We'll go ahead and get started. Welcome to the 2024 RBC Capital Global Healthcare Conference. I'm Shagun Singh, Senior Medical Device Analyst at RBC, and I'm very pleased to have Penumbra here with us, kicking off day two of the conference. Joining us from the company are Adam Elsesser, CEO, as well as Jason Mills, EVP of Strategy. Adam and Jason, thank you so much for being here today. Appreciate it.
Thanks for inviting us.
Great! So, I thought, Adam, we'll start with some high-level questions. It appears to me that there has been a shift in strategy at the company in recent quarters, and really positioning it for the long term by streamlining commercialization. You've talked about a focus on clinical as well as market development, and improving profitability. So maybe you can level set investors and just walk us through this transition and how you think about Penumbra over the next maybe three to five years as well as 10 years.
Yeah, that's a great question, and an appropriate observation. The only caveat is, you know, if you go back 20 years ago when we started the company, we started the company with this idea that, could we come up with a safe, and fast, and simple way to get clot out, initially of the brain and then the rest of the body? And it's really hard to do that, and it's taken us lots and lots of time to continue to innovate and improve the products. And we now, with last year's launch of our CAVT platform, have gotten to the point where those three things have generally been satisfied.
So with that comes the next phase of work, to make sure that the scales have sort of tipped from, you know, yes, it's good to get clot out, but there are lots of ways to do it, to this is the best way to do it, and now we have to go after making sure everyone knows that through the work that you've outlined, both with enough people on the ground to talk about it, with the support, the data support, and of course, the effort in the field, the health economic data, everything else to say, "Now is the time to really get that clot out, using the CAVT platform.
Got it. How do you think about the company over the next three to five years versus 10 years? Any key strategic priorities there?
Well, you know, the clear priority, and that is reflected in the way we, you know, sort of recast the, you know, the revenue streams and so on of the company is around thrombectomy, and around the thrombectomy that is using CAVT, so starting in the U.S. and then going to the international markets after that. That is what's gonna drive the company's growth, but equally importantly, it is the sole mission of the company. You know, we have 10% of the patients getting this technology, and we now have the information that says there's 90% more that should get it. That's an amazing thing. We can do an awful lot of good.
Obviously, the company will do well if we do that, but most importantly, there'll be an awful lot more people who feel better when they have a clot in their body, and it becomes less of a catastrophic crisis.
Got it-
And just to add on to that, you asked about the work we've talked about over the last, you know, several months, but and you also asked about profitability. So, you know, one thing that is true is the work we're doing in market access, market development; this is really now is the time to do that because the product, CAVT, and the platform is here. You know, to have done that work five, six, seven years ago, it wouldn't have been the appropriate or exact right time. We didn't have CAVT. CAVT, this platform, is the right platform to be doing all of this work to try to drive access. And then the other thing, as Adam often says, he likes to run a profitable company.
I think, you know, I wasn't at the company then, but the company was profitable well before it went public. We're, you know, we're enjoying, and we expect to continue to enjoy really strong growth, but the other word we'll talk about is profitability. So growth and profitability are both important.
That, that's really helpful color. Thank you so much. You know, I wanted to dig in a little bit deeper into this initiative. So on the commercialization front, I think you began to expand the footprint more meaningfully at the end of Q3. You know, what kind of expansion have you driven within your vascular and neurovascular businesses? And then how should we think about productivity? I think a lot of your territory managers were put in place in the first part of 2024, so do we see productivity improvements in the back half?
Yeah, it's a really good question. So we philosophically have always had a relatively smaller sales force than a lot of our competitors. There's just a difference in philosophical view. And last year, given the scale of new customers that were interested because of CAVT, to be very candid, we were a little late in sort of pulling that trigger and saying: "You know, we need more help." We just had a lot to do with new accounts coming in and getting through that process. So we started that, and you're right, the first quarter, people were still coming up to speed. You know, they were finishing their training, they were getting organized, and so on. I think we're gonna see the benefit of that...
In the back half of the year, and our guidance even reflects that, in terms of the cadence of that. So, we're pretty happy we did that. I think we now have a team that's in place for this next phase. I think we'll be a little more careful watching those numbers and making sure we don't get caught again. But so far, so good, for this year.
I think you'd indicated 25% more territory-
Yeah
managers on the vascular side. Is that, is that where you've, you've got the headcount that you need to be?
Yeah.
Anything you can share in terms of productivity metrics, like, you know?
You know, we don't really do that historically. You know, we—I will tell you that, we... You know, to give you some sort of sense of numbers, the average, and I might have this slightly off, but generally it's accurate. The average territory size before we hired, or account size before we hired this was about 18-20 accounts per rep. I think we're averaging around 12 now, give or take, so don't hold me exactly to those numbers. So there's some definite benefits, but again, that's still a lot of accounts per rep.
And as more and more people want to use our products, you know, it makes for very productive territories, you know, and cost effective to, you know, be out there doing the work.
Anything you can share in terms of the number of accounts that you're targeting?
Well, we're you know, it's every account in the U.S. that can, does, or can do thrombectomy. I had an interesting opportunity. Recently, we were doing a joint marketing event with Shockwave. It was a group of interventional cardiologists, and I met a cardiologist who's using our product called CAT RX where the coronary clot removal. Loved it, had never done PE, had never done DVT, and was talking throughout the day to a bunch of his colleagues who were also doing PE. And he said, "You know, this is amazing. I should start doing PE. I haven't been doing it. I see those patients.
We just haven't, in my practice, taken them on." And he then spent the better part of, you know, 45 minutes on our simulator in the back of the room, you know, sort of getting the hang of it. And so, you know, it's a small one-person story, but it gave me some, you know, confidence that, again, now is the time. The products have gotten good enough that we're gonna see that kind of transition happen.
That's helpful. Then, you know, with respect to market access, and I think you've indicated that you're collaborating with some of the large hospital systems to validate, you know, clinical benefits as well as, you know, health economics. Any timing you can share there? Are you seeing any impact of those initiatives?
Yeah. Well, that's a longer-term strategy. We've been very clear about that. But what is important, and the reaction that I should share, is everyone that we've talked to so far gets it. You know, they have already done their own math. They've already looked at the data in their own systems, for the most part. There's not a lot of disagreement that, okay, things have changed. With CAVT, outcomes are better, and the health economics are positive. And that, to me, is the most important thing because if that wasn't true, you know, and it wasn't true back in 2013 when we first came up with our first thrombectomy product for the rest of the body, then it just wasn't true. The product wasn't good enough to have that reaction. But now it is.
And so now it's just a question of, you know, what is the work they need to do? Again, we can help support with content and all, but what do they need to do that in the various vascular beds, whether it's in arterial, DVT or PE? The work is slightly different. Patient flow comes to them slightly differently, and we can help, you know, talk to them about the work they need to do to make sure they're capturing all of those patients in their region. And so it's early. It's again not gonna happen overnight, but the reception to that discussion is extremely different now with CAVT than it was before.
That's very encouraging. Let's talk about innovation a little bit, more. So with respect to Lightning Flash, I think you've indicated you have about 46% share in DVT and about 20% in PE.
Yeah.
You know, you're launching Flash 2.0 as well, and you've talked about pent-up demand there. So can you, you know, tie it all together for us and talk to us about, you know, what does this mean in terms of, you know, the adoption of your Lightning Flash franchise?
Yeah. I'm not, you know, gonna quantify yet, you know, the adoption around numbers and share. Obviously, I think that will, you know, continue to shift. I think we saw that in the first quarter numbers. But most importantly, it's what is the product doing? And if you look at the way Flash 2.0 is performing, it's pretty extraordinary. Flash 1.0 was a great product. Obviously, you know, it totally transformed the forefront, particularly in the VTE market last year. 2.0 is just that much better. And to sum it up the right way, you get more clot out faster than ever before, which is kind of extraordinary.
You know, we've had people who are new to the Flash portfolio, to the new product line, doing their first cases with device time in a complicated PE case of two minutes, three minutes of device time. That, that's just unheard of. And again, in those cases, particularly PE, but it's true in all vascular beds, the faster you can do it usually means the less complications, the less mucking around, the less stuff is happening. So we feel pretty good about it. Again, early, you know, we're weeks into it, you know.
Right.
- months into it. But I think there's a lot of interest and momentum. And I think there are people who, you know, were watching Flash 1.0, going: "Okay, that's pretty intriguing, but, you know, I've been doing something else for a while." And now with Flash 2.0, it's hard to ignore.
Is this factored to your guidance fully, or you're still kind of waiting to see how it trends, given that it was launched just in late April? You know, as I look at your guidance for, you know, for the balance of the, on the thrombectomy side, you assumed at 35% growth in Q1. It implies a bit of a step down in the back half of the year. So just curious, is this fully factored in, or is that growth rate just a function of comps or
Yeah, I-
- conservatism?
... yeah, I wouldn't. What we always do when we issue guidance is, we look at all of the things that we know at the time, when we issue that guidance, and we take our best shot at it. You know, when you're talking about a projection, we've been doing that since we went public, you know, you know, nine years ago. So, I don't think it's. I wouldn't characterize our guidance other than we look at the information we have. Obviously, as that changes and we perform, you know, we'll take that into account as we go.
Got it. And then just as a follow-up, I guess, the back half, you know, from Q2 to Q4, guidance implies a bit of a step down. You know, is that conservatism or is it a function of comps, anything to consider there?
I mean, I would just echo what Adam said. We had our earnings call just a couple of weeks ago, and so we factored in everything that we knew at the time into our guidance. Of course, you know, we reiterated what we said three months ago, but we assessed everything again.
Got it. And very strong U.S. thrombectomy numbers in Q1.
Yeah.
You know, on Lightning Bolt side, you know, the market is just 11% penetrated. Can you just talk about, you know, what success you're having in driving that conversion to mechanical thrombectomy?
Yeah. You know, again, it's Lightning Bolt 7 is done in the arterial, what Lightning Flash has done, in DVT and PE. It has sort of re-engaged and reset the idea that, "Oh, hold on, why wouldn't I start with mechanical thrombectomy?" If you're a vascular surgeon and you're about to do an open cut down, maybe, but why wouldn't I start first with this? 'Cause it's gonna work, and it's a lot faster, a lot less intrusive on the patient, and it's more cost-effective for the hospital. So that's the process that people are starting to talk about. Now, again, early, you know, the vast majority, as you just pointed out, are still getting open surgery, in some cases, you know, tPA. That's historical. People have been doing that appropriately for many, many years.
There wasn't anything else to do, and they had to do that, otherwise, you might lose the limb. So that's, you know, been an appropriate method, and that's now changing, and that change takes some time. You know, you have to go out there and talk to people. You have to have physicians talk to physicians. That process is underway. The most important thing, you know, less around time frame and picking an exact time when everything moves, it's the fact that the product is finally performing at a level where that conversation is not only appropriate, but necessary. And that's kind of exciting. Again, it took a lot of innovation to get here, but with that, I think we can see the benefit of that.
Got it. That's helpful. You know, you have alluded to three additional CAVT products that you'll be launching in the next 12 months, and you indicated that we could see one, you know, maybe this year.
Yeah.
Can you just elaborate on, you know, what are these products? How meaningful? Is it in the current vascular beds, or is it, is it, you know, something new?
Well, that's a good question. I'm not gonna be more specific. But I can tell you, like Flash 2.0 has had a big impact in the first weeks of launch, these new products, they're gonna be fun to launch.
Anything else?
I'll leave it at that. It's gonna be fun. Now, I also want to say, you know, we focused on those, you know, initially four, now three, because of Lightning Flash 2.0, as new things coming. We always have, I mean, our list of R&D projects and where they are in the process is even longer than that. You know, this isn't it for us. You know, those are the ones that we have enough information of confidence around where they are, and they're focused on CAVT specifically to talk about. But we have a lot more, you know, coming. As you know, over the 20 years we've been doing this, our R&D capacity, R&D machine is really extraordinary, and this isn't the end of the line or, you know, the only things we're focused on.
Just curious if you're willing to share, is it going to be an iteration, or is it going to be, like, a brand-new product? Anything, any color there?
Yeah, it might be both, yeah.
Okay. All right, fair enough.
It's what you can rest assured is that it will continue to try to optimize what we're doing with CAVT, in one or all of the three things that matter: safety, speed, and simplicity, right? In whatever vascular bed there is clinically significant clot.
Okay.
That's fundamental to what we do with CAVT. That's the only thing that matters to patients and physicians, right?
Got it. Adam, I think you've also talked about integrating procedural and case-specific information within the CAVT-
Yeah
... platform. Can you just elaborate on that? Are you looking to utilize data better? Like, you know, where are you going with all this?
Well, if you think about, you know, if you have just a mechanical pump or a syringe or what have you, there's no way to get information in the case. You know, there's nothing to hold that information. But now we have a computer in every single case because of the CAVT platform. So with that, by definition, becomes fairly obvious that you could incorporate, you know, use that computer to get and process information, both in real time. So, you know, what if you, while you were doing the case, and I'm just, you know, you know, not giving hints about anything, you could look at certain patient data in real time in the case, and go, "Oh, that's happening to that particular patient." As I do the procedure, that's helpful to me, to know, do I stop?
Do I keep going? You know, what, what's going on with that patient? Rather than having to do it blindly, stop, get that information separately, and then go back to doing the case. Streamlines it. You also, if you're a physician, and you can look at your case volume and say, "Okay, I'm gonna review the last 50, 60, 80 cases, how am I-- what, what's changing? What, what's-- how long is my average time? How-- you know, what am I doing?" And learn from that, so that you can be better and re- and focus your techniques, around that. And then the third, of course, is that information benefits us to make the products better and better. Algorithms can be adjusted.
You know, right now, Flash 2.0 got adjusted based on lots of verbal feedback, you know, and both from physicians directly or sales reps in the field in the cases. But that's hearing and listening and trying to adjust. It worked. It's much better. But what if that information was, you know, covering lots, you know, all these cases, and then we would be even more able to fine-tune the algorithms going forward. So, those are the three large buckets. You know, the issues around how to do that, you know, you have to be connected, patient safety.
A lot of those issues, which are challenging for lots, we've been working on actually with our immersive healthcare product, and have made huge strides in validating the ability, you know, through the various sort of, you know, systems to be able to do that. So I think we have a running head start on that part of it, 'cause otherwise, that's the part that usually gets you, you know, slowed down, and we've made huge strides already on that.
That's helpful color. Just a quick one on Thunderbolt. Is there, is there... You know, when can we expect the data readout? I think March 2025 is the primary study completion, June is the total study completion. And, is there a possibility, that we could see, you know, results from initial patients sooner, or can you submit a smaller cohort? Just any color there.
Well, I think you would appreciate. At first, I appreciate the question, but I think you'd appreciate, given my, you know, overexcitement about Thunderbolt a while ago and talking about the date, that I'm not gonna change the date that's on clinical trials that go from now. Needless to say, though, obviously on our last earnings call, you heard my enthusiasm for the way Thunderbolt's going, both enrollment, but equally the anecdotal. You know, we're hearing physicians tell us, "My God, you know, that was an amazing case," this, that, and the other. So we're pretty optimistic about how Thunderbolt's going, and we'll be patient. It's, you know, taking a while. Trials are hard to enroll in stroke.
Some of the competitive products that we compete with, you know, have taken many years to enroll, you know, these patients, given the criteria and how, you know, it's hard to get consent in stroke cases, obviously. But that being said, obviously, Thunderbolt is something that we really are proud of. And, you know, it's pretty easy to see, you know, Lightning Bolt and Thunderbolt, not exactly different fundamental technologies. You know, we've done so many Lightning Bolt cases. We know the technology works. We've seen it also confirmed in Thunderbolt cases.
I think we may get some GLP-1 data for PAD next month. Any, you know, quick take on GLP-1s and, you know, how that might impact you?
You know, we've talked about that last year. I think generally, most people have sort of come around to understanding that it's not going to have a... I mean, it might have a lot of positive impact on patients who, you know, feel better and can get healthier, but I don't think it's gonna fundamentally change the number of people with a clot in their body.
Got it. I know we are out of time. Any, you know, last-minute messages for investors?
You know, we're in a good spot. You know, we've spent the time building the platform, and now we're gonna go out and execute and make sure that everyone who can benefit has the ability to benefit from it. From my standpoint, that's a pretty awesome moment in time in the company. Morale's high, people are excited, and we just have to go out and do it.
Great. Thank you so much for being here. Appreciate your time.
Thanks. Appreciate it.