Good morning. And welcome to the AngioDynamics Fiscal Year 2022 First 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 is being recorded. The news release detailing the fiscal 2022 first 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 Investor 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 one hour after the end of today’s call. Before we begin, I’d 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 2022, 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 identifies specific factors that may cause 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 are 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 Investor section of the company’s website under Events and Presentations. This presentation should be read in conjunction with a press release discussing the company’s operational results and financial performance during this morning’s conference call. I now like to turn the conference call over to Jim Clemmer, AngioDynamics’ President and Chief Executive Officer. Mr. Clemmer.

Thank you, Melissa. Good morning, everyone. And thank you for joining us for AngioDynamics’ fiscal 2022 first quarter earnings call. Joining me on today’s call is Steve Trowbridge, AngioDynamics’ Executive Vice President and Chief Financial Officer. Steve will provide a detailed analysis of our first quarter financial performance and our updated FY 2022 guidance. We delivered a strong first quarter performance, and I am pleased with the commitment and dedication our team has shown, as we continue to execute against the strategic plan that we laid out at our Investor and Technology Day in July. AngioDynamics is in the midst of a transformation into a high growth Med Tech company and in our first quarter, we delivered strong revenue growth and we remained focused on investments, which we believe are critical to driving this transformation. Our first quarter was impacted by the ongoing COVID-19 pandemic and the recent surge caused by the Delta variant. Other medical device companies have discussed softening case volumes during the quarter and we saw similar impacts. We are encouraged, however, to see improving trends in September and we are particularly pleased with our performance, giving this challenging environment and we are confident in our future. We ended the quarter with revenue of $77 million, representing growth of 9.6% year-over-year. Net sales from our Med Tech business, which as a reminder, includes Auryon, NanoKnife and our thrombus management platform were $17.6 million, a 68% increase from the previous year. We remain excited by the continued growth and innovation that we have shown in this part of the business. Our Med Device business which includes the remainder of our portfolio was roughly flat year-over-year. This year-over-year comparison includes the one-time $5.2 million NHS order that we received last year for PICCs and Midlines. We believe these results…

Thank you, Jim. Good morning, everyone. Before I begin, I’d like to point you to the presentation on our Investor Relations website summarizing the key items associated with our quarterly results. During the quarter, we continued to face COVID-related headwinds that impacted both our revenue and our margins and we expect these headwinds to persist in the near- and medium-term due to the uptick in cases associated with the Delta variant. The good news is that we are not currently seeing across the Board impacts, but are instead seeing localized geography-specific slowdowns in elective procedures. At this point in the pandemic, hospitals have more refined protocols in place and we are not seeing full across the Board shutdowns. As certain hospital systems see increasing numbers of Delta cases, they are pulling back on elective procedures temporarily, which is a very different dynamic than what we saw 18 months ago. We plan to continue to maintain same disciplined approach to driving growth and expense management that we employed in the first quarter and throughout FY 2021 in the face of the current environment. As Jim noted, our revenue for the first quarter of FY 2022 increased 9.6% year-over-year to $77 million. Our growth was driven by continued strength in our Med Tech businesses, including Auryon, NanoKnife and AngioVac, as well as solid performance from our Med Device businesses. Med Tech revenue was $17.6 million, a 68% year-over-year increase, while Med Device revenue was $59.4 million, roughly flat compared to the first quarter of FY 2021, which included that $5.2 million NHS order. Revenue in our endovascular therapies business formerly named our VIT business increased 27.5% year-over-year to $38.1 million. This business benefited from continued strong growth of our Auryon platform and a greater impact of COVID-19 on the prior year period.…

Thanks, Steve. As we discussed during our Investor and Technology Day, AngioDynamics is a company in transformation. Our transformation revolves around two important parts. First is the transformation of our portfolio to focus on innovative technologies that help us drive growth in faster growing larger markets, where growth is proven by outcomes and patient wellness. Our transformation in our portfolio is very important and you saw a demonstration of that transformation in this quarter’s report. And the second part of our transformation is our investment in people. We look at our people to help drive the growth and expand our portfolio over time. One example of an addition of a person this quarter was a new Head of International we have. We hired Laura Piccinini, a very seasoned and successful executive, with a strong career in Medical Technology business. Laura joined us to head up our international business. We look forward to her contributions and leadership. So I want to thank the AngioDynamics team for their incredible support of our customers during this challenging period and thank you for listening to our call today. With that, I will turn it back to the Operator. Melissa.

Thank you. [Operator Instructions] Our first question comes from the line of Jayson Bedford with Raymond James. Please proceed with your question.

Hi. Good morning. Can you hear me okay?

Hi, Jayson. Good morning. Sure.

Hi, Jim. So just a few questions. First, just trying to summarize the COVID commentary here, it sounds like Delta was the negative factor in your fiscal first quarter. You’re still seeing some impact, but broadly trends are improving in September, does that kind of capture your thoughts there on COVID?

It is Jayson. Yeah. We don’t want to focus a lot on that but that’s exactly right. So we monitor our landscape very carefully and discuss every day with our customer-facing people, watching the shift. So we have seen during the month of September a little bit of an improvement and we’ve seen some healthcare systems just recently start to do elective procedures again that were challenged during the last kind of part of the summer. So we’re seeing a slow tick back. It’s not normal yet, but we’re monitoring it closely.

Okay. And then I am just going to bounce around a little bit on some product categories. On Auryon, the installed base of 205 lasers was a pretty big jump from fiscal fourth quarter. Was there something specific that drove this jump?

So couple of things, one is our supply chain is really strong and secure. So we’re really confident in our ability to produce lasers now. But two, it’s really customer demand, Jayson. We’ve had a lot of customer demand. Some of which is pent-up demand. We had demand coming into this first quarter and then new demand. So we’re finding more and more adoption about not just the laser itself, but then comfort once they get the laser. They see how easy it is to use and they see the versatility of how they can now treat above and below the knee, hard and soft calcification or maybe other products don’t have that versatility. So, not just seeing increased lasers in the field, but increased usage with our current customers. But Jayson, I do want to make a final comment. I don’t think we will expect to see this amount of laser being placed going forward sequentially.

Sure.

So we will still grow our install base. We have a lot of demand. But I wouldn’t want to mirror itself pretty sequentially.

No. No. Understood. And just as I think to your answer there, utilization among existing users pretty steady. Is that fair?

It is. So, again, both parts of the new users and utilization coming in. It -- now that we have about a year under our belt, we technically launched the product last September. So we’ve really got a year under our belt, a good user base. And we’ve learned too, Jayson, it takes three months to four months from the customer once they have the laser on hand to get comfortable and confident with using it. Then when they see the outcomes it generates. We’re watching even utilization creep up during that cycle, when that customer has a laser for three months to four months, utilization looks like it’s creeping up. So we’re still measuring that and monitoring it. We see it as a strong sign.

Okay. AlphaVac and I apologize if I missed this, but what’s the timing on the 18 French device?

So, as we mentioned, we did launch the limited market release on our 22 French and the 18 French, Jayson, will be in the first half of calendar year 2022.

Okay. And that’s the launch, correct?

Right. The launch of the 18 French device, exactly.

Okay. And then just lastly for me, the 30% gross -- growth expectation on thrombectomy, just -- that’s for the entire thrombectomy bucket, it’s not just mechanical thrombectomy, is that fair?

It is, Jayson. I mean we’re focusing the 30% growth target with respect to our mechanical thrombectomy products, which is the lion’s share of what we have in thrombectomy, so the AngioVac platform, as well as the AlphaVac platform. We do have Uni-Fuse in there when you think about our overall thrombectomy portfolio, but that 30% growth that we’re targeting really comprises growth from AlphaVac and AngioVac.

Okay. All right. Thanks for the clarification. I will get back in queue.

All right.

Thank you, Jayson.

Thank you. Our next question comes from the line of Steven Lichtman with Oppenheimer & Co. Please proceed with your question.

Good morning. Thank you. Hey, guys, I just wanted to ask a couple on Auryon. First, are you seeing a consistency in terms of the OBL hospital mix in terms of where procedures are getting done? And any update you can provide us on the sales force, how many reps you have detailing Auryon and where you think you might be exiting the fiscal year?

Sure. Thanks, Steven. So in respect to your question of the OBL hospital mix. I think we told you we launched this last year during COVID. So out of the gate our OBL mix was probably higher than we had expected it would have been, but due to the hospital challenges that COVID put on. And over the course of the last couple months, we’ve seen a shift go a little bit back, more hospital engagement and probably hospital becoming a larger mix of our portfolio than had been in the first three quarters of our launch. That’s a good sign for us. Because I think you’re also seeing doctors who’ve used it in the OBL gaining that confidence, now going back to the hospital saying, hey, we want to get this unique device in the hospital to treat patients here. So, over time, Steven, we will work with you and share with you that mix, because we want the mix to be a little stronger in the hospital than had started with due to the challenges of COVID. And Steve, do you have a comment on that?

Yeah. So…

Okay.

…Steve, on the size of the sales force, roughly 60 field-based employees that we have currently that are in the Auryon business and that comprises 37 territory managers and our -- and regional managers combined with about two sales VPs. And then we have roughly 23 clinical specialists, which include employees, as well as per diem clinical specialists that are out there to support those cases. So roughly 60 field-based employees.

Great. Thanks. Checking the NanoKnife, great to see the impact that that DIRECT is having on the current business. How are you seeing that playing out in the field, are you seeing pockets of growth in areas where the trials are being run specifically and so what’s the runway you see on that in terms of that pull-through DIRECT onto the NanoKnife business?

So, Steve, it’s interesting. I think the fact that, DIRECT has been out for a little bit, people understanding now the mechanism of action, how it works. We’re seeing physician’s involvement. We’re thinking about using -- utilizing this technology for other aspects of treatment, other organs. So, the DIRECT study we’re committed to. We’re going to make sure that we can do the best we can to treat those patients with Stage III Pancreatic Cancer, because the need that exists there for treatment. We think our device we believe gives them a choice. But beyond this, we’ve always talked about expanding into other care opportunities. And the prostate opportunity, again we’re following the FDA guidance, where a little over a year ago they came out with new guidance for focal therapy treatment options. So we aligned with that guidance they gave and talked to the FDA and that’s how we’re able to get to PRESERVE study initiated. We’re seeing a real lot of interest now. Because I think people know, if there are still limitations with any type of prostate treatment and I think with our product, Steve, what we want to prove is that the quality of life aspect that we can offer. Treating it focally and utilizing the unique device that we have will give physicians a different option and patients a different option for that treatment. So, we’re really pleased. We believe the DIRECT study fostered a lot of that knowledge base that’s now expanding into the market.

Great. Thanks. And then, lastly, Steve, thanks for the details in terms of how some of the macro issues are impacting gross margin -- actually gross margin in the quarter. Going forward, are you assuming those impacts are steady? Do they get less with net some offsets that you guys have going on? How are we -- how are you thinking about sort of the sequential impacts of some of the sort of the macro headwinds?

Yeah. A lot of those macro headwinds, there are some offsets. I mean we talked about the mix impact that we had in Q1. We had a nice pickup year-over-year in product mix, but a lot of that was eaten by some of the macro effects that we talked about. Given the current environment, we really believe we’re probably at the early stages of some of that raw material inflation that we talked about being a roughly 10 basis points. I would expect that may accelerate as we head into Q2. We will see where it goes into our Q3 and Q4. The tight labor market, we’re doing everything we can, I would expect that would continue. We really haven’t seen an influx of applications coming past the early parts of September and so we’re keeping an eye on that and I think that that’s probably with us for a little while too. Freight expense, we’re going to do everything we can to try to mitigate that. We’re seeing both in and out of our facility increased freight expense, a lot of other companies are seeing that too. But there might be a little bit of an opportunity to try to negotiate some long-term agreements or deal with freight that way. So I expect they will continue. We’re going to do what we can to mitigate them on their own. We’re also going to look to other areas that can mitigate the overall margin impact like the mix that we talked about. But it’s a challenging environment, no doubt. We’re going to keep our eye on it.

Got it. Thank you, guys.

Thank you.

Thank you. Our next question comes from the line of Bill Plovanic with Canaccord Genuity. Please proceed with your question.

Great. Thanks. Good morning. You’ve answered a couple of these questions but a little more granularity. Just how -- in terms of the COVID impact, we’re not back to normal and you’re seeing an improvement, but how are you thinking about the impact relative to the guidance you have going forward?

Go ahead, Steve?

So, Bill, we definitely included a assessment of COVID throughout fiscal year 2022 when we came out with our guidance initially. We were expecting that there was going to be some continued impact. There was an element of a quantitative nature. There was also an element of a qualitative nature just based upon the experience we had going in the last year. So we were always expecting there was going to be some COVID impact. As we said, we’ve seen that in Q1. We’re certainly not back to normal. We are seeing some improving trends. And then, if you look at what we did with our increased guidance this call, that’s coming off of the performance that we saw in our Q1. It’s still incorporates some assessment of continued COVID impacts based on what we’re seeing today. Now if that materially changes, that could have an impact on where we’re going. But we’ve always tried to build in our best assessment based on our experience where COVID is going to be, so that’s still baked into what we’re seeing.

Okay. And how should we think about Q2 given that -- you had such a robust Q1 and you’re basically lifting 2022 for the Q1 results and I think historically you will probably see something like a 3% to 5% increase from Q1 to Q2, but I don’t think that’s where consensus is now. How should we think about that?

So you’re correct. We start when we have this seasonality where you have Q2 being slightly up from Q1. We did have a strong Q1. Our typically seasonality is a little bit skewed based upon some of the new product introductions and so you see the strength that we saw in Auryon coming in. So the way that we’re looking at this is, we don’t expect to go sequentially backwards, but you may not see that same full uptick coming from Q1.

Okay. And then, one of the questions we’ve actually received lately from a lot of investors is just nursing staff shortages and especially, and probably, because Wall Street is so New York centric, but especially as some of these mandated vaccine requirements go into effect? And just curious if you have any thoughts regarding, what you’ve seen regarding if any of these mandates going in and nursing staff shortages and impact on your business?

Yeah. Bill, it’s Jim. We’re watching that very closely as well. Again, we have great field intelligence with our people globally. But, yeah, we’re watching it. Hospitals are under pressure and stress. And a lot of times right now I think they’re balancing how they deliver care with stresses on their workforce and also with full ICUs. The good news is, they’ve learned more, when COVID hit a year ago, they’ve learned some lessons and they’ve done a better job, I think, of balancing how to still keep care being delivered in a better way than that we did a year ago. So the whole healthcare system is working collaboratively as part of that. So that’s an important aspect of what we do, Bill and the contact we have with our customers has changed. We’re being challenged at the how we interact. But they ask us for help. They want us to communicate. And if you even look at a couple of our most difficult businesses, we had great performance, in our EVLT vein laser business, driven by a really great product we have, but we have a great team of people who represent that product line and communicate to our customers, how to use and how to treat people quickly and safely. You look at the great performance in our Vascular Access business. You talked about nursing, nursing-driven call point, really important product for hospitals. We have a really tough competitive group there and our team delivered great results. Again, good products, great selling and marketing communication, and that’s adapting to the customer mix as you’re talking about. Our customers are challenged and asking us to deal with them differently. So I am proud of the way our team has reacted and when we have more info we will share with you as well.

Great. And then the last question for me is just, with the Auryon business and what you’re seeing, how much of that is replacing laser atherectomy versus mechanical atherectomy devices?

It’s a really good question. We monitor it really closely. We monitor every case that we can count and we have a mix. I think Bill at first I can’t give you a rough number. I don’t want put a ratio out there yet. But I know out of the gate a year ago when we launched, it seemed like we’re getting mostly customers who are familiar with the other laser that have been in the market jumping to us first, saying, let me try this new product, because they knew the other laser had some limitations and our new product the way it works with the 355-nanometer eliminated many of those limitations. So a lot of initial interest was there. And now over the last few months and quarters, we’ve seen interest coming from across the spectrum. People who have experienced utilizing the other mechanical tools are now looking on, hey, wait a minute, we didn’t know that, they knew Auryon laser actually. It’s not really a laser, because it can treat above and below in three different care aspects and deliver different interventions. So we’re really pleased, Bill, over time we will try to give you a ratio. But my final statement, I guess, is the ratio is expanding beyond just former laser users.

Bill, just to add to that. There’s two things that really make us confident and excite us about the current Auryon business. And one, of course, is the performance that we’ve seen and the sequential quarterly performance that we’ve seen in overall revenue. But that breakdown of procedure volume that Jim talked about above and below the knee, that’s the other thing that excites us. We are roughly half of our procedures are below the knee and half above the knee and so that’s an indication of proving out that thesis that we had when we looked at this technology before we did the acquisition that we felt it could be more than just a replacement laser. So we are seeing it moved into procedures that has historically been done by those mechanical atherectomy businesses and we think that trend will continue.

Great. Thanks for taking my questions.

Thank you. Our next question comes from the line of Matthew Mishan with KeyBanc Capital Markets. Please proceed with your question.

Hey. Good morning, guys, and congratulations on the progress you’re making across the platforms. Just first question on the thrombectomy platform, the 30% growth, is there any chance you could ballpark or range a good starting point from fiscal 2021 on that?

A good starting point from fiscal 2021, oh, on the…

On the revenue? Yeah.

Sure. 25% to 30% is what you can think of as a starting point coming off of 2021 in that business.

Okay. And then how should we think about going from -- and your pathway going from a limited market release on AlphaVac towards a full commercial release on AlphaVac and I am sorry if I missed that, I know you are discussing it…

Okay. No. Thanks, Matt. So we thought a process a few years ago here with our increased R&D investments. We also have a release process that we are -- it has rigor, a discipline and if you look at -- go back to November of 2019, we launched our new AlphaVac Version 3 and our NanoKnife 3.0, really successful launches there following this rigorous LMR process. Then last year, the launch of Auryon, even though we bought Eximo Medical, we put through our process. And now, Matt, we’re excited to launch -- announced today, we just started the launch of our -- the LMR of our AlphaVac. So, again, we expect six weeks to eight weeks doing a limited release, just to make sure that we’re aligning with customer expectations during this period and then we hope to move to a full market release around that six-week to eight-week period, which will -- what that really means is today only a small portion of our sales force has been specially trained for the LMR process and engaging with certain customers. And when we get that confidence that our message is resonating and the product is performing as they expect then we will go into a full release. I will communicate that, but you can expect it about six weeks to eight weeks out.

Okay. Excellent. And then through the quarter, I’ve noticed there’s been a couple of acquisitions by a couple of larger competitors of competitive technologies in that thrombectomy space. As you’ve had a chance to kind of evaluate some of those technologies, are they going direct head to head with AlphaVac or are they coming at it from a different perspective and going after adjacencies or complementary type areas?

Matt, good question. We’ve taken a look at the products that have been available externally, some really great innovations people are thinking about. Because I think the basic thesis and we’ve heard it before and the other companies in this space, the thesis is that physicians are trusting mechanical interventions at a higher rate than they had in the past. We think that’s going to continue and so we designed AlphaVac uniquely, starting with the base of AngioVac and then created obviously the unique handle, other aspects of why it’s so important. So we’re pleased, Matt, to enter the space today. We think the space is going to grow dynamically with AngioDynamics entering it. The two competitors that were there before, the other big competitor has been in the space for a long time and maybe some other innovative products. They’re all going to look diff -- perform differently. If you look at our AlphaVac performance it is very different than the other products in the market today. We’re proud of those differentiable features, I tripped over that word. So, Matt, we think other innovations will come out, but we’re really pleased with the design and development that our team did with AlphaVac. And we hope we can become part of the care continuum as mechanical interventions grow to treat different levels of VTE.

Yeah. And just to add a little bit of what Jim said, Matt. I think more than anything we know these products. We’ve been looking at them. We see this as a validation of this market and the fact that there’s continued growth opportunities and that this is going to be an exciting market going forward. I think the other thing that it validates for us is if you look at where a lot of these products are playing, it really fits into the narrative of how we’ve talked about this market, but there isn’t really a one size fits all product and there’s going to be a number of tools that are going to go after all the different segments in the market. So we see the acquisitions that you’ve talked about as further validation of our overall portfolio position in this business. We love what we have with AngioVac on circuit. We love where we’re starting with AlphaVac with 22 French and as we’ve talked about coming out with some of those smaller French sizes of AlphaVac, we’re going to be creating that full suite of products to go after this market and we think a lot of the other companies who are getting into this space are trying to follow suite with that same strategy.

Okay. Excellent. And then, lastly, just on Auryon, I mean, there was -- I believe there were some proposed changes to reimbursement of physician office that would -- that could if finalize impact reimbursement for some of those procedures. How do you see that impacting the total addressable market and the opportunity there and did you comment on that?

So you’re correct, there’s been a couple of suggestions and we’ve seen some proposed rules. We’re not going to comment on exactly where the government processes are going to land here. I think that that would be a fool’s errand, it could go anywhere. What we are comfortable though is that, wherever this goes, we don’t see this is derailing to our business. We think that our business has that value proposition that we talked about before being both above and below the knee, what has historically been the laser procedures, as well as moving into some of those mechanical procedures. And we think we’re pretty well situated to continue to go after those procedures and we’re well situated that wherever this falls out, it’s not going to be derailing to us and we think that we can continue to grow the business.

Excellent. Thank you very much.

Thanks, Matt.

Thank you. Ladies and gentlemen, that concludes our question-and-answer session. I will turn the floor back over to Mr. Clemmer for any final closing remarks.

Thank you, Melissa, and thanks for joining us on our call today. And I hope we’re able to explain our company delivered terrific performance in Q1 and we believe we have a really bright future as we continue to innovate and transform our company into a company driven by technology that drives patient outcomes that could be measured and those outcomes drive change in physician behavior. I want to again thank the AngioDynamics’ team in this challenging environment from our supply chain team and our quality team, our logistics people, who work really hard to produce these quality products and to get them to where they’re needed for care delivery. We have a dedicated team of people that we’re really proud of. Thanks for joining us today.

Thank you. This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation.