Good afternoon, everyone. My name is Adam Maeder. I'm one of the MedTech Research Analysts here at Piper Sandler. Very pleased to introduce the management team from Inari Medical. With us, we have Drew Hykes, CEO and President, Mitch Hill, CFO, and we have John Hsu from Investor Relations in the audience. Gentlemen, thanks so much for joining us. Yeah, good to be here. Thanks for having us. Of course. So I think maybe a good place to start is on the guidance for Q4. You're coming off a really nice Q3 print, a beat and raise quarter. The implied guide is sequential revenue growth, quarter-over-quarter, about 2%-4%, 19%-22% growth year-over-year. That is a deceleration versus Q1 through Q3, maybe a little bit less of a seasonal improvement quarter-over-quarter than we've seen historically. I'll ask the question this way: maybe just talk about guidance, philosophy, key assumptions, anything that's giving you pause or conservatism. Just maybe flesh that out for us. Yeah. So I can get started with that, or Mitch may want to chime in as well. So we had good momentum heading through Q3. We saw growth in the Core Franchise, ClotTriever, and FlowTriever here in the U.S. We saw nice contributions from some of the new harder addressable markets that we're doing work in, and we saw another nice quarter of sequential growth in our international franchise. I think all of that gives us some nice momentum heading into the final quarter of the year. Relative to guidance, I think, nothing has changed from our historical philosophy. One of the things we've been very deliberate about all along is ensuring that when we put a commitment out there, we're highly confident in being able to deliver on that commitment. I think that same philosophy was reflected, this time around as we updated guidance, coming out of Q3. I would just add, Adam, we, you know, we had a nice beat and raise with the Q3 numbers. I think the midpoint, the Q4 guidance would still have us around 28% growth, you know, for the year. And so we still think, you know, that's kind of something we've been targeting, is to kind of build this business platform to be one that can grow sustainably, you know, for many quarters and years to come. That's great color, guys. Very helpful. I'm sorry to ask the prerequisite question on competition, but, you know, just curious what you're seeing in Q4 from a trialing standpoint or from a competitive dynamic standpoint, anything that's worth calling out or anything that's changed? No big changes. We did see competitive trialing, particularly earlier in the year. We saw some of that continue to taper down through Q3. I'm sure there'll be more of that to come here in Q4. But as you've heard us describe in the past, our view has always been that early couple quarters of a product launch is when you tend to see the biggest impact, the biggest splash. I think that's exactly what we've seen play out, as we've worked our way through this year. That's helpful. It's that time of the year, obviously, people are looking at 2024, so I'll ask a 2024 question. I have your consensus revenue at, I think, $585 million. That's 20% growth year-over-year. Any reaction to that figure, guys? And would love just some puts and takes as you think about the business next year. Yeah. So we're not ready to offer formal 2024 guidance, nor have we made it a practice to comment on forward year consensus. What we can tell you is that we see a lot of compelling growth ahead in 2024. Continued growth in the core franchise here in the U.S., contributions from what will be four additional target addressable markets alongside VTE, and continued growth in international as well. So I think all of those things, we believe, position us well for 2024. But I think we're going to need to wait, likely until early January, for us to put some more color and specificity around the 2024 guidance. Totally fair. That's helpful. So, you know, if I look at your numbers this year, I look at your competitors' numbers this year, year to date, you know, clearly it feels like the market's very healthy. The VTE market's very healthy, potentially accelerating this year. The question is, how do you think about broader market growth for VTE? So if you define the market as mechanical thrombectomy for VTE, it's been a really healthy, market backdrop here as we've moved through this year. Every reason to expect that that will continue. As you look ahead to next year, we'll be bringing out, the first randomized control data that we've had available in the PEERLESS study. That will certainly help continue to support, market growth. The work we're doing with VTE Excellence and the market development, program that we have underway will continue to drive that market growth, more refinement and iteration on the underlying, toolkits. I think all of that will continue to drive, market penetration and market growth, and we see plenty of runway out ahead, for that growth to continue. That's very helpful. Didn't hear you quantify it. I'll give you the opportunity if you'd like to quantify it. Yeah Drew. So, in the past, we have quantified, a gain, if you define the market as mechanical thrombectomy for VTE, at the procedure level, we think the market has grown in the neighborhood of 20%, and our expectation is that would continue, as we look ahead. Very helpful color there. Thank you for that. Let's just spend a minute on market share, and then we'll start to get away from, you know, some of the competition discussion. Where do you think share trends stand today for Inari in pulmonary embolism, in DVT? And, you know, I guess as we think ahead, you just talked about 20% growth for core VTE for the market. Do you envision Inari, you know, being share stable, share accretive, share dilutive? I mean, how do you think about your business going forward? So we believe we are the market leader today in mechanical thrombectomy for VTE. A stronger leadership position in PE than what we enjoy in DVT, but nonetheless, the leader in both. We're confident in continuing to maintain that leadership position. We're gonna do that by continuing to expand the commercial team here in the U.S. We're gonna do that by continuing to refine our market development, VTE Excellence program, more data, enhanced tools and iterations, all of that, we're gonna be able to leverage to continue to protect and extend that leadership position. That's very helpful. Wanted to ask a question on the broader market. You alluded to some of the data that's coming down the pike. You know, there's several large randomized controlled trials that are being conducted in the space, both on the DVT side and PE side of things. You know, maybe just talk at a high level, what timing looks like for those different studies. I know you have a couple. How do you think about implications for the category? Yeah. No, it's a really exciting time, particularly in PE, given the clinical work that's underway. You know, we started that work five, six years ago with 100 patients, IDE study, looking at a surrogate endpoint. We moved beyond that and conducted the two largest prospective registries ever done in PE and DVT, FLASH and CLOUT, and now have moved on to the final chapter of that clinical work, which is three RCTs, two in the PE space, and one in the DVT space. The first of those three studies will read out next year, the PEERLESS RCT. That's randomizing 550 patients between FlowTriever and catheter-directed thrombolytics, one of the historical legacy approaches for intervening in PE. That study is nearing completion from an enrollment standpoint and will be read out next year. That is the kind of level one RCT data that is ultimately going to change guidelines and ultimately gonna contribute to the continued expansion of this market and the shift in standard of care away from conservative medical management, away from lytic-based intervention to definitive catheter-based mechanical thrombectomy as frontline. Alongside PEERLESS, just this week, we announced the first enrollment of our second RCT in PE called PEERLESS II. That's a study even larger than PEERLESS, 1,200 patients randomized between FlowTriever and anticoagulation alone. So the current standard of care for nearly 80% of these patients. That's a 1,200-patient study. We've just announced initial enrollment. That will take a while to enroll, but that will also be a really important contribution to this space. And there are other studies underway as well. There's an NIH study that's up and running called PE-TRACT. There's several other RCT studies. So really exciting, after six or seven years of commercializing, to see the space get to this point where we've got multiple RCTs underway. All of them, hopefully, are going to point in the same direction, just like you saw in stroke, that mechanical thrombectomy frontline, definitive catheter-based intervention, is a better approach for these patients than conservative medical management. So stay tuned. It's gonna be an exciting phase going forward. That's a great overview of what's to come. I'm wondering if you can put a finer point on the PEERLESS timing for next year. Yeah. No. No. No first half, second half? Just- Not yet. Okay. So, a couple things need to happen before we can put a more definitive timeline on it. First, we have to complete enrollment. We gotta gather the data. We need to submit that to a late breaker at a medical meeting. We'd like that data to come from the podium at a late breaker. So lots of moving parts there that need to come together before we're ready to put a definitive date on it, but it will be in 2024. I think we're very confident in that. But when and which conference and where it lands in the year, I think is too hard for us to gauge at this point. Yeah. Yeah. And, Adam, on the RCT discussion, we should also add the DEFIANCE Trial, which we're doing for basically the DVT world, to compare ClotTriever with anticoagulation therapy as well. That started enrollment, you know, some time ago. It's continuing, it's making nice progress, and that's one that was, again, focused on conservative medical management for the treatment of DVT. Yep. No, that's a great point, Mitch. Yeah. I want to go back to something you said earlier in the discussion, Drew. I think you were kind of alluding to new market adjacencies, you know, in 2024. And, I have to admit, you guys are, y ou launched a lot of new products, and it's hard to keep them all straight. So I'll ask the question this way: you know, I think you have six products in full launch mode in the back half of 2023. Mm-hmm. Maybe you could just rattle those off, and which of those do you think is most impactful next year? That's part one of the question. And then part two is, are there additional products that you expect to launch in, in 2024, and can you give us maybe a sneak peek on those? Yeah. So the first part of the question, those six new products, three of them are kind of first-order revenue contributors to the business. So we've got the InThrill product, which is helping patients with dialysis access management, declot. That product is incremental revenue, incremental patient population above and beyond VTE. ProTrieve is a second new product that also has kind of first-order direct revenue contribution. That's a product designed to be delivered through the IJ to provide essentially embolic protection in complex DVT cases. And the third new product that has kind of first-order revenue contribution is RevCore, which is a product that's helping patients with chronic venous disease, another patient population outside of VTE, and specifically patients with chronic venous disease and occluded venous stents. RevCore's been designed to help remove material inside those stents and restore flow. So those three products have kind of first-order revenue contributions. They're currently in full market release in the second half of this year. Three other products will be part of our overall toolkit. They don't have first-order revenue contribution, but are really important additions to our toolkit. Triever16 Curve is an enhancement to our existing 16 French aspiration catheter with a pre-shaped curve on it. And then we've got two enhancements on the ClotTriever DVT side of our business. We've got ClotTriever XL, which, as the name would suggest, is a larger platform of our ClotTriever product designed for larger vessels, the IVC. And then ClotTriever BOLD 2.0, which is some ease-of-use improvements that we brought with that product. So those final three, also in full market release this year, contributing to better outcomes for patients, the competitiveness of the toolkit, but not first-order revenue contributors at the same time. Looking ahead to next year, it's a robust pipeline. You saw us deliver lots of new products this year. That same cadence is going to continue next year. We will have some new products coming out in the chronic venous disease toolkit alongside RevCore, which we're excited about. We'll have new products also coming in the core VTE part of the franchise. And we'll also relaunch the Artix product in 2024. Recall that is a product designed to help patients suffering from acute limb ischemia, another new patient population outside of VTE. We had a first-gen Artix platform that we brought out earlier, decided we needed to do some more development work, and we'll relaunch Artix here in 2024, which will be another kind of highlight of the new product cadence in 2024. Really helpful with color there, Drew. Maybe just to follow on, we can, we can actually start with Artix. You know, maybe just remind us of some of the redesign work there. And I'll ask a similar question with timing. Can you put a finer point on timing for arterial? Yeah. So Artix is designed to address unmet needs in the Acute Limb Ischemia market. So these are patients with arterial clot in the lower extremity. Many of those patients still go on to have open surgical intervention. So there's an unmet need for more purpose-built tools designed specifically to help ALI patients. We had a first-generation platform. It had a proximal flow arrest with a balloon. It had an aspiration component and a mechanical thrombectomy component as well. We brought that product through what we call a Limited Market Release, an LMR. Saw a very good safety profile from the system, but more work that we needed to do from an effectiveness and ease-of-use standpoint. It's an existing market. There's existing platforms and systems in place, and a pretty high bar as a result for effectiveness and ease of use. That's the work that we've been undertaking here over the last year or so. The next gen product is designed to improve upon the effectiveness and ease of use. Not quite far enough along today to put a finer point on when the market release date will be. Next year we will redo the LMR, will be the first step, and then hopefully move from there to a full market release later in the year. Great color. I did also want to ask about the new core VTE products in 2024. To the extent you're willing to share, I guess, you know, one would be, what are they? And then second would be, are these going into the existing, you know, procedure kit, or are these, you know, I'm not sure what the right word is, de novo revenue- Yeah -streams as well. Yeah. So we feel really good about the core, effectiveness, certainly the core safety of those, respective systems, FlowTriever, ClotTriever. These are fourth-generation platforms at this point. We do think there's more opportunity for us to continue to refine, the efficiency, the ease of use. So I think, you'll see some of those kinds of focus areas reflected in the new tools we'll bring out. To a large extent, those will be, within or under the umbrella of the existing, toolkits, alongside, refinements to the existing toolkit as opposed to, new additions. Very helpful. Let's transition over to the LimFlow deal, which you announced on the Q3 earnings call or in conjunction with it. You know, one question I sometimes get it from investors is, you know, just the timing and, you know, why was this the right transaction at, at this particular point in time? You have a lot of runway in the VTE, you know, field. So, you know, maybe just give us your response to that question. Why was now the right time to, to be accretive? Yeah, so we- Excuse me. We had invested in LimFlow back in 2022, in their last round of venture financing, and had taken a board observer seat and had tracked closely the progress that the company was making through the execution of their PMA and then through the final phases of the FDA PMA approval process. As they got to the end of the summer, they were approaching a fork in the road strategically. They either needed to raise another round of private financing to support the U.S. rollout or undertake a dual track M&A process, which is obviously exactly what they did. We had gotten really compelled by this asset, by the impact we were seeing it have on patients, by the size and the spectacular unmet need in CLTI, by the data that they had collected and published in the New England Journal of Medicine, the reimbursement program that they had established, the compelling strategic synergies with our own business. As that asset came up opportunistically, we just couldn't let it pass us by, and we were thrilled that we prevailed in that process with LimFlow now as part of Inari. The other advantage from a timing standpoint is it allows us to now be involved from the start of the U.S. launch, and really help leverage our capabilities, our competencies, to really help guide and drive and leverage that initial launch phase, which is underway as we speak. Very helpful color. You know, as we think about LimFlow in 2024, you know, lots of folks asking about commercial expectations. You know, you have reimbursement in place, you have the New England Journal publication, you're bringing on a decent size, dedicated sales team. How do we think about the revenue contribution in 2024? And if you can't talk revenue, it would be helpful just to hear about how are you thinking about pace of launch, number of centers, just some other kind of metrics that you can share. Yeah. So one of the other reasons we were compelled by LimFlow is it's a very targeted commercial focus, unlike what we've had to build and establish in VTE. We think there's maybe 200 high volume dedicated CLTI centers of excellence, limb salvage centers of excellence. These are non-emerging cases, these are scheduled cases. We think it's going to be serviceable and supportable by a much smaller group of dedicated sales professionals. 2024 is going to be a year of foundation building for LimFlow. A year focused on gaining back approval, on initial training, on ensuring we're very deliberate about initial patient selection, and as a result, getting really good patient outcomes that we can build on going forward. We'll also have, if all goes to plan, some incremental reimbursement coming online late in the year in the form of an NTAP. So all that, I think, points to a year of foundation building, and as a result, a relatively modest revenue contribution in 2024. Looking beyond that, we think given the size of this market, given the procedural revenue, given the fact these patients are no option, literally no option other than amputation, we believe this can ramp quickly and become, over time, a significant contributor to our overall revenue mix. Just, just starting out, Adam, size-wise, the team, there's about 10 people on the commercial team right now at LimFlow. We plan on keeping them separate from the VTE group. The PROMISE II sites, I think there are around 22, 23 sites involved in that. So I think the initial focus will be there, obviously. And if you kind of expand that, you know, by, by two, you're looking at 40 to 45 to 50 sites, I think will be the initial focus of the 200 sites that Drew mentioned. I think that's gonna be kind of our game plan for 2024. Thus, you know, we think it's gonna be pretty modest revenue contribution next year. That's, that's great color, guys. Appreciate that. You know, I, g ood assets cost money. And, you know, such is the case with, with LimFlow. But maybe just talk about the balance sheet after the deal. You know, level of confidence to execute the game plan in the coming years with, with the current capital that you have. Yeah. Without re-accessing the capital markets. Yeah, happy to talk about that. So we ended Q3 with just over $350 million of cash. We also have two credit facilities with BofA. There's a $75 million ABL facility and a $25 million equipment sales leaseback facility, so around $100 million there. Then the third factor I'd sort of put on the sources side would be the internal cash flow generating capability of the company, which has been around $30 million in the past four quarters. So that's kind of the sources of cash side. On the uses side, you know, a couple weeks ago with the closing, that was a little less than $250 million, you know, for the initial payment. We have this $2-$3 million a month of operating deficit support, and just think of that as being payroll and some third-party costs, you know, for the, for the LimFlow team to kind of help them get going. As we start getting traction with the product in 2024, those gross profit dollars from the sale of the LimFlow product will start to offset that $2-$3 million of operating deficit support. And then we have the milestone payments that come up each year. So there's three milestone payments. The payment that is due in Q1 of 2025, there are three factors in that. There's a reimbursement milestone related to the NTAP. There's a reimbursement milestone related to the New Tech APC, and those might end up being kind of in total around $22 million, something along those lines. And then there's a third reimbursement milestone related to 1.5x 2024 revenue, you know, when we expect that's gonna be pretty modest. So when we add those three things together and think about that in the context of 2025, that's something that we think we'll be able to accommodate that. And then the two further milestones in 2026 and 2027, we expect to be self-funding, essentially. Very helpful color. You know, I guess in the interest of time, I think I'm down to my last question. And I hate to finish on a GLP-1 question, but obviously very topical, and I know you guys have done a lot of work here. So, want to give you the opportunity to maybe talk about how you're thinking about GLP-1s, any potential impact to your business. You know, I think I've even seen some literature that suggests it could be a positive or a tailwind for VTE. Mm-hmm. So I'll give you guys the final word, and we can close out with some GLP-1 commentary. As the clock winds down. So the quick answer in terms of Inari and GLP-1's, neutral to positive. There is not a big traditional cardiovascular risk factor associated with VTE. Obesity, diabetes, are not risk factors for VTE. Risk factors for VTE are genetic, cancer, malignancy, and oral contraceptives, so we don't anticipate any impact from that standpoint. And to your point, Adam, most of the big GLP studies to date have shown a pretty clear safety signal for VTE as a complication, as an adverse event associated with the administration of the drugs. That's not well understood. Is that because patients are dehydrated? Is there some underlying mechanism of action? If you look at even the meta-analyses that have been done of GLP-1, you see a pretty clear signal of the potential for VTE to be an adverse event. We'd be happy to help those patients if and when they suffer from VTE as a result of their GLP-1. That's great stuff. I, I think we're unfortunately out of time, but want to say thanks again, Drew and Mitch- Thank you. - for joining us. Appreciate it. Appreciate it. Thank you. Thank you, guys. Everyone for listening.
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