Okay, well, thank you. Patrick Wood on the U.S. MedTech team. And of course, we've got Doug Godshall here as well, CEO of Shockwave. So it's great to have everybody here. I get some fun disclosures that I have to read. So, for disclosures, go to morganstanley.com/researchdisclosures. And if you have any questions, please reach out to your Morgan Stanley sales rep. So that was, that was good fun. Thanks so much for joining and agreeing to do this, Doug. I know you're a busy guy. Maybe why don't we start on, like, the coronary side of things? And, you know, probably big picture, the last few years, IVL uptake's probably been faster than at least the markets expected. If we're looking forward, like, is there anything you can see that would slow down that pace of adoption? Should we think about, you know, growth for the next couple of years moderating heavily, or is there, like, continued, you know, penetration behind the business and coronary? Yeah, I, this is one of the few times where, like, people like me say things like, "It's exceeded our expectations," but coronary keeps, like, legitimately blowing us away. Like, luckily, our ops team was paranoid, and they built a lot of capacity, and we kept up with demand. We actually have three fairly meaningful stimuli, and, and by 2025, four meaningful stimuli for coronary. That suggests to us that, like, growth is the end of growth is nowhere in sight. We're in a limited launch right now in the U.S. for C2+. Very favorable anecdotal feedback. We already have lots of very favorable anecdotal feedback out of Europe, so it's not like, oh, it's a surprise that American physicians like it a lot because American patients are a lot like European patients. So new product launch to refresh a product that we just launched a couple of years back. That's great. Second, in a couple of weeks, we'll have inpatient reimbursement that will kick in with a very meaningful uplift for IVL inpatient coronary cases, which is about half of the coronary volume. So roughly $8,000 incremental to what you would get for a standard PCI if you use IVL instead. That will take a lot of the sort of economic friction out of the cath lab, we think, and there's a meaningful economic friction in place right now. And the third near-term driver is... It's not final yet, but in a draft physician fee schedule that came out in the summer and will be finalized in November, physicians will, via CPT code, get a complexity adjustment when they do IVL procedures and pick up roughly a 30% incremental compensation when they—whether it's cash or RVUs, when they do IVL. And so heading into next year, that's a very sizable, sort of incremental tailwind relative to where we are today. So we think 2024, 2025, and then in 2025, we should get the final sort of uplift to the higher APC for the other half of the patients, the outpatient procedures. And so now we're in a equal or substantially advantaged economic position where the hospital will be, to use IVL, and, and then we start seeing new product launches, in 2025, 2026 for coronary. So sort of the baton hands to sort of technology again, after reimbursement takes us through the next couple of years. You know, you opened with a discussion of C2+. Maybe for the audience members who are less familiar with it, can you give a brief overview on that generation of product and the kind of feedback you've been getting? Yeah. So C2, which is the device that got approved in 2021 in the U.S., obviously great product, we love it, has 80 pulses, so 10 pulses per cycle, eight cycles. We now are going to have 12 cycles, 10 pulses per cycle, so you'll get 50% more energy to deliver to either a single lesion, which is important if you have, like, a really tough eccentric nod or nodular calcium, or you can distribute over, sort of a more long, diffuse lesion. And those are use cases where sometimes you use IVL, or sometimes you'll choose not to use IVL because you're just not convinced you're going to be able to get the job done with the 80 pulses. That's certainly what we've seen out of Europe. Our first case in the U.S., in New York State, actually, was an incredibly tough nodular calcium, and they used all 120 pulses, and it was a beautiful result. Now, would they have used IVL? Maybe, or they might have used atherectomy before. So it's unknowable now in hindsight, but great result, and we're not going to lift price. So for the sort of the customer, like, you get 50% more, no price change, so generate some goodwill, which is important since, you know, we price the product at a premium, which is appropriate given the performance and clinical value. So now even more performance and even more value, same price, which we think will augur well in terms of the perception of the company. Now that you've got that in play, I mean, and also the vast bulk of the reimbursement side of things, we can touch on that in a bit, is fixed, let's call it, or at least the gap is closed. What would stop you getting to 70%-80% penetration within, you know, moderate to severely calcified lesions in coronary? Because we certainly, we've spoken to docs who've been that high in terms of their utilization of IVL, but is there anything from a product development standpoint you think that stops you or? I think the, our current catheter is a very good catheter, but nowhere near as good as the catheter we'll be selling in 2026. We need to make it better. I mean, if we don't, we open ourselves to competitive threats. Just like with C2+, the more I can do to make my customers happy, the stickier our share is and the greater the utilization is. The biggest governor utilization right now is economic, whether it's in the U.S. or outside the U.S. If in countries where you have reimbursement, we're going to have north of 10%, 15% utilization, hopefully more than 20% in the U.S. In countries where you don't have reimbursement, it's just hard to get much north of 10%. So there are going to be sort of tiers of adoption rates, depending on countries that have reimbursement and countries that don't have reimbursement. Our market model describes 30% severe or moderately calcified patients of the total coronary interventions. Every doctor you talk to would say there's probably more calcium than that. And if you look at intravascular imaging, it's more like 40% calcified. So somewhere between 30% or 40% of the patients have severe to moderate calcification, which is sort of where we hunt. And when we first launched, people thought, "Yeah, maybe we could use IVL in 15% of the patients." There are handfuls of examples of sites that are using us north of... Well, north of 20%, which proves to us, like, 20% is very realizable as long as you don't have the economic compression. And particularly once sort of better economics and then better performing catheters, we think we used to sheepishly hope we could get to 20%. Now we feel really comfortable 20% plus is appropriate. I think, you know, the first six months of the year or so, interventional cardiologists and people are working very hard, and the system is quite stretched to get through a lot of patient volume. Is there any risk that people are taking a bit more of a break off the summer and, you know, a bit more short term, that you get a bit more seasonality than normal, or is that stretching? Ignoring the COVID years, which were just whatever they were, weird. You know, U.S. doctors take vacation now, and international doctors take vacation, and so the quarter over time has become more biased towards a September quarter as a higher percentage of the quarter. But, but it's not... Maybe this year they went to France instead of the Jersey Shore, but similar vacation, I think. Probably a good trade. I'm biased, I would say that. Yeah, yeah. Maybe the L6, and we can touch on some of that. That's another new product you've been pushing. How has adoption been there? What's been the customer feedback, and is that the product that helps crack peripheral a little bit more? Yeah, it's. So when we—if you go back to when we launched in the periphery, back, frankly, when I started in 2017, and we were trying to figure out where we fit in the periphery, our customers sort of led the way and brought us to the iliac and common femoral arteries, which are arteries where you don't use atherectomy. So they sort of found heavily calcified anatomy where you didn't have good options, and that really helped us find our footing in the periphery back before we had much data and before we had reimbursement. And those have continued to be real strongholds of our peripheral business. We do a lot of business in the SFA too, the sort of longer vessel in the thigh. But our sweet spot remains iliacs and common femorals, and yet those vessels are often bigger than 8 millimeters in diameter, and often have very dense calcification, particularly the common femoral. And so as we were developing L6, sort of what was unknown to us was like, you know, M5 + has an 8-millimeter diameter. Does it really matter if you have a bigger diameter? And it's quite clear from the feedback from our customers, the larger diameter, up to 10 millimeters, 12 millimeters, putting the emitters closer together so that you have more concentrated power, so the power travels better over distance. It's the angiographic results, which is kind of how you measure success in the periphery. Like, does it look pretty? And do you get good blood flow? That's like, that's a winner. There are so many times where doctors will tell us, "After my L6 case, I couldn't figure out why I was putting a stent in the iliac because it looked so good, but I always put stents in the iliac, so I did it anyway, but I don't really know why I did." We didn't tend to hear that as much with M5+. So I think the combination of diameter and power concentration really seems to have differentiated M5+, I mean, L6 from M5+. And encouragingly, M5+ has continued to grow, even though there's some cannibalization by L6. I think there's sort of a synergistic effect where accounts that use both, both continue to grow. What do you think, what do you think really will drive adoption below the knee, over the long term? So we launched S4, which is our below-the-knee product in 2018. And it's a very good product, and it's a very good product to validate that IVL nicely addresses below-the-knee lesions. It is, however, only a 4-centimeter product, and below-the-knee lesions tend to be longer and more diffuse than above the knee. And so it's not like a perfect design for the anatomy. It's good enough, but if you look at our four products that we're selling right now, M5 +, C2 +, L6 and S4. S4 is growing the least fast and sort of flattish, so we need a sort of a product refresh to really drive that business. Hopefully, you're coming to our Innovation Day, and we'll spend some time talking about sort of the future below the knee in a month. TCT should be good fun. Speaking of a market where you got a little bit more reimbursement, apparently in Germany, they kind of finally- Mm-hmm Pulled the trigger on normalizing, I guess. Yeah -payment rates. How's business been there recently? Excellent. So the-- we had the reimbur-- with the DRG change, uplift in January, Germany was our laggard market internationally, or in Europe at least. It's the, if you spend time in a German hospital cath lab, you will be, more likely than not, you'll run into the controller from the hospital because they just are constantly wandering through and making sure every doctor knows they're not allowed to lose any money on any procedures. Like, I can't believe how many controllers I've met at German hospitals, and I don't think I've ever met one in the U.S. So when we didn't have reimbursement, and we maintained our price in Germany, which we needed to do to drive the reimbursement change, there was tremendous pressure not to use Shockwave. So we only got used on under expanded stents or really complex patients where there was nothing else available. But luckily, we got enough volume that we cleared the hurdle and, and InEK German authorities moved up our DRG level. So we had sub 1% or 1% roughly PCI use in the Q4 of last year, Q2 this year, 2%. So we've doubled in six months. It's... If UK is 6%-7% without reimbursement, Germany has got to be more than that. That's- it's the one European market, in addition to Switzerland, which just got reimbursement, where we ought to be north of 10%. I don't know if our team realizes that yet, but they will sooner than later, that they should have a lot more upsides in Germany. And, I mean, TAVR obviously widespread use in Germany because there's adequate reimbursement, where German physicians can adopt aggressively, provided the economic support is there, and we think we have that now. You mentioned TAVR, maybe for people who are less aware, the potential longer term for IVL use in TAVR cases and how that interrelates. We get used in TAVR cases now, back to the iliacs. Like, that was our first home, was large-bore access. That's what got us through VAC committees back in the early days. We also had... At the time, we were doing feasibility work to treat aortic leaflets with our, a very, sort of former design of a device we called TAVL, with an L at the end. That design was kind of kludgy, and at best, user-dependent, which if user-dependent means it didn't work. And so, we've been in a sort of complete redesign since then. Interestingly, when we, back in those days, five-six years ago, if you said we're working on something to treat aortic leaflets, most physicians would be like: "Why are you wasting your time? TAVR is perfect," or roughly, that's what they would say. Now that they're living with patients who've had TAVR for a lot longer, they're like, "might be nice to have an alternative." And so we'll expect... not to point everything back to our Investor Innovation Day in October, we'll provide an update on design and path forward on our aortic valve program. That makes sense. And, you know, you obviously acquired. You know, for those who are less familiar with the Reducer, the potential long-term there, and what it was that drove you to find that asset so interesting? Yeah, Neovasc, most people knew Neovasc as the mitral valve company that got sued by Edwards and had all sorts of challenges organizationally. Sort of below the surface for many years, they were working on this Reducer, which is an hourglass-shaped implant, a scaffold that goes in the coronary sinus, and it reduces flow, or the volume of—same volume, but it reduces the flow going through the coronary sinus and creates sort of back pressure into the microvasculature of the endocardium. So blood goes through the coronaries, through the microvasculature, and then it exits through the sinus. By forcing the blood to have a longer dwell time in the microvasculature, you're getting more oxygenated supply for patients who have microvascular dysfunction. And while we were having to prove in our trial that that is mechanistically what's happening, because the FDA, when Neovasc went to panel, they're like: "We'd like you to explain exactly how this works, in addition to doing a new trial." You've got all these patients who have angina, who either get revascularized, and they still have angina or don't have any clear coronary disease, and it's sort of 30-ish% of the patients who get angiograms, like, I don't see any problems, so I don't explain—I don't understand why you have chest pain. So it's this massive market of patients who the interventional cardiologist can't treat because I can't open a coronary artery and make you feel better, and who the general cardiologist just put on medication and have this sort of unassignable cause of chest pain.... Luckily, they're doing sort of Philips and Abbott now have catheters to help on the diagnostic side of microvascular disease. But it's sort of like, congratulations, you have microvascular disease, and I'm gonna give you the same meds I would have given you when I didn't know you had microvascular disease. So, Reducer is the first and only therapeutic option that anybody has to potentially treat this population. We are treating it in Europe commercially, and our European effort is like, figure out the model, how do you get patients out of the general cardiologist and steer them to the interventional cardiologist? So figuring out what that referral pathway looks like and develop the model, so that when we have COSIRA-II data in a couple of years, hopefully, we've kinda figured out how to do it. And then with the support of a sham-controlled randomized trial, we can really start to really develop the market internationally, and then do it in the U.S. You obviously went through a reasonably sized convert, you know, raise, I don't know, a month ago, isn't it, I feel like? Ish, yeah. Time flies. Yeah, yeah. I would it be fair to assume some of that is optional firepower if you see other assets available? And should we expect assets that are similar to Neovasc, i.e., it's kind of, you know, investment up front, a little bit dilutive today, but you've got the payoff a little bit further down the line. Is that a reasonable framework to think about it? Yeah, I mean, most, I mean, we're receptive to something that is commercial and profitable now. There aren't a whole, there aren't a whole lot of those. So more likely than not, we'll, we'll be looking at, and we are looking at properties that are either very, very early commercial now or, still have some development, time left, that sort of the more typical, MedTech M&A. What we realized was there's this sort of, unusual window in time right now, where private companies are just getting hammered on valuation in their financings, if they can finance at all. I mean, the good ones can finance, but they don't love the terms. And, and the IPO, IPO window for MedTech, at least as of yet, hasn't opened, so you're in this sort of TBD, how long it's gonna last. But we realized, let's put ourselves in a position where if we find something that is the kind of property we really like, where it's highly differentiated, substantially sort of under-penetrated market or completely unmet clinical need, where we think we can lean in and use the skills that we've developed with IVL to create yet another growth leg on our stool. We certainly hope that... Well, we know IVL is gonna keep growing for some time. We hope and believe that our aortic valve program will grow. We have high confidence in Neovasc, et cetera, so maybe we're being greedy that we're gonna find others, but if we find something special, we wanted to be in a position where we could act. Are there certain areas you're more interested than others? Like, is it all just pure cardiovascular, or like, is there like a... Or, is it like a cultural fit that's a massive chunk of it as well? We've looked at non-cardiovascular, and we realized we'd have to be super convinced because we're - we don't know how smart we are in general, but we know we're probably smarter in cardiovascular than in non-cardiovascular. We'd have to be pretty compelled that it was, like, you could create essentially a non-cardiovascular IVL standalone. We try to be self-aware enough to know, like, we'd better be clear that we can win and build something sustainable, profitable, et cetera, whether it's cardiovascular or non-cardiovascular. We don't like commodity things. We don't like entering in the market where companies are doing an exceptionally good job already, and how could we really win? Like, can I really beat Edwards and Medtronic and BSC and TAVR? Eh, probably not. Let's not do that. So we're, we say no to almost everything we look at, and we probably say no to almost everything we look at, and maybe we'll find another thing to say yes to, like we did with Neovasc. And if we don't, at least we were in the game, and we put ourselves in a position where we had strategic flexibility. And I don't think we'll regret that, given the terms of the deal that we did. Nah, makes, makes sense. And then, you know, there, there aren't many MedTech markets that remain with a single player into perpetuity. You know, at some stage, presumably, competition will come. You have a pretty strong patent estate. You had one player that was sort of talking about it but then disappeared into Abbott. And so I, like, if you're us, how would you think about eventual competition in this market? Do you have any idea on, like, timeline? Because there's, there's very little publicly out there. Yeah, we used to say we thought we'd have peripheral competition in 2024. That looks increasingly unlikely. So now I'll say 2025. We think we'll have peripheral competition in 2025. And the, we've only seen language from Abbott around sort of, we like what we bought, and we might put more resources into it. And great company, like, I agree with them. IVL is a very exciting space. We'll, we like our patents a lot. Even though some of our patents were challenged, that which has survived is, we think, incredibly strong. Like, everybody loves their own patents, so it's gonna be up to a judge someday to decide if competition ever does show up. ... Well, thankfully, GLP-1s have cured every issue in healthcare, so- I'm gonna live forever. Just, just FYI. I mean, like, obligatory question around that. I mean, it's more that we've got a data readout from STRIDE on the peripheral side of things. Do you ever, like, think about it? Is there any sort of thought process in relation to the business? I'm guessing not, but- No, I mean, we're not gonna change what we do. We, we don't think there's gonna be. Like, our patients have been sick for a long time. They tend to be sort of elderly. 73, I think, is our average age in most of our trials. Throwing them on a GLP-1 right now is probably not gonna get rid of their calcium, and, well, it won't. and you're gonna have some percentage of the obese population that is gonna start walking around and then suddenly realize, "Oh, crap, my legs hurt because I'm finally active," and they're gonna go and see somebody and say, "Oh, that's because you have peripheral artery disease." and so whether that's gonna be enough to offset some de minimis reduction in patient volumes because of a reduction in diabetes, we think the overall demographics are still gonna augur favorably, where the procedure volume will be flat to up. and our customers, who are also biased because they're plumbers treating vascular disease, so they wanna believe that their patients aren't gonna go away, but they're quite convinced their patients are gonna go away. They're treating patients on GLP-1s now, so they're still showing up with disease. There's 120,000 leg amputations a year just from diabetics, so- Yeah, we need a portfolio of below-the-knee catheters to help. Yes, absolutely. Yeah, no, that makes sense. Then, you know, you obviously spend your time doing a certain amount of stuff in the business, and then you get external questions and things like that. Where's the, like, I don't wanna say disconnect, that might be too strong a word, but you get a lot of questions about externally that you don't actually end up spending a lot of time internally, or what eats up a lot of internal time that you don't get asked about? Do you see what I mean? I think there are some things that are maybe underappreciated. Like, we have 5,000 generators out in the market. We'll have hundreds and hundreds more at the end of next year. So when there's sort of, "Oh, my gosh, competition's coming," like, we're gonna have an incredible install base of a super user-friendly system and multiple catheters plugging into those generators that are distributed around the globe. I think there's always a first-mover advantage, unless you're, like, stupid and you don't take advantage of your first-mover advantage, and hopefully we're not being dumb. And I think we are. If I look at physician reaction to the new products that we've launched, even things like L6, where I thought, "I don't know how big a difference it's gonna make," my team did a substantially better job than I appreciated that we had done because the physicians love that catheter. And that's sort of a bit more of a niche application than sort of the next wave of launches that we're gonna have. So I think our competitive position in advance of competition, we think is quite formidable, and we think it's gonna get better as we upgrade performance of our system over sort of every six months or so with product launches. And then not, not to open up a can of worms with 1 minute and 57 seconds left, but, outpatient reimbursement on that side of things, I mean... Or not specifically that-... but, you know, there's a lot of moving dynamics, some very positive ones on inpatient in the CPT side of things and then outpatient, but, do physicians even pay attention? Anything there. Yeah, so for just a quick 1 minute and 34 second overview. The inpatient goes into effect October 1st, $8,000 uplift versus other DRGs. Physician fee goes into effect January 1st, 30% uplift in RVUs relative to a standard PCI. Six months later, our tech pass-through payment for outpatient goes away, and then a couple of weeks later, we'll see the proposed rule for outpatient procedures. So a transitional pass-through to date has basically covered the cost of the catheter. We're quite comfortable that new product launch with C2+, very favorable economics, very favorable physician fee, are gonna be more than a overwhelming tailwinds leading into this gap, where it's gonna be really uncomfortable for hospitals and physicians to say: Well, I'm gonna now treat my patients differently in September of 2024 because I have a temporary, sort of outage of my transitional pass-through, and I already have visibility to when it's gonna get better. And we don't, we don't think there's any way that you're gonna say, "You know, this patient's an outpatient, I'm not gonna use Shockwave. This patient's an inpatient, I am gonna use Shockwave." That just is, like, feels unethical, so I don't think doctors will do it. And so I think there will be a Wall Street anxiety, which I already have a Wall Street anxiety about this topic. I just don't really think it's gonna be a practical effect on our business. I love anxiety and perfect timing. Thank you so much, sir. I really appreciate it. See you.
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