Welcome back, everyone. I'm Robbie Marcus, the Med Tech analyst at J.P. Morgan. Very happy to have our next speaker. He's gonna be the CEO of Penumbra, Adam Elsesser. Adam, I'm going to turn it over to you for a formal presentation, and I'll join you in a few for Q&A. Just a reminder, feel free to submit questions online or email me, and I'll do my best to get to all of them. Adam, turn it over to you. Great. Well, good morning everyone. I wanna thank J.P. Morgan for including us in this year's meeting, and thank you, Robbie, of course, for your coverage of Penumbra. I don't see the slides. Can we put the slides up? There we go. Let's go to the next slide. That's our safe harbor disclosure. Next slide. Headquartered in Alameda, California, Penumbra is delivering innovative products to patients in over 100 markets around the world, thanks to the extraordinary work of more than 3,500 teammates. More than 70% of our employees are non-white, and about half of our employees are female in the United States, where almost 90% of our workforce is located. Since our founding in 2004, innovation has been the hallmark of our work at Penumbra, as we have focused intently on developing products that help as many people as possible. We're excited to continue our journey to help patients in neuro and vascular, where we see five large under-penetrated opportunities to help a significant number of patients. In addition, we're just beginning our journey to help more than 50 million people with our immersive healthcare platform. Our strong growth in the past, present, and into the future will be driven by constant innovation, attracting and empowering the best talent and execution. Next slide, please. Today, I will share more details about these six large under-penetrated patient markets, as well as the innovation we are bringing to patients in each of these markets to improve outcomes and augment the value proposition to our customers. We see a clear opportunity to help at least 1 million patients a year in the United States alone in the five thrombectomy markets and over 50 million people in immersive healthcare. While we have been working hard for many years to help patients, we are still very early in our journey. Next slide, please. Let's start by discussing the opportunity to help patients who suffer from acute limb ischemia or ALI. ALI occurs when the leg has immediate change because of an occlusion in the artery, which is almost always caused either because a blood clot forms in the artery or because emboli from the heart or other place within the body travels to the extremity and causes an occlusion. Left untreated, ALI could result in the patient losing their limb. We estimate there are at least 259,000 patients in the United States each year who are treated for ALI, and mechanical thrombectomy accounts for less than 20% of these treatments. Indeed, over 80% of the patients are currently treated either surgically by embolectomy or bypass, or with catheter-directed lytic therapy, or with conservative medical management. We are committed to reaching all of these patients with our Indigo technology. Next slide. Penumbra launched Indigo in 2013 to treat ALI to give physicians a less invasive, safe, and highly efficient way to remove clot in a single treatment session. Less than a year ago, we changed the paradigm in ALI therapy with the launch of Lightning 7. Lightning 7 combines Penumbra's proprietary catheter technology, appropriately sized for the artery, with our Lightning Intelligent Aspiration System, which uses sophisticated software algorithms to differentiate between clot and flowing blood. Lightning enables physicians to focus on optimizing thrombus removal without focusing on blood loss. Visual and auditory signals built into the Lightning 7 System enhance the ease of use for physicians. We are currently enrolling in our STRIDE study, which will provide clinical evidence about the utility of Lightning 7 to salvage limbs, remove clot, and restore blood flow in occluded arteries. Next slide, please. Now, let's turn to deep vein thrombosis or DVT. A DVT occurs when a clot forms in a deep vein, usually in the leg and sometimes in the arm. To be clear, when we size the addressable market in DVT, we refer only to those patients who suffer from iliofemoral or proximal upper extremity DVT, which we estimate occurs in at least 351,000 patients in the U.S. each year. The vast majority of these patients are still being medically managed with anticoagulation, but sometimes catheter-directed thrombolysis is used as an interventional therapy for DVT. However, this method commonly requires an overnight stay in an ICU, and thrombolytic therapy significantly increases the risk of bleeding, not just in the limb, but in other parts of the body, including the brain. We have an enormous opportunity to offer all of these patients a treatment method which removes clot in a single session, does not require a trip to the ICU, and significantly reduces bleeding risk. Next slide, please. Similar to Lightning 7 for arterial patients, we believe we have revolutionized clot removal in venous patients with our proprietary Lightning 12 technology. Lightning 12 combines our latest technology, catheter technology, appropriately sized for the iliofemoral and proximal upper extremity deep vein anatomies, and the computer-aided innovation of our Lightning technology. The catheters are designed to be atraumatic, highly trackable, and torqueable, and when combined with Lightning forms an ideal system for DVT management. This video will demonstrate how the Lightning system works. On the left, you see a tube with a catheter and simulated blood clot. On the right is the Lightning system, including our engine pump and proprietary tubing. I'm gonna ask to play the video now. The blinking light and auditory signals indicate when the catheter is engaged in the clot or flowing blood. Lightning automates the aspiration accordingly, with the pump on continuously when the catheter is engaged in clot, then pulsating on and off when in flowing blood. This enables physicians to remove large clots from the venous system in a single session of treatment while minimizing blood loss. Next slide, please. I'll now turn to our ongoing effort to help patients who suffer an ischemic stroke. Of the more than 800,000 patients in the U.S. each year who suffer an ischemic stroke, more than 200,000 patients have large vessel occlusions or LVOs. Despite extraordinary clinical evidence supporting mechanical thrombectomy intervention in LVOs, we estimate over 140,000 of these patients, or more than two-thirds of those who suffer a large vessel stroke in the U.S. each year, are still not being treated with mechanical thrombectomy because they are not getting to a hospital that offers neurointerventional services. Next slide, please. Penumbra pioneered the treatment of ischemic stroke by innovating aspiration-based mechanical thrombectomy for complete thrombus removal. Our latest catheter technology, the RED series, currently including RED 62, RED 68, and RED 72, provides physicians with a portfolio of advanced interventional tools to best match the patient's vessel size. Our REDglide coating, combined with proprietary catheter architecture, make the RED series catheters highly trackable in tortuous vessels. The RED catheter portfolio will also be a critical component of our most significant innovation in stroke to date, Thunderbolt. Thunderbolt builds on our computer-aided Lightning technology that has proven so beneficial in the vascular space. We are very excited to announce that we will be conducting a clinical trial in the U.S. that we believe will show the strong benefits of this paradigm-changing technology. We believe that this is the best way to demonstrate the performance of this technology. The details of the trial design and estimated timing of this trial will be shared as soon as possible. In the meantime, let me share a high-level view of how Thunderbolt works. Thunderbolt, like Lightning, does not go into the body, but rather connects to our engine pump and the catheter. Our proprietary Thunderbolt algorithm drives the operation of alternating valves in Thunderbolt, which creates a variation in vacuum. This variation in vacuum facilitates thrombus removal by reducing static friction between the thrombus and the reperfusion catheter. We believe Thunderbolt can change the paradigm in treatment of stroke by significantly enhancing the speed and completeness of clot removal. Next slide, please. We are also excited about our opportunity to help patients suffering from large clot burden in their coronary arteries, for which we have differentiated proprietary technology and outstanding recent clinical evidence supporting its safety and efficacy. We estimate that there are more than 193,000 patients in the U.S. each year who present with coronary lesions that have a high thrombus burden. When these coronary lesions have high clot burden, there is an increased risk of embolization and poor outcomes. It is important to note that all of these patients are undergoing an intervention, usually balloon and stent, to reopen their artery. Only 55,000 of these patients are also currently being treated with mechanical thrombectomy, and most of these cases use older syringe-based suction devices that have proven to be ineffective at best. Next slide. Next slide, please. I think we skipped a slide. Sorry, can you go back? There we go. Thank you. Penumbra's CAT RX aspiration catheter utilizes a rapid exchange platform to remove significant amount of clot from coronary arteries. In November 2021 at the TCT conference, investigators presented very compelling data from our CHEETAH study, which demonstrated that the removal of thrombus before treating the underlying lesion in patients with high thrombus burden improves myocardial perfusion and reduces embolization. Of the 400 patients enrolled in CHEETAH, 99.8% achieved myocardial blush grade three, and less than 1% of patients experienced any form of distal emboli. CHEETAH also had zero device-related adverse events. Next slide, please. I would like now to turn to pulmonary embolism, or PE, a condition that occurs when blood clots, which typically travel from the veins in the legs, get caught in the lungs. The symptoms are similar to a heart attack, but the patients experience severe chest pain. We estimate there are approximately 157,000 patients in the U.S. who suffer either a high or intermediate risk PE, also known as massive or submassive PEs. Of these 157,000 patients, we estimate only about 15,000 patients are currently being treated with mechanical thrombectomy. We believe we can eventually help all of these patients with our latest innovation in this field. Next slide, please. Our Lightning 12 system offers a unique solution for the management of symptomatic severe PE. Our EXTRACT- PE study results first presented at the VIVA Conference in 2019 demonstrated the safety and efficacy of Indigo to remove clot in the pulmonary arteries. We are currently enrolling in STRIKE- PE using our Lightning 12 system. This important trial will evaluate the outcomes of patients treated with Lightning 12 and provide data in the clinical and functional status of patients out to one year after the procedure. In addition, a clinical trial randomizing patients to Lightning technology versus medical management is also being planned and could expand the number of patients we can help who suffer a pulmonary embolism. Finally, in 2020, we announced our partnership with RapidAI to enable faster, more efficient clinical decision-making for PE diagnosis and decision-making for treatment. We believe that the combination of advanced innovation, more clinical evidence, and AI technology enabling faster clinical decision-making will allow more patients to be treated with our proprietary Lightning technology. Next slide, please. Finally, I'm excited to turn to our immersive healthcare business. As we discussed at our Investor Day in September, Penumbra is building a platform to provide immersive VR therapy to over 50 million patients across a broad range of healthcare settings. Our goal is to deliver a healthcare-only safe platform that addresses patient engagement, clinical outcomes, and patient satisfaction. This will be accomplished by offering an expansive number of activities with experiences to address patient and caregiver needs for a myriad of health conditions, including physical rehabilitation as well as mental and cognitive health. Next slide, please. We have a huge opportunity in front of us to help millions of patients. I'm sorry. I got stuck on the wrong slide. I'd like to play a video which shares our vision for immersive healthcare, as well as details about our i-Series and y-Series, which are now available to patients and caregivers in the United States. Could you play the video? REAL Immersive System is an advanced technology that brings immersive therapeutic experiences to life using virtual reality. With REAL System, Penumbra is bringing innovation beyond the hospital to empower possibilities for individuals on their rehabilitation and wellness journeys. The vision is to enable a vast network of independent developers to build immersive content on REAL's technology. The result, a rich, expansive, and evolving library of immersive therapeutic activities and wellness experiences, all accessible on REAL System. The flagship REAL System is FDA-cleared for upper body rehabilitation under the supervision of a medical professional. Comprised of TherapyView on a tablet, headset, and proprietary sensors, REAL System transports patients to a fun, positive virtual environment where they engage in activities focused on motor learning, cognition, functional skills, and wellness. Activities are created by leading rehabilitation experts and award-winning game developers to provide rehabilitation experiences that are clinically focused, yet fun and motivating. REAL System is designed for therapists to work alongside their patients, customizing activities and tracking progress with TherapyView on the tablet. REAL i-Series is purpose-built to support cognition and mental well-being. It is designed for self-guided use in a healthcare or residential setting. REAL i-Series consists of a headset with intuitive controller-free gaze navigation that opens up a world of possibilities. Adventures can be experienced solo or with a loved one using the i-Series REAL Connect, an advanced capability that provides real-time video and audio communication to help individuals build social connections. REAL i-Series offers experiences and activities across different genres to support cognitive activation, distraction therapy, reminiscence therapy, mindfulness, and relaxation. REAL System and the vision of an immersive therapeutic ecosystem enable healthcare providers to leverage the power of virtual reality in helping patients and individuals reach their rehabilitation and wellness goals. Next slide, please. We have a huge opportunity in front of us to help millions of patients in the U.S. and around the world. Our commitment to innovation across each of these six large under-penetrated markets has produced extraordinary products customized to the needs of patients within each of these settings. What's more, we are excited about our broad portfolios and new innovation in our embolization business, which we also expect strong growth going forward. We believe we can help over 1 million people in the U.S. within the five thrombectomy markets and well over 50 million people in the U.S. with our immersive healthcare business. We are also excited about the significant growth opportunities in our international businesses as we expand access to our latest innovations in Europe, China, Japan, Asia-Pacific, and Latin American markets, among others. Next slide. As I've said at the beginning, innovation has been and will continue to be the focus of our work at Penumbra, and helping more patients will always be our mission. In order to significantly increase the number of patients we help in the years ahead, we will continue to commit ourselves to constant innovation, attracting and empowering the best talent, and purposeful execution. Thank you for giving us the opportunity to talk about our company, Robbie, and I'm delighted to open it up to questions. Yeah. Great. Thanks, Adam. Lots to talk about there. Maybe we could start with Thunderbolt. You know, we've been hearing about this for a while. We finally now see it. You're running a trial. Maybe give us a little more meat on the bones of what it actually is, and is it so revolutionary in stroke treatment? It's a great question. As I described in the formal talk, what it does is it harnesses aspiration to its greatest. Right now, when you, for example, take a catheter and you put it up against clot, and the clot sort of gets stuck, if you will, in the tip of the catheter. Sometimes it ingests it, but a lot of times it doesn't fully ingest it all out. What we're doing with this technology is enabling it to be ingested very quickly all the time because that moment, and I described the word as static friction, that friction, that moment when it gets stuck, disappears, if you will, because you're constantly enabling it to be sucked out. You gotta see it to believe it. I can't wait to be able to be out there showing it in action. It's something pretty impressive, and I am so proud of the team for working so hard to develop this. We can't wait to get it out there. I think the trial is by far the best way to do it because rather you know with the success of that, if that goes according to plan, there might not be doubt left as to the benefit of it. This trial, you know, when will you be starting? How big will it be? How long will it be? What's the endpoint you're looking for? All the things that I said in more prepared remarks, I will be telling you as soon as possible. Gotta ask. Maybe how about this, Adam? You know, is the goal here to show? I imagine if you're running a trial, you're looking for some sort of claim or some sort of superiority versus current treatment. Yeah. Is it fair to say that your goal here is not for just a better outcome, but a fairly significant better outcome than what you're getting now with current therapy? Yeah, that would make sense, wouldn't it? Well, good. Maybe if we just take a step back, you know, realizing you haven't pre-announced fourth quarter numbers, so you're not gonna give us the exact numbers here. Anything you could say qualitatively about how the quarter went, whether COVID disrupted your business or didn't, neuro versus peripheral? Any color would be helpful. Yeah. I mean, first of all, you know, we don't typically pre-announce. Obviously last year was an exception 'cause of the circumstances. That's not what we typically do. The business is in a really good spot. As it relates to COVID, you know, we have been other than the second quarter of 2020 when everyone sort of had to adjust. For the last year and a half, we really haven't talked about COVID as a factor in limiting our business in any way, and I think people have noticed that. That hasn't changed. It certainly didn't change in the fourth quarter, where somehow COVID, you know, all of a sudden started to have an impact. It did not. We feel really good about our business, both currently and in the long term. As we laid out, we have a lot of drivers, and a lot of under-penetrated markets. We wanted to lay it out that way because a lot of times, you know, people look at the business appropriately 'cause of the way we report segments and all, as, you know, half of it's stroke and half of it's vascular. Okay. You know, when you look at the business, the way we actually manage it, we have, at least on the interventional side, five large under-penetrated markets, all roughly equal size. You know, all of them are in really good shape right now. We can have growth for quite a while across those five, and continue to be pretty successful. I just think we're in the strongest place we've ever been in as a company, given the diversity and the product portfolio in each of those segments. It's a pretty good spot. Great. Let's focus our conversation on those areas of growth, 'cause there are a lot of them, as you said. At TCT, you presented fantastic data from the CHEETAH study, which is in coronary thrombectomy. Right. It's still very early days, just a few months since that data was presented, but any early feedback from the field on the acceptance and how physicians are viewing the clinical data? Yeah. I mean, it's been great. You know, as I think you know, and I'll remind the audience, aspiration as a tool in the coronaries has been around for a long time. The products were sort of different. They were little handheld syringe-type things and not the kind of power that comes with our product. There was a large trial run some years ago that sort of put a little kibosh on it because it showed that there wasn't much difference and potentially stroke rates were unfavorable. Those were on technology that isn't at all comparable to what we do. When we launched, you know, this sort of almost a typical Penumbra-like thing. You know, let's go innovate in a field, you know, where there was a large 10,000 patient trial that said, "Don't do it." You know, that seems like the perfect challenge for us because we knew that no one wants clot in your coronaries. Mm-hmm. You know, that's not a good thing. Most people want it out, if they can take it out. You are looking at a lot of patients that have clot in their coronaries. We developed, I think, a tool that really worked incredibly well to remove that clot. The trial was really a confirmation of that. A couple of just points. You know, it's very different than some of the other areas. Here, the clot isn't always the main issue. There are other underlying issues and the clot's sort of in the way. If you look at the trial data, our product CAT RX was in the body for a little over a minute. That's amazing. The clot was gone in almost every patient with no issue. That's amazing. This business tends to be pretty sticky. It took a long time to convince people to try it initially because of the overhang from that trial. Once they try it's pretty exciting and it becomes very sticky. We're pretty optimistic going forward. There may be necessary work ahead, you know, with more trial work, a randomized trial. There's some discussion about it. There's also a lot of interest in just starting to use it. For those who have been using it, some of the people in the CHEETAH study, you know, have already indicated they don't think they could enroll in a randomized trial because it wouldn't be equipoise. We have to wait and see. There's some time ahead to see what the right answer is there. In the meantime, I think more patients are getting the benefit of this great technology. Well, that's great. Adam, just a reminder. Reimbursement, is that an issue at all in thrombectomy in the coronary? No. There's pretty healthy DRGs. No one's commented really on the reimbursement at all, you know, on being able to cover this. In fact, we don't have data on this yet. There's some people wanting to put it together. There's probably ultimately a cost savings on the total cost, because you in many of these cases use less drugs and other things that cost more. That has not been a hurdle for us. Also within peripheral, you had fantastic success, I guess it's what? Over a year and a half ago? What, since Lightning 12 came out? Yep. Yep. Last year, Lightning 7 on the arterial side. You know, are you still seeing significant adoption on both arterial and the venous side? You know, these are usually patients that are already in the hospital, so it's not so much- Yeah. going out like in stroke and theoretically Yeah. They're available. Yeah. They're there. Yeah. They're ready to be treated. Yeah. Are you still seeing the rate of change continue at a healthy pace in both arterial and on the venous side? Yeah. Absolutely, we definitely continue to see that grow. It's really heartening to see, you know, the ability to, you know, in one session, you know, in a very short period of time, remove all the clot. Sometimes the patient goes home the same day. It's, you know, that's a whole different outcome, you know, than a lot of these patients were experiencing before. I think as more of that gets out there, more conversations between doctors, more peer-to-peer discussions, you're gonna see what we have for a while, which is more and more people coming over to sort of this new idea of a very quick and easy single session. The other thing I do wanna point out, I played that video, I apologize, it was sorta hard to talk over it but showing Lightning work. The benefit of Lightning beyond the obvious blood loss issue, which you know is sort of the most important part, is we built in both auditory and visual signals. You saw that in the video. The lights on the Lightning change color depending on if you're in clot or not, and the sound changes. Because you're doing these cases, you don't know. You can't visualize the clot. You know, if you're looking at your angio screen, it's not a live image per se. You don't know if you're in clot or you're not in clot just by looking at your angio screen. This gives the operator a massive advantage over other things where they know where they are, they know that they're in the clot, and if they don't hear that or see that color, they move it to get into the clot. Saves time, you know, saves energy, saves a lot of other potentially, you know, manipulation of stuff. Physicians have loved that feature as much as the blood-saving feature, which, you know, we hoped, but it's nice to have seen that over the last year and a half. We now Thunderbolt's on the docket for new product launches in neuro. Anything we should be looking forward to in 2022 on the peripheral side? Yes. You want me to tell you what they are? That's the important part. I'm not gonna do that quite yet. I've alluded to the fact that we are not done innovating in both arterial and venous with our products. Even though Lightning 7 and Lightning 12 are really good, you know us, we keep trying to make them better and better, and we think we will continue to do that. I gotta wait for a little longer before I reveal those. All right. Fair enough. Would be remiss if I didn't ask about REAL VR. You had the analyst event in the fall. This is one I feel like it's evolved a little bit from pre-COVID to today. Yeah. Potentially a lot better with reimbursement changes, a different vision. You know, maybe give us, it's now in the market, what's some of the early feedback? I think what investors really are trying to figure out is when can we really call this a win and it's real and put some sizable numbers into the model. What's the early feedback, and then- Yeah. When can we start to see this play through in the P&L? Well, let me sort of reframe the question a touch. Okay. What we're trying to do now is build the platform for all of therapeutic healthcare in VR. We are gonna continue to make great content ourselves. We have three studios, our own, plus the two that we got when we purchased Sixense. They're incredible, and they've done amazing work. You saw just in that short video clip some of the content, but also a lot of it in the Investor Day. More than that, we wanna have everyone else's content on the platform. We wanna build a healthcare therapeutic healthcare safe platform. You know, when you think about right now the state of VR and, you know, you've seen things around the quote "metaverse," it's not a place, you know, that people that are serious about healthcare necessarily wanna be, 'cause, you know, it's not the same. It's not sort of a healthcare-centric, safe place. That's what we're building. There's a large appetite for that. As we talk to the users in these areas, whether it's in, you know, one of the many channels that we outlined, there are about 14 targeted channels, large ones, there's a lot of interest in VR, but there's also a real need to know that they're gonna be sort of in a secure sort of healthcare-oriented place. The same thing with the developers of great content. There's a lot of good content out there. People have done really good work. Some are running some trials, proving things. All of that, we think, will benefit from the kind of platform. In addition to our, of course, our own made, you know, developed content itself. How we're gonna talk about this going forward is we'll try to update you on those conversations, both that we're having with the end users, you know, and how that's going, and also with the third-party developers, as we engage and bring them on board. That's how I think you can measure our success over the next year plus. You know, we'll start to put some real, you know, numbers and focus on it. Let's do the hard work first, to sort of get this up off the ground, and then we can sort of turn it into something that we talk about with numbers. If this is really successful, it would look more like almost an iTunes store for Penumbra, where you have the hardware out around the world, and you process and distribute the content. Yeah. The models for this type of platform, whether it's, you know, Apple or whether it's, you know, a PlayStation, you know, they exist. So we're not inventing that model. Obviously, there are small differences because it's healthcare, but the fundamental model has been out there. It really works if there's a need to have sort of a centralized platform. That's what we're hearing from end users, you know, that they want hardware that's owned, controlled, and focused just on the healthcare world. Yeah. Maybe Adam, we have 2 minutes left. I wanna spend a minute on the P&L. Penumbra has been investing heavily in manufacturing and R&D, expanding the sales force. How should we be thinking from a high level about investment in 2022? Again, realizing there's no formal guidance. Yeah. Yeah. We're not fundamentally changing, you know, our investment. You know, we think, you know, we have had to invest on the manufacturing a little ahead of the curve. Some of that was, as you know, COVID based, where we had a new plant coming online, and that gave us the flexibility to sort of spread people out and grow that a little ahead of things which, you know, dragged it down a touch. We think that by, you know, the end of the year we'll stabilize. But we're not gonna fundamentally change how we think about either the manufacturing investment or build, you know, our investment in the future. You know, we've never gotten ahead of ourselves. As you know, we've always been pretty careful. We are investing, you know, in all of these opportunities, whether it's on the interventional side with new innovation and trials or immersive healthcare. We've been able to do it sort of with real discipline and focus not to get ahead of ourselves. I don't think that will change in 2022. Great. Well, unfortunately, we're out of time, Adam. Thanks so much for taking the time today. Yeah. Yeah. Thank you, Robbie. Have a great day, and thanks everyone for tuning in. All right. Thank you, guys. Thank you, Robbie. Appreciate it. Take care.