Good morning, and welcome to the AngioDynamics Fiscal Year 2023 Third Quarter Earnings Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference call is being recorded. The news release detailing our fiscal 2023 third quarter results crossed the wire earlier this morning and is available on the company's website. This conference call is also being broadcast live over the Internet at the Investors section of the company's website at www.angiodynamics.com, and the webcast replay of the call will be available at the same site approximately 1 hour after the end of today's call. Before we begin, I would like to caution listeners that during the course of this conference call, the company will make projections or forward-looking statements regarding future events, including statements about expected revenue, adjusted earnings and gross margins for fiscal year 2023 as well as trends that may continue. Management encourages you to review the company's past and future filings with the SEC, including, without limitation, the company's Forms 10-Q and 10-K, which identify specific factors that may cause the actual results or events to differ materially from those described in the forward-looking statements. The company will also discuss certain non-GAAP financial measures during this call. Management uses these measures to establish operational goals and review operational performance and believes that these measures may assist investors in analyzing the underlying trends in the company's business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for, or as superior to financial reporting measures prepared in accordance with GAAP. A slide package offering insight into the company's financial results is also available on the Investors section of the company's website under Events and Presentations. The presentation should be read in conjunction with the press release discussed in the company's operating results and financial performance during this morning's conference call. I'd now like to turn the call over to Jim Clemmer, AngioDynamics' President and Chief Executive Officer. Mr. Clemmer?

Thank you, Darryl. Good morning, everyone, and thank you for joining us for AngioDynamics' fiscal 2023 third quarter earnings call. Joining me on today's call is Steve Trowbridge, AngioDynamics' Executive Vice President and Chief Financial Officer, who will provide a detailed analysis of our third quarter financial performance. Turning to our results. We ended the quarter with revenue of $80.7 million, representing growth of 9% year-over-year, led by growth of about 17% from our Med Tech segment over the third quarter of last year. We continue to make progress towards our strategic goals during the quarter, including solid growth from our Thrombectomy and NanoKnife platforms as well as our recently launched AlphaVac system. Year-to-date, our net sales have grown 8%, with our Med Tech segment growing 25% and our Med Device segment growing 2.5%. We are now 21 months into our 36-month plan that we launched in July of '21, and we are progressing at or ahead of our revenue targets. Our Med Tech segment drove growth in the quarter, led by Auryon, AlphaVac and NanoKnife. AngioVac was a soft spot in the quarter, offsetting the strength we saw in the rest of the Med Tech portfolio. Auryon continued its impressive performance in the quarter, growing approximately 43% over the prior year and increasing sequentially over Q2. To date, we have treated more than 35,000 patients since launch, and we remain on track to achieve our full year target for Auryon. Our mechanical thrombectomy business comprising AngioVac and AlphaVac increased 4.5% during the quarter. AlphaVac revenue for the quarter was $2 million. Our launch is progressing according to plan, and we remain on track to meet our AlphaVac revenue expectations for the full year. With that being said, our mechanical thrombectomy business growth fell short of our expectations during the…

Thanks, Jim. Good morning, everyone. Before I begin, I'd like to direct everyone to the presentation on our Investor Relations website summarizing the key items from our quarterly results. And while we had a softer quarter than we would have liked, there were a number of strong points during the quarter. Revenue in the quarter increased 9.1% year-over-year to $80.7 million, driven by growth in Auryon and NanoKnife as well as a strong performance from our Med Device business. Med Tech revenue was $22.9 million, a 16.6% year-over-year increase, while Med Device revenue was $57.8 million, an increase of 6.4% year-over-year. For the quarter, our Med Tech segment comprised 28% of our total revenue compared to 27% of total revenue a year ago. Year-to-date, FY '23 revenue increased 8.1% year-over-year, driven by Med Tech segment revenue growth of 25.1% and Med Device segment growth of 2.5%. Our Auryon platform contributed $10.4 million in revenue during the third quarter, a 42.8% increase compared to last year. We continue to be pleased with the growth of the platform and remain confident in our ability to achieve full year Auryon revenue in the range of $40 million to $45 million. As we head into fiscal 2024 and beyond, there are a number of positive indicators supporting the continued performance of this business. First, we're seeing an accelerated shift towards hospitals from OBLs. Second, we're seeing consistent strength in below-the-knee procedures, which are now outpacing above the knee procedures for Auryon. Third, we have completed supply chain enhancements for our disposables, which will drive improved margins over time And finally, we expect regulatory clearance to enter international markets during our fiscal 2024. Mechanical thrombectomy revenue, which includes AngioVac and AlphaVac sales, increased 4.5% over the third quarter of FY '22. AlphaVac revenue for the…

Thanks, Steve. In closing, I'd like to say, while I'm pleased with many of the things that we're doing in AngioDynamics and our progress that we're making to becoming a long-term, high-growth profitable company, we have also identified and put plans in place for areas that we can do better. So our focus will turn to those areas. We want to bring value to our customers, our employees and our investors. We know that we have a great plan. We'll work hard to do that for each of those three constituencies over time. Thank you for listening today. Darryl, I'll turn the call back to you.

[Operator Instructions] Our first questions come from the line of Matthew Mishan with KeyBanc Capital Markets. Please proceed with your questions.

This is Brett Fishbin on today for Matt. Just wanted to start off a little bit on some of the broader macro trends. Just given a lot of the moving pieces discussed today like staffing constraints and then inflation, supply chain and free costs, have kind of been themes for several quarters, just wondering a little bit like what changed incrementally versus January around some of those dynamics and how you're looking at them moving forward?

Brett, it's Jim. So a couple of things. We actually think that the macro environment from our customer angle, from the hospital side is getting better. We think that their staffing challenges are getting better. It's regional in approach when we speak to our customers. We think it's in a better spot than it was 3 or 6 months ago. So we've seen some of the dynamics from that. The AngioVac challenge we mentioned, again, part of that is due to that, but we don't want to put all the attention there. We also know we can do better, and we will and how we execute there. Also, Brett, we talked about it, we have more stabilization in our internal supply chain from the employee side. And we've seen freight costs abate a bit, which is terrific. But we're still seeing some disruptions from our supply chain partners. Sometimes we're not getting all the parts we order, the raw materials we order. And we're also seeing still inflation hit there. So things are better, but they're still not back to what we call normal.

And then just shifting over a bit to Mechanical Thrombectomy. Just wondering if you could also expand a bit on some of the new selling processes. You mentioned for AngioVac. And would it be challenging to do some of this in the current environment, given like all the staffing that's involved in the procedure, which is limiting current procedural dynamics? And then also just how are you thinking about AngioVac from here? Could we see some sequential growth into 4Q and early thoughts on maybe FY '24 as well?

Sure. Good questions. So a couple of things. So we've taken a look at how we've integrated the sales bag going back to last June 1, our fiscal year, putting the new AlphaVac products in the bag with AngioVac. Remember, we're also running our APEX study aligned with this because we'd love to get that PE indication for AlphaVac F18. But we're being very cautious as we enter this market. We're learning from our customers, learning how great our devices are, but also how to sell them combined in a bag. And again, we only have limited indications at this point. We don't have the full bag we'd like to have as we've identified, Brett. Over time, we're looking to launch our Auryon for thrombectomy for small vessel over time. So we're in the kind of the middle innings of our whole mechanical thrombectomy program. What we can do better is our internal messaging to our customers, making sure we're clearly identifying what we do and what we don't do and how we can do that better. We also believe we can train our own people and our customers better. We have a great team of clinical resources in the field to work with our customers. We'll make sure that we can get our sales force and our customers trained properly. And we'll watch AlphaVac and AngioVac together grow sequentially. We're actually off to a good start this quarter. So it's a good sign that our -- we think program we put in place is working as we're seeing already a positive sign and the uptick back to where we expect performance to be as we look at the current quarter we sit in today.

And then last question from me. Just you mentioned some possible international approvals in the coming quarters for Auryon and AlphaVac. Are there any particular markets that you think investors should be focusing on as bigger opportunities or ones that could come earlier in the time line?

Thanks, Brett. Good questions. We actually think we have a great team now in Western Europe. And today, we're actually holding right as we speak in Rome. Our third scientific clinical symposium that AngioDynamics is hosting with over 200 world-renowned key opinion leaders and clinicians and professors who are attending our symposium today to be trained in our products and speak to some of the outcomes that they've foreseen when they use our products. So we're going to focus on our Western European growth first. where we have a lot of opportunity for these products that are unique and there's a lot of need that we're going to align to. So we'll see, Brett, indications next calendar year, starting with Auryon, then AlphaVac as the first two products will get launched, which are important because we think they can be global growth drivers for a company for years to come. We'll also then make sure we have the right indications in Canada, in Latin America, in Asia-Pacific and the Middle East as well.

Our next questions come to the line of Steven Lichtman with Oppenheimer.

I wanted to ask a little bit about NanoKnife. We've had strong disposable sales profile and effect from the ongoing studies How much of a runway do you guys see for that continuing after trial enrollment complete and before you get indication expansion

So good question. So if you look back at last fiscal year, we guided about 20% disposable growth and we overachieved that. This year, again, we guided about 20% disposable growth and we're overachieving that as well. So we think it's due to -- some of it is the halo effect from the DIRECT study on the pancreatic cancer patients and now are PRESERVE. People are just getting more awareness about how NanoKnife works, why it's so special and can treat very delicate organs in a unique manner. So I think that when there's more awareness generated, I think there's more interest generated, we're seeing more inbound interest from physicians, and we're able to train them properly, let them choose how they want to treat and where they treat while we're committed to getting the data published to prove these sources can be areas. We also know, as we identified, when we complete enrollment and complete the final study 12 months later on preserve, we believe that we'll open up about a $700 million market in the U.S. for those intermediate risk patients, give them a chance for a good focal treatment. So it's going to be a combination of a few factors. We think we'll continue to grow the business at about this rate up until we get that indication end of next year, and we'll give you more guidance there is what we can do. We're trying to align the indication of regulatory approvals with reimbursement and then patient and customer awareness. And when we do those together, we really think we have a special product that can grow in this market.

And then my other question was about Auryon. You guys have said that you got feedback from docs that they want it and you're pressuring that opportunity. But this is pretty new in the field. Can you let us know a little bit about how that development process is unfolding? Have you wished to point where you can say this receivable and definitely going to be followed through?

Yes. So let me take a swing at it. If I get your question wrong, please stop me or chime in again. So we're hearing a lot of great feedback. Again, we launched Auryon in September of 2020 when the pandemic hit, and we are rolling out this product. And there's good competitors in the field, They're effective systems out there. But we knew our is different. And the physician feedback we received from that date has been really tremendous. So we also told our physicians, this is a platform technology. We're going to grow what we do first in PAD and atherectomy. And we've done that already with the hydrophilic coating catheters we launched this year. Later this calendar year, we're looking to launch radio products, give our physicians a new access point, a new way to use our atherectomy tools, a new way to use Auryon in the anatomy. So we'll continue to develop not just the products but we're also working with the science behind it. You've seen and we'll see during the course of this year more publications driven by some of our physicians who believe in the science and have seen unique elements of how it treats the anatomy. We're also committed, as you know, we believe that Auryon will complement a mechanical thrombectomy platform with an Auryon version, a mechanical thrombectomy, coming to the end of calendar year 2024 for small vessel DVT, utilizing the power and energy that Auryon delivers and the safety efficacy within the vessel wall in a manner that we believe will give physicians a new way to treat thrombectomy.

Our next questions come from the line of Jayson Bedford with Raymond James. Please proceed with your question.

I guess just a few questions. Maybe to start on gross margin. I understand some of the headwinds, but I'm a bit surprised at the acute nature of some of the inflationary dynamics, meaning Med Device gross margin kind of down quarter-on-quarter, down year-over-year. Is there anything what was new that popped up more on the Med Device gross margin side in the quarter?

Jayson, this is Steve. Jim had mentioned in his prepared remarks, some of the disruption that we're seeing from some of our supply chain partners and our component suppliers. That has been part of it. As we mentioned, there's about $1.5 million of components that we were expecting to get in that would have allowed us to get about $3 million of revenue out in the quarter. They were scheduled to be earlier in the quarter. We were told that they were going to be pushed out. We do expect those to come into Q4. So some of that was tied up in terms of the WIP and coming from the supply chain disruption. And the other piece really is the raw material inflation. As we've talked about, specifically in the device business, we've got a large number of SKUs in that business all throughout the different products that are there. And we're just not the largest purchaser for most of our suppliers. And so as the macro environment continues, we're finding that we're a little bit in the middle of the line there, not enough to really drive extensive volume benefits. We're not at the end of the line, but at the same time, dealing with some of those price increases, which we found to be stickier this year than we were expecting in the summer and will probably extend a little bit into the next year as well. And we're going to -- we expect that's going to happen as we build into the thinking about the next year. So those raw material components have driven a big part of that as well as just some of the timing and mix of turning product into finished goods and getting them out the door.

And the $3 million that was lost here or pushed out here loss is probably not the right word, but the $3 million that you mentioned, that will all benefit the fourth quarter. Is that the expectation?

We definitely expected to clear the fourth quarter. Now there may be -- we don't expect it to be at that same level. But as we said, it's not like the component supplier issues are going to completely vanish. We're going to be dealing with component supplier issues for a while. And our team is managing that on a day-to-day basis. But yes, we do expect those to clear into the fourth quarter.

And just on the backlog, I think you talked about a little over $5 million in total. Is the math here into it with a reduction of $3 million from the last quarter, but you added another $3 million. Is that kind of the math on it?

The timing that you're talking about is the right way to think of it. So if you think about where the back order stood at the end of the quarter, although the numbers were relatively consistent from the end of Q2 to Q3, the mix of that was very different. And so the way you described it is exactly right. We were eating into it clearing it kind of at the same pace that we had been over the past few quarters. And then some of the timing on the component supply means that you end up with a different mix at the end of the quarter.

Maybe just switching gears to the other dynamic here in the quarter. AngioVac I guess, the question for me is, do you have fewer users in the technology? Or do you have the same number of users just using it for fewer cases? If that question makes sense.

It does make sense, it's Jim. A little bit of -- it's a mix of everything. So we're always gaining new users. And sometimes you lose users, too. So it's just kind of a mix that happens all the time. The product is so unique and special that we're always getting new interest in new users. And sometimes we've been under challenged to continue that usage to make sure that the physicians trained and can use it. With other things happening, -- there's also a gray area between where AngioVac works, our AlphaVac can work or other competitive products can work. So as we're learning that and getting our customers better aligned to the change in market is better trained, we'll see a little of choppiness there. We've learned a lot had a master class 2 weeks ago, where I sat in again over a weekend with some of new users. And right afterwards, a couple of users use it the first week right after the master training class. So we know that people see the value of it, how easy it is to use, although it's complex from user standpoint the benefits it drives and patient outcomes are dynamic. So Jayson, it's choppy. Yes, there's always some accounts leaving, some accounts are coming in. I'm trying to give you a straight answer, but it's a moving target.

And I don't think I heard you mention left heart and where you are with AngioVac or time line regulatory process?

Yes. We're really excited by what we believe AngioVac can do in the left heart, the size of the market, we believe how we can treat. What we've gotten from the FDA is different guidance than they gave us initially. They've kind of rethought the approach that they want us to take and have given us different guidance. So it's changing our approach towards it. So we have to look at the time line again and how that will affect the new level of really they've raised the bar and what they want what they initially communicated with us. So we've got to come back to Jayson and communicate to you what that means from a time line perspective because it will push our time line out. What they've asked us for is a little more comprehensive than the initial request was.

Our next questions come from the line of Bill Plovanic with Canaccord. Please proceed with your questions.

My first question is, as we look at guidance for the year, that will be a pretty big jump in the fourth quarter. I was just -- help us just to get to the low end. So help us understand what you're contemplating in terms of getting to the low end, meeting the low end or even getting to the high end of that updated guidance.

Yes, Bill, it's a good question. I mean, part of the things I understand is structurally the fourth quarter has about 4 more selling days in it than the third quarter. So -- and it doesn't have the same holiday cadence that the Q3 had. So we typically see a big jump going into the Q4 from Q3 every year given our typical seasonality. So I think that's the first part of it. Second part is if you look at some of the products like Auryon and NanoKnife that are on their growth trajectory, we're very excited and they're going to continue their sequential growth, which is going to add to that increased selling days. We do expect we're going to see a pickup in AngioVac, as Jim mentioned. And we have seen that here in the first month of March so far. We've been very pleased with the pace that we've seen at AngioVac coming from some of those changes that Jim had mentioned. And then when you build into that some of the dynamics that we were talking about with Jayson on the previous call around the back order, getting some of those components in and clearing that, all those dynamics together give us confidence, certainly to what you were asking to is the bottom end of the range. But we're -- as you can imagine, we put the range out there, and we're looking at that range and targeting midpoint.

And then from a cash flow standpoint, I think -- and correct me if I'm wrong, originally, you were targeting that you would end the year being cash flow neutral for the year. Given where you sit today, kind of how do you feel about that? Do you still think that's the case?

Look, we're still striving for that. I think given the revenue change that we talked about here, if you look at the kind of midpoint to midpoint from our original guidance to where we're going, we do think that we may be maybe $5 million or so off of that, but we're still going to continue to strive for it. We do expect we're going to see significant cash generation and we'll continue to push towards that.

And then just with the AlphaVac and AngioVac, I mean as you look at the AlphaVac growth and the kind of decrease in the AngioVac, do you think this is just cannibalization of the same doctors and customers? Or is AlphaVac really drawing in a new customer and you're just kind of with the AngioVac just going down and kind of losing some of that share?

So Bill, a little bit of both. Back when we launched the AlphaVac last summer, we tracked every procedure we've done, tracked who did the procedure which specialty, which physician had performed the procedure and what they would have used as an alternative. And early on, we saw some of that cannibalization. Now that was also when last summer and last fall, there was a little pressure in the hospitals as far as employee staffing and some challenges there. Lately, we've seen that shift change, and we're finding less and less. We knew there'd be some cannibalization. It's gotten a lot less so we're finding -- we're replacing a potential other products or other technology or other treatment protocol than we were 6 or 9 months ago. So we like the way that shift is occurring. It has been a challenge for us during this year, and it will always remain there. But we think the shift is working well as we educate our teams and our customers as to when to use which product and how.

I'd now like to turn the call back over to Mr. Clemmer for any closing remarks. Mr. Clemmer?

Thanks, Darryl, and thanks to the listeners today. We appreciate the feedback we've received. We'll work hard to continue to grow our company and show our investors we can become a growth and profitable company as we treat patients in need around the globe. Thank you for listening today.

Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.