Good morning, everyone. My name is John Young. I'm one of the senior med tech analysts here at Canaccord Genuity. Thank you all for joining us for our forty-fourth Annual Global Growth Conference. I have the pleasure today to introduce AngioDynamics. With us today is CEO Jim Clemmer and CFO Steve Trowbridge. Thanks both. And they'll do a quick presentation, then we'll move to a fireside chat.
Thanks, John, I appreciate it. Thanks to Canaccord for hosting us at a great conference. Let me take a few minutes to talk to you about our company, AngioDynamics. We're a company in transformation. We're really proud of the work we've done to prepare ourselves to change how we do what we do in our marketplace and get ready for stable, consistent growth of our top and our bottom lines. Our company is well-positioned to serve our customers, who serve patients treated with cardiovascular and solid tumor diseases. We think these are two of the fastest-growing opportunities we have globally, as obviously they're leading causes of mortality around the globe, and customers are still searching for better care options in these places. We've done the portfolio work necessary to position ourselves in the right places.
We've done the R&D and clinical work to open up access to these global markets. Now we're prepared to execute with a bunch of catalysts in our near-term, short-term future to grow our company. While you look at our financials, I'll bet we're the only company presenting here at the conference with a June 1 fiscal year start. I'll remind you again, our fiscal year 2024 ended May 31. We presented those results about 3 weeks ago to everybody, and then our Q1 2025 will end at the end of August. Unique fiscal year for our company. What AngioDynamics is involved in now is a transformation from a medical device company to a truly different-differentiated med tech company, driven by categories that we think we can win and compete in over time.
Our transformation is driven by our pursuit of larger, faster-growing markets, where science and technology make a difference. We can treat patients, we can measure their outcomes, and we believe when you prove those outcomes, you can change physician behavior and grow your company. We've done this portfolio work to set ourself up with margins now in the med tech segment that are much higher than our corporate gross average. Our med tech segment will grow at a faster pace than the med device segment over time, and that margin profile will shift our corporate gross margins up over time, leading to cash generation and overall EBITDA generation. And finally, today, we sit here today with a stable balance sheet. We've reported at the end of our Q4 in May over $75 million of cash on hand and zero debt.
We have the foundation that we need, not just to operate our company, but to continue investing in our future going forward. We believe we'll spend about $15 million of operating cash this year, and next year be cash flow and EBITDA positive as we continue to grow in the future. So let's talk about our markets, where we compete. We're in really large TAMs, addressable markets. Well, we aren't always that way. In 2019, we made the decision to pursue larger TAMs. There are ones that had faster-growing growth aspects, also ones where we thought our technologies could play a difference. As you can see by the sheet here, these addressable markets are large today, and they're accessible by the products we have. We're in spots where science and technology do make a difference, and we can drive those outcomes I measured earlier.
Two of the three categories we focus on in our med tech segment are cardiovascular, and one is solid tumor for cancer care. Our other operating segment is our med device segment. I'll share with you at the end. It's actually 60% of our revenue today, provides us with stable cash and EBITDA generation. But let me dive into our med tech products for a few minutes. Our first segment we'll talk about in med tech is treating PAD, peripheral arterial disease. It's a disease state that affects thousands of people globally, and the best way we think to treat it is through atherectomy, opening up the channels that get clogged in patients' arteries by calcium or plaque buildup.
Well, in 2019, we acquired a company called Eximo Medical, which had a really unique science using laser energy, which delivers high pulse waves of energy in the vessel wall, treating the anatomy and not risking vessel wall perforation. So we could break up the plaque or calcium that was limiting blood flow to the peripheral artery. So we entered this market September of 2020. There's four really good companies in this space, but the way that our product works, our Auryon product works, delivering that energy, breaking up that calcium, leaves us options to treat above and below the knee in small vessels, opening up those channels and opening up the full market to our spectrum.
So we've taken share over the past 3.5 years from all four of the large competitors in the space based upon a better device and a really good company who's adapted to how to sell and market in this opportunity. So Auryon atherectomy is part of our future. We grew double digits last year. We'll probably grow double digits for the next few years treating PAD. We also believe this science is a platform, and the way the Auryon system works may spin off opportunities to treat coronary artery disease in the future. We believe the same way we can treat peripheral vessels, it can be a safe and effective treatment in the coronary market, which is much larger than the peripheral market.
We also believe an adaptation of our product may make it successful, as you'll see in a few minutes, to treat DVT, deep vein thrombosis in the venous treatment markets. Auryon's a special product. We've done a great job with the rollout. This product will grow for us substantially around the globe. The final catalyst we have short term is we await CE Mark approval to sell in the major European markets. We expect to have that within the coming weeks or maybe a month or two, opening up that large European market for Auryon. Well, as a cardiovascular company, we think it's important not just to treat arteries, but treat venous disease as well. The main areas we're focused on in venous disease is VTE, venous thromboembolism.
It's much easier to spell VTE than it is venous thromboembolism, which is the combination of DVT and PE, two different disease states with different needs to treat in the venous system. Well, we're really focused on this large, fast-growing market. What you've seen in the last number of years is a shift away from historical lytic-based therapies, meaning blood thinners, being applied as the first-line, frontline tool to treat these disease states. Over time, a couple of other companies and us have developed and proven that an interventional, catheter-based approach towards a safe removal of the clot is more effective at treating the patient, getting them healthier faster, and limiting the follow-up for that patient in the space. We think this is a really large and fast-growing market.
It's probably today only 10%-15% penetrated with catheter-based interventions by ourselves and the other companies in this space. We think there's a lot of room for market development here in the U.S. and globally over the next number of years as we gain more confidence in physicians and hospitals using catheter-based interventions to treat PAD, I'm sorry, to treat VTE. And why are we special? Well, we've got a pretty cool portfolio today of three different products that can treat in this space. And we're most willing to talk about our newest product, our AlphaVac, which we just received CE mark and PE approval earlier this calendar year. We ran a study called APEX, a clinical study designed to show we could be safe and effective in removing PE from the body. We presented those results in May. Results were really impressive.
It followed the same pathway that other companies have followed, and we showed with the clinical data results, we could remove more clot, do it more efficiently, and give physicians more control than they had with other products in the market. That wasn't an accident. We had to design our product to be better. There's a couple of really good products on the market, but we had to innovate in spaces where opportunity was created, and we did so. So our product uses a vortex funnel tip at the end of a large bore 18 French catheter that has steerability and blood-limiting switches inside to limit the ability for the physicians to access the clot, pull it out, and limit any side effects of blood loss. It's a really special product. We went live June 1 with our full market release here in the U.S.
We can't wait to share with you guys how we can grow this business over time and how AlphaVac can now join the other products on the market as a market-leading way to treat PE utilizing a catheter-based interventions. We've also received our CE mark at the same time and are utilizing a global approach towards changing this market as well. The third spot in our med tech portfolio that we're interested in is solid tumor treatment of certain cancers. The market we're primarily focused on is prostate, intermediate-risk prostate. As we all know, the prostate market is large and dynamic, and prostate affects men differently, from very low levels of risk to intermediate risk or high levels of risk, where immediate treatment is probably necessary. A radical prostatectomy is the most common and probably will remain the most common approach for men at that disease state level.
But the intermediate-risk patient, which we believe is about 40% of the patients identified annually with prostate cancer, need an option for a better care treatment. Utilizing our NanoKnife, which we think gives them that option in a focal treatment. What a focal treatment means is we leave the gland intact. We can treat the lesion within the gland and limit the risk of the side effects accommodating most other treatments of incontinence or impotence. So treating it focally also allows the physician to go back and treat later again. You're not damaging the organ or the surrounding tissue. We can do that because of how NanoKnife works. It's a non-thermal ablation tool utilizing electrical pulses of energy delivered by the probes that are placed surrounding the tumor you want to treat.
The doctor can create really a mini energy field around the tumor, which creates nano-sized particles in the cell wall of a tumor, allowing that tumor to die naturally in the body, and it does not affect the other critical structures surrounding the tissue we're treating. It's really an amazing piece of science. We just finished our PRESERVE study one year ago. 122 patients enrolled. We just finished the 12-month patient follow-up 2 weeks ago in July. We look forward now to compiling the data and submitting it to the FDA in September. We expect to get approval and be on label by the end of this calendar year to have a new intermediate-risk prostate cancer treatment tool. Really excited. This is a really large potential market.
It's gonna take a lot of market development on our end to help educate the urologists, the physician community, and the patients who now know there's a new treatment option that will risk those side effects but safely and effectively treat the disease they're affiliated with. You'll hear more about this over time. It's a really large market for us, about $700 million in the US and potentially $2 billion globally that we can access. So those are the three products that make up our med tech markets. Those are much higher gross margin than our corporate average. Again, they're in really large, total addressable markets, and those markets also are growing at fast paces. Our science gives us a chance to win globally in those spots. Those are important. The foundation of our company is our med device portfolio.
Still about 60% of our revenue, it's more historic products. It'll grow 1%-3% annually. We grew 2.4% last year, which is fine. It gives us cash and EBIT to still invest on the other side of the house. Doesn't require a lot of resources or investment on our side. These are good, stable products to provide us with the stable basis of the business to go forward. If you've watched us recently, you've seen we've done some portfolio moves. We divested some of these products, areas we're less concerned in, and we capitalized our balance sheet when we did those divestitures. Today, we're a company still, we don't do one thing, we do a few things. Over time, we're focused on med tech, but med device gives us stability to grow going forward.
So we are a company in transformation, utilizing our R&D process and approach, develop unique special products, utilizing our prowess with data and clinical science generation to open up access to those markets, get reimbursement and access aligned, as we've shown you we can do. And the short-term catalysts we have in front of us are real. We think our data alignment and our science-based approach to these markets make a difference. We're growing our international markets. Our international team actually has sold and grew faster than our U.S. team over the past three years, with a great new leader and a great approach towards reaching those markets. And finally, in January, we announced changing our manufacturing platform and our footprint. Reduce overhead costs that are stranded in a manufacturing process that don't drive value to our customers or to our shareholders.
So we'll take more cost out of our system, you'll see in the next 18-24 months, reducing our overall cost and raising gross margins over time. So this is AngioDynamics, a company in transformation, going from a kind of a, I'll call it, less interesting widget company, to a really interesting science-based technology company that's going to grow double digits for years to come, and having the leverage in our P&L because we've already done a lot of the base investments we needed to do to open up access to these markets. Now we'll see some of those new operating revenues drop through our P&L and give our investors growth at the top end and the bottom end for years to come. So thanks for joining us. I'll welcome Steve Trowbridge, our CFO, to join myself and John Young for questions.
He's on board , yeah.
Thanks, John.
Okay, great. Thanks again for that great overview. It's been really interesting watching this company, you know, transform over the past few years, and with lots of growth drivers, too. It's been interesting to watch. So, maybe we'll start just on the guidance that you recently issued for fiscal year 2025. You're projecting growth of 4.2%-6.2% year-over-year. The components of that were the MedTech business growth of 10%-12%, and then device business growth of 1%-3%. You know, can you talk about maybe the methodology or approach to guidance this year? Because historically, you've struggled to reach some of the guidance numbers.
Mm-hmm.
Do you think these numbers now are achievable? Has there been a shift in mindset as you set numbers for fiscal year 25?
Yeah. Thanks, John. Again, thanks, Canaccord, for inviting us to the growth conference. We're really excited to be here. You know, you talked about the overall company guide and what the growth is, and, you know, kind of mid-single digits. But it's important to get to the components that you talked about-
Mm-hmm
... with double-digit growth in the med tech segment, which is what Jim was focusing on when he was giving his presentation, with 1%-3% in the device business. You know, the other thing to focus on, as Jim talked about, was there's really three main products within that med tech segment. So there's the Auryon PAD, there's mechanical thrombectomy this year, which is going to be driven by growth in AlphaVac, and then NanoKnife. Historically, and certainly in last year, we had really solid growth coming from the Auryon business. It was finished the year at mid-teens growth and about 20% probe growth from NanoKnife. We had a strong capital year as well.
Last year, the thrombectomy business didn't have that same growth profile, which gets a little bit to what you were talking about in terms of, of where the overall results came in. We were really competing in that business kind of with hands tied behind our back. So as Jim mentioned, we got the PE indication at the end of our third quarter last year, as well as the CE mark. We're really excited to see the growth now come from that thrombectomy business and have thrombectomy join the growth that you saw with Auryon and NanoKnife. In terms of your question about, you know, philosophy, look, we always try to be kind of as transparent as we can with, with the guidance.
Thrombectomy didn't hit our expectations last year, but we also didn't have all of the catalysts that you're going to see coming in here in 2025, particularly with that PE indication as well as the CE mark. So we're pretty confident in terms of what we put out there. I think this year, with some of the stock performance, I don't think we're going to get a lot of credit for coming out and extending ourselves, and so we knew that. It's a show-me scenario right now. We're pretty confident with what we put out there in terms of all three of those growth drivers.
When it comes to sources of upside, it sounds like it's going to be thrombectomy for fiscal year 25, but just any other additional color on that as we think about the three businesses and sources of upside to the guidance?
Yeah, so definitely the continued execution on the PE indication-
Mm
... here in the U.S., and then some international sales with the CE mark for thrombectomy. I think PE is really going to be the main story for us going into 25. As Jim mentioned, we're expecting, in the not-too-distant future, to get the CE mark for Auryon. I think that can be a nice facilitator for some of the continued growth that you've seen in Auryon. And then we're excited about getting that prostate indication that we think will come in right around the end of the calendar year for NanoKnife, and to see continued growth in that probe space for NanoKnife. We mentioned on our call that we had a very strong capital year for NanoKnife last year. Capital tends to go in kind of an every other year cycle. It's a little bit more lumpy. It's why we focus everybody on the disposable growth.
We expect that disposable growth to continue, you know, right around that 20%. I don't think we're going to have as strong a capital year this year as last year, so overall NanoKnife growth is going to be impacted by that kind of peaks and valleys with capital. But it's important to get that capital out there. It increases the install base. It's what drives future disposable growth.
... Got it. And then, you know, on the gross margin guidance of 52%-53% for the year, can you just talk about the ongoing shift from Queensbury to Costa Rica, this progress on that shift, the manufacturing, and just how we should think of the gross margin fluctuations that you've guided to essentially through this year?
Yeah. So as Jim mentioned, it's a very important initiative for us to do this manufacturing transfer. You know, the real gross margin story for Angio at a very high level is you're gonna see gross margin accretion coming from this mix shift. As a larger portion of our overall revenue base comes from that higher margin med tech segment, you expect to see some, some gross margin accretion. Now, over the past two years, we've seen that. As Jim mentioned, our med tech business went from $50 million a few years ago to over $100 million now. So we've seen that mix shift. It's been completely consumed by the inflationary environment, as well as the tight labor market.
So it's important for us to, to do this manufacturing transfer to mute the effects of that, to then drive the ability to, to really facilitate and see that gross margin expansion coming from the mix shift. Now, in the next couple of years, you're gonna see a little bit of, of gross margin pressure because we can't quite get all of the costs out of that manufacturing facility until we complete the transfer. We still need some of that overhead.
Mm-hmm.
We still need some of that management structure as we do all the work that's necessary to move manufacturing, the verification, the validation, maybe building up some of that inventory. But once we can complete that, you're gonna see a step function up in gross margin. So for the next year and a half, you know, what we've talked about in terms of that gross margin guide is expect a little bit of a headwind coming from the fact that you've got some of that stranded overhead that we can't quite take out. Once we take that out, you're gonna see the step function up in gross margin.
Got it. And then maybe one last one on the financials and a good segue to talking about the business itself, but I think investors really need to, you know, be reminded of the unique setup you have of the med device business that's really funding the growth that you're investing in, the med tech business. Do you still expect to reach cash flow break-even next fiscal year? I know you've talked about that in the past, and just, you know, when you think of this, the cash flow generation for the med device business, you know, do you expect just to invest in those three pillars of med tech, or do you expect to also look to other growth areas in med tech, too, and maybe do some, you know, more M&A or more portfolio optimization?
I know you've been more in selling mode-
Yeah.
But just thoughts around that.
Yeah, we can both answer it. I think, John, we like the portfolio we have today.
Mm-hmm.
The three platforms I talked about really briefly here are really good platforms in complex markets. I mentioned how Auryon could compete in PAD over time or in DVT. Each of the three platforms we have, have adjacencies similar to that, that we can get into in more detail over time. So we think it's better to invest in our own products with so much opportunity for market expansion opportunities than it is to look for external M&A right now. We're really pleased with our own pipeline and portfolio.
Great.
You talked about the device business providing the cash generation and the earnings foundation to allow us to make the investments into med tech. I think it's important, you know, for, in today's macro environment, for a company like us to have zero debt, to have cash on the balance sheet, enough cash to support the investments that we need to get ourselves to that point where we're cash flow positive in our FY 26. So the device business that we have allows us to do that, and then, you know, we can. From there, you've got the med tech business, which is gonna be growing double digits, as we expect, with a high margin profile, and a company that overall, in the corporate perspective, is generating positive cash and positive EBITDA.
Great. I want to move to the prostate opportunity. You know, you've guided to getting the clearance by year-end calendar 2024. You know, how should we think of the ramp up once you get the clearance in prostate? You know, especially because it seems you've gotten some pull-through already today, because you have the clearance for the-
Right
... the broad clearance for NanoKnife there. So do you expect, you know, a hockey stick kind of a growth profile for prostate once you get this clearance? Or just your thoughts on how you're thinking about it today.
Yeah, I don't think we'll see the big hockey stick after clearance. There's a couple of things that are important for us to clear. First of all, in the last three years, we've seen a lot of organic growth. You've seen our probe growth we've grown over 20% without even the indication yet. There's a lot of interest by urologists in focal treatment, and I think it's getting more and more confidence in our NanoKnife and the results that are happening when they're watching their patients get treated, and the results are really strong. So now getting this clearance indication first, we're gonna now educate. We can finally talk about it. Before we couldn't.
So we can talk to the urology community about why this, this unique treatment method is available, and to men my age, who are gonna deal with this issue at one point, and educate the patients and the doctors as to how they can utilize this new tool to treat people in this area. So a lot of education work, and then we also want to realign the reimbursement to follow the indication. We've done a lot of work on a parallel path. Today, a lot of the procedures that are being done are being fully reimbursed, but it's not fully clear yet, so that may take a little bit more work. Then we'll see, I think, a real hockey stick effect after those two catalysts are met.
That's great. Yeah. And I know you've talked about your option versus radical prostatectomy-
Mm-hmm
... but, I mean, there are other options on the market today.
Mm-hmm.
You know, HIFU, cryoablation, all that, too.
Yeah.
You know, is the data gonna show how you stack up against that, or how are you gonna compete against those products on... for, you know, intermediate treatment?
Yeah, it's a great point. If you look globally, there's physicians globally who've used this product and published a lot of data over the years. So we're highly confident in the data and how it works. So we know the success rate of our product and how it works versus the other ones you mentioned. You know, I can't speak for HIFU and cryo. I don't think they've been widely adopted in the focal treatment market. They've been out for a while. I think they're good treatment tools. We think Nano's better, not just from the patient perspective, but the urology community likes it. It's faster, it's easier to use, they get more patients through, and it fits their profile for operating their business while they're treating patients.
Great. And then I know we have about a minute left. I just want to move to the VTE, thrombectomy market. You have the PE clearance now. You know, what are you seeing in terms of difference, in terms of utilization post-clearance?
Mm-hmm.
And also, can you talk about the sales force, size and structure today, essentially, especially given your competition in that market both have, you know, very large sales force presences?
Yeah. So the number one player in PE has about 300 sales reps. Number two has maybe 150 or 160. We have 40. We think we have the right 40 in the right places right now as we're evolving. We're not afraid to invest. When we built Auryon, it was from 1 sales rep to 40 today. So we'll invest going forward. We love the feedback we're getting. The product is terrific. We had to make it better. The other two companies are really good. The final point I'll leave you with, they love the steerability of our product, how they can access the PAs, the left PA to the right PA. It's a wireless approach, how we designed the product.