Stereotaxis, Inc.

Q1 2023 Earnings Conference Call

5/9/2023

spk05: Good morning. Thank you for joining us for Stereo Tax's first quarter 2023 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 risk, 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 of 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. At this time, all participants have been placed in 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.
spk11: Thank you, Operator, and good morning, everyone. Our last call two months ago included a fairly comprehensive overview of Stereotaxis and our strategy. We will keep today's call more brief, focusing on a few commercial and innovation updates. Revenue in the first quarter was essentially identical to last year's first quarter, barring the royalty payments that we no longer receive from John Johnson. System revenue in the quarter reflects partial revenue recognition on the shipment of one Genesis system that is completing installation as we speak. During the first quarter and subsequent to our last earnings call, we received a purchase order for a Genesis system from a US hospital. We received another Genesis system order from Europe so far this quarter. The combination of the partial system revenue recognition out of our backlog and the additional order into our backlog slightly increased quarter-end system backlog to just over $15 million. Hospital construction has remained relatively slow, weighing on the speed with which backlog converts into revenue and then into installed active robots. That said, we have a fairly busy schedule of installs planned over the coming months, and continue to expect the majority of our backlog to be recognized as revenue this year. Since the launch of Genesis three years ago, we have now received orders for 22 robotic systems. Building a capital sales capability, process, and infrastructure has taken time and required significant effort, but these 22 orders over three years is a dramatic turnaround from the period prior to Genesis when only one system was ordered over the same timeframe. Of the 22 robots ordered since our launch, nine have been installed and are doing procedures, five have been shipped to the hospital customer but are not yet installed or launched, and eight remain in backlog waiting to be shipped. Our orders have been broad-based geographically with just over 50% of orders from the United States and approximately 25% each from Europe and Asia. They are also evenly split between greenfield robots and upgrades with 11 of each. We are continuing to improve and refine our commercial capabilities and expect as we do so to see increasing orders of genesis. Our capital pipeline looks healthy and is seeing growth across our three focus regions. We have a few dozen, approximately 50, unique opportunities in our near-term pipeline where we see a possible order over the next 12 months. Order flow remains lumpy, the macro environment remains pressured, and we have still not fully benefited from a normalized replacement cycle. But given the engagement we see from the bottom up, there's increasing confidence in a consistent flow of orders. Most important to the adoption of robotics is the enthusiastically positive experience of the physicians who are using Genesis, along with the reliability and clinical value Genesis robots are demonstrating in the field. Engaged and happy customers who are able to provide great care to their patients and build successful practices are the best ambassadors through which to ultimately increase awareness, change historical misperceptions, and grow adoption. We are pleased with the procedure utilization we are seeing on Genesis robots, which is meaningfully higher than our average global utilization. This is playing out both at accounts that upgraded to Genesis and with those that establish entirely new robotic practices. Last month, I had the opportunity to meet physicians from two of our most recent Greenfield Genesis launches, Poland's National Institute of Cardiology and Broward Health Medical Center in Fort Lauderdale. Where at both, we have happy and excited users who are grateful for our technology and are using it to treat patients in ways that meaningfully improve the quality of care and access to care. Discussions like those reinforce the positive impact of our technology and the relevance and importance of robotics for the field. Our overall experience with Genesys serving as the spark to restart capital adoption and to support utilization is a reminder of the significant impact innovation has on commercial results. This segues well into a few comments on innovation. On our last call, we discussed in detail the key efforts in our strategic innovation plan. and how they deliver meaningful clinical, commercial, and strategic value. Apart from the minority of our users who have been able to upgrade to Genesis, most existing robotic electrophysiologists have remained limited to using essentially the same ecosystem of robot, catheter, and mapping technology for over a decade. SerioTexas' proprietary robotically navigated ablation catheter, MAGIC, is set to positively address this. Since our last call, we have made significant progress on both the EU and U.S. regulatory paths for MAGIC. In Europe, we have been awaiting receipt of the full spectrum of technical, clinical, and microbiology questions from the EU regulator. We have now received questions across all three of those categories and have fully responded to all the questions in what we believe to be a comprehensive and thoughtful manner supportive of CE Mark. It would not be surprising to receive follow-up questions to our responses, but we believe our previously communicated timeline is reasonable and still see receipt of CMRK as most likely to occur late in the second quarter or in the summertime. In the U.S., submission of an IDE application to the FDA has been dependent on successfully completing a dozen preclinical studies. As of our call two months ago, we had established a GLP-level institutional animal care and use program and run a few pilot cases, but had not yet performed those on-the-record studies. We completed all the required studies since that call and will complete all the required follow-up periods within the next two weeks. The results we have seen and physician feedback we received is very supportive of our confidence that the catheter performs well and will be enthusiastically adopted by the community of robotic users. Given this progress, we expect to make an ID submission to the FDA in the third quarter. Our other major innovation efforts, including a smaller self-shielding robot that frees us from the extensive planning and construction currently necessary to adopt robotics, a family of interventional guide wires and guide catheters that expand the benefits of our robot into new endovascular indications, a digital surgery hardware and software offering enabling broad operating room connectivity, and a full electrophysiology product ecosystem being built in collaboration with Microport. There is a significant amount of work and progress being made on each of these in parallel. As we provided much more color on each of these during our last call, I'll just reiterate that the timelines communicated on that call stand. We have line of sight to reaching multiple significant regulatory and commercial milestones this year, with growing commercial impact from each of these technologies next year. As these technologies come to market, we will host focused innovation days to present these technologies in greater detail. While the optics of Stereotaxis' financial results are unexciting, we see ourselves as being on the cusp of a strategic transformation. We have clear line of sight to a future with strategic independence, an attractive revenue model, broad robot accessibility, and platform indication opportunities. This core product ecosystem serves as a foundation for a high-growth, high-value medtech company pioneering endovascular robotics. Kim will now provide some commentary on our financial results, and then I will make a few financial comments as well before opening the call to Q&A.
spk00: Thank you, David, and good morning, everyone. Revenue for the first quarter of 2023 totaled $6.5 million, down from $7 million in the prior year first quarter primarily due to discontinued royalties from Johnson & Johnson. System revenue of $1.8 million reflects revenue recognition on the delivery of one Genesis system. Recurring revenue for the quarter of $4.7 million was predominantly impacted by the absence of the J&J royalty, along with a smaller impact caused by J&J capital production shortages, which pressured procedure volume. Gross margin for the first quarter of 2023 was 59% of revenue. Recurring revenue gross margin of 79% remained similar with recent quarters, with the loss of royalty impacting otherwise operational improvements. System gross margin of 7% continues to reflect significant allocation of overhead expenses over low manufacturing volumes. Operating expenses in the quarter of $9.5 million included $2.6 million in non-cash stock compensation expense. Excluding stock compensation expense, adjusted operating expenses were $6.9 million compared to the prior year adjusted operating expenses of $6.5 million, reflecting increased spending in R&D. Operating loss and net loss in the first quarter were $5.6 million and $5.3 million, compared to $4.1 million for both in the previous year. Adjusted operating loss and net loss for the first quarter, excluding non-cash stock compensation expense, were $3 million and $2.7 million. Negative free cash flow for the first quarter was $3.2 million. At March 31st, we had cash and investments of $26.8 million. I will now hand the call back to David.
spk11: Thank you, Kim. As detailed in today's press release, we are reiterating our expectation of double-digit revenue growth for the year, given our existing system backlog and the view we have into our near-term system pipeline and installation schedule. System orders are also expected to increase in 2023 compared to 2022. Genesis system revenue remains the primary driver of overall revenue growth until we start to see more meaningful commercial contribution from our innovation strategy in 2024. Our core recurring revenue business remains relatively sticky and stable, and we expect will be boosted significantly as we bring the magic catheter and vascular interventional devices to market. That said, procedures and disposable revenue in the first quarter were slightly pressured by catheter shortages J&J experienced due to supply chain and production challenges. These challenges have continued into April, but we are told by J&J that they will be addressed by the end of the quarter. We expect some impact from this, likely in the low hundreds of thousands of dollars during the second quarter. Situations like these further reinforce the strategic, operational, and financial value of the magic catheter and having control over our own destiny. As we advance our innovation strategy to market, we maintain a balanced financial posture. We are investing in the organizational infrastructure and capabilities that will allow us to drive significant revenue growth from those innovations. At the same time, we remain financially prudent to ensure that our existing balance sheet can comfortably fund all our innovation efforts and commercial launches without the need for additional financing. We look forward to now taking your questions. Upbreaker, can you please open the line to Q&A?
spk05: Thank you. At this time, we will now conduct today's question and answer session. To ask a question, please press star then the number one on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. We'll take our first question from Joshua Jennings with TD Cowan. Your line is now open.
spk03: Hi. Good morning. Thanks a lot for taking the questions. Hi, Josh. Good morning. Good morning. Thanks. I wanted to ask about just the replacement cycle channel. And are you seeing any cracks in terms of that opening up? And what do you think needs to happen for that replacement cycle opportunity to start to kick in more fully?
spk11: Sure. So it's been interesting because when we started this with the launch agenda around three years ago, we were always talking about the typical traditional 10-year cycle by which capital equipment gets replaced and by capital equipment we mean mainly x-rays in cath labs. And clearly that has been extended over the last few years where we now have multiple systems that are even 14, 15 years old out there in the field. I think in the past I've mentioned that it's unclear how much of that extension of the life of x-rays is due to cyclical nature, just the macroeconomic environment and the financial pressures that hospitals have been under versus a secular change due to perhaps the reduced use of x-ray overall and so the longer life that they can exist before needing to be replaced. Probably the truth is a mix of both. Either way, we have not seen a contraction in that age where people are now starting to replace x-rays earlier. So it seems like the average age of an x-ray is definitely extending in most settings beyond 10 years. We are starting to see, as some of these sites become very old, we are starting to see obviously much more of a contribution from the replacement cycle of the two orders that we just mentioned. One was a replacement order. One was a greenfield order. But I would expect still that in our normalized level, we should probably be receiving high single-digit number of replacement systems a year. We've still not gotten to that point. We're still probably in the mid-single digits, and so we probably still have a little bit of room to go to get to a more normalized level.
spk03: Understood. I wanted to ask, a question about potential just, you know, your drive for an open ecosystem within the EP world. Are there any potential advancements with, say, an Abbott to integrate your robotic magnetic navigation technology into the InsightX mapping platform or any other mapping system integrations that we should have on our radar for this year?
spk11: Sure. We won't, obviously, we can't comment on any type of collaborative activities that we would be doing prior to them being announced. I'd say that we've talked, obviously, about the importance of open ecosystems more generally for progress of the medical field and for patient care and for physician choice, and more specifically also for stereotaxis in being able to pair the benefits of robotics broadly with a range of diagnostic and therapeutic technologies. And so that concept of an open EP ecosystem is an important one. I think we've made quite a lot of progress on it over the last few years, and there's obviously more progress to be made. And so I'd say stay tuned, and we look forward to sharing updates as we're able to.
spk03: Great. And this last question, sorry to sneak one more in, but I know this post-co-depletion race in terms of getting a commercial cap in the United States is ongoing. the major cardiac operation catheter players kind of teed up to get approvals over the coming 12, 18, 24 plus months. I guess, how would you have investors think about the role that robotic magnetic navigation system like the Genesis or mobile could play and could potentially enhance one of these larger player platforms and help them win this race this PFA raise. Thanks for taking on the questions too.
spk11: Sure. So we obviously see what's going on in the field and overall view kind of how PFA is evolving into the field. In many ways, we view actually robotics as particularly well-suited to be paired with PFA. We've had some experience. We discussed in the past some of the preclinical studies that we've done with different PFA generators and some of the ongoing work that we are doing there. And given the constant and consistent contact that a robotically navigated catheter has with the heart tissue there are actually a particular mechanistic benefits to pairing a robot with pfa and we've done the pre-clinical work and like i've mentioned and we're trying to kind of advance things in a way where we can reach a first in man study and and provide kind of more clarity on a clinical commercial timeline and I'd say kind of overall, I would look though, when I step back and think about PFA and how it's entering the EP field, when you look at kind of all the cardiac ablation procedures more generally, and really kind of PFA is right now being targeted at paroxysmal AF, and there's some thoughts in persistent AF. And we have a vast, we have a majority of our procedures and kind of in the ventricle and certain SVT style procedures where probably it will take still five to 10 years to know the role of PFA in those settings under certain procedures where PFA will likely never be particularly applicable or beneficial or safe, given kind of the type of arrhythmias that you would be dealing with in certain focal arrhythmias. And even in AF, as you have probably noticed the original view of PFA being a panacea has evolved into a more nuanced understanding of its role and its partial role in the field. And so I think, again, we might not be the first mover in the PFA space, but I think we're doing all the right things on kind of the backside to make sure that we have a nice offering there. And that's where, again, this open EP ecosystem does provide a lot of value in allowing us to pair the benefits of robotics with a range of other technologies that are being developed.
spk12: Excellent. Appreciate it. Thanks, David. Thank you.
spk05: Next, we'll go to Frank. Taking in with Lake Street, your line is now open.
spk02: Great. Thanks for taking the questions, and good morning. I wanted to start with one on the construction timelines. You briefly commented on it in the prepared remarks, but I was hoping you could take us a little bit deeper into how the construction timelines have been trending year-to-date and if there's any sign of those starting to be a little bit more predictable as we look at the back half of 2023.
spk11: Hey, Frank. Good morning. So when I look now at kind of our, I guess, history of these 22 orders received since we launched Genesis, it seems kind of almost kind of a – there's a lot of variability around these averages, but almost kind of – you know, one year from an order till, you know, roughly till most sites get kind of revenue recognized and installed and around two years until they go after, revenue recognized that they get shipped and then kind of around two years until they get kind of installed and are starting to do procedures. There's obviously wide variability around that. We've had orders that get shipped and installed and starting doing procedures within, you know, six, nine months. And we've had things where it takes two years and you still don't recognize revenue by shipping the system. And so there's kind of a wide band around that, but that seems to be kind of what the average has ended up being. We are seeing more, definitely more scheduled installations over the next, let's say, nine months or the remainder of this year with a fairly busy schedule of things. Some of those are things that have been backed up for long periods of time, and other of those are from fairly recent orders where the sites seem to be on track for meeting the timelines that they want to have for installation. We still see many anecdotes, many cases of hospitals that have a plan, and that plan gets significantly delayed due to whatever construction issues or permitting issues they have. I still am very much looking forward to the day where we do not have the complexity and the pain of the architectural and construction timeline, but at least we're seeing some movement seemingly that is real, real new movement for the next several months.
spk02: Okay, that's helpful. And then for my second one, maybe speak to some of the usage patterns you've noticed from the new genesis installs over the last couple years and what i'm hoping you can touch on is maybe where are these physicians typically starting to use the technology with patient pool and what's their usage patterns look like at different milestones say three months six months 12 months i was trying to get a better understanding of how the new genesis users are ramping and how their usage is expanding within their patient populations?
spk11: Sure. So I don't have all the data in front of me to answer you kind of in a comprehensive way with, you know, three-month, six-month, 12-month data. But I'll kind of let me think and kind of provide kind of a rough answer for that. And obviously kind of across our installed base, stereotaxis is overrepresented in the more complex ablations. That's where the mechanistic benefits of our robots are particularly pronounced. And so about half of our volume is in ventricular tachycardia, premature ventricular contractions, congenital patients, and those types of patients. And that's also a patient population which is generally underserved. Many of them don't have an option for good therapy without the use of our robot. And so that's where we provide particular clinical value. That said, there is benefits obviously across the spectrum of ablation procedures. And so there are even procedures that might be considered typically as simple procedures where we are being used because of the safety profile and the precision of robotics and the clinical benefits that provides. And so there is kind of a full spectrum. When I think about kind of our genesis install base, generally would say that the types of procedures they perform follows that spectrum of our overall install base. And so we definitely have a pronounced use in the complex cases and that is oftentimes the motivating driver for why let's say a greenfield account would adopt a robot but we do see usage across the spectrum of procedures not just um in the most complex ones at least you know across many of the sites not there are certain sites which uh which might limit us only to the most more complex cases But we definitely do see across the installed base, across the Genesys installed base and across Greenfield Genesys installs, also usage kind of across the spectrum. And does that kind of partially answer you?
spk02: Yes. No, that's perfect. Appreciate the color and thanks for taking the questions. Thank you very much, Frank.
spk05: Next, we'll go to Alex Nowak with Craig Halam Capital Group. Your line is now open.
spk09: Okay, great. Good morning, everyone. Maybe just expand on the J&J royalty going away. Just remind us the dynamics around that. And if the royalty didn't go away, what were going to be the consumable sales in this quarter, just so we can figure out sort of same-store volume trends?
spk11: Sure. Hi, Alex. Good morning. We've had obviously a very long-term relationship with Johnson & Johnson. Several years ago, that relationship was turned from an exclusive relationship into a non-exclusive relationship. And then there was the timeframe where it would remain a non-exclusive relationship. and then where there would be a tail supply period, where still for several years, J&J would have to continue supplying catheters to the market. And that transition from the non-exclusive relationship to the tail supply period started at the beginning of this year, and J&J stopped paying us royalties at that time. We missed out on something like about half a million dollars in the quarter due to the lack of the royalties.
spk09: Okay, that's helpful. And then how long does that tail supply agreement last till? A three-year period. It's three years. And then after the three years, there's basically no assumption that they will continue to supply catheters. Is that right? That will be a timeframe we need to have magic on line by.
spk11: There is no legal requirement, contractual requirement, and I think it's still open to interpretation of how things will play out there, and open to seeing how things will play out. But if we do our job well, there shouldn't be any reason for them to continue supplying.
spk09: Okay, understood. And then any discussion with the FDA around the Gen 3 self-shielded robot? Just what needs to be done internally before submitting that 510 . And then, you know, what could influence the timelines? What could pull it forward? What could drag it out?
spk11: So, we have made an initial, you know, we've informed FDA that this is kind of coming. So, there's some awareness there that we've not kind of submitted any documentation in, you know, in a material way. And there is a lot of very recent experience with FDA on a robotic magnetic navigation system. We received Genesis FDA approval just three years ago, and so we went, and that was a fairly extensive process. For those of you that were on the calls at the time, you may remember we had some catch-up 510Ks that had to be done. So there were multiple steps in the process of that approval, given the long period that Stereotaxis had not been in regular dialogue with FDA. And since that time, we have been in relative dialogue. I think kind of we keep them up to date on our progress. And so overall, I think we have a fairly clear understanding of the of the requirements for submission, obviously regulatory expectations evolve also over time. So let's say we're aware of the fact that there's generally more of a focus on things like human factors testing and on cybersecurity. And so, you know, we know that those are things that perhaps we want to do to at least document in a more extensive fashion versus previously. But overall, I think we feel very comfortable about the regulatory path and and what needs to be done on our side, and we have the very recent experience which guides our path.
spk09: Excellent. Thanks for the update. Appreciate it. Thank you.
spk05: Okay, next we'll go to Neil Chatterjee with B. Riley. Your line's open.
spk09: Hey, guys. Good morning. Thanks for taking the questions. Just on the sales funnel, just curious how, you know, things are shaping up with the current capital spending environment and kind of ongoing hospital headwinds. Sounded like you still kind of see a pipeline of about 50. So just kind of curious to get an update there.
spk11: Yeah. So when we look at kind of the pipeline, I've kind of mentioned in the past that we have a more and more organized way to now review the pipeline and status in each region. And there's approximately two dozen, a little over two dozen in the US, about a dozen in Europe, and about a dozen in Asia. that have kind of accumulated on this pipeline where the sites are talking about potentially getting in order over the next year. And what I've seen generally is that there's obviously a subset of those that will get delayed, but kind of that's how our pipeline looks at this point. And I kind of – so I pair, I guess, this bottom-up relative kind of healthy – a growing pipeline, I think, as our team matures, as kind of their efforts in the field mature, as the general marketplace, I think, sees our overall progress as a company, that helps. And so I see that kind of bottom-up pipeline as it's growing. I pair that with kind of the top-down assessment that it still remains a relatively pressured environment. The macro environment is what I've called in the past still a headwinds environment, not a tailwinds environment. But I think with the balance of those two, we're able to do kind of some progress, obviously, and we feel confident in the guidance that we've given this year. And so I guess kind of that's the balanced viewpoint, giving the spot-up and top-down data.
spk09: Got it. Thanks for that. And then just maybe on China and microport, you know, the ecosystem there, that's being developed. Didn't sound like any huge updates on, you know, there versus the last quarter or last call. Just curious, you know, how things are tracking there. You know, you obviously had Genesis, you know, submitted for approval and the broader platform being developed. Just curious on an update.
spk11: Sure. So, yeah, so MicroPort submitted Genesis at the end of last year and over the last couple couple months has been submitting some supplemental information to the regulator there to that mpa and they you know we're and and has been also working on its submission for uh the catheter and it has to wait until we get the e-mark for magic before it can submit magic uh given the pathway that we want to go through but it's also working on the submission for its own variant of a magnetically driven ablation catheter. And from a mapping integration perspective, we've already done very well. And so that's something that won't be a long pole in the tent at all. And so as we look at kind of all of that and what Microfort feels is a reasonable timeline, given its discussions with NMPA, we're still kind of comfortable in this first half of next year, that full ecosystem coming together. There might be certain approval that can come earlier, but but I'd say that kind of that feels like the right timeline overall, and really it is that ecosystem of robot catheter mapping that should come together well in order to allow for the full launch and taking advantage of the full commercial team.
spk09: Got it. Maybe it's one last quick one. I don't know if I missed it, but just any update on just how you're tracking for the mobile RMN, you know, clearance in Europe in the second half?
spk11: Yes, so we've talked about kind of in the third quarter, and so I'd say we are working feverishly on multiple fronts there to be ready for kind of an approval at that point in the third quarter.
spk09: Great. Thanks. That's it for me.
spk05: Thank you. Okay, next we'll go to Adam Maynor with Piper Sendler. Your line is now open.
spk08: Hi, David. Hi, Kim. Thank you for taking the questions. Two from me. The first one is on the Magic RF catheter. And I think I heard timelines for Europe still stand late Q2 or summer. Can you talk just a little bit about kind of commercial strategy there in terms of the launch? How aggressively will you be rolling Magic out to customers and Will you look to bolster or add sales reps prior to launching that? Just maybe flesh out the commercial strategy a little bit and then add a follow-up. Thanks.
spk11: Sure. Hi, Adam. Good morning. And so, yeah, so the timeline, obviously, it still remains somewhat of a black box. You respond to questions, then you kind of sit and wait. But everything is now kind of back on their court. We were very pleased that we got at least the first set of questions from them across all three categories and that we were able to respond in a timely fashion. And when we look at kind of the commercial, and so assuming we get approval at some point this summer, and the overall commercial strategy is we have invested somewhat in our team in Europe. And so we have kind of two people more than what we have had historically. And that was done in anticipation of kind of magic coming to market and the opportunity that would present itself. And we have kind of done fairly detailed reviews of every one of our 30-some hospitals in Europe that have a robot. And in each one, understanding both the logistics of bringing the catheter to market. Is there a tender? Is there not? You know, a hospital application needs to be filled in just on the logistics side. On the financial side, what should pricing look like? On the kind of clinical side, what are the motivations of the physicians? What do they think about the catheter? What would be the drivers of adoption, the risks to adoption? And so I think we have a fair, we have a good clarity. The team there has worked kind of now for a fairly long time. They've had to work on these business plans and we have a fairly good plan site by site what we want to do. We have designated a few sites, a handful of sites as those that will participate in a limited market release phase. you, while the catheter has, um, has kind of shown itself to be robust and working well, uh, across, uh, kind of many of the studies, you know, many studies now, and we, there is a type of also art to cardiac ablation procedures. And so you do want, uh, good physicians who are interested in being the pioneers who are interested in doing the early procedures, to have a first shot at things, to learn some of the tips and tricks that can only really be learned in that setting, and then to be available to share their experience and help also train others. And so I would think about an LMR period of probably kind of several weeks, you know, a few number of months, a couple months perhaps. And we're really focused on those sites and making sure that they use the catheter across the range of cases and can kind of document and refine best practices, at which point then we would move into a full launch across all the 30 accounts in Europe. And so I think about it as a relatively, with that kind of limited market release period, post that being a relatively quick adoption across our install base, I've talked in the past that there are certain countries in Europe where you do have tenders or other kind of administrative hurdles which don't allow you to fully kind of convert an account and just based off of commercial agreements and just based on kind of the physician's desire. So there are some of those places that countries like France, some of the Scandinavian ones You do have kind of other logistical barriers, which will just take kind of over the course of probably a year or so. You can overcome the vast majority of those. But there are some of those that will slow adoption at certain accounts as we work through them.
spk08: Okay, great. Very helpful color, David. Thank you for that. And for the follow-up, just wanted to ask about HRS, which is scheduled for later this month. And I saw in the press release, something about the potential to share meaningful updates on the innovation strategy at that conference. I was hoping you could just expand on that a little bit. What do you have planned, either from a clinician standpoint or Wall Street perspective? Just any more details on HRS would be great. Thanks for taking the questions.
spk11: Thanks, Adam. Stay tuned. We, at this point, won't share much more, but as kind of it's appropriate and as we're able to share more, we look forward to sharing some news at HRS that we think will be impactful for the EP community and also impactful, obviously, for the company and for the investor base. And so we look forward to sharing it there. And more generally at HRS, we're excited for our showing there. There is a special session, a joint session of the Society for Cardiac Robotic Navigation and HRS at the conference. And so that will be a nice session in which robotics is obviously kind of front and center. And again, apologies, I can't share much more at this point, but we look forward to sharing news in less than two weeks.
spk09: Okay, perfect. We'll stay tuned there. Thank you. Thanks, Adam.
spk05: There are no further questions at this time. I'll now turn the call back over to David Fishel, Chairman and CEO of Stereo Taxes, for any additional or close remarks.
spk11: Okay. Thank you very much for all your questions. We look forward to sharing the updates at the Heart Rhythm Society meeting next week and working hard on your behalf in the coming months. And we'll speak again in a quarter. Thank you.
spk05: This concludes today's conference call. You may now disconnect. Thank you. you you Thank you. Thank you. Thank you. Good morning. Thank you for joining us for Stereo Tax's first quarter 2023 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 risk, 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 of 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. At this time, all participants have been placed in 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.
spk11: Thank you, Operator, and good morning, everyone. Our last call two months ago included a fairly comprehensive overview of Stereotaxis and our strategy. We will keep today's call more brief, focusing on a few commercial and innovation updates. Revenue in the first quarter was essentially identical to last year's first quarter, barring the royalty payments that we no longer receive from John Johnson. System revenue in the quarter reflects partial revenue recognition on the shipment of one Genesis system that is completing installation as we speak. During the first quarter and subsequent to our last earnings call, we received a purchase order for a Genesis system from a US hospital. We received another Genesis system order from Europe so far this quarter. The combination of the partial system revenue recognition out of our backlog and the additional order into our backlog slightly increased quarter-end system backlog to just over $15 million. Hospital construction has remained relatively slow, weighing on the speed with which backlog converts into revenue and then into installed active robots. That said, we have a fairly busy schedule of installs planned over the coming months, and continue to expect the majority of our backlog to be recognized as revenue this year. Since the launch of Genesis three years ago, we have now received orders for 22 robotic systems. Building a capital sales capability, process, and infrastructure has taken time and required significant effort, but these 22 orders over three years is a dramatic turnaround from the period prior to Genesis when only one system was ordered over the same timeframe. Of the 22 robots ordered since our launch, nine have been installed and are doing procedures, five have been shipped to the hospital customer but are not yet installed or launched, and eight remain in backlog waiting to be shipped. Our orders have been broad-based geographically with just over 50% of orders from the United States and approximately 25% each from Europe and Asia. They are also evenly split between greenfield robots and upgrades with 11 of each. We are continuing to improve and refine our commercial capabilities and expect as we do so to see increasing orders of genesis. Our capital pipeline looks healthy and is seeing growth across our three focus regions. We have a few dozen, approximately 50, unique opportunities in our near-term pipeline where we see a possible order over the next 12 months. Order flow remains lumpy, the macro environment remains pressured, and we have still not fully benefited from a normalized replacement cycle. But given the engagement we see from the bottom up, there's increasing confidence in a consistent flow of orders. Most important to the adoption of robotics is the enthusiastically positive experience of the physicians who are using Genesys, along with the reliability and clinical value Genesys robots are demonstrating in the field. Engaged and happy customers who are able to provide great care to their patients and build successful practices are the best ambassadors through which to ultimately increase awareness, change historical misperceptions, and grow adoption. We are pleased with the procedure utilization we are seeing on Genesis robots, which is meaningfully higher than our average global utilization. This is playing out both at accounts that upgraded to Genesis and with those that establish entirely new robotic practices. Last month, I had the opportunity to meet physicians from two of our most recent Greenfield Genesis launches, Poland's National Institute of Cardiology and Broward Health Medical Center in Fort Lauderdale. Where at both, we have happy and excited users who are grateful for our technology and are using it to treat patients in ways that meaningfully improve the quality of care and access to care. Discussions like those reinforce the positive impact of our technology and the relevance and importance of robotics for the field. Our overall experience with Genesys serving as the spark to restart capital adoption and to support utilization is a reminder of the significant impact innovation has on commercial results. This segues well into a few comments on innovation. On our last call, we discussed in detail the key efforts in our strategic innovation plan. and how they deliver meaningful clinical, commercial, and strategic value. Apart from the minority of our users who have been able to upgrade to Genesis, most existing robotic electrophysiologists have remained limited to using essentially the same ecosystem of robot, catheter, and mapping technology for over a decade. SerioTexas' proprietary robotically navigated ablation catheter, MAGIC, is set to positively address this. Since our last call, we have made significant progress on both the EU and U.S. regulatory paths for MAGIC. In Europe, we have been awaiting receipt of the full spectrum of technical, clinical, and microbiology questions from the EU regulator. We have now received questions across all three of those categories and have fully responded to all the questions in what we believe to be a comprehensive and thoughtful manner supportive of CE Mark. It would not be surprising to receive follow-up questions to our responses, but we believe our previously communicated timeline is reasonable and still see receipt of CMARC as most likely to occur late in the second quarter or in the summertime. In the U.S., submission of an IDE application to the FDA has been dependent on successfully completing a dozen preclinical studies. As of our call two months ago, we had established a GLP-level institutional animal care and use program and run a few pilot cases, but had not yet performed those on-the-record studies. We completed all the required studies since that call and will complete all the required follow-up periods within the next two weeks. The results we have seen and physician feedback we received is very supportive of our confidence that the catheter performs well and will be enthusiastically adopted by the community of robotic users. Given this progress, we expect to make an ID submission to the FDA in the third quarter. Our other major innovation efforts, including a smaller self-shielding robot that frees us from the extensive planning and construction currently necessary to adopt robotics, a family of interventional guide wires and guide catheters that expand the benefits of our robot into new endovascular indications, a digital surgery hardware and software offering enabling broad operating room connectivity, and a full electrophysiology product ecosystem being built in collaboration with Microport. There is a significant amount of work and progress being made on each of these in parallel. As we provided much more color on each of these during our last call, I'll just reiterate that the timelines communicated on that call stand. We have line of sight to reaching multiple significant regulatory and commercial milestones this year, with growing commercial impact from each of these technologies next year. As these technologies come to market, we will host focused innovation days to present these technologies in greater detail. While the optics of Stereotaxis' financial results are unexciting, we see ourselves as being on the cusp of a strategic transformation. We have clear line of sight to a future with strategic independence, an attractive revenue model, broad robot accessibility, and platform indication opportunities. This core product ecosystem serves as a foundation for a high-growth, high-value medtech company pioneering endovascular robotics. Kim will now provide some commentary on our financial results, and then I will make a few financial comments as well before opening the call to Q&A.
spk00: Thank you, David, and good morning, everyone. Revenue for the first quarter of 2023 totals $6.5 million, down from $7 million in the prior year first quarter primarily due to discontinued royalties from Johnson & Johnson. System revenue of $1.8 million reflects revenue recognition on the delivery of one Genesis system. Recurring revenue for the quarter of $4.7 million was predominantly impacted by the absence of the J&J royalty, along with a smaller impact caused by J&J capital production shortages, which pressured procedure volume. Gross margin for the first quarter of 2023 was 59% of revenue. Recurring revenue gross margin of 79% remained similar with recent quarters, with the loss of royalty impacting otherwise operational improvements. System gross margin of 7% continues to reflect significant allocation of overhead expenses over low manufacturing volumes. Operating expenses in the quarter of $9.5 million included $2.6 million in non-cash stock compensation expense. Excluding stock compensation expense, adjusted operating expenses were $6.9 million compared to the prior year adjusted operating expenses of $6.5 million, reflecting increased spending in R&D. Operating loss and net loss in the first quarter were $5.6 million and $5.3 million, compared to $4.1 million for both in the previous year. Adjusted operating loss and net loss for the first quarter, excluding non-cash stock compensation expense, were $3 million and $2.7 million. Negative free cash flow for the first quarter was $3.2 million. At March 31st, we had cash and investments of $26.8 million. I will now hand the call back to David.
spk11: Thank you, Kim. As detailed in today's press release, we are reiterating our expectation of double-digit revenue growth for the year, given our existing system backlog and the view we have into our near-term system pipeline and installation schedule. System orders are also expected to increase in 2023 compared to 2022. Genesis system revenue remains the primary driver of overall revenue growth until we start to see more meaningful commercial contribution from our innovation strategy in 2024. Our core recurring revenue business remains relatively sticky and stable, and we expect will be boosted significantly as we bring the magic catheter and vascular interventional devices to market. That said, procedures and disposable revenue in the first quarter were slightly pressured by catheter shortages J&J experienced due to supply chain and production challenges. These challenges have continued into April, but we are told by J&J that they will be addressed by the end of the quarter. We expect some impact from this, likely in the low hundreds of thousands of dollars during the second quarter. Situations like these further reinforce the strategic, operational, and financial value of the magic catheter and having control over our own destiny. As we advance our innovation strategy to market, we maintain a balanced financial posture. We are investing in the organizational infrastructure and capabilities that will allow us to drive significant revenue growth from those innovations. At the same time, we remain financially prudent to ensure that our existing balance sheet can comfortably fund all our innovation efforts and commercial launches without the need for additional financing. We look forward to now taking your questions. Operator, can you please open the line to Q&A?
spk05: Thank you. At this time, we will now conduct today's question and answer session. To ask a question, please press star then the number one on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. We'll take our first question from Joshua Jennings with TD Cowan. Your line is now open.
spk03: Hi. Good morning. Thanks a lot for taking the questions. Hi, Josh. Good morning. Good morning. Thanks. I wanted to ask about just the replacement cycle channel. And are you seeing any cracks in terms of that opening up? And what do you think needs to happen for that replacement cycle opportunity to start to kick in more fully?
spk11: Sure. So it's been interesting because when we started this with the launch agenda around three years ago, we were always talking about the typical traditional 10-year cycle by which capital equipment gets replaced, and by capital equipment we mean mainly x-rays in cath labs. And clearly that has been extended over the last few years where we now have multiple systems that are even 14, 15 years old out there in the field. I think in the past I've mentioned that it's unclear how much of that extension of the life of x-rays is due to cyclical nature, just the macroeconomic environment and the financial pressures that hospitals have been under, versus a secular change due to perhaps the reduced use of x-ray overall and so the longer life that they can exist before needing to be replaced. Probably the truth is a mix of both. Either way, we have not seen a contraction in that age where people are now starting to replace x-rays earlier. So it seems like the average age of an x-ray is definitely extending in most settings beyond 10 years. We are starting to see, as some of these sites become very old, we are starting to see obviously much more of a contribution from the replacement cycle of the two orders that we just mentioned. One was a replacement order. One was a greenfield order. But I would expect still that in our normalized level, we should probably be receiving high single-digit number of replacement systems a year. We've still not gotten to that point. We're still probably in the mid-single digits, and so we probably still have a little bit of room to go to get to a more normalized level.
spk03: Understood. I wanted to ask, a question about potential just, you know, your drive for an open ecosystem within the EP world. Are there any potential advancements with, say, an Abbott to integrate your robotic magnetic navigation technology into the InsightX mapping platform or any other mapping system integrations that we should have on our radar for this year?
spk11: Sure. So, we won't, obviously, we can't comment on any type of collaborative activities that we would be doing prior to them being announced. I'd say that we've talked, obviously, about the importance of open ecosystems more generally for progress of the medical field and for patient care and for physician choice, and more specifically also for stereotaxis in being able to pair the benefits of robotics broadly with a range of diagnostic and therapeutic technologies. And so that concept of an open EP ecosystem is an important one. I think we've made quite a lot of progress on it over the last few years, and there's obviously more progress to be made. And so I'd say stay tuned, and we look forward to sharing updates as we're able to.
spk03: Great. And this last question, sorry to sneak one more in, but I know this full-scale depletion race in terms of getting a commercial cath in the United States is on the major cardiac depletion catheter players kind of teed up to get approvals over the coming 12, 18, 24 plus months. I guess, how would you have investors think about the role that robotic magnetic navigation system like Genesis or mobile could play and could potentially enhance one of these larger player platforms and help them win this race, this PFA race. Thanks for taking all the questions, David.
spk11: Sure. And so we obviously see what's going on in the field and overall, view kind of how PFA is evolving into the field. In many ways, we view actually robotics as particularly well-suited to be paired with PFA. We've had some experience. We discussed in the past some of the preclinical studies that we've done with different PFA generators and some of the ongoing work that we are doing there. And given the constant and consistent contact that a robotically navigated catheter has with the heart tissue, there are actually particular mechanistic benefits to pairing a robot with PFA. And we've done the preclinical work, and like I've mentioned, we're trying to kind of advance things in a way where we can reach a first-in-man study and provide kind of more clarity on a clinical commercial timeline. I'd say kind of overall, I would look though, when I step back and think about PFA and how it's entering the EP field, when you look at kind of all the cardiac ablation procedures more generally, and really kind of PFA is right now being targeted at paroxysmal AF, and there's some thoughts in calls of persistent AF. And we have a vast, we have a majority of our procedures kind of in the ventricle and certain SVT style procedures where probably it will take still five to ten years to know the role of PFA in those settings under certain procedures where PFA will likely never be particularly applicable or beneficial or safe and given kind of the type of arrhythmias that you would be dealing with in certain focal arrhythmias and even in AF as you have probably noticed the original view of PFA being a panacea has evolved into a more nuanced understanding of its role and its partial role in the field. And so I think, again, we might not be the first mover in the PFA space, but I think we're doing all the right things on kind of the backside to make sure that we have a nice offering there. And that's where, again, this open EP ecosystem does provide a lot of value in allowing us to pair the benefits of robotics with a range of other technologies that are being developed.
spk12: Excellent. Appreciate it. Thanks, David. Thank you.
spk05: Next, we'll go to Frank. Taking in with Lake Street, your line is now open.
spk02: Great. Thanks for taking the questions, and good morning. I wanted to start with one on the construction timelines. You briefly commented on it in the prepared remarks, but I was hoping you could take us a little bit deeper into how the construction timelines have been trending year-to-date and if there's any sign of those starting to be a little bit more predictable as we look at the back half of 2023.
spk11: Hey, Frank. Good morning. So, when I look now at kind of our, I guess, history of these 22 orders received since we launched Genesis, it seems kind of almost kind of – there's a lot of variability around these averages, but almost kind of – you know, one year from an order till, you know, roughly till most sites get kind of revenue recognized and installed and around two years until they go after, revenue recognized that they get shipped and then kind of around two years until they get kind of installed and are starting to do procedures. There's obviously wide variability around that. We've had orders that get shipped and installed and starting doing procedures within, you know, six, nine months. And we've had things where it takes two years and you still don't recognize revenue by shipping the system. And so there's kind of a wide band around that, but that seems to be kind of what the average has ended up being. We are seeing more, definitely more scheduled installations over the next, let's say, nine months or the remainder of this year. with a fairly busy schedule of things. Some of those are things that have been backed up for long periods of time, and other of those are from fairly recent orders where the sites seem to be on track for meeting the timelines that they want to have for installation. We still see many anecdotes, many cases of hospitals that have a plan and that plan gets significantly delayed due to whatever construction issues or permitting issues they have. I still am very much looking forward to the day where we do not have the complexity and the pain of the architectural and construction timelines, but at least we're seeing some movement there. kind of seemingly that is real, real new for the next several months.
spk02: Okay, that's helpful. And then for my second one, maybe speak to some of the usage patterns you've noticed from the new Genesis installs over the last couple years. And what I'm hoping you can touch on is maybe where are these physicians typically starting to use the technology with patient pool And what's their usage patterns look like at different milestones, say three months, six months, 12 months? I'm just trying to get a better understanding of how the new Genesis users are ramping and how their usage is expanding within their patient populations.
spk11: Sure. So I don't have all the data in front of me to answer you kind of in a comprehensive way with three-month, six-month, 12-month data. But let me think and provide kind of a rough answer for that. And obviously kind of across our installed base, stereotaxis is overrepresented in the more complex ablations. That's where the mechanistic benefits of our robots are particularly pronounced. And so about half of our volume is in ventricular tachycardia, premature ventricular contractions, congenital patients, and those types of patients. And that's also a patient population which is generally underserved, undertreated, and many of them don't have an option for good therapy without the use of our robot. And so that's where we provide particular clinical value. That said, there is benefits obviously across the spectrum of ablation procedures. And so there are even procedures that might be considered typically as simple procedures where we are being used because of the safety profile and the precision of robotics and the clinical benefits that provides. And so there is kind of a full spectrum. When I think about kind of our genesis install base, generally would say that the types of procedures they perform follows that spectrum of our overall install base. And so we definitely have a pronounced use in the complex cases, and that is oftentimes the motivating driver for why, let's say, a Greenfield account would adopt a robot. But we do see usage across the spectrum of procedures, not just in the most complex ones, at least across many of the sites. There are certain sites which might limit us only to the more complex cases. But we definitely do see across the installed base, across the Genesys installed base and across Greenfield Genesys installs, also usage kind of across the spectrum. And does that kind of partially answer you?
spk02: Yes. No, that's perfect. Appreciate the color and thanks for taking the questions.
spk11: Thank you very much, Frank.
spk05: Next, we'll go to Alex Nowak with Craig Halam Capital Group. Your line is now open.
spk09: Okay, great. Good morning, everyone. Maybe just expand on the J&J royalty going away. Just remind us the dynamics around that. And if the royalty didn't go away, what were going to be the consumable sales in this quarter, just so we can figure out sort of same store volume trends?
spk11: Sure. Hi, Alex. Good morning. We've had obviously a very long-term relationship with Johnson & Johnson. And several years ago, that relationship was turned from an exclusive relationship into a non-exclusive relationship. And then there was the timeframe where it would remain a non-exclusive relationship. and then where there would be a tail supply period where still for several years J&J would have to continue supplying catheters to the market. And that transition from the non-exclusive relationship to the tail supply period started at the beginning of this year, and J&J stopped paying us royalties at that time. We missed out on something like about half a million dollars in the quarter due to the lack of the royalties.
spk09: Okay, that's helpful. And then how long does that tail supply agreement last till? A three-year period. It's three years. And then after the three years, there's basically no assumption that they will continue to supply catheters. Is that right? That will be a timeframe we need to have magic on line by.
spk11: There is no legal requirement, contractual requirement, and I think it's still open to interpretation of how things will play out there, and open to seeing how things will play out. But if we do our job well, there shouldn't be any reason for them to continue supplying.
spk09: Okay, understood. And then any discussion with the FDA around the Gen 3 self-shielded robot? Just what needs to be done internally before submitting that 510K? And then, you know, what could influence the timelines? What could pull it forward? What could drag it out?
spk11: So we have made an initial, you know, we've informed FDA that this is kind of coming. So there's some awareness there that we've not kind of submitted any documentation in a material way. And there is a lot of very recent experience with FDA on a robotic magnetic navigation system. We received Genesis FDA approval just three years ago, and so we went, and that was a fairly extensive process. For those of you that were on the calls at the time, you may remember we had some catch-up 510ks that had to be done. So there were multiple steps in the process of that approval, given the long period that stereo taxes had not been in regular dialogue with FDA. And since that time, we have been in relative dialogue. I think kind of we keep them up to date on our progress. And so overall, I think we have a fairly clear understanding of the of the requirements for submission, obviously regulatory uh, expectations evolve also over time. So let's say we're, we're aware of the fact that there's generally more of a focus on things like human factors testing and on cybersecurity. And so, you know, we know that those are things that perhaps we want to do, uh, to at least document in a more extensive fashion, uh, versus previously. But, uh, but overall I think we feel very comfortable about, uh, about the regulatory path and, um, and what needs to be done on our side, and we have the very recent experience which guides our path.
spk09: Excellent. Thanks for the update. Appreciate it. Thank you.
spk05: Okay, next we'll go to Neil Chatterjee with B Riley. Your line's open.
spk09: Hey, guys. Good morning. Thanks for taking the questions. Just curious how, you know, Things are shaping up with the current capital spending environment and kind of ongoing hospital headwinds. Sounded like you still kind of see a pipeline of about 50. So just kind of curious to get an update there.
spk11: Yeah, so when we look at kind of the pipeline, I've kind of mentioned in the past that we have a more and more organized way to now review the pipeline and status in each region. And there's approximately two dozen, a little over two dozen in the US, about a dozen in Europe, and about a dozen in Asia that have kind of accumulated on this pipeline where the sites are talking about potentially getting in order over the next year. And what I've seen generally is that there's obviously a subset of those that will get delayed, but kind of that's how our pipeline looks at this point. So I pair, I guess, this bottom-up relative kind of healthy growing pipeline, I think, as our team matures, as kind of their efforts in the field mature, as the general marketplace, I think, sees our overall progress as a company, That helps. And so I see that kind of bottom-up pipeline as it's growing. I pair that with kind of the top-down assessment that it still remains a relatively pressured environment. The macro environment is what I've called in the past as still a headwinds environment, not a tailwinds environment. But I think with the balance of those two, And we're able to do kind of some progress, obviously, and we feel confident in the guidance that we've given this year. And so I guess kind of that's the balanced viewpoint, giving the spot-up and top-down data.
spk09: Got it. Thanks for that. And then just maybe on China and microport, you know, the ecosystem there that's being developed, Didn't sound like any huge updates on, you know, there versus the last quarter or last call. Just curious, you know, how things are tracking there. You know, you obviously had Genesis, you know, submitted for approval and the broader platform being developed. Just curious on an update.
spk11: Sure. So, yeah, so MicroPort submitted Genesis at the end of last year and over the last couple couple months has been submitting some supplemental information to the regulator there to that MPA and they you know we're and and has been also working on its submission for the catheter and it has to wait until we get the e-mark for MAGIC before it can submit MAGIC given the pathway that we want to go through but it's also working on the submission for its own variant of a magnetically driven ablation catheter and and from the mapping integration perspective we've already done very well and that's something that won't be a long pole in the tent at all and so as we look at kind of all of that and what my report feels is a reasonable timeline given its discussions with with NMPA and we're still kind of comfortable in this first half of next year that full ecosystem coming together there might be certain approval that can come earlier and but but I'd say that kind of that feels like the right timeline overall. And really it is that ecosystem of robot caps that are mapping that should come together well in order to allow for the full launch and taking advantage of the full commercial team.
spk09: Got it. Maybe it's one last quick one. I don't know if I missed it, but just any updates on how you're tracking for the mobile RMN, you know, clearance in Europe in the second half?
spk11: Yes, so we've talked about kind of in the third quarter, and so I'd say we are working feverishly on multiple fronts there to be ready for kind of an approval at that point in the third quarter.
spk09: Great. Thanks. That's it for me.
spk05: Thank you. Okay, next we'll go to Adam Mayer with Piper Sendler. Your line is now open.
spk08: Hi, David. Hi, Kim. Thank you for taking the questions. Two from me. The first one is on the Magic RF catheter. And I think I heard timelines for Europe still stand late Q2 or summer. Can you talk just a little bit about kind of commercial strategy there in terms of the launch? You know, how aggressively will you be rolling Magic out to customers and Will you look to bolster or add sales reps prior to launching that? Just maybe flesh out the commercial strategy a little bit and then add a follow-up. Thanks.
spk11: Sure. Hi, Adam. Good morning. And so, yeah, so the timeline, obviously, it still remains somewhat of a black box. You respond to questions, then you kind of sit and wait, but everything is now kind of back on their court. We were very pleased that we got at least the first set of questions from them across all three categories, and we were able to respond in a timely fashion. And when we look at kind of the commercial, and so assuming we get approval at some point this summer, and the overall commercial strategy is we have invested somewhat in our team in Europe. And so we have kind of two people more than what we have had historically. And that was done in anticipation of kind of magic coming to market and the opportunity that would present itself. And we have kind of done fairly detailed reviews of every one of our 30-some hospitals in Europe that have a robot. And in each one, understanding both the logistics of bringing the catheter to market. Is there a tender? Is there not? You know, a hospital application needs to be filled in just on the logistics side. On the financial side, what should pricing look like? On the kind of clinical side, what are the motivations of the physicians? What do they think about the catheter? What would be the drivers of adoption, the risks to adoption? So I think we have a good clarity. The team there has worked kind of now for a fairly long time. They've had to work on these business plans, and we have a fairly good plan site by site what we want to do. We have designated a few sites, a handful of sites, as those that will participate in a limited market release phase. while the catheter has kind of shown itself to be robust and working well across kind of many studies now, there is a type of also art to cardiac ablation procedures. And so you do want good physicians who are interested in being the pioneers, who are interested in doing the early procedures, to have a first shot at things, to learn some of the tips and tricks that can only really be learned in that setting, and then to be available to share their experience and help also train others. And so I would think about an LMR period of probably kind of several weeks, you know, a few number of months, a couple months perhaps, And we're really focused on those sites and making sure that they use the catheter across the range of cases and can kind of document and refine best practices, at which point then we would move into a full launch across all the 30 accounts in Europe. And so I think about it as a relatively, with that kind of limited market release period, post that being a relatively quick adoption across our install base. I've talked in the past that there are certain countries in Europe where you do have tenders or other kind of administrative hurdles which don't allow you to fully kind of convert an account and just based off of commercial agreements and just based on kind of the physician's desire. So there are some of those places that countries like France, some of the Scandinavian ones You do have kind of other logistical barriers, which will just take kind of over the course of probably a year or so. You can overcome the vast majority of those. But there are some of those that will slow adoption at certain accounts as we work through them.
spk08: Okay, great. Very helpful color, David. Thank you for that. And for the follow-up, just wanted to ask about HRS, which is scheduled for later this month. And I saw in the press release, something about the potential to share meaningful updates on the innovation strategy at that conference. I was hoping you could just expand on that a little bit. What do you have planned, either from a clinician standpoint or Wall Street perspective? Just any more details on HRS would be great. Thanks for taking the questions.
spk11: Thanks, Adam. Stay tuned. We, at this point, won't share much more, but as kind of it's appropriate and as we're able to share more, we look forward to sharing some news at HRS that we think will be impactful for the EP community and also impactful, obviously, for the company and for the investor base. And so we look forward to sharing it there. And more generally at HRS, we're excited for our showing there. There is a special session, a joint session of the Society for Cardiac Robotic Navigation and HRS at the conference. And so that will be a nice session in which robotics is obviously kind of front and center. And again, apologies, I can't share much more at this point, but we look forward to sharing news in less than two weeks.
spk09: Okay, perfect. We'll stay tuned there. Thank you. Thanks, Adam.
spk05: There are no further questions at this time. I'll now turn the call back over to David Fishel, Chairman and CEO of Stereo Taxes, for any additional or close remarks.
spk11: Okay. Thank you very much for all your questions. We look forward to sharing the updates at the Heart Rhythm Society meeting next week and working hard on your behalf in the coming months. And we'll speak again in a quarter. Thank you.
spk05: This concludes today's conference call. You may now disconnect.
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