Stereotaxis - Earnings Call - Q1 2025

Executive Summary

• Revenue $7.47M (+9% y/y) with recurring revenue $5.50M (+29% y/y) and system revenue $1.96M; gross margin 54%.
• Revenue beat Wall Street consensus ($7.47M vs $6.88M*) and EPS was in line (-$0.07 vs -$0.0725*) as reported estimates involved 4 covering analysts*; revenue beat and EPS inline.
• Guidance reiterated: double-digit FY25 growth, system revenue $2–$3M per quarter, recurring revenue scaling to ~$7M in Q4; assumptions include modest GenesisX contribution in Europe and no system revenue from China.
• Catalysts: MAGiC EU commercialization (active at ~20% of customers), first GenesisX order, first commercial GenesisX installation targeted for summer, with multiple US/EU regulatory reviews progressing (MAGiC US 2H25; GenesisX US summer; MAGiC Sweep and EMAGIN 3Q approval expected).

What Went Well and What Went Wrong

What Went Well

• Map-iT catheter adoption: “Map-iT sales in the first quarter were over $1 million… growing 30% sequentially in the first quarter from the fourth quarter”.
• MAGiC EU launch traction: “At approximately 20% of our hospital customers, we’ve got through… and begun commercial sales… reiterate… MAGiC revenue in Europe will reach approximately $1 million per quarter by the end of this year”.
• GenesisX momentum: “Successful demonstrations… EHRA and HRS… first GenesisX purchase order… preparing for the first commercial installation… this summer”.

What Went Wrong

• Profitability/margins: System gross margin 15% and recurring margin impacted by acquisition-related accounting; operating loss widened y/y ($5.9M vs $4.7M).
• US capital environment: “Tougher capital environment… until we get GenesisX on the market and… catheters… approved”.
• China uncertainty: Despite Genesis approval in China, macro/tariff dynamics make timing of orders uncertain; guidance excludes China system revenue.

Transcript

Operator (participant)

Good afternoon. Thank you for joining us for Stereotaxis' first quarter 2025 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 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. Please go ahead.

David Fischel (CEO and Chairman)

Thank you, Operator, and good afternoon, everyone. Our last call two months ago included a comprehensive overview of Stereotaxis' strategy. We'll keep today's call more brief. I'll focus our prepared remarks on a few key commercial and innovation updates. Our commercial results for the first quarter were solid, with 9% year-over-year growth. While the structural challenges of our old product ecosystem remain a significant headwind, we are starting to show commercial progress. There are three areas specifically where we are orienting our focus and seeing results: growing recurring revenue with our MAPIT portfolio of differentiated EP catheters, starting to commercialize our recently approved MAGIC catheter in Europe, and early launch of Genesys-X to expand robot adoption. Our recurring revenue growth in the first quarter reflects predominantly the contribution of the MAPIT family of differentiated diagnostic EP catheters.

Our global commercial team is increasingly driving adoption of these catheters as we approach the anniversary of acquiring APT. MAPIT sales in the first quarter were over $1 million. Sales in the United States, where entering the acquisition we identified the most untapped opportunity and commercial synergy, have particularly done well, growing 30% sequentially in the first quarter from the fourth quarter. MAPIT catheters provide differentiated clinical value in the complex ablation procedures where robotics is most valued and our team most experienced, treating complex VTs and PVCs along with pediatric and adult congenital patients. The process of getting catheters adopted is gradual. There is the need to generate awareness and interest, the administrative effort to get on contract at hospitals, and the clinical support to turn initial adoption into recurring use. We're still in the very earliest innings of working through these processes.

Our first focus was existing U.S. robotic customers, a third of which have by now begun first MAPIT purchases. Our early marketing campaigns are also building awareness with measurable impact in the EP community, where there is essentially no awareness of the catheters. The response to these efforts has been very positive and reinforces our confidence in the clinical value and market opportunity. We're working through many hospital value analysis committee assessments at both robotic accounts and entirely new hospitals to translate that new awareness into first purchases. We expect a long runway for continued growth in MAPIT catheter revenue as we continue to build awareness and work through hospital approvals. The most significant driver of recurring revenue growth in the coming quarters will be the robotically steered MAGIC ablation catheter. We were delighted in the first quarter to receive European approval for MAGIC.

As described on the last call, we began commercial efforts across many of our EU hospital customers. Initial adoption of MAGIC requires administrative submissions at each hospital and, for many hospitals, also additional regional or national administrative efforts. We're continuing to work through these processes across EU hospitals, regions, and countries. At approximately 20% of our hospital customers, we've got through these initial administrative efforts and begun commercial sales. Just the initial use of MAGIC at these initial accounts should conservatively generate a couple hundred thousand dollars of revenue this quarter. We expect this revenue to ramp up significantly in the coming quarters and reiterate the expectation shared on our last call that MAGIC revenue in Europe will reach approximately $1 million per quarter by the end of this year. Building an attractive razor-razor blade business model with portfolios of proprietary catheters is core to our overall strategy.

That said, a larger installed base of robotic accounts is the critical foundation for robust recurring revenue. We spoke in detail on previous calls about how Genesys-X serves as the innovation making robotics broadly accessible across cath labs. After receipt of European CE mark for Genesys-X and then European approval of MAGIC, we were pleased to announce our first Genesys-X purchase order in the first quarter and began an initial soft launch. The most impactful aspect of this launch was bringing Genesys-X to the two largest electrophysiology conferences in our field, ERA in Vienna in March and HRS in San Diego in April. While Stereotaxis has attended both conferences for 20 years, this was the first time we were able to install a functional robot in our booth. Doing so was a dramatic demonstration of how far we've advanced the technology.

We were delighted by the reception, with busy booths and positive commentary from many physician visitors. Several key opinion leaders in the field, from hospitals that adopted but gave up on robotics in its earliest iterations or never adopted robotics at all, came by and were impressed and interested. These interactions are reflective of the power of innovation and an increased relevance we and many physician experts expect robotics to play in EP and endovascular surgery. We have been busy preparing for the first commercial installation of Genesys-X this summer. It will be an important milestone to demonstrate the robot working reliably in the rigorous environment of daily clinical use and will serve as the pivot from which to enter into a more robust commercial effort.

In tandem with working towards that installation, we've been working to enhance compatibility of the robot with various X-rays and preparing our supply chain, manufacturing, installation, and commercial processes for a full launch. We expect a full launch in Europe and the U.S. shortly after initial commercial use and pending U.S. regulatory approval. While we view Genesys-X as a significant driver of robotic system growth in the coming years, we continue to have a healthy pipeline of Genesys customers. We were pleased in the first quarter to receive an order for an additional Genesys system from a U.S. customer. We continue to expect a steady flow of Genesys orders in the next few quarters, with additional Genesys-X orders building on top of that base. We are pleased with the initial commercial impact of MAPIT, MAGIC, and Genesys-X.

That said, the majority of our focus remains on driving multiple innovations through key development and regulatory milestones. Realizing these milestones in our comprehensive innovation strategy sets the stage for breakout revenue growth. This will be a milestone-rich year, and we're making significant progress on multiple fronts. We discussed the full breadth of innovation efforts on our last call. It's an amazingly busy time. We have six active regulatory reviews ongoing, key products being reviewed by either the U.S. FDA or EU-notified body. There are an additional five regulatory efforts ongoing for products we expect to submit for regulatory approval in the near term. This is an amazing bolus of innovation and takes a significant amount of effort to shepherd forward. I'll share a few brief regulatory updates on the key technologies. First, MAGIC in the U.S.

We submitted MAGIC to the FDA last year and continue to work collaboratively with FDA on the review of the catheter. We've also continued enrolling patients in our ongoing European study, which is supporting this submission, and are nearing 100 patients enrolled. Given our interactions with FDA, we continue to expect U.S. regulatory approval for MAGIC in the second half of this year. Second, Genesys-X in the U.S. In the first quarter, we responded to FDA's original questions, whittling down a list of approximately 25 outstanding questions to a few final topics. We received additional feedback and questions recently from FDA on these remaining topics. We're working to address these and continue to view regulatory approval of Genesys-X in the summer as realistic. Third, our robotically steered high-density mapping catheter, MAGIC Suite.

We submitted this catheter for regulatory approval in the first quarter and recently received our first round of questions from the FDA. We see no significant concerns with these questions and will respond soon. We continue to see both U.S. and EU regulatory approval for MAGIC Suite in the third quarter. Finally, our vascular guide catheter, Imagine, which allows our robot to begin to expand its use beyond just electrophysiology. We also submitted this catheter for regulatory approval in the first quarter and, similar to MAGIC Suite, continue to expect both U.S. and EU regulatory approval in the third quarter. Beyond these products in active regulatory review, we are finalizing regulatory paperwork for our Synchrony cath lab technology with regulatory submissions still this quarter and are making good progress on our robotically steered vascular guidewire, which we believe we will complete by the end of this year.

Other R&D activities, like our recently announced AI effort with NVIDIA and the multiple PFA efforts, are also very exciting and are being advanced in parallel, but not expected to lead to regulatory submissions this year. It's an exciting period seeing so much of what we've invested in at the cusp of coming to market. We are heads-down focused on advancing all these technologies through the development and regulatory processes, on ensuring we are able to manufacture them with high quality and at scale, and on commercializing the technologies with creativity. This year, we will demonstrate the tangible reality of our overall strategic transformation into a company with an easily adopted robot that can navigate a proprietary set of catheters in EP and broadly across endovascular procedures.

These milestones will increasingly contribute to commercial results as we progress through the year and set us up for breakout growth as we look towards 2026. Kim will now provide additional commentary on our financial results, and then I will make a few financial comments as well before opening the call to Q&A. Kim?

Kim Peery (CFO)

Thank you, David, and good afternoon, everyone. Revenue for the first quarter of 2025 totaled $7.5 million, growth of 9% from $6.9 million in the prior year first quarter. System revenue for the first quarter was $2 million, and recurring revenue was $5.5 million, compared to $2.6 million and $4.3 million in the prior year first quarter. System revenue in the quarter reflects revenue recognition on the installation of one Genesys system and partial revenue recognition of other ancillary systems. Recurring revenue growth reflects primarily the contribution from last year's acquisition of APT technology.

Gross margin for the first quarter was 54% of revenue. Recurring revenue gross margin was 68%, and system gross margin was 15%. Recurring revenue gross margins remain impacted by acquisition-related accounting that temporarily reduces disposable margins. This is an accounting treatment and not reflective of cash margins or activity. Prior to the acquisition, recurring revenue margins were approximately 75%. Following the acquisition, they dipped down below 60%, and we expect recurring revenue margins to get back to our normal level by this year's third quarter. System gross margins have been fairly consistent in the 15%-20% range and are impacted significantly by fixed overhead allocated over low production levels. Operating expenses in the quarter of $10 million included $3.2 million in non-cash charges for stock compensation expense, mark-to-market adjustment for acquisition-related contingent earnout consideration, and amortization of acquired intangible assets.

Excluding these non-cash charges, adjusted operating expenses were $6.8 million compared to the prior year adjusted operating expenses of $6.1 million. The increase in operating expenses reflects the addition of APT operating expenses following the acquisition. Operating loss and net loss in the first quarter of 2025 were $5.9 million and $5.8 million, compared with $4.7 million and $4.5 million in the previous year. Adjusted operating loss and adjusted net loss for the quarter, excluding non-cash charges, were $2.7 million and $2.6 million, compared with $2.2 million and $1.9 million in the previous year. Negative free cash flow for the first quarter was $1.8 million compared to $2.3 million in the previous year. At March 31, Stereotaxis had cash and cash equivalents of $10.7 million and no debt. I will now hand the call back to David.

David Fischel (CEO and Chairman)

Thank you, Kim.As mentioned in our press release, we are reiterating the revenue guidance we provided on the last call. We expect double-digit revenue growth for the full year 2025. In any given quarter, we expect system revenue to fluctuate between approximately $2 million-$3 million. Recurring revenue will continue to scale throughout the year, reaching an expected $7 million in the fourth quarter. Our revenue expectations assume only modest contributions from Genesys-X in Europe this year and no Genesys-X revenue from the U.S. We believe this is conservative but warranted pending regulatory clearances. These revenue expectations also assume no system revenue from China. While we viewed the recent approval of Genesys in China as a potentially significant tailwind this year, the ongoing macro situation creates substantial uncertainty onto the extent Chinese hospitals will be able to purchase Genesys systems.

We and our partner, MicroPort, are continuing to work on a meaningful pipeline of Chinese customers but believe it is prudent to view this as an upside given the uncertainty. Growing recurring revenue and stable operating expenses support our expectation for reduced cash use in 2025 compared to 2024. I'm pleased with our relatively modest cash use in the first quarter, and our cash level is approximately flat with our cash balance at the end of last year's third quarter. Tariffs, assuming current rates persist, are anticipated to cause less than a 1% increase to our expenses. We view our existing balance sheet as allowing us to reach key milestones, commercialize our innovation, and profitably grow. We'll now take your questions. Operator, can you please open the line to Q&A?

Operator (participant)

This time, I would like to remind everyone that in order to ask a question, press star and then the number one on your telephone keypad. We also ask that you please limit your questions to one and one follow-up so that everyone can have the opportunity to engage with our speakers for today. We will pause for just a moment to compile the Q&A roster. Please say your first question comes from the line of Adam Maeder with Piper Sandler. Please go ahead.

Adam Maeder (Research Analyst)

Hi, good afternoon, Dave and Kim. Thank you for taking the questions and congrats on all the progress.

David Fischel (CEO and Chairman)

Thanks, good afternoon.

Adam Maeder (Research Analyst)

Yeah, good to hear from you, David. Maybe just one from me to start on the capital side. Multi-part question, but just wanted to dig into the backlog a little bit more and just kind of get a better sense for kind of how that's shaping up. I guess both on the Genesys side as well as the Genesys-X mobile system, both in the U.S. and in Europe. One of the questions I have is, is the capital equipment environment still relatively healthy and resilient? In the U.S., particularly, just wondering if folks are deferring purchases, waiting for the Genesys-X to become available, and if that's kind of impacting you guys a little bit. I had a follow-up, and sorry for the long-winded question.

David Fischel (CEO and Chairman)

Sure, sure. No, it's a great question. I think when you look at the capital environment overall, you do really have to look at the three key geographies each independently because there is very much its own dynamic in each of the three, just in terms of our product ecosystem and kind of what we're working within. I'd say that our experience is probably not necessarily reflective of broader macroeconomics. I don't know. We're still such a small fish that it's very hard to say that what we experience is reflective of the broader capital equipment environment because, again, we're kind of a small fish in a huge ocean. I think that irrespective of how the macro goes, we're going to be mainly driven by our own swimming capabilities.

That said, if we look at kind of the three regions, in the U.S., we have still the least advanced of an ecosystem in that we do not yet have MAGIC approved. We do not have the catheter approved. It is kind of a tougher capital environment for us. We do have various interested customers on the Genesys side. As kind of we announced, we had one Genesys order from a U.S. customer in the first quarter. Obviously, there continues to be a pipeline there. There continues to be activity. I would say that is probably one of our most challenged markets until we get Genesys-X on the market and have some of the catheters that are critical for Genesys-X also approved. We do have hospitals that are very much, and you probably saw some of them at HRS.

There are hospitals that are very much interested and engaging with us in understanding how Genesys-X could fit into their labs. They like the fact that they do not have to necessarily think about a major construction project for it. There is kind of a group of interested hospitals there. Obviously, we are waiting towards later in the year when we have approval both of Genesys-X and MAGIC to view that as being really actionable. In Europe, we have a more kind of robust pipeline in that we have both on the Genesys side and on the Genesys-X side. I would say that the Genesys side is still in some ways a larger pipeline than Genesys-X just because there are physicians and hospitals that have interacted with us for the last couple of years and have advanced interest in that over the years.

If they're already planning to do construction or they're building out new wings of hospitals, their baseline assumption is to use Genesys just because that's what's been in their mind all along. We are starting now to also build a separate pipeline of physicians that would be most interested in Genesys-X. I recognize that the investment community already counts it as a given that Genesys-X works, and I give it as a given. Obviously, we added at the conference, we were able to show it. That is very helpful. There is something with physicians and hospitals. There is, I think, a natural conservatism which wants to see things actually working in the real world, treating patients before they are fully on board and fully confident to jump.

There is more of that market confidence in Genesys given that people have seen it working now at many hospitals consistently treating thousands of patients than there is still on Genesys-X. It is up to us over this coming year as we install the first system, maybe a second system, that we kind of demonstrate Genesys-X working well, and that will kind of increase the confidence and allow us to grow there. Again, I expect relatively consistency in we should have almost every quarter at least one or two Genesys orders coming out of Europe. China is its own dynamic. We obviously just got regulatory approval. MicroPort is a great partner with us in China. They are pushing aggressively despite the macro noise to start to build or to start to convert the pipeline that we have into actual orders.

The whole tariff situation and what that would mean in terms of the price of Genesys for a Chinese hospital customer is obviously a little bit challenging, and there is uncertainty there. The news today is probably somewhat more helpful in that. That uncertainty does kind of raise questions, and that is why we are viewing that all as upside. That is not part of our guidance, but definitely there should be upside there, particularly if the macro situation is improved versus what it was last week. I hope that helps. If there is any follow-up, can obviously talk a bit more about it.

Adam Maeder (Research Analyst)

No, that is great color, David. Thanks so much for all of that. For the follow-up, just pivoting over to the catheter side, your MAGIC RF ablation catheter. I guess just wanted to kind of get a better understanding of the feedback from your European customers that have adopted that catheter. How is the catheter performing? Is it being used predominantly in SVT and VT, or is it really across a garden variety of cases? As you think about that 20%, I think you said of customers that are now using MAGIC and kind of through the VAC process, just kind of how should we think about that scaling over the course of the next couple of quarters? Thanks again for taking the questions.

David Fischel (CEO and Chairman)

Sure. Overall, the reception to it is very positive. It isn't very surprising for us because we did have obviously the clinical study before, and we got multiple physicians who had experience with MAGIC even before the launch. It's in many ways, right, a very, it's just improvements in various ways that make the experience with the catheter nicer and the performance nicer. What we experienced in the clinical study is now playing out also in these initial adoptions commercially. It has been used like in the clinical study across the full spectrum of procedures. SVTs, AF procedures, VTs, PVCs, congenital patients, really across the spectrum of patients. Though like our overall volume, there is more of a propensity of using it in VTs and PVCs, the complex cases where we add the most value, and that just matches our overall procedural volume. We are continuing to ramp hospital by hospital, physician by physician, the number of sites that will start using and then kind of switch over fully to MAGIC.

We've given the guidance of MAGIC in Europe scaling to about a $1 million run rate at the end of this year. That kind of equals about a $4 million annual revenue from MAGIC. That would be a fairly good penetration, but that's probably about half of the penetration or a little bit less than half of the penetration that we'd kind of expect overall from our European customers. I think in the past, I've talked about that generally you should expect a two-year process to fully convert the market over. I think we're very much on track on that.

Adam Maeder (Research Analyst)

Great color. Thanks again.

David Fischel (CEO and Chairman)

Thank you.

Operator (participant)

Our next question comes from the line of Frank Takkinen with Lake Street Capital Markets. Please go ahead.

Frank Takkinen (Senior Research Analyst)

All right. Thanks for taking the questions. Congrats on all the progress. I was going to start with one on MAGIC just to continue that conversation a little bit. How have ordering patterns looked for the 20% that are now active? Have they essentially started to use it, and maybe they're testing a few units before they fully implement it and use MAGIC exclusively, or are they getting confidence kind of right up front to switch over all of their RF magnetically driven catheters to MAGIC?

David Fischel (CEO and Chairman)

Sure. Hi, Frank. Good afternoon. It's a great question. Generally, when we see the first order, we see an order for five or ten catheters kind of in a box of five or ten, and then they'll work through those. We make sure our trainers are on site. We make sure that kind of there's real discussions. It's not that they just pull it out and use it one day without any discussion.

We want to make sure their experience is good. There are differences, right? You're given an analogy that kind of all of us can remember. You have a car that you've driven for 15, 20 years, and suddenly you have a new car. Even if it's a better handling car, there are differences in the experience. It is useful kind of to both discuss those before they do the first drive and then to kind of be with them on the first drive and make sure it's going well and they're enjoying it. We've gotten very positive feedback. We've had some now kind of second orders after that first order, this even I think third order from a couple. We are starting now to get into some repeat orders from some hospitals and otherwise are working through those initial batches.

Sometimes also in some hospitals, there are multiple physicians, and you'll see kind of one who will take the flag and say, "I want to be the one to do the first few," and then they'll talk about it with their colleagues, and then the other colleagues want to do it. Every hospital has its own little dynamic, but overall kind of that's the way it's playing out. We have kind of multiple hospitals obviously where we're in certain aspects of either the hospital review or the national review to get it in. It's a grind just working through these processes, but overall, we're very happy with kind of the physician reception.

Frank Takkinen (Senior Research Analyst)

Got it. That's helpful. Maybe just MAGIC in the U.S. Heard the updated comments that you're working collaboratively with the FDA. What's kind of left on the docket as you look at that submission process? Is there anything specific that they're waiting to see, or is it more just in their court and related to timing of when they can get to the file?

David Fischel (CEO and Chairman)

Overall, I'd say that actually despite all of the news articles and things like this that were painting a dour picture of things, FDA seems to be working very hard, is still doing very detailed reviews, is responsive, and they're so I kind of say that's overall been a pleasure kind of seeing that in practice. It doesn't seem like the stuff on the news are having an impact, at least from our vantage point. When you look at kind of our FDA review of MAGIC, we have received very, very detailed questions, comments on various parts of the submission.

Those kind of we've either addressed or sometimes you do some secondary biocompatibility or sterility tests to supplement the test that you had before. The vast majority of that I think is done. I think there might be a couple of tests that we are now running at third-party labs kind of to supplement the submission, but largely that is all done. As we are continuing to enroll patients in Europe, particularly we've kind of we're not trying to enroll a specific number of patients now. We're really enrolling complex congenital, complex anatomy patients that kind of seem to be the most suited for FDA to review at this point. As we're doing that, we're compiling all the data, sharing it with FDA, they're getting that and being able to review it.

I'd say kind of it's the mix of working through the questions and some of the remaining topics, ensuring that the clinical data that has been generated out of the European study is reviewed thoroughly and kind of that the FDA feels comfortable with that. Those are probably the largest items. There is the potential for an on-site audit of the manufacturing facility, but that may not be required. That's still a question mark.

Got it. That's helpful. I'll stop there. Thank you.

Maybe one other comment just kind of similar to your first question, but more fitting with the second one in the U.S. is obviously the U.S. doesn't have as many administrative complexities as Europe. Generally, I would expect U.S. adoption of MAGIC post-approval to be quicker. You obviously don't have any of the national or regional registrations.You still have to work through VAC committees in the U.S., but we've had now quite a lot of experience with VAC committees with the MAPIT catheters in the U.S. Sometimes that goes slowly, but when a physician is vocal about it, that can move overall very quickly. I think we have good experience now with that, and that will help us with the MAGIC program in the future.

Operator (participant)

Your next question comes from the line of Jason Wittes with ROTH Capital. Please go ahead.

Jason Wittes (Managing Director)

Hi. Thanks for sharing the questions.First off, I assume if MAGIC gets approved in the U.S., that would potentially be some upside in the numbers if we got it, say, early in the second half, or is that the right way to think about it?

David Fischel (CEO and Chairman)

Hi, Jason. Yeah. We didn't include MAGIC in the U.S. In our guidance for $7 million of recurring revenue in the fourth quarter. That doesn't include MAGIC revenue in the U.S.

Jason Wittes (Managing Director)

In terms of just penetration in Europe, and I think you sort of spoke to it in the U.S., what's your kind of timeline that you think before we can be sort of fully converted or fully sat, maybe not saturated, but fully converted to MAGIC in the U.S. and Europe?

David Fischel (CEO and Chairman)

The general statement I've made is that I'd expect a full conversion to play out over a period of approximately two years. That would say in Europe, you should expect at some point in the course of 2026 that really substantially all of the usage has converted to MAGIC. The U.S. would probably, the U.S. is at a quicker timeline than that, but it's obviously starting later.

Jason Wittes (Managing Director)

I got it. For Genesys-X, it sounds like you're already having conversations in the field. I appreciate that they don't have to do a major construction, but have they looked at alternative ways of financing? I know you've talked about in the past that you could potentially lease these systems or even place these systems. Has that been part of the discussions, or is that something that you're saving for later?

David Fischel (CEO and Chairman)

It's a good question. Obviously in Europe, we're having those open discussions on commercializing Genesys-X and kind of building a pipeline. In the U.S., it's not yet approved. We're kind of sharing it as part of our innovation strategy, but we're obviously not commercializing it or quoting it or doing anything of that sort in the U.S.

When you look at the different financial models, we are still at the point where we are ramping up manufacturing and supply chain and everything of that sort. There is demand that is open to acquiring systems, and so we're not trying to push. I kind of think that at some point in the coming few quarters, we will start to present hospitals three models: a purchase model, a leasing model, and a placement with a disposable revenue, disposable catheter commitment model. We will place the three of them to some extent on the desk of a hospital, and we will be agnostic to the three, and we will just kind of streamline the speed of adoption by sharing these three models all at the same time upfront.

At this stage, we are still predominantly talking about the sales model other than in a few scenarios where with particular KOLs where we would really like to switch them onto robotics, and the leasing model would be kind of would be attractive to us to get them to try it at least and to start to kind of share their experience with it because it would be kind of impactful for overall awareness of the robot in the field.

I'd say we're mainly still focusing on the sales model, but as we ramp up manufacturing and supply chain, as we go into a full commercial launch, you'll see us be much more agnostic between those three models with the goal, again, of I think I had a comment in our prepared remarks where ultimately the real driver of growth is going from having 100 robot installed base to having 1,000 robot installed base. How do you kind of accelerate that as much as possible? Luckily, with a good portfolio of catheters, you can do that in a leasing model or a placement with disposable commitment model, and it still ends up being financially kind of prudent and attractive to do so. Great deal.

Jason Wittes (Managing Director)

Appreciate all the color. I'll jump back into you.

David Fischel (CEO and Chairman)

Thank you.

Operator (participant)

Once again, if you would like to ask a question, press star one on your telephone keypad. Your next question comes from the line of Josh Jennings with TD Cowan. Please go ahead.

Joshua Jennings (Senior Research Analyst)

Hi. Good afternoon. Thanks, David and Kim. Wanted to ask David, just as you're building out your catheter portfolio, I mean, if we think about the commercial era where you have the MAGIC RMN ablation catheter, MAGIC Sweep high-density mapping catheter, and the MAPIT portfolio, I mean, how do you envision the case mix for robotic magnetic navigation cardiac ablation procedures evolving? I mean, do you think the kind of percentages of ventricular versus atrial? I mean, I think you described in some of the cases that MAGIC catheter is being used in terms of your case mix. Would you expect that to change? Do you expect the platform to be utilized in more atrial ablations as well?

David Fischel (CEO and Chairman)

Hey, Josh, thanks for the question. That's a good one. Maybe kind of just to start, you saw it obviously at HRS, the portion of our booth where we displayed all the catheters, and we have it obviously also on our investor slide and image of that. This transition from a year ago selling zero catheters to having, I think it was 10 catheters displayed, and 8 out of the 10 of them are going to be commercial this year, and already I think the majority of them are commercial at least in one of the key geographies. That is really kind of a major strategic transformation for Stereotaxis. Again, we've had 20 years of commercial experience and never selling our own catheter. That is a big, big one for us.

When you look at the case mix specifically, and we are working on all sides that kind of each of those portfolios, MAPIT, MAGIC, and Imagine, end up being much kind of big significant portfolios of catheter revenue. When you look at the case mix specifically in EP, where the majority of our procedures currently are VTs, PVCs, congenital patients, I think that that will probably persist also as we get our own portfolio of catheters. Our mechanism of action, whether you apply that mechanism of action, robotic magnetic mechanism of action to an ablation catheter or to a mapping catheter, really provides its most value in challenging cases where kind of manual catheters have difficulty being navigated well or being stable or being safe. I think kind of that's obviously where we shine.

I'd kind of say that's our best foot in the door with any individual physician. Once you have your foot in the door and they like to use you, you see adoption of us also in SVTs, also in some AF cases. I kind of think that we're, at least for now, we can be in order of magnitude larger, even more than, I mean, 30-fold larger just in the VT, PVC, congenital space. That is a good niche, a good large niche for us to focus on at this time. Again, as you get your foot in the door, there's always the opportunity to expand your usage into other procedure types. That's kind of how I would view things now.

I think kind of sidestepping the slugfest that is taking on in the AF space right now is probably also a healthy thing from just a commercial team focus perspective. We can have a much bigger impact with much lower hanging fruit in the complex ablations.

Joshua Jennings (Senior Research Analyst)

Makes sense. Thanks. I wanted to follow up on Imagine. I know you've been interacting with neurovascular physician experts over the years and are understanding that there's some buzz that you've generated. I was hoping you could walk us through, I know this may be a review, but walk us through approval of Imagine, approval of Genesys-X. Maybe how do you see the neurovascular community engaging and potentially adopting robotic magnetic navigation using the Imagine guide catheter guidewire for some of the neurovascular cases over the next 12 months-24 months? Thanks a lot.

David Fischel (CEO and Chairman)

Sure. Thanks. That's a great question too. Our Imagine portfolio will initially have the Imagine 5F guide catheter. It's a 5 French guide catheter. We hope to submit by the end of this year also the 014 guidewire, which is a much, much smaller, kind of almost like the diameter of a piece of hair, little wire. Those are kind of the two key families. Each one of them will have kind of a family of devices that are relatively similar but slightly different. The guide catheter has already been submitted. As we gain approval, there are certain procedures that are better suited for a catheter and others that are better suited for a wire.

Let's say in the neuro field, one of the areas where we expect the guide catheter to provide a lot of value is just navigating up the carotid. I think I might have mentioned on some previous call, some of the feedback we were receiving from neurointerventionals was navigating from the aorta into the carotid and up the carotid in a subset of patients, whether it's 15% or 20% of patients, can be very, very difficult, and they'll spend 20-30-40-50-60 minutes trying to do so, and sometimes they'll fail completely. During that whole time, they're on X-ray. Obviously, if it's a stroke case, that amount of time is critical for the outcome of the patient.

There is kind of similarly, there's other cases that would be useful for the guidewire that are just kind of different or other parts of a case where a guidewire could be helpful. As we get the guide catheter approved, I would say that the guide catheter can work obviously with Genesys-X, but can also work with Niobe and Genesys. The quickest, easiest adoption of the guide catheter will be in existing labs where they already have a robot. An interventional cardiologist or radiologist wants to step into the lab and kind of try it in some complex cases. Essentially, every EP department is part of the interventional cardiology department. Even if you have a room that is a dedicated EP room, usually the cardiologists are literally right next door and able to use those labs.

It's probably more difficult for neurointerventionalists to use an EP lab just because the other tools that they have in a neuro lab are different. That would probably only take place in an existing Niobe or Genesys lab if it was really part of a series of cases that were particularly difficult that they wanted to move into the EP rooms for that process. I'd see slower, but kind of good interest adoption in the neuro field. Probably that's going to be predicated also on having Genesys-X available and also on some of our efforts I kind of touched upon in some of the prepared remarks on making Genesys-X compatible with various other X-rays in the field. We're working on that in tandem. There are physicians in the U.S.

from various hospitals who are very interested in the clinical value that Imagine can provide. As we get that on the market, as Genesys-X is on the market, I expect we're going to be able to establish Genesys-X at a couple of hospitals at least and start to demonstrate the clinical value in the neuro field. Probably you're going to see more value being shown in interventional cardiology, interventional radiology just from existing installed base.

Joshua Jennings (Senior Research Analyst)

Understood. Appreciate that. Thanks, David.

Operator (participant)

Thank you, everyone. That concludes our Q&A session for today. I will now turn the call back over to David Fischel for the closing remarks.

David Fischel (CEO and Chairman)

Okay. Thank you very much for all your questions and for the continued support. We look forward to working hard on your behalf over the coming quarter and speaking again soon. Thank you.

Ladies and gentlemen, that concludes today's call. You may now all disconnect. Thank you for joining. Have a nice day.