Hey. Hi, everyone, I'm Steve Lichtman, Medical Devices Analyst at Oppenheimer. Welcome to the Oppenheimer MedTech and Services Healthcare Conference. Up next for us in the MedTech track, very happy to have Surmodics Incorporated with us today, are Gary Maharaj, as President and CEO, excuse me, and Tim Arens, CFO. We will have a presentation, but we should have some time for Q&A. So if you do have a question, just key it in and I will get it over to management. But with that, happy to turn the mic over to Gary. Thanks. Thank you, and thank you for the invitation to the conference. I will just try to get from slide to slide here. Just bring your attention to our safe harbor statements, which represent the intrinsic risks and possibilities and probabilities of any forward-looking statements that we make today. So let's talk a little bit about Surmodics. I mean, the company was founded in 1979. We're based in Minnesota and in Ireland. We have three sites, about 400 employees, and fiscal 2023 revenue was $133 million. Market cap back at the end of December, it's certainly different today, it was just above $500 million. And really, when you think about the company, I think the things to get your arms around is that we, we're a bit of a small micro conglomerate. We have different businesses that have different financial footprints and free cash flow generation. So our legacy businesses in diagnostics and coatings technologies really operate at significant scale and have really strong return on invested capital and predicted cash flow. EBITDA margins north of 50%, operating margins around that same. We're not very capital intensive. And then we have the baby business that we're trying to create, which is really going all the way from technologies to the fully devices that we take to market ourselves, and we talk about vascular intervention-type products. And those really are one of a kind to accelerate revenue growth, but do require significant investment on the commercial front. And we'll talk about that, and SurVeil Drug-Coated Balloon, which is included in that category. So these devices, however, are really focused on large unmet needs or not well-met needs, and really growing unpenetrated, currently underpenetrated markets. So we'll talk a little bit about those product segments and what's exciting to them. And then the executive team here, they're all triple decades. No one here showed up and is doing on-the-job training. Multiple great performance in the past, and then we intend to have that continue into the future. Good, strong balance sheet, access to capital to keep going and building the value as we see it. The glamour shots of the executive team. As I said, everyone here is... I think our weighted experience now is well over 30+ years, and these are team members I've worked with for all the way from 28 years to the 13 years, since I came to Surmodics, so a really significant, and a real team as well. So if you look on the left side, the core businesses, right? Think of technology B2B. That's what those, those markets that those businesses serve, and they do it incredibly well. They are market leading in their categories. And, you know, one thing you'd find interesting about Surmodics, and something we are proud of, is you can't line up any of our products or our technologies with anything else that's out there. And then I always encourage investors to go fact-check this, right? Because it's easy to say it. And so when you look at those technologies, they are one of a kind, and they are all gold standards. On the right side, again, we're going into really large competitive markets, but the platforms we're bringing to bear there are simply the best in the world, and we'll talk a little bit more about that. So when you think about the product side of it, not the technology side, we think of platforms. So on the one hand, we have a platform, the internal term for it is a drug excipient-mediated drug delivery. It's a fancy way for saying our suite of drug-coated balloons. One of them is now commercially approved, SurVeil. We have two others, one for below the knee using sirolimus, and one for AV fistula that are at the first-in-human follow-up stage. Abbott has agreed and signed a contract with us to commercialize SurVeil based on getting the PMA, which we did last year, and so we'll talk a little bit about that. We did the only worldwide pivotal study against the high dose, the market-leading impact device, and the three-year data were presented recently and came out incredibly well. The other two platforms deal with thrombectomy, removing thrombus in different vascular beds. So we're starting clearly in the arterial side, and we're also, in the latter half of this year, launching our devices for the venous side. And so a little more about that to come, but unique devices that don't currently exist. And then radial access. The ability to treat the coronaries from the wrist is now actually the primary of treating patients around the world. Less bleeding equal less death, less mortality, less complications. But no one has really talked about getting the full suite of products to go from the wrist to the big toe. Peripheral radial access, as we talked about, but there's really a dearth of products available, and we have the only products of the type that can reliably get you from the wrist, 2.5 m down, all the way to your big toe. So proud of those and a little more about it. The one thing we will see, as I said, we're, you know, a $133 million company, a large market opportunity, doesn't have to be that large.... but these are actually large at any scale. These are, you know, opportunities that get up close to $4 billion in aggregate, and the penetration is not there, and the ultimate solution architecture still isn't there. There's a lot of success in these markets, but there's room to grow, and then that's how we see it in terms of the ability to penetrate these markets and compete. So, you know, strategic objectives, we keep them very straightforward internally, right? We've got to really capitalize on the vascular interventions portfolio, those unique products, and start seeing that ramp in revenue or and growth from those product contributions. As you saw in our first quarter, it was significant. I think our product revenue grew over 40%, and we like to continue to see that trend, if not accelerate. And then, what's funding these initiatives for growth is a high ROIC, the return on invested capital, of the legacy technology businesses. So we're, we're partially being funding it from an internal start-up with some of our credit facilities in addition, and so can slip into cash flow generation and mid-single-digit growth of those businesses. And I'll say one thing, when you have a high ROIC, and a high EBITDA, and high operating margins, let's say, we don't hang our head in shame for mid-single-digit growth. That's still phenomenal, in our opinion. And then, R&D is our lifeblood. We have multiple, a strong pipeline of things that we hope to actually launch and bring to market in the latter part of fiscal 2024. So let's talk about SurVeil. Really, the key attribute there, and something we discovered in our small interfering RNA research a decade plus ago, is that loading up drug in a balloon is like bringing a food truck to a picnic. It's not how much food is in the truck, it's how much food gets into people's bellies. And so you want the efficiency of whatever drug you bring, the food in the food truck, to get into the tissue, which is an analogy of the people's bellies. And efficiency in that technology segment is not great yet. It works nonetheless, but it can be improved. So we set out to design a device that uses 75% less paclitaxel, which is a cytotoxic drug, it's used in oncology, and still get the same results, with much less drug loading. Other companies claim they have much less drug loading, and I always challenge them, "Well, show me your randomized controlled, pivotal worldwide trial." We did that, and with three-year data, and so we have the only level one evidence of our device actually being as effective as a high-dose device, and that's what makes us and Abbott excited. So our three-year data, right, versus the IN.PACT Admiral market-leading high-dose device, was 80%, 80% pretty much neck and neck with rounding errors in terms of efficacy, and then the safety profiles were also closely identical. Excellent device using that much less drug. It's a big opportunity since the FDA unwound their paclitaxel label warning. We expect this market to get back into growth and penetration, and adoption here. We made Abbott's opening order in our Q1 and delivered it, and we continue to make their follow-up orders as we speak. Thrombectomy. Now, let's split that into two archetypes, two vessel beds. Arterial thrombectomy really is in the vessels of the arterial side, venous. Let's talk a little bit about arterial thrombectomy. So thrombus occurs in all different vascular beds for different reasons. A very archetype type of thrombus that you get is, a clot leaves the heart, if it goes to the brain, it could kill you, but if it goes south, it usually gets stuck somewhere in the popliteal vessels, and then it stays there, and it gets very fibrinous and rubbery. It's a very difficult clot to remove. You can't suck that out. It doesn't suck well, it doesn't collapse well. So our Pounce system was designed to remove all archetypes of thrombus. The highly organized thrombus that you usually have to do a surgical cut down on, we can deal with that in a endovascular technique. We can also deal with acute and sub-acute, like, the players. So what's unique about it is, it works really quickly, it's ridiculously easy to use, does not require capital equipment, and, and so far, in our head to heads with all incumbents, I have not seen that device not fail to perform and actually help that patient. So quite excited about that. We just started with, the Pounce original that really treats the superficial femoral artery and some vessels down to 3.5 mm. We got FDA approval, and by the way, it's a—as we said, it's a big market, and we believe it's growing because the tools, like what we're bringing, are bringing it up. We've also initiated a registry, which we hope to get on the podium, to really talk about all the patients that have been treated and their outcomes. It's retrospective, so we're not controlling it, but we are getting and mining that data to be presented. So, I'll go back one more here. So Pounce LP is the one we're doing our limited market evaluation now. So that goes not just down to the knee or a little below, it has the ability to go to 2.5mm vessels, all the way down to the ankle. There aren't solutions for these patients currently. We talk about them, they're marketed a set sometimes, but they're not really viable solutions. Very often, physicians just treat the vessel they can get to, they don't treat the clot that's actually causing it. The Pounce LP, which we hope to launch in the second half of our year, we can actually get to the vessels that's causing the clot, or the clot in the vessels of very small diameter. Again, with the same type of architecture, which makes us even more excited. Sublime, so someday we'll wake up, and we'll recognize that transfemoral puncture is a medieval practice. And I'm not saying that in a bad way, but if you can access the vascular system through the radial artery, it's far better for the patient, for their comfort, for their dignity, for their patient satisfaction, which we sometimes forget. Secondarily, we believe the costs of radial access is gonna be much less. You don't have expensive closure devices, right? You can treat bilaterals if you needed to, going through the wrist. And then finally, economics for things like office-based labs, now they don't have to stop practice around 2:30 P.M. or 3:00 P.M. With radial access, that patient walks out of the cath lab, sits in the Barca lounger, and could be out the door in an hour and a half. That's not the case with transfemoral access, where you may have to keep that patient prone with closure devices. So they can get a couple more procedures in done per day, so very strong legs in it. The issue has been literally not enough devices to fully get adoption. We think about three things: You've got to access the lesion, and if you could get to the lesion, way down in the knee from the wrist, but you can't cross. If you can't get a guidewire across, you can't really treat, and some difficult lesions are like that, and then you can treat with these devices. So right now we have the left and the right, and we're doing our limited market evaluations, and soon to launch the middle, which is really being able to now cross difficult lesions all the way from the wrist. Again, an exciting development for us. Smaller market, but I'll tell you, one thing that we're recognizing is the archetype of atherosclerosis in the periphery is different than the coronaries. The coronaries have a lot of atheroma. I think it's coming out more and more and becoming more well-acknowledged that peripheral artery disease has a lot more thrombus in it. So if we look at this addressable market here, this only really speaks to acute limb ischemia, piece of clot from your heart getting stuck. Doesn't speak to the broader market of thrombus and peripheral artery disease. Nonetheless, these are, these are big markets for us, and we intend to capitalize on that. Tim, I could turn it over to you for a quick financial summary if you want me to drive. Absolutely. Thank you, Gary. So I think this is a really helpful slide and puts some context around the discussion that Gary just walked us through with regard to our catalytic products, including, SurVeil, Pounce, and Sublime. But let's take a look here at the, the bar charts. Looking at 2019 to 2023, you can see our annual revenue highlighted, and we've also noted what the SurVeil license fee and milestone revenue. This is essentially, revenue recognized from previously earned milestones. There will no longer be any milestones generated off of the SurVeil and Abbott relationship. But if you look at the annual revenue CAGR, it's about 5% from 2019- 2023. Looking at our 2024 revenue guidance of $117 million-$121 million, and you back out the SurVeil license fee, milestone rev rec, we're looking at revenue growth of between 10%-14%, so a stepwise function higher than the five-year 5% CAGR. It's really being driven by these catalytic products that Gary's just walked us through. We continue to expect that our legacy coatings and diagnostics business will contribute about low- to mid-single-digit revenue growth. The vast majority of the revenue growth will be coming from these newly, recently introduced products. We'll move on to the next slide and take a look at our financial guidance, which was last updated here on February 1st on our earnings call. Today we're not gonna be updating guidance, so total revenue, $117 million-$121 million. As I mentioned, excluding the SurVeil license fee rev rec, we're looking at revenue growth of 10%-14%. Our GAAP diluted loss per share is estimated or expected to fall within a loss of $1.40-$1.10 for fiscal 2024. If we look at our next slide, we'll highlight our capital and capital allocation priorities. We have, as of the end of December, Q1, approximately $99 million of total available capital, which includes the cash and investments on the balance sheet. We have sufficient liquidity to support the financial requirements associated with the investments to support the strategic objectives that Gary had previously described. Important to note, our priorities as they relate to capital allocation have not changed. They continue to focus on supporting those objectives. Notably, we'll continue to invest in innovation, as well as activities to drive the growth associated with these catalytic products. We'll close with the final slide here in terms of our cash flow. It's important for folks to recognize that over the last year, we've been really focused on cash efficiency as being a top priority. We're focused on disciplined expense management, as well as optimizing our working capital. Those focus areas, along with revenue growth and gross profit growth, are gonna be strong contributors to improving our cash flow today and over time. And with that, Gary, I'll turn it back to you. Sure, Tim, I like that because I think what we want to articulate is we're very disciplined when we do capital allocation. This is not because we said it six months ago, we just keep driving it. We're always looking at the risks and opportunities and sifting to make sure that the best opportunities get the allocation, and so we're very dynamic on that. Steve, I believe that's all we had.... you know, I mean, it, but we see a lot of upside potential here with the pipeline that we have and the strength, the enduring strength of these core businesses that we operate. Great. Thank you, Gary and Tim. I guess the first question I want to jump to is that would be around SurVeil. I'm wondering what the, you know, sort of the response has been from the clinical community to the TRANSCEND trial, and what your and Abbott's messaging has been on that. I mean, obviously, you showed, you know, very clear non-inferiority. So as you think about the differentiation of SurVeil, what's sort of been the what's the messaging now, and the response from surgeons? You know what, one thing I will say is, the TRANSCEND trial, I believe from physicians I've talked to, is now seen as the archetype of the best-run trial in drug-coated balloon. Very difficult to run head-to-head trials, especially as a very strong pro product like Medtronic. I believe that there are two things here, you know, pharmacotherapy, as I've been taught, if you have a lower dose formulation of a cytotoxic drug that works with durable evidence going three years plus, which we have now, right? You know, ethically, you really should consider treating that patient with a lower dose formulation, right? But you need level one evidence to do it. No one else has that. Other people have done head-to-heads, but they're not pivotal trials that the FDA is looking at every 100 patients as an example, or they're not worldwide. They are in-country trials and stuff. So, Abbott is an incredible clinical marketing organization, so having that clinical data in their arsenal, we believe it bodes really well. The issue, I believe now in markets like this, and this is not on Abbott's stance, is that you also have to penetrate the group contracts, right? You need the hunting license, and a product like this with level 1 evidence, I believe, will be able to get fact committee approvals much faster because of that evidence. You can look at the products as well. I've seen some of the marketing, and you put SurVeil next to any of the other current drug-coated balloons, and I'll challenge anybody to look at, to actually look at the physical products and see what they are. You can see the capability of process control. Remember, it's a drug we're putting in someone. So process control and drug delivery is pretty much everything. It's not just a balloon; it's a drug that has to be coated uniformly, the right content, the lower impurities, and the look of the device compared to everything else, I think, tells the entire story, and I believe Abbott has seen that in practice with physicians. Great. A couple of questions on Pounce Venous. Certainly, a competitive market, a lot of players there, a couple entrenched, some other newer players, including yourselves. Right. Can you talk a little bit more specifically about what the differentiation is, of Pounce versus competitors? You mentioned some, you know- Right -that totally head-to-head looks- Right -looks good. So on the arterial side, I'll just start with that. Arterial side, you either suck and remember, when you get down to a 2.5 mm vessel down to the ankle, that suction device looks like a little coffee stirrer, right? Just really tiny. And the physics of it, trying to suck from that length through such a small thing are incredibly difficult. So the trade-off curve, we break the trade-off curve by not using capital equipment, huge factor, and something that's really simple to use in a clinician's hand. It snares the clot, devolumizes it, that's what our patents are, Dr. Ansel's patents are on, and so you can pull it out. On the venous side, very competitive market. You know, you got Inari's and the Penumbra's and how they both... High respect for all of these technologies. But when you think of it, again, technology should continue to improve, right? And that's what we're doing. We like the fact that Inari can actually pull the clot out mechanically. What we prefer to do is to be much gentler on the vein. The vein is a living organ. I don't want to. If I'm shaving, I don't want to peel off my skin, right? I want to shave, right? And so our device has a constant tension spring that doesn't, in our testing, does not affect the vein and floats on it as the vein's size changes. What we like about the suction device is that you can continuously remove it. So when you look at our device, it's got a cage, somewhat like Inari, not the same, obviously, but just architecturally, right? Where you can actually capture the clot, but it's got an Archimedes screw that's continuously pulling it out. So you're not pushing and pulling, and you're not pushing and pulling. And an Archimedes screw is not suction, is a shuttle, right? So we believe we've given a much lower venous entry point. Venotomies shouldn't be too large. You want them to be smaller if you can. Arteriotomies are different than venotomies. We don't have huge guide wires going up through the internal jugular vein. You know, my son is a cardiologist at a major university institution. They can do that till the cows come home. Out in the, you know, smaller towns and stuff, you really don't want to have that physician, or they prefer not to do that. So what we believe is we're looking at optimizing things that exist, but putting them together, and that's what we like about our Pounce Venous device. Which again, we're doing a limited market evaluations. I think, Tim, we said we had 70-something cases. And of course, we have more than that now. We'll report on that on May the eighth, but we're looking forward to launching that in the second half of the year. ... and certainly market share will be, you know, a principal focus, I'm sure, for- Yeah for you. But I'm wondering your thoughts on the market overall on the venous side. And so where do you think we are in terms of, you know, mechanical thrombectomy penetration, and what do you think it's going to take to continue to drive that higher versus other, Yeah standards of care? We don't have independent data of our own, but what I've seen, I've seen clearly the other companies' presentations, and I tend to believe it. It's still woefully under-penetrated. You know, a lot of people don't come in for venous disease very often, and so now that you have the tools, I think you'll find more and more opportunities to do that. The difference for me, though, is, I'll give you an example. My son had a patient up in Ely, Minnesota, both legs, one clot on the arterial side. By the time the ambulance transferred the patient to the University of Minnesota, he had to get a vascular surgeon consult, and they had to amputate, right? That's a big issue in America. You should be in Dothan, Alabama, Duluth, Minnesota, you know, medium-sized towns without tertiary medical centers. You should be able to get treated. So what we're looking at is that part of the market we believe is underserved. There's also another thought in these markets that a rep has to stay in the case for every single case. I don't know why. I mean, can a physician drive a car? Would we have to drive physicians around? I'm making a broad analogy there, right? And the simplicity of our devices, our thesis is, you shouldn't have to have someone babysitting the devices for every case. That adds cost. That adds opportunity. So we're looking at a market a little different. But as I said, we have a lot of respect. Companies like Inari have almost 500 reps. We have 23. But we're not trying to win on all fronts, we're trying to win where the locus of where we're competing, establish that beachhead before, amplifying it. That, that's really the goal. Yeah. Couple of other opportunities that you guys are going after, you know, with Pounce LP, you know, below the knee has been a, you know, a tricky area to treat. Can you talk about, you alluded to it, about what the size of the opportunity is, and- Yeah ... and what is the competition like? Yeah. Yeah. I am Tom Cruise and Oprah excited about the below-the-knee opportunity because nothing works. You know, often physicians, again, treat the vessel they can get to, not where the issue is. So something that's coming out, as I said in the literature, coronary atherosclerosis and peripheral atherosclerosis don't present the same, right? Coronary atherosclerosis, a lot of atheroma and some, and plaque and some thrombosis. Superficial femoral artery and BTK vessels have a lot more thrombosis as well. So when we think of acute limb ischemia, which is the market we're defining now, clot goes south, got to get it out, otherwise, you lose a leg. There's a concern also in peripheral artery disease, and this is what we're hoping to find more of in the PROWL registry that we're doing, of, thrombosis being part of really PAD. It's, it's, it is a dominant presentation. And so as we look at that, there's so much, so much emphasis on BTK arterial disease, right? But what if BTK arterial disease is also a lot of thrombus-generated disease through the atherosclerosis there? And so I'm excited that it, it may be a small opportunity. I don't have data to guess of what percentage of the pie of ALI it is, right? But I do know, as we're getting this in the hands of physicians in the LME, they are using it. In fact, they're using Pounce above the knee, and then they're chasing clot below the knee with it as well, which tells me they've just been leaving it there because, "Eh, it's three vessel run-off. One of the vessels is clogged. Maybe I'll be okay." As a patient, I wouldn't want. I'd want somebody to clean all of the vessels. So it's emerging, and I don't have a real clear answer yet, but the answer is up, not flat. Great, okay. I think we have just less than a minute, but just really quickly, in terms of your ability to really drive the radial access business, is Sublime going to be sort of critical to, to really putting the foot down there? I believe so. A lot of physicians, you know, there's always an intimidation factor. You start, then you hit some calcium somewhere in SFA, and you're trying to poke from there to get through. And so I believe it's one of the remaining barriers, that the coronary world has had things like the Turnpike, spin deliverable, torque, corkscrew your way through CTOs and stuff, right? That's been done. We believe that if you had the high-performance microcatheters for the periphery and for the radial. And by the way, our microcatheters can also be used transfemoral. So we expect to see a lot of adoption for transfemoral operators as well. But we want to provide that high-end performance to cross that lesion from any access point. The peripheral world is a lot more price-sensitive, though, than the coronary microcatheter world. So we have to work through. We don't want to overfeature it, we want to hit that sweet spot. And so far, the cases we've taken on, it's worked like a gem. I think one physician couldn't even get the wire across, but he got a crossing catheter across, which I don't know how that happened. So excited about that. One thing I will say, the caveat, these are exceedingly difficult devices to make. They're thread-like, they turn like a shoelace, and they're 85% metal. So really, our launch window really comes down to the, how quickly we can validate in manufacturing, and we hope that's in the second half of this year. Okay, perfect. Well, we're out of time. Gary, Tim, thanks so much for being with us. Thanks, everybody, for dialing in. Hope you have a great rest of the day. Perfect. Thanks so much. Thank you. Take care.