AngioDynamics, Inc.

Good morning and welcome to the AngioDynamics Fiscal Year 2025 Fourth Quarter Earnings Call. At this time, all participants are in listen-only mode. The question and answer session will follow the formal presentation. As a reminder, this conference call is being recorded. The news release detailing AngioDynamics' Fiscal Year 2025 Fourth Quarter and Full Year 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 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 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 forms 10-Q and 10-K, which identify specific factors that may cause the actual results or events to differ materially from those described in the forward-looking statements. The company will also discuss certain non-GAAP 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 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 in the Investor Relations 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. Now, I'd like to turn the call over to Jim Clemmer, Angio Dynamics' president and chief executive officer. Mr. Clemmer?

Thank you, operator. Good morning, everyone, and thank you for joining us for Angio Dynamics' fiscal 2025 fourth quarter and full year earnings call. Joining me today is Steve Trowbridge, AngioDynamics Executive Vice President and Chief Financial Officer. Unless otherwise noted, all financial metrics and growth rates provided during the call today are on a pro forma basis, which excludes the impact of our divested dialysis, biocentury, PIC, and midline businesses and our discontinued radio frequency and Syntrax support catheter products. We capped off a tremendous 2025 with a very strong fourth quarter. Total revenue was $80.2 million, representing growth of over 12% year over year, led by med tech growth of over 20% and med device growth of more than 6%. Beyond the top-line performance, we drove solid gross margins, positive adjusted EBITDA, and strong free cash flow, all as expected. As we've talked about in the past, we have been navigating a long-term strategic transformation over the past several years to simplify our business and move into large, high growth, high margin MedTech markets. Our performance in the quarter and throughout fiscal 2025 validates that strategy and reflects our ability to drive execution. As this is our fiscal year-end call, I wanted to take the opportunity to highlight the progress we have made operationally this year as we have achieved great things here at AngioDynamics over the past 12 to 24 months, including key regulatory approvals, international market expansion, new product introductions, clinical data development, and critical reimbursement wins, among others, all of which have set us up to deliver profitable growth moving forward. Starting with our MedTech portfolio, Ariane has continued to be our largest MedTech product line. Since its launch in 2020, we've driven over $185 million in cumulative sales, and we are now the third largest product in this space. In the fourth quarter, the platform delivered its 16th consecutive quarter of double-digit increases, and for good reason. We believe Ariane, is the best-in-class peripheral atherectomy platform because of its demonstrated safety profile and versatility. A big focus of our commercial efforts in 2025 was the hospital setting, a customer base that for us represented a really compelling growth opportunity. As of the end of this year, our hospital customers represented approximately 36% of total Orion revenue, up from 28 percent at the beginning of 2025, validating that with a better technology that provides superior clinical outcomes, we can take meaningful market share from larger competitors regardless of the site of care. Outside of the U.S., we have started to see solid traction. Following Aurion receiving a CE mark approval In September of 2024, which opened up the European PAD market, we began the process of commercializing in that region. In the fourth quarter, we generated over $1 million in revenue from Europe, highlighting the great work done by our commercial team to increase awareness of the platform, which has driven demand from clinicians within the geography. We also have continued to work to develop compelling clinical data in support of its adoption. In January, we launched the Ambition BTK trial and registry with the BTK standing for below the knee. This trial will evaluate clinical outcomes in treating patients suffering from critical limb ischemia below their knee using Arion, in combination with standard balloon angioplasty. We believe this rigorous trial, which builds upon our earlier Ariane study, could demonstrate an important advancement in the evidence supporting the benefits of Ariane's laser arthrectomy in achieving acute and long-term procedural success in a U.S. market where there is an unmet need potentially driving increased adoption of Arion. Beyond PAD, we believe Arion's unique mechanism of action can lead to great outcomes in coronary interventions. While not currently indicated for use in coronary applications, we are investing in the R&D and clinical work necessary to potentially unlock this $900 million U.S. market. We believe the Arion platform technology, with its current market leadership and future opportunities, will continue to be a growth driver for angiodynamics in the short, medium, and long term. Arion is a prime example of how we have been able to take a novel solution and drive it to become one of the leading technologies in a competitive, difficult-to-penetrate market. We know what it takes to win a great product, high quality clinical data, highly effective market access programs, and a well-established sales and marketing infrastructure. We are running that playbook with our mechanical thrombectomy portfolio, and we are in the early stages of replicating the success we have achieved with Ariane. To that end, Our mechanical thrombectomy portfolio, made up of AngioVac and AlphaVac, has become the fastest growing part of our MedTech segment. In the quarter, we delivered approximately 45% year-over-year growth. These two technologies are clearly differentiated, and much of the work done over the last 18 months has helped spur a solid adoption trajectory. Following AlphaVac's FDA clearance and CE marking during the first half of calendar 2024, this product has delivered five consecutive quarters of sequential revenue growth. This was aided by the strength of our clinical data, in particular, the publication of our APEX trial results in December of 2024, which demonstrated AlphaVac's strong performance in the U.S., showing a 35.5% reduction in clot burden from the baseline compared to a 9.3% reduction for the current market leader's IDE data. We also initiated the RECOVER-AV trial in Europe in September of 2024, aimed at further strengthening our clinical evidence base in the European market. While AlphaVac is a fantastic product that was purpose-built to mitigate the need for blood return, we continue to believe that its rate of adoption would have been even more rapid if we also offered a version that offers blood return functionality. We now have a fully developed product, and we are working with the FDA to establish a regulatory pathway for a version of AlphaVac that includes blood return, and we believe that by offering two versions of the technology, with and without blood return, it will further enhance our competitive positioning and offer a better suite of solutions for all customers. We continue to be very encouraged about the performance of our other mechanical thrombectomy platform technology, AngioVac, which grew nearly 40% during the quarter and just over 25% for the full year. We attribute much of this success to the ongoing synergistic benefits that we have seen as a result of our concerted joint commercialization efforts within the mechanical thrombectomy portfolio. AngioVac and AlphaVac together provide angiodynamics With an unparalleled product portfolio option and with a fully trained and optimized sales force, we continue to realize commercial adoption synergies between these two product lines. To support the demand we are seeing in the market for these products, we plan to add additional dedicated reps to this sales force during fiscal 2026. We also believe we have other tailwinds influencing the adoption of this portfolio, particularly within structural heart. As this sector continues to grow, AngioVac has a role to play, giving our team an accelerated opportunity to engage with interventional cardiologists and cardiothoracic surgeons. As the overall structural heart market continues to progress, we believe we will benefit from incremental synergies within our portfolio. And lastly, NanoKnife. Although NanoKnife has been commercially available for a number of years, we achieved multiple key clinical reimbursement and regulatory milestones during the year that has positioned it for accelerated adoption moving forward. Preserve met its primary effectiveness endpoint demonstrating the performance of a nanonife system for the ablation of prostate tissue in patients with intermediate-risk prostate cancer. And just as importantly, the study demonstrated extremely compelling quality-of-life outcomes, validating what we already knew about the technology and its ability to provide better care for prostate cancer patients. Next, in October of 2024, a CPT Category 1 code was granted for the treatment of lesions in the prostate and in liver using IRE. The new codes will be effective on January 1, 2026, and have put us in a fantastic position to ensure that reimbursement will be widely available across both the commercial and private payers. as we move into calendar 2026. And lastly, in December, we received an expanded indication for the NanoKnife system for prostate tissue ablation. With this clearance in hand, we have been able to more proactively market, educate, and train for the procedure in ways that we've been previously unable to do. With these three milestones achieved, we have established the three pillars necessary for long-term growth, regulatory clearance, reimbursement pathway, and market awareness. Coming as a result of these efforts, we are very encouraged by the trends we have seen in nanolife business. In particular, with its adoption and utilization within prostate cancer care. We're seeing significant organic interest from the urology community and are seeing solid increases in the number of surgeons trained. The inbound interest in our technology has been strong. Importantly, we continue to receive exceptional feedback from physicians using NanoKnife in real world settings. While we are very excited about the demand for NanoKnife in prostate, we have continued to push to broaden its applicability within other disease states. In fact, a CPT level one code was granted for IRE in its use in pancreatic cancer care. Admittedly, this is a smaller market than prostate, but it highlights the ability of this technology to change the way patients are cared for across a variety of oncology applications. The CPT-1 code for IRE and pancreatic applications will become effective in January 2027. As you've just heard, we've made significant progress across our MedTech portfolio during 2025. We have systematically executed on our strategy to drive growth in large, fast-growing markets. this execution has already paid off. For the full year, our MedTech segment generated nearly $127 million in revenue, representing growth of approximately 20%. Over the last five years, since we initiated our strategic transformation, our MedTech segment, as a percentage of total revenue, has doubled from 22% to 43%. and delivered a five-year revenue CAGR of approximately 25%. Beyond our commercial achievements, we've successfully executed on our operational efficiency initiatives while maintaining our commitment to innovation and growth. During the quarter, we yet again generated positive adjusted EBITDA and over $15 million of free cash flow, And as Steve will go into more detail, we expect to be cash flow positive during fiscal 2026. As we continue to work to deliver consistent, profitable growth, we remain on track to deliver incremental cost optimization through our manufacturing transition process. We continue to expect to deliver approximately $15 million in annualized savings by fiscal 2027, fundamentally improving our cost structure. This year's results demonstrate the successful transformation of AngioDynamics into a profitable, growth-oriented medical technology company. We've systematically built a portfolio of innovative products while achieving sustained profitability. The combination of regulatory achievements, clinical validation, commercial momentum, and operational excellence provide strong momentum as we enter fiscal 2026. With our strong balance sheet, expanded market opportunities, and proven ability to execute, we expect to continue to deliver for our shareholders. With that overview, I'll turn the call over to Steve.

review our financial performance in more detail thanks jim 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 as jim mentioned 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 biocentury businesses that we divested in june 2023 the PIC and MIDLINE products that we divested in February 2024, and the radiofrequency and SYNTRAX support catheter products that we discontinued in February 2024. Additionally, unless otherwise noted, all comparisons will be the fourth fiscal quarter of 2025 versus the fourth fiscal quarter of 2024. Revenue increased 12.7% to $80.2 million, driven by growth across both our medtech and meddevice segments. MedTech revenue was $35.8 million, a 22% increase, while our MedDevice revenue was $44.4 million, an increase of 6.2%. For the fourth fiscal quarter, our MedTech platforms comprised 45% of our total revenue compared to 41% of total revenue a year ago, further illustrating the sustained execution of our strategy to increase the percentage of our overall revenue base coming from our MedTech segments. Our Arion platform contributed $15.6 million in revenue, growing 19.7% compared to last year. Arion has now delivered double-digit year-over-year growth in each of the 16 quarters following the anniversary of its launch in September of 2021. Mechanical thrombectomy revenue, which includes angiovac and alphavac sales, increased 44.7% year-over-year. As Jim mentioned earlier, we continue to be very pleased with our ability to take share in an increasingly competitive mechanical thrombectomy market, coming as a result of the efforts of our skilled commercial team, the innovative differentiation of these products, and the synergistic benefits we are seeing as a result of our joint commercialization efforts. In the quarter, AngioVac revenue was 8.2 million, a 39.5% year-over-year increase, and AlphaVac revenue was 3.1 million, a 60.8% year-over-year increase. Total NanoKnife revenue was $7.2 million, a decrease of 2.5%. Now, this decrease is due to the year-over-year comparison of capital sales. Throughout our fiscal 2025, we consistently discussed that we expect capital sales during the year to be approximately half of what they were in 2024. While capital sales were less than they were a year ago, we have continued to see strong demand for new systems, with fourth quarter capital sales down just 24.9% and 26% for the full year, ahead of our initial expectations. Disposable sales, the more consistent barometer of our NanoKnife business, remain strong, growing 5.5% in the quarter, and we continue to be encouraged by the sustained utilization of NanoKnife within prostate cases, which hit our projections for the full year. NanoKnife prostate procedures in the quarter were 81% of all NanoKnife procedures, a record to date. In the fourth quarter, our med device segment increased 6.2% year-over-year. Now, before turning to the rest of the income statement, I wanted to provide an update on the impact tariffs had on our business during the quarter. We announced our third quarter results on the morning of April 2nd, which was just hours before the administration unveiled its tariff program. During our call, we had indicated that we believed we were positioned to not be derailed by tariffs. Even though the tariff program that was ultimately announced clearly was more extensive than we were anticipating at the time, we've continued to execute on our strategy and illustrate that we will indeed not be derailed by tariffs. That being said, there obviously was an impact on our business stemming from tariffs in the fourth quarter, and there will be an impact on our business during the new fiscal year. As you are all well aware, the tariff environment remains unclear and unpredictable. However, We will provide an estimate of tariff impacts in connection with our fiscal year 2026 guidance that incorporates our best estimate of the impacts as of today. Now, projected tariffs changed over the weekend, so the situation remains fluid. As the situation evolves, we will continue to be transparent regarding any changes in expected impacts. In the fourth quarter of FY25, we incurred $1.6 million of tariff expense, with more than half of that cost associated with our MedTech segment. This $1.6 million is included in our cost of goods sold and does impact gross margins and ultimately our EBITDA and EPS results. Given this dynamic, we're particularly pleased with our results and our ability to drive accelerated profitability despite this headwind. As I'll discuss further towards the end of my remarks, we currently expect the full year impact of tariffs in FY26 to be approximately $4 to $6 million. and we continue to expect that tariffs will not materially alter our trajectory or our ability to execute on our strategic plan for fiscal 26. We do not expect it to alter our stated goals of continuing to generate positive adjusted EBITDA for the full year, and we continue to expect to be cash flow positive for the full year of FY26, inclusive of paying all associated tariffs. Now, moving down the income statement, our gross margin for the fourth quarter of FY25 was 52.7%. For the quarter, MedTech gross margin was 59%, and MedDevice gross margin was 47.6%. In this quarter, total gross margin saw an approximately 204 basis point negative impact from tariffs. Absent the $1.6 million paid in tariffs, full company gross margin would have been 54.7%, MedTech gross margin would have been 62.1%, and MedDevice gross margin would have been 48.8%. Total operating expenses in the quarter were $48 million, or 60% of sales, compared to $52.9 million, or 74% of sales, last year. As a reminder, during the fourth quarter of fiscal 2024 last year, we incurred a number of one-time expenses, including amounts related to the settlement with C.R. Bard and our manufacturing transfer program. Turning that to R&D, our research and development expense was $6.6 million, or 8.2% of sales, compared to $6.7 million, or 9.5% 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 fourth quarter of FY25 was $36.7 million, representing 45.8% of sales, compared to $35 million, or 49.2% of sales a year ago. Our adjusted net loss for the fourth quarter of FY25 was $1.1 million, or an adjusted loss per share of $0.03 compared to an adjusted net loss of $2.3 million, or an adjusted loss per share of $0.06 in the fourth quarter of last year. This year-over-year improvement is largely attributable to our revenue growth and the success of our expense management initiatives. Adjusted EBITDA in the fourth quarter of FY25 was $3.4 million compared to an adjusted EBITDA of $1.5 million in the fourth quarter of 2024. As noted previously, during the fourth quarter, we entered into a revolving line of credit agreement with JPMorgan, which allows us to draw down up to $25 million at our discretion. Now, while we are very comfortable with the amount of cash we have on the balance sheet, we view the addition of a revolver as a matter of prudent financial housekeeping and a good safety net to ensure that any short-term working capital fluctuations associated with the Spectrum Transition Manufacturing Agreement doesn't impact our execution on our strategy. At this point, we have not drawn down any of the available capital as part of the revolver agreement. At May 31, 2025, we had $55.9 million in cash and cash equivalents compared to $44.8 million in cash and cash equivalents at February 28, 2025, which is inclusive of payment of the final revenue performance-based milestone payment of $5 million made as part of the company's acquisition of Arion in 2019, and the $1.6 million in tariff-driven COGS impacts and fees associated with our revolving credit facility. In the quarter, we generated $18.8 million in operating cash, had capital expenditures of $0.8 million, and additions to Arion placement and evaluation units of $1.8 million. As expected, we generated $16.2 million in free cash flow. Now turning to a quick review of the fiscal full-year results, revenue increased 8.1% to $292.7 million, primarily driven by growth across our MedTech segment. MedTech revenue was $126.7 million, a 19.5% increase. Our Arion platform contributed $56.9 million in revenue, growing 20.8% compared to last year. Mechanical thrombectomy revenue, which includes angiovac and alphavac sales, increased 32.9% year-over-year. In the fiscal full year, angiovac revenue was $28.9 million, a 25.1% year-over-year increase, and alphavac revenue was $10.8 million, a 59.5% year-over-year increase. Total NanoKnife revenue was $24.5 million, flat compared to the prior fiscal year. NanoKnife probes grew 9.6% for the year, and capital sales were down 26%. In fiscal year 2025, our med device revenue was $166 million, an increase of 0.8%. In the fiscal full year 2025, the company incurred limited revenue impacts because of tariffs. Our gross margin for FY25 was 53.9%, For the year, MedTech gross margin was 62%, and MedDevice gross margin was 47.7%. In the year, total gross margin saw an approximate 56 basis point negative impact from tariffs. Absent the $1.6 million paid in tariffs, full company gross margin would have been 54.5%. MedTech gross margin would have been 62.9%, and MedDevice gross margin would have been 48%. Turning to R&D, our research and development expense during FY 2025 was 26.2 million, or 9% of sales, compared to 30.9 million, or 11.4% of sales a year ago. SG&A expense for FY 2025 was 145.2 million, representing 49.6% of sales, compared to 139.2 million, or 51.4% of sales a year ago. Our adjusted net loss for FY25 was 10.2 million, or an adjusted loss per share of 25 cents, compared to an adjusted net loss of 18.2 million, or an adjusted loss per share of 45 cents last year. This year-over-year improvement is largely attributable to our revenue growth and the success of our expense management initiatives, very similar to the story for the quarter. Adjusted EBITDA in the full fiscal year 2025 was 7.6 million, compared to an adjusted EBITDA loss of $3.2 million in fiscal year 2024. Turning now to guidance. For the fiscal year 2026, we anticipate net sales to be in the range of $305 to $310 million, representing growth of between 4% and 6% over fiscal 25 revenue of $292.7 million. Within each of our businesses, we expect MedTech net sales to grow 12% to 15% year over year, and we expect med device sales to be roughly flat. For fiscal 26, we expect gross margin to be in the range of 53.5% to 55.5%. Now, this is inclusive of our estimated tariff impact of $4 million to $6 million. Absent this impact, gross margin guidance would have been 55% to 56%. We expect adjusted EBITDA to be in the range of $3 million to $8 million, again, inclusive of our estimated tariff impact. Absent this impact, adjusted EBITDA guidance would have been $7.5 to $10.5 million. And finally, we expect adjusted loss per share in the range of negative 35 to negative 25 cents. Absent the tariff impact, adjusted loss per share guidance would have been negative 30 cents to negative 25 cents. Beyond our P&L guidance, we continue to expect to be cash flow positive for the full fiscal year 2026. As is the case with all companies, Our first fiscal quarter will exhibit the highest use of cash. This is typical for angiodynamics, and the first quarter of fiscal 26 will be no different. In the first quarter of 26, we expect to utilize approximately $20 million of cash. We will return to cash generation in subsequent quarters, and we will finish FY26 having generated positive cash for the full year. Our guidance on cash is inclusive of any tariffs that we expect to pay during the year. With that, I'll turn it back to Jim.