My name is Mike Sarcone. I'm an analyst on the U.S. Medical Supplies and Devices team, and this is a session with Inari Medical. So with us today, just going down the line here, we've got Dr. Tom Tu, Chief Medical Officer. We've got Drew Hykes, CEO, and Kevin Strange, CFO. So gentlemen, welcome, and thanks for joining us today. Thanks, Mike. Thanks, Mike. Good to be here. Thank you. Great. So I guess just to start off, maybe, Drew, we can start with you. Just for those who aren't as familiar with the story, maybe just give a brief overview of Inari, the mission, and some of the key strategic initiatives on which you're working. Sure. Love to. So thank you all for your interest in joining us this morning as well. So Inari was founded in 2011 in Southern California by a group of serial med tech entrepreneurs and focused on venous thromboembolism, which is a massive patient population, but historically has not garnered a lot of interest or purpose-built tools. Inari changed that and has developed two purpose-built platforms designed specifically for venous thromboembolism, two different manifestations of that same disease, PE, pulmonary embolism, and DVT, deep vein thrombosis. We began to commercialize in the U.S. back in 2016 and have since that time treated over 165,000 patients using those two platforms. We've iterated those technologies. We've invested heavily in high-quality clinical evidence. We have approached this as fundamentally a market development opportunity. We have built a sizable commercial engine, primarily in the U.S., but increasingly internationally as well. And then finally, we have spent a lot of time trying to understand what we as a company could do to help develop VTE programs at the hospital level. We can talk more about that. Alongside the work we've been doing in VTE, we've also begun expanding into four other adjacent target addressable markets where we see an unmet need, and we see an opportunity to help address that unmet need with purpose-built tools just like we've deployed in VTE. And we can talk more about those four emerging therapies. That's our second growth driver alongside VTE. And then finally, our third growth driver, third strategic priority, is focused on international expansion. We began working internationally about four years ago, focused initially here in Western Europe, but since then have expanded now to 15 or so other markets arrayed across Latin America and Asia-Pacific, and are seeing nice growth now from all those markets together internationally. So those are our three strategic growth drivers: VTE, emerging therapies, and international. Great. Thanks, Drew. Helpful overview and a lot to dig into. I guess just to start with the core U.S. venous thromboembolism markets, you talked about how you're building the market. We're trying to increase penetration. Could you just give us an update on how you're thinking about market growth and what you're underwriting for U.S. VTE growth as you kind of budget for 2025? Sure, so taken together in the U.S., the two manifestations of VTE, PE, and DVT together are 700,000 patients annual incidence. That works out to be about a $6 billion TAM in the U.S. alone, and despite all the progress and the growth that we've made over the last five, six years, we believe over the last 12 months, we treated maybe 8% of patients that could benefit from FlowTriever and ClotTriever treatment. So we're in the earliest innings of converting this market away from conservative medical management with anticoagulation alone, which is how the majority of patients are still treated today. A minority of patients are still being treated with catheter-based interventions using lytics as a lytic-based platform. We're also converting some of those patients to frontline therapy with FlowTriever and ClotTriever treatment. So we're in the earliest phases of that conversion. That same evolution has unfolded in stroke and ST-elevation myocardial infarction, the two other major cardiovascular thrombotic diseases, which also historically had been addressed with conservative medical management, flirtation with lytic-based intervention, and finally, the emergence of definitive catheter-based intervention as frontline therapy. So we're in the early phases of that evolution. Lots of runway out ahead to continue that work. And that's where our investments are focused. Our energy is directed every day. Got it. That's helpful, and across PE, DVT, maybe interventional penetration with mechanical thrombectomy is around 10%. Where do you think those numbers can go in terms of penetration? You mentioned STEMI and stroke as analogs. I think STEMI, we're up to something like 90%. Stroke has kind of plateaued at 30% for various reasons. Where do you see pulmonary embolism and DVT penetration going when you look out five to 10 years and then maybe elaborate on what are the drivers to get us there? Sure. So if you look at that overall 700,000 patient TAM, we believe still today, 80% of those patients are being treated with conservative medical management, anticoagulation alone. Of the remaining 15%-20%, they're being treated with any kind of advanced catheter-based intervention. Still, a third of those patients today are being treated with lytic-based intervention. The other two-thirds with mechanical thrombectomy led by our own technology platforms. So we're in the early innings of that conversion. Those two proxy examples, Mike, that you pointed out, I think are good proxies. STEMI today, after decades of work, as you noted, anywhere in the developed world, likely 95% plus penetration with definitive catheter-based intervention. If you look at stroke, probably a decade into that market development effort, we think it's probably in the 40% penetrated range. We think over time, as evidence continues to build, as awareness builds, as the technology is further refined, as guidelines are updated and reflected, we believe there's every reason to expect that VTE will land on that spectrum, likely closer to the STEMI end of that spectrum. We believe these patients ought to be treated definitively with catheter-based intervention as frontline therapy and should not be relegated to conservative medical management, should not be exposed to the risks associated with lytic-based therapy, and I think over time, not going to happen next week or next month or next quarter, but over time, our vision is this will eventually become frontline therapy closer to the STEMI end of that spectrum. Got it. So it could happen next year. You mentioned building clinical evidence as one of the catalysts to get us there, and highly topical, Inari. We just recently saw results from the PEERLESS trial evaluating FlowTriever versus catheter-directed thrombolysis. Dr. Tu, maybe you can just give us an overview of what we saw from PEERLESS, how that stacked up to your expectations, and what you think that can do for market penetration. Yeah, happy to address that, Mike. So just to set the scene here, pulmonary embolism has really been treated conservatively for the most part, and there's been a dearth of high-level clinical data in the space. In fact, the last major randomized controlled study in pulmonary embolism was over 10 years ago and looked at a systemic lytic agent for the treatment of intermediate-risk pulmonary embolism patients. So really, the rise of catheter-based intervention hasn't been assessed using the rigors of an RCT up until Inari brought forth the PEERLESS study. The PEERLESS study looked at intermediate-risk pulmonary embolism as a patient population. That is the vast majority of our TAM. These are patients who present with pulmonary embolism that's serious enough to increase their mortality, roughly around 10% mortality at 30 days by previous data with conservative management, but not the critical risk, high-risk PE patients, so to speak. We randomized FlowTriever versus catheter-directed thrombolysis, and the results were quite in line with what we expected. It's what we saw with clinical experience. It's what we saw in our large prospective registries. What we found is when you use our devices to take the clots out mechanically, you get on-table patient improvement. You see immediate benefit from the patients in terms of their symptomatic relief, in terms of their clinical stability, and in terms of the shorter patient journey in the hospital, one full day shorter hospital length of stay. I think the surprising upside was we also found that these patients had a 60% lower 30-day hospital readmission rate compared to intervention with catheter-directed thrombolysis, pointing to the fact that mechanical therapy gets the clot out better and the patients recover more fully so that when they come home, they don't have as high of a chance of returning to the hospital as you do with catheter-directed lysis. So this really truly spells the end of the line for that legacy therapy. Just like you saw with heart attack, just like you saw with stroke, the era of lytics for treating these thrombotic disease states is supplanted by definitive catheter-based therapy, and I think PEERLESS I tells us that. In terms of the commercial impact that that might have, despite our increase in growth of patient treatments at the cost perhaps of share shift from CDT, CDT still remains 30% of the interventions being performed for pulmonary embolism in the United States, and I think PEERLESS will help accelerate that growth. Putting that in dollar terms, that's about a $150 million revenue opportunity to completely shift the share of CDT towards FlowTriever. Got it. That's helpful. So still a pretty large opportunity to convert. I guess, can you talk to us about what doc feedback has been since the publication of the study? Yeah, I think several. The results? Several things, Mike. Firstly, I think a lot of applause from physicians across the spectrum to Inari for being able to successfully complete a study in pulmonary embolism. Like I said, no major RCT in over 10 years. So I think it's a big accomplishment there. The top-line results that FlowTriever was superior to CDT in terms of clinical deterioration, bailout, and hospital ICU utilization, those were expected advantages. And I think now we have RCT-level evidence that confirms the superiority of FlowTriever over CDT. I think one of the things that was quite advantageous about the PEERLESS study over and above the direct comparison with CDT was that it confirmed the very excellent safety and efficacy profile of FlowTriever in general. We knew this was true from registry data. We knew it was true from our commercial experience. Now we have RCT-level evidence that confirms the significant advantage of this treatment over what's been done previously. Got it. That's really helpful. And we're not just stopping there. Inari is invested in other randomized clinical trials that are currently ongoing. Is there any read-through from PEERLESS into PEERLESS II that compares FlowTriever to anticoagulation? I think there are several important read-throughs. Firstly, the PEERLESS study compared two interventional therapies for pulmonary embolism, FlowTriever and catheter-directed thrombolysis. I think it's a very relevant comparison because we really want to see what the best of the interventional therapies is, and FlowTriever proved to be superior. But now it's time to test that superior interventional therapy versus the standard of care, which, as Drew mentioned, represents roughly 80%-85% of how patients are being treated today, and that's just plain old anticoagulation. The fact that you saw a very robust safety and efficacy signal that's now confirmed through multiple different types of studies, I think gives us great confidence that PEERLESS II is going to be not just a relevant study, but a successful study for FlowTriever. Got it. Just one last one on the clinical data front. I know you haven't provided definitive timelines, but could you remind us when we could potentially see data around PEERLESS II? And then you've also got the DEFIANCE trial. Yes, absolutely. So I think one of the things that we pride ourselves in is moving the space forward through robust clinical data generation. PEERLESS I was just the first in a series of RCTs. That was a 550-patient study. We've now kicked off PEERLESS II, which is a 1,200-patient study that we already talked about, FlowTriever versus anticoagulation. We're ahead of schedule in terms of enrollment. There's a great appetite for research in the space. We haven't committed to a specific timeline, but given the relative size of the population, you can estimate how long it might take for us to complete that study. And then before we leave pulmonary embolism, it's worth mentioning we also have a randomized controlled study in the highest-risk patient population. These are the ones with predicted mortality anywhere from 30%-50%. That's called the PERSEVERE study. This was a study that was previously thought not even able to be completed successfully due to the complex nature of these patients and the challenges, but through our clinical research efforts, we've been able to align on a path forward for that study, and I think by the end of this, in two or three years, we'll look back on this time and say that was really the glory period of clinical data generation in the space, not just important for science, but from a commercial perspective. You only have to look at heart attack and stroke as proxies for what happened to the adoption inflection curve after a series of RCTs come out that are positive, so we're greatly anticipating the results of those. A nd then we're the only company running a randomized controlled study in the DVT space. That's the DEFIANCE study. That's really an update to the ATTRACT Trial, which is now over 10 years old, and I think we're very pleased to be leading the space in that area as well. Awesome. Thanks, Tom. And maybe we can get Kevin in the mix here and shift to profitability. So you've continued to reiterate the expectation to reach sustained operating profitability in the first half of 2025. And you're also expecting 4Q GAAP EBIT break-even. So maybe you can take some time and elaborate on what's driving the inflection toward profitability and what's going to support the sustainability there. Sure. Thanks, Mike. So overall, I think we're very pleased with the progress that we're making on our path to profitability. As you saw in Q3 alone, we drove an incremental $13 million improvement on the operating income line sequentially from Q2. As we had expected, SG&A, which was a bit elevated in the last quarter, stepped back down as a percent of sales in Q3 and reverted back to more normalized levels like Q1. We were very pleased with that. Also, on the R&D line, excluding a one-time charge that we took in the quarter, the percent of sales staying roughly in the 16%-17% range. That's where it's been over the last several quarters. We would expect sequential improvement into Q4 on both of those metrics, and we do expect continued operating income improvement into Q4. To your point, Mike, to being roughly in the neighborhood of break-even in Q4 is what we had said on the call. Overall, we do remain very committed and very confident in our ability to continue driving leverage in the business, some operating efficiency as well, and reaching our commitments to being consistently GAAP operating income positive in the first half of 2025. Got it. Thank you, Kevin. And I guess, how do you balance the need to invest versus continuing to drive operating leverage? We've got a bunch of different TAMs we're trying to expand to. So maybe I guess talk to that. You can stop there. Yeah, thank you. Yeah. We are very sensitive to that dynamic. I can tell you our first and foremost goal is to continue making the thoughtful and disciplined investments that we have been making to continue driving robust top-line growth. I think you'll continue to see us doing that. It's the reason we made the investments that we did several years ago into our U.S. core VTE commercial infrastructure. It's the reason we've made the investments that we have into generating top-tier clinical data. It's the reason we've made the investments that we have into some of the emerging therapies, adjacent products that you talked about a moment ago, Mike, including the acquisition of LimFlow. It's the reason we have been investing in establishing infrastructure outside the U.S. to be able to expand our business internationally. So I think you'll continue to see us making those kinds of thoughtful investments. But as we move forward and as the business continues to grow and continues to scale, we're already starting to see the need for incremental investments and incremental infrastructure start to slow a little bit. So you're going to start to see more and more leverage coming through on the P&L. We're already starting to see that. But particularly as the international business scales, it's only about 7% or 8% of the business today. And as our emerging therapies product line, which only is about five or six%, continues to scale and grow, we'll continue to see operating leverage, which takes us into consistent operating income profitability in the first half, but also allows us to be able to continue driving operating leverage in the P&L longer term beyond the first half of 2025. Got it. Just, I guess, a quick follow-up there. I sat in on a meeting with you before, and I think you had talked about ASPs overseas holding up or being better than expected. I mean, can you talk a little bit about that and maybe, I guess, how much of a surprise was that to you as you're going out overseas? Yeah, sure. So overall, our ASPs, we've been very pleased, have been very stable over the last several years, and in fact, a modest tailwind. And overseas, as we had talked about earlier, Mike, we've been very pleased with the ASPs that we've been able to garner with our products. Gross margins overseas are only slightly dilutive to our overall average gross margin across the company. So I think longer term, that gives us confidence that we've got a mid-80% gross margin business that is durable longer term. Great. And I do want to bring it back to Drew with the question about emerging therapies, but we've got about five minutes left. So I wanted to see if anybody in the audience had any questions. Okay, I can keep going. Yeah. So actually, it was, I think, the day before this conference last year that Inari announced the LimFlow acquisition. So you're about a year in. You've been laying the groundwork for the commercial ramp, and we should start to see increasing contribution in 2025. So maybe just talk to how the LimFlow deal has tracked versus your expectations and how you're thinking about 2025. Happy to. So just to level set quickly, LimFlow was an acquisition targeting an unmet need, a spectacular unmet need for no-option CLTI patients, patients with chronic limb-threatening ischemia who have exhausted all of their other endovascular options and are therefore facing a below-the-knee amputation. LimFlow has developed a purpose-built toolkit to offer new hope for those patients to avoid amputation. We made that acquisition, as Mike stated, a year ago. And I think in general, so far, so good over the last year. We've done a lot of good work from an integration standpoint. We've got that business now firmly part of Inari. We've done all the back-office integration work. We've strengthened and stabilized the supply chain. We've got a separate business unit and team aligned around that opportunity. We've got incremental reimbursement that we have established for both an inpatient procedure as well as hospital outpatient. All of that has laid the foundation for us to be able to really leverage LimFlow, particularly next year as our first full year of commercial activity. We've also made some good progress commercially in this first year. We're seeing nice growth sequentially, week after week, month after month. We've done cases now in north of 50 initial accounts and succeeded in getting VAC approvals at those accounts. We're seeing good outcomes in these initial cases akin to what we saw in the clinical work that was done with LimFlow. So so far, so good, although it's early on the commercial front as well. And I think all of that gives us optimism that LimFlow is going to be an important contributor to us on a go-forward basis, certainly beginning in 2025. That's helpful, and you're no stranger to launching new products at Inari. Can you talk about how that end market for LimFlow compares to maybe your core business and kind of what the differences are in terms of the ability to commercially address that? It's another large TAM. We believe there's 55,000 patients per year in the U.S. alone, incidence of no-option CLTI. That equates to about a $1.5 billion TAM, and we are just barely scratching the surface of that patient population. It is at its core a market development opportunity similar to what we've undertaken in VTE. The real challenge for us going forward will be to help understand how we can, as a company, help identify these patients who are being cared for in wound care, podiatry, and in some cases with GPs, and get them in front of a group of interventionalists who can assess whether or not LimFlow is an option for those patients. That's very similar kind of work that we've done in VTE training, education, awareness building, leveraging of high-quality clinical data, iterating and refining a first-generation interventional toolkit. All of those competencies and capabilities we've developed in VTE, and I think we're going to bring those to bear going forward with LimFlow. Great. And we have about a minute left. So maybe one last one we can touch on OUS. I think you're getting ready to get into the Japan and China markets at the end of this year. So maybe talk about the commercial strategy there, timing. Could we see more of a contribution in 2025, or does it take a little bit of time to ramp? Yeah. So quickly, we've been working really two years now to bring our technologies to both China and Japan. Complex regulatory paths in each of those markets. We do have regulatory approval for the ClotTriever product in Japan and are working to finalize reimbursement in that market. Once that's in place, we'll begin treating patients in Japan in the context of an initial 100-patient post-market study in that market. Similarly, in China, lots of progress over the last two years. We did do a small study in China with 25 patients and anticipate formal approval here in the short term ahead of us. And that will give us access to both those large European markets, Asian markets. Okay, great. I think that's all the time we have. So, gentlemen, thanks for joining us. And for the audience, thanks for your interest. Thank you. Thank you. Appreciate it. Thanks.