Stereotaxis, Inc. Q3 FY2025 Earnings Call

Good afternoon. Thank you for joining us for Stereotaxis' Third 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 within 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. 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.

Thank you, operator, and good afternoon, everyone. We are in an exciting period with a lot of progress on multiple fronts. We've discussed our strategy and efforts more comprehensively on previous calls, so I'll keep today's remarks focused on a few key commercial and innovation updates. Our commercial activity can be viewed as two primary efforts: first, to scale robotic system sales with continued adoption of Genesis and the initial launch of GenesisX; and second, to build a robust, high-margin recurring revenue business with our portfolio of novel catheters. These two efforts are independent, but obviously synergistic, and together support an attractive razor-razorblade business model that can deliver substantial long-term growth. On the capital side, we were pleased to receive hospital orders for two Genesis robots since our last call. Both orders came from European hospitals establishing entirely new robotic programs. We expect both robots to be installed and to begin clinical use in the first half of 2026. These Genesis orders are reflective of the healthy pipeline and continued interest we see across our regions, particularly in Europe, where we are slightly ahead in having a more complete product ecosystem approved and commercialized. These orders add to our existing system backlog, which had over $10 million, supports a steady baseline of robotic system revenue as demonstrated by our results over the last several quarters. The launch of GenesisX significantly enhances our system opportunity by removing structural barriers that limited physician interest from translating into tangible adoption. We're delighted to announce FDA approval for the GenesisX system. This is a landmark approval for Stereotaxis. There are very few companies that can successfully develop, gain regulatory approvals, and deploy complex surgical robots that operate reliably in daily clinical use. This is Stereotaxis' second such robot in five years and a reflection of our unique expertise and our capacity and commitment to significant innovation. We are initiating a limited launch of GenesisX while we await approval for the MAGiC catheter work to enhance compatibility of the robot with various x-rays and refine our supply chain manufacturing, installation, and commercial processes for a full launch. While we are pleased with the steady demand for Genesis, we expect GenesisX orders to outpace the tempo of Genesis orders following the full launch. Turning to our recurring revenue, the key driver of growth over the coming years will be our burgeoning portfolio of proprietary catheters. Stereotaxis' recurring revenue has to date been predominantly driven by service contracts and a small single-use disposable with relatively little revenue per procedure. Catheters are the primary disposable in any procedure, and Stereotaxis did not previously benefit from this revenue stream. The paucity of robotically steered catheters reduced interest in our technology and limited our revenue opportunity and razorblade business model. Over just the past year, we have started to demonstrate the tangible reality and commercial impact of our catheter portfolio, with growing sales of Map-iT catheters following our acquisition of APT last year, adoption of the MAGiC ablation catheter in Europe, following CE Mark in the first quarter, and over just the past two months, adoption of the MAGiC Sweep high-density mapping catheter in the U.S. following the FDA approval this summer. MAGiC Sweep has been a particular recent highlight. On our last call, we described the importance of high-density mapping in the electrophysiology field and have the introduction of robotic HD mapping promising several clinical and workflow benefits. It is also important to note that MAGiC Sweep is Stereotaxis' first catheter launch in the U.S. and the first catheter innovation that allows our robot to be used in new ways, enabling clinical care that was previously not possible. We began the commercial launch of Sweep in late August and have had a very exciting reception to date. Physicians have shared multiple examples of MAGiC Sweep allowing them to better diagnose the source of arrhythmia safely and efficiently in areas of the heart that were otherwise inaccessible with manual mapping catheters. The clinical interest in the catheter has translated into a strong commercial start with over $300,000 in Sweep revenue in the first two months of launch. We are still in the earliest innings of the launch, with only about one-quarter of robotic accounts in the U.S. ordering the catheter to date as we work through multiple hospital approval processes. We are excited to see the catheter continue to scale this impact in the U.S. as well as gain approval and launch in Europe. The commercial impact of MAGiC Sweep, measured in direct revenue and as importantly, in the halo effect it creates for robotics in our field, demonstrates the significant impact of innovation. We have a robust pipeline of innovation efforts that will continue to strengthen our commercial results. These include multiple products in the late stages of regulatory review, development projects approaching submissions, and earlier-stage efforts that haven't yet been disclosed. They span technologies including robotic systems, software solutions, and several electrophysiology and vascular catheters and devices. I'll add a few brief updates and comments on three specific projects most impactful in the short term: MAGiC in the U.S., post-field ablation, and the Synchrony digital cath lab system. MAGiC is our proprietary robotically navigated ablation catheter that will replace the older J&J catheter used with our robot. We received CE Mark and launched the catheter in Europe earlier this year, have been working through manufacturing ramp-up and country-by-country commercial processes, and are working diligently with the FDA to advance U.S. approval. Late in the third quarter, we responded fully to a body of questions that represented the FDA's outstanding questions upon a comprehensive review of all modules in our submission. We maintain regular dialogue with the FDA and appreciate their collaborative effort during the review. Post-field ablation, PFA, has had a dramatic impact on the electrophysiology field over the last couple of years, driving billions of dollars in market growth and significant share shift among the large med tech players. On previous calls, we described having a few earlier-stage PFA collaborations with different partners working through the preclinical testing process. Last month, we were pleased to announce successful completion of preclinical testing and entering into a collaboration agreement with CardioFocus for their PFA system with our MAGiC catheter. The agreement provides a framework for how we will advance this first-ever robotic PFA solution for a first-in-human clinical study, regulatory approval, and commercialization. CardioFocus' PFA generator and our MAGiC catheter both already have regulatory approval in Europe, and so the effort to add compatibility to our label is expected to be relatively contained. We are preparing formal regulatory documentation to initiate first-in-human testing, expected to perform these procedures in the coming few months, and believe it's possible to see MAGiC approved for PFA use in Europe before the end of next year. Finally, let me make a brief comment on Synchrony and SynX, our digital solution that streamlines, modernizes, and introduces secure remote connectivity to the cath lab. In October, we announced that we obtained CE Mark in Europe and had submitted technology for FDA approval. The technology has received less attention than most of our other innovation efforts but holds significant promise as an entirely new business pillar. We have spent over six years and many millions of dollars developing Synchrony and SynX, benefiting from our previous experience with our Odyssey system but completely rearchitecting it with an improved technological foundation. Synchrony and SynX are central to our digital surgery efforts to modernize the interventional lab with enhanced workflow, remote connectivity, and smart AI capabilities. The technology improves the robotic cockpit, but we believe all cath labs tend to benefit from improved workflow, connectivity, collaboration, and intelligence. We have had the opportunity recently to lead EPs and technology administrators to evaluate the system. The feedback was very positive, describing it as the most well-designed cath lab display technology they have seen. We expect Synchrony to contribute at least a couple of million dollars of revenue in the first year of launch, and a growing installed base will provide the foundation for an attractive software-as-a-service revenue stream from our SynX connectivity app and future AI features. 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.

Thank you, David, and good afternoon, everyone. Revenue for the third quarter of 2025 totaled $7.5 million, system revenue of $1.9 million and recurring revenue of $5.6 million compared to $4.4 million and $4.8 million in the prior year third quarter. System revenue reflects partial revenue recognition on one Genesis system and ancillary devices. Recurring revenue growth over the prior year reflects a full quarter's contribution of Map-iT catheters and initial sales of Stereotaxis' new robotically navigated devices: the MAGiC ablation catheter and the MAGiC Sweep high-density mapping catheter. Gross margin for the third quarter of 2025 was 55% of revenue. Recurring revenue gross margin was 67% and system gross margin was 19%. Gross margins remain impacted by fixed overhead allocated over low production levels. Operating expenses in the third quarter of $10.7 million included $4.1 million in noncash charges for stock compensation expense, mark-to-market adjustment for acquisition-related contingent earn-out consideration, and amortization of acquired intangible assets. Excluding these noncash charges, adjusted operating expenses in the quarter were $6.6 million, a decrease from $7.2 million in the prior year third quarter primarily due to lower general and administrative expenses. Operating loss and net loss in the third quarter of 2025 were $6.6 million and $6.5 million compared with $6.3 million and $6.2 million in the previous year. Adjusted operating loss and adjusted net loss in the quarter, excluding noncash charges, were $2.5 million and $2.4 million compared with $3.1 million and $3 million in the previous year. Negative free cash flow for the third quarter was consistent with the previous year at $4.2 million. At September 30, Stereotaxis had cash and cash equivalents of $10.5 million and no debt. Including the $4 million Stereotaxis will receive in the upcoming second closing of the registered direct financing announced in July, Stereotaxis would have had $14.5 million in cash with no debt. I will now hand the call back to David.

Thank you, Kim. As mentioned in our press release, we expect revenue this quarter to exceed $9 million with system revenue of approximately $3 million and recurring revenue greater than $6 million. This will result in over 20% annual revenue growth for the full year 2025, in line with our previous guidance of double-digit annual revenue growth. While we are not yet providing formal guidance for next year, we want to offer directional color to help with modeling. We expect sustained growth of both systems and recurring revenue through 2026, with system revenue benefiting from our existing Genesis backlogs and the launch of GenesisX, and recurring revenue continuing to ramp with increased adoption of MAGiC, MAGiC Sweep, and Map-iT catheters. We expect quarterly revenue to surpass an average of $10 million per quarter in 2026. We continue to advance technologically and commercially while remaining prudent with expenses. We see significant leverage in our business with increased revenue. We expect to enter 2026 with a healthy balance sheet that allows us to advance our new technologies to market and launch them with a balanced focus on accelerating growth while also ensuring improved margins, earnings accretion, and achievement of profitability. We will now take your questions. Operator, can you please open the line to Q&A?

And we will now take our first question from Josh Jennings from TD Cowen.

Congratulations on the GenesisX approval. I was hoping to ask about GenesisX a couple of questions. I guess, first, just maybe an update on the sales pipeline for GenesisX mostly in Europe now with approval in the U.S., but can you talk about any pent-up demand in the U.S. and just how we should be thinking about the mix of orders going forward? I think you talked about GenesisX outpacing them, but should we think about more GenesisX placements next year? Or will there still be a healthy amount of Genesis placements in centers, old customer accounts that are replacing their Niobe systems?

Josh, thanks for the good questions. I’d look at GenesisX as additive to Genesis. As you see just in the last quarter, even with GenesisX being approved in Europe, we continue to see demand for Genesis from sites that have been engaged with us for longer periods of time in the process that are either replacing existing labs or like the two hospitals that are establishing new robotic programs. They’re building new wins to the hospital, new areas and the construction process then isn’t that much of a factor for them. And so we continue to see demand for Genesis that has generally been at a pace of approximately one to two systems a quarter. I think that’s going to continue for the foreseeable period, both in the U.S. and Europe. GenesisX is really additive to that by offering access to robotics to many physicians that otherwise would have wanted it but just couldn’t advance through the process because of the challenges logistically at the hospital level. We have been engaging with multiple hospitals in Europe over this past year. We’ve done a little bit of work in the U.S. with a few hospitals, and so we have to start to have a pipeline of physicians and hospitals that are interested in engaging with us. We have historically only sold our robot and we will also be opening up the model to leases and placements with significant disposable commitments. Our goal is to make sure that manufacturing is in place to demonstrate that the system is working reliably in the real world and in regular clinical use, then to be able to start a full launch. We expect that once we start a full launch, the rate of orders for GenesisX and sales of GenesisX is going to be meaningfully higher than what it's been to date with Genesis.

I appreciate that, David. And then just a reminder, is GenesisX going to be sold at a price point that’s similar to Genesis or at a premium? And then, just as you think about or as we think about the high-level color you provided for 2026 and quarterly revenues averaging at $10 million-plus range, within that, are you assuming that GenesisX systems are sold to non-EP accounts or neurovascular, endovascular centers in 2026? Or maybe just help us think about when that could kick in?

Sure. So GenesisX is a new technology. It’s a premium system. We expect the system to save a hospital materially on their expenses, and we are pricing the system at a premium to Genesis. It’s in the same ballpark but at a premium price to Genesis. And so we’re comfortable with that decision. And we believe the market is accepting of that as a reasonable appropriate price. Regarding the non-EP applications, we do expect to have at least one or two non-EP centers next year that will start using the robot in non-EP procedures. We still do not have approval for guide catheter or guidewire. and so that is still in the regulatory process. As those come to market, I would expect the majority of their use to be in existing robotic accounts where every EP department is part of an interventional cardiology department, making it easy for interventional cardiologists to start using the robot and experimenting with it in a range of other procedures. However, we do believe that there will be a few sites that do not currently have the robot where non-EP applications are the driver of adoption.

Your next question comes from the line of Adam Maeder from Piper Sandler.

I actually wanted to piggyback off of Josh’s line of questioning. Starting on the approval in the U.S., are you able to put a finer point on when we should expect that to kind of move to full launch? It certainly sounds like you’re working through supply chain a little bit. Understand you’re waiting on the MAGiC RF approval in the U.S. I don't know if you can give a timeline update there as well. Just trying to think about when we move from the limited launch phase to full steam ahead.

Sure. The two things you mentioned, getting the MAGiC approval in the U.S. and ramping our manufacturing are the major factors in transitioning from a limited launch to a full launch. In terms of MAGiC in the U.S., I gave some color on the prepared remarks about our interactions with the FDA. I believe those interactions are going well. Things like the recent permit shutdown have some impacts on FDA activity, but they don’t seem to have any major impact on the review of MAGiC, which is funded as a PMA submission previously. I think overall, we expect MAGiC to be approved in line with what we've described previously. In terms of manufacturing, we continue to progress, and we’ve already produced the first GenesisX commercial system earlier this summer. We are ramping the manufacturing and the supply chain overall well, and that progress continues. I’d expect probably a transition to a full launch of GenesisX sometime in the early parts of next year, at the latest during the ERA and HRS conferences in the spring, which would seem like a natural time to do so.

That’s really helpful color, David. And the second question is around the early commentary for 2026. I was hoping you could give us just a little bit more color in terms of how you're thinking about the revenue mix. You talked about the average of $10 million per quarter, but how that kind of bifurcates between system revenue and consumable revenue?

Sure. The split between systems and disposables can be somewhat lumpy. This quarter, we are at the lower end of the $2 million to $3 million range for system revenue. I expect we will be at the high end of that range next quarter. There’s a lumpiness to the distribution between system and recurring revenue in any given quarter. Generally, if you're modeling this year’s system revenue at about $10 million and recurring revenue in the low to mid $20 million range, we expect the recurring revenue to scale relatively linearly as we get the catheters further approved and launched in each geography. Systems will fluctuate but generally, you should expect numbers clearly in the teens or high teens in system revenue amount. So that probably places system revenue somewhere between 30% to 50% of overall revenue.

Our next question comes from the line of Frank Takkinen from Lake Street Capital Markets.

Congrats on the GenesisX approval. Could you talk about the MAGiC FDA interactions? Can you share some of the questions that the FDA had for your Q3 response? Any significant areas outstanding that they still need to review?

Sure. The FDA's questions from the comprehensive review involved many modules included in the PMA submission, including preclinical testing, clinical data, biocompatibility, sterility information, packaging, labeling, and various technical testing of the device. Their questions stemmed from a detailed analysis of the comprehensive submission data. We responded comprehensively, and we felt good about our response. There was nothing particularly troublesome in their questions, and we maintain regular dialogue with the FDA. It's a significant submission, and while we haven't received anything in writing yet, we feel good overall having received the response and believe things are continuing to progress as we would want.

That’s helpful. What about guidance for Q4?

We originally anticipated something like $7 million in revenue in the disposables and service line for Q4, but now we’re estimating that at $6 million. The change is due to the timing of approvals, which have affected our ramp from the catheters. That said, we’re pleased with the adoption pace, especially for MAGiC Sweep. Guidance feels appropriate at this time.

Our next question comes from the line of Kyle Bauser from ROTH Capital Partners.

This is Kevin on for Kyle. Congrats on the GenesisX. What’s your outlook for head count in the commercial organization expanding over the next 12 to 24 months?

Thanks for the question, Kevin. We’ve previously stated that we have a commercial team of approximately 40 people globally, with about 20 in the U.S., 15 in Europe, and a smaller team in Asia. We expect meaningful growth in the clinical team over the coming one to two years as we scale catheter revenue. We’re shifting more toward a model where we can have a one-to-one relationship between clinical reps and hospitals, which is something we've traditionally managed with multiple reps per hospital. Having catheter revenue allows us to sustainably and attractively grow our clinical team to drive greater utilization. The clinical team will be the largest source of growth for us going forward. On the capital side, we’ve maintained a lean model, but we’ll start to invest incrementally in dedicated capital reps as we ramp up system sales with GenesisX.

That’s very helpful. What about long term with the disposables business? Are there opportunities you’re looking at to build out this portfolio?

There’s a lot of thought and energy being put into the disposables side. Most businesses generate a significant portion of their revenue from catheters, and the higher-margin aspect is indeed crucial. Our robot has unique capabilities that allow physicians to perform tasks that were previously impossible. A robot is only as effective as the catheters associated with it; a standalone robot has limited value. Our catheter R&D and manufacturing expertise allow for innovative explorations that we hadn’t previously been able to pursue. The overall portfolio will comprise three main areas – the MAGiC family of robotically steered catheters for cardiac ablation, interventional devices for endovascular magnetic interventions, and our Map-iT manual diagnostic EP catheters. There’s ongoing innovation planned across these categories, and we have a pipeline of additional projects that haven’t yet been disclosed.

There are no further questions. I will now turn the call back to Mr. Fischel for closing remarks.

Okay. Thank you for all the questions. We’ll work hard on your behalf to finish the year strong and to set things up for a very successful 2026. Thank you very much.

The meeting has now concluded. Thank you all for joining. You may now disconnect.