Stereotaxis, Inc. (AMEX:STXS) Q1 2026 Earnings Call Transcript May 12, 2026
Stereotaxis, Inc. beats earnings expectations. Reported EPS is $-0.03, expectations were $-0.04.
Operator: Good afternoon. Thank you for joining us to Stereotaxis First Quarter 26 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, forward looking statements within the meaning of the Private Securities Litigation Reform Act of 2 thousand. 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.

David Leo Fischel: It is now my pleasure to turn the floor over to your host, David Leo Fischel, chairman and CEO of Stereotaxis. Thank you, operator, and good afternoon, everyone.
Operator: Stereotaxis has had an amazing start to this year. While our reported quarterly numbers do not yet reflect it, we are going through 1 of the most exciting periods in Stereotaxis’ history, given the amount of progress the initial commercial green shoots of success, and the clarity on the opportunity ahead of us. These give us confidence in our overall vision reaching a new level of maturity in our near term and long term growth.
David Leo Fischel: In my prepared remarks, I will touch upon the key areas of progress, the commercial green shoots, and the opportunities ahead of us. Kimberly will then review our first quarter results, and we will open the line to questions. The most notable achievement of the past year has been a string of regulatory approvals in The US and Europe for an entirely new foundational ecosystem of products. While Stereotaxis has a long history, our clinical and commercial experience is nearly all with first generation technology from 20 years ago. After spending the past 8 years and over $75 million rebuilding an R&D pipeline, we brought to market an entirely new foundation of products. In just the past few months, we received 4 US FDA regulatory approvals.
Q&A Session
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For a complex surgical robot, robotically steered therapeutic and diagnostic catheters, and a digital surgery cockpit. Outside of the US, we received multiple approvals in Europe and China. These product approvals are not just incremental innovations, but rather we structurally change our opportunity. We essentially developed a fresh new start up company on the shoulders of our legacy technology and funded by our legacy business. The streak of regulatory success that began last year continued in the first part of this year, with 2 essential FDA approvals. First, in January, we received PMA approval for the Magic cardiac ablation catheter. Then just last month, we received FDA clearance for Synchrony, our digital surgery cockpit that introduces connectivity, intelligence to the operating room.
MAGIC is Stereotaxis’ first proprietary therapeutic catheter. And is the first ablation catheter ever to be approved by FDA specifically for arrhythmia patients with complex congenital heart disease. The catheter strategically allows us to overcome our historical dependency on Johnson and Johnson, and to participate robustly in the recurring revenue of each procedure. Following regulatory approval, we recently announced that we began first MAGIC procedures at multiple US hospitals. Those procedures have gone well. The first patient treated with the catheter had complex congenital heart disease was being cardioverted, weekly, failed multiple attempts to be treated with manual catheters, and was now successfully treated using magic. The most beautiful example for why our innovations are critical, and improve lives.
The physician who did that procedure later commented and I quote, that was the most gratifying case I have ever done. I could have never done this without robotics. Demand for magic is much higher than supply, and we are rolling out the catheter in both Europe and the US in line with the manufacturing ramp. While the ramp is gradual, we are seeing meaningful progress in our contract manufacturers still expects production to top 500 catheters per month by the end of this year. In addition, to mitigate catheter shortages, we began selling an additional catheter in Europe that we have exclusive rights to through our collaboration with MicroPort. And we are making meaningful progress on other efforts that expand production capacity and redundancy.
For now, the still small contribution from our new catheters is being countered by the headwind of winding down our relationship with Johnson and Johnson. This transition is messy, and makes it difficult in reported quarterly financials to observe the underlying ramp of our new disposable business. The green shoots of this new business model are very evident to us, though, and are very attractive. In our initial US Magic procedures, we are seeing disposable revenue often >$8 thousand per procedure, and always >$5 thousand. This robust razor blade business model benefits from our strategy to build a synergistic portfolio of catheters, including magic, Magic Sweep, and Map It. In Europe, just this month, we received an order for $100 thousand in disposables from a single hospital for what it expects to be a month’s worth of procedures.
These amounts are in line with the EP market but are unprecedented for us. They demonstrate the transformation that is just starting to take shape in our business model. Still at low numbers but increasingly very material, as we advance through this year and transition our installed base of robotic accounts over to this new ecosystem. By the end of this year, we expect to have substantially transitioned customers as they use up remaining inventory of J and J catheters, work through hospital approvals and tender processes, and gain experience with MAGIC. The structural transformation to our disposable business model is taking place as we simultaneously structurally transform our capital business. This is happening primarily through the launch of Genesys X, the new robotic system that we received FDA clearance for at the end of last year, and which does not require construction to be installed in existing cath labs.
We have a healthy pipeline of physicians and hospitals that are working towards orders for GenesisX, and who are prepared to be the first to demonstrate it installed rapidly in existing labs while working compatible with nonmodified X rays from major X-ray manufacturers. Compatibility testing and commercial agreements are advancing in tandem. We continue to expect to establish at least 5 active Genesis programs over the course of this year. These initial adopters and their demonstrations of the technology’s accessibility, interoperability, and performance will be very beneficial in expanding adoption. The second significant change to our capital business is the start of a synergistic but independent capital opportunity with Synchrony and SynX.
As a reminder, Synchrony and SynX are our digital solution that modernize the interventional surgical suite with enhanced workflow, remote connectivity, and smart AI capabilities. Just last month, we received FDA clearance for Synchrony. We have already received orders for multiple systems have shipped the first systems to customers. We are very confident in our guidance of $3 million in revenue from Synchrony this year. The initial commercial green shoots from our new product portfolio are exciting. The operational and commercial friction to ramp manufacturing and implement new products makes progress gradual, but everything is moving in the right direction and we are efficiently driving broad based progress on many fronts in parallel. We are doing this while weaning ourselves away from the dependencies and challenges of our legacy business.
it is a tough transition, but we are building a very attractive business on solid foundations. What is particularly exciting for me is that we are not resting on our laurels. While the benefits of this first wave of innovation start to become operational and commercial reality, we are energetically planting the seeds for significant opportunities that will blossom over the next few years. Our vision for what Stereotaxis can and will accomplish is becoming increasingly clear and tangible. That vision can be summarized as follows. Our core mission is to pioneer robotics across endovascular surgery. That means building fantastic robots that enable what is otherwise impossible improving patient outcomes and physician experiences. It means these robots should be fully mobile, unobtrusive, interoperable, and accessible.
It means robots that can do the full range of activity necessary across the breadth of endovascular procedures, EP, neuro, cardiac, and peripheral with a matching portfolio of advanced interventional devices. It means embedding these robots with the digital innovation such that they not only mechanically manipulate devices, but add intelligence, connectivity, and automation to make procedures smarter, better, and quicker. This is not an idle vision. We established a solid foundation for it with our initial portfolio of products. We have also been advancing the background multiple efforts to realize the full vision. A few examples. First, at the European Heart Rhythm Association conference last month, we showed off a future generation of the Genesis X robot that is fully wireless battery operated, and mobile.
We have invested in this project for a few years, and it is moving along well. In the future, all our robotic platforms will be fully mobile and wireless. Second, we are busy at work with 2 significant AI efforts. 1 for decision support AI features incorporated into Synchrony help physicians intraoperatively benefit from the wisdom of thousands of procedures And the second, a rehaul of our automated navigation software so physicians simply designs a procedure and the robot executes it. A specific project here is with a larger industry partner sees the opportunity for automation to offer the most efficient, and yet personalized patient specific therapy. And finally, and most significantly and transformationally, we announced the acquisition of Robocath last month, which as mentioned at the time, gives Stereotaxis a fully complementary and separate robotic mechanism of action for endovascular device navigation.
The combination of our technologies offers a clear vision for how our robotic solution including the full ecosystem of digital innovations, will enable remote, automated, and fully robotic treatment of stroke and cardiovascular disease. The puzzle pieces have come together in a remarkable fashion. We are fully focused on executing the key operational and commercial activities to reap the rewards from our recent regulatory approvals, grow revenue, and reach breakeven. We are simultaneously busy at work through the acquisition of Robocath, other business development activities, and in house R&D on a robust innovation effort across robotics, interventional devices, AI, and automation. The goals, direction of the path, and stepping stones of progress along the path have become increasingly clear to us.
We are energetically and enthusiastically advancing forward. Kimberly will now provide commentary on our financial results and then I will make a few financial comments as well before opening the call to q and Kimberly?
Kimberly R. Peery: Thank you, David, and good afternoon, everyone. Revenue for the 2026 first quarter totaled $6.3 million, compared to $7.5 million in the prior year first quarter. System revenue of $1.3 million and recurring revenue of $5 million compared to $2 million and $5.5 million in the prior year first quarter. System revenue in the current quarter reflects revenue recognition on the installation of 1 Genesis system and partial revenue– revenue recognition of other ancillary systems. Recurring revenue in the quarter was pressured by the transition from the Johnson and Johnson ecosystem. Gross margin for the 2026 first quarter was 60% of revenue. Recurring revenue gross margin was 66%, and system gross margin was 39%.
Operating expenses in the quarter of $9.8 million included $3.1 million in noncash charges for stock compensation expense, mark to market adjustment for acquisition related contingent earn out and amortization of acquired intangibles. Excluding these noncash charges, adjusted operating expenses were $6.7 million, similar to the prior year adjusted operating expenses of $6.8 million Operating loss and net loss for the 2026 first quarter were $6 million and $5.9 million compared with $5.9 million and $5.8 million in the previous year. Adjusted operating loss and adjusted net loss for the quarter excluding noncash charges, were $2.9 million and $2.8 million compared with $2.7 million and $2.6 million in the previous year. Negative free cash flow for the first quarter was $3.5 million compared to $1.8 million in the previous year.
At March 31, Stereotaxis had cash and cash equivalents of $14.6 million and no debt. I will now hand the call back to David.
David Leo Fischel: Thank you, Kimberly. I want to conclude by emphasizing that while not yet reflected in our quarterly financial results, the commercial green shoots I mentioned previously have begun. Over the coming months, the positive impact will grow in momentum, and overshadow the pressures on our legacy business. We are reiterating our revenue guidance for the year of double digit revenue growth, with annual revenue expected to surpass $40 million Revenue will ramp up sequentially each quarter, and we expect both the third and fourth quarters of this year to have revenue of above $10 million a quarter. From a financial perspective, we are confident that we can advance our strategy integrate Robocath, and grow significantly without subjecting investors to substantial dilution.
Operating losses will be reduced as we grow recurring revenue, with the majority of recurring revenue dropping to the bottom line. We have opportunistically taken advantage of the ATM at prices significantly higher than our current valuation, with overall minimal dilution strengthening our balance sheet and bridging us through the acquisition of Robocath and time needed to build momentum with recurring revenue. We have invested significantly in inventory that supports meaningful GenesisX and Synchrony revenue, and maintain a clean balance sheet. And we continue to pursue strategic opportunities for nondilutive nondebt financing. It is a delicate balancing act and there is much being done in parallel but we feel comfortable with our balance sheet allowing us to advance our innovation strategy to market, fund the commercial ramp, and achieve profitability.
We will now take your questions. Operator, can you please open the line to Q&A?
Operator: Thank you. Yes. We will now begin the question and answer session. Please limit yourself to 1 question and 1 follow-up. If you would like to ask a question, please press *1 to raise your hand. To withdraw your question, press *1 again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your question from the line of Danny Stauder with Citizens. Your line is now open. Please go ahead.
Analyst (Danny Stauder): Yes. Great. Thanks for taking the questions. So just for my first 1, on catheters, you mentioned some initial green shoots, and I know it is still early days. But for your comp customers that have started to use the Magic portfolio, I know you commented you are seeing revenue per procedure above 5 thousand sometimes around 8 thousand which is great to hear. But I was just curious if you could give us more color here specifically in terms of how sticky utilization has been for new users of Magic. And are you seeing a pretty immediate uptick following adoption? Does it take time to ramp? And any more commentary would be great. Thank you.
David Leo Fischel: Sure. Hi, Danny. Good afternoon. So Magic adoption is right now still limited by production capacity. So we have sites that would like to transition 100% over We have sites that have tried it and still have J and J catheters and are kind of, for a period would like to use both and then gradually transition. And we have sites that have stayed, only with J and J at this point but know that they have to transition over the coming months. And so, really, all of our sites fall into 1 of those 3 buckets. Right now, we are still capacity constrained, and so that is the main barrier. There will be sites where as many continues to ramp, and it is getting better as the weeks go on, but as manufacturing ramps, there will be sites that will just, you know, they have completely shifted over, and every procedure they do will be with magic sweep.
And mapping kind of our ecosystem of catheters. There are other sites that will likely run things side by side for a period of time. And then there is others, like I mentioned, that kind of will stay in the J&J and J ecosystem as long as they can. But essentially, they all know that over the coming months, probably over the next year, they essentially have to transition, given the available J and J catheters, and so that kind of will drive a transition point. So we are working really to ground game account by account to get them over that transition, to get them comfortable and working well with Magic and the and the whole new ecosystem. And then kind of comfortable to start ordering magic in a robust fashion as they have shifted over. Okay.
Great. And just 1 follow-up for me on that. Just as we look at the quarter’s results and your reiteration of guidance, I was hoping you could give us a little bit more on what is assumed in reaching that $40 million+ number in terms of the timing of manufacturing improvement? And I know you still called out the 500 per month catheter metric by year end, but you know, have you seen a meaningful shift in catheter production yield or any notable trends since the March? And how should we be thinking about some of the head headwinds in the second quarter? And really here just trying to get a sense of how confident you are in the continued improvement throughout the year on this front. Thank you. Yeah. Sure. So if you think about the ASPs that our catheter portfolio provide and you think that we are working towards 500 catheters per month by the end of this year, you can do kind of back of envelope math, and you can see that the type of just disposable revenue that we would have in a quarter around the end of this year is higher than all of our recurring revenue right now.
And so that is– there is a lot of benefit to the shift in business model. Where you actually capture the revenue per procedure. And again, this is not what is charging the hospital any more than what they are used to paying. This is really just, participating in the revenue that previously we did not participate in. And so that is the primary driver, obviously, to revenue until you can start to model things where our recurring revenue by itself is reaching the near $10 million or so level. And as we ramp manufacturing of catheters to that level. On the system side, there is obviously this was a particularly weak, quarter from a system perspective. We still have a pipeline. We still have a backlog. We still engage with accounts both on Genesys and Genesys X.
I think the majority of Genesys X accounts will be in the lease plus disposable commitment category, though there is some definite opportunities for sales there. But the Genesis system is still fully a sales. And so that would be kind of revenue recognition upfront. And so that is kind of the way we are looking at the opportunity as we go through this year.
Operator: Your next question comes from Adam Maeder with Piper Sandler. Your line is now open. Please go ahead.
Analyst (Kyle): Great. Thanks. This is Nelson Cox on for Adam. I guess, first, to dig in a little more there on the disposable business was wondering if you could just kind of quantify the impact in the quarter for us, just kind of try to help us understand where these impacts are in the quarter?
David Leo Fischel: Sure. So Magic and Magic Suite, the Magic Portfolio, was very small in the quarter overall. And I think, we mentioned in our call in March, we had very little production in January, February because they were shifting over a process in the manufacturing line, to a newer process, which improved the yield significantly. And so, essentially, in January and February, the entire all production was meant for validating that shift in the process. And then we did a– you know, decent production in March, but that was most of the revenue from that production comes into April. By the time it gets produced and sterilized and shipped to us, and then we can actually ship customers and recognize revenue. So there was very little revenue in the first quarter from Magic and Magic Sweep.
The primary headwind is that Johnson and Johnson has not been supplying catheters well to accounts, and so there is obviously a pressure there in our accounts from that. And, and so that is kind of where the pressure on procedures from the Johnson and Johnson catheter and behavior versus the step up in revenue from shifting procedures to the magic environment. that is kind of the give and take that is happening in our disposable revenue right now. And again, the step up from the Magic portfolio should overshadow as we start to get meaningful numbers in the second quarter, third quarter, should overshadow by far. Any pressures that we are seeing from Johnson and Johnson.
Analyst (Kyle): Okay. Great. that is helpful. And then for my follow-up, maybe on the system side, heard some of the discussion around the pipeline and where discussions are. I was just hoping you could maybe dig in a little more if you could just give kind of more on the qualitative measures, just what is the early feedback? What then? What are the discussions like? And then that can kind of help us understand, when you expect that first order to come in for Genesis X.
David Leo Fischel: Yep. Sure. Maybe I will step back a little bit and provide, context for why this is a structural change that we are working through that is very beneficial as you come out on the other side of it. But is more complicated than perhaps many people have been until now. Historically, in our entire history, we have only sold our robot with an integrated magnetically modified, magnetically shielded X-ray. In all of our systems to date. We have built Genesys X such that it can work compatible with nonintegrated X rays. That is a structural change that as you implement it, provides you a much, much bigger base of accounts and labs where you can place your robot. And it makes the process of installing your robot much, much easier because you are not having to always install it concurrent with a specific unique X-ray.
And so implementing that and making the right. We obviously did receive our first order for Genesys X last year. We, shipped the system. The system is awaiting installation at an account. That was done according to the historical model, which we will still continue to do where we sell our robots concurrent with selling magnetically shielded and integrated X rays. And so that is kind of how all Genesis sales are still being done. that is, that is how we did the first Genesis X shipment as well. But making Genesis X such that it can work compatibly with the broad range of X-rays from the major X-ray manufacturers is a big effort. We have done a huge amount of that effort already. We are very confident in the assessments and testing that we have done to date.
And what we are really looking right now for the first few Genesis systems apart from that 1 that we have already sold is proving the model that Genesys X can work compatible with any of the large X-ray manufacturers And that, to some extent, opens you up to a whole world of capital opportunity that previously was not available to us. The first users who are going to work with us in that effort are obviously need to be physicians and hospitals who are comfortable in that type of pioneering work and in the kind of working through the uncertainty and the risk, we obviously do all the kind of scientific testing. We can explain, and we can document why there is not a real risk. But there is always a somewhat of a risk when you are the first ones to demonstrate something.
So we are glad that we do have accounts that are kind of open and interested in working with us to demonstrate the robot working in this nonintegrated fashion, but that is really what we are doing with these first kind of pioneering accounts that are going to start using X and serving as kind of the show places where Genesys X works in existing labs.
Operator: Your next question comes from Joshua Jennings with TD Cowen. Your line is now open. Please go ahead.
Analyst (Josh Jennings): Hi. Thanks, David and Kimberly. Appreciate taking the questions. Wanted to just ask about some of the Johnson and Johnson turbulence I am just thinking about the MAGIC integration at these centers, what mapping platform are electrophysiologists using today when they integrate MAGIC into an ablation case? And could there be any turbulence going forward? I mean, should we be thinking that MAGIC will be used with CARTO as well as this catheter supply relationship ends with JNJ?
David Leo Fischel: Sure. Good afternoon, Joshua. So we have been committed to the concept of open ecosystems around our robot. Where you can pair the benefits of our robot with a broad range of diagnostic and therapeutic technologies out there, and that has been kind of 1 of our commitments from the beginning to our physicians. it is the right thing for patients, for physicians, for hospitals. And overall for the progress of medicine. And as part of that, we integrated with Abbott’s ENSIGHT system, its latest mapping technology, and we are fully integrated with ENSIGHT. And that has been the predominant mapping system that is being used with MAGIC. There are some ways to make MAGIC work also with CARTO. And we also obviously have a full integration with them.
MicroPort mapping system, Columbus. That is not available in the US, but that is available in Europe and in China, obviously. So there are kind of some others, in the majority of cases, and definitely in the US and mostly in Europe, you are seeing ENSIGHT X being used with MAGIC. Abbott InsightX system. Thanks for those details. And, also, at HRS, in the robotics symposium, I think 2 topics we were impressed with. I mean, 1, just some of the progress on the PFA development. Can you share any incremental progress today. And then also, there seem to be optimism from some electrophysiologists that are already involved in the cardiology ASCs or cardiology ambulatory procedure centers that robotics could be incorporated. Sorry for 2 questions in 1, but maybe you could touch on both of those topics and how you see the PFA evolving with robotic platform integrating in the magic catheter and then also just the opportunity in ASCs for taking the questions.
Sure. Thanks a lot. And, yeah, and I will definitely touch upon both PFA and ASC setting. And maybe before that, just since you mentioned HRS, and the Society for Cardiac Robotic Navigation, symposium that happened at HRS. I mean, that was a beautiful demonstration of how the fact we are innovating and bringing new solutions to the market does create a different level of excitement in the field There, with all of the challenges and all of the messiness to the transition, we had at HRS about I do not know. it is a huge room and probably about 200 people who came at the far end. You have to walk all the way at the end of the hallway order to get to the room of SCRN. And, right, you have probably about 200 people who attended that, that session.
With fantastic talks from, from multiple physicians. And KOL physicians. And so that was kind of a really, really nice event, and I think it is reflective generally of the type of interest. We are still a small player in the EP field. But there is a renewed interest for many physicians who long had thought that robotics was an old technology and a stale technology and are interested and kind of an starting to recognize that the technology that they remembered is not anymore how it is today, and the opportunity is there for them to actually engage with us in a much more meaningful way. That was 1 of the highlights, obviously, over the last few weeks is the whole HRS conference. EHRA conferences, and then specifically that SCRN session there.
If we look at PFA specifically, I know I did not include any discussions about that in the prepared remarks, not because there is anything, negative just because we are continuing as we have discussed in the March call. And we had enough other things to speak about on this call. And we are still working, obviously, with Cardio Focus. We have the announced collaboration. We are working on the effort of then getting compatibility between magic and Cardio Focus’ generator, PFA generator, approved in Europe. We have done kind of meaningful work and started actually the kind of regulatory engagement with a notified body. And so that is, that is that is kind of clearly underway. We also have kind of another collaboration, 1 of those that we kind of not mentioned the name but discussed over the last couple years.
And that is also overall clear opportunity for leveraging a variant of MAGIC and with their generator. And so we continue to view that kind of as an exciting space. I think during the talks, the physician talks at that SCRN symposium, there was a few kind of where the speakers were noting how despite all of the enthusiasm for PFA, there is still various safety signals that things like stability of catheter with the tissue are particularly important for PFA, both efficacy and safety. Our stability of the catheter is 1 of our hallmarks of our catheter and a great benefit there. And that as you start to think about PFA in the ventricle, and we have an ability to obviously get anywhere in the ventricle stay steady on that tissue, and so we are probably in a very good position in some of the speakers there were not part of our animal studies, and so they did not share data from those animal studies in their presentations.
And on the ASC side, the ASC side is fascinating. it is obviously still a minority. Right? The vast majority of cardiac ablation procedures are still done in the hospital setting, but you have seen in several states ASCs starting to get set up to do cardiac ablation procedures. there is obviously the precedent in many other areas of medical devices where ASCs have kind of become a dominant setting for, for procedures. We think and believe that the robot, the Stereotaxis robot, should be very well suited for the ASC, particularly because of our safety profile. that is obviously 1 of the biggest risks from moving from the hospital setting to the ASC setting is that you do not have the same safety net in terms of all of the hospital resources around you.
And so we think that our robot can provide a big benefit there. The vast majority of procedures currently being done in the ASC setting are paroxysmal AF. that is not where our robot shine. Our robot can shine in things like PVCs and in various other areas where stability and safety and navigation is more challenging. And so I very much hope and believe that 1 of those Genesys X installations this year will be in the ASC setting, and that will start to demonstrate also the financial and clinical merit of having a robot in the ASC setting. Again, this is small. This is something that will be a long term will have a long term tailwind to it in the US. But definitely, we think there is merit to us being there early on and starting to demonstrate the value there, and, hopefully, that will give us another opportunity over the next few years, to grow kind of in help the ASC setting grow as a field for cardiac ablation.
Operator: There are no further questions at this time. I will now turn the call back to David Leo Fischel for closing remarks.
David Leo Fischel: Okay. Thank you very much for your questions. For your continued support. We look forward to hosting any investors visiting our on Thursday for our annual shareholder meeting. We will continue working hard for your benefit and look forward to speaking again soon. Thank you very much.
Operator: This concludes today’s call. Thank you for attending. You may now disconnect.
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