Good morning. Welcome to the 2023 Piper Sandler Healthcare Conference. My name is Adam Maeder, and I'm one of the med tech research analysts here at Piper. I'm very pleased to introduce the management team from Surmodics. With us, we have Gary Maharaj, CEO, and Tim Arens, CFO. Gentlemen, thanks so much for joining us, and I will pass it over to you. Thank you. Appreciate it. Well, let's chat about Surmodics and, you know, just to make sure you understand the inherent risks and probabilities behind the statements I'm going to make in the safe harbor. So Surmodics as a company may seem complicated for a small company, but I hope to share with you today the juices worth the squeeze in terms of the nature of the company. Founded in 1979, about 375 employees, and we are based in Minnesota, is our headquarters, and we have a manufacturing plant in Ireland. Last year, we were about $133 million of revenue, and our market cap today is probably $475 million. So the key highlights here is we have two genres of businesses. We have two, what we call our legacy business units, which are technology-based business-to-business support, and one of them is our medical device, high-performance coatings, and one is our diagnostic reagents. Those core businesses generate substantial cash flow. They're greater than 50% EBITDA margin. They're all mid-single-digit type growth. So the high ROIC, nothing to hang our head in shame with those types of margins with that growth. The second business is really our baby business, which is intended to be a very high-growth business. That's a direct model where we're taking our technology capability, putting it on devices, and going direct to the market. So you'll see, many innovative vascular devices. The one thing I'll challenge you, it's not often noted about Surmodics. Go find these devices and their performance anywhere else on the planet. They don't exist. That's something that is a hallmark of something we've done for the last 37 years, which is really create unique new devices that really bring a different level of patient outcomes. They're very large attainable markets. Really invest a lot in R&D. I know that makes some investors uncomfortable. You can't be in this game for the long term if you don't invest substantially in R&D. And our R&D investment last year was north of 50%, or 45%-50% last year of revenue into R&D. We have an experienced leadership team, and you'll see we have a strong balance sheet and capital. The glamour shots of the leadership team, almost triple decades on average in the industry, so these are not first-timers at anything. At the top, really, Gordon, General Counsel, and Tim and I really are in the corporate sector. I mean, we run the divisions, and below are the three presidents of the individual business units. Joe runs the diagnostics business unit, Charlie runs the medical technologies, and Terry runs the Go Direct products business units. Again, executives with almost triple decades in the industry. So coming back to the sort of the left brain, right brain, on the left there you see our medical device performance coatings and diagnostics businesses. Stable businesses, really good commercial scale, high EBITDA, high operating margins, not that capital intensive. And again, as we say, we don't hang our head in shame with the ROIC, with mid-single-digit growth. And so what we're doing is we're using, we're sort of an internally funded startup. We're using the cash flow from those businesses to really drive our vascular interventions business to get to that 100% type growth in that business. So, and then on the right, you see the vascular intervention devices. We have differentiated drug delivery devices. And one thing that's unique about Surmodics, I'll step back, I don't know of any company at this scale in the medical device sector that both has technology, meaning we could do with drugs, combination products, drugs on devices. We also have the device design and development, which really, is the hardcore mechanical engineering and materials engineering to develop pure play devices. And then we have a very cost-efficient, high, low cost, high production operating environment in Ireland and in the United States. So most of the big companies, the strategics, the Medtronics, the Abbotts, the Bostons, they're complete with technology all the way. At this scale, there's only Surmodics that could deal with both drugs, devices, and that production environment. A m I stuck here? Oh, my screen isn't advancing. I apologize. I don't think it's advancing. Yeah. Might need a little help in the back. Maybe I can do this. Did I just do that? Okay. So in the vascular interventions portfolio, I want to spend significant time on that because to pull it apart and understand what we have. We are the only company, I think, at this scale, or maybe at any scale, that has three drug-coated balloon devices in development. One just a ctually, the one got approval from the FDA in June, and Abbott has paid us almost $91 million for the rights to commercialize that. So they're our commercialization partner. That's SurVeil, and that treats vessels in the side of the superficial femoral artery. A week and a half ago, at the VEITH Conference here in New York, we presented our two-year data for our below-the-knee drug-coated balloon, which uses a different drug called sirolimus versus paclitaxel. I think VEITH has embargoed the presentation, but I can share with you the highlights until they put it on their website. At two years, in the protocol patients, we had 71% patency in those patients. The vessel is open. That is almost unheard of for a drug-coated balloon. And we also presented a year and a half or two years ago, our AV fistula drug-coated balloon. Andrew Holden presented that with excellent patency as well. In the middle there, you see thrombectomy. It's probably one of the fastest growing interventional markets. There's a lot of big competition. We have two devices that are FDA cleared. One is commercial, and one will soon be commercially available, and we'll talk a little bit about that in a little bit here. And then radial access. This suite of devices are super. I think someday we'll realize we live in medieval times, where you're doing an intervention on a patient in a peripheral space, and you puncture their femoral artery. For coronary vessels, more than half the time you go through the radial artery, substantially better outcomes for those patients and health economics. No one has these devices that go from the wrist down to your big toe. So we really have the devices that, the only devices that exist currently in that scheme. Again, not insignificant markets for companies of any size, but particularly at our market cap and our revenue, these are large, underpenetrated and growing markets. In, for SurVeil Drug-Coated Balloon that Abbott will be commercializing in the first half of our fiscal year f or peripheral arterial thrombectomy. I'll just step back. Thrombus kills many more people than we recognize around the world and in the United States. Coronary, neuro, which is stroke, coronary and MI, peripheral arteries, are acute limb ischemia, where you lose the leg, and of course, DVT and pulmonary embolism. So really huge markets there. We try to keep our strategic objectives quite simple. One is we really have to get in our direct sales force, a very small direct sales force, around 22 district managers, get the awareness and adoption of these unique devices out there. And then the legacy businesses, what we're trying to do is drive sustainable cash flow. Now, there's a difference between cash cowing something and capital allocation. We don't starve these businesses because the returns are very high. So Tim and I do what we call dynamic capital allocation, where we give an influx of capital to those legacy businesses to get even a bigger return and more cash. So very different than cash cowing something. And then really, keep that R&D and innovation engine going really strong. So drug-coated balloons, SurVeil is a product that Abbott is a commercialization partner. As I said, they'll be commercializing in the first half of our fiscal year. And what's unique about that is we use some incredible technology to dramatically improve drug transfer. Paclitaxel is a toxic molecule. It's an oncology drug, right? It kills any cell that's dividing, tumor cells, hairs, nails, whatever. And so we're able to significantly reduce the load compared to the market leader, Medtronic. And we are the only company that took on a head-to-head trial versus the market leader, Medtronic. Keep in mind, Medtronic is one of our largest customers in our coating business. Now, the results of that trial, the commercial strategy first. Abbott's going to commercialize it. We get revenue when we ship it to them. We also get a portion of the profit-sharing pool when they sell it, and it's all disclosed in our 10-K and in our decks as well. We received the PMA, and now we're really shipping product to Abbott as we speak, which took a while to get there. Pounce Thrombectomy. This is a unique device for arterial thrombus, and arterial thrombus occurs in many different parts of your body, and right now, they use very complex capital equipment to go retrieve it. If you're in Duluth, my son's a cardiologist, and he got a patient at the University of Minnesota from way up north in Ely, Minnesota. A young lady had two babies, had a baby, both legs went cold. By the time the ambulance showed down to University of Minnesota, he had to amputate. He got vascular surgery to amputate the legs. If a device like this, two years ago, had existed at, at Duluth hospitals, in 10 minutes, you can snare that clot, pull it out, and that person will be discharged. So significantly, the little hotspots there where we have actually pulled thrombus. We are continuing to use R&D to extend the use of the device from the thigh to below the knee. We just got approved a clearance for a device that goes down to 2 mm vessels, and we're working on a device of that family to go up to 10 mm vessels in the iliac. So the idea is we intend to own the whole distal anatomy in terms of removing arterial thrombus. No capital equipment, really easy to use. Huge opportunity, again, and we've started a registry. I think we have over 50 patients in the registry to demonstrate the power of this device in actual real-world use. Our radial access. This is the one that I'm a fan favorite of. The returns are not going to be as quick as the thrombectomy, but I always tell our sales force, your grandchildren will remember and thank you for this. So this is the ability to actually go to the toe from the wrist, and that patient could walk out of the cath lab and walk out of the hospital in an hour and a half, right? Significantly less bleeding, less complications. Always think of blood loss equals death. Blood loss and mortality are almost always correlated. So now the devices exist to go to the heart, but that's a very short distance. It's pretty easy. To go all the way from the left or the right, around the heart to the toe, come back up, is unheard of, and that's what these devices do. The sheath is like the Starbucks sippy straw, which everything traverses through, the Sublime Guide Sheath at the top. The micro catheters we're launching, hopefully in our second quarter, that allows you to be able to penetrate difficult lesions to cross. And then the treatment balloons, 0.014 and 0.018. The only devices that are 2.5 m long in the industry or in the world, very difficult to replicate from a mechanical engineering viewpoint. These are all of the benefits of radial access. Keep in mind, for office-based labs, they shut down around 2:30 P.M. if they do a femoral puncture because you have to stop that bleeding. And so your airline gate, which is the cath lab, is shut down. With radial access, you could have two more cases because the patient's out of there quickly, much less complications. Fixed asset utilization in that cath lab goes up dramatically to where those are the two cases of free cash flow. So significant economic benefits as well. So access, cross, and treat, and we have the full suite of devices there. Looks like a smaller market opportunity, but I always say the whole world isn't wearing slippers yet. So when we count the market as how many people are wearing slippers, what do you call it in America? Sandals. Flip-flops! All right. Yeah. So, so the market opportunity sort of seems small because of the adoption and the intended adoption, but I believe it's significantly bigger. A quick financial summary. Now, the one thing you have to think about Surmodics when you decouple is we have significant revenue recognition from milestone payments. Remember I told you Abbott gave us $90.8 million? So every time we get that, Tim and the team have to go through a rev rec procedure there that's prorated to the clinical expenses. Most of that is behind us. We have some in 2024. So you have to decouple that to see actual revenue growth from operations. And so o ur midpoint of our guidance, I believe, is $118.5 million this year. It looks like we're shrinking, but we got a $27 million milestone payment in June, so you have to take that off. So without that, however, what we're saying is we're growing anywhere from 9%-14% this year, and that's the comparable you really should be looking at. There are the GAAP results and also the non-GAAP results. So we're aiming for double-digit growth this year and in terms of the actual revenue growth. We have access to capital. I know people in this macroeconomic condition worry about access to capital, but we have a lot of cash investments, we have borrowing capability, we have a revolver, and we do have cash on hand. And we're using that capital to drive significant allocations. So we got the PMA. Our Vascular Interventions business appears to be growing about 250% account growth for Sublime and Pounce. We haven't even launched the Pounce Venous product yet, which we expect will launch in the first half of this fiscal year. So the VI business as a young baby is growing handsomely. We're very disciplined on cash. I mean, we have the balance sheet, but we're always watching where that ledge is, right? We're not just going crazy eyes over the waterfall in terms of use of cash and cash management. And in fact, this year, we intend to grow between 9% and 14%, but use significantly less cash than we did last year, net of that milestone payment. So summary, experienced leadership team. We have core businesses that are truly gems and have amazing independent value. And then we have very successful early commercialization of some really new-to-the-world products, and we have a very strong pipeline because of our investments. We have the balance sheet to continue to do this until we get that hypergrowth and eventual close to profitability. Thank you. Are we out of time or? We might have a couple questions. Oh, yeah, yeah, we have faced any questions. Oh, good. I hope you do your homework, and we're open for questions, you know, to help you think through the investment. But it's an exciting company that I don't believe personally actually gets the recognition it deserves, but that'll come. Thank you.
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