Travis Hewett again, Bank of America Medical Device Analyst. Next up, we're glad to have Penumbra, Adam Elsesser, President and CEO. Thanks for coming.
Yeah, my pleasure. Thank you for having us.
I wanted to start kind of like a big picture question. You're one of the few companies to kind of go new IPO to a billion dollar market cap to now like $11 billion-$12 billion market cap. You don't see that very often. And I think you kind of reinvented your growth drivers. You're in competitive markets. Like, you know, maybe we think they're more competitive than they really are, but they're pretty competitive markets. So like what's kind of been your success for Penumbra over the past decade to take a company from a billion to $11 billion-$12 billion market cap?
I am, first of all, thank you for that question. That is like my favorite question to get to address. It goes to our ability as a company to constantly innovate. We have talked about that a lot. It is sort of one of our four-pronged strategies for the next number of years. It has really been how we have gotten here. The moment we launch a product, we are working on making it better. In some areas, that would be sort of a sign that your first product was not good. With us, it is a different thing because in the idea, the world of thrombectomy and the idea of taking clot out, it is really challenging.
We started this 20 years ago, long after other interventional spaces were pretty mature because the idea, which sounds simple, you just go and take out the clot, brings with it huge challenges and safety risks and so on. The idea of being able to constantly make these things better and better has been why we continue to succeed because there are times way back in the history of the company, before we were public, where we might have a product, someone else would come up with one that was a little bit better than us. That would put us in a tough position for a little bit until we came up with the next one that was better than that. That process has kept us here.
We're now sort of entering a different era though, where we're not really competing as much, and I say this with all due respect, against other companies as much as ourselves because we're entering, as we've talked about, the age of the digital age of using a computer to actuate the valve and do that versus sort of an analog system. It's just hard to compete. Just watching what the product does and how fast it can remove clot and how safely it can do it, it's going to be hard to go backwards to a catheter and a pump or a syringe and a sheath kind of thing. I think it is now on us. We don't have an external competitor in the same way. We have ourselves and just trying to make this better and better.
The good news is we have, I think, a pretty clear vision. What does the next four or five years look like? What can we do by harnessing this technology? I think we're entering a really fun phase. I think it's going to be a lot of fun to just keep moving on this. Our R&D team, if anyone ever wants to come out and spend a little time not to find out what they're working on, but to think how they think, it's amazing. This is a group of people, young, energetic, incredibly clever folks who really don't give up. That's the secret sauce.
Are you pushing the innovation cycles faster and faster?
We don't really think about time like that. It's about what does it do. Sometimes innovation takes, the first CAVT took a long time from the idea to the first product was the longest innovation cycle we've had. Now, once those are launched, changing algorithms is a much faster thing because you're just changing software, not hardware. It really depends on what it is that we're working on. I think it could accelerate.
Sounds like the kind of the next five years that you're super excited about. A lot of that's on the digital side, like more computer aspirated stuff.
Yeah. Yeah, I don't, other than, you know, and I've talked about this before, I think even on the last earnings call, the coronary is the one area where we haven't yet gone the route of bringing in CAVT. Is that necessary given what the consistency of that clot is and how well our current product works? That's an open question. In the other areas, obviously we have CAVT in arterial and PE and DVT, and with Thunderbolt finishing its trial and all, bringing that in when it comes. I think we're in that phase now.
You can take that CAVT and make it better in terms of Lightning or Flash 2.0, kind of 3.0 and stuff like that? Is that the idea? Thunderbolt 2.0?
Yeah, I mean, whatever the names are, but yes. It's probably more than just a better algorithm. It's a broader, there's more on the table than that. That is part of the good coming. We'll leave it at that.
Okay. Probably as much as I'm going to get out of you.
Probably.
Maybe just moving to neuro. I guess maybe talk about just open up the state of affairs in the stroke market. We've seen more of this market move to aspiration. Some of the legacy players are kind of giving up on the market even potentially. Just kind of what do you see kind of the state of affairs in stroke right now?
Yeah. Yeah, the players have changed since back in the day when we went public. We obviously were one of the real only aspiration companies. The rest were century companies. That dynamic has shifted pretty dramatically, obviously, over the years. Now there's a lot of private companies with sort of catheters that are sort of similar. I think there's a lot. If you were to ask most customers, I mean, we're still the dominant leader, but of these new things, how much of it is, oh my God, that's amazingly different? It starts to blur. I think that will sort of somewhat take care of itself over time.
View of the market growth kind of from here in neuro?
You know the biggest challenge, and this is the one thing I don't mean to be negative on because I've got to stay optimistic. When the stroke trials all came out in 2014 and into 2015, there was a big period of time where we saw growth, where it was pretty significant. Obviously, we were newly public and everyone could sort of measure that. We haven't seen that same level of growth, not for reasons that the data doesn't support it and all, but you have this structural issue that you don't have in the vascular side where the patients aren't always showing up at the hospitals that could do the treatment. You would have to move them. Sometimes that happens. Sometimes it doesn't happen. That's sort of the structural element in more growth.
I have personally gotten involved and certainly we have helped fund the society's work to get laws passed at a state-level that require triaging of patients and so on. In some places, that's had a positive impact. It's really hard to do. We're 10 years into that and I don't see that magically changing anytime soon. What I hope happens is that the group, and this isn't for me to decide, is that we come up with a solution where we don't necessarily have to move the patient. I know there was some hope back in the day when Carindus was coming around as, oh, we could do robotics. That had technology challenges, but more importantly, it's not a practical solution because you've got to sort of see where who's going to pay for what. There's only one DOG. How does this economically work?
It does not really work. There are other solutions. I am hopeful that physicians and the groups and hospitals start to sort of think about those solutions. I think that is the challenge. In the vascular space, you do not have those challenges. PE patients are there. DVT patients are there or in the community easily enough. Same with arterial. They just are needing to move to the right thing. There, like Take STORM - PE, that trial, which we have put on clinicaltrials.gov, is scheduled to read out next year. That could be a significant catalyst if it is positive because it is just a matter of, oh, we now should do this. We are now treating 10% of those patients and we could be treating all of them. That is what we wanted to see in stroke, but we ran up to that structural problem of moving the patient, which we do not have.
Of the biggest catalysts, that's something that I'm pretty excited about to watch. DVT is sort of a slightly different animal where it's the work we're doing on market access, which I'm very excited about where we're showing the clinical benefit, the economic benefit, and hospitals can change their own protocols and all that to treat more patients. I think there's a lot of optimism across all boards, but the scale of the growth will likely still be more on the peripheral side.
Okay. Makes sense. Sounds like you're not going down the robotic side in stroke though.
Yeah, again, we spend time, I was optimistic, but I don't think that seems like the right way to go. I could be wrong, but I think you have to also not, you have to look at how things are going to get paid for, particularly in today's world, and it becomes tricky.
Makes sense. On Thunderbolt, submitted the data. Just curious, any questions from the FDA? You know how the review process and back and forth is going with the FDA there?
Yeah. You know I'm going to stay true to my word on the earnings call a couple of weeks ago. We are in a process. We submitted that. Everyone sort of knows that back and forth. We'll just sit back and let us run the process, and we'll let you know when we know something.
That's fair. That's fair. You can give an update if you want, but what's kind of the latest thinking on the launch though, kind of post-approval and how fast can you get this rolled out? It sounds like the back committees aren't going to really be as big of a limiting factor this time around.
Yeah. Look, let's get approval, then we can start talking about the launch timing and all that. Yeah, it's different than the vascular side where you have so many more hospitals. That process, there's just that many more VACs and so on. Neuro is a little bit more contained. Obviously, we have almost 20 years of experience going through that process in the neuro side. It's not likely the VACs that are the process. It's just getting the word out and doing the work to launch a product. We've done that before.
Okay. Anything else you'd compare kind of Thunderbolt launch versus the Flash launch?
Yeah. I think there are different diseases, different physicians treating them, different types of things people think about. There are some differences. Having several years of technology, FLASH is a little different because it's slightly different technology than the LIGHTNING BOLT launch and the arterial. Having that experience, having that many cases done over the last couple of years with similar technology, I think is obviously a benefit to us in launching THUNDERBOLT.
When will we see the data? Is it July?
No. We do not want to obviously present the data before it is approved because companies have done that and their data changes and it is a little awkward. We will wait till it is approved. I just cannot tell you that timeframe now. If it is either in July, it could be in November at the SVIN. I just do not know.
Okay. That's fair.
It'd be premature to tell you that.
Okay. Now that the medium vessel occlusion stroke data that came out, the New England Journal of Medicine, now that's been out for a couple of months. Curious, are you seeing any impact from that? I guess that would be your RED 43 product.
Yeah. There was some anecdotal stuff right at the beginning. It seemed in a few places a little bit short-lived where conversations were then had after the headline about, oh, we're talking about treating them with aspiration, not stent retrievers. Most of those trials were using stent retrievers. There was some discussions within centers like that. I can't swear that there was zero impact in referral patterns, but I don't see it as a material thing. I think now you're having a conversation of do you run another study, but with aspiration? It is a study really on the M3 and beyond, not M2, which is part of the protocol. Those are people have to just deal with, is that necessary? And it's too early to do.
I did have one more on going back to Thunderbolt. You talked about RED 72 and I guess Silver Label or something like that.
Silver label. That's a nickname because it's the same SKU, slightly updated. The box has a label that has some silver on it. It wasn't meant to be clever. It was how do you differentiate between those? Let's pick the color of the not so clever.
Right. How is that going to help the launch of Thunderbolt though?
Yeah. Look, it's a different conversation with someone who says, look, I would love to try Thunderbolt, but I don't like your catheters. Somebody could say that. At least conceptually, they might not be right, but they could say that. If that's true, then you have to convince them to like your catheters first because if they don't feel comfortable tracking it there, then Thunderbolt doesn't do any good. Silver Label is tracking really, really well. It's, I think, the best thing we've ever made in that size category to track, particularly if you send it inside it. To the extent people are trying it, and they are, then it means a conversation with Thunderbolt's that much easier. All you have to do is use this to get the clot out. Nothing else changes. That's obviously an easier conversation.
Okay. And then going more to the VTE market, I mean, just like maybe talk about kind of the state of affairs as you see them today. It's been also some changes with acquisitions in that market. Yeah, just the competitor landscape obviously has changed as well. We thought it was going to be a pretty competitive market and a lot of the smaller players have fallen out. Even some that have gotten acquired are falling out. It seems to be less competitive than we even thought a few years ago.
Yeah. Again, it goes back to what I said at the beginning, which is our strength, our best part of what we do is our ability to keep innovating, innovating. By definition, particularly when you have clot on PE cases that have sometimes a life or death aspect to them as well, getting the clot out as fast as possible with a safety profile at the highest level, that's what you want. Ultimately, as people experience differences in the technology, they're going to ultimately gravitate to how fast do they do that? If they're pretty trained in and wedded to a certain technology and they're getting results that are pretty good, they're going to take longer. At the end of the day, most people will switch, in fact, if not all, to products that do better. That's the phase we're in.
It's really not related to mergers or to disruption or all those kinds of words that we hear. It's just people learning and hearing that from their colleagues and better products. I mean, if you just go back to fourth quarter growth, that happened long before an announced merger. It was already well underway by the time that happened.
I mean, you've even seen companies, large companies with huge sales forces acquire small technology in the space and get out of the space.
That's true. Yeah, technology matters. This isn't a question of everything is the same. That has been true in other spaces. It is not true in thrombectomy right now.
Right. Your growth rate and U.S. VTE 42%, kind of two really strong quarters. What are you seeing that kind of inflected the business last quarter, this quarter?
It's just that, again, going back to not to sound like a broken record, but it is the process of people talking to physicians, talking to each other, hearing about, deciding to continue to try a new product, which was driving that sort of volume growth coming out of VTE, particularly on the PE side where we had less share. It's fun to see. We had expected this. Did it take a little longer than we had hoped? Probably. We're impatient, but it's nice to see the product benefiting so many people right now.
Do you think you started kind of taking share if we look at our market model every quarter? Do you think that's kind of sustainable? Kind of the share gains that you've been doing?
Yeah. You already know the answer to that question because I've said it over and over and over again. This is not a linear process. It's not like an announcement of one thing and everyone moves at once. It isn't linear. We say that not to be saying anything about a particular quarter or anything. We've seen that in stroke for years and years. After we were newly public, I had to say that over and over. I think I said it on this very stage in 2016. It's not linear because of all of those things. That's true. It's just a process. It takes time. I'm not, again, I can't tell you it could be higher one quarter, it could be lower one quarter. It's just movement in the right direction.
Makes sense. When you think about PE versus DVT, anything you'd call it, like where the share gains are coming more or the other, where you're doing better?
Right now, in the last couple of quarters, I think it's been more in PE, in large part because we have more share to gain. We had much less share. We're probably over 50% share now in DVT that improved, but we already had more DVT share. I think over the last couple of quarters, it was more heavily PE focused.
Maybe thinking about the market development for DVT and PE and probably somewhere around 10% penetrated now. You've got lytics and anticoagulation to kind of convert over. What are you kind of seeing in kind of both those categories and kind of the market development here?
Yeah, what we call market access is the work that we've laid out and in fact even presented the clinical part of the data at a variety of conferences. How well do patients do clinically that are treated with CAVT compared to patients that either get anticoagulation or lytic? That data was presented. Obviously, the patients are doing better clinically. That's the first baseline. If patients didn't do better, you wouldn't have, you shouldn't be doing it. On top of that, what we're showing, and we're not really presenting this publicly in scientific meetings because it's not something people typically do, we have data on the economics of it and what does that mean for a hospital? It's a little tricky, particularly now if, hey, your patients will get better, but don't worry, you'll make a lot less money.
That's not a good thing in today's world. It might be the right thing, but it would be a hard argument. The reality is though, because of the reimbursement for obvious reasons and so on, and the less hospital time and all that, the profit margin is actually significantly higher for a hospital to treat these patients with CAVT than doing anticoagulation, which is counterintuitive, not counterproductive. Counterintuitive because, oh, a drug doesn't cost anything. It's no big deal. But when you look at it, and that's why the data that we got with Vizient's help and their sister company, SG2, is really critical because it's across a huge number of hospitals, a significant propensity match dataset that really shows, looking at all the costs, adding them all up, what the benefit is.
We can, with all those same codes, have hospitals pull their own data, validate that, and then decide to implement certain protocol changes, all to see an increase. It is early stages. Obviously, we know enough to know that is the right strategy. We just have to scale it. You are talking about having conversations with every hospital at a pretty senior level. We are starting that. We are doing that. It is going to take a while, but we are pretty excited because I think when that is done, we are going to dramatically change how things work. I think the other part of that is what I said at the beginning, which is STORM trial. That will help accelerate that because that randomized data will help, assuming it is positive, help all of the protocols change much faster.
When you think about the opening centers, I know in stroke, you could go to the hospital over here, but just depending on what you went to the wrong hospital, is that kind of the situation today in VTE or is it most hospitals?
It is very different. The difference is, and I wish it was as simple as a hospital across the street because then you could just move. It was usually across town and you would not get moved. In stroke, every minute matters. That is the impediment. Here, I cannot say every single patient, but the vast, vast majority of patients who have this type of PE are coming to the hospital and they are getting screened at the hospital. If those protocols were changing, you would see that dramatically change because you do not deal with the patient issue in the same way you dealt with it in neuro.
After their STORM PE, potentially rather than get on anticoagulants, it's just like, we'll just do the mechanical procedure instead.
I mean, again, let's wait till we finish the trial. That's certainly the hope.
When I was looking at the endpoints for STORM - PE versus PEERLESS II, you're looking at RV/LV ratios and they're looking at a win ratio, like all-cause mortality and all that. How are you thinking about designing your trial and the endpoints?
Yeah, we had a lot of experts join us through a long range of different subspecialties. If you notice, there's also a quality of life measure. That, I think, was really important. You can get anticoagulation. You might not, you're alive, but you spend many, many months really suffering. You want to compare that to getting treated and not suffering as another endpoint. I think it's an important additional measure, not a lone definitive, but I think that the totality of our endpoints are going to be pretty important to the field.
There's usually not a mortality issue in intermediate PE, right? It's more of a quality of life issue.
Yeah. I mean, the only rub is obviously in intermediate, it can convert to something else and then it's a different story. You have to be a little careful on that. It is, quality of life does matter. If you spend six months really suffering and you didn't have to, that is something that people would take into account.
Right. Makes sense. From a tariff perspective, you did not have really any exposure at all. You called out the China revenue over the news over the weekend. I do not know if that changed the economics of China in your mind.
Yeah. I mean, it's not for me, like it's not my issue. I'm sending it over there. They have to pay the tariff. So I have not yet received an order or we haven't received an order over the weekend. I think everyone's like, things are changing every day. Let's wait and see. Obviously, if that changes, it's not a huge amount of money one way or the other. We'll try to accommodate them if they want it. I think the last thing you want to do is order the product, have it on the way, and then it changes again. I think everyone's probably, I'm guessing, just waiting to see what happens a little bit. Again, it's not, I don't think, a huge thing either way.
Yeah. You took China out of the guidance, but it's not necessarily like China is going to zero necessarily.
It would pretty much.
Go to zero.
Yeah. Again, going forward, that's somewhat sort of been the pathway. Obviously, if you look at the last couple of years, 2021, 2022, 2023, there was pretty significant China revenue. 2024 came down significantly and we had to deal with that comp. If you were to take out China from 2024 and 2025, so it's a fair comparison, it's about a four-point headwind. Our guide of 12%-14% would be 16%-18% without China in 2024. We're here. We want to help. We want people who need our product to be able to have it. From a percentage standpoint, it's.
Small.
Yeah.
In the last 20 seconds, I did want to ask about Ruby XL. I don't know if there's anything you wanted to. It seems like a cool product launch.
Really excited about it. Amazing in the nine seconds we have left.
Go ahead a little bit.
Today was the day we did our first three or four cases ever. It went well. We're pretty excited. There are only three or four cases. We'll wait and see as we keep going, but we're off to a good start. Thank you for ending on that note.
Of course. All right. Thanks a lot.
Thanks.