STXS - AMEX

Good afternoon. Thank you for joining us for Stereotaxis' Second 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. [Operator Instructions] As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to your host, Mr. David Fischel, Chairman and CEO of Stereotaxis.

Thank you, operator, and good afternoon, everyone. We've described this year as a pivotal milestone-rich year in which we advance a broad portfolio of strategic innovations to market and demonstrate their initial commercial impact. We are diligently executing on multiple fronts, and I'm pleased with our results. From both a regulatory and commercial perspective, our results are in line with the guidance provided at the start of this year. I'll keep our prepared remarks brief, providing updates on our key innovation and commercial efforts. As a reminder, our innovation strategy rests on 4 primary pillars. First, making our robot widely available by innovating it such that it doesn't require construction and can be rapidly installed in the majority of labs. Second, building an ecosystem of catheters and integrations in our core EP ablation market, so physicians have greater choice in technologies while we reduce our dependencies and build an attractive razor blade business. Third, developing the right interventional devices so that our robots become a platform for endovascular surgery more broadly, providing value in several new clinical indications. And fourth, establishing a digital backbone that introduces connectivity and AI to our robot and the broader cath lab environment. GenesisX is the key technological innovation, enabling robotics to be more broadly accessible. We received CE Mark in Europe and have been working through the regulatory process for FDA clearance in the U.S. On our last call, we described having addressed the vast majority of FDA's questions and that we received additional questions on a few final topics. We addressed these topics in a submission to the FDA late in the second quarter and view regulatory approval of GenesisX as likely still this summer. Concurrent with the regulatory effort, we are 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 successfully completed transfer to manufacturing of GenesisX in the second quarter, manufacturing the first commercial GenesisX system. That system is expected to be installed at our first customer in Europe as soon as they complete installation of X-ray in their lab as they are placing GenesisX in a newly built cath lab. We expect to demonstrate GenesisX working in daily clinical use in 1 or 2 hospitals still this year, upon which we should be ready for full launch in Europe and the U.S. We continue to see steady demand for Genesis, but expect GenesisX orders to outpace the tempo of Genesis orders following full launch. Our effort to build an ecosystem of proprietary EP catheters in our core EP ablation market has seen 2 significant regulatory milestones so far this year. CE Mark of the MAGiC ablation catheter during the first quarter and FDA clearance of the MAGiC Sweep high-density mapping catheter just a couple of weeks ago. We have talked about the importance and impact of MAGiC on previous calls. In line with our guidance, MAGiC contributed approximately a couple of hundred thousand dollars in revenue from initial European customers during the second quarter. Initial procedures have now taken place at approximately 30% of our EU accounts and administrative efforts at others are ongoing. We continue to work on an FDA approval for MAGiC and maintain a continuous dialogue with FDA. FDA received formal clinical results from our ongoing MAGiC study in the second quarter, and we are working with FDA through a body of questions on sterility, biocompatibility and manufacturing practices. We continue to expect U.S. regulatory approval of MAGiC later this year. U.S. regulatory clearance of MAGiC Sweep was a major milestone for Stereotaxis. We discussed on our previous call, the impact of high-density mapping on the EP field and why a robotic HD mapping catheter is a significant opportunity to positively impact physicians' clinical results and workflow, the relevance of robotics in EP and our commercial results. Prominent KOLs were quoted in the press release announcing Sweep's clearance, describing the importance of the catheter and how the lack of a mapping catheter has held back overall adoption of robotics. MAGiC Sweep promises rapid and detailed electroanatomical mapping with the precision and inherent safety of our technology, the ability to map otherwise difficult to reach areas of the heart and more anatomically accurate maps by avoiding distension caused by rigid catheters. There are many EPs who think similar to those KOLs and are excited to use the catheter. We're already working through hospital administrative processes at several hospitals that will be the first users of the catheter and expect usage at multiple accounts this quarter. We expect the combination of MAGiC and MAGiC Sweep to increase our disposable revenue per procedure significantly and expand our user base and robotic utilization. Stepping back, FDA clearance of MAGiC Sweep is reflective of a major strategic transformation underway. It's the first FDA clearance Stereotaxis has received for a catheter in nearly 20 years. It demonstrates the foresight of our strategy to bring catheter development and manufacturing expertise in-house with the acquisition of APT last year. It's a tangible reflection of our progress building a robust ecosystem of robotically navigated interventional devices, a strategy that provides a much more attractive technological and commercial foundation for growth. It is even more exciting that this is just one of several proprietary catheters we are advancing to market across key geographies this year. In addition to MAGiC and MAGiC Sweep, we've developed a portfolio of catheters and wires that enable our robot to provide value in several new clinical indications. We submitted the Imagine catheter for regulatory approval earlier this year and continue to expect clearance this quarter. Following clearance, we look forward to beginning the process of demonstrating that our robot can serve as a broad platform for endovascular surgery. We have initial physician interest in working with us to pioneer use across several neurointerventional, interventional cardiology and interventional radiology procedures. We expect that following regulatory clearance, we'll have several quarters of clinical updates demonstrating initial use and clinical value in these procedures. This transition of Stereotaxis from a single application robot to a platform endovascular robot is a significant driver of strategic value and ultimately increases our total addressable market multiple fold. The final significant innovation effort nearing regulatory milestones is our digital surgery platform that enables operating room connectivity and smart AI capabilities in the cath lab. Synchrony and SynX digitize the various disparate systems in the cath lab, allow for seamless control of all those systems from a consolidated cockpit, offer modern cloud-based connectivity between the lab and the external world and provide attractive opportunities for smart AI features to be integrated into the operating room. The technology has been designed for use with our robot, but also as a very attractive independent offering across non-robotic cath labs. We have completed all regulatory testing for Synchrony and expect to submit it for FDA clearance and declare CE Mark in Europe very shortly. During the recently completed second quarter, we began limited commercialization of just the first technologies in this comprehensive innovation strategy. Our results in the quarter benefited from revenue recognition on the first GenesisX system and initial MAGiC sales in Europe. These launches will accelerate and as we achieve additional regulatory milestones, we will benefit from the layering of additional growth tailwinds. While these innovations are modestly contributing to system and recurring revenue in 2025, they set us up for breakout growth as we look towards 2026. Kim will now provide additional 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 second quarter of 2025 totaled $8.8 million, growth of 95% from $4.5 million in the prior year second quarter and growth of 18% sequentially compared to $7.5 million in the first quarter of 2025. System revenue for the second quarter was $3 million, and recurring revenue was $5.8 million compared to $0.2 million and $4.3 million in the prior year second quarter. System revenue in the quarter reflects revenue recognition on a Genesis system and our first GenesisX system. Recurring revenue growth reflects the contribution of Map-iT catheters from last year's acquisition of APT as well as initial sales of our robotically navigated MAGiC ablation catheter. Gross margin for the second quarter 2025 was 52% of revenue. Recurring revenue gross margin was 68% and system gross margin was 22%. Gross margins remain impacted by acquisition-related accounting that temporarily reduces disposable margin and by fixed overhead allocated over low system production levels. Operating expenses in the quarter of $8.6 million included $2.6 million in non-cash charges for stock compensation expense, a favorable mark-to-market adjustment for acquisition-related contingent earn-out consideration and amortization of acquired intangible assets. Excluding these non-cash charges, adjusted operating expenses were $6 million compared to the prior year adjusted operating expenses of $6.8 million. Approximately half of the decline in adjusted operating expenses is from the receipt of an employee retention tax credit for the 2020 tax year, with the remaining decline due to natural reductions in R&D spending with the completion of certain larger projects. Operating loss and net loss in the second quarter of 2025 were $4 million and $3.8 million compared with $6 million and $5.8 million in the previous year. Adjusted operating loss and adjusted net loss for the quarter, excluding non-cash charges, were $1.4 million and $1.3 million compared with $3.5 million and $3.3 million in the previous year. Negative free cash flow for the second quarter was $3.7 million compared to $3.1 million in the previous year. At June 30, Stereotaxis had cash and cash equivalents of $7 million and no debt. Subsequent to the end of the quarter, in July, Stereotaxis announced a registered direct financing for the sale of $12.5 million of its shares of common stock to a strategic industry partner and select institutional investors. A first closing of $8.5 million was completed in July with the remaining $4 million to be completed in a second closing within 4 months. Incorporating the net proceeds from this offering, Stereotaxis would have $18.8 million in cash and no debt. I will now hand the call back to David.

Thank you, Kim. As mentioned in our press release, we are reiterating our revenue guidance of double-digit revenue growth for the full year 2025 with system revenue in any given quarter fluctuating between approximately $2 million to $3 million and recurring revenue scaling to approximately $7 million in the fourth quarter. Our revenue expectations assume only modest contribution from GenesisX and no system revenue from China. We have demonstrated the ability to launch new technologies while maintaining stable operating expenses. Our recently completed equity financing offers us a stronger balance sheet with which to accelerate adoption of our comprehensive innovation strategy as the puzzle pieces come together, and we are preparing for a full launch. We expect to launch our new technologies 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?

[Operator Instructions] And your first question comes from the line of Adam Maeder with Piper Sandler.

Congrats on all the progress. Great to see. David, maybe we can start on kind of your closing remarks there and a little bit of discussion around the financing and kind of how you're thinking about use of proceeds. The portfolio has obviously transformed a lot here over the past 12, 18 months and kind of a complete refresh. And so will you -- I think you've run pretty lean from a commercial standpoint historically. Will you start to build up the sales force to push more aggressively? Maybe just talk about the commercial strategy there with the new products in hand. And if you could provide some kind of headcount figures, too, that would be appreciated.

Sure. Thanks a lot, Adam, for the questions. So it's a great question. We -- obviously -- this is the year in which we are getting regulatory approvals and starting the initial launches of many technologies as described in the prepared remarks, both capital systems and then several catheters in the EP space and outside of EP. And so that is kind of exciting for our sales team and for us as a company. We have a good existing commercial team direct in both the U.S., Europe and even have direct sales members in Asia. In total, the commercial team numbers about 40 people, of which about 20 are in the U.S., 15 are in Europe and 5 are in Asia, that spans clinical support and capital sales and sales management and training. So it's kind of a broader commercial team with the predominant focus on the clinical side. We have demonstrated, I believe you've seen pretty nicely that both with the Map-iT catheters since the acquisition of APT a year ago and more recently with the MAGiC catheters, and we're seeing already the start of activity with MAGiC Sweep very quickly after the regulatory approval that our team has the ability to do much more than what historically they were doing. And in some ways, it's not just adding additional work to them, it makes their work much more successful and it contributes to the success of their work. So I think there's a lot of synergy to the product portfolio and the way it's coming together in allowing each of the team members to actually be much more successful than what they've been historically. It's very synergistic all of these product approvals and the addition of them to their back. With that said, I know that we have a relatively lean team, and we could increase our team significantly. And so there's going to be a balanced approach between -- on the one hand, during the initial launch stage, our existing team is fantastic and able to do everything with the products that are gaining approval and starting to launch. As we start to see traction at individual accounts, we definitely plan to shift gradually to the model of having 1 clinical rep per hospital rather than our current model where we have about 1 clinical rep for every 3 or 4 hospitals. That will allow us to go much deeper in terms of utilization and provide much better support and the revenue model with our own proprietary catheters allows that model to be very attractive and sustainable. And so that's definitely a model that we're going to be implementing both in Europe and the U.S. as we gain the regulatory approvals. I think we can do that in an accretive way, so we can build up the sales force while the adoption of these new catheters is growing, and that all can happen accretively, but we will be reinvesting a lot of the incremental gross profit and operating profit from these catheters back into the sales team for that growth. On the capital side, we have a very lean team. They've been able to continue a relatively steady tempo of Genesis orders and sales, but as we have GenesisX transitioning to a full launch later this year, we'd probably invest a couple of million dollars in a more robust dedicated capital team, both in Europe and the U.S., and that should allow us to see capital sales next year growing very significantly. And so that's kind of our -- that's our overall high-level plan. I hope that gave you enough color to help you.

That was fantastic, David. And for the follow-up, I'll ask about Europe and the catheter business. And a 2 part question. I guess, first, you talked a little bit about the progress that MAGiC RF is making in Europe in terms of account penetration. Could you just maybe double-click on how your customers are using the MAGiC RF catheter? Is it still largely SVT, VT? Are they doing kind of broader, more simple cases as well? And then just quickly, Genesis Sweep, (sic) [ MAGiC Sweep ] the mapping catheter, just OUS time lines there, and I'll drop back in the queue.

Sure. Thanks. So yes, MAGiC in Europe, we talked about approximately 30% of our European accounts have now started to use MAGiC in procedures. That's up from about 20% when we talked last quarter. And we see kind of steady -- it's amazing the administrative burdens in various countries in Europe and how just getting through tenders and getting on contract in certain countries and certain hospitals just takes -- it's kind of an administrative grind, but we're working on many of those in tandem. So kind of I see that percentage very naturally increasing month-by-month. We see usage of MAGiC so far across the full breadth of procedures. So you're correct that predominantly, our robot has been used and is being used to treat more complex arrhythmias, VTs, PVCs, congenital patients. But we've seen MAGiC being used already in AF, in AVNRTs, AVRTs, flutters. So really kind of across the spectrum from the simpler cases to the most complex. And so that's kind of obviously been nice to see that usage and to see the value that the catheter can provide across a broader spectrum of procedures. In Europe, we have a very broad label for ablation in all 4 chambers of the heart. And so that obviously supports kind of a broad utilization across the spectrum. We're still in the earlier stages of this launch, right? The second quarter was our first real quarter of sales and revenue. And so I kind of -- I don't have any statistics yet on how MAGiC will grow utilization at individual accounts. But obviously, as we kind of -- as we penetrate further in these accounts and go kind of more broadly across all of the accounts in Europe, I do expect MAGiC to have a positive halo effect on overall utilization. If we step back to your second question was related to, I remember MAGiC Sweep, European regulatory time line, and there was something else that I'm now missing. But on the Europe MAGiC Sweep, we've talked about still getting clearance in Europe this quarter. That's our expectation. But it obviously depends on the notified body. And so as we know more, we will share more.

And your next question comes from the line of Frank Takkinen with Lake Street Capital Markets.

Congrats on all the progress in the nice quarter. I was hoping to start with some additional color on MAGiC FDA interactions. I appreciate the update you provided today, but maybe help us understand kind of the -- how long some of these interactions could take with the FDA, when those could be submitted and then the time line from when those are submitted, answered and then hearing back, just bridging us from kind of where we are today to that second half approval.

Okay. Sure. So we -- FDA does professional diligent work in its reviews. We see that across all of our submissions. They're very much active and kind of fulfill their professional mandate in reviewing submissions. We have been working with FDA very collaboratively in a lot of back and forth on the many topics that are part of the PMA submission and PMA approval process. I mentioned in the prepared remarks that we are predominantly working through a body of questions on sterility, biocompatibility and GMP, good manufacturing practices. And so that's where most of the effort is. We submitted clinical data from the ongoing trial in Europe in the second quarter. And so overall, kind of there is a regular tempo of interaction between FDA and us. We feel given that tempo and given the type of commentary from the ongoing discussions that approval in the second half of this year still makes a lot of sense. I think FDA is also aware of that and of the importance of this catheter to U.S. patients and U.S. physicians who benefit from robotics. And so we're just grinding through the process and have appreciated the collaborative nature of FDA in this process.

Got it. That's helpful. And then maybe just sizing up Sweep in the U.S. a little bit more. Happy to hear that's off to a strong start, but maybe talk about kind of what that can contribute per procedure, what -- how many of your current cases today may use the catheter and then just kind of extrapolating that into how much revenue that could contribute?

Sure. So high-density mapping catheters are typically priced north of $2,000 per procedure. And so you should expect kind of similar numbers for us. I'd say that high-density mapping is probably used in the majority and the majority probably means somewhere in the 70% or so, perhaps a little bit more than that percent of the procedures that we see on our robots. So it's not every procedure, but it's a significant number of them. I think that kind of one of the big benefits of MAGiC Sweep, though, is not just having it used in our existing procedures, but this is really -- if you think about our existing utilization and our core business, it has been -- it's predicated on still a catheter that is by now 20 years old with no catheter innovation for these physician users for many, many years, essentially since they started using us. And so this is a significant opportunity, I think, to have them rethink how they do workflow and to kind of -- to have other benefits from the robot beyond what they've historically experienced. And so I think this is a real opportunity also to grow utilization to engage with physicians at existing sites that perhaps historically weren't using our robot as much. And so I think that there's going to be a broader benefit beyond just the step-up in revenue per procedure.

I'm not showing any further questions in the queue. I would now like to turn it back to David for closing remarks.

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