Stereotaxis, Inc. (AMEX:STXS) Q4 2023 Earnings Call Transcript

David Fischel: No, it’s fine. And then, and so overall, we would estimate – and I’m looking at Kim right now, she wants to correct me – that typically you would estimate that approximately 80% percent of that will be recognized as revenue. I’m getting a thumbs up, so that seems correct. About 80% of that should be recognized within a given year. We have seen scenarios where hospitals that were planning, to take delivery at a specific date, push back that date, due to their own challenges. And so, there is – there’s not guarantees, of that playing out, as we’ve seen even up, till the fourth quarter obviously, in the results of our fourth quarter. But generally, that 80% within one year for backlog, is a general rule that holds.

Jason Wittes: Okay. That’s helpful. Then last question. Just in terms of supply issues with the current catheter. Are there any updates from your supplier? Or is there any change in outlook? Or how should we be thinking about this for 2024?

David Fischel: Yes. So just to be clear, the catheter shortages are not from a supplier of ours, nor from a company that we have any control over. This is all related to the dependency, which I described before, where Johnson & Johnson independently manufactures, sells and supplies the magnetic ablation catheters that, are used alongside our robot. And so, we do not have control over them, or even influence over them in the same way that, we would have influenced with a supplier that, we have hired and worked with. We have seen – these cropped up over a year ago now, about a year and a half ago. We have seen continued shortages that flare up in various specific geographies, various accounts. And there is a randomness to it, though it does definitely pressure the physicians, and hospitals that rely on our technology, and create disturbances to their normal practices.

And so, I think given where we stand right now, it seems like the intensity and distribution of those flare-ups, doesn’t seem worse than it was a year ago. And so, it seems like overall, the numbers this year, should look similar to last year, but there is an aspect of dependency there. And that again speaks, to how valuable and important having MAGiC on the market will be.

Jason Wittes: Great, thanks. I’ll jump back in queue.

David Fischel: Thank you very much, Jason.

Operator: Our next question comes from the line of Alex Nowak with Craig-Hallum. Please go ahead.

Alex Nowak: Okay. Great. Good afternoon, everyone.Continuing the manufacturing question there. Just with regards to MAGiC, if you get the approvals, let’s just say, second half of this year for both Europe and U.S., how quickly can you ramp up manufacturing?

David Fischel: Hi, Alex, thanks and good afternoon. So overall, that is something that we’ve been working with Osypka, our contract manufacturing partner in Germany, to improve. They have significant experience, manufacturing thousands of units, of various interventional devices. And so, they have the organizational capabilities to do that. With every product, there is its own scaling effort during the formal regulatory testing of MAGiC, we did produce – I believe it was near 1,000 units of the catheter. So, they demonstrated their capability to scale manufacturing to those – to that type of level. We are working with them, have been working with them. We’ll continue working with them, so that they can scale, to the point where we’re able to service the entire European, and U.S. installed base.

I think that probably reaching that level still, over the course of this year is probably aggressive, but that’s what we’re shooting for, and there are all sorts of incentives in place, to increase that manufacturing.

Alex Nowak: Okay. That is great to hear. Maybe expand on the qualitative commentary, with the physicians who are using MAGiC in the European study. Just, what do they like about it, versus the J&J device specifically?

David Fischel: Sure. So, I had the good fortune of being able to actually watch eight procedures, when I visited Vilnius University in January. And I think that kind of obviously, you recognize that the financial, the strategic, the independence benefits of having a catheter, the fact that the catheter serves, as the enabling technology for our mobile robot. So all of those, are kind of the more strategic, aspects from our side. From a clinician’s perspective, how does the catheter benefit the patient and the physician. I’d say that some of the main benefits that were described by the physicians. One was an observation that, the stability of the catheter was particularly nice. And we are – magnetic catheters are known that, one of their key benefits is stability.

Oftentimes, that stability is dependent on your approach towards, the tissue. And they felt that, irrespective of how they approach the tissue with the catheter, they had very, very good stability, beyond what typically they consider very good stability, with the existing magnetic catheters. That was one thing that was particularly called out. The ease of navigation, and how that was more intuitive than what they were used to was the second observation that was called out. And then the fact that reduced fluid is required, to cool the catheter that should benefit patients that, have renal issues, or longer procedures, and that just generally creates a reduced fluid load, for patients. And so, some of those, were some of the things that I remember, from a visit and from the discussions with physicians.

I think kind of those are, some of the key, key benefits, both for patients and physicians, as they switch to MAGiC.

Alex Nowak: Okay. Great. And then just last question. Are you teeing up any U.S. studies just in case the supplement, the FDA comes back and request additional U.S. data? Just how quickly could you turn something like that around?

David Fischel: I believe in the coming months, we will have a much clearer feeling – coming few months, we’ll have a much clearer feeling for the regulatory path in the U.S., given what we’ve done in Europe that, has been very helpful in educating us, and giving us certain infrastructure, to run clinical trials more broadly. If you step back, and think about Stereotaxis as a company, we have a very, very unique and kind of a special capability, in terms of building robots – that’s something that, almost no other company has, very few companies have demonstrated the capability, to build robots that, can actually be deployed in a real-world clinical setting, and can work robustly and reliably there. We have that capability in-house.