ANGO

Good morning, and welcome to the AngioDynamics Fiscal Year 2026 Third Quarter Earnings Call. [Operator Instructions] As a reminder, this conference call is being recorded. The news release detailing AngioDynamics' fiscal 2026 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. A 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'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 2026 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 Form 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 and pro forma 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 and pro forma measures in addition to, not 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 in 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 operating results and financial performance during this morning's conference call. Unless otherwise noted, all metrics and growth rates mentioned during today's call are on a pro forma basis, which exclude the results of the Dialysis and BioSentry businesses that were divested in June 2023. The PICC and Midline products that were divested in February 2024 and the Radiofrequency and Syntrax support catheter products that we discontinued in February 2024. Also, unless otherwise noted, all comparisons will be the third fiscal quarter of 2026 versus the third fiscal quarter of 2025. Now I would like to turn the call over to Jim Clemmer, AngioDynamics' President and Chief Executive Officer. Mr. Clemmer?

Thank you, operator. Good morning, everyone, and thank you for joining us for AngioDynamics' Fiscal 2026 Third Quarter Earnings Call. Joining me on today's call is Steve Trowbridge, AngioDynamics' Executive Vice President and Chief Financial Officer. Our third quarter was strong across the board, and I am proud of how our team continues to execute. We maintained our trend of driving top line growth, led by impressive growth in our Med Tech segment. Beyond the top line, we continued to deliver strong profitability by expanding our adjusted EBITDA. Our performance continues to show that our strategy to drive profitable growth in our high-margin, large Med Tech markets is working. Based on that, we are once again raising our full year guidance for net sales and adjusted EBITDA. That is our third consecutive quarter of raised guidance, and Steve will touch upon the details shortly. I am very proud of the resilience we have built into the business. We've developed this company around cardiovascular and oncology markets with 3 product portfolios that we are really excited about. Along the way, we've had to work through a manufacturing transition, deal with tariffs and manage through a lot of macro uncertainty. None of that has slowed us down. That is because we have great people who know how to get the job done and the results we are putting up are not because 1 thing went right, it is years of work coming together. Within our Med Tech business, Auryon continued its strong momentum with the 19th consecutive quarter of double-digit year-over-year growth, which is a track record we are very proud of. We have consistently driven revenue growth by leveraging our superior technology to take share and our push into the hospital market keeps paying off driving both top line growth and better economics. And it is not just about taking share with our AMBITION BTK study, we are not only winning in the current market, we are working to make the market larger. Internationally, we are seeing continued traction following our CE Mark approval. Turning to our Mechanical Thrombectomy business. We loved what we saw this quarter. Our combined portfolio of AlphaVac and AngioVac grew approximately 18% over the prior year, demonstrating the superior clinical performance of this portfolio. AlphaVac in particular, had an outstanding quarter, delivering strong year-over-year growth and driving the largest sequential revenue increase we have seen since its launch. New accounts are coming on, more hospitals are bringing us through the VAC process and into inventory. And utilization within existing accounts keeps increasing. The physician feedback on this product is consistently strong. Our training and clinical education programs continue to be well received, and we are seeing strong demand from physicians who want to learn how to use this technology and bring it into their practice. On the regulatory front, we have enrolled our first patients in the APEX-Return pivotal trial, evaluating the AlphaReturn Blood Management System when used with the AlphaVac for treating acute PE. That is an important milestone, and we expect it to be a catalyst for accelerating adoption. We continue to strive to complete the approval process during the first quarter of calendar 2027. AngioVac continues to see strong demand. Together, these 2 products give us a differentiated position that we believe is unmatched in Mechanical Thrombectomy and the portfolio selling approach keeps paying off. Our sales teams are doing a great job positioning both products based on clinical need and physician preference, and we expect to see continued strong growth from the combined thrombectomy portfolio going forward. Finally, NanoKnife. We had a very strong quarter for both disposables and capital. As you know, our CPT 1 Code became effective on January 1. And what we have seen thus far has been positive. There is continued opportunity to broaden coverage across both public and private payers, and our market access team remains focused on that. With respect to the patients being treated, what our physicians are seeing in practice lines up with what our PRESERVE Study showed, in particular, excellent quality of life outcomes. We continue to see lots of organic interest in NanoKnife. And as a result, more patients are being treated each month. During the quarter, we also announced expanded European indications for NanoKnife to include soft tissue ablation for tumors of the liver, pancreas, kidney and prostate. This expanded indication supports our broad-based market in Europe and positions NanoKnife as a true multi-organ platform internationally. Our Med Device segment keeps delivering as expected, and the team running this business does a terrific job competing across multiple markets simultaneously. I am really proud of where this company is today. 5 years ago, we set out to transform AngioDynamics into a faster growing, more profitable company by getting into larger markets with better products. We've reshaped the portfolio, built the teams to support it and figured out how to make it all work. And that is what you're seeing in our numbers. Three consecutive quarters of raised guidance does not happen by accident. It is the right people doing the right things every day, and we are just getting started. With that, I'll turn the call over to Steve Trowbridge, our Executive Vice President and Chief Financial Officer, to review the quarter.

Thanks, Jim, and good morning, everybody. As always, 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. Unless otherwise noted, all metrics and growth rates mentioned during today's call are on a pro forma basis, which exclude the results of the Dialysis and BioSentry businesses that we divested in June 2023, the PICC and Midline products that we divested in February 2024 and the Radiofrequency and Syntrax support catheter products that we discontinued also in February '24. Additionally, unless otherwise noted, all comparisons will be the third fiscal quarter of 2026 versus the third fiscal quarter of 2025. Company top line revenue performance was strong again in the quarter. Revenue increased 8.9% to $78.4 million, driven by growth across both our Med Tech and Med Device segments. Med Tech revenue was $37.3 million, a 19% increase. Year-to-date, our Med Tech segment is up 19.1%. For the third fiscal quarter, our Med Tech platforms comprised 48% of our total revenue compared to 44% of total revenue a year ago, reflecting the ongoing shift in our business mix. When digging into our Med Tech segment, our Auryon platform contributed $16.3 million in revenue, growing 17.9% compared to last year. Auryon has now delivered double-digit year-over-year growth for 19 consecutive quarters. Beyond what Jim mentioned, we have continued to invest in product line extensions based on what we are hearing directly from our physicians including our radio access and 1.7 millimeter catheters. That focus on listening to our customers and improving the platform is a big part of why Auryon keeps winning. Mechanical Thrombectomy revenue, which includes AngioVac and AlphaVac sales, increased 17.9% year-over-year with revenue of $11.5 million. In the quarter, AlphaVac revenue was $4.4 million, a 47.4% year-over-year increase and a greater than 24% sequential increase over Q2 of this year. AngioVac revenue was $7.2 million, a 5% year-over-year increase. In Mechanical Thrombectomy, we are seeing strong adoption driven by new accounts, increasing utilization within existing accounts and the continued expansion of our dedicated sales force. AngioVac revenue returned to growth in the quarter, and we remain pleased with the sustained procedure volumes and demand for this product. Total NanoKnife revenue was $7.6 million, an increase of 21% with probes growing 20%. Probe sales are primarily driven by demand for NanoKnife in prostate care. NanoKnife capital sales grew 24.9% and were bolstered by strong demand for new systems as new physicians and providers adopt the technology. As these systems are placed and new physicians and providers experience the improved patient outcomes our technology enables, we expect them to drive increased probe utilization going forward. The leading indicators are encouraging. Demand for our training programs is strong and the procedural trends we track give us confidence in where this business is headed. In the third quarter, our Med Device segment increased 1.1% year-over-year. Year-to-date, our Med Device segment is up 3%. This business generates consistent cash and profitability, allowing us to keep investing in the growth of our Med Tech platforms. Now moving down the income statement. Our gross margin for the third quarter of FY '26 was 52.9%, a 110 basis point decrease from the third quarter of FY 2025. As we discussed during our last earnings call for our Q2 results, the year-over-year decrease was primarily driven by the impact and timing of tariffs, inflation and certain costs associated with our manufacturing transition. These expected structural elements were partially offset by continued product mix shift towards Med Tech sales and pricing initiatives across both Med Tech and Med Device. Total operating expenses in the quarter were $54.4 million, representing 69% of sales compared to $48.8 million or 68% of sales last year. Turning to R&D. Our research and development expense was $7.1 million or 9% of sales compared to $6.9 million or 10% of sales a year ago. We remain committed to investing in R&D initiatives to support the long-term growth of our Med Tech segment and are targeting approximately 10% of sales going forward. SG&A expense for the third quarter of FY 2026 was $38.2 million, representing 49% of sales compared to $36 million or 50% of sales a year ago. This result illustrates our strategy of simultaneously investing in sales and marketing to support sustained growth, while driving operating leverage. Our adjusted net loss for the third quarter of FY 2026 was $3 million or an adjusted loss per share of $0.07 compared to an adjusted net loss of $3.1 million or an adjusted loss per share of $0.08 in the third quarter of last year. Adjusted EBITDA in the third quarter of FY '26 was $1.8 million compared to adjusted EBITDA of $1.3 million in the third quarter of '25. This year-over-year improvement is largely attributable to our Med Tech revenue growth and the success of our gross margin and operating efficiency initiatives. We've done all this while absorbing tariff costs that were not there a year ago. Now touching briefly on tariffs. Tariff expense of $1.3 million in Q3 was again in line with our expectations. As we discussed last quarter, while the tariff landscape remains dynamic, we continue to expect to incur between $4 million and $6 million of tariff expenses for the full fiscal year 2026. As a reminder, there were no tariff-related expenses in our fiscal third quarter last year. At February 28, '26, we had $37.8 million in cash compared to $41.6 million in cash at November 30, 2025. In the third quarter of fiscal '26, the company used $3.1 million of cash, slightly better than our expectations. Turning now to guidance. Based on another strong quarter and our expectations for the balance of the year, we are raising multiple components of our full year fiscal 2026 guidance. We now expect net sales to be in the range of $313.5 million to $315.5 million raised from our previously issued range of $312 million to $314 million. This increased range represents growth of between 7.1% and 7.8% over fiscal 2025 revenue of $292.7 million. On a segment basis, we are raising Med Tech net sales growth to 15% to 17% and now expect Med Device sales to grow at approximately 1%. For fiscal 2026, we continue to expect gross margin to be in the range of 53.5% to 55.5%. This is inclusive of our reiterated estimate of $4 million to $6 million tariff impact for the full year. We now expect adjusted EBITDA to be in the range of $10 million to $12 million, up from prior guidance of $8 million to $10 million, again, inclusive of our estimated tariff impact. As a reminder, adjusted EBITDA will be lower in the second half of the year than the first as our planned investments in clinical data development hit the P&L as well as the structural gross margin impacts I previously discussed. We now expect adjusted loss per share in the range of $0.30 to $0.23, improving from our prior guidance of a loss of $0.33 to $0.23. Turning to cash. We remain on course to illustrate that our business model will be cash flow positive as we expect to generate substantial cash in the fourth fiscal quarter, in line with historical trends. During the third fiscal quarter, we were advised by our sterilization vendors of their plan to implement 2 upcoming temporary shutdowns to perform maintenance activities during the fourth quarter. To proactively address this and avoid any potential commercial disruptions, we are planning to increase inventory levels for certain products during the fourth quarter. The net result will be the acceleration of the use of approximately $3 million to $5 million of cash to build inventory in the back half of this fiscal year, which normally would have been used in future periods. Now this may result in cash flow for FY '26 being slightly negative, but there is literally no modification to the positive cash generation pathway we have been on in the cash generation profile of our business. We maintain a strong balance sheet with 0 debt. With that, I'll turn the call back to Jim.

Thanks, Steve. And looking to the fourth quarter, we remain focused on finishing the year strong. We have built this company with a new portfolio aligned with the market and where the market is growing. We have built tremendous technologies. Every day, we bring value to our customers and the patients they serve. We are committed to grow our company in a really important way. We are committed to our shareholders to grow our value along the way. Before turning the call over to Q&A, I want to provide a quick update on the leadership transition. The Board has formed a search committee and has engaged a leading executive search firm. The process is moving forward on the time line we laid out until my successor is appointed, Steve and I will continue leading the team, driving the company's strategic and financial initiatives. And I am committed to making sure we have a seamless transition. With that, I'll turn the call back for questions.

Our first question comes from the line of John Young with Canaccord Genuity.

Congratulations on the quarter. I first want to start on AlphaVac, the sequential growth there was really impressive. Any additional color on the drivers? I know it was a bit subsequent to the quarter, but are you seeing any benefit today from the PE guidelines that were released in February? And maybe just how do you expect that to benefit the company in fiscal Q4 and in the following fiscal year?

Thanks, John. Good question. John, it's really going through according to what we expected. Each quarter that goes by, we're able to get our product into new hands or hands of a physician who heard from his partner another KOL, how well the product performs. You saw the APEX data that was generated to get our product on label. What we do is remove more clot faster and in a safe, really safe manner. So that's becoming more exposed day-to-day, John. This is normal business cycle that we expect to grow our share. Two primary ways we're doing that are more hospitals approving us through their VAC process or VAC, for everybody not knowing, is Value Analysis Committee or term, whatever each hospital uses. That basically means we pass their test to get into inventory, get on the shelf to be utilized. And usually with 1 or 2 of the other products in the market, let physicians choose. And then second, John, also, we're getting physicians who've now used it a few times getting really comfortable in the innovative features we've built into the product and getting more comfortable and choosing it over the other competitive products. So John, we expect the product to grow sequentially going forward, because it's a great design, and it's a really good market. We have 2 good competitors, as you know, but we'll win more than our share going forward.

Great. And then, Steve, just on the guidance. Given the climate we're in, I think investors are probably also curious, have you baked in any impact from higher energy costs? Are you seeing any impact yet in terms of rising supplier costs? And are you giving any specific buffer for that, for the fiscal fourth quarter? And if costs do rise, what's the ability for Angio to pass on those costs to customers?

Yes. Thanks, John. Absolutely. We're living in a dynamic environment, as you know that. You talked about inflation, you talked about energy costs. We mentioned tariffs in the prepared markets. All of those elements definitely have an impact on the business, and they're all very hard to predict. We have built into our guidance, our expectations of the best we know today of how we're going to manage all of those different dynamic elements. So if you think about the guidance that we have, both in terms of EBITDA, profitability, as well as gross margin, we're expecting that we're going to have an impact that's embedded in there, both in terms of inflationary costs, which could include the energy increases that you've talked about as well as tariffs. And again, that remains dynamic, but it's our best guess of where things are going today. In terms of rising prices and passing on to our customers, I did mention in the prepared remarks around gross margin. We are seeing a benefit from our ability to raise prices in certain areas. That is not specifically tied to these dynamics of inflation or tariffs. It's more our ability, which is within the natural course of the commercial dealing to be able to take price with some of our superior products, both in Med Tech as well as in Med Device. We'll continue to take price where we can, but we haven't been able to explicitly take price related to some of those rising costs. So that's really up to -- it's up to us to continue to manage through the way that we have been.

Our next question comes from the line of Frank Takkinen with Lake Street Capital Markets.

I was hoping to also a follow-up on AlphaVac, just given how strong the number was there. As we think about future quarters and any gyrations in ordering patterns, should we kind of view this $4.4 million as a new baseline to grow off of? Or was there potentially some pull ahead into the quarter that could have that number step back as we go forward? I know historically, we've seen it pretty consistently grow sequentially. Just curious if that is expected to continue to be the trend going forward for the last quarter as well as into '27?

Frank, thanks for the question. We expect AlphaVac to continue to grow sequentially. As we've talked about, we think this is one of the drivers of growth for AngioDynamics this year as well as heading into future periods. We're very excited about the product that we have. We're very excited about being in this market. It's a huge market that's going to continue to grow. We're going to continue to take share as well as grow along with the market. So I would expect you would see AlphaVac continue to grow sequentially heading into the future periods.

Perfect. Very helpful. And then just for my second one, I was hoping to follow up on Auryon a little bit more. Any color you can provide on volume versus price and progress hospital versus OBL, would be really helpful.

Yes. As we've mentioned over the last number of quarters, moving into the hospital site of care has been a strategic imperative of our company. It helps us, as you mentioned, on price, it helps us on the nature of the customers, but it also helps us on setting the stage for the future. We talked about Auryon as a platform technology moving into areas like coronary. And so it's important for us to be in the hospital setting. Our team has done a great job, changing that dynamic of moving from being very OBL-centric, which is where we started due to the time frame when we launched this product. That was during COVID. We can get into the OBLs, you couldn't get into the hospitals. But now making that shift and focusing on the hospital side of care. But they've also done a great job making sure that we continue to grow that OBL business. So if you look at the Auryon results, it's being driven by both elements. The price that we're seeing by having a higher percentage of our overall revenue base in the hospital, but also by driving additional procedure volume in the OBL. We expect to continue to do that. Now we expect to continue to do that because of the product that we have, the versatility that the Auryon laser has in treating calcification, both above and below the knee. It can do things that no other product can do. So we're excited about the continued future, which is why we said we expect Auryon to be a grower as we continue to head into future years, even though we're getting to much larger revenue base than we had when we first started launching the product.

Ladies and gentlemen, our final question this morning comes from the line of Yi Chen with H.C. Wainwright.

This is Katie on for Yi. I had 2 quick follow-on questions for supply chain, things that have come up. Could you give us a sense of what proportion of Med Tech cost of goods are still exposed to China sourcing of components? And how much of that is kind of addressed by the Costa Rica transition? And then if you could also provide a little color on how continuous the sterilization shutdowns might be? Is that something that will happen annually? Just something how we can think about that in terms of the supply chain?

On the first one on the supply chain, we haven't historically had a significant risk to component sourcing coming from China. So over the years, we didn't necessarily get some of the benefit that you may have expected in 3, 4 years ago, but we don't have the risk as we sit here today. So we don't identify component sourcing out of China as a big risk for us, either in Med Tech or our Med Device products. Inflationary impacts, we have talked about in terms of the supply chain, but it's not necessarily what I would call a China exposure. On your question around the sterilization shutdown, is it continuous. Look, these happen. It's not something that happens all the time. The reason we called it out was more because there was a little bit of a stack tolerance going into our inventory buildups as we were finishing the supply manufacturing agreement with Spectrum, which is who we sold the PICC and Midline business to, while we were continuing to our move from the rest of the products that we had out of Queensbury down to Costa Rica. So you had a couple of things that were stacking on top of this. The reason we bring it up is, it is going to be a little bit of a use of cash ahead of our expectations in the quarter. But we're doing exactly what you expect us to do. We're managing the business. That's why we have a very strong balance sheet to start with, with really good quick and current ratios. If you go through the assets and the liabilities that we have, we have a significant net cash position. We're going to generate significant cash in the fourth quarter, along with historical trends and along with our current business model updates. It allows us to be able to do what we're talking about doing and mitigate any potential disruption from sterilization shutdowns. They happen, we're going to stay close to our sterilizers. I wouldn't think of it as something that is going to be derailing in the future. We're just calling it out because we're managing our business. We're doing what everyone would expect us to do, and we're making sure there's no disruptions because of the strong position that we're in.

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

Thank you, and thanks for joining us today and hope you got insight to what makes AngioDynamics special and shows how we can compete and win in this marketplace today, tomorrow and going forward for a long period of time. I'd like to thank our employees for really making this happen. We have a great team of people at work. But I also want to mention here at Angio this week, we lost an important member of our team. We want to recognize Jim Culhane for his work as a leader, one of our research and development leaders. Jim really lived our culture of patients first. Jim helped to build products like the AlphaVac. His great design work, the team he led really enables patients today to get better and get healthier due to our products. Jim Culhane was an important leader here, and we express our condolences to his family and friends with his recent passing. Thank you for joining us today.

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