Stereotaxis, Inc. Common Stock 2026 Q2 Earnings Call

Please go ahead. Thank you, operator, and good afternoon, everyone.

On our last call, we discussed in detail the structural transformations taking place at Stereotaxis. We have just celebrated a particularly milestone-rich period with regulatory approvals for a new robot, both therapeutic and diagnostic catheters, and a digital surgery system. These products individually and collectively as a synergistic ecosystem, create an attractive foundation for us to scale commercialization with reduced barriers to adoption and a much more attractive business model. During the second quarter, Stereotaxis reached an important commercial inflection point as our expanded product offering is now generating accelerating adoption. It is still just the initial green shoots of commercial success, but the early experience and feedback provides confidence in sustained progress. I'll discuss on today's call the primary areas of commercial progress, the feedback from the field, and our efforts to accelerate growth.

I'll then share some additional updates on the robust pipeline of innovations that we continue to advance and that will drive a second wave of growth over the coming years. Kim will then share financial details for the quarter, and we'll open the line for questions. A key area of focus in the second quarter was on the launch of MAGiC in the U.S. following FDA approval in the first quarter. While supply-constrained and still just in the early adoption phase, that launch allows us to reach a multiyear high point in recurring revenue, which surpassed $6 million in the quarter, driven by over $1 million in robotic catheter revenue. Our robotic catheter revenue is scaling significantly in both the U.S. and Europe, with nearly 300% sequential growth from the first to the second quarter.

We are in the early phase of adoption of MAGiC, with about a dozen U.S. sites receiving hospital approval to purchase the catheter and beginning procedures in the second quarter. Several physicians sent me unprompted feedback as they started to use the catheter. One physician commented, quote, "MAGiC performs so much better than the old ablation catheter. Basically, you can more reliably target tissue and more effectively ablate the target tissue. It fundamentally changes the utility of the Stereotaxis system, more than doubling the value of having a robot." Another physician, upon completing his first 10 procedures, mentioned that he is, quote, "Loving it" and that the catheter is improving his efficiency significantly with a more stable and more powerful catheter delivering rapid, effective ablations. Another physician, after his first day of procedures, mentioned, quote, "Wow, this catheter navigates well. You guys have something special." This feedback is highly encouraging.

We have long known that the perception and value proposition of robotics in EP is only as good as the catheters available for use with the robot. Being tied to a decades-old catheter that did not benefit from continued innovation limited our potential. It is very satisfying to see the innovations we took from concept to commercial reality benefit critical patients with complex arrhythmias and the physicians that treat them. It gives us confidence that our efforts to reestablish Stereotaxis on a healthy foundation and trajectory are off to a good start. We are continuing to methodically work through hospital approvals and initial launches of our robotic catheters across our U.S. and European installed base. We expect the vast majority to shift from their historical dependency on Johnson & Johnson to our catheters within the next year.

While working through the commercial friction of transitioning each customer, we are putting significant effort into ramping manufacturing of catheters. Sales remain supply-constrained as we work to increase output, with catheters still on backlog as we receive more orders from customers than the supply we receive from our contract manufacturer, Osypka AG. We are seeing methodical progress in increasing supply and are separately reaching key milestones in establishing supply redundancy. These support our expectations of sustained growth in our catheter revenue stream, and we are guiding for an approximate $1 million incremental step-up in catheter revenue in each of the next couple quarters, with significantly more opportunity beyond that in 2027. Shifting now to system revenue. There are two primary items to discuss, Synchrony and GenesisX. During the second quarter, we received FDA clearance for the Synchrony system.

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. Synchrony serves as the cockpit for every robot, but also has an independent, much larger opportunity in non-robotic operating rooms. Shortly after receiving regulatory clearance, we received orders for multiple systems from several hospitals. We shipped the first few systems in the second quarter, have continued to ship systems in the third quarter, and there are already several systems in daily clinical use. They are performing well in the field, and we have a pipeline of software feature enhancements over the coming months and years that will continue to expand the value proposition. Without a significant dedicated sales effort, we are seeing organic interest that should support over $1 million in Synchrony system revenue each quarter for the next few quarters.

Most excitingly, there are several hospitals that are planning or considering standardizing their catheter labs on Synchrony and SynX. While the current contribution of Synchrony is a nice but modest boost to revenue, the market opportunity is large, and we intend to increase the sales effort as our pipeline builds and our manufacturing capacity matures. As these initial installs mature, they will also start to drive service contract and Software-as-a-Service recurring revenue streams. Most impactful to system revenue over the coming few years will be scaling the adoption of our robotic technology. Our robotic technology has significant real-world validation, with over 150,000 patients treated at over 100 leading hospitals globally. That said, we still have just a fraction of a percent market share in our beachhead market of electrophysiology and no presence yet in the larger interventional cardiology and neurointerventional fields.

There is a market opportunity for many thousands of robotic systems across these markets. Our historical need to construct robotic labs was a major barrier to ever realizing that opportunity. GenesisX allows us to start envisioning a realistic way to scale robotic adoption much more significantly. Since we received regulatory clearance for GenesisX, we have been focused on how to ensure GenesisX can be installed alongside standard X-rays from leading manufacturers, removing the historical requirement that our robot only work with a specific modified X-ray. We focused our initial commercial launch on the early adopters who will demonstrate that potential and serve as reference sites for broad compatibility with various X-rays. We are pleased that in addition to the previously announced GenesisX purchase in Europe, we are able to announce our first GenesisX purchase in the U.S. from an academic medical center.

The system is expected to be installed this fall with a non-modified X-ray from one of the larger X-ray manufacturers. With that installation, we expect to declare formal compatibility with that manufacturer's X-ray. The construction of the new wing of the hospital in Europe, where GenesisX is scheduled to be installed, also seems to be finally back on track, with installation expected prior to year-end. We are continuing to advance several additional GenesisX sale or lease agreements that will further demonstrate the system being used in a variety of lab environments. With demonstration of GenesisX working reliably and compatibly with various X-rays, along with increased availability of MAGiC, we will initiate a more aggressive commercial launch of the technology. These initial green shoots of commercial success demonstrate the opportunity to build a highly successful business with our new product ecosystem.

A proprietary catheter portfolio with its high-margin razor blade business model has been central to our strategy and is now starting to become a material contributor. Accessibility of our robotic system, such that we can reasonably scale to selling tens and then hundreds of robots a year, is critical if we are to impact medicine in the way we should, and we have now begun that journey and will demonstrate the robot's performance in daily clinical use in the near term. This progress does not come easy, and I want to recognize and congratulate the many Stereotaxis team members who make it possible. There are always hurdles and unforeseen challenges in the effort to pioneer new advanced technologies and to implement them in the complex healthcare market and demanding operating room environment.

As a lean team working on multiple significant transitions in tandem, they are demonstrating our ability to rise to the challenge. Thank you everyone who makes this possible. It is particularly exciting for me that we are driving this operational and commercial progress while not slowing down on a robust innovation effort. There is much going on in the background, and we are energetically nurturing significant opportunities that will blossom over the next few years. Our efforts can be summarized in a few key categories. First, robot accessibility. We are advancing a future generation of the GenesisX robot that will be fully wireless, battery-operated, and mobile. Second, a more robust portfolio of EP catheter innovation.