Morning, everyone. I get to kick this off. Thank you so much for joining us for the Canaccord's 43rd Annual Global Growth Conference. I'm John Young. I'm a member of the MedTech research team here. I have the pleasure of hosting AngioDynamics for our first chat today. With us today is Jim Clemmer, CEO, and Steve Trowbridge, CFO. The format today is a brief overview presentation. Then will be followed by a fireside chat Q&A session. With that, I'd like to invite Jim to the podium. Thank you.
Great. Good morning. Thanks, John, thanks to Canaccord for inviting us to your conference. Let me tell you about AngioDynamics, but before I do, I'll remind you, check your forward-looking statements. You know that everything I tell you today will be our best projections, our strategies, and what we'll do, but I can't guarantee you everything will happen, so please understand the risks of investing. Let me talk to you about AngioDynamics. Many of you may know us, a company that's been founded in upstate New York 35 years ago to serve the interventional radiology community with vascular access technologies and other things. Today, we're transforming our company. We have a broad portfolio, and we may be hard to understand for some investors. We get that.
We're a complicated company in a complicated industry, but we want to look differently than we have in the past, so we're transforming our company. To the left side of the screen, you'll see things we've done recently to be different. We've changed our portfolio, aligning it more to three areas, three platforms you'll hear about in a few minutes, that are our focus for growth in the future. These are large, total addressable markets. They're areas where technology makes a difference in patient outcomes. We can measure those patient outcomes, and through that, change physician behavior and grow our company. That's our future. To get there, we had to do a few things on the journey. We sold a large business, we bought a small technology startup, we launched some products. We've done all this during the pandemic.
Today, we're sitting here at a company in the middle of this transformation. We moved the ball down the field. We've accomplished a lot of the investments that we've set forth to do. Today, we have products that are in the clinical study process or exiting that process, which open up and expand market access for us. We also have a balance sheet that's very strong. A few months ago, I think one of the pressures from investors in this current market was that we had a tight balance sheet, with some cash on the balance sheet, but some debt. We sold an asset in June, which provided us much cash on the balance sheet and helped us streamline our strategic portfolio goals. Today, we're a company with a strong balance sheet, funding our own investments, and have the capital to go forward.
What you'll see from us in the not-too-distant future is a continuation of our portfolio journey, where portfolio will probably look different in the next two years, more aligned and streamlined to our MedTech focus areas, more aligned to higher growth in larger addressable markets. You'll also see us clearing some of the clinical access hurdles and market access hurdles that exist for all companies like us in MedTech. We'll get the access we need from the regulatory side, we'll align reimbursement, and we think we'll excel with our product launches in the future. There's our company. We're changing and transforming. Tough to do that in a public market during this atmosphere, but we have the courage and the knowledge of our space. We're really excited by how we do it.
Today, our company serves really, disease states, the two primary causes of mortality globally: cardiovascular care and cancer. We have unique, innovative approaches to these two areas. I'll show you more in a minute. You know, this may be the most important slide you'll see from us, and we'll talk about it in a few minutes. This gives you a good one-pager look at our company today. We have a MedTech platform. We run our company in two reportable segments. Our MedTech business is about 30% of our business today, and that's outlined on the screen today. Our Med Device platform is slower growth, more historic products, provides a stable business. This is our future. Today, we're players in the PAD market. We bought an Israeli-based startup three years ago.
We launched the Auryon system in September 2020, and on our May 31 year-end, two months ago, we reported over $41 million of revenue. Zero to $41 million in less than 3 years. Why? We have a special, unique technology, that we're changing how this market can be disrupted and how care is delivered through the energy that Auryon delivers. Well, we also know that it can deliver the same thing in coronary, open up a larger market for us. Today, we're indicated for PAD. We don't yet have our European approval. You see that on the slide. We'll get that this winter. Then we're also embarking on a pathway to open up the coronary market to us. We believe it's safe and effective.
There's a study that'll be published next month in Europe, where a society has used our product to treat coronary arteries and has proven that it's safe and effective. We look forward to reading that report and, and, and showing you more over time. You'll see under this, underneath that, our thrombectomy platform. In two years from today, we'll have a full platform to be a major player in the venous thromboembolism market. Today, we have a couple products. We have a limited market expansion. We have a PE study being enrolled as we speak, looking forward to that indication next summer. Two summers from now, we'll launch an Auryon version for venous thrombectomy, which will give, access to small vessel deep vein thrombosis, that'll give people a choice to use a product with strong aspiration and the energy behind Auryon to disrupt clot.
We think it'll be special. Finally, in the bottom of the screen, you'll see our NanoKnife product, which I'll talk about in a moment. Briefly, I mentioned Auryon PAD. This is an amazing device. The science behind it delivers laser energy in different pulse and wavelengths than other lasers on the market. It's enables us to do in-stent restenosis, clear arteries above the knee and below the knee, hard and soft calcification. Really, no other product in the market can do what we do. It's why we believe we've been invited into a lot of other labs and hospitals the last two years and have taken a lot of market share. We've learned a lot. There's been other scientific publications by physicians who are intrigued by the science.
You'll see a, see a study real soon that's been done that shows that there's a effect in breaking up medial calcification when an Auryon is applied to do a PAD or atherectomy treatment. There's a side effect where we crack medial calcification. We're gonna watch how our, our doctors are studying that and see how it could open up other markets for expansion of this unique technology over time. As I said, we'll give you more details on our pathway to pursue a coronary artery indication for Auryon. Now, thrombectomy or VTE, really exciting large market. As many of you know, there's two really good companies in this space that are kind of out ahead of us a bit, and we're ahead of everybody else. We're third in this market. We have great scientific technology.
We're major players with two products today, our AngioVac on-circuit product, which can deliver the highest pressure for removing clot from a body and still reperfuse the patient's blood back into the body during the procedure, keeping it safe and effective. We launched AlphaVac about a year ago, which is a handheld mechanical version to aspirate clot from the body. AlphaVac is our subject device for our APEX-PE trial to prove that we can be a safe and effective PE treatment. We expect to complete enrollment for that trial this winter and be on label by this time next year with a PE indication. Really exciting. Finally, the Auryon version for venous thrombectomy launched about a year later in summer of 2025, giving us a really great portfolio, able to treat small vessels, large vessels, DVT, and PE.
We think we'll have a unique product, and we'll work with the other two companies in this space to help move care from lytic-based frontline care delivery to catheter-based or mechanical interventions. There's a lot of market to develop here by us and the other companies in the space. We think we'll be a major player for years to come. Finally, the third piece of our Med Tech platform is really unique and special. It's our NanoKnife, a non-thermal ablation tool. What NanoKnife does, it creates energy using electricity and delivers that energy through probes that we can place around a tumor that needs to be treated. What we found is the highest opportunity for us to turn this unique science into a product and a successful business is for men with intermediate-risk prostate cancer.
Nearly 300,000 men in the U.S. are diagnosed annually with prostate cancer, about 40% of them are diagnosed in what's called intermediate risk, Gleason 3+4 or 4+3, if you're a urologist. These men today fall between the watchful waiting cycle with, "Go home, you're fine, we'll watch you," or the need for a radical prostatectomy. Many have been over-radicalized over the years, nobody wants the side effects of radical prostatectomy, which happen many times with incontinence or impotence. Well, the way that NanoKnife delivers energy to the tumor, protecting the surrounding tissue and vascular structure, we disrupt the cell by creating nano-sized particles in the cell wall, allowing the cell to die naturally.
It can be an effective focal treatment, treating the gland, not removing the gland, and enabling the patient to go home the same day, play golf or go fishing the next day, be healthy and well. Also, from a urology perspective, they can do this treatment in 40 minutes or less. They're highly skilled with the brachytherapy grid. We have great imaging technology today, and it's really easy to use. We've just completed enrollment and treatment in our PRESERVE study. We have a 12-month follow-up in PRESERVE, and by this time next year, we expect to be submitting our data to the FDA and looking to gain an indication by the end of next calendar year. What's exciting about this, NanoKnife's been around for a while. We have great opportunity now to expand the business and market access. This slide has 2 different clips.
The top is a press release we put out 1 week ago when we completed enrollment in PRESERVE here in the U.S. Really exciting, fully enrolled study. The bottom, I woke up on Sunday and saw that in the U.K., the Daily Mail in the U.K. put out a really great story on NanoKnife. As just 1 month earlier, NICE advised the NHS, as you know, in the U.K., their National Health Service, they moved NanoKnife up from investigative to the second level. More men have access to treatment now within the NHS system. More men in the, in the U.K. will now have access to utilize NanoKnife to treat intermediate-risk prostate cancer. Gaining access to markets can be difficult in this space, but we're opening up access as we speak.
We will be a company combined with great technologies and market access gains along the way. We've also made sure we're not a U.S.-focused company, as we've been in the past. We have a great international leader we brought in two years ago. She's established a great strategy to work with some really special distributor partners that enable us to have clinical and scientific support, as well as selling our products overseas. You'll see our U.S. or sorry, our international growth exceed our U.S. growth for the next three to five years. A company with balanced growth along the way. We do have a unique fiscal year. Our FY 2024 just started on June 1, and we gave guidance in the middle of July. Last month, we gave our year-end earnings report and gave guidance for this year.
Got about a $306 million base of business, as we did do a asset deal on June 8th, 8 days into our current fiscal year. You look at a $306 base for revenue. We've guided in this range during the course of the year. We would've had a - $0.43 base again on the EPS line. This shows accretion in EPS during the course of this year, revenue growth during the course of this year, and again, we have a well-capitalized balance sheet. We only expect to utilize between $5 million and $10 million of cash during the fiscal year. Enables us to fully fund our investments, keep our growth trajectories going forward, and change the direction of our company. I believe there's a disconnect today between our current valuation and the real value of our company.
It's our job to unlock that. I say that to you, two years ago, we did an Investor Technology Day in July of 2021, and while we were presenting that Investor & Technology D ay, our stock at $32, the highest in its history. Today, it's much under that. We're a better company today. Things I told everyone we would do two years ago, we've done a lot of those. We've improved the company, opening up the market access, launched new products, and got us closer to a high-growth company over time. Take a look at that. We're a really great company. We'll do our best to deliver value to our patients that we serve and the shareholders that support us. John, thank you for the time today. We look forward to questions. Thanks.
All right, is this on? Okay, great. Thanks. Thanks again for that great overview of the company. I think it'd be great to actually start off on guidance.
Sure.
everyone's favorite question, as you just talked about, you provided 2024 guidance on the earnings call, which was revenue of $328 million-$333 million, which on a pro forma basis, is 7.1%-8.7% year-over-year growth. Diving deeper into that, the high-growth Med Tech business was projected to be in the range of 20%-25% year-over-year, where the Med Device business growth was projected to be 1%-3%.
First on that, that Med Tech business, you know, the revenue guidance came in below which we originally had modeled for 2024. This is after the business itself had struggled to meet investor expectations in 2023 across the three product categories. Could you talk about the individual components in the setup for 2024? Why has growth been slower this past year? What's baked into the current expectations? What are you currently seeing in the field?
Steve?
Yeah, it's a, it's a good question. I think, you know, you talk about the Med Tech segment. We said we're, we're guiding 20%-25% for that segment, combined over the course of this year. I agree with you. I think last year there were elements of that segment that didn't really perform according to our expectations and certainly according to some of the external expectations. Primarily, that was in our thrombectomy business. That's where Jim talked about our AngioVac and our AlphaVac, product lines. You know, we talked about that, that there was two, two main things that were driving that. We think there were some external market realities.
We've talked about AngioVac as being one of those products that is going to be the most susceptible to some of the hospital staffing challenges, given the complexity of having to set up the circuit, bring in perfusionists. Then there was some execution, you know, and we talked about that, and we've had some staff changes, we've had some, some reorganization that we've done in that business. We still feel very bullish about that business. We think that we are in a very good position with unique product offerings, to be a significant player in that thrombectomy business. You know, one of the things that I think it's important to reiterate is, is where we are in the life cycle of our product offerings, getting into that market. Very attractive market. There's some really good companies that are out there, too.
Inari, Penumbra, you know, they've been really setting the market and showing that you can move patients that maybe used to be managed medically into being patients that are going to have these interventions. That's why we're really excited about our product offerings, starting with AngioVac, that can do something that no other product can do with a simultaneous reinfusion, limiting blood loss. That's got a role to play. AlphaVac, and that's, you know, one of the things that we did with AlphaVac was take the benefits of AngioVac, the catheter, take it off circuit, put it on a handheld. As Jim mentioned, for PRESERVE, for NanoKnife, you know, we just completed enrollment in the PRESERVE study. We're also running a study in AlphaVac, and that's our APEX study for pulmonary embolism.
We don't have a pulmonary embolism indication. The other companies that we're going after do have that indication, but we're really pleased with the pace of enrollment that we're seeing in our APEX study. We're more than halfway enrolled. We expect to finish enrollment, in, you know, by the end of the calendar year, and then there's a, you know, just a 30-day follow-up, so that may actually start to outpace PRESERVE. Once we get the indication, you know, we've only launched the first generation of our AlphaVac. Although, you know, we're going into a big market, it didn't perform according to our, our internal expectations, but that doesn't change how we think about this business going forward. We think there's a lot of great opportunities to really drive continued growth there.
If you talk again, about the guidance for Med Tech, I think this year you're going to see a turnaround. We, we talked about AngioVac, kind of leveling out, and we expect to see sequential growth going forward. I think we'll see that. Auryon, I expect that that's going to continue to grow ahead of that 20%-25% segment growth rate. Thrombectomy will probably be the one that's going to be a little bit below that as we continue this turnaround. As Jim talked about, NanoKnife, we've been really pleased with what we've seen with the NanoKnife probe growth over the last two years, more than 25%.
As we continue to, to execute on the, on the, the prostate initiative, you're going to see, you know, kind of above that [20%-25%] growth there for NanoKnife too. You put all those together, you get to that 20%, 25%. You know, I think the, the execution piece, we're going to continue to focus on thrombectomy, but we're in, we're in great markets with really unique products.
Okay, great. Okay, great, and then, moving to the Med Device business, you know, can you speak about what you're seeing today in the field from that? In particular, what are your thoughts on the current backlog? I know it was standing at $2.7 million at the end of, FT 4, and just, you know, the impact of that, that backlog going forward, too, and just how that impacts growth.
Yeah, you know, the backlogs hit us during the pandemic. We were challenged not just with inflationary cost pressures, but also labor and other pressures in our supply chain. Getting sub components and raw materials caused some of our challenges in our supply chain and our backlog. What you saw, we opened up a new facility in Costa Rica during this period. We've, we've leveraged our supply chain base. We're not just, you know, situated in upstate New York and using third-party suppliers. We have a new factory in Costa Rica, balancing that effect. We're getting through that. We're almost done, but it's affected more of our medical device, our historic products.
They require higher levels of assembly, hand assembly, and over time, as we shift our portfolio thinking, you'll see a company tomorrow, the new AngioDynamics and Med Tech focus, have less of an issue with supply chain-related projects. We learned that during the pandemic.
Great. I think let's move to the, another important topic, which was the recent divestiture. You know, it happened early in the fiscal year. You divested both the dialysis and the BioSentry product lines, the Merit Medical, for $100 million in cash. The sale helped you pay off your debt and firmed the balance sheet footing. Can we just talk about operating leverage first? How should investors think of the direct versus indirect costs to the sold businesses, timing of when you might rightsize the cost in each of those businesses, if at all, and also what key variables to be making in those decisions in terms of the future divestments or more?
I'll start, and Steve will finish the question. It's strategic first. As I mentioned earlier, we have a portfolio journey at AngioDynamics. I opened the conversation with, we're gonna be a Med Tech-focused company. Our Med Device assets over time will be a smaller part of our company, and we're less interested in competing in lower growth, slower markets with more large historic competitors. Strategically, this made sense for us to streamline our portfolio, getting it closer to what we'll see as our ideal state. You'll probably see us two years from now being closer to that ideal state. Steve, financially?
Yeah, I think this starting with strategy is exactly right. This was an opportunistic opportunity for us. It was, as you, as you had mentioned, it was an opportunity for us to get $100 million in cash, recapitalize the balance sheet, pay off the debt, kind of take away what I think had been an, a financing overhang that had been on the stock for a while. As we mentioned at the time that we announced the divestiture, there really weren't a lot of direct costs that went with this business, so it was sold within our Med Device business. They were part of a shared bag for the sales force. The strategy trumped the, the, the financial point for the bottom line at, at that point.
It was important for us to recapitalize the balance sheet, there isn't a lot of direct costs. You know, as we mentioned on our earnings call, you know, kind of the next step in our transformation is going to be to really go after gross margin, that operating footprint, and rightsize the operating structure, as you had mentioned. You know, Jim talked about the transformation where we were before we started this process. You know, we sold what was our largest business, was also our lowest gross margin business at the time. We brought in what became the Eximo business. We've now recapitalized the balance sheet. We've got three great platforms in our Med Tech business. In 2020, that was less than 17% of our overall revenue. It's now 33% of our total revenue base. You've seen that transformation.
The next step is to really go after that operating footprint and drive the corporate gross margin profile.
Just to follow up on that too, can you just talk about your thoughts on striking the balance between leveraging the cash flow provided by their remaining business versus the potential future divestitures of it, just, and thoughts surrounding that?
Yeah, it's a great question. As Jim has said, we're going to be active portfolio managers, and we've been very clear that the future of AngioDynamics is gonna be the growth provided by that MedT ech segment. The Med Device segment, we've got really good products in there. We're in good markets, but they're very different markets than the ones that we're seeing in the Med Tech segment. Lower growth, a bit more mature. A lot of times you're going up against scale players, not really where we want to be competing. We've said that, you know, that business can provide the cash generation for us as we continue to own it, and we can earn rents off that business. We're also gonna be opportunistic, and if we can take an opportunity to maybe monetize those assets, we're gonna look at that too.
I think the balance that you talked about is exactly what we're looking at every day. You know, if we were to do another step transaction, that one would have a lot more of a operating direct cost impact than the one that we just did.
Got it. Then I know you've guided to a cash flow break even by the end of fiscal year 2025. Does that guidance contemplate the Med Device business remaining the same size as it is today?
Yeah, exactly. Well, remaining the same size in the same profile that we talk about.
Yeah.
It's about a 1%-2% grower.
Yeah.
We think that that's gonna be consistent throughout that time frame.
Okay, great. Let's move to the Med Tech business, which is really exciting. You know, have a lot of high growth, and it's becoming a much more important part of the business. Maybe start on Auryon, which is for atherectomy, which in our view, has been the best performance to date of the three. First, can you talk about the capital environment you see today, especially as you begin to focus on hospital outpatient sales versus the Office-Based Labs? How penetrated are you today in U.S. OBLs and in, in hospital outpatient, would you estimate?
It's a great question, John. We launched this product again in September of 2020, when the market had changed and hospital access was limited. The OBLs were our first target customers, and there's a high degree of interest in the product and how the laser performed, how it did safe and effective atherectomy treatment. Probably had 90% of our share in the initial sales in the OBLs. We just finished our, our FY 2024, sorry, FY 2023, with a 75%, 25% split. 25% now in hospital, that's growing. You should see that split be over 30% by the end of this fiscal year. Two main reasons that's important for us is getting sometimes more stable customers in the hospital. We also want to place-- we've placed over 400 of our, our Auryon lasers in the field.
We want to get more of those placed at hospital markets, as I mentioned to you earlier. Our portfolio journey goals are to launch a coronary atherectomy version for Auryon and the venous thrombectomy version. We'd love to have more of the lasers ready to go, placed in the hospitals, in the cath labs. They can be accessed by different physician specialties to treat different treatments for patients. Really, the method to our madness is to kind of shift that and get those lasers more aligned to hospitals.
Got it. You spoke a lot about international expansion. You're targeting a CE mark in the first half of fiscal 2024. How should we think about this, the OUS opportunity when it comes to Auryon? Also in terms of distribution strategy and commercial ramp, would you sell through distributors? What reimbursement exists OUS today in terms of like countries you would initially target?
It's a good series of questions. We have a great distributor partnership we've aligned. Our, our leader in Europe has aligned ourselves with three great partners and a couple more to come, that do more than just sell and service our products. They give us that clinical support and education at the customer level. Some great, great partners we have. That's important. We look forward to getting the CE mark approval later this calendar year. We're doing the pre-work now. We're educating their clinical support teams, educating our teams, providing people with the knowledge they'll need to go support our customers, and our growth we'll see start next calendar year. We have target markets based upon reimbursement, as you said. We'll give more clarity there soon when we get the CE mark and approval.
Great. I know we have just a few seconds left-
Yeah
I'm gonna sneak one more in here, but just the regulatory process related to the expansion to coronary. I think investors are probably very interested in that, given all the, the, the high growth in coronary. What do you expect the best use case to be there, and how do you think you can compete against the existing technologies already on the market there today?
Yeah, good question. You know, we, we know the product is safe and effective, already to be used there, and you'll see a study next month published that's been done in Europe. We look forward to seeing those results to show it's safe and effective. The FARO study we publish next month, and then we'll follow a pathway that exists today. There's a great pathway already outlined that the FDA has. We're gonna sit down and talk to the FDA about the pathway and timing that you should expect, but we look forward to sharing more details with you soon.
Great. Thank you so much for joining us today, Jim and Steve, and thanks to the investors for joining.
Thank you. Thanks, John.