Good morning, everyone. Thank you so much for joining us for Canaccord's 45th Annual Global Growth Conference. My name is John Young., I'm one of Canaccord's Med Tech analysts here. We're excited to host AngioDynamics. With us today is Jim Clemmer, the company's CEO, and Steve Trowbridge, the company's CFO. The format today will be a brief overview, and then we'll follow up with a fireside chat Q&A session. Jim, if you want to give the overview.
Great. Thank you, John. Thanks to Canaccord for the invitation and hosting a great conference. There we go. Here we go. Another click. There we go. Before I begin, I'll remind investors, please do your research. Make sure that you listen to what we say today. What we'll give you is our best perspective of our direction, our vision of the marketplace, and how we'll grow significant value for our shareholders. Please do your research, as we cannot guarantee anything without your extra homework. AngioDynamics is a company in transformation. We're transforming this 40-year-old company that was founded to serve the interventional radiology community many years ago. We've got a great base and a lot of respect from those folks for making high-quality tools and products. We had to shift our company to become more valuable into areas of higher margin, higher growth. We did that.
Today, you'll hear our company is focused on the two leading causes of mortality around the world: cardiovascular disease and cancer. That's what we're focused on, treating these two large areas. Our company is through this transformation. We've now shifted our portfolio to two reportable segments that we run our business in. Our Med Device segment is our more historic products. Slower growth doesn't require a lot of investment. It actually provides us with free cash and EBIT during this period to fund our investments in our fast-growing Med Tech segment, which is really our future, a high-growth segment. You'll see already really great growth that we've posted. Over the last five years, we've actually got a 25% CAGR of growth in our Med Tech segment. Three really special properties we'll talk to you about. Our company has a unique fiscal year. June 1 is when we start.
About three or four weeks ago, we just gave you our Q4 and final year report for our FY 2025 that ended on May 31. We also gave you guidance I'll share in a few minutes for what you can expect in FY 2026. Our company is run in the two segments I mentioned. This slide will show them. On the top is Med Tech. The bottom is Med Device. It's a little busy slide. We have a lot going on. On the left side is our cardiovascular products. On the right is our cancer treatment products. Trying to make it easy to show you that we compete in really large TAMs. These TAMs are also fast-growing. They're areas where innovation matters. You have to back up your innovation with data to prove the science of your products work. We're really excited. The Med Tech markets you see here, the U.S.
TAMs alone are about $7 billion in the three areas that we're in in Med Tech. Global TAMs are about $10 billion. That is a far cry from 2019 when we started our transformation. The whole company's TAM was only about $1.5 billion at that point. We've done a good job strategically divesting assets that didn't fit and investing in products that we think can expand our markets, expand the value of our company, and higher growth, fast-growing markets. What are they, and why do they matter? In a Med Tech segment, we do cardiovascular disease. We treat the venous system, veins, and the arterial system, arteries. The venous market is really exciting right now. Many of you may be familiar with Stryker, purchased Inari earlier this year. I'll give Inari a lot of credit.
They were really the market leader in using a mechanical way to treat venous thromboembolism, focusing really on PE. Inari did a nice job helping to establish this market. What we're trying to do together, us, Inari and Penumbra, are the three good companies in this space today. There are a lot of small guys trying to get in. What we're trying to do today is give doctors an alternative treatment where lytic-based therapies or blood thinners have been the historic treatment for PE for years. We think using a mechanical intervention, getting the clot out, is a better, safer way to treat these patients. The three of us will continue to grow this market development activity for years to come. We think today less than 20% of PEs are being treated with a mechanical thrombectomy product like ours.
Our AlphaVac product that received PE indication about a little over a year ago was launched last year. Our APEX S
tudy that supported us getting our indication showed that AlphaVac can pull more clots than Inari, the market leader. We do it faster than the market leader, and we lose less blood in the process. The doctor gets clot out and not a lot of blood that you want to keep in the body. AlphaVac was designed purposely to do those things better. We feel we have the best product in the market, now with the smallest of the three companies in the space. We're investing forward in the space. We've got the best product. For FY 2026, we just expanded our U.S. sales force from 40 direct sales reps to 50.
We'll look to continue to expand as we're getting really great feedback in the space about our products from doctors who are converting over to us from our competitors. We know how much room there is over time to grow. Venous thromboembolism, I'll say that again, no spelling test here. Venous thromboembolism is really important for us. Treating veins is a really important growth area for our company. In 2024, AngioVac and AlphaVac are two products in this space generating about $30 million in revenue. Last year, FY 2025 was $40 million in revenue. We expect to do over $15 million this year. This will be a double-digit grower for years to come for us. We'll also invest and expand our sales force over time to continue that growth. Cardiovascular disease also affects arteries. Peripheral arterial disease, or PAD, leads to over 150,000 amputations in the U.S.
alone if PAD is not treated. Using atherectomy, we think, is one of the most versatile forms of treatment. Breaking up the plaque or calcium that clogs those arteries is really important. We launched our product called Auryon nearly five years ago, September of 2020. We entered the market. There are five other players there. We entered in the market share slot of number six out of six. Today, we're number three. We're really, really proud. This product is really safe and effective, uses laser energy that we deliver through our disposable catheters into the arterial system, breaks up plaque or calcium above or below the knee. We also treat in-stent restenosis in a very safe and effective manner. We've passed some pretty good companies: Becton Dickinson, Boston Scientific, and Philips Medical, really good companies. We're now number three in this market. We grew over 20% last year.
We expect to grow double digits for years to come and even open up new areas for treatment. We believe our product can be safely and effectively used to treat coronary atherectomy disease as well, treat CAD. We're looking to get on label, working with the FDA to get an outline for a study to get on label for CAD, which is a market we think double the size of the PAD market that we're in today. We also just launched our Auryon system outside of the U.S., got our CE mark last year. In our Q4 numbers, we reported about $1 million of revenue in Europe in Q4. We expect that to contribute even more in our FY 2026 and beyond. AngioDynamics cardiovascular business is focused on treating arteries and veins. With these two basic products, these are really, really large potential markets. We've got really great products today.
We have R&D pipeline at our disposal to continue to add innovation to these products. Like any company in our space, we're investing in data collection to expand opportunities for indications of what we can treat and where we can treat it. Globally, these are really large markets and will be a large player for years to come in these spaces. The third part of our Med Tech portfolio is treating solid tumor cancers using our NanoKnife System. NanoKnife is a unique ablation product. It does not use thermal energy, but it uses electrical pulses of energy. NanoKnife can treat a tumor by disrupting the cell wall, creating nano-sized particles in the cell wall, letting the cells die naturally. It's really, really effective in things like prostate treatment. We just got on label in December of last year with the FDA for a focal treatment prostate option.
We're getting our CPT-1 code kicks in this January 1, about four and a half months from now. We'll have the best option, we believe, to treat people with a focal treatment, which is today about 40% of the men diagnosed annually. 300,000 men are diagnosed every year in the U.S. with prostate cancer. We believe about 40% of those fall in the Gleason 7 range and are ideal candidates. In between watchful waiting, where you don't do anything, or radical prostatectomy, it has still, even with a robot, a really high rate of incontinence or impotence. The PRESERVE study that supported our indication showed that we can treat the patient safely and effectively and really reduce the risk of incontinence or impotence. It's the only device on the market that does all three of those things. We're really excited about the opportunity that NanoKnife brings for interventional oncology.
The way it works, the science about it is special. It delivers that energy to the cell wall using electricity, no heat, no thermal energy, and not disrupting the other organs in the body. It allows us to treat that prostate, interior or posterior, any part of the prostate, disrupt the tumor that's growing, and safely let the man have his dignity back on incontinence or impotence, not having a side effect there. We're really, really excited about this product. FY 2026, we'll have our reimbursement kick in halfway through. FY 2027 and beyond, we'll have full reimbursement with a great clinical study for NanoKnife. AngioDynamics now is a company with this Med Tech segment that's grown at a 25% CAGR over the last five years while we're kind of building this plane, getting indications, getting our products launched. Here we are today as we look forward.
This will be our growth driver for years to come. We think AngioDynamics will have a stable revenue base with our Med Device products, lower margin, lower growth, but gives us stable business to build Med Tech on going forward. We'll be a true, we'll be a company that's hard to define as a growth company totally. FY 2025, we grew a little over 8% as a company and 20% in Med Tech. We're always going to have a balance there between our two businesses. Here's the guidance we gave in July for FY 2026. We expect Med Tech again to compete and grow at double-digit rates. Our Med Device business will be roughly flat, which we're fine with going forward. We are a company in transformation, but not in the first inning, guys. We've done this. We're playing the game.
We're delivering growth in areas of value and delivering growth in areas that are higher gross margins. Over time, our company is going to have a P&L with high revenue growth, increasing gross margins due to the mix of these products taking a higher percentage, and bottom line EBITDA being generated. FY 2025 was our first year we broke even, generated positive adjusted EBITDA in FY 2025. We're still investing going forward. In this year, FY 2026, we'll grow our EBITDA and we'll be breakthrough on cash. We'll generate positive cash flow this year as well and beyond. That's our company. Thank you guys for joining. I'm g
oing to ask Steve Trowbridge, our CFO, to join me and John Young.
Thanks, Jim, for that overview. That's really helpful. I think we'll probably actually start on the guidance from the last slides that you gave, probably more for you, Steve, to kick it off. You know, you provided fiscal year 2026 guidance on the recent fiscal Q4 earnings call, which was revenue in the range of $305 million - $310 million. The high-growth Med Tech business, as we talked about, was projected to be in the range of 12% - 15% year-over-year growth. Med Device is supposed to be flat. You know, can we just walk through how you're expecting each of the three Med Tech franchises to contribute to that 12% - 15% year-over-year growth throughout 2026?
Yeah. In Jim and his presentation, he walked through the products that comprise our Med Tech segment. It's our mechanical thrombectomy business, which is made up of AngioVac, AlphaVac. It's our peripheral arterial disease business, which is the Auryon business, and then NanoKnife. If you look at last year, we were really pleased with the growth that we saw in the Med Tech segment. It was right around 20% for the full year. We exited Q4 even a little bit ahead of that. The Auryon business, the PAD, grew a little bit north of 20% that year. We were really pleased with the performance of that business. We took that business over the last three or four years, went from 0 revenue, and now, as Jim said, to over $50 million in revenue in that business.
We think of that going forward as kind of a mid-teens grower with some potential upside from there. You should think about Auryon as being in the mid-teens. It's the mechanical thrombectomy business that we expect to continue to drive growth probably at the fastest pace in FY 2026. We saw that in FY 2025 too. If you look at AlphaVac, really strong growth in terms of AlphaVac, but it's coming off of low numbers. I expect that growth into 2026 to actually exceed what we saw in 2025. One of the really nice stories for us for 2025 was AngioVac returning to growth. We're really seeing some nice synergistic selling opportunities when you put AngioVac and AlphaVac together in our bag. We expect AngioVac to continue to be a grower as well. It grew over 20% last year. It may not grow at 20% this year.
It's a little bit of a larger number, a higher base. That's going to continue to grow. You're going to see AlphaVac really start to accelerate. At some point, it may not be this year, but it may be relatively soon, you're going to see AlphaVac on an aggregate basis be a larger product line than AngioVac going forward. The third piece of our Med Tech business is NanoKnife. As Jim said, we've got the CPT-1 code that's kicking in in January. We expect to see double-digit growth in probes and maybe with a little bit of an acceleration towards the back half of this year after that code kicks in in January of 2026.
Just to follow up on that one too, any color on capital versus disposables for NanoKnife as you think about that code coming online and more people being attracted to the prostate opportunity?
Definitely more people are being attracted to the prostate opportunity. We're really excited about the enthusiasm that we are seeing in the urology community today. People looking for an alternative treatment, particularly looking for a focal treatment. The flexibility that NanoKnife offers really sets it apart from other focal modalities that are out there. There is no doubt that the enthusiasm is increasing. We expect that to continue throughout this year and into the future. Capital sales, we had said last year that we expected capital to be about half of what it was the year before. We had a pretty big capital year in 2024, and in 2025, capital actually outpaced our expectations. It came in at about maybe a 30% decline as opposed to a 50% decline.
Still don't expect to see a huge uptick in capital this year. There is a little bit of a different dynamic in terms of capital sales when you're talking about the urology community versus when we were primarily focused in pancreas and liver that was in a surgery setting in the hospital. We don't want access to capital to be a governor on the number of urologists that are choosing NanoKnife or starting up a program. We're looking at other placement models. It could be through use agreements. It could be through leases. We want to make sure that we get capital in their hands and drive disposables. Disposables is what's going to be the barometer of the health of that business going forward. We've always, the last three or four years, broken out capital and disposables in terms of how we've reported this business.
I think the thing to do is to look at the disposable sales. Capital is going to be lumpy. It's going to continue to be a little bit lumpy. That growth trajectory of disposables is what we're looking at.
I think actually it might be a good segue to just think about, you know, cash flow. In fiscal year 2026, you know, Q1, you've got a burn of $20 million, but you'll be cash flow generating through the rest of the year. First, I want to ask you, you know, considering these alternate models for capital, is that factored into the cash flow guidance today? Also, you know, can you think you could achieve cash flow break even without having to use the revolver that you have currently?
Yeah, so we do. Our expectations today are to not use the revolver. We put the revolver in place towards the end of last year, more as a sign of just good financial housekeeping. It's always good to have a safety net. We know that the capital markets today are different than they were five, six years ago, right? It was important for us to build that safety net. More importantly, we want to continue to prove that the business is going to generate positive cash going forward. We are guided to a cash utilization of about $20 million for last year, kind of came in at exactly that in 2026. We will be cash flow positive for this full year. We're no different than any other company. Our Q1 is going to have a lot of cash utilization.
That's when incentive compensation, sales compensation, D&O insurance, which is more expensive these days. There are a lot of things that happen in Q1 that then don't repeat as you go through the rest of the year. Look for us to use cash here in Q1. For the balance of the year, the aggregate of Q2, Q3, and Q4, we're going to get back and we'll be positive cash flow. That's dealing with what you talked about in terms of the capital dynamic. That's also dealing with what our expectations are currently in tariffs. We're going to chew through that.
Have your expectations on tariffs moved since the conference call?
Yeah, it's a great question. My answer is yes and no, right? It's yes in that your expectations on tariffs move every day. They probably move five times during the day as you're reading social media or news or whatever it is at that time. In the aggregate, the answer is no, right? I think that what we try to do is we don't want to whipsaw the investor community in terms of how they want to track this every time that it changes based upon some piece of news that comes out. We still feel that around a $5 million number overall is what we can do. We're looking to mitigate that every day. We don't think even with some of the changes that have come out recently, it's going to derail our plans. We're going to be cash flow positive this year.
We're going to continue to see some nice movement in terms of gross margin with or without tariffs.
Awesome. Jim, I want to start on Auryon. Really, you know, great performance this last fiscal year. I wanted to start just talking about, you know, how penetrated are you today in the U.S. opportunity in terms of the OBL, but also the U.S. hospital outpatient? How much do you think the mix will be in terms of OBL to hospital in fiscal year 2026?
Yeah, you know, we launched this product in September of 2020, six months into the pandemic. The office-based lab setting was the most available to us at the time. Most hospitals said, "Hey, guys, stand down." We got a lot of initial penetration growth in OBLs a couple of years ago, and things came more back to normal after COVID. We've started penetrating the hospitals. Our team has done a terrific job. Many doctors who used us in OBLs wanted to bring us in the hospital, knew how safe and effective the product was. Today, John, we think our mix is nearly 40% hospital, 60% OBL. That's terrific for us. We're going to grow the hospital business at a faster rate. It's higher gross margin. It's higher ASP. It's more stable. Going forward, John, we'll probably get to about a 50/50 mix over the next year or two.
That might be sustainable for years to come. We think that's a good mix of keeping the Auryon business there for our U.S. business.
Can you remind us of the premium that you get in the hospital setting compared to OBL?
Nearly double. It's about $3,000 per catheter, whereas it's under $1,500 for OBL. To us, the margin hit, the gross margin hit, stable business, and a lot of upside in the hospital. We're being well received. You saw our business last year grew at a really great rate.
You recently got CE mark for the product and launched internationally. I believe you had about $1 million in OUS revenue last quarter for the product. How should we think of the OUS opportunity for this for Auryon too?
Atherectomy is not used as a PAD treatment at the ratio OUS that it is here. We'll grow. We'll have good growth OUS. I don't think you'll see that great ramp we did in the U.S. over years. We're going to expand atherectomy. We just launched a new study showing, you know, we're sponsoring a study as we speak today, showing that patients who don't have atherectomy as a treatment today should be utilized. We're responsible to randomized controlled trial that just started as we can expand and open up the atherectomy market, we believe globally, which will help expand our TAM here and grow over time.
That's AMBITION BTK, right?
You got it.
What is the timeline you think for enrollment for that study?
We just started enrollment. We think we'll enroll in about two years for the full study. There's a lot of enthusiasm in the space. A lot of doctors really were excited that we had the courage to do this. Doctors had wanted, you know, in our community to do it for a while. We know how good our product is. We weren't afraid of the risk that you take when you do a randomized controlled trial.
I think this is the last one on this one. Just long term, how should we think about this technology in terms of timelines being applied to either DVTs or coronary interventions that you just spoke about earlier?
Yeah, you know, each of these three products in our tech business are platforms. These are really good platforms that have large TAMs. What's unique about Auryon today is treating PAD. I mentioned earlier, coronary is a market we think we're going to be safe and effective in. Finally, John, you know, you and I have talked before, back to VTE, venous thromboembolism for venous disease. We're treating PE today with AlphaVac. We think Auryon could be a DVT treatment option. The way it works, a smaller catheter size can disrupt the clot. We think it'll give us another option to enter a larger market that we're not in today. Auryon has a lot of legs.
I think we'll move to VTE too for the time we have remaining. It's been an interesting dynamic between AlphaVac, which is your newer DVT off-circuit, PE products versus AngioVac. Last quarter, AlphaVac was a bit lighter, I think, than investors had expected. AngioVac had a really fantastic quarter. Can you just talk about what's going on with AlphaVac, the cross-selling, where one is being used versus the other, and really the potential for AlphaVac growth?
Yeah, again, as Steve has said earlier, we think AlphaVac could be our largest product in three or four years. When we started this, our company was an IR-focused company. We sold mostly to interventional radiologists. Two years ago, when we launched AlphaVac and started expanding our sales force, we're now calling on interventional cardiologists who now make up the largest user for AlphaVac. These guys didn't know us two years ago. We didn't know them. We built some new relationships based on the product, on AlphaVac. While we're there, they said, "Wait a minute, you've got this AngioVac product with simultaneous reinfusion. Maybe I could try this in a patient I didn't know I could treat." We're seeing really good cross-selling opportunities. Ultimately, the AlphaVac market is much, much larger. Now we're calling on the ICs and the cardiovascular surgeons that we think will drive AlphaVac sales over time.
We designed the device to be better than a Penumbra. We had to. We're third in. They've got great devices. Ours is better. Pull more clot out, take less time, and less blood is lost. We're the smallest company, but we've got the best product. We'll invest in that going forward.
I think you highlighted you have 50 reps now selling this product. How do you expect that to grow? How do you expect the randomized data we'll be seeing in the space in the fall, essentially, to impact your sales either positively or negatively?
Yeah, I think the data that other folks are collecting will help expand the usage for all of us, help us capture, as I said earlier, less than 20% of PEs today are being treated by a device from one of our three companies. We think that can expand that market. We'll participate in market development with the other two companies. We think that's important. We'll be opportunistic here. Go back to the Auryon thing you mentioned a few minutes ago. We went from $0 revenue less than five years ago. This year we'll do well over $60 million. We showed we can build a startup in this old operating company and grow. We think we can do the same thing with AlphaVac.
We have one minute left. I just want to touch quickly on NanoKnife. There's been a lot of enthusiasm around the PRESERVE data, around the prostate opportunity too. How should we think about once this CPT level 1 code comes online on January 1? I know you guys are not predicting hockey stick growth. How should the street model prostate growth, essentially? How are you thinking about it through the whole fiscal 2026?
Yeah, so 120,000 men in America, 500 men tonight will go home being told by a urologist they have intermediate risk prostate cancer. 500 men tomorrow, 500 yesterday. They're not being treated in a focal manner. They're being either radical prostatectomy, having no side effects, or no treatment. There's a giant spot there for us. We are going to now prove the effectiveness of our device, how safe and effective it is. The PRESERVE study showed it. We are going to capitalize on educating, creating awareness for patients in the urologist community to grow this product for years to come at double digits.
OK. It's really a January 1st inflection.
January 1. We're on label now. We can talk about it, educate, and create awareness. We will have consistent reimbursement kicking in to get the doctors paid. We're really excited about this hospital.