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Stereotaxis, Inc.
11/11/2025
Good afternoon. Thank you for joining us for STAIR Tax's 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 a 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. 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 Fishel, 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 Genesys and the initial launch of GenesysX. 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 razor blade 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 at over $10 million supports a steady baseline of robotic system revenue, as demonstrated by our results over the last several quarters. The launch of Genesis X significantly enhances our system opportunity by removing structural barriers that limited physician interest from translating into tangible adoption. We were delighted yesterday to announce FDA approval for the Genesis X 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's second such robot in five years, a reflection on our unique expertise and our capacity and commitment to significant innovation. We are initiating a limited launch of Genesis X 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 Genesis X orders to outpace the tempo of Genesis orders following full launch. Turning to our recurring revenue. The key driver of growth over the coming years will be our budding 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 procedures. Catheters are the primary disposable in any procedure, and stereotaxis did not previously benefit from this revenue stream. The dearth of robotically steered catheters reduced interest in our technology and limited our revenue opportunity and razor blade 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 MAPIT catheters following our acquisition of APT last year, adoption of the MAGIC ablation catheter in Europe following CMARC 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 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 EP field and how the introduction of robotic HD mapping promised several clinical and workflow benefits. It is also important to note that MagicSweep 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 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 stir, 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 a 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 its impact in the U.S., as well as gain approval and launch in Europe. The commercial impact of MagicSweep, measured in direct revenue and, as importantly, in the halo effect it creates for robotics in our field, demonstrate 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 EP 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 FDA to advance U.S. approval. Late in the third quarter, we responded fully to a body of questions that represented FDA's outstanding questions upon a comprehensive review of all modules in our submission. We maintain regular dialogue with FDA and appreciate their collaborative effort during the reviews. Pulse field ablation, PFA, has had a dramatic impact on the electrophysiology field over the last couple years, driving billions of dollars in market growth and significant share shift among the large medtech 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 to pair 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's 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, expect 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 Syncs, a 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 the technology for FDA approval. The technology has received less attention than most of our other innovation efforts, but it holds significant promise as an entirely new business pillar. We have spent over six years and many millions of dollars developing Synchrony and Syncs, benefiting from our previous experience with our Odyssey system, but completely re-architecting it with an improved technological foundation. Synchrony and Syncs 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 stand to benefit from improved workflow, connectivity, collaboration, and intelligence. We have opportunity recently to host leading 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 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 Sync 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. Kim?
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 MAPIT catheters and initial sales of Stereotext's 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 non-cash charges for stock compensation expense, mark-to-market adjustments for acquisition-related contingent earn-out consideration, and amortization of acquired intangible assets. Excluding these non-cash charges, adjusted operating expenses in the quarter were $6.6 million, a decrease from $7.2 million in the prior year's 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 for the quarter, excluding non-cash 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 30th, stereo taxes had cash and cash equivalents of $10.5 million and no debt. Including the $4 million stereo taxes will receive in the upcoming second closing of the registered direct financing announced in July, stereo taxes would have had $14.5 million in cash with no debt. I will now hand the call back to David.
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