Good afternoon. Thank you for joining us to Stereotaxis' first quarter 2026 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.
Thank you, operator. Good afternoon, everyone. Stereotaxis has had an amazing start to this year. While our reported quarterly numbers don't yet reflect it, we're going through one of the most exciting periods in Stereotaxis' history, given the amount of progress, the initial commercial green shoots of success, and the clarity on the opportunity ahead of us. These give us confidence in our overall vision, reaching a new level of maturity in our near-term and long-term growth. In my prepared remarks, I'll touch upon the key areas of progress, the commercial green shoots, and the opportunities ahead of us. Kim will then review our first quarter results, and we will open the line to questions. The most notable achievement of the past year has been a string of regulatory approvals in the U.S. and Europe for an entirely new foundational ecosystem of products.
While Stereotaxis has a long history, our clinical and commercial experience is nearly all with first generation technology from 20 years ago. After spending the past 8 years and over $75 million rebuilding an R&D pipeline, we brought to market an entirely new foundation of products. In just the past few months, we received 4 U.S. FDA regulatory approvals for a complex surgical robot, robotically steered therapeutic and diagnostic catheters, and a digital surgery cockpit. Outside of the U.S., we received multiple approvals in Europe and China. These product approvals are not just incremental innovations, but rather we structurally change our opportunity. We essentially developed a fresh new startup company on the shoulders of our legacy technology and funded by our legacy business. The streak of regulatory success that began last year continued in the first part of this year with 2 essential FDA approvals.
First, in January, we received PMA approval for the MAGiC cardiac ablation catheter. Just last month, we received FDA clearance for Synchrony, our digital surgery cockpit that introduces connectivity and intelligence to the operating room. MAGiC is Stereotaxis' first proprietary therapeutic catheter and is the first ablation catheter ever to be approved by FDA specifically for arrhythmia patients with complex congenital heart disease. The catheter strategically allows us to overcome our historical dependency on Johnson & Johnson and to participate robustly in the recurring revenue of each procedure. Following regulatory approval, we recently announced that we began first MAGiC procedures at multiple U.S. hospitals. Those procedures have gone well. The first patient treated with the catheter had complex congenital heart disease, was being cardioverted weekly, failed multiple attempts to be treated with manual catheters, and was now successfully treated using MAGiC.
The most beautiful example for why our innovations are critical and improve lives. The physician who did that procedure later commented, and I quote, "That was the most gratifying case I've ever done. I could have never done this without robotics." Demand for MAGiC is much higher than supply, and we are rolling out the catheter in both Europe and the U.S. in line with the manufacturing ramp. While the ramp is gradual, we're seeing meaningful progress, and our contract manufacturer still expects production to top 500 catheters a month by the end of this year. In addition, to mitigate catheter shortages, we began selling an additional catheter in Europe that we have exclusive rights to through our collaboration with MicroPort, and we are making meaningful progress on other efforts that expand production capacity and redundancy.
For now, the still small contribution from our new catheters is being countered by the headwind of winding down our relationship with Johnson & Johnson. This transition is messy and makes it difficult in reported quarterly financials to observe the underlying ramp of our new disposable business. The green shoots of this new business model are very evident to us, though, and are very attractive. In our initial U.S. MAGiC procedures, we are seeing disposable revenue often above $8,000 per procedure and always above $5,000. This robust razor blade business model benefits from our strategy to build a synergistic portfolio of catheters including MAGiC Sweep, and Map-iT. In Europe, just this month, we received an order for $100,000 in disposables from a single hospital for what it expects to be a month worth of procedures.
These amounts are in line with the EP market but are unprecedented for us. They demonstrate the transformation that is just starting to take shape in our business model. Still at low numbers, but increasingly very material as we advance through this year and transition our installed base of robotic accounts over to this new ecosystem. By the end of this year, we expect to have substantially transitioned customers as they use up remaining inventory of J&J catheters, work through hospital approvals and tender processes, and gain experience with MAGiC. The structural transformation to our disposable business model is taking place as we simultaneously structurally transform our capital business. This is happening primarily through the launch of GenesisX, the new robotic system that we received FDA clearance for at the end of last year, and which doesn't require construction to be installed in existing cath labs.
We have a healthy pipeline of physicians and hospitals that are working towards orders for GenesisX and who are prepared to be the first to demonstrate it installed rapidly in existing labs while working compatible with non-modified X-rays from major X-ray manufacturers. Compatibility testing and commercial agreements are advancing in tandem. We continue to expect to establish at least five active GenesisX programs over the course of this year. These initial adopters and their demonstrations of the technology's accessibility, interoperability, and performance will be very beneficial in expanding adoption. The second significant change to our capital business is the start of a synergistic but independent capital opportunity with Synchrony and SynX. As a reminder, Synchrony and SynX are our digital solutions that modernize the interventional surgical suite with enhanced workflow, remote connectivity, and smart AI capabilities. Just last month, we received FDA clearance for Synchrony.
We have already received orders for multiple systems and have shipped the first systems to customers. We're very confident in our guidance of $3 million in revenue from Synchrony this year. The initial commercial green shoots from our new product portfolio are exciting. The operational and commercial friction to ramp manufacturing and implement new products makes progress gradual. Everything is moving in the right direction, and we are efficiently driving broad-based progress on many fronts in parallel. We're doing this while weaning ourselves away from the dependencies and challenges of our legacy business. It's a tough transition. We are building a very attractive business on solid foundations. What is particularly exciting for me is that we aren't resting on our laurels.
While the benefits of this first wave of innovation start to become operational and commercial reality, we are energetically planting the seeds for significant opportunities that will blossom over the next few years. Our vision for what Stereotaxis can and will accomplish is becoming increasingly clear and tangible. That vision can be summarized as follows. Our core mission is to pioneer robotics across endovascular surgery. That means building fantastic robots that enable what is otherwise impossible, improving patient outcomes and physician experiences. It means these robots should be fully mobile, unobtrusive, interoperable, and accessible. It means robots that can do the full range of activity necessary across the breadth of endovascular procedures, EP, neuro, cardiac, and peripheral, with a matching portfolio of advanced interventional devices.
It means embedding these robots with the digital innovation, such that they not only mechanically manipulate devices, but add intelligence, connectivity, and automation to make procedures smarter, better, and quicker. This isn't an idle vision. We established a solid foundation for it with our initial portfolio of products. We've also been advancing in the background multiple efforts to realize the full vision. A few examples. First, at the European Heart Rhythm Association conference last month, we showed off a future generation of the GenesisX robot that is fully wireless, battery-operated, and mobile. We've invested in this project for a few years, and it is moving along well. In the future, all our robotic platforms will be fully mobile and wireless. Second, we are busy at work with 2 significant AI efforts.
One for decision support AI features incorporated into Synchrony to help physicians intraoperatively benefit from the wisdom of thousands of procedures. The second, a rehaul of our automated navigation software, so a physician simply designs a procedure and the robot executes it. A specific project here is with a larger industry partner who sees the opportunity for automation to offer the most efficient and yet personalized patient-specific therapy. Finally, and most significantly and transformationally, we announced the acquisition of Robocath last month. Which as mentioned at the time, gives Stereotaxis a fully complementary and separate robotic mechanism of action for endovascular device navigation. The combination of our technologies offers a clear vision for how our robotic solution, including the full ecosystem of digital innovations, will enable remote, automated, and fully robotic treatment of stroke and cardiovascular disease. The puzzle pieces have come together in a remarkable fashion.
We are fully focused on executing the key operational and commercial activities to reap the rewards from our recent regulatory approvals, grow revenue, and reach breakeven. We're simultaneously busy at work through the acquisition of Robocath, other business development activities, and in-house R&D on a robust innovation effort across robotics, interventional devices, AI, and automation. The goals, direction of the paths, and stepping stones of progress along the path have become increasingly clear to us. We are energetically and enthusiastically advancing forward. Kim will now provide commentary on our financial results, and then I'll make a few financial comments as well before opening the call to Q&A. Kim?
Thank you, David, and good afternoon, everyone. Revenue for the first quarter of 2026 totaled $6.3 million, compared to $7.5 million in the prior year first quarter. System revenue of $1.3 million and recurring revenue of $5 million, compared to $2 million and $5.5 million in the prior year first quarter. System revenue in the current quarter reflects revenue recognition on the installation of one Genesis system and partial revenue recognition of other ancillary systems. Recurring revenue in the quarter was pressured by the transition from the Johnson & Johnson ecosystem. Gross margin for the first quarter of 2026 was 60% of revenue. Recurring revenue gross margin was 66%, and system gross margin was 39%.
Operating expenses in the quarter of $9.8 million included $3.1 million in non-cash charges for stock compensation expense, mark-to-market adjustment for acquisition-related contingent earn-out consideration, and amortization of acquired intangibles. Excluding these non-cash charges, adjusted operating expenses were $6.7 million, similar to the prior year adjusted operating expenses of $6.8 million. Operating loss and net loss in the first quarter of 2026 were $6 million and $5.9 million, compared with $5.9 million and $5.8 million in the previous year. Adjusted operating loss and adjusted net loss for the quarter, excluding non-cash charges, were $2.9 million and $2.8 million, compared with $2.7 million and $2.6 million in the previous year.
Negative free cash flow for the first quarter was $3.5 million, compared to $1.8 million in the previous year. At March 31st, Stereotaxis had cash and cash equivalents of $14.6 million and no debt. I will now hand the call back to David.
Thank you, Kim. I want to conclude by emphasizing that while not yet reflected in our quarterly financial results, the commercial green shoots I mentioned previously have begun. Over the coming months, the positive impact will grow in momentum and overshadow the pressures on our legacy business. We are reiterating our revenue guidance for the year of double-digit revenue growth, with annual revenue expected to surpass $40 million. Revenue will ramp up sequentially each quarter, and we expect both the third and fourth quarters of this year to have revenue of above $10 million a quarter. From a financial perspective, we're confident that we can advance our strategy, integrate Robocath, and grow significantly without subjecting investors to substantial dilution. Operating losses will be reduced as we grow recurring revenue, with the majority of recurring revenue dropping to the bottom line.
We have opportunistically taken advantage of the ATM at prices significantly higher than our current valuation, with overall minimal dilution, strengthening our balance sheet and bridging us through the acquisition of Robocath and time needed to build momentum with recurring revenue. We have invested significantly in inventory that supports meaningful GenesisX and Synchrony revenue and maintain a clean balance sheet. We continue to pursue strategic opportunities for non-dilutive, non-debt financing. It is a delicate balancing act and there is much being done in parallel, but we feel comfortable with our balance sheet allowing us to advance our innovation strategy to market, fund a commercial ramp, and achieve profitability. We'll now take your questions. Operator, can you please open the line to Q&A?
Thank you. Yes, we will now begin the question and answer session. Your question from the line of Danny Strauger with Citizens. Your line is now open. Please go ahead.
Yeah, great. Thanks for taking the questions. Just for my first one on catheters. You mentioned some initial green shoots, and I know it's still early days, but for your customers that have started to use the MAGiC portfolio, I know you commented you're seeing revenue per procedure above $5,000, sometimes around $8,000, which is great to hear. I was just curious if you could give us more color here, specifically in terms of how sticky utilization has been for new users of MAGiC. Are you seeing a pretty immediate uptick following adoption? Does it take time to ramp? Any more commentary would be great. Thank you.
Sure. Hi, Danny. Good afternoon. So MAGiC adoption is right now still limited by production capacity. We have sites that would like to transition 100% over, we have sites that have tried it and still have J&J catheters and are kind of, you know, for a period would like to use both and gradually transition. We have sites that have stayed only with J&J at this point, but know that they have to transition over the coming months. Really kind of, all of our sites fall into one of those three buckets. Right now we're still capacity constrained, that is the main barrier. There will be sites where as manufacturing continues to ramp, and it is getting better as the weeks go on.
As manufacturing continues to ramp, there will be sites that will just, you know, they've completely shifted over and every procedure they do will be with MAGiC Sweep and Map-iT kind of, our ecosystem of catheters. There are other sites that will likely run things side by side for a period of time. There's others, like I mentioned, that kind of will stay in the J&J ecosystem as long as they can. Essentially, they all know that over the coming months, probably over the next year, they essentially have to transition, given the availability of J&J catheters. That kind of will drive a transition point.
We're working really to ground game account by account to get them over that transition, to get them comfortable and working well with MAGiC, and the whole new ecosystem and then kind of comfortable to start ordering MAGiC in a robust fashion as they've shifted over.
Okay, great. Just 1 follow-up from me on that. Just, you know, as we look at the quarter's results and your reiteration of guidance, I was hoping you'd give us a little bit more on what is assumed in reaching that $40 million plus number in terms of the timing of manufacturing improvement. I know you still called out the 500 monthly catheter metric by year-end, but, you know, have you seen a meaningful shift in catheter production yield or any notable trends since the end of March? How should we be thinking about some of these headwinds in the second quarter? Really here, just trying to get a sense of how confident you are in the continued improvement throughout the year on this front. Thank you.
Yeah, sure. If you think about the ASPs that our catheter portfolio provide, and you think that we're working towards 500 catheters a month by the end of this year, you can do kind of back-end envelope math, and you can see that the type of just disposable revenue that we would have in a quarter around the end of this year is higher than all of our recurring revenue right now. That's there is a lot of benefit to the shift in business model where you actually capture the revenue per procedure. And again, this is not with charging the hospital any more than what they're used to paying. This is really just participating in the revenue that previously we didn't participate in. That's the primary driver, obviously, to revenue.
You can start to model things where our recurring revenue by itself is reaching the near $10 million or so level as we ramp manufacturing of catheters to that level. On the systems side, this was a particularly weak quarter from a system perspective. We still have a pipeline, we still have a backlog, we still engage with accounts both on Genesis and GenesisX. I think the majority of GenesisX accounts will be in the lease plus disposable commitment category, though there are some definite opportunities for sales there, but the Genesis system is still fully a sale, that would be kind of revenue recognition up front. That's kind of the way we're looking at the opportunity as we go through this year.
Your next question comes from Adam Maeder with Piper Sandler. Your line is now open. Please go ahead.
Great. Thanks. This is Kyle on for Adam. I guess first to dig in a little more there on the disposable business. I was wondering if you could just kind of quantify the impact in the quarter for us, just to kind of try to help us, you know, understand where these impacts are in the quarter.
Sure. MAGiC and MAGiC Sweep, the MAGiC portfolio was very small in the quarter overall. I think like we mentioned in our call in March, we had very little production in January, February because they were shifting over a process in the manufacturing line to a newer process which improved the yield significantly. Essentially in January and February, the entire all production was meant for validating that shift in the process. Then we did have decent production in March, but that was most of the revenue from that production comes into April by the time it gets produced and sterilized and shipped to us, and then we can actually ship to customers and recognize revenue.
There was very little revenue recognition in the 1st quarter from MAGiC and MAGiC Sweep. The primary headwind is that Johnson & Johnson has not been supplying catheters well to accounts, there's obviously a pressure there in our accounts from that. That's kind of where the pressure on procedures from the Johnson & Johnson catheter and behavior versus the step up in revenue from shifting procedures to the MAGiC environment. That's kind of the give and take that's happening in our disposable revenue right now. The step up from the MAGiC portfolio should overshadow as we start to get meaningful numbers in the 2nd quarter, 3rd quarter. Should overshadow by far any pressures that we're seeing from Johnson & Johnson.
Okay, great. That's helpful. For my follow-up, maybe on the systems side, you know, heard some of the discussion around, you know, the pipeline and where discussions are. I was just hoping you could maybe dig in a little more, if you could just give kind of more on the qualitative measures. Just what's the early feedback? What are those discussions like? Maybe that can kinda help us understand, you know, when you expect that first order to come in for GenesisX.
Yep, sure. Maybe I'll step back a little bit and provide, again, context for why this is a structural change that we are working through that is very beneficial as you come out on the other side of it, but is more complicated than perhaps many people have appreciated till now. Historically, in our entire history, we have only sold our robot with an integrated, magnetically modified, magnetically shielded X-ray, all of our systems to date. We have built GenesisX such that it can work compatible with non-integrated X-rays.
That is a structural change that, as you implement it, provides you a much, much bigger base of accounts and labs where you can place your robot, and it makes the process of installing your robot much, much easier because you're not having to always install it concurrent with a specific unique X-ray. Implementing that, we obviously did receive our first order for Genesis X last year. We shipped the system. The system is awaiting installation at an account. That was done according to the historical model, which we'll still continue to do, where we sell our robots concurrent with selling magnetically shielded and integrated X-rays. That's kind of how all Genesis sales are still being done.
That's how we did the first GenesisX shipment as well. Making GenesisX such that it can work compatibly with the broad range of X-rays from the major X-ray manufacturers is a big effort. We've done a huge amount of that effort already. We're very confident in the assessments and testing that we've done to date. What we're really looking right now for the first few GenesisX systems, apart from that one that we've already sold, is proving the model that GenesisX can work compatible with any of the large X-ray manufacturers. That, to some extent, opens you up to a whole world of capital opportunity that previously was not available to us.
The first users who are going to work with us in that effort are obviously need to be physicians and hospitals who are comfortable in that type of pioneering work and in the kind of working through the uncertainty and the risk. We obviously, through all the kind of scientific testing, we can explain, and we can document why there isn't a real risk. There's always a somewhat of a risk when you're the first ones to demonstrate something. We're glad that we do have accounts that are kind of open and interested in working with us to demonstrate the robot working in this non-integrated fashion.
That's really what we're doing with these first kind of pioneering accounts that are gonna start using GenesisX and serving as some of the show places where GenesisX works in existing labs.
Your next question comes from Joshua Jennings with TD Cowen. Your line is now open. Please go ahead.
Hi. Thanks, David and Kim. Appreciate taking the question. Wanted to just ask about some of the Johnson & Johnson turbulence and just thinking about the MAGiC integration at these centers. You know, what mapping platform are electrophysiologists using today when they integrate MAGiC into ablation case. Could there be any turbulence going forward? I mean, should we be thinking that MAGiC will be used with CARTO as well as this catheter supply relationship ends with J&J?
Sure. Good afternoon, Josh. So we've been committed to the concept of open ecosystems around our robot, where you can pair the benefits of our robot with the broad range of diagnostic and therapeutic technologies out there. That has been kind of one of our commitments from the beginning to our physicians. It's the right thing for patients, for physicians, for hospitals, and overall for the progress of medicine. As part of that, we integrated with Abbott's EnSite X system, its latest mapping technology, and we're fully integrated with EnSite, and that has been the predominant mapping system that is being used with MAGiC. There are some ways to make MAGiC work also with CARTO, and we also obviously have a full integration with MicroPort's mapping system, Columbus.
That is not available in the U.S., that is available in Europe and in China obviously. There are kind of some others, in the majority of cases and definitely in the U.S. and mostly in Europe, you're seeing EnSite X being used with MAGiC, Abbott's EnSite X system.
Thanks for those details. Also at HRS, you know, in the robotics symposium, I think two topics we were impressed with. I mean, one, just some of the progress on the PFA development. If you could just share any incremental progress today. Then also, there seemed to be optimism from some electrophysiologists that are already involved in the cardiology ASCs or cardiology ambulatory procedure centers that robotics could be incorporated. Sorry for two questions in one, but maybe you could touch on both of those topics and how you see the PFA evolving with robotic, on the robotic platform and integrating in the MAGiC catheter and then also, just the opportunity in ASCs. Thanks for taking the questions.
Sure. Thanks a lot. Yeah, I'll definitely touch upon both PFA and the ASC setting. Maybe before that, just since you mentioned HRS and the Society for Cardiac Robotic Navigation symposium that happened at HRS, I mean, that was a beautiful demonstration of how the fact that we are innovating and bringing new solutions to the market does create a different level of excitement in the field. There With all of the challenges and all of the messiness to the transition, we had at HRS about, I don't know, it was a huge room and probably about 200 or so people who came. At the far end, you had to walk all the way at the end of the hallway in order to get to the room of SCRN.
Right, you had probably about 200 or so people who attended that session with fantastic talks from multiple physicians and KOL physicians. That was kind of a really nice event. I think it's reflective generally of the type of interest. We're still a small player in the EP field, but there is a renewed interest from many physicians who long had thought that robotics was an old technology and a stale technology, and are interested and kind of, starting to recognize that the technology that they remembered is not anymore how it is today, and the opportunity is there for them to actually engage with us in a much more meaningful way.
That was one of the highlights, obviously, of the last few weeks as the whole HRS conference, neuroconferences, and then specifically the SCRN session there. If we look at PFA specifically, I know I didn't include any discussions about that in the prepared remarks, not because there's anything negative, just because we're continuing as we've discussed in the March call, and we had enough other things to speak about on this call. We're still working, obviously with CardioFocus. We have the announced collaboration. We're working on the effort of getting compatibility between MAGiC and CardioFocus' generator, PFA generator approved in Europe. We've done kind of meaningful work and started actually the kind of regulatory engagement with a notified body. That's kind of clearly underway.
We also have kind of another collaboration, one of those that we've kind of not mentioned the name, but discussed over the last couple of years. That is also overall a clear opportunity for leveraging a variant of MAGiC with their generator. We continue to view that kind of as an exciting space. I think during the talks, the physician talks at the SCRN symposium, there was a few kind of where the speakers were noting how despite all of the enthusiasm for PFA, there is still various safety signals that things like stability of the catheter with the tissue are particularly important for PFA, both efficacy and safety. Our stability of the catheter is one of our hallmarks of our catheter and a great benefit there.
As you start to think about PFA in the ventricle, we have an ability to obviously get anywhere in the ventricle to stay steady on that tissue. We're probably in a very, very good position. Some of the speakers there weren't part of our animal studies, and so they, I believe, shared data from those animal studies in their presentations. On the ASC side, the ASC side is fascinating. It's obviously still a minority, right? The vast majority of cardiac ablation procedures are still done in the hospital setting. You've seen in several states that ASC starting to get set up to do cardiac ablation procedures.
There's obviously the precedent in many other areas of medical devices where ASCs have kind of become a dominant setting for procedures. We think and believe that the robot, the Stereotaxis' robot should be very well suited for the ASC, particularly because of our safety profile. That's obviously one of the biggest risks from moving from the hospital setting to the ASC setting, is that you don't have the same safety net in terms of all of the hospital resources around you. We think that our robot can provide a big benefit there. The vast majority of procedures currently being done in the ASC setting are paroxysmal AF. That's not where our robot shine.
Our robot can shine in, things like PVCs and in various other areas where stability and safety and navigation is more challenging. I very much hope, believe that one of those GenesisX installations this year will be in the ASC setting, and that will start to demonstrate also the financial and clinical merit of having a robot in the ASC setting. Again, this is small. This is something that will be a long-term, will have a long-term tailwind to it in the U.S. Definitely think there's merit to us being there early on and starting to demonstrate the value there.
Hopefully that will give us another opportunity over the next few years to grow kind of and to help the ASC setting grow as a field for cardiac ablation.
There are no further questions at this time. I will now turn the call back to David Fischel for closing remarks.
Okay. Thank you very much for your questions and for your continued support. We look forward to hosting any investors visiting our office on Thursday for our annual shareholder meeting. And we will continue working hard for your benefit and look forward to speaking again soon. Thank you very much.
This concludes today's call. Thank you for attending. You may now disconnect.