This is Briana Gotlin. Thanks for being here. Thank you for hosting us, Mike. Nice to be here. Good afternoon, everybody. Vlad, you're my third LivaNova CEO in three years at the Wolfe Healthcare Conference, so we're going to get to that. I want. It's your fault, then. I'm just pointing out a fact, and I look forward to our follow-up chat next year. We'll get to the bigger picture vision, but let's maybe start smaller picture. You showed some data to the world last week for one of your pipeline assets, your obstructive sleep apnea device. And look, it looks good. I guess the first question to you is, do you think this will be competitive? Yeah, it's a great question. So I was very pleased. We were at LivaNova, we were very pleased when we saw the data at seven months, six months since the first month was idle. We have high confidence in the fact that 12 months' data will continue to improve. And we also have now, I think, very high confidence that this is an asset where we can create significant value and for us, but more importantly, for patients. Highlights of that data. I mean, the safety rate looked was zero. That looked exquisite. We saw median response rate for the cohort. We didn't see the responder rate, which seemed to be the primary endpoint itself, other than it statistically was different than sham. Why not? Why show Why show us what you showed us, and why not the responder rate as an example? So I'll let Brianna talk a little bit about the data, because I think it will be good to unpack it. But obviously, we have the responder rate and the results. We didn't show it because the competitive technologies on the market today they did not show responder rate at six months. And we didn't want to confuse the market by comparing six months of our data to 12 months' responder rate of competitive technologies. But you can kind of look at the AHI and ODI data and draw certain conclusions on the direction that the responder rate performed. Just to build off of that a little bit, so based on the data that is available on the market, the AHI reduction and ODI reduction demonstrated in OSPREY is showing superior outcomes and faster onset compared to what we're seeing in competitor trials within the same time frame, so that's important. As is typical with neuromodulation therapy, we would expect to see the reductions improve from six months to 12 months, and it is even more specific in hypoglossal nerve stimulation. We've seen that before, and then OSPREY is unique because it is a randomized controlled study. Competitors were single-arm 12-month studies, so that is definitely a differentiator. The trial also includes patients with Triple C, so the trial did not require DICE, and you can assume that roughly 20%-25% of the OSA market actually has Triple C. And that's currently contraindicated by existing therapies today. Also, the OSPREY patient baseline characteristics demonstrated a higher BMI, AHI, and ODI, and then if you look at the reduction in AHI and ODI, it actually was lower. Do you have an interest in understanding the performance of the Triple C cohort, or would a commercial strategy here be, here was the trial criteria, this is how we enrolled, and so long as you're within reason around that, say, mean, you're an acceptable patient? Asked differently, how would you expect a label for your device to read relative to how the competitor's label reads? Yeah, that's a good question. So I mean, obviously, the way we look at the data today, like Brianna said, we see this clinically differentiated because of the patient cohort that we can treat. Exactly how this is going to come out in terms of label, and obviously, we're going to have to work with the FDA and framing it. I think what's important to know is we will use the data that we had at seven months for the submission to the FDA, which will happen in the first half of 2025. And then to your question, that then will become part of the conversation with FDA. So let's jthe ust finish on sleep with the path from here. Submission in the first part of 2025, let's say April at the midpoint of a 1H, six to nine months. You're looking at maybe an FDA label by the end of 2025. And sounds like you're enthused by what you see. Commercial launch in 2026, or how do you see this playing out? That's a great question. So I think your timeline is correct, that the FDA sometimes is, I would assume, a year. So maybe early 2026 as the approval. Look, and then from that, what we do know today already, we don't need to wait for 12-month data on that. We do know that we will create value with this asset, right? Because that is clear based on the six-month data. What we don't know yet is which way we're going to take on that. And there's various internal and external options on how we bring this technology to the market. And part of it does depend on how differentiated our data will be at the end. Part of it depends on our portfolio strategy moving forward. We are looking at kind of our portfolio strategy for the next decade, entering faster growth markets, faster growth technologies. And we will have to assess where OSA fits in that map. So at this point, we're still kind of in a discussion phase and design phase on how it will fit in our strategy. I guess I'll follow up one more here. Ease of use of your product relative to the incumbent. My understanding, the procedure, even relative to the next generation of the competitor's device, should be faster. It's a little more straightforward and easier for the physician, cuff around the trunk of the tree instead of the distal branch. Time is money. That will appeal to implanters. Is that fair? Then the other thing is the device is more distal, so it has more electrodes to compensate for that, and it activates the nerve in different ways. I've heard anecdotally that programming post-procedure can be a little bit more of a challenge. As you assess the commercial potential of this from the physician experience perspective, are those two buckets you see? Are there others you might call out? Yeah, it's an important one. I think the time, so our procedure in the study was on average 72 minutes. I think as competitors continue to improve, we still think our procedure is faster. Part of it is because you said it's easier to perform the surgery, this implantation, because of the distal positioning of the proximal positioning of the electrode of the lead. So there's two dimensions. One is time, one is ease of use. So we believe that on both dimensions, we are a bit ahead of the curve. But I think ultimately, that decision is important from a physician's point of view if the clinical outcome is equal. If the clinical outcome is differentiated, then I think there's a discount on how easy the procedure is. There's a lot of topics to get to with LivaNova, so let's, in the interest of time, move on. I'm going to do cardiopulmonary. This seems to be a great story for the company. On one hand, you have the equipment business, the generational product cycle seems to be going well in its early stages. Demand is good. You can supply that demand. You've laid out a fairly rhythmic, hey, we're going to go 40% of mix 60/80/100. What keeps you up at night on the Essenz launch? Is it the supply side or something else? Yeah, on the Cardiopulmonary, you're right. I mean, we were very fortunate to enjoy that kind of now seven quarters of double-digit growth, strong market share gained, and more importantly, we have a really good technology in the hands of the customers now. And within the business, look, what keeps me up is our ability to manufacture more product. What we saw on the oxygenator side is that normally, this is the procedure growth historically has been 1%-2%. Post-COVID, what we saw is the elevation of that procedure growth to 4%-5%. And we attribute two things for that. One is emerging markets are becoming a bigger part of the overall volume, so that drives growth faster. And then the second one is the hypothesis that during COVID, when the hospitals were locked down and people didn't get diagnosed early enough with cardiovascular disease, when hospitals opened up, and the disease progression was further along, instead of getting stenting procedures, for example, people are now getting more bypass procedures. So the industry, which is really in this case, Medtronic, Terumo, and us, are the kind of supplier of oxygenators and disposables around the world, was not ready in my mind for that type of growth. And then LivaNova reacted with agility and started to create extra capacity and improve manufacturing efficiency to produce more oxygenators. And so what you see this year, we've increased our output by 10% just doing what we do better. We have a path to do the same next year. And then beyond that, we have a path, obviously, to reinvigorate our footprint in order to create more capacity, but also in order to manufacture a new generation oxygenator. So at the same time, what we see from the competitive point of view, they stayed at the same capacity as they had. And so there's no growth coming from that. So you asked the question, what keeps me up is the, ability to continue to manufacture more product at a faster rate so that people don't have to wait for surgeries. And also that, as a consequence, we enjoy continuous growth. On the Essenz side, on the manufacturing capacity front, you feel good? Yeah, Essenz, the issue is how fast we can roll it out. There is absolutely no limit to what we can produce. OK. I have a question on an innovation item here. I think it was on the last call, like a next-generation oxygenator, and you just alluded to it there. What is the basis of innovating an oxygenator? I don't have a tight appreciation for the product. So when was the last time you did it? What was better about this new version versus the last? Or what can you make better about the next version? And why is that good for patients and practitioners? I'll start, and then Brianna, you build up on that. But look, when I was looking at it from the outside world, you kind of look at oxygenators, at least I did, as more or less a commoditized product. And the more I learn about the technology, it's actually not. There's a significant opportunity to differentiate. And so there are a number of parameters that you can measure in terms of performance. And you can clearly see of all the competitors today on the market how these parameters meet across different product lines, across different technologies. So one of them, for example, is the rate of oxygenation. The other one is the pressure when blood comes in and comes out of the oxygenator. And there's a number of other ones that should make actually an important clinical difference to the patients. The next-generation oxygenator, what we have in development, at least in the preclinical work, showed improvement across those parameters. Again, versus what is on the market today, it would be best in class. I think, combined then with our commercial footprint and our 70% market share in heart and lung machines, this would be a really good path for us to continue to improve market share. Don't forget, we started a few quarters ago with low 30s in terms of market share on oxygenators. We're now in mid-30s. I I think we have a really good momentum to continue to build on that with manufacturing and with innovation. I don't know, Brianna. Vlad covered most of it, but we launched the Inspire oxygenator in 2014 and then made some minor updates in 2020. OK, so a decade. Time. Yeah, OK, understood. We'll wrap up with this on CP. Look, the oxygenator market dynamics well explained here. Is there any part of this, either currently or something you could push for in years to come, where the Essence launch helps with the oxygenator kind of share capture efforts? Is that a commercial initiative, or is that not something that's practical? It's a great question. So from a commercial point of view, absolutely. And now, when we have a new heart-lung machine and our commercial teams go into the customers with something new, it also creates a pool for the rest of the business, oxygenators and cannula. So there is already that impact. It is an open market, meaning any oxygenator can be used with any heart-lung machine on the market. And I think that's market practice. And we don't want to deviate from that. However, we can create certain benefits, for example, sensing technologies that actually will stimulate a little bit customers using our heart-lung machine with our oxygenators with the hypothesis that it would improve clinical outcomes. Let's shift to epilepsy, the other kind of half of the business. Let's just model junkie question. The volume piece, US epilepsy, kind of replacement, tailwinds, abating. You've been clear about that. I think the message for four Q was replacements flat year on year on these tougher comps. We're kind of entering the replacement era of Epidiolex, some of the new drugs, early COVID where NPI was suppressed. Replacement volume growth expectation US next one to two years, is it the zero from four Q, or is there still an ability to grow replacement unit volumes, just not at the rate that we've seen? Great question. So you're right. We're anticipating a slowdown in the fourth quarter in terms of U.S. replacement volumes for all the reasons that you just stated. But we are expecting that trend to continue into 2025. And our model output is projecting flat to low single digits over the 2025, 2026 time frame. Low single-digit growth? Yes. Up low single digits. Yes, up low single digits. OK. That's correct, and that's just for replacements. This is, I mean, this is the Epidiolex era. I mean, it just kind of it's formulaic in terms of the NPIs from five, six, seven years ago. Yes, exactly. What about on the NPI side? Stephanie, maybe a year back in the seat-ish, seems to be refocusing the team on execution. The growth rate has perked up. I guess what's working and kind of what's the opportunity on the new patient side? And what are the two or three things that the company focuses and executes upon are going to drive kind of a good solid return to growth on that front? Yeah, no, thank you, Mike. And Steph is a great leader. And we're very proud of her growth within LivaNova. She's been in the companyin for many years, in different roles, different regions around the world. And she built a great team and really is creating a winning spirit across the organization. And really, the first step was just to improve commercial execution. And there's some tactical things, just how the team targets accounts, the focus that she's driving, the accountability. So those things add up to kind of better execution and ultimately growth. Number two is, remember, there's still a million patients out there with drug-resistant epilepsy that don't get treatment. And the procedure penetration is very low. And so continue to improve the procedure penetration is a big source of growth for new patients. And then finally, I would say is the innovation that we have. The next step for us is to take the platform of what we have and create a better digital ecosystem around it so that programming and reading the data can be done remotely, that it's easier to use. Then there's much better data exchange between the patient and the physician. Those are the three key drivers, I would say, of continued growth in the business. Is the digital stuff knocking on the door, or is it, hey, we need a cycle here to invest in? So we don't disclose the timeline for competitive reasons, but it's not an early project. It's mid-development. What about on the generator side? I mean, SenTiva, I think was the last cycle. Is there an innovation vector there? Yeah, I mean, right now our focus is on the digitalization of SenTiva, and we're making some improvements to the technology itself, but we're not discussing new generation yet. We'll wrap the epilepsy discussion with kind of reimbursement. As a med tech covering analyst, the coding and payment stuff, it comes and goes. It matters. Can be some brain damage. So neurostimulation companies, yourself included, have been petitioning for this concept of a new Level 6 payment. It looked like maybe this year was the year Medicare did not establish that. What happens now? Is this going to be every year the pitch is made and odds rise over time, or is there a you can't go back to pitch for another couple of years? How does that work? And then the second question is, do you view this as a need to have or nice to have? Kind of how important is this outcome? So we believe that Level 6 is the appropriate payment for these patients. And we can start petitioning again next year. So this decision was only set for 2025. And we have an opportunity to approach again for 2026 next year. And then the Level 5 decision is business as usual for LivaNova. So it doesn't really impact the business. But it would be a nice to have going forward. Can I ask what is holding CMS back from this? The technical, procedural dollars, coding, what's the hang-up? And therefore, what might be the path for them to view it differently? Good question. So there are multiple different technologies that are within that code. Some of these technologies are actually much lower paying and much higher volume, other neuromodulation therapies, such as spinal, sacral, which are probably priced in the low teens to low 20s. And VNS and the other companies that were in the coalition with us, they are priced much higher. So two of the companies that were in there with us are actually in the New Tech APC. And they were granted that for another year. So they're actually receiving a higher reimbursement rate for 2025. There is an opportunity for 2026. Basically, CMS would have to decide on what they're going to do with those technologies also. So for 2025, they were given the higher reimbursement. We were left in Level 5. But come 2025, for 2026, they'll have to make another decision about those technologies that also have a higher ASP. In some pricing and reimbursement in the U.S., price has been a lever for revenue growth. Despite not getting it this year, is it still reasonable to think kind of a low single digit price input for the epilepsy U.S. revenue growth algorithm? Is that still fair? Yeah, roughly 1%-2%. OK. Let's move on. We got to do depression. And then we got to ask Vlad about his almost one year, what he thinks, what's going to happen. All right, depression. Five critical papers are coming in the next couple of quarters. The first two sounded like the standard, hey, trial's over. We got to do our primary and secondary endpoint analysis. The other three, my words, not yours, they sound like kind of interesting things you found in the post-hoc work. And it sounds like those other three might be more interesting for all of us. I know you can't say what we're going to see, but as these things roll out, what would you have us consider, especially as we try to calibrate, will payers step up for this? Yeah, that's a great question. So right after Thanksgiving, the first two will come out. You will basically see the results of the RECOVER trial. I mean, what I would look for there is how the sham arm performed and how the kind of I mean, we've disclosed that the sham arm performed better than expected by a significant degree. And then the treatment arm performed as planned, as expected. So I mean, that's one thing to look at. And you can look at different types of patients there. And also, it's interesting, I think, the timing of when the improvements in the sham arm started. So that's number one. Number two, I would look at all the secondary endpoints and kind of draw some of the conclusions based on what you see in that data. Again, there are some interesting data on that. Number three, I would really dig into what types of patients have been included. Because ultimately, that is part of the decision for us to go further with the approval, is that it's massive unmet need. We have patients that on average failed 13 different therapies before the RECOVER study. There's no alternative treatment to that, and then you start seeing what the control arm did and what the treatment arm did, and it's an interesting philosophical discussion there. In the next three manuscripts that are going to come out early next year, I would then look for the details on the data on different subgroups. I presume some speculation might be in the paper, but for the why behind the sham might have outrun, is there an interesting hypothesis you can share? We looked at this different ways. Neither of our clinical partners nor anybody in our organization ever saw a sham arm perform that well. So there were a number of hypotheses. But I don't know if any of them hold ground. So we'll see the papers. And then this is the basis to engage with payers. And that's kind of the 2025 agenda? After the fifth paper is published, the submission to the CMS will then follow. And then, I mean, normally, it's about a year if you look at historical data. But we will continue our dialogue with CMS throughout the period. Is it fair to say that we're taking some investment out of the depression model? That was news earlier this year, clearly. Given that SG&A kind of OpEx commercial readiness doesn't happen until you have a signal on the coverage side. Is that kind of a fair way to think about? Yeah. So first of all, this is going to be a little bit rigid. But if we receive approval for a full or a subset of the patients, we will launch the product. That's the plan. It's connected to our R&D. It's connected to our manufacturing. And then we already have capability in this area, right? So manufacturing is relatively quickly to ramp up because we have that. have that. It's relatively similar to what we do in epilepsy. Again, from R&D point of view, we have kind of the scientists that are dealing with technology. From a commercial point of view, we have the capability because there is a team that is focused on the trial. They would just now kind of take a bit of a different role. So it's a relatively quick ramp up. We will not, unless we get some strong indication that this is going positive, we will not increase investment until we get approval, but post-approval, the ramp up is going to be relatively quick. Understood. We have a few minutes, and I want to ask: We hit on a lot of, I think we hit all the components. So roll it up. Keep it simple. Growth, revenue growth, margin expansion, earnings growth. You're getting to know the company. What's achievable? What is the financial framework that you think fair and good to set for this company over the next few years to establish performance boundaries? For next year, I mean, first, it starts with really strong core business, right, and we will continue building on that. I talked about the growth levers that we have. I'm not going to repeat myself, but we feel optimistic about our future growth, and our guiding principle is going to be grow sales faster than the markets in which we compete and then grow operating income faster than sales. I think that's the assumption you can make, and that's the principle we're going to use when we guide next year. Beyond that, moving forward, we're trying to build a benchmark company in med tech, and you can either do it through scale or growth, and since we don't have big scale, our story will be a growth story, and it's really about four things then within that. It's being a true innovator, having great talent and culture, having benchmark operating execution, and then finally, it's about growth, so those are the four things that we will continue driving, and we are doing the work today. Healthy core gives us optionality moving forward. Obviously, DTD and OSA are potentially very interesting additions to our innovation portfolio, but beyond that, we're looking at the strategy on how we're going to look over the next decade in terms of the portfolio, and we're using those four principles that I talked about to guide our decisions. Can I ask for one more teaser there? I mean, on the innovation front, depression and sleep, we talked about. We get it. They're there. You'll assess and make a call. Oxygenator innovation is interesting. Digital innovation in epilepsy is interesting. VNS is kind of a big scientific concept. Is that interesting to you, earlier stage stuff there? Or do you think this organization, you get through Italy, you know what your balance sheet looks like, you become kind of a little bit of an M&A-driven organization? VNS, kind of big long-term scientific opportunities or M&A? Are those interesting? I think both are on the table at this point. And these are options that are open to us. And what you mentioned is there are some external factors that will shape the way we're going to go and the scale at which we can do that. But both are interesting directions. And we are assessing them. And we will share them with the external world in the first half of next year. Excellent. We're going to leave it there. Great conversation, Vlad, Brianna. Thank you for being here. Thanks. Thank you.