Stereotaxis, Inc. Q2 FY2025 Earnings Call

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. 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 four 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 one or two 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 two 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.

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's 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's 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 four 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 contributions 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?

And your first question comes from the line of Adam Maeder with Piper Sandler.

Congratulations on the progress. It's great to see. David, let’s begin with your closing remarks and discuss the financing and your thoughts on the use of proceeds. The portfolio has undergone significant transformation over the last 12 to 18 months, essentially a complete refresh. You've typically operated with a lean commercial structure in the past. Are you planning to expand the sales force to focus on more aggressive growth? Please share your commercial strategy regarding the new products, and it would be helpful if you could provide some headcount figures as well.

Thank you for the question, Adam. This year, we are focused on securing regulatory approvals and launching several technologies, including capital systems and various catheters in both the electrophysiology (EP) field and beyond. This is an exciting time for our sales team and for the company as a whole. We have a solid commercial team, with about 40 members in total: around 20 in the U.S., 15 in Europe, and 5 in Asia. This team is involved in clinical support, capital sales, sales management, and training, mainly concentrating on the clinical aspects. Since acquiring APT a year ago, we have seen positive results with the Map-iT catheters and more recently with the MAGiC catheters. We've already started seeing activities with MAGiC Sweep shortly after receiving regulatory approval. The team is now equipped to do much more than in the past, which not only enhances their workload but also boosts their success. There's a lot of synergy within our product portfolio, enabling our team members to achieve greater success than before. While our team is somewhat lean, we are considering expanding it significantly. Initially, our current team is capable of handling the launches of the newly approved products. However, as we begin to see more traction with individual accounts, we plan to transition to a model with one clinical representative per hospital instead of the current model of one representative for every three to four hospitals. This shift will enable us to provide deeper support and improve utilization. The revenue model from our proprietary catheters makes this approach viable and sustainable. We aim to implement this strategy in both Europe and the U.S. as we receive regulatory approvals. We believe we can grow the sales force in an accretive manner alongside the adoption of the new catheters, reinvesting a significant portion of the incremental profits generated into growing the sales team. On the capital side, while our current team has maintained a steady flow of Genesis orders and sales, we plan to invest a couple of million dollars in establishing a more dedicated capital team in Europe and the U.S. as we transition GenesisX to a full launch later this year, which should lead to significant growth in capital sales next year. That sums up our overall high-level plan.

That was fantastic, David. And for the follow-up, I'll ask about Europe and the catheter business. And a two-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, the mapping catheter, just OUS timelines there, and I'll drop back in the queue.

Sure. Thanks. In Europe, about 30% of our accounts have begun using MAGiC in procedures, up from 20% last quarter. We are seeing steady progress despite the administrative challenges in various countries, which can slow down the contracting process. I expect this percentage to increase gradually each month. MAGiC is being utilized in a wide range of procedures, including more complex arrhythmias as well as AF, AVNRTs, AVRTs, and flutters, showcasing its value across different case complexities. In Europe, we have approval for ablation in all four heart chambers, supporting diverse usage. We are still early in the launch phase; the second quarter marked our initial sales and revenue. While I don’t have specific statistics on how MAGiC will grow utilization at individual accounts, I anticipate a positive impact on overall use as we expand our presence across Europe. Regarding MAGiC Sweep, we expect to receive clearance this quarter, but it hinges on the notified body. We'll provide updates as we learn more.

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

Congratulations on the progress made in the last quarter. I would like to start with some additional information regarding the FDA interactions for MAGiC. I appreciate the update you shared, but could you clarify how long these interactions with the FDA might take, when submissions could be made, and what the timeline looks like from submission to receiving responses? I'm trying to understand the path from our current status to the approval in the second half of the year.

The FDA conducts thorough reviews of our submissions, and we appreciate their active involvement in the process. We have been working collaboratively with the FDA, engaging in extensive discussions on various topics related to the PMA submission and approval process, focusing primarily on questions about sterility, biocompatibility, and good manufacturing practices. We submitted clinical data from our ongoing trial in Europe during the second quarter. There is a consistent flow of communication between the FDA and us. Given this ongoing interaction and the feedback we’ve received, we believe that seeking approval in the second half of this year is still realistic. The FDA understands the significance of this catheter for U.S. patients and physicians who utilize robotics, and we value their cooperative approach throughout this process.

Got it. That's helpful. Could you provide more information on Sweep in the U.S.? It's great to hear it's off to a strong start. Can you discuss what it might contribute per procedure, how many of your current cases might use the catheter, and estimate the potential revenue that could come from that?

High-density mapping catheters are usually priced over $2,000 per procedure, so you can expect similar pricing from us. High-density mapping is likely utilized in around 70% or more of the procedures performed on our robots. While it’s not used in every procedure, it represents a significant portion. One of the main advantages of MAGiC Sweep is that it encourages a reevaluation of workflow, especially since our core business has relied on a catheter that is now 20 years old, with no innovation for those using it for many years. This presents a considerable opportunity for us to engage with physicians and potentially increase utilization at sites that may not have previously used our robot extensively. There are likely to be broader benefits that extend beyond just an increase 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.

And ladies and gentlemen, this concludes today's call. Thank you all for joining. You may now disconnect.