AngioDynamics Inc

NASDAQ:ANGO

Good morning, and welcome to the AngioDynamics Fiscal Year 2025 Second Quarter Earnings Call. [Operator Instructions]

As a reminder, this conference is being recorded.

The news release detailing AngioDynamics' fiscal 2025 second quarter results crossed the wire earlier this morning and is available on the company's website. This conference call is also being broadcast live over the Internet at the Investors section of the company's website at www.angiodynamics.com, and the webcast replay of the call will be available at the same site approximately 1 hour after the end of today's call.

Before we begin, I would like to caution listeners that during the course of this conference call, the company will make projections or forward-looking statements regarding future events, including statements about expected revenue, adjusted earnings and gross margins for fiscal year 2025 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 include 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 to the company's financial results is also available on the Investors section of the company's website under the 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.

I'd now 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 2025 second quarter earnings call. Joining me on today's call is Steve Trowbridge, AngioDynamics' Executive Vice President and Chief Financial Officer.

I will begin today's call by providing an overview of our recent performance. Steve will then provide a detailed analysis of our second quarter financial performance, and I will conclude with our outlook for the balance of the year before opening the line for questions.

Unless otherwise noted, all financial results 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, and the PICC and Midline products that we divested in February 2024 and the Radiofrequency and Syntrax support catheter products that we discontinued in February 2024.

We had a very strong second quarter. Total worldwide revenue was $73 million, representing growth of approximately 9% year-over-year. Our Med Tech segment had yet another excellent quarter, growing 25%, led by growth across all of our platforms.

Beyond the top line, we continued to show strong results with respect to profitability, reporting adjusted EBITDA of $3.1 million and generated $2.5 million in operating cash flow.

Based on our first half performance and the momentum we expect to deliver in the back half of the year, we now expect to deliver positive adjusted EBITDA for the full year, illustrating continued execution on our goal of delivering sustained profitability.

Starting with an update on our Med Tech business. Auryon continued on its sustained delivery of solid results, growing approximately 22% over the prior year. We have continued to execute on our strategy by taking share with a better product, allowing us to increase penetration and drive a higher mix of revenue from hospital customers.

Turning to our mechanical thrombectomy business. We are very encouraged by the performance of both AlphaVac and AngioVac which, in combination, grew approximately 46% over the second quarter of last year and further validates the strength of this broad, innovative portfolio. AngioVac and AlphaVac together provide AngioDynamics with an unparalleled product portfolio option, and we will continue to leverage the synergies between these 2 product lines to cement AngioDynamics as a solid [indiscernible] competitor in this large, fast-growing, high-margin market.

Beginning with AlphaVac, we saw solid performance in the quarter with revenue increasing by over 33% versus prior year. This also marks the third consecutive quarter of sequential revenue growth, highlighting its adoption for treating PE following our FDA clearance in early April and our CE marking in late May.

As noted on our prior call, supported by our excellent clinical data and a fully trained sales force, we moved into full market release in both the U.S. and Europe in June. We remain very encouraged by physicians and hospitals' willingness to evaluate AlphaVac for the treatment of PE, evidenced by the positive utilization trends we are seeing within existing customer accounts as well as progress we are making within our new customer pipeline as AlphaVac is being reviewed as part of a growing number of hospitals value analysis committees.

As expected, the vast majority of our growth in the quarter was driven within the U.S. as our focused commercial efforts, in combination with the strength of our APEX data, have been very successful. In late December, data from the APEX trial were published in the Journal of the Society for Cardiovascular Angiography and Interventions, one of the premier peer-reviewed journals in this space.

The publication confirmed the outstanding results announced in May of 2024, which highlighted that AlphaVac is safe, effective and highly efficient in treating patients with acute intermediate risk PE. Importantly, the paper highlighted AlphaVac's 35.5% reduction in clot burden from the baseline, which compares favorably to the 9.3% reduction reported in the current market leaders IDE data. This publication is yet another point of validation within the clinical community and should act as a catalyst as many physicians and hospital value analysis committees use studies like these to support their decision-making process when evaluating new technologies.

Turning to AngioVac. The PE indication for AlphaVac has proven to be a positive catalyst for AngioVac. As the awareness and utilization of AlphaVac has grown, it has created opportunities for our commercial organization to educate physicians on our entire mechanical thrombectomy portfolio. This increased engagement, has opened doors to new facilities and physicians, which helped to drive revenue growth of approximately 51%. While we don't expect to see this level of growth during the balance of 2025, we do expect continued broader adoption to drive year-over-year growth moving forward.

And lastly, within our Med Tech segment is NanoKnife, which has recently seen a number of exciting developments. We continue to be encouraged by trends in the adoption and utilization of NanoKnife, in particular, within the urology community, as evidenced by approximately 23% growth in probe revenue in the quarter.

As outlined on our last call, we expected to achieve multiple key milestones for NanoKnife by the end of calendar 2024, all of which we did. We identified 3 key pillars that are necessary to drive long-term adoption and exciting growth for NanoKnife. First, regulatory clearances for specific indications; second, reimbursement and market access; and third, increased market awareness. We have made significant progress on all 3 fronts since our last update.

With respect to regulatory clearance, we received an expanded indication for the NanoKnife system for prostate tissue ablation from the FDA in early December. With this clearance in hand, we can now more proactively market, educate and train for the procedure in ways that we've been previously unable to do.

With respect to reimbursement and market access, in mid-September, we participated in the CPT Editorial Panel meeting related to a proposal to create a new CPT Category I code, specific to IRE and prostate procedures. In October, we were thrilled to have been granted a new CPT I code for the treatment of lesions in the prostate and in liver. The new codes will be effective with physician relative value units attached on January 1, 2026. We continue to work diligently with our market access teams on coverage, coding and payment initiatives to ensure that reimbursement will be widely available across both the commercial and private payers in advance of that effective date.

Finally, with respect to our marketing and education strategy to both urologists and patients, we began highlighting the quality of outcomes generated during our PRESERVE clinical study. the pivotal trial we ran in support of our NanoKnife prostate expanded indication. PRESERVE evaluated the safety and effectiveness of NanoKnife for the ablation of prostate tissue in patients with intermediate risk prostate cancer, which included 121 patients enrolled across 17 clinical sites. PRESERVE met its primary effectiveness endpoint, demonstrating the performance of a NanoKnife system for the ablation of prostate tissue in patients with intermediate risk prostate cancer. At 12 months post procedure, 84% of men were free from any clinically significant cancer in the targeted area.

Just as importantly, the study demonstrated extremely compelling quality of life outcomes. When men have prostate cancer and are evaluating treatment options, they are forced to choose between effectively treating the cancer or maintaining the quality of life post treatment, particularly as it relates to sexual and urinary function. While traditional treatments such as radical prostectomy in radiation therapy often result in significant rates of erectile dysfunction and urinary incontinence following treatment, NanoKnife targeted approach demonstrates that men need not be forced to make this trade-off and represents a meaningful advancement in prostate cancer treatment.

In the PRESERVE study, men treated with NanoKnife did not have any higher rates of sexual dysfunction after 12 months than is seen with active surveillance or men who undergo no intervention. Just as impressively, approximately 99% of men did not suffer increased urinary incontinence 12 months post procedure. The PRESERVE study validates the robust safety and clinical efficacy we have seen in more than 32 clinical studies involving over 2,600 patients. In addition to the publications that we expect over the coming months, the PRESERVE data will be featured at the AUA Annual Meeting in Las Vegas at the end of April 2025.

As we look forward to the future of NanoKnife, we are very excited about what this product can be with the validation of a specific prostate indication and line of sight to a well-established reimbursement pathway. With a solid foundation of existing users in the U.S. and then established commercial infrastructure, we are able to hit the ground running. NanoKnife has the potential to redefine the standard of care for prostate health and deliver treatment outcomes that patients and physicians need with its unique mechanism of action. In combination with its efficiency and efficacy, it is a fantastic alternative to radical therapies, which force patients to make significant quality-of-life trade-offs. We believe that these trade-offs have historically limited the widespread adoption of other focal therapies, and we are confident that NanoKnife can provide a new paradigm for men.

We are very excited to provide a deep dive into NanoKnife and how it can revolutionize the treatment of prostate cancer with Virtual NanoKnife Technology Event following this earnings call.

Turning to our Medical Device segment. Revenue was approximately flat to the prior year with our U.S. Med Device business increasing about 2% year-over-year. Beyond our commercial execution, we illustrated another significant step towards sustained profitability. We reported adjusted EBITDA of $3.1 million during the second quarter compared to a loss of $10,000 during the second quarter of fiscal 2024. In the quarter, adjusted EPS was a loss of $0.04 per share, improving from a loss of $0.08 per share in fiscal 2024. And importantly, we generated $2.5 million of operating cash flow. These results highlight that our strategy to drive towards profitability is tracking ahead of plan, and we now expect to deliver positive adjusted EBITDA for the full year.

Before turning the call over to Steve, I wanted to provide a quick update on our shift to outsourced manufacturing. We have continued to find ways to optimize the process. And as part of that, we have made the decision to keep a portion of our Queensbury facility open, which allows us to make our supply chain more resilient. The process remains on track with our expectations and will allow us to fundamentally change our manufacturing overhead structure and take out those overhead costs, which will ultimately flow through to our bottom line. As a reminder, we expect this transition to generate approximately $15 million in annualized savings by fiscal 2027.

We are very excited about our performance during the second quarter and the momentum we have been able to generate during the first half of the year. Our achievements over the past 6 months in combination with the efforts of our organization over the last 3 years have transformed AngioDynamics. Our focus on driving growth within large and fast-growing markets has paid off through strategic investments in R&D, clinical research, regulatory submissions and market access initiatives within our Med Tech portfolio. We have now successfully expanded our total addressable market, which now stands at over $10 billion globally, up from just $3 billion in 2021. Not only have we delivered improving growth but we have also accelerated our pathway to profitability through operational efficiency initiatives. Supported by the strength of our balance sheet, we are in a fantastic position to bring our innovative technologies to more health care providers and more patients, while at the same time, creating shareholder value.

With that, I'll turn the call over to Steve Trowbridge, our Executive Vice President and Chief Financial Officer, to review the quarter in more detail.

Thanks, Jim. Good morning, everybody. 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 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 in February 2024.

Our revenue for the second quarter of FY 2025 increased 9.2% year-over-year to $73 million, driven by growth in both our Med Tech and U.S. Med Device platforms. Med Tech revenue was $31.6 million, a 25% year-over-year increase, while Med Device revenue was $41.5 million, flat compared to the second quarter of FY 2024. But as Jim mentioned, our U.S. Med Device business was up 1.6% over the prior year.

For the second fiscal quarter, our Med Tech platforms comprised 43.2% of our total revenue compared to 37.7% of total revenue a year ago, illustrating sustained execution on our strategy of increasing the percentage of our overall revenue base coming from our Med Tech segment.

Our Auryon platform contributed $13.7 million in revenue during the second quarter, growing 21.8% compared to last year. Auryon has now delivered double-digit year-over-year growth in each of the 14 consecutive quarters following the anniversary of its launch.

Mechanical thrombectomy revenue, which includes AlphaVac and AngioVac sales increased 46.2% over the second quarter of FY 2024. AlphaVac revenue for the second quarter was $2.5 million, an increase of 33.3% year-over-year and 14% sequential increase over the first quarter of 2025, resulting from the continued adoption of AlphaVac for PE. We're pleased to see the strong performance of AngioVac during the quarter, which generated $8.1 million of revenue, an increase of 50.7% year-over-year.

As Jim mentioned, the combined strength of AngioVac and AlphaVac illustrate the strength of our comprehensive mechanical thrombectomy portfolio. We are definitely seeing synergies between the 2 product offerings. We remain very encouraged by the universally positive feedback we're receiving regarding AlphaVac as well as the increased adoption of AngioVac.

The mechanical thrombectomy market continues to be one of the most exciting, fastest-growing med tech markets. And although the market is currently led by 2 large-scale competitors, AngioDynamics continues to demonstrate our ability to take share, positioning us as a strong #3. We are excited about our current growth trajectory and our future prospects in this market led by our innovative portfolio.

Total NanoKnife revenue was $6 million, an increase of 4.9% over the prior year quarter. NanoKnife's disposable revenue during the quarter increased 23.1%.

As we've discussed throughout the year, we expect capital sales during the year to be approximately half of what they were in 2024. And in line with those expectations, capital sales declined 39.7% during the quarter. We were very pleased with the trajectory of prostate cases in the quarter and are on track for our projections for NanoKnife for the full year.

While we expect to see increasing contribution from NanoKnife following the positive reimbursement decision received in October and the prostate indication received in December, these milestones were built into our expectations for fiscal year 2025 and are already reflected in our guidance for the year.

Moving down the income statement. Our gross margin for the second quarter of FY 2025 was 54.7%, a decrease of 10 basis points compared to the year ago period, but ahead of our expectations for the quarter. For the second fiscal quarter, Med Tech gross margin was 63.7%, an increase of 120 basis points, primarily driven by mix associated with increased AngioVac revenue. Med Device gross margin was 47.8%, a decrease of 240 basis points, primarily driven by inflationary pressures and costs associated with the transition to outsource manufacturing.

Turning to R&D. Our research and development expense during the second quarter of FY 2025 was $6.4 million or 8.8% of sales compared to $8.3 million or 12.5% of sales a year ago. The year-over-year decrease is primarily related to timing, including the completion of our PRESERVE and APEX clinical studies. We remain committed to investing in R&D initiatives to support the long-term growth of our Med Tech segment.

SG&A expense for the second quarter of FY 2025 was $36 million, representing 49.3% of sales compared to $33.2 million or 49.7% of sales a year ago. Our adjusted net loss for the second quarter of FY 2025 was $1.7 million or an adjusted loss per share of $0.04 compared to an adjusted net loss of $3.4 million or an adjusted loss per share of $0.08 in the second quarter of last year. The year-over-year improvement is largely attributable to higher revenue and improving operating leverage during the second quarter of this year. Adjusted EBITDA in the second quarter of FY 2025 was a gain of $3.1 million compared to a loss of $10,000 in the second quarter of 2024.

Turning to an update on our balance sheet. At November 30, 2024, we had $54.1 million in cash and cash equivalents, inclusive of the cash utilized in our stock repurchase program, compared to $55 million in cash and cash equivalents at August 31, 2024. As a reminder, we currently have 0 debt.

In the second quarter of fiscal '25, we generated $2.5 million in operating cash, had capital expenditures of $0.8 million and additions to Auryon placement and evaluation units of $1.2 million.

For the balance of the year, we expect to utilize approximately $10 million of cash in the third quarter before returning to cash generation in the fourth quarter. As we stated in July, we're targeting to end the year with approximately $60 million of cash on the balance sheet.

Cash utilization in the third quarter will be driven by scheduled payments associated with the settlement of our patent litigation with [indiscernible] Bard that we executed last year and working capital usage connected with our transition manufacturing arrangement with Spectrum Vascular, the company we sold our PICC and Midline business to in February of last year. While we've been managing working capital associated with this transition manufacturing arrangement since the divestiture, we do expect working capital requirements to increase during the back half of our fiscal year as we progress towards full manufacturing transfer during our calendar 2025.

To leverage the strength of our balance sheet, we're evaluating the addition of a working capital revolving credit facility. While we're very comfortable with the current amount of cash on the balance sheet, we view the addition of a revolver as a matter of prudent financial housekeeping, one that further bolsters our balance sheet and provides for increased flexibility and optionality at a relatively low cost capital and 0 dilution. We are extremely proud of our cash position and balance sheet management, and we'll continue to appropriately manage working capital as we turn to proving that our business model generates cash for the full year in the next couple of quarters.

Through the continued execution of our growth strategy and operational efficiency initiatives and our demonstrated progress towards profitability, we remain on track with our stated goal of being cash flow positive for the full year of fiscal 2026.

As announced in July of calendar 2024, the company approved a stock repurchase program, authorizing purchases of up to $15 million of our outstanding common shares. Through the end of the fiscal second quarter, we purchased approximately $1.7 million worth of stock at an average share price of $6.82. We will continue to be opportunistic about our decision to make further repurchases on a number of factors, including market conditions as well as the need to balance investment in our growth strategy as we seek to leverage the strength of our balance sheet to create value for our shareholders.

And turning now to guidance. For fiscal year 2025, we continue to expect revenue will be in the range of $282 million to $288 million, representing growth of between 4.2% and 6.4% over fiscal year 2024. Within each of our businesses, we now expect Med Tech net sales to grow in the range of 12% to 15% ahead of our previous guidance of 10% to 12%, and we now expect Med Device net sales to be about flat, down from the previous guidance of 1% to 3%.

From a quarterly cadence perspective, we expect the balance of the year to follow a typical seasonality pattern with total revenue in the third quarter being slightly down sequentially from the second quarter, with the fourth quarter being the strongest of the fiscal year.

For fiscal 2025, we continue to expect gross margin to be in the range of 52% to 53%. We now expect adjusted EBITDA in the range of a gain of $1 million to $3 million, up from the previous guidance of a loss of $2.5 million to 0.

And finally, we now expect an adjusted loss per share in the range of $0.34 to $0.38, an improvement from our previous guidance of a loss per share of $0.38 to $0.42.

With that, I'll turn it back to Jim.

Thanks, Steve. Looking to the balance of the year, we will remain focused on a number of key strategic areas of our business aimed at driving growth. Starting with Auryon. In the U.S., we will leverage the momentum built during the first half of the year to continue to drive increased penetration with a particular focus on the hospital setting. Having received a CE Mark in late Q1, we have now shifted to a full market release in Europe, which we expect to make a positive impact on revenues during the back half of the year. We will continue to develop supporting clinical data and launching new product line extensions as we move forward.

With AlphaVac, we continue to push ahead commercially as we focus on driving increased adoption for the treatment of PE. To support that, we will continue to invest in high-quality clinical data, highlighting the differentiation of our products to help support long-term adoption. In addition, we continue to expect to launch new product enhancements over the course of year to refine and improve usability.

And lastly, with NanoKnife. With prostate indication in hand as well as the clarity around the reimbursement pathway in the U.S., we expect to leverage our well-established commercial infrastructure and high-quality clinical data to drive increased long-term adoption in the U.S. for prostate. To that end, I would like to remind everyone that we will be hosting a virtual NanoKnife specific event at 9:30 a.m. Eastern Time to provide an in-depth overview on our market opportunity, the NanoKnife technology and our go-to-market strategy.

We continue to be very excited about the future at AngioDynamics. With the tremendous work done across our organization to transform our portfolio to focus on large, high-growth markets and overhaul our financial profile, supported by the strength of our balance sheet, we are on the precipice of being able to deliver sustainable, profitable growth for years to come.

With that, operator, I will now open the line for questions.

[Operator Instructions] Our first question today comes from the line of John Young with Canaccord Genuity.

Jim and Steve, congrats on a great quarter. I think I'll hold my prostate question until the event later. So maybe I could just start on the thrombectomy progress that you've guys made. It's really encouraging to see it.

First, what drove that sort of acceleration in AngioVac and how sustainable do you think that acceleration could be?

And then two, for AlphaVac, really, it's just a matter of effective commercial execution here to be successful. What are the plans? What's working? What's not? And how do you think about that Vac pipeline that you guys mentioned on the call?

And then maybe just to sneak in a third question here, too, just in light of the M&A in the sector that we saw this week, what changed within your commercial plans because of that? And then also, how do you think about monetizing in value creation here in terms of getting the best [indiscernible] of technology in your hands versus someone else's hands?

John, thanks for the question. A few things we learned. It is going really well now with our selling and marketing team and our clinical support teams are fully trained on both AngioVac and AlphaVac. And we've really found from the customer pointing synergies back to us. So our teams are sometimes -- I'll give you an example, making a sales presentation on the PE device with AlphaVac, why we think it's so safe and effective to use. And along the way, we get a lot of agreement. And then the doctors are saying, "Wait, but you guys also have this AngioVac device. I've seen it before. I'm not sure about it. Walk me through it." So we're getting a lot of synergistic selling opportunities that didn't occur before, either one is opening a door for the other, which is terrific.

So as we go forward, our selling and marketing teams are really selling mechanical thrombectomy products. And that's really what the pipeline that we have built out around both products, which are both unique, both very, very different and solve different needs in the market. So we're going to continue to do that, John. We've learned a lot and we're adding new selling and marketing resources as we go. And we're getting more people who join our company that come already from the space that are skilled, knowledgeable and have relationships. They want to join our team, represent our products. So that's been helpful, John. We think that will keep the momentum going in both AngioVac and AlphaVac. Steve?

Yes, I think that's exactly right. Just to build a little bit on what Jim said. We are learning that there is a very identifiable benefit to the comprehensive portfolio offering that we have with both AngioVac and AlphaVac. I think it's something that we're finding some -- that we're pleasantly surprised about it, how well they're working together as we go to market now. We talked a little bit last year about some of the changes in AngioVac and some of the new training with our sales force. As Jim said, I think the training of the full sales force has allowed us to really leverage this comprehensive portfolio. And so when you look at our results, the overall mechanical thrombectomy combined with AngioVac and AlphaVac is something that has us really excited. We're pleased with AlphaVac. We're pleased with the progress that we're seeing. The feedback we're getting is universally positive from physicians who have had their chance to get their hands on the device. We think our device in AlphaVac can do things that no other device on the market can do.

As a reminder, we're still in our first generation. So we've got some line extensions that Jim talked about coming out this year. We'll continue to innovate on that. But we're going to continue to really leverage the combined portfolio that we have because we're seeing that, that gives us a little bit of a different story than some other folks in the market.

With your question on the Vac pipeline, absolutely getting the data published, we think is going to be important. You know that this is a little bit of a crowded space. There's been kind of some top heavy market leaders and there's a lot of folks who are in trials as we speak. We've already gone through that. We've committed. We performed in our trial. We completed it. You saw the results, particularly when it comes to removal of clot burden and how we believe that AlphaVac is significantly better than the other products that are on the market. We think continuing to leverage that is going to drive some expansion through the Vac process, while we go back to what we were saying before and really leverage that combined portfolio.

Not lost on us, the news that you were talking about and some of the M&A activity. Your question in terms of what changes in our commercial plans. Look, we're always going to assess that on what it means for us. I think the -- what we're going to continue to do is leverage the combined portfolio, as Jim mentioned, continue to invest in our sales and marketing teams and invest in the resources that we give those teams, and we think that we are very well positioned to continue to show that we are a strong player in this exciting market, and we're going to continue to take share and drive growth.

And then maybe just a follow-up on Auryon. Just quarter-over-quarter, seeing a little bit of slowing here. I know you guys are really focused on the hospital health patient opportunity. When it comes to OBLs, do you think that opportunity essentially has reached its ceiling? And then on the OUS opportunity for the second half of this year, can you just talk about the reimbursement dynamics in Europe and maybe impacts the [indiscernible] that we should expect?

Thanks, John. I think the Auryon team is off to a great start in the first 6 months of this year. Quarter-to-quarter dynamics, we don't measure that closely. There's always a couple of little things, but they're off to a great start. There's great momentum there. And it's really built upon -- the actual product itself is a really amazing product. It's been proven already how safe and effective it is. Then our shift, our team really did a great job about 18 months ago, we talked about it publicly. With that shift in our focus going from the OBL initial focus over to the hospitals, it's going really well. I think we're now a little over 35% of our revenue, it's from the hospital customer, shows how well we'll receive now.

And again, when we win share there, we're winning it from really good companies that are entrenched in those spaces that have abilities to bundle other products that we don't have. So we're winning those share based upon the ability of our product to outperform the other products. So we're bullish that we'll continue to do so, John, and grow in that space. But we're not abandoning the OBL. Those are still good customers. We're getting new opportunities all the time there. But for us, we talked about it publicly, we stand by it. The shift to the hospital customers is really important for us, and we'll continue there.

Back to your point on the European reimbursement, that's probably very complicated. I don't know if I have all the knowledge here, John, to give you that country by country, the people who lead our business are very well knowledgeable in this space. They plan for this. They've been fully trained. Our distributor partners are fully trained, ready to go and establish ourselves in the European market based on opportunity first. As you know, a company our size can't approach all markets. We have a targeted approach platform ready to go, and we're doing that as we speak. So maybe over time, we can give you more details on that.

And specifically to your question on reimbursement here in the U.S. and the dynamics in the OBL versus the [ ASC ] or Auryon hospital, as you know, there's been some reimbursement pressures in this business over the last few years. As we said from the beginning, it's something we expected. It's something we expected when we did the due diligence and looking to buy this product. So if we took it from 0 revenue when we bought it to a run rate that exceeds over $50 million now. We're pretty pleased with the process. And we've said that we didn't think any of those changes would be derailing, and they haven't been. And in terms of what you've seen recently over the last quarter, not surprising to us and fits right within our strategy.

Our next questions are from the line of Steven Lichtman with Oppenheimer.

Congrats on the continued progress. I wanted to start on mechanical thrombectomy. Great to see the cross-selling opportunities beginning here. As you look at the portfolio across the 2 products, what is your outlook for growth here in the back half of the year? Obviously, AngioVac came in well ahead of expectations in the second quarter. So trying to get a sense of how you're thinking about the combined as we look out here over the next couple of quarters.

Yes. So we haven't given specific guidance on what we expect, Steve. We did say that we expect mechanical thrombectomy as a portfolio to be a meaningful contributor to our growth for this year. And we feel we're clearly on track to show that. We're very pleased with the performance that we saw in the first half. We expect to continue to see sequential growth as well as significant growth year-over-year as we proceed through the full year. As we continue to assess and have learnings around the portfolio opportunity that we have, we'll refine those expectations a little bit. But your expectation should be continue to see double-digit growth in the back half.

Okay. Great. you already spoke to some of the near-term potential drivers for Auryon. Longer term, I know you had been looking at potential indication expansion to iliofemoral DVT and in coronary. Can you update us on where you are relative to those?

Yes. So a couple of things going on. We believe this unique product could actually perform really well in the 2 areas that you just mentioned. We believe it could be a DVT product the way it works. That will take a little more work from us, not just on the R&D work, but the regulatory clearances that are in front of us. So we've not talked about a pathway there yet to open up a program there.

We've also talked about, we believe it could be really effective in the coronary space. We understand the pathway process there. It's complicated. So we're looking at it internally. Does that make sense for us? It's a really great market opportunity. We think our product will perform really well in that space. So really, we got to decide if that's the right place to put our energy and our resources.

We also think, too, the study that came out last year that showed that we can crack [indiscernible], like some of the [indiscernible] products can do, and we're really effective at cracking that calcification from what this study showed. That interests us as well. As we know, there are a lot of people interested in that space.

So what we've got, Steve, is a product that's really performing well, taking share in the PAD market, where we're focused on today. But there is at least these 3 runways for us to pursue over time. As you know, a company our size only has so many resources. We want to make sure we apply them to the right area for us to give our shareholders the growth opportunity they deserve, and we'll give you more detail on that when we have those decisions made.

And then just, I guess, lastly, Steve, on gross margin. The first half coming in north of 54%. Obviously, you came in ahead of expectations in the second quarter and maintained the full year guidance. Any conservatism in that full year? Or are we thinking back half mix would be the delta that would bring the full year down? How should we think about that?

Yes. So the main driver for the performance that we saw is the mix that you mentioned. And so the continued growth in tech and the uptick in the tech guidance will be a tailwind to gross margin in the back half.

The other thing that's happening, though, is the dynamic we talked about is we're working through our manufacturing transfer as we get products out of Queensbury and get them to Costa Rica, it kind of accelerates us double paying overhead and having some additional unabsorbed overhead in the structure until we're able to take those costs out as part of the manufacturing transfer.

So as we mentioned, we're right on track of that manufacturing transfer. We're going to get the benefit of our program for the full year '27, but it does have a structural impact where it may create some under-absorption here in the back half.

So you're going to see those 2 dynamics happening. Benefit coming from the mix shift, which is really our overall gross margin long-term strategy for AngioDynamics. If you remember, when we first started reporting in our 2 segments, Med Tech was less than 17% of our overall revenue base. Jim mentioned, it's 43% of our revenue base this quarter. So you're seeing that mix shift. And then as we can get through the manufacturing transfer and take out some of those overhead costs, rightsize that overall structure, you're not going to see the full benefit of that drop to gross margin as well as the bottom line.

Our next question is from the line of Yi Chen with H.C. Wainright.

Could you comment on the feedback from the limited market release of Auryon in EU countries? And when do you plan to transition to a full market launch?

Good question. So really good feedback. We've been able to participate. Steve and I have both been able to attend, our European team has done a really good job setting up a series of scientific symposiums on a semiannual basis. So over the last 18 to 24 months, we've really developed a good understanding of the global market. A lot of the thought leaders have attended our symposium. Some have tried our device, they're reporting some of the results of their studies and their findings. So it's kind of generated a lot of organic interest overseas, which have been helpful for our teams and to target where the best spot for us to put our energy is. So our team is really focused.

We got through the regulatory clearances that we needed to get the CE Mark. And now we have access to that market. We have mentioned that this year, we don't expect a lot this year. It will be a small single-digit contributor to our revenue. You'll see that come in, in the back half of our year. And then we'll see more revenue performance into next fiscal year. But our team is well prepared. They're going to do a great job with this amazing product. But again, a company our size has limited resources. We're very selective as to where we're going to target how we get there, and we know there's a lot of demand and interest in the product.

Got it. And could you talk about the status of the RECOVER-AV trial in EU of AlphaVac for PE? And do you expect sales of AlphaVac for PE to be limited compared to the U.S. until the readout from the RECOVER-AV trial?

So I'm starting with the last question. I don't expect the sales in the U.S. to be limited until the readout of RECOVER. I think APEX, as we talked about, the publication there and how that helps us with some of the [indiscernible] here in the U.S. and just continued commercial execution around our combined portfolio in the U.S. is what we're focusing on for AlphaVac here.

In the European question around RECOVER, ongoing, it's part of our continued commitment to providing data generation in this space. We think that data is very important to continue to support your own product, support physicians who are moving from medical interventions to adopting mechanical interventions for thrombectomy. We're going to continue to invest in that area, again, as we really continue to cement ourselves as a primary player in thrombectomy globally. So we're excited about where we're going with RECOVER.

Thank you. At this time, I'll turn the floor back to Mr. Clemmer for closing remarks.

Thank you, operator. Again, I'd like to thank everybody for participating today on the call. We'll invite you to join us at 9:30 this morning, Eastern Time, for our special presentation on why we believe our NanoKnife product is a really effective opportunity for people with intermediate risk prostate cancer to be treated.

I also want to thank our employees for their hard work and dedication to our customers, the patients that they serve. And I also want to mention, too, that we're thinking of our employees and the other folks in the West Coast affected by the terrible wildfires today. We hope they got all be safe from this terrible tragedy.

Thank you, operator. Thanks for joining us today.

Thank you. This will conclude today's conference. You may disconnect your lines at this time.