Good morning, everybody. Next up we have Inari Medical at the Bank of America Healthcare Conference, so thanks for joining us. We've got Drew Hykes, Chief Executive Officer, Mitch Hill, Chief Financial Officer, and Dr. Tom Tu, Chief Medical Officer. So thanks for joining us. Maybe starting out with just report of the quarter recently, Q1, talk about some of the momentum you saw kind of end of last year, end of Q1, and it sounds like Q1 got better kind of over the course of the quarter, and kind of what some of the trends you saw in the quarter. Sure. I can get started with that. Mitch and Tom may want to join in as well. And thank you for all of you. Appreciate the interest and the time here, this morning, and thanks, to Travis for having us. Good, strong quarter for us, 23% growth during the quarter. We saw strong momentum across all three of the segments of our business. Our VTE segment, which is the largest part of our business, grew 20% during the quarter, a little bit faster than that internationally, a little bit slower than that here in the US, but nice, strong growth. Across VTE we saw growth in both the FlowTriever and ClotTriever parts of the franchise, driven by procedural momentum. also some strong growth in emerging therapies during the quarter, led by RevCore and InThrill, and a really strong quarter with nice momentum across the international part of our business, led by Western Europe, but some nice contributions from some of the other international markets, as well. So nice momentum as we exited 2023, and we saw nice momentum all the way through Q1, and I think that's reflected in the 23% growth and also reflected in the update to guidance that we made, a $5 million beat, and a $10 million raise coming off the quarter. How do some of the recent trends you saw, how durable are some of the strength that you've seen kind of in Q1? Durable. We see plenty of runway out ahead in each of those three segments of our business, for continued, sustained, durable growth. Within VTE, we continue to see, first of all, robust underlying market growth. When we talk about the market, we define that as mechanical thrombectomy for DVT and PE, frontline, mechanical thrombectomy. If you define the market that way, we believe the underlying growth rate, here in the U.S. has been in the neighborhood of 20%, and we certainly saw that same range in Q1 to us. That means, you know, 18%-22% growth. So robust underlying market growth, within that segment, within that fast-growth market, we, remain the market leader, and we have a lot of confidence in continuing to be, the market leader and, as a result, continuing to deliver, robust growth. So lots of runway out ahead for sustained growth within VTE. As you look across the other two segments of the business, emerging therapies, some nice catalysts shaping up in the second half of the year, we can talk more about, and similarly, we feel like we are just getting started in international, still a relatively small part of the business, but tons of runway we see out ahead of us to continue to deliver growth in the international markets as well. So in Q1 you beat by $5 million and actually raised the guidance by more than that, but $10 million. How should we think about that falling into the different buckets and also any color on Q2? I think you said flat to slightly up, kind of what you're seeing in that. Yeah. So we talked about the year kind of playing out with Q2 being flat to slightly up. We've historically seen some seasonality in our business in Q2, kind of different factors for that, you know, going back over the past two, three years. As we think about Q3 and Q4, we were sort of applying prime most of the beat to that part of the business, Travis, at least timing-wise, and we have some nice catalysts. The kind of the year goes on. We have a couple of new products that are going to go into the marketplace and continuing progress, you know, we believe, with both the VTE Excellence efforts as well as we have the data readout that I'm sure we'll talk about for the PEERLESS later in the year. For the 2024 guidance, now at 20%-22% year-over-year growth, and we kind of strip out some of the new products and try to get to the core and see what you're estimating. We got the global core around 19%, U.S. core kind of around 16%. Is that kind of a fair view of what you're assuming in the model? You know, we don't kind of dig down at that level of guidance in terms of providing the component parts to it that way. We talk in terms of the three parts of the business that Drew described and, you know, that business growing essentially by 20%-22% for the year as a whole. Going back a few years, even back to like the 2019 timeframe when we were pre-public, you know, we very deliberately set up the business to become a multi-product, you know, platform company, and we're pleased with the progress we made to grow from two revenue streams at that time to six revenue streams at this time, including the one inorganic revenue stream being the LimFlow acquisition from November of last year, and, you know, I anticipate that we'll have additional revenue streams as the years go on. Last year, I think the core actually grew closer to 25% in last year, and just thinking about your full-year total company guidance is even below that this year. Is that just some conservatism you're baking into the 2024 guidance? Part of it is this kind of feeling that we'd like to be confident in the numbers we put out, you know. We've executed very consistently over the past four years. We believe, you know, as Drew mentioned, you know, we're just getting started with the business. We also look at the business different ways, so either the sequential growth or the year-over-year growth is one way of looking at it, but we also try to compare the actual sequential quarter-to-quarter revenue change, and there we actually felt like we had some acceleration in the business if you look at Q3- Q4 of last year compared to Q4, Q1 of this year. I think as we're getting bigger, the percentage comparisons are a little bit, you know, kind of tougher and challenged because of the law of large numbers issue, but there are different ways of also kind of gaining perspective on is this business growing and are we accelerating and making the kind of progress that we, we see in front of us. You saw better dollar growth year-over-year, I think, right? This quarter was like some of the best dollar growth you'd had? Exactly. Yeah. You think that there's nothing really changing so you can't really keep that from stopping, right? But certainly, you know, our plan is to continue to, you know, build and execute. There's a lot of opportunity in front of us in the U.S. as we are continuing this VTE Excellence program. We'll probably touch on that, you know, through the course of the morning. As we have the PEERLESS readout later this year and then over the next, you know, probably two to three years, the readouts hopefully of the PEERLESS II trial and DEFIANCE, there we're really attacking the large opportunity, which is the, you know, conservative medical management and the use of anticoagulant drugs. Kind of thinking about the VTE Excellence and some of the market penetration, I think you've at least estimated the market only 6% penetrated now and potentially getting to 60%. So maybe talk about some of the things you're doing now and things that actually can maybe show up sooner rather than later on some of the penetration. So we believe if you look over the last 12 months, we treated maybe 7% of the patients here in the U.S., that could have benefited from our therapy. So despite all the growth, the momentum, the enthusiasm, still tons of runway out ahead of us to continue, to drive, growth and continue to shift patients from being treated with lytic-based interventions and, most importantly, with conservative medical management. If you look at where we've invested, where we have, focused our efforts, it has been on, investments designed to develop and grow that market. We've invested in purpose-built tools, designed specifically for these patients, and we've iterated and refined those tools. We've invested in high-quality clinical evidence, going all the way back, beginning with an IDE study to get on-label for PE and then, the two largest prospective registries ever done, respectively, in DVT and PE, and now moving into an era of three randomized controlled trials that we've invested in. We've invested in a very purposeful and differentiated approach to market development that we call VTE Excellence, designed to support the development of VTE programs. We've invested in a formidable commercial engine and footprint here in the U.S. to raise awareness and tell the story to the frontline care providers. All of those things designed to drive adoption, and I think that's what's driven the success to date. Those same areas are going to be what continues to drive this market forward. We've got some exciting new catalysts, just on the horizon, the RCT data, coming here in the fall, which will be the first of our RCTs, to readout. I think is going to continue to move this market towards, you know, if you look at some of the proxy markets, you know, stroke is maybe 30%-40% penetrated, TAVR maybe 60% penetrated, PCI for STEMI, you know, 95% penetrated. We think over time, given the investments we've made and the traction we've seen to date, we think over time this is going to land ultimately, towards the STEMI end of that spectrum, and that frontline therapy with FlowTriever and ClotTriever will become the standard of care for these patients. So lots of work still ahead to make that happen, but, so far so good, and we like the progress we've made, to date. When you look at some of your leading accounts, more mature accounts, or ones that you've had the VTE Excellence in longer, what's the kind of penetration in some of those accounts? So we think of our VTE Excellence program in three different phases. The final phase that Travis was referring to, we call the Excel phase. And across our 1,700 accounts, these are about 50 accounts that have progressed the furthest along. If you look at the penetration within that group of 50 accounts, it is in the range of 20%. If you look at the highest penetrated accounts within that same bucket, we see TAM penetration rates of 50%. So it gives us some confidence and some evidence that we are making progress, that we are moving along this continuum, and that the playbooks that we've developed under VTE Excellence are succeeding in driving penetration. And if we can continue to make this reproducible and scalable, we're going to continue to see progress along those lines. What is there anything different about those higher centers, the penetration? Is it maybe more buy-in, you know, more help from you? Just kind of curious, what's different? Is there anything structurally different about those centers versus the ones that aren't quite there yet? Yeah. Maybe I'll tackle that one, Travis. So, first of all, I'll tell you what's not kind of unique. It's not a particular physician subset, right? We have highest penetration accounts run by interventional radiology, vascular surgery, and interventional cardiology. It's not a particular predilection for academic versus community hospital-based. We have them across that spectrum as well. What we see are particular elements of highly successful, highly penetrated accounts are a few things that we've gleaned from this VTE Excellence process. Number one is you need a passionate champion, you know, a physician who's willing to take it on his or her shoulders to change the standard of care to what we know is better. That's really essential. You also need the ability to draw in support from other like-minded interventionalists, maybe not the ones who want to lead the way, but certainly support the efforts because there's so many patients out there that need this therapy. It's more than one individual operator can manage in any given facility. Then also what you need is you need the top-down support from the hospital administration. We've done a great job articulating to the administrators the economic value proposition as well as the clinical value proposition of building these programs. When you have all of those elements kind of working together, you can see the kind of TAM penetration that Drew described. We'll get to clinical data, but is the clinical data going to be an accelerator for some of this stuff before we kind of talk about some of the trials? Oh, yeah, certainly. I think if you look at any of the proxy disease states that Drew mentioned, stroke, aortic stenosis with TAVR, heart attack, you see kind of a very characteristic evolution of TAM penetration, right? First, you need technology that actually works, and we have delivered safe and effective therapies that are now in fourth generation. And then you see the program building and the training and education of passionate users. But what you need at the end is high-quality clinical data that is broadcast at the highest levels of kind of academics in order to really shift the standard of care. And that's, we're right on the cusp of the glory era for clinical data generation in VTE. Next up is PEERLESS I, later this year, just thinking through kind of expectations for that trial and how you expect that to kind of shape the market once the data's out. Sure. Maybe just to level set, PEERLESS I is the culmination of years of strategic planning and work to get us to this point where we have the first in our series of RCTs reading out. We didn't come up with the idea just out of the air. This was really built on a strategy of IDE studies to get on-label indications, the largest ever prospective registries in both PE and DVT, so that we can define the safety and efficacy profile of our devices as well as to understand how to capture that data in the framework of a clinical study because we've all had experiences where promising technologies underperformed in the RCTs, and we wanted to mitigate that risk. And only after we reached that, established that foundation have we built not one, not two, but three RCTs in the VTE space. PEERLESS I is the first of these RCTs to read out. As a reminder, it's randomizing FlowTriever versus catheter-directed thrombolysis for intermediate-risk PE patients. Right now, lytics still remains about 30%-40% of the interventional market for PE, steadily eroding over time, coincident with Inari's success, but still there's some holdouts, academic folks who want data, folks who are, you know, kind of, passive until there's data that kind of shifts them away from, what they're doing currently. And I think an RCT like PEERLESS, which has high-level clinical outcomes as well as important hospital resource utilization metrics in a superiority format, I think that's going to really, move the needle. PEERLESS Two, which is to anticoagulation alone, is that just as important of a trial in your mind, and can it impact the market? I don't know. Which one do you think would impact the market more? Yeah. So PEERLESS One will impact the market in a more proximate manner. It's going to read out later on this year. You'll see probably some early impact, probably further erosion or acceleration of the erosion of CDT in Q4, but I think the biggest economic impact is probably going to be in the first half of 2025 as those data get communicated and disseminated. PEERLESS II is targeting the bigger portion of the market, the 80% of pulmonary embolism that's still treated with anticoagulation. So, more important in terms of broadening the access of care. It's going to take a little longer to enroll 1,200 patients in that study, probably a few years, but also just as important in terms of the impact it's going to have in the space. When some of the data comes out in next year, would you think about some of the other markets in, like, TAVR, for example? You actually saw a growth change. Is that what we should expect potentially from a data set as important as PEERLESS? Yeah, indeed. That's the plan. Okay. Great. I did want to move into, actually, yeah, is when you think about the moat around the business because there's competitors coming, so I wanted to ask the competition question. Is, you know, you look at the investments you're making in VTE, looking at the investments in clinical data, is that going to be the competitive moat in your mind around the business, or because in how you think about competition as it comes, like, another competitor, in 2025 even? So we're confident that we are the market leader today. We believe we're a 4-to-1 lead, if you look at mechanical thrombectomy for PE, 4-to-1 share advantage over the next nearest market participant in mechanical thrombectomy for PE. We think we're 1.5-2x lead, over the next nearest market participant for mechanical thrombectomy for DVT. And we are highly confident in continuing to be the market leader as we move forward. And that confidence comes from multiple areas. It comes from the confidence we have in our purpose-built tools, and the platforms that we've developed that remove all the clot, acute and chronic, and safe, efficient procedures with minimal to no blood loss. We have confidence in the high-quality data, that is best in class and only getting stronger by the day, including this fall with the addition of RCT data. We're confident in our robust IP portfolio, in the highly differentiated approach we've taken to market development, VTE Excellence, as we were discussing. We're confident in the commercial engine that we have established that is growing bigger each quarter. All of those things give us confidence that we're going to continue to be the leader in this space. There will be new entrants, undoubtedly. This is one of the most attractive end markets in MedTech, so there will be competitive dynamics in this market. But just as you've seen us deliver growth as we moved all the way through 2023, 28% growth in 2023 despite competitive dynamics, 23% growth in Q1 of this year despite competitive dynamics. Those competitive dynamics and our leadership position factored into our guidance, which is pointing to 21% growth this year at the midpoint. So I think, you know, the competitive landscape will certainly continue to evolve, but what we're really confident in is our ability to continue to lead and help develop this market. On new products, Artix, you've got VenaCore, VenaCore. Some of the other new products, just kind of touch on those and rolling out later this year into next year. Yeah. Maybe I'll jump on those one at a time. So, as a reminder, Artix is our product portfolio focused on acute limb ischemia, so this is an arterial thrombectomy platform. We had the first-generation device rolled out about a year and a half ago. What we saw with that limited release was that it had a pristine safety profile. It was very effective in certain instances, pulling out thrombus in cases where no other existing technology could be successful. But what we also realized in that market release was that we could make some improvements in terms of the ease of use, how the different elements played together, as well as to improve the thrombectomy efficacy. So what we chose to do was bring that back in-house. We've made significant improvements. We're very excited about the Gen 2 system that will be released in limited market release middle of this year. What I would say about the ALI market, that's different than the VTE market that we currently play in, is that it is a mature market. These patients already get therapy, but there's still vast unmet needs. Many of these therapies require multiple interventions. Lytics are still used. Open surgery's still performed in 40% of the patients. We think Artix is going to play a big role in changing how those patients get treated. And then shifting briefly to VenaCore, VenaCore is a novel device in our chronic venous disease portfolio. So these are patients with scar tissue in their legs related to old DVT. We have the RevCore product. We have ClotTriever BOLD as the elements in that CVD portfolio. VenaCore is going to be the next edition. It's currently in limited market release. We're really excited about the results that we're seeing so far, but we'll talk more about the market and the go-to-market strategy once we get into full market release. How should we think about the cadence of other, other new products, later this year into next year? So I think the two key product launches this year are going to be VenaCore and Artix. Against that backdrop, of course, we'll be continuing to execute the initial launch of LimFlow here in the US, which we can talk more about. So I think those are the highlights for the remainder of this year. As we look ahead to next year, I think you're going to continue to see a robust cadence of new product introductions. I think you'll see that across our emerging therapies portfolio, and you're going to see new product introductions and iterations and refinements across our VTE franchises as well, both FlowTriever and ClotTriever. On LimFlow, maybe just an update on how the integration's going and when that's going to actually start to bring in some actual material revenue. Yeah. So just to remind everybody, we closed the acquisition of LimFlow back in November, so we're five, six months into the integration. And I think, bottom line is so far, so good. We've made some really nice progress, from an integration standpoint, bringing that business under the Inari umbrella, getting the business integrated, getting the team established, strengthening and stabilizing the supply chain. Some really good work, from an integration standpoint. Some other milestones out ahead of us, but we're feeling like we've made some really good progress, in fact, slightly ahead of where we hope to be at this point from an integration standpoint. From a commercial standpoint also, some really encouraging progress. It's early in the launch, but we're seeing lots of enthusiastic feedback from physicians. We've completed two initial training courses with physicians. We're gaining VAC approvals systematically and getting at least an initial cadence of cases completed with really positive outcomes for these patients who are in desperate need of new options and new solutions. So lots of good traction on the commercial front as well. We have framed 2024 as a year of foundation building for LimFlow, and I think that continues to be how we're thinking about this year. We're focused on getting the business fully integrated, establishing the initial commercial launch on a solid foundation. We've got NTAP that was announced back in April that will, if all goes to plan, come online on October 1st, which will add even more strength to the economic value proposition. We've got some additional development work we're going to be bringing out later in the year for the first-gen platform. All of those things, I think, will establish the foundation for LimFlow this year. We will see incremental progress as we move through the year commercially, but I think from a revenue contribution standpoint, this is really a year of foundation building. As you look ahead from here to 2025 and beyond, we believe this can absolutely be a really important growth driver for the overall business and most importantly, be a really important new option for a group of patients that are in desperate, desperate need of new solutions. And, Mitch, on operating margins and profitability, they have a goal, first half 2025, sustained profitability. Can you talk about some of the levers that are going to pull that forward a little bit more as you continue to kind of beat and raise and let that flow through to the bottom line? Yes. Certainly with, you know, the outlook for 2024, with the 20%-22% guidance for this year, and then the commitment to returned operating profitability in the first half of 2025, we feel like we're on track to do that. We have really nice alignment across the executive team for that. And, the business, I think, is, kind of vetted at a greater level of sort of sophistication on those topics, you know, than we probably were a year or two ago. The gross margin profile of the business for this year, I think we were just slightly below 87% in Q1, and we've sort of seen it staying in that range as we move through this year. There's a longer-term sort of trend in the gross margin to kind of trail off into the 85% range as we continue to get more international business, but we think we can kind of keep it in that mid-80s. We have a number of projects in mind and sort of executing on, to keep the gross margin really at that best-in-class level as time goes on. We've framed the operating margin journey of the company as sort of a three-phase journey. The number one phase would be kind of the return to operating profitability. Secondly, we'd continue to operate probably at a low double-digit level of operating profitability, you know, for a period of time that could be one, two, three years. That's primarily a function of these investments that we're making both in the business internationally as well as in the randomized clinical trial work that's going on, you know, sort of through that 2026-ish timeframe. Then longer term, we think this is a business that has very positive prospects, you know, for a 20%+ operating margin. So we're excited about that, and we feel like this is really going to be a terrific, you know, financial model for the company as we continue to execute. When you think about going from kind of breakeven to just turning profitable to, to double digits, usually companies with very good gross margins like yourself can get there pretty quick. That ramp's pretty, pretty steep on how quick you get there. Is that how would you think about it for you guys as well? We maybe have a slightly slower ramp to the return to profitability to the kind of the phase three part just as a result of these investments, you know, that we're making. We're also continuing to kind of focus on the different parts of the income statement. So part of that'll just happen as a function of the revenue growth of the company, but also, you know, we're looking at all of the pieces of the puzzle in terms of our SG&A, you know, how can we gain operating leverage in the sales as a percentage of revenue as the company continues to grow. With sales force in pretty much every case, I think, if that's right. How do you plan on getting kind of leverage out of the sales force? So we still have reps present in the vast majority of cases, someplace in the 80%-90% range. We've done that very deliberately, not because the technologies require our support for the docs to get through the cases. We've done that historically because we believe when the physician and the product and the patient come together, having an Inari sales professional, in that environment has been really valuable. The information that we've been able to gather has helped inform our development strategies, our commercial strategies, our clinical strategies. It's also really effective commercial time, as well to update physicians on, new data, new technology. So that's been an important part of our commercial model, up until this point. Looking ahead from here, as you heard Mitch describe, you know, thinking about how to begin to deliver operating leverage within the selling expense line specifically, that may be one lever that we explore, whether or not we could ease back on the commitment we make to 90% case coverage to something lower than that and free up some bandwidth, still garner a lot of the benefits I described, but at the same time, free up some bandwidth to increase productivity in other places. We've also begun to look at different types of resources within our field team. So clinical specialists, associate account managers, we're beginning some pilots with those kinds of resources to understand where they might fit in to our commercial model and where they might contribute also to the path to profitability and operating leverage. Still early days in a lot of that work, but we're beginning to put those strategies in place and execute on those, those strategies. The new head of sales that just came in recently, how's that start going and any, any changes there strategically? So far, so good. Our previous VP of Sales, John Borrell, who had started alongside myself at Inari seven years ago, retired in October at our national sales meeting. We began a search at that point and brought a new sales leader on board midway through Q1. Tim Benner is his name, deep prior experience in leading commercial teams across MedTech. He's going to be a great fit, off to a good start so far. Keep in mind this commercial model that we've been following has been really effective for us. So the mandate for Tim certainly isn't to come in and, you know, fix something that's broken or fundamentally reinvent the commercial model. For sure, we will continue to iterate and refine, as I've talked about, but this is really a question of Tim leading the next phase of our growth and building on the success we've had to date, as opposed to some fundamental radical change in the commercial strategy or execution. All right. Great. I think that's it on time. Thanks for joining us. Good stuff. Thank you so much. Thanks, Drew. Appreciate it. Thanks, you guys. Appreciate the time. Great support.
Loading workspace