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spk07: At this time, we are assembling audience members and plan to be underway shortly. We'd like to thank you for your patience and ask that you please continue to stand by.
spk01: Thank you.
spk07: Please stand by, we're about to begin. Good morning, thank you for joining us for Stereo Tax's fourth quarter and full year 2021 earnings conference call. Certain statements during the conference call and question and answer session period to follow may relate to future events, expectations, and as such, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the company in the future to be materially different from the statements that the company's executives may make today. These risks are described in detail in our public filings with the Securities and Exchange Commission, including our latest periodic report on Form 10-K or 10-Q. We assume no duty to update these statements. At this time, all participants have been placed on a listen-only mode. The floor will be open for questions and comments following the presentation. As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to your host, David Fischel, Chairman and CEO of Stereo Taxes.
spk09: Thank you, operator. Good morning, everyone. I'm joined today by Kim Peary, our Chief Financial Officer. My prepared remarks today will be a bit longer than normal as I use the occasion of our annual call to provide a broader overview of Stereotaxis and our vision. I will then review our progress in 2021 and our key goals and expectations for the year. Stereotaxis is the pioneer and leader of robotics for endovascular surgery. We've developed a highly innovative suite of technologies that address the inherent limitations, risks, and challenges posed by manual handheld catheters. Our mission is to make minimally invasive endovascular surgery more broadly available, to improve its safety and outcomes, and to modernize it with the benefits of digitization and robotics. Endovascular surgery is a broad and growing field of medicine where small interventional devices are navigated through a patient's vascular system. Endovascular procedures positively impact millions of patients annually, but the mechanism of action of manual handheld catheters has fundamental flaws. During a procedure, therapy takes place at the catheter tip, but a manual catheter is held and manipulated several feet away at the handle, like holding a pencil from its eraser. It's not precise, not stable, and there's limited reach. Manual catheters need to be rigid to allow for any control of the tip, increasing the risk of patient injury. Procedures are complex and operator-dependent, and visualization of the catheter exposes patients and physicians to X-ray radiation. Stereotaxis' robotic technology addresses the inherent limitations, risks, and challenges of traditional endovascular surgery by allowing for direct control of a catheter tip using precise, computer-controlled magnetic fields. This allows for unprecedented precision and stability, enables reaching areas previously unreachable, and enhances patient and physician safety. Physicians operate our robot from a computer cockpit, seated and protected from radiation, with full control over the procedure, and with an ability to focus on the cognitive aspects of their profession. These benefits are not theoretical, as hundreds of physicians at over 100 leading hospitals have treated over 100,000 patients with our technology, and there are over 400 scientific publications documenting our clinical value. A highly differentiated platform technology that confers meaningful clinical value in a large field of medicine serves as the perfect foundation on which to build a preeminent medical robotics company. To realize our great potential to positively transform endovascular surgery, we've spent the last years putting in place the necessary foundations, financial, commercial, and technological, for a healthy company with substantial long-term growth. The first necessary foundation was financial stability and strength. We start 2022 with $40 million in cash, no debt, and with a business that can make significant investments in key value drivers while still maintaining financial discipline and operating near break-even. In 2021, we invested 30% of our revenue in R&D, a level that dwarfs the typical medical device company and allows for a robust innovation pipeline. We built and moved into a new headquarters and manufacturing facility that will serve as the foundation for many years of growth. We invested in improved IT infrastructure, and we are methodically growing and enhancing our team with key hiring across the organization. With all those investments, we maintain cash utilization of approximately a million dollars a quarter, a level that we are very comfortable with given our balance sheet, and that importantly conveys long-term stability and reliability to our customers and partners. The second necessary foundation was implementing the right commercial infrastructure and processes that support adoption of our technology and allow existing customers to showcase their leadership. While we still have substantial work to do here, key cornerstones of those foundations have been established. Our Robotic EP Fellows Program graduated 23 physicians globally last year. These fellows represent the future of EP and enter the community confident in our technology and its values. We recently expanded the robotic EP fellowship program with a light version designed for existing EPs that want an introduction to robotics. Much of this training has been possible through realistic training simulators. We just launched our latest generation simulator, which has enhanced realism, gamification features, and is available online. We continue to support a community of engaged EPs that are advancing clinical knowledge in the field. The Society for Cardiac Robotic Navigation has grown as an independent society with an engaging conference in November. Physicians using our technology published 22 peer-reviewed publications last year, including highly positive ones showing superior clinical outcomes for robotics in the treatment of pediatric patients and an 82% reduction in the rate of silent strokes during AF ablation. Clinical supportive procedures remains highly important in EP, and we pride ourselves on building a skilled and impactful commercial team. This team works in an integrated fashion, leveraging proprietary connectivity technology to provide a network of in-person and telerobotic technical and clinical support, a model for the future of procedural support across healthcare. We look forward to building this team substantially in tandem with the introduction of new disposable products that drive higher utilization and revenue per procedure. In 2021, Stereo Texas demonstrated it could meaningfully restart capital sales. After many years of minimal activity, we sold seven systems during this year. The restart of system sales played out globally, with three of these in the US, two in Europe, and two in China. Five of these systems were to hospitals establishing entirely new robotic practices. We've been pleased with how reliable and well our latest robot, Genesis, is performing in daily real-world use with the utilization of Genesis accounts and with the positive feedback from users. Since FDA approval of Genesis exactly two years ago, we've received orders for 13 robotic systems in total, the majority from new Greenfield customers. This rebuilding of a capital sales capability has taken place despite the backdrop of a challenging macro environment. Four of these orders, received in the latter month of 2021 and start of 2022, will contribute to our capital revenue this year. The makeup of these orders both geographic and customer mix, is fairly similar to last year, with two from the U.S., one from Europe, and one from China. Half are greenfield and half are replacement projects. On our last call, we expected several near-term replacement system orders. There were four specifically that seemed very close to completion and that should have been received by now. In each of these cases, clinical support remains high, and the hospital will need to initiate a replacement project in the near term. We are still working towards the orders and believe they should be received soon. The delays highlight the challenge of scaling a capital business dependent on construction project timelines, particularly with the destruction of COVID and with construction hampered due to supply chain and labor issues. We have a pipeline of over a couple dozen high likelihood capital projects globally, reflecting a good mix of both greenfield and replacement projects. We still expect a similar amount of capital revenue from Greenfield accounts this year as received last year, which was five systems. We had previously expected a normalized level of replacement cycle capital in 2022, which given our install base, should be in the high single digit number of systems a year. While the replacement cycle opportunity is essentially a guaranteed revenue stream, it has remained muted as hospitals continue to extend the life of labs. We expect 2022 to have more replacement activity than the two systems recognized last year, but likely still below a normalized level. Our launch of Genesis was an initial demonstration of how meaningful innovation can drive revenue growth. We continue to expect Genesis to contribute to growth this year and in the future, but it was really the first stepping stone in our effort to build a product ecosystem that allows for widespread adoption of robotics as a platform technology across endovascular surgery. At our recent innovation day, we outlined a pipeline of technologies that are in the latter stages of development. These are the technological foundations necessary to fulfill our potential, and they serve as multiple independent drivers of growth in the coming years. Specifically, we view our key growth drivers as, first, a mobile robotic magnetic navigation system that enables broad accessibility of robotics. Second, our own independent ablation catheter portfolio for the EP market. Third, a family of guide wires and catheters that expand the benefits of our robot into new endovascular indications. Fourth, a separate China-specific EP product ecosystem we are developing in collaboration with Microport EP, and fifth, a digital platform for broad operating room connectivity. Each of these opportunities by themselves can serve as substantial growth drivers that dwarf our existing business. They have value being advanced independently, but are also synergistic and complement each other. Collectively, they serve as the foundational product ecosystem as we look to transform endovascular surgery with robotics. The first technology, a smaller, self-shielding mobile robot, frees us from the extensive architectural planning and construction currently necessary to adopt our technology. It makes our robotic technology more accessible to the many physicians and customers that have wanted to adopt or try it, but weren't able to navigate the logistic and economic hurdles. We are aggressively advancing through mechanical, electrical, and software development, and our R&D team benefits from its recent success with the Genesis system. We have working prototypes and near-final designs of most aspects of the robot, and have made this progress despite myriad supply chain delays. We expect to complete development in the second half of this year, perform testing and file for regulatory approvals in the U.S. and Europe at year-end, and to start limited commercialization in both geographies next year. While Stereo Texas can grow sales without the system, our mobile system is designed for manufacturing and deployment at scale so that we have a line of sight to selling over 100 systems a year. The second technology, a portfolio of ablation catheters for the cardiac ablation market, is important in that it significantly improves upon the aging catheter technology our current users are limited to, and in that it provides for a stronger strategic and financial foundation for us in electrophysiology. MAGIC, a robotically navigated auric ablation catheter, is the first catheter in this portfolio, and we've methodically advanced MAGIC towards CE mark and IDE trial submissions. Our partner of SIPCA faced multiple labor and material delays, and just completed the manufacturing of the hundreds of catheters necessary for regulatory testing. We are in the midst of formal testing and regulatory documentation of these catheters, but given the manufacturing delays and specific tests with longer lead times, we now estimate a CE mark submission in summer and an IDE submission shortly thereafter. We remain highly pleased with the feedback physicians provide on MAGIC and in its clinical, commercial, and strategic impact. Our regulatory submission in Europe will benefit from the experience that SIPCA recently had, bringing several of its own catheters through the new MDR regulations. Separately and importantly, we also are continuing to advance the pipeline of robotically navigated EP catheters that follow MAGIC, including a pulse field ablation solution and a single-shot cryoablation catheter. The third technology, a family of interventional guide wires and guide catheters, will allow our robot to be leveraged into several additional clinical indications where endovascular navigation can be challenging. We mentioned five specific indications of focus. Neural interventions, coronary angioplasty, peripheral intervention, tumor embolization, and AAA grafts. The first guide wires in this family have begun manufacturing for formal regulatory testing, and we expect to file regulatory submissions in Europe and the U.S. in summer, allowing for approvals late in the year. A family of similar guide wires and then larger guidance catheters will follow next year. We've started sharing this strategy with a select group of physicians that we believe will be early adopters of the technology across clinical specialties, both within existing hospitals that have our robot and in new potential hospitals, and are very pleased with the many scenarios where they view distal tip controllable wire as very helpful in reducing procedure time and challenge. The launch of these devices will demonstrate the power of our robot as a full platform across endovascular surgery. Fourth, in China specifically, we have a collaboration with Microport EP to develop and commercialize a product ecosystem for cardiac ablation that is independent of the ecosystem we're building in the U.S. and Europe. Microport has been advancing regulatory work for Genesis and subsequently the mobile robot, is developing compatible ablation catheters, and is integrating its mapping system with our robots. development of this ecosystem will allow us to benefit from my reports substantial commercial team in China and fifth we have always viewed connectivity as a core value proposition for our robotic technology and are leveraging our historical experience to build a modern platform for collaboration and remote support of operating rooms this enhances our robots and as independent value as a solution across operating rooms collectively These technologies serve as a foundational product ecosystem for a preeminent medical robotics company with the ability to transform endovascular interventions. They allow for significant growth in electrophysiology and the broader field of endovascular surgery in the coming years. Kim will now provide some commentary on our financial results, and then I'll make a few financial comments as well before opening the call to Q&A.
spk06: Thank you, David, and good morning, everyone. Revenue for the fourth quarter of 2021 totaled 8.2 million, a 21% increase from the prior year fourth quarter. Recurring revenue for the quarter was 5.7 million and system revenue was 2.3 million. Revenue for the full year 2021 totaled 35 million, growth of 32% from 26.6 million in 2020. Recurring revenue of 22.9 million for the full year 2021 increased 4% from the prior year, reflecting a partial recovery in procedure volumes from the depths of the COVID-19 pandemic in 2020. System revenue of $11.2 million for the full year 2021 increased from $3.6 million in the prior year, reflecting increasing adoption of our Genesis RMN system. Gross margin for the fourth quarter and full year of 2021 were 72% and 66% of revenue. For the full year 2021, we reported gross margins of 86% on recurring revenue and 33% for system revenue. These margins are consistent with our previous commentary and expected to remain stable with margin expansion and system revenue driven by scale. Operating expenses in the fourth quarter were 9.3 million, including 2.6 million in non-cash stock compensation expense. Excluding stock compensation expense, Adjusted operating expenses in the current quarter were $6.7 million compared to the prior year adjusted operating expenses of $5.7 million. Adjusted operating expenses for the full year 2021 were $26.9 million, up approximately 20% from $22.6 million in the prior year, with the increase driven predominantly by R&D project spending and measured hiring across key areas of the company. Operating loss and net loss for the fourth quarter of 2021 were both $3.4 million, compared to $1.2 million for both in the previous year. Adjusted operating loss and adjusted net loss for the quarter, excluding non-cash stock compensation expense, were $0.8 million, compared to $0.4 million for both in the previous year. For the full year of 2021, adjusted operating loss was $3.6 million and adjusted net loss was $1.4 million. compared to 3.6 million and 3.5 million in the prior year period. Net loss in the current year includes a favorable $2.2 million adjustment for the forgiveness of the Paycheck Protection Loan. Negative free cash flow for the full year 2021 was 4.3 million, compared to 3.6 million for the full year 2020. Excluding significant investments in our new headquarters and manufacturing facility, negative free cash flow for the full year 2021 would have been $1.8 million. At December 31st, we had cash and cash equivalents of $40.1 million and no debt. I will now hand the call back to David.
spk09: Thank you, Kim. As we look out on 2022, we anticipate revenue growth for the year driven by continued commercial adoption of the Genesis RMN system and stable recurring revenue. Based on current customer schedules, the majority of system revenue for the year will be recognized in the second half of the year. As mentioned previously in my prepared remarks, we anticipate a similar level of greenfield capital sales as the last year and some growth in replacement capital, but still below a normalized level. We continue to invest in the team, infrastructure, and projects that are critical for success and expect modest growth in operating expenses. We are proud that we can do this while maintaining financial discipline. A robust balance sheet allows us to reach profitability without the need for additional financings. We'll now take your questions. Operator, can you please open the line to Q&A?
spk07: Certainly. Thank you. To signal for a question, please press star 1 on your telephone keypad. Also, if you are using a speakerphone, please make sure that your mute button is turned off to allow your signal to reach our equipment. Once again, it is star 1 at this time for questions, and we'll pause to give everyone the opportunity to signal. Our first question will come from Alex Nowak with Craig Hallam Capital Group.
spk13: Great. Good morning, everyone. It sounds like you're pretty confident Genesis here could have at least six installs in 2022, if I'm adding this up correctly. So for orders, they talked about that at least.
spk05: Hi, Alex. I think we lost you for a moment. Mr. Nowak, if you would please check your mute button. We're unable to hear you. Maybe we'll move on and get back to Alex later.
spk07: Thank you. And moving on, we'll go to Adam Meter with Piper Sandler.
spk02: Hi, David. Hi, Kim. Thanks for taking the questions and congrats on the progress last year. Wanted to start with system outlook for 2022. I think you had previously talked about the expectation of a doubling of system revenue in 22 relative to 21. Sounds like that's no longer the expectation given what sounds like are some headwinds on the replacement front. So can you talk maybe a little bit about some of the developments in past months that have kind of colored that new viewpoint? you know, are you getting any feedback from customers that they're interested but potentially waiting on the next-gen mobile system in 23, or is this really just kind of a function of COVID-19, Omicron, and, you know, kind of the ripple through effects? Just any more color there would be helpful, and then I'd have a follow-up or two. Thanks.
spk09: Sure, Adam. So I think we've managed the introduction of new technology in our pipeline well, and I don't see that as having a material impact. As we described in the call, there are We have a relatively nice pipeline of customers that are interested. Generally, I was out in the field visiting customers also this week. Generally, when we're out, we can sense positivity that is growing on our technology and on our innovation pipeline as a whole. And so generally, it feels good. What's challenging is that it's very difficult to time customers. when exactly orders get received and when hospital construction advances. And so we have had, I mentioned on the call, that in November when we had our last earnings call, there were four replacement cycle orders that were seemingly imminent and that should have been received, and those four have still not been received. They remain seemingly imminent, And one of the primary drivers of the delays in each of those has been their own construction schedules and their own challenges with labor shortages or material shortages getting construction projects moving. And so there are macro headwinds that add to that. I think it highlights the value of some of the innovations that we're doing, particularly the increased accessibility of robotics in the future. But those are some of the challenges that we face. Our guidance, as we put it now, I think it's prudent given the fact that we, at this point in the year, have four systems that are kind of for revenue this year. I think it's prudent to give a guidance like we did, which is more or less similar greenfield numbers and more replacement than last year, but not yet at a standardized replacement cycle level. And so that felt like the prudent thing to do, given where we stand today. I can be surprised in a month from now and all four of those go through, or there's obviously others in the pipeline, but those should be the most easiest to bag. And we'll have to see how those go.
spk02: Got it. That's really helpful, Culler. Appreciate all that, David. And then maybe I'll ask about the, you know, the disposable side of the business. I think, I'm not sure it was addressed on the call, but I think I saw in the press release you're assuming more or less kind of a stable business in 22 relative to 21. So did I interpret that correctly? We should kind of think of disposable revenue kind of being similar to 2021 levels, or should we expect potentially some increase over last year? And then maybe just talk about kind of, you know, your expectations and what that implies from a system utilization standpoint.
spk09: Yeah. So I think the way that you read the press release is correct. And I think we, if you think about the primary drivers of recurring revenue will be increases in procedure with right now, which right now are driven predominantly by macro factors. And while there is some improvement in the COVID situation, in reality, we are, it is still overall you know, kind of a fairly similar environment for the last year or so. And so we don't necessarily know when COVID impacts will be completely gone at hospitals. And so I think that that kind of feels prudent. And then obviously the second much more substantial impact will be the introduction of new disposable devices. Given the timeline, we're not guiding for any material revenue this year, but we hope that we can start to, those can start to contribute to revenue late in the year. And when you think about kind of the other driver of utilization overall is the launch of new greenfield robotic practices. And overall, we've actually been very happy with the utilization and launch of greenfield practices. But given that there's no service revenue for the first year, they're under warranty. And given the natural ramp up in utilization that takes place as you train new physicians, as you get a new, completely new site up and running, those are relatively more minor contributors to recurring revenue. And you have the counteracting force that replacement cycle projects, you lose service revenue for that first year during the warranty period. And so given all of those dynamics, I think a relatively stable recurring revenue seems like the reasonable option. estimate for this year.
spk02: Okay. That's helpful. And I have more questions, but I'll let some others jump in. Thanks again for taking my question. Thank you.
spk07: We'll return to Alex Nowak with Craig Hallam Capital Group. All right. Excellent. Thanks.
spk13: Not sure what happened there, but thanks for bringing me back on. Sounds like the question I had was asked. I'm going to move over to kind of the prospective centers here. When you're speaking to them and sharing some of the interventional tools that you shared during the Innovation Day and the pipeline, what kind of has been their feedback? I guess how critical is it knowing that Stereotaxis is going to have additional capabilities beyond RF for those centers to be willing to go ahead and buy a Stereotaxis robot?
spk09: It's hard to answer that too clearly now. We have talked with several of our electrophysiology customers at first about tools like the guide wires and guide catheters, and there are actually some procedures in electrophysiology where there seems to be value. And through them, we've also been introduced or have had some discussions with interventional cardiologists and with other physicians kind of at their hospitals to And then obviously independent of that, there were some physicians that have been helping us in neurosurgery and in other fields. I can't say that for the specific Greenfield accounts that have been on our pipeline, high on our pipeline list, that suddenly the demonstration of these has changed the dynamic and they're suddenly accelerating versus what they were doing before. What I'd say is that it adds to the positivity of those discussions, particularly with administrators who kind of can start to see potential for broader use of the robot. And I think that as we also launch the devices and there starts to be real clinical use and demonstration of utility in other clinical indications, I think that that will be even a much stronger but much stronger kind of weight on the positive side of those discussions.
spk13: Okay, I've noticed that makes sense. And then in the interventional tools beyond EP, or I guess beyond your own magic catheter and some of the additional pipeline items here, you mentioned the regulatory submission timelines, but are there any other milestones that we should be tracking around manufacturing, technical feasibility, that we should be watching for throughout this year, just to confirm that we've got a working product here in these new categories?
spk09: Yes, it really will be the submissions because we have a product that has gone through many animal studies, a lot of testing, demos with many physicians. So I think I'm fairly, fairly, very confident that we have a working product. There is an extensive amount of documentation that is required for the submissions. and formalized testing for that documentation. There was obviously the ramp-up in manufacturing, which for disposable devices is much more stringent in its quality controls and in the requirement that from day one for those manufactured units, you have no flaws whatsoever in the manufacturing. And so those things obviously are... are kind of all necessary for prior to submission. I think kind of the main milestone that will be visible externally is when we actually submit for CMARC and IDEs or for the guide wires for CMARC and the 510K.
spk13: Okay, I hope that makes sense. Appreciate the update. Thank you. Thank you.
spk07: And next we'll go to Jason Wittes with Loop Capital.
spk12: Hi, thanks for taking the questions. Maybe just some follow-ups here. You mentioned four systems were imminent, and it looks as if they're just to be determined at this point. So I suppose some of that might have been built into your expectations for 2022. And then the second question related to that is, When you get that type of order, which I assume is a replacement, how quickly does it normally get into the ground? Is there still sort of a six- to nine-month delay, or can those go in relatively quickly?
spk09: Sure. So, yeah, when we think about the guidance of a doubling of system revenue, it was predicated on more or less similar levels of greenfields. and a return of replacement cycle to the high single-digit number of systems, that would lead to a doubling of system revenue. If we would have come out today with entering the year with two greenfield orders and six replacement cycle orders, I think it would have been obvious that that doubling of revenue was very, very much likely in the cards. And so we'll have to see how those play out. Like mentioned in the prepared remarks, these are the replacement cycle projects are essentially almost can be considered guaranteed in terms of their ultimate contribution to revenue, but they are dependent on when the hospital actually decides that it's changing its x-ray and the construction timeline of the hospital for those types of refurbishments of labs. And that is something that is kind of really outside of our control for the most part. And so that's kind of the dynamic there. In terms of when that order goes into revenue, it really depends on the site itself and how they advance the construction and when they want to accept delivery of the robots. And so I would say that at the lowest end, you're talking about three months usually, two to three months, and at the highest end for the replacement cycles, probably nine months would be a relatively longer time. And so probably six months is a good reasonable estimate for most of those.
spk12: Okay, and that's very helpful. And, you know, I agree that – Those, I think, are roughly 100 systems out there that are likely to be replaced. But I would, in terms of what's holding them up, I think you alluded to some of it. I suppose it's COVID and staffing are kind of the main themes. Is that your take in terms of what's going on, especially in the replacement market?
spk09: I'd say it's actually less COVID and staffing of labs and more the... challenges that some hospitals are having when working with contractors and architects on finalized construction plans. And so I think that there's a general challenge in the construction world, and that leads to projects oftentimes being delayed. And oftentimes, you know, when hospitals are doing construction, and let's say we are lab four in the interventional suite, and And they usually have kind of a relatively continuous plan where they're doing lab two, and then we're supposed to be plotted after that. And so if lab two's construction finalization is delayed, then lab four's is delayed, and they just kind of bet. There's that trickle effect. And so I think as generally there is delays in construction, that does impact the timing of hospitals.
spk12: That's very helpful as well. One related follow-up, then, is just the mobile system, I assume, doesn't really have that bottleneck to deal with the way it's designed. Is that the correct assumption?
spk09: For the most part, that would make it a much simpler process there, yeah.
spk04: Great. I'll jump back in queue. Thank you very much. Thank you.
spk07: And next, we'll go to Josh Jennings with Callen.
spk11: Hi. Good morning. Thanks for taking the questions. David is hoping to just understand better the four orders that are in backlog currently and just the expectation for those placements and beginning of revenue recognition. I think you talked about majority of system revenue coming in the back half, and does that include a couple of these four orders that are in current backlog, or could they be installed in the first half of the year?
spk09: Yeah, so of those four orders, I guess that the majority will, at least half of them will turn into revenue in the second half of the year, just based on when specifically the hospitals want those delivered. And so that's the dynamic of the four that we are kind of assured of.
spk11: Great, great. Thanks. Sorry, I think you probably laid that out. I just didn't digest it appropriately. And then I also wanted to just ask about China. And you have one China order in backlog. I think that would bring you to eight systems in China. Was that order generated through the collaboration with microport? And maybe just give us a status of microport selling efforts. I mean, our understanding is that as you build out this ecosystem, you're expecting an inflection in 2023 and 2024. with that collaboration. We just wanted to get an update on what Microport's doing this year in terms of marketing Niobe and then also when Genesis could get approved in China. Thanks for taking the questions.
spk09: Sure. Thanks, Josh. So, yeah, all commercialization now does happen in collaboration with our direct team in China and that has existed from before and the Microport commercial team. And what kind of is important in terms of building a product ecosystem is most of the collaboration with Mike40P is still on the development of the ecosystem, both the technical and the regulatory work for that. We have some commercial engagement, particularly from a leadership to leadership perspective, but in order for Mike Report to be able to go out to its entire commercial team and to start putting in place the types of expectations on each commercial individual on their team for adoption of robotics in their territories, you really need to have a product ecosystem. And so there is commercial engagement that can take place, obviously, prior to that, primarily between the leadership of both teams. There is collaboration across the board. But really that ecosystem with mapping integration, with catheters, with regulatory approval of Genesys is the foundation that we are working towards so that we can really take advantage of the broad commercial organization.
spk11: Great. And maybe just to throw one last one in, sorry. Just thinking about collaborations and strategic partnerships, You announced one last year with Microport, and could there be other strategic distribution partnerships in the future or strategic development collaborations with other companies? Thanks. That's my last one, so sorry. Thanks, Dave.
spk09: Sure. Thanks, Josh. So I would say geographically, we are focused on the core markets of the U.S. and Europe, and then And we viewed the collaboration with Microport as a very opportunistic way to take advantage of the significant interest we were seeing from clinicians in China and from the strategic interest we were seeing in China. And obviously there's an opportunity there that is substantial, very substantial. And so that made a lot of sense. We are not going out of our way to try to broadly geographically diversify because I think it's far more valuable and impactful to demonstrate that we can become a significant market share player in EP, in new clinical applications in Europe and the US. And so that's really our primary drive, and I think that that's where most of the value creation will be made, apart from obviously this independent effort in China. If we think about collaborations generally in China, both in electrophysiology and in new clinical applications, I'd say that there is continuous dialogue with various companies in the field. We have plotted a path towards multiple significant revenue drivers that is independent of any collaborations. And I think that that is a healthy way to advance a business. And I think that it is a very viable path and a very attractive path. But obviously you want to build robust ecosystems around robotics. I think there's significant value to robotics in many of these clinical applications. And so if the right types of collaborations emerge, that is something that sometimes is discussed. And so there is that type of natural dialogue that takes place over the course of business.
spk04: Great. Thanks for those answers, David.
spk05: Thanks, Josh.
spk07: And next, we'll go to Frank Tickenen with Lake Street Capital Markets.
spk10: Hey, David. Hey, Kim. Thanks for taking my questions. I wanted to start with procedural volumes, if you have any data around that. Can you share anything related to what procedures look like in December, January, and February? And if you don't have hard data, maybe talk directionally to how that trend has been looking.
spk09: Yeah, so generally, The COVID impact that started in the, let's say, late summer, fall of last year got a little bit better, then got a little bit worse at the very end of the year. Generally, January was tough like December, and then we see some improvements since then. And it seems like we're obviously just at the very beginning of March, but it seems like March should be the best month of the first quarter. And kind of that's what, when we look at schedules that we get from physicians and in general, that type of activity, it seems like there's some, some more returning to normal. It's obviously very spotty where you have some hospitals that have had no impact. And you see other words where there's have been marked impact, you know, within the December, January period. But so generally, it seems like it's getting better. I'd say that most of, again, these motions, if we look at a return to pre-COVID utilization, that is where we don't know how to guide towards that. And so we are assuming relatively stable levels with probably some variation given the macro environment, but relatively stable as it has been over the last year, year and a half.
spk10: Okay, got it. And then thinking about the supply chain, given there's an extensive sourcing process to get all the components needed to manufacture the Genesis system, any disturbances in the supply chain that you're seeing yet?
spk09: Constant disturbances in supply chains. Overall, we've been able to manage them in a way where we haven't had any material impact to production for revenue, though it's always a challenge and there's a constant grind to ensure that that doesn't have a negative impact. On the development side, there has constantly been delays when you're waiting for components to come in and you're sourcing new components that you want to test out for development projects, both on the disposables and on the mobile system. So there is that general macro challenge out there. We do spend more money and sometimes take more risks, sometimes spend more money just to reduce those types of risks of supply chain. But that's a constant grind. And overall, I think that we've managed that side well. So we haven't seen kind of material impacts there other than generally development goes slower because of it, but that's kind of been the dynamic there.
spk10: Okay. And then last one for me, I wanted to specifically ask about the leasing model. If I remember correctly, the mobile system will be able to leverage the leasing system, but I don't think that the Genesis right now is doing that. Juan, is there any chance or opportunity to start offering a leasing model with the Genesis? And is this something you're hearing as a request from your customers?
spk09: Yeah, I think that, alternative financial models for adopting large capital equipment is something that would be attractive to customers. And we do hear it. It does seem to be something that has become very common with other robotic systems out there, whether it's leasing type models or disposable commitment type models. And so I think there is a lot of value to that. There is a challenge in offering that type of model with a system that is in some ways a permanent installation that cannot be removed easily because you have limited recourse if things don't advance as predicated. It's much easier with the mobile system because if the hospital decides it doesn't want to continue the lease or it can kind of be reversed. The capital that's placed there can be reversed very quickly without an impact to the hospital. And so it really is not a very relevant model for a capital system that is a permanent installation. In terms of financing of systems, that can be done, obviously, also with a permanent system. But that doesn't seem to be really something that hospitals need from us because hospitals usually have access to their own capital, to their own kind of financial kind of lines, and usually they have it at better rates than we could ever offer. And so that's not kind of the option. I think it's really the question of having the flexibility to say that we don't want to make a 10-year commitment. We want to try something for a couple of years. and then decide, and that's something that's very difficult to do with a permanent install.
spk10: Okay, that's helpful. I'll stop there. Thanks for taking my questions. Thank you, Frank.
spk07: And as a final reminder, Star 1 at this time for questions. Next, we'll move on to Javier Fonseca with Spartan Capital.
spk08: Hi, David and Kim. Thanks for taking my question. In regards to R&D, can management provide any additional guidance on the key pipeline products showcased during Investor Day in late 2021, and specifically the impact on R&D going forward for 2022? And what should investors expect in R&D relative to revenue and or just operating costs in general?
spk09: Sure, Javier. So, As mentioned in the prepared remarks, we do expect a continuous gradual increase in R&D expenses as we advance these innovations. We're advancing multiple projects that are each substantial projects in terms of both their investment and their impact. I'd view those gradual increase in operating expenses as something that is still very much sustainable with maintaining a proven financial profile as a company. And so we do it within our means in a nice fashion. In terms of the commercial impact, I laid out and also in our investor presentation, we've laid out how we view these innovations and their impact on overall growth and the view that there are really five independent drivers of growth through these innovations. Obviously discussed it much more during this call, but I think that if you look at a future which is in a not so distant future over the course of this year and kind of with initial commercializations of all these technologies, either this year or next year, There will be a relatively near-term future of highly accessible robots that can navigate both a family of EP interventional devices that are proprietary to us, as well as new interventional devices that impact new indications in endovascular surgery. We have geographic expansion beyond the U.S. and Europe, also into China with a very capable partner, and we have this kind of completely side effort that is both synergistic with our robot offering, but is a real independent growth driver in an operating room connectivity solution. So I think those are the five things that are on our mind as a substantial revenue drivers for the next few years.
spk08: Okay. And a quick follow-up as far as more in the near term for, again, on R&D. Is there any sort of quantifiable guidance you could provide or is there still a lot of factors to consider before throwing that out to investors? In terms of operating expenses? Yeah, but specifically R&D or maybe like the actual amount or a percent relative to revenue.
spk09: Yeah, I think that the 30% of revenue that we have spent at this last year is relatively a good number. We expect to grow revenue this year. I expect on the expense to grow as well. It might fluctuate to 35% or so of revenue. It's not going to go to 50% of revenue.
spk05: Excellent. Thanks for taking my questions. Okay. Thank you.
spk07: And next we'll go to Chris Basta, investor.
spk03: Hi, David. Congrats on the results and the progress. I just had a question around some of the publications in the fourth quarter. You had strong clinical data around reducing silent cerebral embolisms and also another publication around superior outcomes with pediatric arrhythmias. Prior to that, you also had a publication on the pulmonary hypertension and the positive benefits of the system. Are these translating? Can you discuss whether these are translating into higher procedure numbers in these respective areas? And if not, how the company looks to increase physician awareness around the system benefits in these newer areas with the clinical results? Thank you.
spk09: Sure, Chris. So we are particularly proud of the clinical data on our technology and specifically the publications that you mentioned and the many others that have come before it that kind of corroborate that type of positive impact in electrophysiology with our robot. What I've said before, I think there's been kind of similar questions to this on some prior calls, but I've said before that in procedural medicine and electrophysiology specifically, most physicians seem to be driven not necessarily by clinical data, but by their own personal experience using a technology in their own patients and kind of the feel of how that went. And so these types of publications do allow us to open the conversation with the physician again, to try to have kind of a foot in the door to change behavior or to at least experiment with something that they haven't done previously. And it doesn't lead to a switch where a physician reads the publication and says, oh, wow, now I'm convinced. Now I'm going to do X procedures robotically where previously I was doing it by hand. It really is kind of a gradual process of trying to change ingrained behaviors at physician accounts. And so we do use these publications. We view them as kind of this – foundation, which is a very attractive and beneficial foundation for our engagement with the community, but it isn't at all a light switch in terms of how it impacts actual behavior in the field.
spk03: Got it. Understood. And one follow-up with respect to the upcoming catheter portfolio, I'll call it. What are you most excited about? I mean, we've read about some doctors talking about the robotics advantages in the areas of pulse field ablation. Can you share with me, what do you think out of the cryo and the PFA and obviously the upcoming MAGIC-RF, what excites you most?
spk05: So on the EP-specific portfolio? Yes.
spk09: So I'd say that the MAGIC tasks that are there is very, very clear knowledge of a broad range of electrophysiology procedures where that is going to be, given all we know, a significant advantage and step forward versus historical technology and the available offering in the space. And so that is, I think, a great workhorse foundation for the thousands of procedures that are currently being done on our robot, and I sense that that will also allow for an expansion of utilization with many physicians re-looking at us for procedures that maybe they haven't been thinking about as they get their ability to navigate that catheter. Pulse Field is a big, trend and area of interest in this field. And so I would view that as the second most important effort that we're making. I'd say that right now all of the clinical literature and thinking about pulse field is fairly limited to paroxysmal atrial fibrillation. And so it is and there are still questions on exactly how Pulse Field will be a part of the ablation ecosystem, where it will add benefits versus RF, where it will not be worthwhile to be advanced versus RF. And so I'd say that that is clearly the second most interesting and attractive pipeline product of ours in EP. And I think there is a lot of value that stability and precision can provide in that. But I think that that is a less clearly defined role for it, given that still a pulse field as an entire field is still kind of in earlier innings of being explored and being understood.
spk03: And can you just confirm, will you be in human testing this year on PSA? We look to be in first-in-man testing by the end of the year.
spk05: Okay, thanks. Thank you.
spk07: And that concludes the question and answer session. I'd like to turn it back to Mr. Fishel for any additional or closing comments.
spk09: Yep, so thank you very much for your question. We'll continue to work hard on your behalf and look forward to speaking again in a couple months. Thank you again.
spk07: And that does conclude today's call. We'd like to thank everyone for their participation. You may now disconnect.
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