistic commercial infrastructure that drives such success. Two highlights from the second quarter include graduation of an additional cohort of fellows in our Robotic EP Fellows Program and the publication of the Robotics Special Issue in the Journal of Atrial.

11 Electrophysiology Fellows graduated from our Fellows program in the past quarter. We expect to graduate 19 this year and in total 65 Fellows have graduated from our program globally since it was launched. These Fellows represent the future of the field, and enter with appreciation and confidence our technology, which bodes well for us going forward.

The body of clinical literature supporting the clinical value of robotics and EP also substantially increased with 16 Peer-Reviewed Publications included in a special issue of The Journal of Atrial in June. The publications covered the broad range of topics, including the use of our technology across the spectrum of arrhythmias and in several more novel way alongside pre-operative imaging and interoptive mapping technology, without the use of X-Ray and remotely over long distances. We continue to view the quantity and quality of clinical data on our technology as a strong foundation for future adoption.

Most impactful to our mid and long term commercial performance remains the realization of Stereotaxis strategic innovation plan. As a reminder, our innovation strategy consists of five key pillars; a mobile system that enables broad accessibility of robotics; our own independent ablation catheter portfolio; devices that expand our technology to new endovascular indications; China specific product ecosystem; and a digital platform for broad operating room connectivity. Each of these will individually service as substantial growth drivers that dwarf our existing business, but the five efforts are also synergetic and collectively serve as the foundational product ecosystem in our mission to transform endovascular surgery with robotics.

We were very pleased a month ago to announcer CE Mark’s submission of our proprietary robotically navigated ablation catheter MAGiC. Submission of MAGiC reflects the culmination of extensive design, development, manufacturing and testing effort, and I want to congratulate the many individuals who were instrumental in that effort.

The submission was made on schedule with the timeline we provided at the start of this year, and complies with the recent more stringent MDR Regulations in Europe. While the timeline for approval of the catheter is not knowable at this stage, we're preparing for commercialization upon receipt of CE Mark as early as year-end. The catheter design build upon nearly 20-years of experience and learning since the existing Biosense Magnetic Catheter was developed and we are very excited for the clinical, commercial and strategic benefits MAGiC will provide.

Beyond the significant milestone with MAGiC, we are methodically advancing the other technological pillars to our innovation strategy. These are advancing against the headwinds of supply chain challenges, of COVID quarantine in China, personnel disruption and the regulatory distractions caused by MDR in Europe. Despite those, we still view an initial launch of the mobile robot around this time next year, as realistic and the hardware electronics and software aspect of the system are advancing nicely.

The MicroPort and Stereotaxis' collaboration continues to progress well and we view a comprehensive product ecosystem in China, coming together during the second half of 2023. Ramping up production of guide wires for the required regulatory testing has gone slower than projected at our contract manufacturer, and we now expect regulatory approvals and an initial launch in the first half of 2023, rather than at the start of the year.

Finally, submission of an application to the FDA to initiate a prospective IDE trail for the MAGiC catheter is currently waiting on certain animal trial that we expect to complete by year end. Development progress is inherently nonlinear, particularly in this environment, but we are pleased by the breadth and quality of impactful developments being advanced.

The methodical progress across multiple fronts on our innovation strategy brings us closer to a commercial break out and consistent long term revenue growth. As our technology pipeline becomes derisked and approaches the market, we are placing increased focus on ensuring the right commercial team, infrastructure and processes are in place to drive substantial revenue growth.

I was very excited to be able to announce last week that two highly experienced and successful commercial leaders are joining Stereotaxis. Frank Van Hyfte and Tim Glynn bring to Stereotaxis decades of significant and highly relevant experience. They have scaled businesses like ours in order of magnitude larger, and lived through the complexity and rapid pace of pioneering new markets.

Their skill sets and geographical focuses are complementary to each other and are complementary and additive to our commercial leaders Michael Tropea and Casey Payne. That we were able to find leaders of this caliber to enthusiastically join us is a testament to the opportunity in front of us and the company we are building. I personally feel grateful to have these commercial leaders as partners in our journey, and encouraged by the fact that their leadership will guide our commercial activities.

The puzzle pieces are starting to come together on both the technological ecosystem and commercial organizations. Our progress on both these fronts supports substantial long term growth in Electric Physiology and more broadly in endovascular interaction.

Kim will now provide some commentary on our financial results, and then I'll make a few financial comments as well before opening the call to Q&A.

Kim Peery

Thank you, David and good morning everyone. Revenue for the second quarter of 2022 totaled $6.2 million. This was down from $9.1 million in the prior year second quarter, primarily due to recognizing revenue on just a partial robotic system this quarter, compared to two systems last year.

Recurring revenue for the quarter was $5.6 million compared to $6.1 million in the prior year second quarter, reflecting headwinds and procedure volumes and some reduction in service revenue as hospitals approach replacement cycles.

Gross margin for the second quarter of 2022 was 76% of revenue, with system gross margin of 16% and recurring revenue gross margin of 83%. Operating expenses in the quarter of $9.8 million included $2.7 million in non-cash stock compensation expense, excluding stock compensation expense. Adjusted operating expenses were $7.2 million consistent with the prior year second quarter.

Operating loss and net loss for the second quarter of 2022 were both $5.2 million compared to $3.4 million and $1.2 million in the previous year. Adjusted operating loss and adjusted net loss excluding non-cash stock compensation expense were $2.5 million in the current quarter compared a negative $0.6 million and positive $1.6 million in the prior year quarter.

Negative free cash flow for the second quarter was $1.8 million, compared to $0.1 million in the prior year second quarter and $1.2 million in the second quarter of 2020. At June 30 we had cash and cash equivalents of $35.1 million and no debt.

I will now hand the call back to David.

David Fischel

Thank you, Kim. I wanted to add a few additional comments on two key topics, revenue expectations for the remainder of this year and our balance sheet and financial stability.

On the first topic, we view the revenue reported this quarter as a naviar in our performance. Our pace of system orders and current system backlog of over $12 million supports our prior guidance of system revenue and overall revenue growth for the year.

If we were able to install all the systems in our backlog, we would expect approximately $15 million in system sales for this year. Typically we have discussed an approximate three to 12 months timeline between when a robot in order to when it is shipped or installed for revenue recognition.

We have seen significant variability in these timelines, with various hospital projects delayed long beyond what our customers originally expected. Those hospital construction delays introduced risk that a sufficient portion of backlog may not be recognized this year and instead next year, introducing caution to that guidance.

As all of the orders in our backlog will be delivered eventually, any such delays would generate revenue growth in the coming year. The significant timelines associated with capital purchases and hospital construction reinforce the importance of our strategy to make robotics broadly acceptable by bypassing logistic and construction complexities. As mentioned earlier, based on our current progress, we expect commercial availability of our mobile robot by the middle of next year.

On the topic of financial stability, we are obviously cognizant of evolving macro concerns and the potential for extended periods of economic and capital market pressure. Our commitment to managing Stereotaxis in a financially prudent and disciplined fashion, served us well in that environment.

Recent inflationary pressures have started to impact various costs for supply, services and transportation. We are working to mitigate cost increase and overall remain confident in our financial position and ability to manage the business with a modest controlled burn as we invest for growth.

While we had higher than normal cash utilization in the first half of this year, much of this was due to increased spending on inventory and one-time cost to establish our new headquarter. We expect continued investment in inventory in the back half of the year, but expect to end the year with approximately $32 million in cash and no debt. I view our normalized operating business as having a proximately $1 million cash burn rate per quarter. That financial prudence combined with our strong balance sheet leaves us in a comfortable position to continue advancing our strategy in a self-sufficient fashion without the need for additional financing.

I recognized the poor optics of our financial results, but view this alongside of confidence that our fundamental progress is significant and position is strong. We have continued demand for our technology. We are advancing a transformative innovation pipeline with multiple impact for launches in 2023 and beyond. We are assembling an all-star commercial team, and we are able to do this while maintaining financial stability and strength.

We look forward to now taking your question. Operator, can you please open the line to Q&A.

Question-and-Answer Session


Certainly. [Operator Instructions]. And we will now take our first question from Josh Jennings with Cowen. Please go ahead.

Josh Jennings

Hi! Good morning! Thanks for taking the questions David. It was great to see some new system orders come in this quarter and our checks suggest that demand for robotic navigation is building. Just wondering if you could just help us think about the sales funnel, about the replacement channel and the Greenfield channel as we sit here today and relative to earlier in the year.

David Fischel

Hi Josh! Good morning! And so we’ve continued to make progress on the infrastructure for managing a sales pipeline. I think on the last call we talked a little bit more about that new infrastructure that was being built and that has been fairly kind of fully operationalized now in the United States and in the process of being operationalized outside the United States.

Overall the sales funnel looks relatively good. I don't think there's dramatic differences from the type of commentary we gave at the beginning of the year, where we said we had a few dozen, a couple of dozen, more than a couple of dozen systems in that pipeline. But we have more – there is better quality of information now that we have the improved capital sales pipeline infrastructure, and then overall we still see a good range of both replacement cycle and Greenfield systems in that pipeline globally and we’ve been grinding away at them.

I think like you say, the pace of orders that we had is consistent with overall a guidance that would drive growth this year and that will drive growth in future years, but hopefully we can also increase that pace at some point.

Josh Jennings

Thank you. And just thinking about the orders attached to – well, out of the second robotics lab at one of your customers center. I mean our sense is that center is within a big hospital network. And I know we’ve talked about this before, a little bit on the last earning call as well. But just, could you remind us of how you are positioned and your sale, your commercial team is attacking IBM's and any other details you can share about the decision by this EP lab to build out a second robotic lab.

David Fischel

Sure. So you are correct. That was a good guess that it is hospital that has a good historical experience with our system. It’s part of the large idea and across the U.S. and decided based off of that experience to buy a second robot.

And overall I’d say that, obviously the reason why they adopted a second system is because they have experience with both the clinical value of our technology and with the economic value for the hospital of our technology, in allowing them to treat patients that otherwise they wouldn’t be able to treat, and in driving efficiencies across the system. It was very nice earlier this year visiting the hospital and the head of the cardiovascular service line was talking so highly about how, when they review all those data how our system has made complex oblations far more efficient and reduced the variability and timelines of those procedures, and so that kind was really a vote of confidence, not just from the clinician, but also from the administrators there.

From an IDM perspective, we do think that we have sufficient experience in the field, again both from a clinical data perspective and from economic value for a hospital perspective to have meaningful conversations with larger IDNs; with the goal of having a relationship that spreads robotics more broadly across an IDN and proves that there's value and not just when robotics is adopted from the bottom up perspective, but also from the top down perspective.

Those discussions are obviously larger, strategic to sell discussions and so it’s always difficult to know when or how those will evolve. But we definitely have those discussions and think that at some point that makes a lot of sense for an IDN to enter into. So hopefully at some point we’ll be able to update you more.

Josh Jennings

Thanks a lot David. I appreciate it.

David Fischel

Thank you, Josh.


And the next question comes from Adam Maeder with Piper Sandler. Please go ahead.

Adam Maeder

Hi David! Hi Kim! Good morning and thanks for taking the questions. Maybe just to start, one clarification question on the mobile RMN System. I think I heard you expect launch by both U.S. and OUS, just wanted to clarify that. And then maybe just talk about kind of where are we from a design standpoint. We have designed lock and just level of confidence in hitting these timelines, and then I have a follow-up or two. Thanks.

David Fischel

Sure. Hi Adam! Good morning! And so you came out a little bit during your question. So I think I understood it fully, but in case I'm wrong please correct me. So we talked about given where we are right now in the development process, feeling confident that we should be able to have a launch by this time next year. I’d say that that would be in one of those two major geography, either Europe or the U.S. at least, and so I would assume that both geographies would be relatively soon after each other, so in a couple of months, within a few months of each other, but at least one of those we should have a launch by mid next year.

And overall from a development perspective, again, there's the mechanical aspect, the electrical aspects, the control software, the user interface software, so there's various parts that have to come together. There has been all sorts of challenges along the path, particularly on the supply chain side, on the electronic side and also on the mechanical hardware side. But overall the parts are coming together.

We have not yet started the testing of a system, but we’ve done large amounts of the development and overall feel very good where we stand and that we’ll start the VNV [ph] testing prior to year end and will have – will be able to submit for regulatory approval around that time, and that that will be kind of to the timeline we suggested of a launch by midyear.

Adam Maeder

That's very helpful color David, thank you for that. And then maybe for the next question, just on the MAGiC RF ablation catheter. You know I heard the message on expected timelines for Europe and launch there, but maybe I wanted to ask a question on how far in the U.S. market place – you know just when do you think the U.S. IDE trial can get going? Anything on trial design that you can share at this point in time and ultimately how do we think about potentially U.S. approval for that technology? Thanks.

A - David Fischel

Sure. So the European submission required a huge body of testing, that kind of bench testing, lab related testing and required a whole range – I mean dozens of animal studies and did not require a human study. It will require a post approval study in the EU. In the U.S. we have all of those same requirements and the vast majority of the CE Mark dorcei [ph] will be identical or nearly identical for the U.S. IDE submission and so that’s kind of all set and all ready.

We do have though a few, about a dozen additional animal studies that were requested by the FDA beyond a few dozen studies that we submitted for the European submission and those animal studies require kind of a follow-up period, a relatively short, but still a follow-up period and so we've been building out – in order to run those studies we've been developing our own animal study capability and that has been really, that’s the one gating factor to being able to complete those studies and submit the IDE to the FDA. And so we expect to complete those studies before year end and to be able to submit the IDE kind of immediately upon that.

We had multiple discussions with FDA so far, so we have a fairly clear understanding of what the trial design should be and I would expect around, let’s say 150 or so patient study in one specific clinical indication, one specific type of arrhythmia with a relatively short follow up, a maximum three month follow up.

And so given that it’s a very common arrhythmia, given that we have an installed base of users and the catheter would be able to be used either with the Niobes or the Genesis system, so we can really benefit from our fully installed base there. I think that that’s a trial that should enroll very quickly once we gain the IDE approval and we can actually start the study, both enrollment and follow-up should be done fairly quickly.

Adam Maeder

Okay, great, that's very helpful color, and if you don't mind I'm going to try and sneak one more in. You know I noticed in the – I think it was in the press release, there was some commentary about you know the commercial infrastructure and the progress being made there and kind of laying the foundation and you know historically been very judicious and conservative with spend.

But I also think in the past you talked about the MAGiC catheter launch kind of being impetus for kind of ‘don't go in more on the offensive,’ and you know I know we're not quite there yet, but you know just wondering what are the plans looking ahead for commercial infrastructure and building out the teams. Any additional color you can provide would be much appreciated. Thanks again David.

A - David Fischel

Sure. So yeah, I think you're completely right that we are – we take seriously our commitment to running the company in a financially judicious fashion and I think that kind of – that discipline does create a lot of value for Stereotaxis and it ensures that we don't waste shareholder value and capital, and so – but as now that product ecosystem starts to come together and obviously the catheter, but also the mobile system and the range of technologies that are coming together, it does obviously warrant focusing more on the commercial team and how to ensure that we have an excellent commercial organization. And so with that kind of obviously Europe is going to be a particular area of focus given the launch next year.

Putting in place the right leadership is the first step in that, and as we start the launch and go through the launch, I would expect a fairly substantial build out of our European commercial team. Again, I think that given the step-up in revenue per procedure that the MAGiC catheter provides, that will be a fairly – from a financial perspective for the company, a fairly low risk build out of the team, as you can do that very much hand-in-hand with adoption of the MAGiC catheter at specific accounts, and so you can do a very kind of laser focused, pinpointed hiring, where there's a high ROI for each hire and so I think you'll see us kind of probably over the course of next year doing a fairly substantial build out, perhaps even a doubling of the European team.

Adam Maeder

Thanks for the color David.

A - David Fischel

Thank you.


And our next question comes from Neil Chatterji from B. Riley. Please go ahead.

Neil Chatterji

Hi! Thanks for taking the questions. Maybe just circling back just on the hospital construction environment, just curious you know that we're you know about a month over into the new quarter. I’m just kind of curious if you’re seeing any signs of improvement here in July and now August, and then also if there’s any way to potentially characterize any barriers to conversion you would see for the systems that are in backlog, you know for example or some tied to larger hospital construction projects.

David Fischel

Sure. So hi Neil! So overall on the commentary we gave today is as of today, so we continue to see delays in hospital construction where even you know a couple of the orders that we received late last year, they are where we would have expected to be installing systems around now. It's still unclear whether we are going to deliver systems in a couple of months, a few months or if it's going to take them longer. So there is kind of a – quite a lot of uncertainty and just kind of delays when it comes to our hospital customers and their own processes in building out labs, in getting themselves organized to be ready for us to install.

So I’d say kind of it still is a fairly messy world out there, and on the side, your second question you kind of asked about uncertainty with conversion, and so as I didn't know if that’s kind of in terms of the timeline of when an order or backlog would be converted into revenue or the risk in terms of the overall, will it convert into revenue. Could you clarify that just?

Neil Chatterji

Yeah, I mean maybe just in relation to the construction environment, so just in terms of is it – are some of these tied to larger construction projects where that’s you know – because it’s a larger project, that’s delaying it even more so than if that was just the EP lab conversion.

David Fischel

Yeah, it's a mix and there are some where you have full build outs of wings or full – you know full blow outs of a floor of a hospital. So those are kind of part of obviously a much larger project and other ones might just be that lab. But then often times what you see is that there might be eight labs in a cardiovascular kind of wing of the hospital and the hospital will just go through lab by lab by lab. So they are doing lab one. When lab one finishes, they are going to do lab two, when lab two finishes they are going to do lab three and we might be lab whatever in that line, and so as you have – any delays you have kind of start to impact like a domino effect, the labs after them and so that’s – usually that is a fairly common scenario.

Neil Chatterji

Got it, got it. Maybe if I can add another question here. So just curious in terms of switching gears to the potential MAGiC launch in Europe, just curious in terms of you know what your expectation is for how quickly sites could switch over to using MAGiC, including any I guess regional nuances you might see there.

A - David Fischel

Sure. So there's a range obviously. I think kind of there will be from up purely logistic and legal ability to launch. Upon CE Mark in certain countries will be able to launch pretty much immediately. We’ll have to have a hospital contract for purchasing the product, but that should happen very, very quickly and we can be prime to enter into those agreements almost immediately upon CE Mark, and so that’s kind of very easy from a logistics perspective.

While in some countries, particularly the Nordic countries and France let’s say, and there are tenders, you know country tenders or regional tenders that you have to enter into. So you can usually sell some amount of an approved product outside of the tender as a new – under new technology clauses or other things, but you can't pursue wholesale adoption, wholesale transition of a site until you go through that tender. And so that logistic aspect will mean that in certain countries, that certain accounts you know there will be, there will be only partial adoption for the first let’s say – until you get over those tenders, which could take let’s say anywhere between six months to a year after the CE Mark process.

But again at other hospitals, let’s say particularly in Netherlands, Belgium, Germany, some of the other countries in Europe, kind of you really have no logistic hurdles once you have CE Mark. And the other kind of real effort that we’ll have to overcome is obviously that some physicians will be motivated and excited to be the first ones in the world to use it and will be very kind of very much pioneering in that effort, while other hospitals, I'm sure other physicians will want to see that one of their peers has first done 10 cases of arrhythmia A or arrhythmia B and kind of has good outcomes and will want to be able to speak with that physician and then based off of that will be comfortable trying it themselves. So that's just kind of the normal variability in physician dynamics.

I think kind of we're working hard on our side as an organization to ensure that there is a thoughtful business plan for every one of our 30 some hospital accounts in Europe, where we are thinking about what are the drivers for adoption, how do we kind of approach that, the individual physicians, how do we approach the hospital as an account, if there are any logistic things, how do we know exactly what application and forms and logistic efforts we have to go through to get into the account, and so I think we're going to kind of be ready. That’s – our role is to be ready, so that as we gain approval we can move as efficiently as possible and as thoughtfully as possible throughout that process.

Neil Chatterji

Great! Thanks for that. I’ll jump back in queue.

A - David Fischel

Thank you.


And we will now take the next question from Alex Nowak with Craig-Hallum Capital Group. Please go ahead.

Alex Nowak

Great! Good morning everyone. I was hoping to expand on the construction question around hospitals, but maybe speak to the CapEx environment at the hospitals. What is their willingness to go out there and place orders right now, particularly if they are seeing these delays in construction projects? I know some of the peers are seeing a recovery, others are not so much. So just the current state on the CapEx for the cap lab.

A - David Fischel

Sure. Hi Alex! So overall obviously we have been receiving still orders at a relatively regular pace. We still see a pipeline of hospital customers that are interested, and so I'd say that you are right. That when there are construction delays, that does often times lead to delays in us receiving an order, but at some point they need to order and then there might be delays even after that, beyond what they thought were the delays that they were expecting.

And so I – I mean definitely there have been delays of orders because of the construction dynamic at hospitals. But in the end of the day, the world is still running, hospitals are still operating, they still need to upgrade the labs, they still need to build new labs, and so those delays do impact the order scheduled. But orders to get done and then unfortunately sometimes they get done and then you still have delays after that, and then you're waiting kind of on the sideline to be able to deliver and install. But again, that's really a kind of a matter of timeline not a matter of ‘if,’ and so kind of we sit here and do our best given that environment.

Alex Nowak

Yep, understood. And then maybe explain on the real world study of MAGiC in Europe. What is that going to look like, how many patients, follow-up time and is there specific number of selected or this is just going to be basically depending on demand.

David Fischel

And so the post market study in Europe will be – that will be defined more clearly in our discussions with the notified body in Europe over the next few months I assume as we get questions, and so we proposed kind of a study design to them. Overall, again I would not use – that will be kind of across a broader range of arrhythmias, probably kind of in the low hundreds of patients overall. We'll be able to do that across a broad range of our site in Europe and so overall kind of we think that will be a good trial for just building a relatively broad kind of data on the catheter in Europe given that it's kind of post approval. There is kind of obviously somewhat less pressure on that, but obviously it will be important for us to be able to run that trial and to be able to kind of show that there is a value across a broad range of arrhythmias through that trial.

Alex Nowak

Okay, got it. And just lastly, just a clarification. What is the system backlog right now? I think it was $12 million, $1.5 million per system roughly, just going to ace the number.

David Fischel

George, it’s over $12 million of system backlog. It’s a little bit complicated to define it as exactly one system, because you saw, let’s say in the second quarter we reported revenue on kind of half of the system. We have both, the X-Ray component, the robot component. There's also sometimes a large screen display component and so we have some hospitals where there’s a mix of those kind of in play, but in total, yes, it’s kind of – its a mid-high single digit number of systems that come up to that. Again depending on – there is some half systems out there where we’ve shipped one of the parts but not the other part and so it's kind of it's a partial shipment.

Alex Nowak

I see, I understand. Alright, thank you.


We will now take our next question from Frank Takkinen with Lake Street Capital Markets.

Please go ahead.

Frank Takkinen

Hey David! Thanks for taking my questions. I wanted to ask a little bit more on the mix of replacement versus Greenfield. You provided some color around the funnel and I think what I heard was dozens. Maybe just talk to what the mix of that looks like from a replacement versus Greenfield perspective and then how you expect that to trend on a go forward basis?

David Fischel

Sure, hi Frank. So overall it's a good mix between the two; I think a relatively even mix, and when we look at the late stage pipeline, I think there is more and more – the replacement cycle that we talked about in the past is becoming more and more real. You see that obviously in the results over the last quarter. I expect it also probably in the results in kind of the upcoming quarters. There’s definitely kind of – some of those replacement projects are now taking place and so kind of we are seeing some of those now come through.

With that I’d say that obviously from a fundamental perspective process, the company driving Greenfield adoption is valuable and so we're putting kind of more and more focused there, and we still have a range of Greenfield hospitals in the pipeline. And so I think kind of you’ll see a mix, but I’d say that at least in the very late stage pipeline it’s probably skewed more towards the replacement side.

Frank Takkinen

Okay, that's helpful. And then maybe just an update on utilization. I know some of the newer sites have been trending above some of the legacy sites. So maybe just any color you can provide about utilization in the quarter and how that's been trending.

David Fischel

Yes. So if you exclude the dynamic of kind of Asia last quarter, overall the utilization has been – I don't have the exact numbers again for the Genesis installs or the new Greenfield installs that we just had from the beginning of this year. But overall the utilization has remained very nice and kind of above average levels in the second quarter, and so kind of we're very happy with the way the Greenfield sites and Genesis System are being used.

I don't if anyone on the call had an opportunity. The new launch that we had in Warsaw in the first quarter, late in the second quarter they had a conference that they hosted at the hospital. Two of the live, two I think out of the four live cases from that conference were using our technology. They had a commentary at that conference where they commented how impressed they were with the system, how they were using it across the broad range for arrhythmias. And so overall kind of I’d say that the experience at our existing sites, as the new launches at the Genesis sites has been overall very nice.

And so that’s kind of – and outside of that I’d say overall utilization remains kind of relatively stable. We have kind of sometimes pressures like the second quarter in Asia Pacific, but overall have a relatively sticky recurring revenue base and so that kind of has been, that’s been obviously a bright spike in along the stuff, kind of an overall stable foundation for the business upon which to build upon.

Frank Takkinen

Okay, that's helpful. I'll stop there. Thanks for taking my questions.

David Fischel

Thanks Frank.


And we will now take the next question from Nathan Weinstein with Aegis Capital. Please go ahead.

Nathan Weinstein

Hi David! Good morning and thanks for taking my questions. These questions are about the innovation pillars. Basically, can you remind us from your perspective what you see as the top endovascular adjacencies that could be most attractive for Stereotaxis? And then secondly, any update on the China specific product ecosystem and does that remain an attractive opportunity as you see it?

David Fischel

Hi Nathan! Good morning. Sure, so let me touch upon both of those. So from an endovascular intervention and kind of as an adjacency to what we are doing in electrophysiology, that’s kind of obviously one of the big pillars of our growth. I think our technology, the Robotic Magnetic Navigation, the concept of moving endovascular devices from their distal tip and by doing so allowing for precision and safety and reach and stability that otherwise is not possible with a manual catheter. I think that's kind of – it has inherently a lot of advantages across a range of endovascular surgery.

At our kind of R&D, Innovation Day that we hosted late last year, we talked about five specific clinical applications where there is kind of challenge and unmet medical need that we think can be addressed very nicely with robotics with our technology, and so we are kind of building the ecosystem of interventional devices, guide wires, guide catheters that can be used across those clinical applications.

I think places like neurointervention, where you have particularly complex anatomy, particularly delicate anatomy, there is significant unmet medical need with many patients not getting therapy at all or not getting the therapy that would be beneficial to them. Those that are particularly kind of attractive areas that I think we can provide a lot of value in.

But again, they were kind of all five of the critical areas where we kind of have our site on. The others outside of neurointervention being interventional cardiology, peripheral arterial disease, AAA grafts and embolization for cancer. And so I think kind of those five are where we currently have our sites on, and as bring out the right tool set to address them, I think you will kind of hopefully see in the first year or so, a range of clinical literature addressing kind of multiple different clinical specialties.

On the China side, obviously the disruptions and quarantines defined in the second quarter were not very beneficial to overall progress, but it was very impressive. We are continuing to work with Michael Tropea even while many of them were in quarantine and advancing the ranger of this kind of product ecosystem that we are developing together in China.

Again, the product ecosystem includes obviously regulatory approvals for our robot and X-Ray system, and mapping integration with Microbot's mapping system, and then a range of ablation and potential diagnostic catheters also in China, bringing the MAGiC catheter there, development of several Microbot catheters, and so there is kind of lot going on in that collaboration.

And overall kind of we’re very happy and very pleased to see the way that that collaboration is working well together. The way we're developing a range of - advancing a range of the technologies together there and so I think kind of that right ecosystem coming together. Like I said in the prepared remarks, it should be available in the second half of next year.

Probably kind of different aspects of that ecosystem will come in and be available at different times. But that kind of coming all together, I think kind of as we start to get towards the back half of next year, you'll start to see kind of that coming into play and that's really when you can start to benefit from the substantial commercial organization of Microbot in really driving kind of a broader adoption across again a fairly large sales team.

Nathan Weinstein

Great! Thank you, David.


Our next question comes from Javier Fonseca with Spartan Capital. Please go ahead.

Javier Fonseca

Hello! Thanks for taking my question. I have a quick question on the front for capital sales. So with the underline macro challenges that we've seen so far in 2022, how does overall commercial strategy for the new system installed changed. I know the sign is still there, you know still a good system, there is still demand. But you know in the face of all these challenges, you know has there been any changes to overall strategy.

David Fischel

Hi Javier! So no, I don't think there is any real change to the overarching strategy. As the overarching strategy is obviously we have a technology which provides a lot of value. We have still very small market share, less than 1% market share of just electrophysiology market.

I think the clinical value and health care system value that we provide is its being a substantially higher market share in electrophysiology and so we are doing the right things on the commercial side to gain a fair share of that market. And then in tandem obviously, doing the strategic innovations that allow us to kind of gain adoption much more easily in the current product set up, which requires construction as it provides us with our own proprietary disposable, giving us the ability to build sales teams in a different fashion, in a much more substantial fashion and building out the technology ecosystem, so that we can be used across multiple clinical applications and not just electrophysiology. So I think that strategy is very sound and we are continuing to advance that.

Javier Fonseca

Okay, thank you very much. No follow-up question.

David Fischel

Thank you, Javier.


And we have a follow-up question from Josh Jennings with Cowen. Please go ahead.

Josh Jennings

Alright, David. Thanks for taking the follow-up, David and Kim, sorry.

I wanted to just ask about the neurovascular indication. I mean since the Innovation Day in December, it’s been a number of months. I’m sure you’ve interacted with some neurovascular ventures, some neurosurgeons and I wanted to just hear from you what type of feedback you’ve gotten. Are there any specifics on clinicians to use on the clinical value proposition and then your teams internal I guess optimism level. Sure it’s increased over the seven months, but if you could share that, that would be great. And I think you gave some – provided part of the answer already in one of the previously question. I appreciate the follow up.

David Fischel

Sure, so actually in the second quarter we hosted two neurosurgeons from two different hospitals and who came to St. Louis and were working with us, with the devices we developed, with [inaudible].

We’ll have probably a few more visiting us late in the third or fourth quarter, early fourth quarter and so we've kind of had – we've been fortunate to benefit from kind of a fairly passionate group of prestigious and neurosurgeons who have been helping us in that development, and overall I think that the kind of the clinical value of being able to navigate torturous vasculature is significant in neurointervention, whether you look at us from vasectomy cases, kind of aspirational cases for ischemic stroke or you look at coiling cases for hemorrhagic stroke.

There are a large range of patients who do not get therapy at all, or who – when the physician is trying to reach the site that needs therapy, could struggled for at 20, 40, 60, 80, 100 minutes trying to just get through the tortuous vasculature, and that'll begin stroke at times in its brain, and so there's a lot of clinical value to be had if you can improve the efficiency of reaching the target site and you can do so in a safe fashion.

And so I think that's really what motivates those physicians so that they see that with our tools they can get places that otherwise they wouldn’t be able to get or they can get to places much more efficiently, much more quickly, without using the whole range of tools. And so that is kind of really where the value proposition is and I think kind of as we get those tools to market, that will allow us to start to obviously prove it in the clinical literature.

Josh Jennings

Appreciate it. Thank you.


And we have no further questions for today's call. So I would like to turn the call back to David Fischel for any additional or closing remarks.

David Fischel

Okay, thank you very much everyone for your questions and for your continued support. We look forward to working hard on your behalf in the coming months and speaking again next quarter. Thank you very much.


This concludes today's call. Thank you for your participation. You may now disconnect.

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