AngioDynamics, Inc.

Good morning and welcome to the NGO Dynamics fiscal year 2021 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. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference call is being recorded. The news release detailing the fiscal 2021 21 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 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 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 2021, 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 10Q and 10K, which identify 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 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. This presentation should be read in conjunction with the press release discussing the company's operational results and financial performance during this morning's conference call. I'd now like to turn the call over to Jim Clemmer, Angio Dynamics President and Chief Executive Officer. Mr. Clemmer?

Thank you, Melissa. Good morning, everyone, and thank you for joining us for Angio Dynamics Fiscal 2021 Third Quarter Earnings Call. Joining me on today's call is Steve Trowbridge, Angio Dynamics Executive Vice President and Chief Financial Officer. Steve will provide a detailed analysis of our third quarter financial performance. In line with commentary on our previous calls this fiscal year, both Steve and I will be providing slightly more inter-quarter detail than we would during a normal operating environment. I am very pleased with our performance during our third quarter, which continued to face challenges from the COVID-19 global pandemic. Third quarter revenue, was $71.2 million, representing growth of 2% over our third quarter last year. I am particularly encouraged with our performance, especially in the face of the clear impacts of COVID-19 on procedure volumes across our entire business in January and in the first half of February. In addition, our third quarter year-over-year revenue growth last year was 9%, which of course did not include any COVID-19 impact. So our third quarter of 21 was already facing a challenging comp. Our revenue growth was driven by strong performances from key technology platforms, particularly Arion and AngioVac. We also generated adjusted EPS of two cents during the quarter as we continue to balance near-term cash and expense management with strategic investment in our key platforms. Our adjusted EPS did see a four cent benefit during the quarter related to certain expense reimbursement provided by the CARES Act. Steve will provide some additional detail on this later in the call. Consistent with what many businesses have discussed, January and the first part of February experienced more acute impacts from COVID than what we experienced during the October through December. That said, we began to see improving trends towards the end of the quarter and during the month of March. In the face of these challenges, I am especially proud of the way our team continues to navigate the ongoing global health crisis while investing in and delivering on key growth initiatives and building upon the momentum we've generated through the first half of our fiscal year. We will continue to prioritize driving top-line growth while taking a disciplined financial approach to managing our business. Diving deeper into our performance in the quarter, the positive trend within our Ariane business continued into the third quarter. We reported Ariane revenue of $3.3 million in the quarter bringing our total FY21 year-to-date revenue to $6.5 million. As we stand here today, given the continued sequential growth, Arion is trending towards the high end of our previously provided range of $7 to $10 million. Third quarter procedure volumes remained robust for our AngioVac platform, with revenue growing 27% year-over-year. Additionally, as I mentioned during last quarter's call, we are thrilled about the upcoming planned launch of our new multi-purpose mechanical thrombectomy device later this calendar year. This device will expand the breadth of our angioVac platform, allowing us to serve a much larger segment of the venous thromboembolism market than we currently serve. We also believe that our current on-circuit angioVac system will continue to be a growth leader in the complex right atrium-focused market. And we expect the new multi-purpose mechanical thrombectomy device will provide meaningful incremental growth as we have the opportunity to participate in more cases in this larger, fast-growing market. NanoKnife probe sales were strong in the United States particularly offsetting softness in international markets and a year-over-year decline in capital sales. We did anticipate this decline in capital sales even prior to the added headwinds from COVID-19. The continued positive momentum in the U.S. is a direct result of two main drivers. First, our increased capital base that we developed last year. And second, increased awareness fostered by the direct study. We remain focused on investing in the Nanonife as we progress toward expanding indications and an improving OUS environment in the future. On the internal R&D investment front, our growth investments continued in the third quarter as we supported our key platforms already in the market, as well as products in our development pipelines. We will continue to invest in internal R&D and sales and marketing resources to further advance our current portfolio and expand into larger, faster-growing addressable markets. M&A remained on the back burner during the third quarter as we continued to focus on balancing growth and profitability in the face of COVID-related challenges. However, strategic Opportunistic M&A remains a key piece of our long-term growth strategy, and we continuously monitor the landscape for these opportunities. In the near term, we anticipate maintaining our disciplined approach to capital allocation and expense management. Turning to clinical and regulatory, we are excited about our progress with the Pathfinder 1 study as we completed enrollment and surpassed 100 enrolled patients during the third quarter. This milestone allows us to collect valuable, scientifically-backed data via assessments at six, 12, and 24-month intervals following the patient's procedure, in which we believe will further drive Ariane and angiodynamics in the large and fast-growing atherectomy market. Turning to our direct study, as of today, we have 22 sites that have secured IRB approval, which you'll note is down from the 26 that we reported on our second quarter earnings call. We remain pleased with the number of leading hospitals that we have operating today. We had several lower volume sites that we elected to decommission, but we don't expect this to have a direct impact on our execution. Moving forward, we continue to anticipate shifting efforts from additional site initiation to patient screening and enrollment. As can be expected, screening activity has remained challenged in the current environment due to COVID-related protocols at many hospitals. Before I turn the call over to Steve, I would like to thank our team for their continued hard work and dedication to the angiodynamics mission. These last 12 months have been difficult for everyone, but throughout this unexpected journey, our team has remained diligently focused on driving success for our customers, our patients, and our shareholders. With that, I'd like to turn the call over to Steve Trowbridge, our Executive Vice President and Chief Financial Officer, to review the quarter in more detail.

Thanks, Jim, and 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. Our net sales for the third quarter of fiscal 2021 increased 2% year over year to 71.2 million. As Jim mentioned earlier, we're very pleased with this performance given the continued COVID-19 headwinds and the strong performance during last year's third quarter prior to any COVID impacts. During our last earnings call, we indicated that we might see a more pronounced impact from COVID-19 during our third quarter than we had seen during the second quarter, and that's exactly what happened. While December trends remained largely positive, January and the first part of February exhibited clear slowdowns. We are pleased to see reversal of this negative trend during the back half of February, and this positive trend has continued through March. While we are not back to pre-COVID levels yet, we are encouraged by the current trends coupled with accelerating vaccine administration as we drive toward our fiscal year end. Turning to our results for the quarter, our total VIT business increased 8.8% year-over-year, and the continued strength highlights the success we are having with two important growth products, AngioVac, which grew 27% year-over-year, and Arion. Arion contributed $3.3 million in revenue during the third quarter, building upon the momentum we saw following the product's official commercial launch in the second quarter. We continue to see Arion as an important growth driver in our VIP business as we invest in further building out our commercial presence and supporting the Pathfinder study. This growth in angiovac and Arion was partially offset by a decline of 16% from the prior year in our Venus portfolio. This weakness continues to be driven by lower procedure volumes largely tied to COVID impacts. We have seen this softness in our Venus portfolio throughout the course of this fiscal year, and we expect it to continue through the fourth quarter. Although we note that comparisons during our fourth quarter for most of our products across all of our businesses will be muddied by the acute impacts from COVID that we experienced during that quarter last year. Vascular access revenue increased 0.7% during the quarter, driven by growth in midlines for the third straight quarter, as well as growth in dialysis. While revenue from our oncology business declined 10.1% during the quarter, nanonife disposable sales in the U.S. grew 12% year over year. This growth was offset by a decline in nanonife probe sales in the rest of the world, resulting in an overall decline in probe sales of 7%. International nanonife probe sales and the broader oncology business were impacted by market pressures in EMEA and APAC, lower capital sales, and a 9.8% decline in sales of our microwave and RF ablation products. Our oncology business was clearly impacted by the increased pressure on procedure volumes experienced during January and the first half of February. In spite of this, we have continued to benefit from the larger installed base of nanonive units, and we anticipate that we will continue to see positive probe sales growth in the U.S. and ultimately in international geographies as market pressures abate and procedure volumes rebound. Moving down the income statement, our gross margin for the third quarter of fiscal 2021 was 54.1%, a decrease of 370 basis points compared to a year ago, and a decrease of 110 basis points sequentially from our second fiscal quarter. The decline was largely tied to continued staffing pressures, sales mix, and COVID-related costs. We are seeing impacts from customer mix in our Orion business versus our prior expectations. To provide a bit more detail on this, during this fiscal year, we have experienced a much more robust sales cadence for Arion in office-based labs than in hospitals. This is not at all surprising given the ongoing COVID pandemic. However, as we have discussed in the past, pricing in the hospital environment is more favorable than it is in OBLs due to the differing sales and use models. This shift from hospital-based placements to OBLs has impacted our gross margin And we anticipate that this customer mix trend will continue and have an increasing impact on margins into FY22. Additionally, and as anticipated, we incurred a number of startup costs related to the ongoing launch of our ARION platform during the quarter. As we've discussed in the past, the majority of the year-over-year gross margin decline was anticipated, given the ongoing focus on employee safety and manufacturing predictability. We also continued to reduce inventory during the third quarter, ending at $49 million. During our first quarter call, we stated that we expected to see a step function up from Q1 to Q2, Q3 to be in line with Q2, and then another step function up to Q4, exiting the fiscal year closer to pre-COVID gross margin levels. We do expect to return to pre-COVID gross margin levels, but it is likely to take a bit more time before this occurs. Our research and development expenses during the third quarter of fiscal 2021 were 8.6 million or 12% of sales compared to 8.4 million or 12% of sales a year ago. We continue our strategy of disciplined investment in R&D to drive our key technology platforms, particularly in the COVID environment, and we do expect investment during our fourth quarter to increase sequentially from the third quarter due to the timing of certain investments in our growth platforms. We are investing in anticipation of the launch of our new multipurpose mechanical aspiration thrombectomy device in calendar 2021. This elevated investment during the fiscal fourth quarter is reflected in our R&D guidance, which we still anticipate will come in within our previously provided range of between 35 and 40 million. SG&A expense for the third quarter of fiscal 2021 decreased from the previous year to 28.6 million, representing 40.2% of sales, compared to $31.1 million, representing 44.6% of sales a year ago. We are pleased with our ability to control SG&A spending in the COVID environment and remain committed to disciplined expense management and managing our cash while investing in our key technology platforms. Accordingly, we now anticipate that our full-year SG&A spending will come in below our previously provided range of between $123 and $127 million. There's no doubt that SG&A spend has been positively impacted by reduced travel associated with the ongoing COVID-19 pandemic. We expect travel costs, along with our ongoing investments in the sales organization, to increase into FY22 as the global environment improves, which will drive incremental expenses in 22. Our adjusted net income for the third quarter of fiscal 2021 was $0.7 million, or earnings of $0.02 per share, compared to adjusted net income of 0.4 million, or one cent per share, in the third quarter of last year. It's worth noting that we had a $1.9 million benefit to net income, or roughly a four cent tailwind to EPS, related to the CARES Act this quarter. This reflects reimbursement of expenses we actually incurred, related to sales employees, manufacturing, and R&D, providing a $700,000 benefit to gross margin, and a $1.2 million benefit to operating expense. Since the beginning of the COVID-19 disruption, we have not reduced headcount or cut back on R&D investments, and this CARES Act benefit reflects reimbursements of these types of expenses for companies that did not lay off employees or take PPP loans. Adjusted EBITDA in the third quarter of fiscal 2021 was $5.4 million compared to $3.8 million in the third quarter of fiscal 2020. Turning to our balance sheet, We began the quarter with roughly $58 million in cash and cash equivalents, and we generated $5.9 million of cash from operating activities. During the third quarter, we had capital expenditures of $1.4 million. At February 28, 2021, we had $54.5 million in cash and cash equivalents and $30 million in debt outstanding, having repaid $10 million of our outstanding debt during the fiscal third quarter. In March, we also paid down an additional $10 million on our revolver, leaving us with $20 million in debt outstanding and a net cash position. Turning now to guidance. Based upon our strong third quarter results and our observations in the marketplace, we now anticipate our fiscal year 2021 net sales to be in the range of $285 to $288 million compared to our previous range of $278 to $284 million. We now expect full-year adjusted earnings per share to be in the range of 4 to 6 cents compared to our previous range of 0 to 5 cents. We're proud of our ability to drive year-over-year revenue growth this quarter despite COVID headwinds and our strong performance in the period one year ago, which occurred prior to the onset of COVID-19. We continue to build on this positive momentum of our key technology platforms coming out of the third quarter. And we will continue to drive targeted, meaningful investments into these platforms to drive future top-line growth. With that, I'll turn it back to Jim.

Thank you, Steve. I'd like to say thank you again to all of the members of the angiodynamics team for their hard work, and particularly for the strong finish while facing the resurgence in COVID headwinds during the quarter. Our team has successfully maintained our balanced approach to managing expenses and cash while continuing to invest strategically in our three key technology platforms, AngioVac, Arion, and NanoKnife. I continue to have the utmost confidence that this strategy is the right one to drive long-term profitable growth in our business and create value for our shareholders. With regard to one key product in development, we remain on track to deliver our off-circuit mechanical thrombectomy device later in calendar year 2021, which we anticipate will accelerate further growth in our VIT business. As a reminder, this is the first step in our market expansion strategy as we continue to make focused investments in the thrombectomy space with the goal of delivering additional product line extensions over the next three years. This first step is instrumental to the success of the ongoing transformation of Angio Dynamics. We are not the same company that we were five years ago and we won't be the same company two years from now that we are today. We've exited businesses where we were not the best owners and we are looking to invest in and acquire technologies that position us to take share in larger and faster growing segments of the market where innovative and differentiated technology drives measurable outcomes, and those outcomes can change position behavior. As we look ahead, we are encouraged by the recently improved market trends as the threat posed by the pandemic recedes and broader vaccine distribution takes place. Our team remains laser focused on long-term growth through our investments in internal R&D, targeted M&A, and the expansion of clinical and regulatory pathways for our key technology platforms. With that, I'd like to turn the call back to the operator to open up for questions. Melissa?

Thank you. At this time, we'll be conducting a question and answer session. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question comes from the line of Jason Bedford with Raymond James. Please proceed with your question.

Thanks and good morning. Just a few questions. On the intra-quarter trends, Did the harsh weather in Texas and the southeast have much of an impact in the quarter?

Hi, Jason. This is Jim. Thanks for joining today. You know, Jason, it did have a temporary effect. We definitely saw that. I guess I didn't want to comment on it because we expected that hopefully those patients will get treatment that they deserve at some point, but we did see a temporary effect, to be fully transparent.

Okay, but it's tough to quantify, I assume.

It is. It's really hard. I didn't want to put it out there, Jason, but there was a factor of salespeople mentioned. Okay. Okay.

You alluded to better conditions in the second half of February and into March, but it looks like the lower end of the implied fourth quarter guide is kind of flat to down slightly. I'm just wondering, why would that be the case?

Yeah, it's a fair point, Jason. We still have increased uncertainty and limited visibility with COVID. As we mentioned, we did see the increased COVID impact in Q3 that we were expecting coming off of our Q2. We do see improving trends. We are hoping that those trends will continue, and we've got reason to be optimistic that those trends will continue with the increased vaccine availability and the increased openings. That being said, there's still limited visibility in this COVID environment, and I think our guidance is looking to be cognizant of that fact.

Okay, okay. On AngioVac, you mentioned the 27% growth. Can we assume that volume growth roughly matched dollar growth?

You can. We are seeing the revenue growth, the dollar growth that we're seeing coincide with increasing growth Procedure volume, we are tracking that. And so, you know, it was a very good quarter for us in terms of procedure volumes on AngioVac. And those two things are moving relatively in lockstep.

Okay.

And just on the new thrombectomy device, have you filed the 510K?

So, Jason, we haven't filed yet. We're in final validations of the work that you do prior to filing. Okay. We'll probably let folks know when we file. As I said earlier, we anticipate filing in the first half of the calendar year and then expected 510K approval second half, but we've not yet filed. Okay.

And just a couple quick ones on NanoKnife, and then I'll jump back in queue. You mentioned that you're looking to expand indications. I'm just wondering, was that more of a near-term comment, a longer-term comment, and just a little bit more on kind of where you are with prostate. And then I'll ask the second one up front here. When do you lap your anniversary, the tough nano knife capital comps?

So a couple of quick points, Jason. So your question about the expanded indications, it's actually short-term and long-term. I hate to give you that, but the truth is this is a platform technology. And our company now has a really good grasp of what to do with it. For years, I don't know if the company did the right things. But the direct study was important to us, getting the pancreatic IDE started because the pancreas is so difficult to treat as we know. Now that we've gotten the study going in momentum, we've highlighted that prostate is our next interest. And for different reasons of pancreas due to, you know, the acute nature of the disease is different. But also the FDA has new guidance documents about how to treat the focal therapy disease. regulatory process. We're following that carefully. We also think improved guidance and improved visibility that physicians have with the prostate will help treatments like nanolife. So we're excited. We'll give you more details soon on our prostate indication aspirations. And then beyond that, Jason, again, we think this is a foundational technology that the science works, the mechanism of action works well to treat other organs. So it should be a long-term opportunity to grow this. And Steve, would you like to comment?

Sure, and Jason, on the question around the comps, you know, really it is at the end of our FY21, well, anniversary of the comps. We headed into our fourth quarter last year, and as we mentioned on the call, we did see the largest impact of COVID hit us in our fourth quarter. That being said, there was still some capital sales that occurred in the fourth quarter, a little bit less of a, you know, a little slower pace than what we saw earlier in our FY20. But for the most part, we're going to anniversary that big capital year once we get through 21.

Okay, thank you.

Thank you. Ladies and gentlemen, as a reminder, if you'd like to join the question queue, please press star 1 on your telephone keypad. Our next question comes from the line of Matt Mission with KeyBank Capital Markets. Please proceed with your question.

Hey, good morning, guys. First question on Arianne. Do you have a good sense of where the procedures are coming from and what's being used for?

Hi, Matt. Good morning. We do. As you know, we have a dedicated team that we hired to just work in Orion. We now have over 40 people dedicated to this business unit. And Matt, they track almost every case. So what's encouraging, we've seen an increasing ratio of the cases that we're treating have been below the knee. Early on, I think physicians treated above the knee. It's a brand new technology. People are getting used to it. But as you know, we're very encouraged in how it works. And because it has the ability to treat above and below and treat hard and soft calcification, we're watching it and watching the ratios change. We'll look forward to communicating that with you as we grow that business.

Okay, excellent. And you mentioned the recent improvements in UA markets. Can you go into a little bit more detail into what you've seen in March so far?

Yeah, we mentioned in March, Steve and I can both comment, but we're seeing a little bit more just slow, steady growth. the case procedures, you know, ORs are being booked again. I spoke to a physician last week, Matt, here's a kind of a good and bad analogy for all of us to watch what's happening in our industry. But a physician I spoke to last week told me he did a surgery on a patient that he had to remove a tumor. He said normally it was a complex procedure. It may have taken two hours in a normal environment. Well, it took nearly six because the patient had progressed and the tumor had gotten worse. So I think what we're going to see, Matt, is situations like that, all of us in the healthcare space, where now we're getting back and treating people that need to be treated, but the acuity may be a little higher than before. So we're being cautious, Matt, but we're letting our customers guide us, and they're telling us that they're trying to rebook OR suites, get people treated at a little faster pace.

Okay. That's kind of unfortunate. And then... Just on the expense reimbursement from the CARES Act, is that a one-time reimbursement or is that something you expect over the course of the next 12 months?

It's a one-time hit. So this was based upon the law that was passed previously that we were able to fit into and make our application. As it sits today, it's a one-time. We're keeping our eye on the current law that was passed to see if there's any other benefits. As of right now, we don't think there are. We'll continue to monitor that and we'll continue to assess the situation. But you should think of it right now as a one-time.

Okay. And that actually helped the gross margins. The underlying gross margin was a little bit worse. Can you go back to the dynamic that you were talking about with office-based labs versus hospitals and that mix and the impact to gross margin of that? Sure.

So I think, you know, to tell the gross margin story, you know, what we're focusing on to drive top-line growth, you know, in the immediate timeframe as well as in the long term is going to be those three growth platforms that Jim has talked about, Arianne, AngioVac, and Nanonife. All three of those will be accreted to corporate margins, and that will drive our margin profile over time. Certainly, AngioVac and Nanonife today, we talked about some Arianne startup costs, but that we expect that to, as we get through the initial phase, is going to be accreted to corporate margins. One of the things that we've talked about in looking forward is Arianne and that mix between hospital sales and OBLs. As we've said in the past, pricing in the hospital environment is usually higher, and it's noticeably higher than what you see in the OBLs based upon their sales and use model. In the COVID environment, what we've seen is a little bit of a shift in the mix from where we initially expected when we bought the product from the hospital-based placements to the OBLs. It's not surprising, right? The OBLs have been opened. They've had less restrictions. They don't have to follow some of the same protocols that a general hospital does. And so you've seen a lot of those procedures continue to be done in the OBLs where maybe hospitals have been cutting back as they've been preparing for COVID opportunities. Honestly, we expect that mix shift to probably be sticky and continue as you move forward. So what you'll see is our expectations are you're going to have a shift to more OBLs doing procedures. So when we thought it was maybe 50-50 or 60-40, it may end up being 70-30 or higher in terms of 70% of atherectomy procedures being done in the OBLs as opposed to the hospitals. So as you look out into the end of our FY21 and 22 and beyond, that mixed shift, is going to have an impact because of that pricing differential that we talked about. It's not necessarily pricing pressures, it's just more of a customer mix shift. And so we think that that will impact that accretive margin benefit that you're going to see from the increasing Arianne contribution over time.

Okay, I get that. And last question, I'm assuming that as we go out to next quarter, you guys are thinking about FY22 guidance. Just what are some of the moving pieces you'd like us to consider at this point?

So we will come out with guidance when appropriate. Hopefully that will be at the time that you normally see it. We're going to keep our eye on COVID and the continuing impact that we see there. I think a lot of the things that we've been talking to you throughout FY21 are going to be the moving pieces. I think first and foremost, we've got a line of sight to top-line growth through our growth platforms in Arianne, AngioVac, and what you're seeing clearly in the U.S. in terms of nanogrobes. That focus, of course, will continue as we head into FY22. We've talked about our plans on continuing to invest in R&D as well as continuing to invest in the sales force to drive that top line growth. And we're going to look to be as transparent as we can about those investments. But I think the expectation is we will be investing to support that top line growth that we think is going to be important to our long-term strategy. And then beyond that is the gross margin, which is what we've talked a little bit about this quarter in terms of our expectations. Again, the big point being we expect our margin profile to be positively impacted by our growth platforms over time. As we sit here today, a large part of our revenue base is coming from those more mature businesses. We've got one plant. It's in upstate New York. It's in an area where there is a tough job market in the sense that there aren't too many openings and a lot of people are hiring. It's some of the headwinds that we're facing currently. But I think those are the major drivers that you should expect, very similar to what we saw in 21 as you head into 22.

All right, excellent. And really nice quarter. Thanks, guys. Thanks, Matt.

Thank you. Ladies and gentlemen, that concludes our question and answer session. I'll turn the floor back to Mr. Klemmer for any final comments.

Thank you, Melissa. And again, I'd like to thank the Ingenamics team for working through this COVID environment, the period of uncertainty. We focused on the health and safety of our employees first, and continuing to ensure a robust supply chain for our customers who need our products. Our team has done a really great job. I thank you for paying attention to our results today, and we look forward to growing our strategic initiatives, investing in our key platforms, and investing in our people. Thank you again. Have a great day.

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