Good afternoon, everyone. Welcome to day three of the 41st annual JP Morgan Healthcare Conference. Great to have everyone in person once again. My name is Lisa Cohen. I'm an associate with the healthcare investment banking group out in San Francisco. I'm very excited to introduce Inari Medical, who's ready to tell their story. With us today, we have Drew Hykes, CEO, and Thomas Tu, Chief Medical Officer, will likely be joining for Q&A. Before I pass it off to Drew, I do just wanna remind everyone that we will be having Q&A session following the presentation. Feel free to submit questions through the portal. We'll also have a mic runner if you want to just ask live. With that, I'll pass it off to Drew. Thank you, Lisa. Good afternoon, everybody. Thank you for your interest in Inari, and thank you to JP Morgan for inviting us to the conference this year. We're honored with the opportunity to tell you a little bit more about Inari Medical and about the mission we're on to try and improve patient outcomes. That's really where I'd like to start this afternoon. It's with that mission. This has been a mission-driven company since we were founded back in 2011. You can see that mission described here. Three very small but powerful ideas, the first of which is to put patients first. We try and do that in everything we do. All our decisions are focused on trying to put patients first and solve first and foremost for improving patient outcomes. Secondarily, we are trying to think big and make no small plans. We are not interested in introducing a widget and taking, you know, a point or two of market share. We are thinking aggressively and audaciously about the markets in which we're participating and really trying to change the standard of care. Finally, we are trying to take care of each other along the way. We have a unique culture, a unique way of collaborating with one another, and we're trying to build on that and amplify that as we move forward. That mission has led us to where we are today, where we have a purpose-built and highly differentiated set of toolkits and solutions. We've got a large and growing and efficient commercial team. We're active in large markets that are under-penetrated with lots of runway out ahead of us. We have a robust product pipeline, and we offer, in addition to the clinical value proposition, a very compelling economic value proposition for our technologies as well. We're led by a very solid leadership team. We've got two other executive officers besides myself, Mitch Hill, our CFO, Dr. Tom Tu, who's with us today as our CMO, and you can see listed there some of our other senior leadership. More important than any single individual are the 1,200 of us that have joined this team and are all bought into this mission and are all committed in the same way to trying to improve patient outcomes. Our roadmap to date has been focused on five growth drivers, and these continue to be areas that we're focused on going forward and are guiding our investment and our time and our energy. You can see these five listed here. First and foremost, continued expansion of our U.S. sales organization. We've added to this group very aggressively over the last 4.5 years since we began to commercialize here in the U.S., and it now numbers over 275 territories here in the U.S. alone. Second growth driver is driving deeper penetration and adoption of our therapies in existing accounts. VTE is a terribly fragmented disease. Historically, there's been a lack of systematic and programmatic approaches to helping these patients. Our second growth driver is focused on trying to change that and help develop VTE programs, and in the process, drive penetration at our existing accounts. Thirdly is clinical evidence. We have invested a significant amount of resources in building a body of clinical evidence to support our therapies. We've got two Randomized Controlled Trials up and running now in a series of additional major clinical studies underway in a large and growing portfolio of data. The fourth growth driver is innovating on new products. This is another area we've invested in quite aggressively, but we have a robust pipeline and purpose-built toolkits to show for it. Finally, market expansion, both into new target addressable markets, new patient populations beyond venous thromboembolism, as well as international expansion. We began here in the U.S., exclusively, four and a half, five years ago, and just within the last two years or so have begun expanding internationally, which is our part of our fifth growth driver. The markets we're participating in are large. We believe here in the U.S. alone, only from an incident standpoint, they total $8 billion in target addressable market in aggregate. We began with a focus on venous thromboembolism, both PE, which is a $2.8 billion target addressable market, and the second manifestation of VTE called deep vein thrombosis, a $3 billion market opportunity. More recently, over the last six months or so, we've begun leveraging the capabilities and the competencies that we've established in VTE to branch out and try and address unmet needs in additional patient populations. You can see there are three additional TAMs. The chronic venous disease patient population, which is a $1 billion incidence TAM and a $10 billion TAM from a prevalence standpoint. Small vessel thrombosis, which is another $1 billion target address market. Finally, we're beginning work in the arterial thrombosis market. Smaller market, a $600 million market, but taken together, it totals $8 billion in the U.S., and when looking internationally, that number climbs to north of $20 billion. I'll talk about each of those markets and our work in each of those markets in a little more detail. We'll start with pulmonary embolism. That was the first market that we focused on, back, going all the way to the founding of Inari back in 2011. This is blood clots on the venous side of your body. These clots can form anywhere, but tend to form in the lower extremities. These are clots that form slowly over time, and as a result, you get chronic wall-adhered clot, acute clot on top of that chronic clot. Risk factors include genetic disorders, cancer, pregnancy, oral contraceptive use. People get venous thromboembolism when they've had surgery and aren't ambulating. All of those are risk factors. Two different manifestations of venous thromboembolism. PE is what happens if that clot embolizes, travels north through the right heart and lodges in the pulmonary artery, and then the right heart strains to push past that clot. That is a pulmonary embolism, a highly mortal disease, the third leading cause of cardiovascular death behind stroke and MI, in a large patient population, 280,000 intermediate and high-risk PE patients annual incidence here in the U.S. About 70% of those patients, despite that mortality profile, are treated only with conservative medical management, with anticoagulation alone that does nothing to address the existing clot, simply tries to prevent a new clot from forming. The long-term complications of that are horrendous. There's not been purpose-built tools designed specifically for PE until Inari. We believe that's the reason so many of these patients have been managed conservatively historically. We have developed a purpose-built tool to help these patients. It's the FlowTriever system, and it's a comprehensive toolkit approach to this disease state. We have a series of catheters and a sheath that provide access to the physician, femoral access through the right heart into the pulmonary artery. We've got large bore aspiration catheters placed in front of the clot where we apply suction with a syringe and are able with that large lumen to generate a significant amount of aspirational force. That's what allows the clot removal of these major clots that you have in venous thromboembolism. We've got additional tools designed for challenging clot and anatomy. And then finally, and importantly, we've got a FlowSaver blood return system that allows physicians to filter out the clot and return the blood right back to the patient, allowing for bloodless thrombectomy. It's a comprehensive toolkit, purpose-built, designed from the ground up for the specific clinical and tactical challenges associated with PE. We've invested significantly in the clinical data to support the safety and effectiveness of that toolkit, most notably in our FLASH registry. This is the largest prospective thrombectomy registry ever conducted in PE. Over 800 patients across 50 sites, and we had excellent safety and effectiveness results. You can see here zero device-related MAEs, a dramatic improvement in that mortality profile down to 0.8%. On-table hemodynamic improvement, you can see here as evidenced by a reduction in mean pulmonary artery pressure. Those benefits help these patients longer term as well, with only 1.5% suffering from post-PE syndrome over time. Building on that foundation of the FLASH registry, we have now begun our first randomized controlled trial called PEERLESS. We took the learnings from the registry and have applied that into this RCT, a 550 patient study randomized one to one between FlowTriever and catheter-directed thrombolytics, which still today comprise a significant amount of the interventions that are done for PE are still in the form of historical lytic-based interventions. This study is designed to demonstrate that mechanical thrombectomy is a better approach to treating these patients and should support a shift in the standard of care. You can see there the endpoints. This study is up and running, enrollment proceeding nicely and actually ahead of schedule. That's our first RCT that we've invested in. Switching gears to DVT, this is the second manifestation of venous thromboembolism. These are patients that still have the clot adhered to their vessel wall. We're most interested in the iliofemoral segment. That's the most dangerous type of DVT. That's clot that is formed kind of between the back of your thigh and your belly button through your pelvis and the deep venous system of your upper leg. Not a highly mortal disease by itself, but a terrible morbidity and set of symptoms that go along with DVT. 50% of these patients go on to develop what's called post-thrombotic syndrome, a truly debilitating disease with quality of life akin to what cancer and advanced heart failure patients report. Another very large patient population, 430,000 patients, U.S. incidence, on an annual basis presenting with that iliofemoral deep venous thrombosis. Here again, only 20% are benefiting from any kind of interventional treatment. Even those are still being done with lytic-based interventions. 80% of these patients still being managed with conservative medical management, with anticoagulation alone, which is not particularly safe, not particularly effective for these patients. Another patient population with a clear unmet need for a purpose-built toolkit. That's exactly what we have developed with our ClotTriever toolkit, completely separate set of systems and catheters that's distinct from FlowTriever. We've got two access sheaths, usually deployed in the popliteal vein behind your knee. Then the ClotTriever catheter itself, which features a radial nitinol frame called a coring element that's deployed above the clot, and then the physician drags that coring element down through the vessel and is able to liberate the clot, separate the chronic clot from the vessel. We've got a braided nitinol bag to prevent that clot from embolizing on the back end of that coring element. Most recently, we've also introduced our Protrieve sheath, which is deployed from the IJ and designed to provide embolic protection for advanced DVT cases, about 15% of cases that are advanced. Similar to what you saw with our FLASH registry, we've also invested a significant amount in the clinical data to support the safety and effectiveness of our ClotTriever system, most notably in our CLOUT registry, another large registry, the largest mechanical thrombectomy data set in DVT. 500 patients across 47 sites. Excellent safety results. 0.2% device-related serious adverse events. No valve damage, no vessel damage, and 0% acute kidney injury. Also excellent safety. That coring element that we designed specifically to remove the clot does a really good job. Over 90% of patients had complete or near complete thrombus removal, that thrombus removal benefits these patients longer term. Getting the clot out matters for these patients in the short term and the long term. We had over 90% who were free from moderate or severe PTS at 30 days. Just like you saw with the FLASH registry, we are building on the CLOUT registry with our second randomized controlled study that's called DEFIANCE. 300-patient study, randomized one to one between ClotTriever and that existing standard of care, conservative medical management with anticoagulation alone. Also designed to transform the standard of care and to continue evolving these patients away from conservative medical management to catheter-based intervention. Excited to announce even this week that we have just begun enrollment in DEFIANCE. We've now got both the RCTs up and running, both PEERLESS and DEFIANCE. Taken together, we have invested a significant amount in that clinical portfolio. I've talked about four of these studies. One last one to highlight is our FLAME study. This is a PE study focused on the sickest of the PE patients with the highest risk, massive PE. These are patients with a mortality of 25%-50% if treated with the current standard of care. We have done this FLAME study focused on that patient population. We've completed enrollment, conducted an interim analysis and have been accepted to present that interim analysis as a late breaker at the ACC meeting in March. Taken together, 2,500 patients across five separate studies, a significant investment, and one that we think will help continue to evolve the standard of care in VTE. Switching gears out of VTE and looking at some of the new markets that we participate in. Those three are listed here. I touched on these briefly earlier. The first is chronic venous disease. These are patients that have had acute DVT, had it gone untreated, and now as a result have developed chronic venous disease. This is a huge patient population with dramatic unmet needs. The worst of these patients have venous leg ulcers that are unhealed over time. The only offer that we can give them right now is compression stocking. That is the standard of care for chronic venous disease. Large patient population, a billion-dollar total addressable market. We've just begun work in building a toolkit to help these patients. Small vessel thrombosis is the second new TAM. These are patients with thrombotic disease in the small vessels of their upper extremity, lower extremity, as well as AV fistula, dialysis access thrombosis as well. Also a billion-dollar market. Lastly, the arterial thrombosis market, which is a developed market, but still one with significant unmet needs, where 50% of patients presenting with acute limb ischemia go on to have open embolectomy to address that clot. We think there's an unmet need there that an endovascular purpose-built endovascular solution can address. Just like you've seen us in the VTE market, we are developing purpose-built toolkits to address each of these three new markets. We are in full market release with the initial set of tools for chronic venous disease. We are in full market release with our initial set of tools, the InThrill system, for small vessel disease, and are still executing our limited market release with our very first set of tools in that toolkit for acute limb ischemia. Over time, we're really excited to leverage the capabilities, the competencies that we built in VTE to try and help some of these additional patient populations, leveraging those same set of competencies and capabilities. Along the way, we have deployed a very efficient and very deliberate, intentional commercial system to bring these technologies to patients and to physicians. We have over 275 sales territories deployed into that system here in the U.S. It's a single-tier sales organization, 100% commissioned sales professionals. Those individuals are present in the vast majority of our cases. They are mining information in that setting, and we leverage that information then to help inform our clinical work, our development work, additional commercial barriers that we need to address. They're taking those solution-based toolkits in a comprehensive way to the market above and beyond a single widget. We believe that approach is going to be scalable into some of these new markets. The other activity that that sales organization is focused on is the market development work that we are undertaking to try and develop VTE programs around the country. We have codified all of that work under an umbrella called VTE Excellence. It involves a playbook, specifically designed to help support accounts as they develop their VTE programs. We have three different phases that we are supporting accounts as they move through this VTE Excellence framework. We execute these playbooks. Along the way, our penetration into the target addressable market, at the account level increases. The work we're doing is showing evidence here we are on the right track. These patients are there in the hospital. Much of this work is focused on systematically ensuring that they are identified, risk stratified, and brought forward to a group of physicians that really understand the disease, just like you've seen take place with stroke and MI. This is a problem we think we can solve. These patients are there in the hospital. We just need to systematically connect them and identify them in a programmatic way. Lots more work to do here, but we like what we're seeing so far, and we think we're on the right track with VTE Excellence. In addition to the clinical value proposition that you've heard me describe, we also have a very compelling economic value proposition that goes along with both of our therapies. From a cost standpoint, both offer a single interventional session, a short procedure in the lab. We're able to remove all of the clot without the need for thrombolytics, which are an expensive drug. If you're administering thrombolytics, patient needs to be generally in the ICU. We're able to avoid the consequent ICU expense. Because we're removing all the clot, these patients recover quickly, and we have a short length of stay. Lots of important cost savings that we can point to as part of this economic value proposition. On top of that, both procedures qualify for robust, procedurally oriented DRGs that you can see reflected on the slide. The combination of low cost, high reimbursement, these are very positive contribution margin procedures for the hospital, and that economic value proposition has been an important part of our growth going forward historically and will be going forward as well. Lastly, from an international standpoint, we began work internationally in the spring of 2020 and have pretty steadily progressed. These diseases are just as pronounced internationally, as what you see here in the U.S. and the unmet need just as spectacular internationally. The same strong bias towards conservative medical management. We began our efforts primarily in Western Europe, but subsequent to that have also begun doing cases now in Asia as well as Latin America. Over time, we firmly believe that this fifth growth driver of international expansion can become a really important part of our overall mission, and these patients are just as in dire need of new approaches as the U.S. patient population. Maybe just to finish with some financials and closing remarks. You may have seen yesterday morning, we pre-announced our Q4 revenue range between $107 million-$108 million. That represents a 29% increase over the Q4 2021 period and a 12% sequential growth from Q3. That translates into a full year revenue range between $382 million-$383 million, and that represents a 38% increase year-on-year, 2021 to 2022. We also announced yesterday our initial revenue guidance for 2023. You can see listed here, $470 million-$480 million, which translates into 23% to 25%. Relative to the legacy ClotTriever product, it's got a stronger radial force of that coring element, and as a result, has shown some utility already in that chronic venous disease patient population. These are patients where it's not really clot anymore. It's actually transitioned over and is scar tissue and fibrotic tissue. That's the initial part of the toolkit. We've got additional tools coming that we think will further help these chronic venous disease patients. We've got one tool called RevCore that we've talked about publicly that will be released in the H1 of this year, designed for venous stents that many of these patients have had implanted, and those stents have gone on to have clot and thrombosis and tissue form inside the stent, rethrombose the stent. That RevCore product is a tool designed to help those patients. We've got a couple others coming as well. Over time, I think you'll see us execute the same kind of evolution and iteration and refinement of that toolkit for chronic venous disease, just like you've seen us take place in PE and DVT. Could you speak a little bit to, your view of U.S. versus OUS sales? As I mentioned, the incidence and prevalence of VTE is just as pronounced internationally. There's nothing unique about the U.S. patient population. There's a dramatic unmet need internationally. We focused initially our commercial effort just in the U.S., and as I mentioned, just within the last couple years, have begun working internationally. We've had nice growth internationally, particularly coming out of Western Europe, month after month, quarter after quarter, procedural growth. We've obviously got regulatory approval. We've got a little more work to do in some of the markets in Europe from a reimbursement standpoint. Despite that growth, we've been clear up until now that that international franchise is not a material part of the overall business, so we've never broken out explicitly the international business. I think over time, obviously, as it continues to grow, we'll likely change that. Lots of runway out ahead of us, and again, it's one of these five growth drivers that we've been investing in significantly, and we will continue to invest in going forward. Thank you. Of the potential $2.8 billion in PE and $3 billion in DVT, sorry. Currently, I think you mentioned only 30% using interventional in PE and 20% using interventional in DVT. For your long-term projection, what would you expect the final penetration using your product? How about the timeline expectation as well? Yeah. So I, I think there's a couple markets we could point to as proxies for what we think is possible with VTE. Um, if you go back in time, um, STEMI and stroke, uh, are two other, uh, thrombotic cardiovascular diseases, number one and two, uh, cause of cardiovascular death. Historically, those diseases were treated with conservative medical management. Uh, there was a phase where lytics, uh, were used to help those patients. But what has emerged in both stroke and MI is definitive catheter-based intervention as frontline therapy. In STEMI today, Dr. Tu would put a better number on it, but it's gotta be close to, what, ninety, ninety-five percent? Yeah, 95% penetration in heart attack. Stroke has gotta be closing in on 50% probably. We think those are good proxies for what we think is possible in this market. A lot of our growth drivers are focused on, obviously, driving that evolution over time. We're making progress. Hard to say exactly, you know, how this happens. I don't think we anticipate necessarily a big inflection point at any given point in time. These growth drivers, the data that we're generating, the tools that we're bringing out, the work that we're doing to develop these programs, I think all of that over time will continue to shift this market away from conservative medical management to catheter-based intervention, just like you've seen in these other cardiovascular markets. If I could add just one point. Between the two guideposts that Drew laid out, heart attack and stroke's penetration is limited by factors that are not applicable to VTE. You know, the problem with stroke is the time to diagnosis, the time to reaching a certified stroke center. To increase the penetration at this point requires a lot of upstream work that is outside the hospital. That is not the case with VTE. Our TAM is defined by in-hospital diagnosed patients with this disease state. One can imagine the ultimate penetration may approach more like what we see for heart attack. What would you say are the biggest barriers to physicians adopting Inari's technology? I'll tackle that one. I would say that despite all of the activity you've seen us and other competitors make in the DVT and pulmonary embolism space, the biggest competitor, honestly, is ignorance and apathy still. There's been decades of investment in the status quo of doing little more than just anticoagulation pills, which we all agree do not treat the underlying disease state but simply reduce the chance of further clot development. I think a lot of our effort still is about educating boots on the ground, interventional doctors, non-interventional doctors who see these patients and refer, emergency room doctors, et cetera, about the possibilities that can be had with mechanical thrombectomy using our devices. Nothing speaks more loudly than excellent patient results. Of course, we're backing that up with strong investments in technical improvements as well as strong clinical data to move the needle. Would love to also hear a little bit more about, you know, clearly a great Q4. Maybe can you elaborate a bit on the drivers of that growth and performance? Yeah. It was a nice quarter and a nice way to finish the year. It was driven primarily by strength in the core franchise, in procedural growth with both ClotTriever and FlowTriever. We did have some stocking revenue, as we always do, but actually the stocking revenue, on a percentage basis, was less in Q4 than we've seen, at any point, previous, in 2022. A really strong quarter driven by procedural growth, and I think that reflects the continued productivity gains we're seeing in our sales organization. I think it reflects the continued progress we're making in our second growth driver, VTE Excellence, in developing these programs and driving adoption. I think it reflects the data from both CLOUT and FLASH. We had new data readouts in the quarter, from both of those two large registries, that I described. We obviously also had, on top of that, two new products that we were bringing to market in Q4, Protrieve and InThrill. We had additional traction from the R&D portfolio. I think all of those things, stacked together, delivered the kind of performance that we showed in Q4. Looking ahead, what do you think are gonna be the most important growth drivers this year in 2023? You touched on it briefly, but. That's like which of my kids do I love the most? You know, I think it's all five of those growth drivers. These continue to be the roadmap that we've had historically. They continue to be the areas that we are investing in. We continue to see lots of runway out ahead in each of these areas. We're at, you know, 275 sales professionals. We continue to see lots of opportunity to continue to add to that team, to split territories, to continue to enlarge and expand that sales organization. Continued investment in VTE Excellence. The market development work that I described. Lots and lots of runway there to continue to help develop these programs. We talked about the clinical efforts underway, two RCTs now enrolling. Lots more work to do from a clinical perspective. Over 20 active development programs in the R&D pipeline, and then obviously, continued traction internationally as well, not only in Western Europe, but also in some of the other regions as well. I think it's all five of those growth drivers as we look out to 2023 that we continue to see contributing to the growth, and they were all included in the guidance that we provided yesterday. Now that I gave you that softball, which one of your kids do you love the most? Can you tell us a little bit more about, you know, how Inari's clinical data, like the impact that it's had, and how you kind of see that changing moving forward? Sure. Thanks for that question. I think Drew already did a really good job highlighting the different clinical studies that have been done in both the DVT and PE space. I won't belabor that, but I will talk a little bit about the strategy behind this clinical initiative. You had IDE studies first getting FDA approval for the products, and then large clinical registries, FLASH being 800 patients, the largest ever prospective clinical registry of mechanical thrombectomy and PE. CLOUT, 500 patients, similar accolades in the DVT space. Not only does that allow us to learn more and promote the safety and efficacy of these approaches, but it allows us to really understand very carefully how to design the next level of high-level RCTs that we know are necessary to really push these therapies to standard of care. You can see that we've made investments starting to enroll, in fact, excellent enrollment in both PEERLESS and DEFIANCE, and those aren't the end of the story. There's more RCTs in the pipeline. The last thing I'll say is that what you've seen is continued presence of Inari clinical studies at the highest level of cardiovascular scientific meetings. We've presented at TCT for two years running. We've presented at ACC late-breaking clinical trials. SCAI, European Society of Cardiology. We all know here in the room what happens when you get a lot of motivated cardiovascular professionals with data interested in this disease state. I think you're gonna see a lot of that same progression like we've seen with both heart attack and stroke previously. When will we see data on PEERLESS? I think the question is, when will we see data on PEERLESS? What we've announced, obviously, you see the trial design, you see that it's 550-plus patients. We've been very pleased with the enrollment. We have not given a target date for completion or readout, but, needless to say, we're very pleased with how things are coming along, and you're gonna see a steady cadence of data releases. The next one will be at the ACC meeting in March of this year for the FLAME study. Now we're coming up on time, but we have time for one more. Maybe I can go ahead with this one. You talked about VT having, you know, larger end markets and being pretty under-penetrated today. Can you elaborate on how you see that penetration in a longer term? I think we touched a little bit on the question over here. I think longer term, we believe that catheter-based intervention is a better approach for these patients, and I think the potential is for this to emerge as frontline therapy for all of these patients. In one way or another, all of the investments we're making across these growth drivers are designed to continue to drive towards that goal and continue to help move the standard of care towards that target. Awesome. With that, I will say, Drew, Tom, thank you very much for the time and sharing your story. Yeah. Thank you. Thank you, guys. Appreciate the interest. Appreciate it.
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