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Citi Healthcare & Medtech Conference

Mar 2, 2023

Speaker 2

Thank you everybody for coming back. We are now moving to the presentation for Penumbra and thrilled that Jason Mills is here today. We also have Jee in the audience for other questions.

Jason Mills
EVP of Strategy, Penumbra

Thank you for having us.

Speaker 2

I'm gonna kick it off.

Jason Mills
EVP of Strategy, Penumbra

Yeah.

Speaker 2

With a big picture question.

Jason Mills
EVP of Strategy, Penumbra

Sure. [crosstalk]

Speaker 2

I mean, we've been following. Oh, man, I've been following Penumbra for many years. There's a lot going on this year. What is it that you wanna make sure that investors hear in terms of how the year lays out, and set expectations, both financially but also from a product launch standpoint?

Jason Mills
EVP of Strategy, Penumbra

Well, I think what investors should hear is that we have a lot of patients that we need to help in our core markets. As you know, in the thrombectomy business, we are targeting patients that need help in five vascular beds. We have new, we think, paradigm-changing technology to improve patient outcomes in all of those areas. This year, we've talked a lot about, and we'll be talking a lot about, the two products that are launching right now, Lightning Flash, which we'll talk about it, I'm sure, for venous anatomy. Lightning Bolt, which will be for the arterial anatomy, covering three out of those five vascular beds.

You know, the innovation at Penumbra has been a hallmark of the company since its founding in 2004. The productivity and innovation year after year has been, to some extent, I think, unprecedented or very, very good in med tech, generally speaking. You know, that continues, and we're excited about these products' ability to improve patient outcomes in a profound way.

Speaker 2

We'll start with Lightning Flash right now.

Jason Mills
EVP of Strategy, Penumbra

Okay. [crosstalk]

Speaker 2

Was there anything about the timing of that approval that surprised you? I mean, I think The Street was surprised back in November when you announced a delay for it. You got it out pretty quickly in early January.

Jason Mills
EVP of Strategy, Penumbra

Yeah. I mean, the delay we talked about in the fourth quarter was of our own doing. We, this is a computer-assisted technology. There are a couple of aspects to the system. One is a catheter, which is a significant advancement in catheter technology. The computer part of that, there are algorithms that our team is constantly working on. What we discovered was that there was a set of algorithms that was significant advancement that we wanted to integrate into this technology at first launch, Lightning Flash. We took the time to do that. We are pretty excited about that investment in time.

Speaker 2

Flash, we'll start with that. What makes it different than Lightning 12, Lightning 7, and I'll even add the competition?

Jason Mills
EVP of Strategy, Penumbra

Lightning Flash is the most powerful thrombectomy technology ever invented. And power allows for you to act on a relatively large amount of clot in the venous anatomy, be it DVT or P, in a very, very fast way. The fundamentals of getting clot out of the body, and this is true anywhere, is to get all of the clot out as fast as possible without taking much blood out and without damaging the vasculature within which you are working. The appropriately sized catheter and during to us, the appropriately the appropriate system from a computer orchestration standpoint, is perhaps a little different depending on the anatomy.

Lightning Flash, what we've been able to dial into that technology is that unprecedented power and the ability through the algorithms inherent in Flash, to discern clot from blood faster than anybody's ever been able to do. Of course, we're the only ones able to do computer orchestrated innovation, so faster than we've been able to do. That helps us really optimize the act of getting clot out of that anatomy and optimize the definition of optimization are those fundamental principles of getting clot out of the body that I just mentioned.

Speaker 2

I'm gonna translate that to it's the algorithm. Is that the right way to just sort of say that's what makes it special?

Jason Mills
EVP of Strategy, Penumbra

It's really important. Of course, that's proprietary to us, and we're gratified to have patents around that stuff finally, around our technologies. The catheters. We hear a lot about the trackability of our catheters.

Speaker 2

Uh-huh. [crosstalk]

Jason Mills
EVP of Strategy, Penumbra

The trackability of the catheter that is inherent in Lightning Flash, we're hearing a lot of great feedback about. That's important for DVT, but it's also important in PE, where you're crossing through the heart and the interaction with that catheter with the heart is important. That's been, you know, that's been discussed by societies and organizations with respect to size. It's important to be able to track through the heart and get to the lungs and be able to suck out clot even faster than anyone has ever been able to do, and then not take the blood out, because you shouldn't take it out.

Putting it back in is not a good idea.

Speaker 2

Not a good idea. When I was in your offices in January, one of the things that struck me about Lightning Flash was just even the size of the box, the flexibility of the catheter, and I'm not a physician, and then the decrease in the amount of time that it takes to get the blood out. what is-

Jason Mills
EVP of Strategy, Penumbra

Clot out. [crosstalk]

Speaker 2

Clot out. See, you suggested blood out. Clot out. What is it that the physician is resonating to?

Jason Mills
EVP of Strategy, Penumbra

You're right. The system comes together. The computer is embedded in the tubing of the system. Of course, within that box, within that system is the catheter. The pump is relatively ubiquitous. We developed it internally, the ENGINE pump , it's been, it's relatively ubiquitous in the country. For new accounts, we, you know, make sure that they have a pump. The system or the technology itself is inherent in Lightning Flow system that comes in every box. What's resonating with them is what I just said.

I mean, they understand the principles of getting clot out of the body and getting all of it out as fast as possible without doing damage, without causing other problems, without trade-offs, is another way to say it, is what's resonating with them. That'll be true for a Lightning Bolt as well. It'll be true for Thunderbolt. As we're going through that study, I'm sure we'll talk about all of this. The fundamentals of clot removal, and ultimately what we're trying to do here is for physicians to allow for removal of clot from anywhere in the body to be relatively routine, as quick and powerful and safe as possible.

With these innovations, I think what the team has done at Penumbra is move that needle along that arc of innovation further than anyone ever has, including ourselves, which have been doing this longer than everyone.

Speaker 2

Do you see it as a cannibalization of your current portfolio, or do you see it as market expansion? How now that you have a little over two months experience with Flash in the field, are you positioning it?

Jason Mills
EVP of Strategy, Penumbra

Within the venous anatomy, it's all of the above is the short answer. Within the venous anatomy, DVT, and PE, I would more than, you know, 9 out of every 10 patients that have clinically significant clot, that are, you know, that, you know, in the incidents per se in the United States are not getting, you know, not getting a mechanical thrombectomy procedure. Over time, it's reaching those patients. That's the primary goal. There will be, with respect to how we grow our business, a big component of that, as well as given that it's the most optimal thrombectomy system ever created, we think it's the best solution for either of those procedures, regardless of what you're deciding to do, mechanical thrombectomy, lytics or surgery, depending on the anatomy.

Speaker 2

Okay. Can you talk a little bit about pricing and how you thought about pricing Lightning Flash?

Jason Mills
EVP of Strategy, Penumbra

I mean so, pricing philosophy has been something that's been important for Penumbra going all the way back to the early days, when it sort of created the art of aspiration in stroke. If you remember back then, and moving into the time period of MR CLEAN , et cetera, stent retrievers set prices very high. Adam has always had a philosophy that we need to share the value with the customers, notwithstanding that we're developing the most innovative technologies out there. All of that to say that we will share in the value with Lightning Flash and Lightning Bolt. Is it more valuable from an innovation standpoint to patient outcomes than anything else out there? Yes. Is it more valuable than what our previous generation technologies are? Yes, we believe they are.

There will be some price increase, but that will be, you know, very, very small portion of the growth that we expect to get will come from price. It will be from generating better patient outcomes and therefore utilization of this product in the venous anatomy.

Speaker 2

Why do you think nine out of 10 patients are not using mechanical thrombectomy? What's the hurdle in the hospital?

Jason Mills
EVP of Strategy, Penumbra

Well, I think, I think it varies. I think, if you just take them separately in PE, it has been just the way that the doctors have practiced and were trained in using anticoagulation medication and lytics. Thrombectomy generally is relatively new. I think the development of those markets on the venous side, the other hurdle generally is that those patients aren't managed initially by the physician, who is ultimately doing the procedure. That they could come in through the emergency rooms, general practitioners. There is a triaging necessity to venous procedures that is a little different in arterial when those procedures are, you know, acute.

And you have, let's say, a cold leg, you're going to come in and be referred immediately to either an interventional cardiologist, vascular surgeon, sometimes interventional radiologists who are ultimately going to do your procedure. That's, you know, that's part of it in developing this market, is to raise the awareness, not just among the interventionalists themselves who may have been doing something else previously, but the referral networks of physicians, internists, general practitioners, ER physicians, that will be referring on those patients for an intervention.

Speaker 2

Is it just a matter of education, you know, while they're in medical school, or is it a matter of working or smoothing the referral pathway or both?

Jason Mills
EVP of Strategy, Penumbra

I think [crosstalk] it's like anything else in life, it's raising awareness. As awareness grows about clot and the deleteriousness, if you will, of clot in the body among this physician group. COVID did some of that. I mean, unfortunately. I don't know that COVID generally has raised the number of people that have clot, but it certainly raised the awareness to look for it, right?

Speaker 2

Mm-hmm.

Jason Mills
EVP of Strategy, Penumbra

All of that helps as patient outcomes get better and better, via the utilization of Lightning Flash in venous anatomy. You're gonna see the awareness grow because of that naturally. That will float down to the referral network, I you know, in varying degrees of time, but I think fairly quickly, generally.

Speaker 2

Okay. Anything else we should be asking about Flash?

Jason Mills
EVP of Strategy, Penumbra

You can ask all you want. We're pretty excited about it.

Speaker 2

Okay. The excitement comes through. I got that. Cool. I do want to spend some time on the more recent FDA approval of BOLT.

Jason Mills
EVP of Strategy, Penumbra

Mm-hmm.

Speaker 2

Is the story the same as Flash? I mean, other than it being in a different part of the anatomy, or is it maybe a different story, a different, marketing or competitive approach?

Jason Mills
EVP of Strategy, Penumbra

Yeah. I mean, the only thing sort of monolithic about these vascular beds is the fact that you want to get the clot out fast and holistically.

Speaker 2

Yep.

Jason Mills
EVP of Strategy, Penumbra

The other thing that's the same is exerting power will drive the speed with which you can get the clot out. When in the arterial system, the vessels are smaller, so obviously the appropriately sized catheter is smaller. With less real estate, you've got to try to exert, you know, the power necessary to ingest the clot the vast majority of the time, which is the point, get the clot out so that it comes back through the canister and you can see it. In doing that, we've figured out that Lightning Bolt, which uses a slightly different algorithm, modulated aspiration, which is proprietary to Penumbra, to do that work. The end result is the same we think.

The speed with which we're getting clot out vis-à-vis that power, while different algorithms is similar, and doing so without taking too much blood out, without damaging the vessel. Again, I'm going back to the fundamentals of taking clot out of the body. It's the same, you're just doing it differently. The appropriately sized catheter, the algorithms are different. We can innovate really fast, even faster now because part of that innovation is software driven, and you can just innovate faster. The timelines for approval, you get a new catheter approved, it takes, you know, 9-18 months, 12 months, whatever, right? Just to go through the compatibility testing, et cetera. It's different with software.

Speaker 2

Okay. I'm trying to think about modeling all of this. You've got Lightning Flash, which is ramping. You've got Lightning Bolt, which has just begun ramping. Same sales force, same doctor, different. How do you think about doing two large product rollouts at the same time?

Jason Mills
EVP of Strategy, Penumbra

Yeah. Let me talk about how we launch products at Penumbra.

Speaker 2

Sure.

Jason Mills
EVP of Strategy, Penumbra

I'm happy to say. We launch products, through first starting with, once you get clearance and evaluation period of, you know, a couple of dozen cases, and you're doing that for design control, making sure things, this is the first time you're in the human body. To make sure things are progressing as you expected.

Speaker 2

Yep.

Jason Mills
EVP of Strategy, Penumbra

We've already gone through that period that with Flash obviously rolled right into a full launch, and we're pretty excited about that. I'm happy to say that, you know, after clearance, we've now done our first patient in Lightning Bolt in that evaluation period, and it will follow the same process. If all things go well, which, you know, we're pretty excited about what we've seen so far in the early in the early days, literally days that will fully launch subsequent to that. We've talked about it being before the end of the quarter.

Speaker 2

Okay. Doesn't fully answer my question, so I'm gonna push you a little bit.

Jason Mills
EVP of Strategy, Penumbra

Please ask it again. I probably missed it. I apologize.

Speaker 2

A lot's going on today. sales force.

Jason Mills
EVP of Strategy, Penumbra

Oh. Yeah, sorry. That's right. It's the same. The vascular sales team has since its inception done a very astute job of helping patients in thrombectomy and all vascular beds. Remember, we launched CAT RX for coronary, which we haven't yet talked about in 2018. That's been a really strong grower in perpetuity since then. Embolization. Our embolization portfolio is second to none. In fact, we're the market leader, and we've continued to grow that in large part because physicians are finding new areas and applications for our unique coil set. That's the same sales force. They're able to sell all of this. It's the culture is important among our sales force. The professionalism is important.

We're very, very, I don't know, picky is a technical term, but, I think.

Speaker 2

Selective [crosstalk]

Jason Mills
EVP of Strategy, Penumbra

I think the team has done a fantastic job finding the right people that carry the right character, the right professionalism, and of course the, you know, maximum ability to compete at a high level. That's what you see in Penumbra sales force.

Speaker 2

The same sales team is selling both produ cts at the same time.

Jason Mills
EVP of Strategy, Penumbra

Yeah [crosstalk]

Speaker 2

into the physician base.

Jason Mills
EVP of Strategy, Penumbra

Yeah. The interventional community, you know, in our realm is interventional cardiologists, interventional radiologists, and vascular surgeons. They all do to some extent, all of those procedures, you know, it's sort of different by vascular bed. PE either, it's predominant. We're going to SIR in a couple of days by interventional radiologists. Interventional cardiologists do a lot of those procedures too. Occasionally vascular surgeons, rarely. DVT is all three of them. Vascular surgeons do more, and interventional cardiologists and some interventional radiologists and in arterial, it's vascular surgeons and interventional cardiologists predominantly.

Speaker 2

Could Lightning Bolt outpace Lightning Flash?

Jason Mills
EVP of Strategy, Penumbra

I think both will outperform for patients. How's that?

Speaker 2

That's good. I'll start there. Is there a different financial profile for the two different products?

Jason Mills
EVP of Strategy, Penumbra

Not significantly so. You're asking about ASPs. I mean

Speaker 2

COGS, ASPs.

Jason Mills
EVP of Strategy, Penumbra

Not-

Speaker 2

Anything.

Jason Mills
EVP of Strategy, Penumbra

There's no difference in the margin, standard margin profiles for those. They're both Thrombectomy in general for us is our highest margin business, and that's part of the expansion to 70%+ over the next few years is positive mix shift in our business as thrombectomy, we think will grow the fastest, vis-à-vis our other businesses. From, you know, a price standpoint, like I said, I think we share value with hospitals, but it's a slight premium for both in both cases relative to the previous generation products.

Speaker 2

Is there a benefit to launching two at the same time, either from a sales cycle or a manufacturing perspective?

Jason Mills
EVP of Strategy, Penumbra

Oh, I think you cut out, but it-

Speaker 2

Did I cut out? [crosstalk]

Jason Mills
EVP of Strategy, Penumbra

Nope.

Speaker 2

Nope, I'm good.

Jason Mills
EVP of Strategy, Penumbra

You're good.

Speaker 2

I need pockets in my clothes. Thank you.

Jason Mills
EVP of Strategy, Penumbra

Sorry. Could you ask that again? I was distracted by that period.

Speaker 2

Of course. As I drop things. Yes. The question was, is there a benefit to selling-

Jason Mills
EVP of Strategy, Penumbra

Oh, both at the same time. [crosstalk]

Speaker 2

Both of these at the same time, either [crosstalk] from manufacturing, sales or COGS?

Jason Mills
EVP of Strategy, Penumbra

It won't be there's no, not a deterrence to having both. There could be some benefits, I don't know that they're necessarily, you know, worth focusing on. I mean, for example, if you're with some hospitals, you might be going through, if it matches up, the value analysis committee review processes for a Lightning Flash and Lightning Bolt at the same time. There might be a bit of leverage of time there that could be beneficial to how quickly you get both products through those respective value analysis committees. You know, I think for if you talk to the sales team, having, you know, sort of paradigm changing technologies that address, you know, all of those vascular beds, is better than, you know, than not.

I don't think that They're definitely not saying, you know, hold off on one so that we can get our arms around both. These technologies are, you know, are both important for patients. Our sales force are gonna wanna have them in the hands of our physicians as soon as possible. They'll be able to do that.

Speaker 2

At some stage, do you start to rationalize some of the older products, with these newer ones here?

Jason Mills
EVP of Strategy, Penumbra

It's a good question. I mean, generally speaking, Penumbra, has carried a portfolio approach because there are opportunities, or reasons patients to use other technologies that maybe are used less. For example, in DVT, you might have smaller vessels within which you would wanna use Lightning 12. I think that'll be, you know, a relatively small number. We need to help those patients too.

You know, in arterial, you know, some doctors, albeit it's a huge, I think, unmet need that we're addressing, thrombus below the knee and down into the ankle, Lightning 7 could be too big for some of those vessels. They will take, they will sometimes use, and it's a very small percentage use of CAT RX . They'll take CAT RX down there with some good success. The portfolio approach has been apropos to Penumbra for quite some time. As you know, in stroke, it's a portfolio approach. It's not just the sort of the catheter that gets all the headline, be it RED 72, RED 68. There are other catheters that are really important to those procedures. Now, when Thunderbolt comes, Thunderbolt's gonna change that paradigm.

Nonetheless, the portfolio approach is important.

Speaker 2

Before I get to Thunderbolt, do you have the manufacturing capacity, and is everything still being made in California?

Jason Mills
EVP of Strategy, Penumbra

Yes and yes.

Speaker 2

Okay.

Jason Mills
EVP of Strategy, Penumbra

We have a new facility, sort of new, not new anymore, but a couple of years ago, we started to build out Roseville, which is outside of Sacramento, which is a significant footprint for us that, we're, you know, we will slowly take advantage of and will be part of our ability to expand our margins as our volumes increase.

Speaker 2

Okay. Thunderbolt, end of the year? In guidance or not in guidance?

Jason Mills
EVP of Strategy, Penumbra

Not in guidance.

Speaker 2

Not in guidance.

Jason Mills
EVP of Strategy, Penumbra

It's not included because we don't have control over the biggest aspect of it, which is, you know, the FDA timeline. You know, the enrollment is tracking. It's like every stroke trial. It's, you know, fits and starts. You might have a couple of patients in one week or one over a weekend, and you're like, "Gosh, we should be faster." Then 6 in 2 days.

Speaker 2

Okay.

Jason Mills
EVP of Strategy, Penumbra

That's how stroke goes. With the parameters of this study, like any stroke study, the patients have to come in within an eight-hour window. It's the same. I'm not telling you anything you don't already know because you've seen lots of stroke studies. It's tracking the way that we expected it to track. No, to include it in the lower limit, which is all we've given at this point, the $1 billion lower limit for our guidance, we did not include it because we didn't have control over that. Yeah. You don't need it to-

Speaker 2

What makes Thunderbolt special versus the rest of the portfolio in neuro?

Jason Mills
EVP of Strategy, Penumbra

What makes it special is what I've been talking about, the power with which you can get the clot out. The speed with which you can get the clot out and the ability to do that work potentially with a smaller catheter. By using a smaller catheter to do more powerful work, counterintuitive but true, when you're using modulated aspiration proprietary to Penumbra, is that you're able to track smaller catheters to the place the clot is faster than larger catheters. Just obvious, right? 'Cause the tortuosity is significant in almost every case, and some more than others. You know, using smaller catheters to do even more powerful, speedy work is sort of the holy grail. More physicians, I think, would be adept at doing that, and feeling comfortable.

It could be, you know, incremental technology in stroke care. I think doctors are looking for more than that these days. The paradigm has been, can we get a, you know, a 72 versus a 70? It used to be 68 versus a size 64. You know, that's incremental improvements. The RED technologies are the best on the market, but they're incremental catheter improvements. What stroke physicians want, what patients need is a sort of a revolutionary improvement. Thunderbolt, we think, is that.

Speaker 2

How much time does Thunderbolt save?

Jason Mills
EVP of Strategy, Penumbra

Perhaps a lot. I mean, it could be. I mean, you've seen the models, right? It could be, you know, it could cut the time when you get to the clot, which, you know, part of it is how fast can I track the catheter? If you're able to use a smaller catheter, you should be able to get there faster. Once you're there, you should be able to ingest all the clot out more of the time faster. A lot of this, you know, the time component is getting the clot ingested and working on adapting it through the tortuosity if you're not able to fully ingest it. It could be profound.

I don't want to put a number on it, but, you know, the goal would be over time, and has always been, and we could get pretty close to it, if not achieve it, is to do a stroke procedure in five minutes or less in terms of the device time.

Speaker 2

Okay. Time is brain.

Jason Mills
EVP of Strategy, Penumbra

Yes. Time is important.

Speaker 2

If you're able to make the procedure as straightforward as you're describing and as fast as you're describing, why would this not be done in all hospitals versus stroke centers?

Jason Mills
EVP of Strategy, Penumbra

It's a tricky question. Right now, the modus operandi is, you know, moving these patients to comprehensive stroke centers.

Speaker 2

Yep.

Jason Mills
EVP of Strategy, Penumbra

You know, moving the patient comes with, you know, certain trade-offs. It sometimes takes longer to get to that hospital, and time is brain. Those are all considerations that right now folks, you know, that, you know, make these decisions, which isn't me, and certainly not me and not us, have decided that's worth the trade-off of time. At some point in time, may that change? Sure, that won't be driven by Penumbra. We're certainly, you know, you're gonna hear us talk about neuro trained physicians or those physicians that are doing these procedures and we're not gonna advocate for anything other.

If the industry decides that, what is important is to maybe treat faster, and they believe that this technology allows for that to happen, then the societies and the doctors will make those changes themselves, and that will be a natural, very ethical way to do it.

Speaker 2

Where are these products in terms of an international launch?

Jason Mills
EVP of Strategy, Penumbra

They will be in the United States first. We haven't given timelines for international, but what we did say in the prepared remarks for the last call purposefully is that we will bring all of these technologies to patients in Europe, China, Japan, Latin America, Asia Pacific. We're in all of those areas today. The regulatory submission process is different in every one of them. As soon as possible. The other thing we're working on too, especially as it relates to peripheral thrombectomy, is the reimbursement infrastructure in some of these countries. It's not the same as the United States. These are, you know, next generation technologies we've spent a lot of money on. Excuse me. We're working on that as well. We're cognizant of that.

I don't think that, you know, if you think about, well, three, four, five years from now, do you expect? Of course. I mean, I hope it's sooner than that, but we haven't put a timeline on it.

Speaker 2

Okay. Just some basic questions. Patient volumes, staffing, general state of the union, anything that we should be aware of or business impact?

Jason Mills
EVP of Strategy, Penumbra

Yeah. We haven't called out staffing issues for quite a while.

Speaker 2

Yeah.

Jason Mills
EVP of Strategy, Penumbra

It's certainly. Most of our procedures are those where, you know, it's pretty obvious to those physicians they need to act on that patient as quickly as possible. That having been said, I got to tell you, speaking on behalf of Penumbra and Adam, we have enormous admiration for the physicians and their teams and what they've had to go through. You know it, everyone in this room knows what they've had to go through in terms of not just COVID, but the staffing challenges-

Speaker 2

Right.

Jason Mills
EVP of Strategy, Penumbra

that they face every day. It seems like that's the productivity in solving that puzzle is progressing. They're getting better and better. You know, it's still a hard job and still something they're working towards. I think the technologies we're bringing to bear help that in decent ways. Meaning, you know, if we're able to keep a patient out of the ICU because they don't need a lytic drip, we can just take the clot out.

Speaker 2

Right.

Jason Mills
EVP of Strategy, Penumbra

-that's going to have a, you know, a profound impact on utilization of hospital resources.

Speaker 2

When you think about the expense side of the equation, none of these launches come for free. How do you think about operating leverage as you go forward?

Jason Mills
EVP of Strategy, Penumbra

We think it's important is the short answer. I think what you're gonna see us continue to do is invest in our growth, we will also invest in our growth with a disciplined approach to it. That doesn't mean we invest less. We're gonna invest more on dollar volume. We will invest in a way that, you know, our operating expense infrastructure grows at a slower pace than our top line, we think. We also have, we think, you know, levers that we've talked about on the gross margin line that are important. We've talked about approaching double-digit operating margins exiting this year. We look forward to that continuing.

Speaker 2

Okay. The REAL reality platform has quieted, and do we take that for it's done, or do we take that for something that management is moving along?

Jason Mills
EVP of Strategy, Penumbra

Absolutely, the latter, not the former.

Speaker 2

Okay. [crosstalk]

Jason Mills
EVP of Strategy, Penumbra

The quieted comment I think is fair. Internally, the progress we've made is probably, you know, worthy of being even louder than we've been. There are two things we're watching that are, you know, are less That are things that may not be as easy for Wall Street. They're not quantitative. The first thing is we're evaluating on an increasing basis if this technology is doing for patients what we need it to do for them to improve in a number of areas. That's happened.

The second thing we're working on, and our work with both public and private institutions, including the Department of Veterans Affairs, is helping us with this but is longer-term in studying and evaluating is where does and how does virtual reality work into the workflow of any given modality of healthcare, be it rehab, be it anxiety or mental health issues, be it aging and anxiety for older adults. All of those there's profound literature that suggests virtual reality positively impacts all of those areas. Where in the workflow as those patients engage with the healthcare system is it most appropriate and which, you know, healthcare professional is most appropriate to introduce that to the patient? None of that's been done. Adam likes to talk about it being similar to stroke.

When the company started with an idea of getting clot out of the brain, there was no reimbursement. Doctors didn't really wanna treat or be on call to do it. It was like the perfect setup for starting a company that focused on getting clot out of the brain, right? It took, you know, it wasn't until 2014 or 2015 that the preponderance of evidence validated that decision. I'm not saying it's gonna take 10, 11 years. Hopefully, you know, we can move a lot faster than that. There is a precedent for really great things, you know, being worth the wait.

Speaker 2

CAT RX, you've mentioned it a couple of times. Where is that in its development? There was some clinical data presented two years ago now, if my memory serves, that should support-

Jason Mills
EVP of Strategy, Penumbra

Yeah. The CHEETAH study. [ crosstalk]

Speaker 2

That should support that.

Jason Mills
EVP of Strategy, Penumbra

Yeah. CAT RX is a really, really great catheter, and it's the first and only catheter, thrombectomy catheter that's shown positive results in the coronary vessels. We are doubling down on those results with the CHEETAH-ACS randomized study, which will be use of CAT RX to take the clot out of coronary vessels in STEMI patients coupled with normal PCI, what you would do normally, versus just PCI alone. What we expect to show is that taking the clot out prior to PCI has profound impacts on patient outcomes, which is exactly what we saw in the CHEETAH study, albeit it was, you know, it was big study, foreign patients, but slightly smaller and non-randomized. You know, cardiologists wanna see randomized data in this field and in this field, it's appropriate.

We do that, so we're doing that. The patient outcomes, and it's growing really well, you know, in every year since 2018 because in their own practices, doctors that are using it are seeing the benefit, and that will continue.

Speaker 2

Okay. The billion-dollar question, and I've chosen that number. On the fourth quarter call you sort of set that as a goal for 2023 revenue.

Jason Mills
EVP of Strategy, Penumbra

Mm-hmm.

Speaker 2

Well, you said it on the third quarter call.

Jason Mills
EVP of Strategy, Penumbra

Mm-hmm.

Speaker 2

on the fourth quarter call. What takes you below $1 billion, and what takes you above it? I'm gonna add a little more crinkle.

Jason Mills
EVP of Strategy, Penumbra

Mm-hmm.

Speaker 2

to the question. How does it ramp throughout the year?

Jason Mills
EVP of Strategy, Penumbra

Yeah, all great questions. $1 billion is the lower limit of what we expect from ourselves this year. We have not set the upper limit. We haven't set the upper limit yet because we've talked a lot about two products that are currently launching that, you know, just give us a little bit more time, give us a quarter. You know, you can obviously hear excitement about those products. You know, look, how it ramps throughout the year is I think it will, you know, it will increase throughout the year. We talked, I think, in our prepared remarks about the growth on a year-over-year basis likely accelerates throughout the year. That's probably a good way to think about it.

Speaker 2

Okay. When we're here next year, and we're talking again, what do you think we'll be talking about as it relates to Penumbra?

Jason Mills
EVP of Strategy, Penumbra

That we've helped a lot more patients and that have clot in their lungs, clot in their deep veins, clot in their arterial system, and by the way, clot in their coronaries as well as stroke as well. We're gonna be talking about continued innovation.

Speaker 2

Continued innovation meaning?

Jason Mills
EVP of Strategy, Penumbra

Well, I mean, we're gonna be talking about, you know, Thunderbolt 2, and we're gonna be talking about, you know, CAT RX. We're gonna be talking about clinical studies that, you know, haven't yet started, but we've announced and studied. You know, STORM-PE and pulmonary embolism, which could expand that market and certainly, shine a really, really positive light on Lightning Flow, as well as the CHEETAH-ACS study in coronary. I think we're gonna talking about, you know, having treated a lot more patients but still a lot to go.

Speaker 2

Any readouts clinically we should be aware of this year?

Jason Mills
EVP of Strategy, Penumbra

We have several trials that will have results throughout the year. We have, you know, the STRIKE PE study still going on, which is a real-world registry study in PE. We have the STRIDE study, which finished, but you're gonna see readouts. We've seen the interim results or, sorry, early results on STRIDE, which is for peripheral arterial, and the thrombectomy in arterial. We have the BOLT study still enrolling. Those are registry studies. I'm not sure exactly what the clinical trial presentation timelines look like throughout the year, but there will be clinical data that support, you know, our research and technology in all vascular beds this year.

Speaker 2

Excellent. The last remaining minutes, anything else you'd like to add?

Jason Mills
EVP of Strategy, Penumbra

That we're really excited about, the opportunity we have in front of us, and it's a humbling opportunity to be able to bring this technology for so many patients. In these markets, taking clot out of the body is not a new idea, but the penetration of our ability to do that, you know, it's been good, but we're still not reaching very many of the patients if you look at the penetration rates. These technologies, given what they do to act on those fundamental principles of thrombectomies is pretty exciting.

Speaker 2

Excellent. Jason, thank you so much for joining us today.

Jason Mills
EVP of Strategy, Penumbra

Thank you. Thank you very much, Joanne. Thank you to Citi as well.

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