Perfect. Thank you, everyone. I'm Kallum Titchmarsh, Medical Device Analyst here at Morgan Stanley. Delighted today to be joined with the Inari Medical team. We've got Drew Hykes, CEO, Mitch Hill, CFO, and Tom Tu, CMO. Gents, thank you so much for joining. Before I get started, I need to read you the research disclosures. So for important disclosures, please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. So just wanted to start, Drew, you know, curious to hear what's occupying your time now, you know, nine months as CEO. You know, how has that changed from the start to where we're at this point? Yeah. Thank you for the question. Good to be here. Appreciate the interest. You know, my time is really spread across a few different areas. First and foremost, we've recently completed our five-year strategic plan. That took a fair amount of my time, but was nice to spend some time thinking a little more long term and what's gonna drive our growth for years to come. I'm still involved with the operations, not clearly at the level, kind of day-to-day that I was in my previous role as COO, but still involved in helping coordinate and lead our kind of underlying operations. I'm still spending time with customers, both physician customers as well as administrative customers out in the market and traveling. Spending some time with our board, keeping them informed and gathering their feedback. And then lastly, spending time with this group of stakeholders, as well along the way. So it's a nice mix of different activities. Perfect. Any thoughts on the next strategic priorities you have? So I think the immediate term, you're gonna see us focus on the same areas we've been focused on historically. The five growth drivers you likely have heard us discuss in the past, you know, continuing to drive and expand our commercial footprint here in the U.S., doing work to develop VTE programs under our VTE Excellence program, continue to invest in clinical evidence, continuing to bring new purpose-built tools to market, and new innovations to market, and then continuing the work we're doing internationally. Those five growth drivers will certainly continue to be the focus here over the immediate future. Great. And obviously, good performance in Q2 and H1 in general. How would you characterize the growth drivers throughout the first half of the year, and how are you expecting that to change throughout the second half? By far, the biggest growth in the first half of the year was from our core franchise, FlowTriever and ClotTriever, here in the U.S. market, and I think that will continue to be the case in the second half of the year. On top of that, we're beginning to see some incremental nice contributions from some of our new products and some of the new target addressable markets that we're participating in. And then clearly also growth from our international effort. Still a relatively small part of the overall revenue mix, but a high growth runway out ahead of us to continue to expand our international franchise. And I think that will play a role certainly in the second half of the year as well. Great, and we'll touch on the competitive side of things soon, but curious to hear how July and August have been tracking, you know, whether that's roughly in line with the comments you made during Q2, and any thoughts, you know, as we head into September and so on. Yeah. So we saw some nice momentum in the first half of the year. We grew 31%, Q1 and Q2 combined, and that set us up with some nice momentum heading into the second half of the year. We feel really confident about how we're positioned here, looking out, for the next couple of quarters. Confidence in how the products are performing, their ability to remove, you know, acute and chronic clot, and safe, efficient procedures with minimal blood loss. We... I like the way our field team is executing. We've got great evidence to be able to leverage and more coming along those lines. New products in the mix. We'll have 6 new products here in the mix in the second half of the year and then, again, continued traction internationally. Lots of reasons for confidence and enthusiasm and momentum heading into the second half of the year. Got you. And could you just remind us where you see penetration of PE and DVT in terms of the mechanical thrombectomy and maybe any trends you're seeing in the wider market regarding, like, CDT and alternative treatments? So just to level set, from a TAM perspective, this is a massive patient population, 710,000 patients, split between PE and DVT. And if you looked across that patient population today, we believe only 15% of those patients are receiving the benefit of any kind of interventional treatment. 85% are being treated with conservative medical management, with anticoagulation alone. There's nothing to address the existing clot. All it's designed to do is prevent a new clot from forming. So still today, despite all the traction and enthusiasm and the growth that we've experienced, still 85% of patients are being treated with conservative medical management. If you look at the 15% of the patients that are receiving intervention still today, nearly half of those patients are receiving intervention in the form of a lytic-based legacy platforms, so EKOS and AngioJet, for instance, respectively between PE and DVT. The balance then of that interventional segment is made up of mechanical thrombectomy, and we're the market leader in that segment of the market. That's obviously growing very quickly, a healthy growth rate. We believe the underlying growth rate of mechanical thrombectomy is, you know, 20%+. So lots of runway ahead of us, but we are just barely scratching the surface for the number of patients that we could benefit. Great, and probably a good time to touch on the VTE Excellence program. You know, any update on what you're seeing there? Maybe some numbers you can give us around the conversion you're getting over for that? Sure. So VTE Excellence is a codified, comprehensive market development program that we have developed over the last two or three years, designed over time to help hospitals develop a systematic approach to caring for these patients, just like you've seen hospitals adapt for STEMI and for stroke. That doesn't exist today. Fragmented care pathways, many of these patients slipping through the cracks, many of these patients never being consistently identified, risk stratified, and brought forward to a group of physicians that really understand the disease. So VTE Excellence is designed and targeted at that challenge. We've got 1,600-1,700 accounts here in the U.S. we're doing work in, and we view each of those accounts at some stage of a journey towards what will eventually, over time, emerge as a VTE center of excellence, again, just like you've seen with stroke and STEMI. Most of our accounts are in the very earliest stages of that evolution. We're focused on helping establish the foundation of good clinical outcomes. We're focused on ensuring that the coding and reimbursement that's taking place is correct and establishing a strong foundation from that standpoint. We're focused on educating the interventionalists. The penetration at the TAM level in that first group of accounts, in this first phase of VTE Excellence, is very modest and low single digits. As we do that work, we graduate those accounts into the second phase. We've got a couple hundred accounts that have made it to this stage, and the playbook here changes, and we're really focused now on building on that foundation and spreading awareness across the non-interventional stakeholders that care for these patients, the ER physicians, the hospitalists, the pulmonologists, the oncologists. We're focused on engaging with the administration in this second phase and ensuring they understand not only the clinical value proposition, but the economic value proposition as well. And as we do that work, we see the TAM penetration build to high single digits or even low double digits. And then the third and final phase, we've got a couple dozen accounts that have graduated to this final third phase. We call that Excel. And in this phase, the playbook is focused on really helping accounts fundamentally change their care pathway, standardized algorithms. Many of these accounts, we work to help support the business case for investing in a VTE coordinator, just like you've seen with stroke and STEMI coordinators. Many of those accounts are also availing themselves of AI-based platform to help identify these patients systematically. And in that third group of accounts, our penetration is someplace north of 20%. So a nice progress that we're making. We see evidence that we're able to repeat this and move these accounts along the continuum, but tons of runway out ahead of us. And even in that third group of accounts where we're most penetrated, again, nearly 80% of those patients still aren't receiving the benefit of our therapies. Lots and lots of work to do, but we believe over time, this is a problem that we can and will solve. Gotcha. And, and I assume a lot of the time, the questions you're getting is focusing on competitive pressure, at least that is definitely for me. I know H1, a lot of trialing through there, and you performed well through that. A lot of noise now about what's gonna be happening through the second half of the year. You know, what are your thoughts on that, and, and what do you expect to happen from here onwards? So we did see competitive trialing in the first quarter and the second quarter. That's exactly what we anticipated. Those are cases that are lost, right? Those are foregone cases, foregone revenue. So it definitely had an impact, on our business in the first half of the year. Despite that competitive trialing, we grew 31%, in the first half of the year. So we continue to feel confident in our ability to compete and lead in this market. In our experience, the first six months of launch is where you tend to see the biggest bang for your buck, the biggest splash. Invariably, that's when you engage with the physicians most excited about the technology. So I'm sure some of this competitive trialing will spill over into the second half of the year, but we feel, again, very confident in how we're positioned here. Looking ahead, the performance of the products, the performance of our team, the data we have, the new products we're bringing to market, we feel very confident in our ability to continue to compete and lead in this market. You would say you believe you're probably in the later innings of share shift, if there was to be any? Yeah. Again, I think the bulk of the competitive trialing activity is concentrated in the first six months of a product launch. Okay, gotcha. And aside from the obvious competitor, any other products out there on the mechanical thrombectomy side of things that you think could pose a threat down the line? Anything you're seeing in the pipelines? We're not seeing anything, along those lines. There are clearly a number of additional competitors- Mm-hmm. that have taken note of the progress that we've made in this market and what a large patient population it is. I think new entrants are gonna discover this is harder than it looks. They look at our products, and they see a long, skinny purple tube, and they say, "Well, why don't we, you know, do what those guys did? That looks easy." It's harder than it looks. It took us a number of years, over $50 million in venture capital, to bring products to market that work reliably and safely and effectively, with minimal blood loss. So I think some of these new entrants we're gonna discover that this is harder than it looks. I think the basis of competition has also shifted in this market already, beyond just a single widget being able to have an impact on the market. If you look at the work we're doing, the size of our commercial footprint, the work we're doing under VTE Excellence that you heard me describe, the investments that we've made in evidence and the kind of high-quality clinical data that we have, the robustness of our product portfolio, I think all of those, all those areas give us some confidence that we're gonna be able to continue to compete effectively in this market, even if we do see new entrants down the line. Got it. And Tom, probably a good time to pull you in. On the clinical data side, obviously a key driver to, you know, get that penetration speeding up. Maybe give us an overview of, you know, the current core clinical trials that you have set up right now, and any data points we should be looking out for down the line. Thanks for the question, Kallum. So I think maybe it's worth starting with the clinical strategy. You know, as we contemplated how we want to execute on our mission to better the care of patients with venous thromboembolism, you only have to look at predicate diseases like heart attack and stroke to see how standard of care can evolve over time. And it really takes transformational products and then, you know, strong clinical data around RCTs that establish the treatment of standard of care. And then you can really invest in the systematic approach to identifying these patients and providing care broadly across the population. And so we are committed to generating that kind of clinical data to become standard of care, guideline-directed therapy. That started with the largest prospective registries in both PE and DVT, the FLASH and CLOUT registries, 1,000 patients in FLASH, 500 patients in CLOUT, that really have demonstrated that our products are best in class at performing thrombectomy safely and effectively. You then can see the pivot to RCTs. We're running two simultaneous RCTs in pulmonary embolism and an RCT in deep venous thrombosis. In the PE space, we have PEERLESS. That's looking at the intermediate risk PE population, randomizing them to either FlowTriever or catheter-directed thrombolysis. We are very excited about the enrollment in that study. We anticipate a 2024 data release on that. Secondly, you have PEERLESS II, which is randomizing FlowTriever to anticoagulation, so that's the 85% of the markets that Drew referred to that's just treated with conservative therapy. So I think that really has the opportunity of opening up this market, very effectively and establishing, our therapies as standard of care. 1,200 patients, to be randomized in the US as well as internationally. And, we've announced that trial. We're in site selection, and we hope to enroll, patients, shortly. That will take a little bit of time to enroll, given the size of the trial, but I think that's going to really be a blockbuster. And then, our third RCT is the DEFIANCE study. We're the only company running an RCT in, deep vein thrombosis. This is looking at ClotTriever versus anticoagulation for the iliofemoral DVT population. Got it. When do you think we get to a point where we're at a comparable level for interventional treatment in DVT and PE, where we're at now, like with stroke, et cetera? Like, when do you think that timeline is, is going to be achieved? Yeah, that's a great question. If you look at intervention for myocardial infarction, pretty much that standard of care, penetration of catheter-based therapies is 95%, maybe 99% in the developed world. That took 2 decades and multiple RCTs to obtain. Stroke is in that evolutionary process. We're at about 30%-40% market penetration there with definitive therapies. There's some uniqueness to the stroke market, where it's hard to get these patients to certified stroke centers in time. VTE doesn't suffer from those same limitations. Our TAM is defined as patients in the hospital who carry the diagnosis of DVT or PE, so they're much more capturable. I think we're going to see this market evolve very similarly to how heart attack evolved. Hopefully, we can leverage some of the learnings of how that evolutionary change occurred by expediting the process with RCTs and definitive transformative technologies. So I'm very excited about the prospects of this. Absolutely. Drew, maybe, you know, lots of new products entering the market now. I think you have six or so entering through the second half of the year. Maybe give us some highlights of the key ones we should be looking out for, and then also keen to understand how you're managing, you know, pitching a lot of these new products to the docs at the same time. I guess it's a bit different with the PPP setup you have, but just, just curiosity on what's there. Yeah. Yeah. It's a challenge. Nice challenge to have, but it's a challenge. So we have 6 new products in the market here in the second half of the year. I think one way to think about them, there's 3 that provide access to incremental revenue opportunities. I'll talk about those 3 quickly, and then we can talk about the other 3. First of the 3 is called Protrieve, a device designed to be used in complex DVT and delivered through the IJ, deployed in the IVC to protect against embolization of clot that's being embolized from a DVT treatment. So that's a product that's incremental to our existing DVT cases, the $4,000 device on top of the ClotTriever device that would be used at the same time. Second new product is for a brand-new patient population, called RevCore, and this is for chronic venous disease patients. So these are patients distinct from acute DVT. A subset of those patients have venous stents that have been implanted and have become occluded, and RevCore has been designed to help remove the thrombus from inside those occluded venous stents. Completely new patient population, incremental revenue stream for us, dramatic unmet need, and we price that product at $6,500, and it's usually used in conjunction with other parts of our toolkit. And then finally, the third new product we talked about, Triever16 Curve, which is part of our FlowTriever toolkit, and then two additional products on the ClotTriever side, ClotTriever XL, and ClotTriever BOLD.... So those are incremental enhancements, and then the final is InThrill, designed for small vessel disease, primarily AV fistula clots, also an incremental patient population and revenue stream for us. So six new products, it is a lot to juggle. One of the advantages we have is we've been really aggressive at splitting count territories, and having relatively manageable sized territories. So our reps have bandwidth to take on some of the work associated with these new products. There's also a significant overlap with these new products, even the new revenue-generating products, both in terms of site of service as well as the interventional call point, as well. So those are some advantages we have as we're trying to juggle these new product introductions. Got you. And how are you expecting the mix to shift around time? Like, which products specifically, are you expecting to drive more revenue growth than the others? I guess 2024, probably time horizon there. Yeah. So, you know, those three products that are designed and focused on unmet needs and new incremental revenue opportunities, that's obviously where the growth is going to come from. The other products will help, you know, improve the effectiveness of the existing toolkits, improve clinical outcomes, but we'll have more of a second-order revenue impact. Protrieve, InThrill, RevCore, those three really first order incremental revenue, and that's where the revenue growth will come from in 2024 and beyond. Got you. And any further enhancements you'd like to make further down the line? Any feedback you're getting from docs about the, I guess, FlowTriever and ClotTriever specifically? Yeah. So FlowTriever and ClotTriever, specifically, we're on really fourth generation platforms at this point. Feel very good about the safety profile, the effectiveness of those products, their ability to remove acute and chronic clot, the ability to do that with minimal blood loss. So we feel really good about those areas. I think we have some more work we can do from an ease of use and efficiency standpoint. And I think as you look forward, from here, you'll see us bring, some refinements in those areas, on the FlowTriever and ClotTriever platforms. Got it. Exciting. And one question on GLP-1s. I have to do it right. You know, how are you doing this internally? What have you been doing, you know, the past few months when traction has been building? And how are you viewing this as maybe a risk or opportunity moving forward? Yeah. Thanks, Kallum. So, I've been, as an interventional cardiologist, very excited about the GLP-1 story. I've seen patients treated with these, and many of my physician colleagues who prescribe these drugs report their effectiveness. I do want to highlight, however, that really the disease state that GLP-1s target is what I like to call the cardiometabolic syndrome, which is this combination of diabetes, obesity, hypertension, hyperlipidemia. That really translates into what we call atherosclerotic artery disease, which is the underlying pathology in heart attack and stroke, for the most part. Note, I didn't say venous thromboembolism, because that's a totally different disease state. Not only is it venous in origin, and veins and arteries are completely different, but the risk factors for VTE primarily include orthopedic surgery, critical illness, genetic risk factors for hypercoagulability, none of which are affected by GLP-1s. So even if we cured obesity overnight with these drugs, I don't think it's going to have much of an impact on the VTE market. Okay, so you're pretty comfortable with the current setup, and you don't see it as a risk, in your opinion? Absolutely. Okay. Moving on to some financials, Mitch, this is where you, you come in. Q2 profitability, I know you mentioned to me you're pretty, pretty pleased with, with how that went. So maybe talk about your midterm expectations here and how you can maintain that profitability while also building the business. Sure. We appreciate the question. We made really nice progress in Q2 of this year. So we came very close to break-even operating profitability, and we were net income positive, so that's great. We were just going back in time a bit, you know, we were operating profitable in 2020 and 2021. We like to say we were profitable before it became popular. We plan, as you guys may remember from our Investor Day last year, to return to operating profitability in the first half of 2024. So we feel like we're making nice progress, maybe even a little bit ahead of schedule. We'll see. As we finish out 2023, we're seeing some nice operating leverage opportunities both on the SG&A line of the business, kind of the infrastructure side of the business, as well as in the R&D section. So think about our clinical group and our R&D group. You know, certainly we're making some significant investments there, but they're at a level that we feel they can probably kind of stay at that level. And then as the revenue line grows in the company, we'll see some nice, you know, operating profits emerge. We believe the business can be consistently profitable kind of from that mid-2024 point going forward. Got you. And those gross margins, you know, high 80s%, low 90s%, you think they're sustainable with the new products coming in long term? Yeah, I believe we had an 88% gross margin in Q2. Mm-hmm. So that's a nice figure, a nice place to start, you know, when you're trying to be operating profitable. We see that migrating probably over time due to the internationalization of the business, probably into the mid-eighties, I'd say. We have some projects underway that are actually going to help our gross margin kind of stay at that level, so we're excited about those. ... that's a big factor in terms of ultimately where we think the business can be. We kind of look at the operating profit journey of the business in three stages, kind of that initial point in 2024. We see a kind of a low double-digit operating profitability for the business, either later that year or kind of in the 2025 time frame. But we'll probably intentionally pause at that level. We're continuing to make these investments, not only in the RCTs, but also in the international development. A significant amount of the company's operating loss, for example, in Q1 of this year, was tied into the international sort of efforts that we're making. You know, you've heard us talk about the progress we're making in both the European market, in Canada, Central and South America, as well as in Asia. And we hope to have some updates actually on the Asian markets, particularly China and Japan, later this year. So we're excited about that, feel like we're making some nice progress and hopefully, have some go-to-market information for both of those. But ultimately, I think that continued investment in all of those areas will kind of keep us in that low double digits for a period of time. We do believe, though, that this is a business that has a 20% plus, you know, operating margin potential, and we'll get to that, you know, at the right point in time. We just don't want to sacrifice sort of growth potential of the business for profitability at this point. Got you. And I know briefly touched on the international side of things, about 4% of, also of revenue, in Q2. You touched on Asia, I'll push you a bit there. Like, which region specifically, and, and where are you seeing the most opportunity? And how hard is it, I guess, to establish reimbursement there for these products? So the bulk of the traction to date in our international business has come from Western Europe, where we've established a pretty robust footprint at this point. We're seeing nice month-to-month, quarter-to-quarter growth at this point. We've got eight or 10 other markets where we're treating patients, but still relatively early on. We're going to see growth from those markets alongside the traction in Europe. And then over the horizon a bit, we're going to gain access to China and Japan. We've been working really almost two years now to get the regulatory approval and reimbursement established in those two markets. We've made good progress, but it's still a bit over the horizon. I think looking ahead from here, we'll have some more updates to share as we get through the next quarter or two. More generally in Asia, we're also doing cases in Australia, New Zealand and Singapore, so we do have some other markets within Asia. But, we see those kind of three legs of growth, continued traction in Europe, some of the other eight or 10 international markets growing alongside that, and then, kind of a third leg of growth once we gain access to the two big markets in Asia, China and Japan. Okay. Exciting. That's the runway. Absolutely. Final question from me: and what's something you're surprised investors don't ask you more about that's important for the Inari story? So one of the things we always enjoy spending time talking to investors about is the size of this market and just how early we are in developing the market and penetrating the market and really bringing these therapies to patients. Oftentimes we, you know, get sidetracked by a kind of zero-sum market share focus and a tit-for-tat kind of dynamic between market participants. The real story here, in our view, is on this enormous market, a $6 billion market here in the U.S. alone, where we believe we're maybe 6%-7% penetrated with our technologies. So we like spending time talking about that part of our story, making sure investors appreciate the steps we're taking, the investments we're making, the areas we're focusing in to drive that market penetration and development over time. We think this is the third major cardiovascular thrombotic disease that's going to go through the same evolution you saw take place with STEMI that Tom described, and we're out ahead and leading that development effort. So that's one area that we can never spend too much time talking about. When do you think we get to a point where, you know, that zero-sum game is no longer a debate? When do we get to a point where that is, you know, all but a dream, I guess you could say? Yeah. Well, I'd like to think, you know, 31% growth in the first half of this year, in the first six months of a competitive product launch, I hope that demonstrates just what a robust market this is, and how much opportunity there is for us to continue to grow for quarters to come. I hope that part of that answer has already been delivered, and, you know, all we can do is continue to execute our plan and continue to deliver results and focus in the areas we're focused in. And, you know, I think the rest will take care of itself over time. Okay. Gentlemen, thank you so much. Yeah. Thank you. Thank you. Everyone, thank you for joining as well, and-