Stereotaxis Inc

NYSE-MKT:STXS

Earnings Call Transcript 2024-Q1

[Operator]

Good afternoon. Thank you for joining us for Stereotaxis' First Quarter 2024 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 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, David Fischel, Chairman and CEO of Stereotaxis.

[David Fischel, executive]

Thank you, operator, and good afternoon, everyone. Our last call 2 months ago included a fairly comprehensive overview of Stereotaxis and our strategy. We'll keep today's call more brief. I'll focus on 3 specific topics: our commercial results, progress in our comprehensive innovation strategy and the acquisition of APT, which was just announced in a press release this afternoon. It's an exciting period with a lot of progress.

Our commercial goal has been to maintain sales momentum and preserve our financial strength while preparing for a breakout enabled by our comprehensive innovation strategy. While the structural challenges of our old product ecosystem serves as a significant headwind, we continue to show commercial progress. Revenue in the first quarter grew 5% over the previous year, driven by increased robotic system sales.

We grew system backlog since our last call with the receipt of 2 additional orders for Genesis robots. Both orders came from existing customers in Europe that are upgrading older labs to Genesis. The net impact of receipt of those orders and system revenue recognition in the first quarter has increased our current system backlog to $16 million.

As discussed more fully on our last call, there remains a healthy active pipeline of greenfield and replacement cycle customers for Genesis across our 3 key geographies, though the weaknesses in our historic product ecosystem, including the recurring catheter shortages of Johnson & Johnson, harm and delayed purchase decisions. Our recent regulatory submissions of MAGiC and the positive clinical experience observed in our clinical trial partially helps.

Our recurring revenue remains impacted by J&J's catheter shortages, which is impacting procedure volumes. We continue to see inconsistent availability of the J&J catheters flare up in various geographies and accounts, but expect overall recurring revenue in 2024 to be consistent with 2023.

Our innovation strategy remains key to driving substantial commercial success, and we are making significant progress in multiple fronts. Stereotaxis' proprietary ablation catheter was submitted to the EU-notified body and FDA during the first quarter. We were pleased with the responsiveness of both regulatory agencies.

In Europe, we received a completeness check shortly following the submission of our CE application and, soon after, received a first round of clinical questions. We responded to those questions and, at the very end of last week, received a single follow-up question. That question did not raise concern, and we intend to respond shortly. We are still awaiting technical and biocompatibility questions though note that there was substantial progress on those topics during the review last year.

In the U.S., the FDA reviewed our PMA supplement and, during the collaborative discussion, determined to convert the submission into a traditional PMA. That conversion took place, and the traditional PMA is now going through its initial review, leveraging the data we continue to collect from the MAGiC study taking place in Europe, along with the broader body of preclinical and bench data. Enrollment in the European study has progressed well with a continued perfect safety record for MAGiC and overall excellent performance. We plan to enroll additional patients in the study, appreciate the responsiveness and collaborative nature of both regulators and look forward to working with them in the coming months to ensure the MAGiC catheter becomes available for patients and physicians who depend on it.

Our second major innovation effort is the development of a smaller self-shielding robot to significantly enhance the accessibility of our technology. We are methodically working through the extensive testing needed for regulatory submission and successfully completed the majority of all tests with the robot performing very well. We continue to expect regulatory submissions in both the United States and Europe this quarter with European regulatory clearance expected midyear, followed by FDA clearance in the second half of the year.

Following approval, we plan to use the current year to demonstrate the reality of the robot in the real-world use, enhanced compatibility of the robot with various X-rays and prepare our supply chain, manufacturing, installation and commercial processes for a full launch in 2025. Our initial demonstrations of the robot to physician customers reinforces our confidence that the availability of a smaller and more accessible robot will serve as a significant structural improvement to the pace and scale of adoption. Our third effort is to expand the scope of our robot's value beyond electrophysiology into a broader range of endovascular indications. This has been predicated on the development of a family of robotically steered guidewires and guide catheters. The ramp-up in manufacturing of the guidewire is slightly slower than expected, but we expect regulatory submissions later in the third quarter with commercial availability at the end of the year. The guide catheter is being manufactured by APT, and we are delighted to be bringing that project in-house with the APT acquisition. We expect the catheter to be commercially available in early 2025.

In China, our partner, MicroPort, has submitted all the key aspects of our product ecosystem for regulatory approval and has been responding to questions from China's NMPA regulatory body. MicroPort continues to expect approval of Genesis this summer and approval of the robotically navigated ablation catheter as well as integration with their mapping system before year-end. MicroPort is ramping up training of its commercial team in anticipation of the launch, and we have begun a methodical program that provides group and one-on-one training on our robotic technology to all approximately 100 members of the MicroPort EP clinical sales team. Our last key innovation effort is our digital surgery platform for broad operating room connectivity. The [ Sync ] cloud-based connectivity app remains in limited release during which time additional features and improvements are being incorporated as we await the launch of the Synchrony-integrated lab display. Synchrony should begin formal regulatory testing in a couple of months with regulatory submissions later in the third quarter. While this is a synergistic and opportunistic venture to our core strategy, early feedback has been very positive, and I can see this being a substantial independent business in the coming years. We will dedicate a future event to showcase the technology fully.

These innovations, each individually and especially in combination, are leaps forward clinically, commercially and strategically. They improve the care we can provide patients, experience we provide physicians and our ability to meaningfully scale a business with a healthier and more attractive revenue and cost profile. As these key puzzle pieces come together, we are setting ourselves up with multiple shots on goal for breakout growth in 2025 and beyond.

I want to recognize the Stereotaxis team driving this progress forward. It is amazingly impressive what our small team has been able to accomplish, the breadth of innovation, the quality of our work and the ability to advance multiple projects forward in parallel as a lean team in a financially prudent fashion. We really have unique expertise and capabilities that are second to none.

As we reflect on our experience advancing this wave of innovations over the past several years and look forward and strategize for the coming years, it becomes clear that one gap in our expertise is the lack of in-house capabilities to develop interventional disposal medical devices. Our reliance on various contract manufacturing partners has worked as a reasonable solution but is unlikely to be ideal for a future in which we are driving robust innovation and manufacturing of a broad family of interventional devices that work with our robot. With that eye towards the future, I'm very excited that APT will be joining Stereotaxis and contributing that expertise and capability. Our acquisition of APT is opportunistic, synergistic and strategic.

By way of background, I was introduced to APT by highly respected electrophysiologists that were using APT's differentiated, manually navigated diagnostic catheters and wanted a robotically steered version made to work with Genesis. As we had the opportunity to engage with APT's team, we were impressed with their expertise and the quality of their work. We began collaborating to develop a unique, high-density mapping catheter, the first magnetically, robotically steered diagnostic catheter for our community of robotic users. As that collaboration advanced well, we expanded our efforts to include a vascular guidance catheter.

Earlier this year, the opportunity emerged to consider bringing APT into Stereotaxis. An acquisition made a lot of sense from a commercial and strategic perspective, and we appreciate that we were able to reach agreement on a transaction and ensured long-term alignment of interest and was financially prudent.

From a commercial perspective, APT currently distribute -- uses distributors and sales agents around the world to sell its catheters. A substantial majority of these sales come from outside the U.S. The opportunity for these differentiated, high-quality catheters in the U.S. is meaningful but requires a dedicated sales team, which Stereotaxis can provide with synergies from a practical and messaging perspective. Stereotaxis has over 20 people in the field across the U.S. who are particularly skilled and focused on enabling and improving the treatment of the most complex arrhythmias. APT's catheters have the potential to contribute incremental value and revenue in the practices our team already calls upon and to serve as a door opener at centers focused on complex arrhythmias to pave a path for the adoption of robotics. We expect APT to contribute approximately $5 million in annual revenue during the first year post acquisition.

From a strategic perspective, I mentioned earlier how the lack of in-house catheter development and manufacturing expertise has been limiting. APT's team, expertise and capabilities will significantly amplify and accelerate Stereotaxis' next wave of innovation efforts as we look to develop a broader family of interventional devices that are navigated by our robots across a range of endovascular procedures. I warmly welcome the APT team to Stereotaxis and look forward to their contribution as core members in our mission.

While specific financial terms of the transaction are not being disclosed, the majority of the acquisition consideration is predicated on meeting key regulatory and commercial milestones. Those milestones include regulatory approvals for specific robotically steered catheters, both in electrophysiology and endovascular applications, and revenue milestones that will play out over the coming 5 years and are predicated on meaningful growth and adoption of APT catheters. The upfront and milestone considerations can be paid fully in stock. The acquisition is expected to close in the third quarter, subject to customary closing conditions.

I'll now hand the call over to Kim, who will provide commentary on our financial results. After which, I'll make a few financial comments as well before opening the call to Q&A. Kim?

[Kimberly Peery, executive]

Thank you, David, and good afternoon, everyone. Revenue for the first quarter of 2024 totaled $6.9 million, a growth of 5% from $6.5 million in the prior year first quarter. System revenue for the first quarter was $2.6 million and recurring revenue was $4.3 million compared to $1.8 million and $4.7 million in the prior year first quarter. System revenue in the quarter reflects revenue recognition on the delivery of a Genesis system and partial revenue recognition of other ancillary systems. Recurring revenue continues to be pressured by Johnson & Johnson catheter shortages. Gross margin for the first quarter of 2024 was 58% of revenue. Recurring revenue gross margin was 76%, and system gross margin was 27%. Operating expenses in the quarter of $8.7 million included $2.6 million in noncash stock compensation expense. Excluding stock compensation expense, adjusted operating expenses were $6.1 million compared to prior year adjusted operating expenses of $6.9 million. The lower adjusted operating expenses reflect natural reductions in spending on various R&D projects as they have neared fruition and a general effort to be financially prudent across the organization, partially offset by increased clinical trial and regulatory spending.

Operating loss and net loss for the first quarter of 2024 were $4.7 million and $4.5 million compared to $5.6 million and $5.3 million in the previous year. Adjusted operating loss and adjusted net loss for the quarter, excluding noncash stock compensation expense, were $2.2 million and $1.9 million compared with $3 million and $2.7 million in the previous year. Negative free cash flow for the first quarter was $2.3 million. At March 31, we had cash and cash equivalents of $18.2 million and no debt.

I will now hand the call back to David.

[David Fischel, executive]

Thank you, Kim. We're continuing to advance our technology and strategy in a financially prudent fashion. The first quarter is generally the highest cash burn quarter of the year, and we expect the remainder of the year to have a lower rate of cash utilization, even incorporating the expenses associated with acquiring, integrating and operating APT.

Estimating revenue in any given period remains a challenge, and we are still too early in the quarter to provide a reliable estimate for this quarter. As we look out at the full year, we continue to expect modest double-digit revenue growth for the full year, driven by revenue recognition of system backlog and new system orders and not incorporating contribution of revenue from APT.

We look forward to now taking your questions. Operator, can you please open the line?

[Operator]

[Operator Instructions] And your first question comes from the line of Frank Takkinen with Lake Street Capital Markets.

[Frank Takkinen, analyst]

Congrats on the progress. I was hoping to start with one on APT. Maybe just talking about current catheters you have in development MAGiC and the guidewire, is there any immediate synergistic help that they can provide with any of these products? Are those pretty much form factors locked down, sticking with Osypka for manufacturing and APT is more for future developments, such as the robotic mapping catheter? Kind of curious how it can impact the business today.

[David Fischel, executive]

Frank, thanks for the question. So we're -- we obviously have a good long-term relationships with existing contract manufacturing partners, and we don't plan to make any changes. We plan to have continued long-term relationships with those partners. So this acquisition is really not relevant for the MAGiC catheter or the guidewire at this stage. We're really looking towards both the diagnostic EP catheter, the guide catheter and then a series of additional disposable sterile interventional devices as we look towards the future.

[Frank Takkinen, analyst]

Okay. Fair enough. That makes sense. And then maybe shifting over to the PMA change related to the MAGiC catheter. Can you give a little bit more background on the switch from a PMA supplemental to a full PMA and how that might impact needed data for that submission and timelines?

[David Fischel, executive]

Sure. So from a point of view of time line for the submission, that is kind of is -- kind of the same as what it was before. FDA converted it internally on their side from the PMA supplement to a traditional PMA. There are certain things that are not allowed during the PMA supplement but are kind of supported by a traditional PMA, like, for example, auditing manufacturing facilities as part of the review process and that were important to do, and those help drive the decision for the conversion.

And so we had a good collaborative discussion with FDA after they received our PMA supplement submission and kind of -- and as discussing some of what would be important in order to allow FDA to do a comprehensive review, they felt that, that change would be beneficial. And as kind of described in my prepared remarks, we anticipate still the existing data that we've been collecting to be sufficient for the submission, and so that is obviously helpful in the overall timeline and process. And so I think we've been fortunate to be able to have collaborative relationships with the regulators, both in the U.S. and Europe, and to be able to kind of advance things in a fashion that is looking for the right solutions that allow a comprehensive review in a timely fashion.

[Frank Takkinen, analyst]

Okay. Got it. And then last one, maybe just on the capital equipment environment. Any update you can provide there as it relates to installation timelines, construction variability, ordering patterns or hesitancies around it, given some of the macro elements?

[David Fischel, executive]

Nothing major to speak about there. I think that we're still kind of in this middle ground. There's obviously challenges and headwinds, both in the macro environment and given our product ecosystem. There's also the tailwinds of general interest and demand in our technology and watching our innovation strategy come closer to fruition. And so I think kind of there's that balancing act to both of those. We're able to create some progress, given the gives and takes there. It's obviously not the type of scale of progress that we ultimately want to be able to show. And that's why we have our innovation strategy and look forward to being able to actually start to bring that out into the world.

[Operator]

Your next question comes from the line of Jason Wittes with ROTH MKM.

[Jason Wittes, analyst]

Congrats on the progress here on all the submissions. Just on the -- just a follow-up on the PMA conversion to a traditional PMA. How does that affect timing? Is there a few extra months added or -- and both in terms of just converting this to a traditional PMA and the additional steps that might be required for the full submission?

[David Fischel, executive]

Jason, thanks. And so as I described on our last call, we view the submission to FDA not as an event where we submit something, sit back and then wait the statutory clock to play out and then get a result. This is really part of a continuous dialogue and then -- and collaborative engagement on the regulatory process. And so I think that's exactly what played out over the last 2 months since our last call, and we're pleased with the responsiveness of the agency to our submission.

I think it was a particularly quick review and outreach to have a follow-up call and brainstorming on what the best path would be going forward. The conversion to the traditional PMA documentation, the payment of that application all played out already, and now there is the initial review taking place of the traditional PMA application. The statutory timeline, again, is, I believe, a 6-month time line with ability for there to be stopped during questioning. But again, I think about this much more as a process. And I think that given kind of the engagement to date, I'm pleased with how we're able to find paths forward to make sure that this important device is available for patients and physicians in the U.S.

[Jason Wittes, analyst]

Okay. That's helpful. And then on the APT acquisition, it sounds like a pretty good addition from a technological standpoint for you guys. You mentioned they have -- it sounds like they have quite a few unique catheters. It sounds like also, from your description, they're primarily sold in Europe at this point. So just the plan here, is it to convert those unique catheters to the robotics platform and sell them sort of alongside with the robotics -- with robotics? And also -- or do you also plan to sell the manual parts in the U.S. as well?

[David Fischel, executive]

Sure. So a little bit more color there. APT makes a series of diagnostic manually navigated handheld catheters used in cardiac ablation procedures. It has some catheters, which are kind of have high-quality construction but, from a design perspective, are relatively similar to existing catheters out there. And then they have a few catheters that are fairly differentiated in providing kind of additional clinical value in specific styles of cardiac ablation procedures.

They sell the catheters globally. I say that, actually, their strongest region is a few countries in Asia. And then they have a decent amount of sales in Europe, and they have their weakest geography being the U.S., which is obviously interesting given typically, sales in the U.S. is kind of outshines other geographies.

We -- currently in robotic cardiac ablation procedures, manual handheld diagnostic catheters are always being used. There are no robotically steered diagnostic catheters that are available now or have ever been available. It's purely the ablation catheter, which is robotically steered. And so there's definitely the opportunity for their existing manually navigated catheters to be used in robotic procedures as they currently are and to be used more broadly in non-robotic procedures in the U.S. at the accounts that we already call upon and where we have relationships.

There is a specific diagnostic catheter that we have worked with, and that was, to some extent, the start of our relationship with APT, that we've been working with to make robotically steered. And that is in the late stages of development and will be exciting to bring to market. That'll be the first time there's a robotically steered, high-density diagnostic catheter available to our community. And so that is definitely part of the strategy, but there is value to be had both -- in synergies, both from the existing portfolio of manual catheters and from that robotically steered variant in the future.

[Jason Wittes, analyst]

Got it. And then just one more for APT. I think you mentioned the initial payment is going to be through stock issuance. The additional milestones, are those cash or stock payments?

[David Fischel, executive]

Those are all stock-based payment paid upon the milestones.

[Operator]

Your next question comes from the line of Adam Maeder with Piper Sandler.

[Adam Maeder, analyst]

Congrats on the deal. I wanted to follow up on the last line of questioning and ask about the commercial synergies. So for complex AF ablation procedures today and I guess specifically for complex arrhythmias, how many of those cases or what percentage of those cases use diagnostic catheters? And then I'd also be curious to hear a little bit more about the competition on the diagnostic catheter side. Who are you going to compete with there? And why does the APT technology win? And I have a follow-up or 2.

[David Fischel, executive]

Okay, great. Adam, thanks for the question. So diagnostic catheters are used in, I mean, almost every cardiac ablation procedure. They're widely utilized. There are obviously some of the high-density mapping catheters like PENTARAY or an HD grid catheter that are -- have driven significant commercial growth for companies like J&J and Abbott. There's also all sorts of catheters that sit in the blood vessels surrounding the coronary vessels, surrounding the heart and give you electrogram data from this -- from those region.

And so there's kind of a broad array of such catheters. And in some ways, these catheters will compete against -- particularly catheters that sit in the coronary sinus or in some of the vessels surrounding the heart during the procedure. And there are a few catheters, as I mentioned, that are particularly differentiated in their design and capability and add value in cases where we add -- well, we are also adding predominantly the value for a robot. And those are kind of some of the complex ventricular tachycardia, some of the complex ventricular cases, congenital, pediatric cases.

And so that's kind of where the synergy will be most applicable. Our goal is not to try to have a broad array of every product that gets used in every cardiac ablation procedure. We want to remain laser-focused on advancing and enabling the most complex cardiac ablation cases and really adding a differentiated value to the field of EP. I think these catheters, they share that type of messaging. And so our goal is not to become kind of a generic catheter distributor, but really to add value in a differentiated way. And again, there's the commercial synergy and then there's a strategic synergy in terms of bringing in an in-house development and manufacturing capability, which I think will provide a lot of value over the next several years as we really build out the razor blade aspect of the business in a far more robust fashion than what we previously discussed.

[Adam Maeder, analyst]

Got it. That's a very helpful color, David. And then just one quick clarification. The $5 million revenue contribution from APT, did I interpret that correctly as being for calendar year 2025? Or is that for 12 months from close, which I think is expected in Q3?

[David Fischel, executive]

That would be for the first year post closure. So it's -- let's see that might be 3 months, 4 months, 5 months before the end of this year, but kind of for the first year of full option.

[Adam Maeder, analyst]

Okay. Understood. And just one last one. Just curious, from an APT standpoint, do they have any pipeline initiatives that are targeting pulsed field ablation or any catheter IP that could potentially be helpful there? And if not, just curious kind of how the company is thinking about pulsed field ablation, the importance there to potentially adding that to the portfolio over the long term?

[David Fischel, executive]

Sure. Thanks a lot, Adam. So APT actually has done some work in PFA with one of the very prestigious hospitals in the United States. They do have some IP there, and they do have -- they've done kind of various clinical trials with a differentiated catheter that they built in conjunction with the physicians at that institution. And so there is some assets in the PFA world that come with this acquisition.

Outside of APT, we have -- as we've talked in the past, we have been working with a few companies to explore robotically steered catheters that can deliver PFA during procedures, both in the atrium and in the ventricle. And we actually have a few animal studies with 2 different companies planned for the next, call it, 1 to 3 months looking forward. And so there was kind of some meaningful work going on there. And then -- and when there's something kind of more material where we can provide an actual timeline and when the first PFA catheter either is able to approach the market or approach a human study, we'll update you guys further.

[Operator]

Your next question comes from the line of Josh Jennings with TD Cowen.

[Joshua Jennings, analyst]

I was hoping another APT follow-up, just with the high-density mapping or all the diagnostic mapping catheters in the portfolio. Are they integrated into a high-density or 3D anatomic mapping system? Or are they compatible with current mapping systems that are out and commercialized? Or how does that whole integration work and play out as you advance this platform?

[David Fischel, executive]

Josh, very good question. So APT's catheters are currently compatible with a range of mapping systems out there. You're correct that the primary high-density mapping catheters, like an HD grid or PENTARAY, are generally have to be fully integrated with the mapping system. There are though ways to pin various secondary diagnostic catheters, things like a coronary sinus catheter, into the various mapping system without it being fully integrated, but being compatible. And so that is kind of very much a part of this industry, and that's how the catheters are currently being used.

[Joshua Jennings, analyst]

And then just wanted to ask about not the pipeline as we're moving forward, making progress to getting the mobile system approved, just -- I think you made some comments in your prepared remarks, David. But just how is the pipeline shaping up U.S. and OUS as we sit here today in 2Q '24 versus maybe a year ago?

[David Fischel, executive]

So overall, we're -- I mean, from a development perspective on the robot side, we're delighted with how it's progressing. The device is working nicely in the testing. We're kind of methodically grinding through all of the tests necessary. We've started to share the system with visitors to our office, and the system is looking more and more -- as we receive the covers and have the LED lights, everything else, it starts to look more and more like a real commercial system. And so kind of we're happy with how that looks.

From a pipeline in the field perspective, I'd say that Europe is starting to -- as kind of the first geography where we would expect the MAGiC catheter to come approved and the new robot to come approved. That is taking the lead in terms of the pipeline development. It also benefits from the availability of a newer, more modern X-ray that is available in Europe now in which we just completed the first installation of in Italy. And so there is -- there was kind of an improving pipeline, I'd say, there. And overall, I think we have kind of a good pipeline.

We've not yet been able to go out in a robust way to commercialize and market aggressively this new ecosystem and this kind of concept of having a robot that doesn't require construction and that can be adopted more easily with various ways of being adopted, whether it's a capital sale or a lease or a placement with disposable commitments. And so there is kind of -- we are looking forward to being able to do that. We're doing some preparatory work to make sure we have a good pipeline as we're able to do that more fully. But we haven't obviously gone out yet until we have the approvals and are ready to do so -- to do that more fully.

[Joshua Jennings, analyst]

And then maybe just a similar question or a follow-up question on just China, the collaborate with MicroPort. And just when should we be expecting orders to start flowing through to their sales force and that combined effort?

[David Fischel, executive]

So MicroPort, it still expects Genesis approval in the summertime and, by the end of the year, expects to have its catheter and to integrate it with its mapping system and us approved. I think about it probably in 2 steps. Having Genesis approved in China will be very helpful to start to allow some of the capital activity to flow. Having the full ecosystem available with the catheter will allow the broader MicroPort sales team to really actually participate in the commercial activities. So while MicroPort has a relatively smaller capital sales team that has been active and is kind of -- and will be particularly motivated and capable when Genesis is approved, we are starting to train both group settings and one-on-one settings for actually every single one of them, all approximately 100 people on the MicroPort EP clinical sales team.

And as the catheter is approved, that provides really the impetus for that entire team to talk with their daily customers and to try to drive adoption of their mapping system and their catheter portfolio using the robot as kind of this differentiating lynchpin. And so I think about it kind of in those 2 phases, particularly excited for that second phase, but I think there'll be some impact from the first phase.

[Operator]

All right. That concludes our Q&A session. I will now turn the conference back over to David Fischel for closing remarks.

[David Fischel, executive]

Okay. Thank you very much for your questions. We look forward to working hard on your behalf to realize key milestones prior to when we speak next quarter. Thank you.

[Operator]

Ladies and gentlemen, that concludes today's conference call. Thank you all for joining. You may now disconnect.