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Edited Transcript of ANGO earnings conference call or presentation 2-Apr-19 12:00pm GMT

Q3 2019 AngioDynamics Inc Earnings Call

NEW YORK Apr 10, 2019 (Thomson StreetEvents) -- Edited Transcript of AngioDynamics Inc earnings conference call or presentation Tuesday, April 2, 2019 at 12:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Brent J. Boucher

AngioDynamics, Inc. - Senior VP & GM of Oncology Business

* James C. Clemmer

AngioDynamics, Inc. - CEO, President & Director

* Stephen A. Trowbridge

AngioDynamics, Inc. - Senior VP & General Counsel

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Conference Call Participants

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* Cecilia E. Furlong

Canaccord Genuity Limited, Research Division - Associate

* Lucas Grant Baranowski

Craig-Hallum Capital Group LLC, Research Division - Research Analyst

* Matthew Ian Mishan

KeyBanc Capital Markets Inc., Research Division - VP and Senior Equity Research Analyst

* Matthew Jay Wizman

Raymond James & Associates, Inc., Research Division - Senior Research Associate

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Presentation

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Operator [1]

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Good morning, and welcome to the AngioDynamics Third Quarter Fiscal Year 2019 Earnings Call. (Operator Instructions) As a reminder, this conference call is being recorded.

The news release detailing the 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, 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 free cash flow for fiscal year 2019. 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.

A slide package offering insight into the company's financial results is also available on the Investors section of the company's website under events and presentations. This presentation should be read in conjunction with the press release discussing the company's 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?

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James C. Clemmer, AngioDynamics, Inc. - CEO, President & Director [2]

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Thanks, Rob. Good morning, everyone, and thanks for joining us today for AngioDynamics Third Quarter Fiscal 2019 Earnings Call.

Joining me today on the call will be Michael Greiner, AngioDynamics' Executive Vice President and Chief Financial Officer; and Stephen Trowbridge, Senior Vice President and General Counsel, who is also the leader of our clinical team. Michael is under the weather today and will not be doing the financial portion of the call, but is with us to answer any questions that you may have during the Q&A portion of our call.

Today, I will provide a brief overview of our operating highlights and financial performance for the quarter. Before I close our prepared remarks, we'll have a discussion of the NanoKnife pancreatic cancer DIRECT study. Stephen has joined us to answer specific questions that you may have related to the approval of this study that we announced yesterday morning.

Overall, we are really pleased with our results for the third quarter. Despite some pockets of softness, we were encouraged by our solid results in a number of areas, and we continue to generate profitable growth with a focus on operational excellence and building a market-leading cohesive product portfolio. As I will discuss later, our third quarter performance positions us to achieve our annual guidance for revenue, adjusted EPS and free cash flow.

Our net sales for the third quarter of fiscal 2019 increased 3% to $86.3 million, driven by growth in our Oncology and Vascular Interventions and Therapies businesses, including contributions from our recent acquisitions of BioSentry and RadiaDyne, which are in line with our expectations for the third quarter.

At the product level, our AngioVac, dialysis catheters, fluid management and Solero products exhibited solid growth during the quarter, offsetting lower NanoKnife capital sales, which were primarily a result of timing and continued expected slowing of our radiofrequency ablation products as market adoption focuses on our microwave ablation technology.

With regard to the performance of each of our businesses, our VIT business grew 3.3% year-over-year as strong growth in the AngioVac and fluid management product lines, along with continued strength in our core business were partially offset by an anticipated decline in the Venous Insufficiency business. The pace of this decline continues to decelerate, and we continue working diligently to stabilize this business and anticipate better comps in fiscal year '20. AngioVac procedural volume remains strong with procedures increasing 19% year-over-year, representing our sixth consecutive quarter of double-digit volume growth and further validating this unique technology.

As we mentioned in detail at the JPMorgan conference in early January, we are continuing to make targeted R&D investments in our thrombus management portfolio while also identifying external growth opportunities. We believe there is a significant opportunity available to us in the moderately complex segment of the thrombus management market based upon the success of our Uni*Fuse and AngioVac platforms, which serve the simple and complex end of this space, respectively.

The middle of this market is a significantly larger addressable market than we currently serve with meaningful opportunities for growth and share gains.

Our Vascular Access revenue declined 4% during the third quarter as continued strong performance in sales of our dialysis products was offset by declines in sales of PICCs, midlines and ports. We experienced very strong growth in port sales during the second quarter, which we believe impacted our ability to drive growth in the third quarter. We do anticipate returning to low single-digit growth in the fourth quarter in both our ports and our midlines businesses.

Revenue from our Oncology business increased 15.1%. Strong sales of our Solero microwave product and revenue contributed by our BioSentry and RadiaDyne acquisitions helped to offset a decline in NanoKnife capital sales during the quarter. We remain pleased with the early success of our Oncology acquisitions, which are both progressing in line with our expectations as we continue to build out our Oncology business around a continuum of care portfolio. We also recently received 510(k) approval for electron and cancer treatments related to our OARtrac real-time dosimetry device. This approval both defines and supports the future growth profile of our OARtrac while positioning us to obtain additional indications in the future.

Despite the softness in NanoKnife capital sales, we continue to see momentum in increasing global adoption of this groundbreaking technology, and we are thrilled to have received IDE approval from the FDA, which we announced yesterday morning, for the use of our NanoKnife technology in the treatment of Stage III pancreatic cancer, which I will discuss in more detail after going through the financials. In addition, another positive development in the quarter included our previously announced successful outcome in the Delaware intellectual property litigation with Bard. We were pleased with the court's decision to dismiss this case.

After reviewing the financials, I want to remind everyone that each quarter, we post a presentation on our Investor Relations website summarizing the key items associated with our quarterly results as well as our financial guidance. Those slides are intended to complement our prepared remarks.

Our net sales for the third quarter of fiscal 2019 were $86.3 million, representing a year-over-year growth of 3% when including our RadiaDyne and BioSentry acquisitions and declining 0.8% on an organic basis. Our gross margin for the third quarter of fiscal 2019 contracted by 10 basis points to 54.1% from 54.2% a year ago. We continue to see gains in gross margin related to operational and supply chain improvements as well as positive impacts associated with our portfolio optimization strategy, specifically the RadiaDyne and BioSentry acquisitions. These gains were offset during the third quarter by headwinds related to FX, which were approximately 20 basis points compared to the prior year, as well as a onetime benefit that we received in the prior quarter -- prior year quarter related to our plant closures worth approximately 50 basis points. We continue to anticipate our full year 2019 gross margin will finish in the range of 54% to 55%, with a fourth quarter exit gross margin exceeding 55%.

Our research and development expenses during the third quarter of fiscal 2019 were $7.2 million or 8.4% of sales compared to $6.5 million or 7.7% of sales a year ago. Consistent with our comments over the past several quarters, we are spending more in R&D and clinical around some of our core technologies, and we continue to anticipate R&D spend to be approximately 8% of net sales for this fiscal year. This already contemplates additional spending related to the rollout of our NanoKnife study and also to support our recent acquisitions.

Moving down the income statement. SG&A expense for the third quarter of fiscal 2019 increased to $28.2 million or 32.7% of sales compared to $25.7 million or 30.7% of sales a year ago. We anticipate SG&A expense as a percent of revenue to be approximately 32.5% for the full year, inclusive of approximately $4 million in SG&A expenses as a result of the 2 acquisitions earlier in the year.

Our adjusted net income for the third quarter of fiscal 2019 was $7.4 million or $0.19 per share compared to an adjusted net income of $8.7 million or $0.23 per share in the third quarter of last year. The 2018 Tax Reform Act went into effect for us during our third quarter last year. Adjusted net income for the third quarter of fiscal year 2018 was based upon a tax rate of 23%. We have updated our full year prior year post-tax reform rate to 30.62%, resulting in a $0.02 impact on last year's adjusted net income. Our current statutory tax rate is 23% in fiscal year 2019.

Adjusted EBITDAS in the third quarter of fiscal 2019, excluding the items shown in the reconciliation table in our presentation, was $14.9 million compared to $16.8 million in the third quarter of fiscal 2018. This 11.3% decline is attributed to the previously noted increase in R&D and SG&A spending, partially offset by our increase in revenue. In the third quarter of fiscal 2019, we generated $8.3 million of cash from operating activities and our free cash flow was $7.5 million.

Now turning to our balance sheet. As of February 28, 2019, we had $41.7 million in cash and cash equivalents and $133.8 million in debt. This excludes the impact of deferred financing costs recorded on the balance sheet. As a result, our net debt to adjusted EBITDAS ratio is currently 1.55, providing us with sufficient access to capital to execute against our investment and capital deployment strategies.

Finally, we are reaffirming our financial guidance for fiscal 2019. We continue to expect 2019 net sales in a range of $354 million to $359 million. We also continue to expect adjusted EPS between $0.82 and $0.86 as well as free cash flow between $26 million and $31 million.

Now I'd like to take a moment to continue our earlier discussion on the recently announced NanoKnife IDE approval and to provide more details on the DIRECT study. As noted in our press release yesterday, we are very excited to begin enrolling patients into our DIRECT study and improving the standard of care for pancreatic cancer. This disease afflicts approximately 57,000 new patients every year in the United States alone, and approximately 25% of those patients present at Stage III, making them good candidates for our DIRECT study with NanoKnife.

In terms of the details of the DIRECT study, it will include a real-world evidence, next-generation registry at up to 30 sites as well as a randomized, controlled trial at up to 15 sites, each with a NanoKnife treatment and control arm. Our design anticipates each NanoKnife arm to consist of approximately 250 patients with an equal number of control patients. The primary endpoint of the study is overall survival.

As a reminder, we also received a determination from the FDA that the DIRECT study will receive a Category B designation. This means that the FDA has determined that the information we provided demonstrates that their initial questions around safety and effectiveness for the NanoKnife system for the treatment of Stage III pancreatic cancer have been resolved. This is a significant positive as the device and the related treatment during the study will be eligible for reimbursement, significantly mitigating the overall costs of the study.

We are not updating our guidance at this point, but we intend to have a further readout on our 3-year strategic and financial plan to share with you by our fiscal year-end call. We are looking forward to this comprehensive study that will demonstrate our technology's unique capabilities and benefit pancreatic cancer patients. We are thrilled to be able to start enrollment soon, and in fact, we've launched AngioDIRECT.com as a website to facilitate enrollment and educate patients and their families. All of us at AngioDynamics are dedicated to the idea that the standard of care for this deadly disease can and should improve.

With that, I'll turn the call over to the operator for your questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question is from the line of Matt Hewitt with Craig-Hallum.

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Lucas Grant Baranowski, Craig-Hallum Capital Group LLC, Research Division - Research Analyst [2]

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This is Lucas Baranowski on for Matt Hewitt here at Craig-Hallum. I guess, first off, congrats on the IDE approval. And yes, we've just got a couple of questions around that. It sounds like enrollment is going to be starting soon. So maybe you could just give us some color on how we should think -- be thinking about this trial from a time line perspective and when there might be a readout.

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James C. Clemmer, AngioDynamics, Inc. - CEO, President & Director [3]

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Lucas, this is Jim. In a moment, I'll give Steve a chance to answer you in more detail, but first, I want to talk about for a second how we got here. And again, AngioDynamics has invested heavily in resources to support this trial. We're very committed to having this opportunity to prove our technology to help these people in need of care.

What we've done, Lucas, in the past 1.5 years or so, internally, we've invested very heavily in bringing really good people to our team, led by Steve Trowbridge, I mentioned earlier, who'll answer your question, who runs our clinical group; led by Warren Nighan, who runs our regulatory and quality group; and led by Brent Boucher, who is the General Manager of our Oncology business. These 3 people have brought really talented folks to our team that have helped us accomplish this goal of getting this IDE approved by the FDA. So we're very excited by what can happen.

Let me have Steve chime in with a bit more detail for you.

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Stephen A. Trowbridge, AngioDynamics, Inc. - Senior VP & General Counsel [4]

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Thanks, Jim. Lucas, thanks for the question. With respect to enrollment, what we're stating is that we're targeting June as the time for the first enrollment of these patients. As you know, we've been working on this trial for a while. We've been working collaboratively with FDA for a very long time. We're very pleased to get the approval, and we're looking forward to starting.

As we've talked about before, this study comprises 2 parts. So there's an RCT aspect to it as well as a real-world evidence, registry aspect to it. We are hoping that enrollment in either of those will start by the June time frame.

And then with your question to the readout, we do expect that we'll be giving periodic updates around enrollment as we go through this. But as we've talked about, we're expecting to enroll this trial to the end. We have an interim analysis set up to test our statistical assumptions, not to try to have any early readouts. So our current expectation is just to run through this trial.

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Lucas Grant Baranowski, Craig-Hallum Capital Group LLC, Research Division - Research Analyst [5]

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Okay. That's helpful. And then you've also talked in the past and on this call about how physicians in the trial will be getting reimbursed. I mean, is there any color you could give around kind of those reimbursement amounts and where they've been set at?

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Stephen A. Trowbridge, AngioDynamics, Inc. - Senior VP & General Counsel [6]

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Sure. So as we've talked in the past, we did receive specific ICD-10 codes from CMS for the treatment of -- for using NanoKnife to treat pancreatic cancer as well as specific codes to use NanoKnife to treat liver cancer. We do know that those ICD-10 codes have mapped into specific DRGs, and again, as we said before, we were pleased where they mapped. We think that they were the exact right mapping. They went into the appropriate DRGs that carry the appropriate level of reimbursement to the physician. Now the third leg of the stool for reimbursement is coverage, and that's where this trial comes in.

With FDA designating our IDE approval as a Category B, we'll then be talking to CMS. And as we've talked before, we've had a lot of conversations with CMS that are very well down that path. Once CMS also agrees to approve this trial as Category B, anybody who treats patients under our IDE, so that's either in the RCT or in the registry, will be receiving coverage using those ICD-10 codes that will then map into what we think are the very appropriate high-paying DRGs.

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Operator [7]

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The next question is coming from the line of Jayson Bedford with Raymond James.

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Matthew Jay Wizman, Raymond James & Associates, Inc., Research Division - Senior Research Associate [8]

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This is Matt Wizman on for Jayson Bedford. So my question is really on the NanoKnife trial. So could you walk us through the difference between the RCT and then the real-world side? What are the physician and patient incentives for each of those? And if you could just kind of walk through the differences there that'd be great.

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Stephen A. Trowbridge, AngioDynamics, Inc. - Senior VP & General Counsel [9]

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Sure, Matt. I'll take that. Appreciate the question. So as we've talked about in the past, AngioDynamics is very committed to this technology. We really feel that NanoKnife is a game changer for patients, and the trial design that we've been able to develop collaboratively with the FDA, I think, is a very great illustration of how committed Angio is to this technology. Anytime that you're doing a trial, there's design elements that are going to be more important than others, and we think that our comprehensive design is aimed at trying to get to all of those very important elements.

So if you think about a randomized, controlled trial, what you're looking to do is to isolate as many variables as possible to prove out that whatever survival benefit that you're seeing is coming from your technology, but that comes at the expense of a very hyper-controlled environment. So there's some very specific inclusion/exclusion criteria. Not every patient may qualify to meet either of those criteria to then show up into the RCT. And what you end up doing is you randomize the patient, after they've gotten through the initial staging of having Stage III cancer, to either the NanoKnife arm plus chemotherapy or the standard chemotherapy arm, but they are trying to isolate those variables.

But as is also very well known in the clinical arena, not every treatment happens in a hyper-controlled environment. So the real-world registry that we have is looking to provide the flip side of the coin: What is the benefit of this technology in a real-world setting? So in that setting, patients are not randomized and the inclusion/exclusion criteria is a little less severe and robust as it is in the RCT. So by putting these 2 things together, our comprehensive study design will give us great data on how it looks when you're controlling as many variables as possible, but also what you can expect when you're using this technology in a real-world setting. And we feel that that's going to be most meaningful to patients, physicians, payers and all the other stakeholders.

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Matthew Jay Wizman, Raymond James & Associates, Inc., Research Division - Senior Research Associate [10]

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Got it. And then, I guess, as a follow-up to that, has the FDA stated or have you talked to the FDA about what specifically they're going to require for the approval? In other words, does the RCT need to be completed for approval? Or could it happen sooner depending on the real-world evidence? And then, obviously, I'm assuming the real-world evidence trial will enroll quicker due to the less inclusion criteria.

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Stephen A. Trowbridge, AngioDynamics, Inc. - Senior VP & General Counsel [11]

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So that is true. We do expect that the real-world evidence side will enroll quicker. Anytime that you're running an RCT, getting through that exclusion/inclusion criteria that I talked about, sometimes does create a little bit more prolonged time line than you would expect.

I will say that the conversation that we've had with FDA -- now we've been talking about this for a little while, and it took a little longer than we wanted to get to the approval. But the underlying reason for that is we engaged in very in-depth, very collaborative conversations with FDA about the overall design considerations for this trial. So we have a sense, as we've gone through this, with the study design that we have now, if this technology proves out exactly the way that we think it will, it will get us to an ultimate approval. So that was, I think, what was very beneficial about the time that we spent working with FDA.

Our current expectations right now are to enroll both of these things. We think that there's very valuable evidence that comes out of both the RCT and the real-world evidence arm. We think they complement each other and get us to that overall approval. So our current expectation is that we are going to be enrolling both of these to get to the end of the trial.

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Operator [12]

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The next question comes from the line of Matthew Mishan with KeyBanc.

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Matthew Ian Mishan, KeyBanc Capital Markets Inc., Research Division - VP and Senior Equity Research Analyst [13]

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Jim, the fourth quarter seems like it's going to require a pretty strong quarter to hit your guidance, and you seem fairly confident in that. What's behind that confidence in the fourth quarter?

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James C. Clemmer, AngioDynamics, Inc. - CEO, President & Director [14]

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If you take a look, really, Matt, at our 3 quarters coming into this year combined, we're really right where we thought we'd be. Always something is a little softer or something's a little stronger. In a complex company like us with a diverse portfolio, you have those challenges. But Matt, we have pretty good view of our customers. We have really, really great sales and marketing people that give us customer feedback, and we really have a good sense of what's going on in our marketplace due to the connections and the relationships that our salespeople have.

So we feel strong, Matt, about 2 things: the revenue associated with our base businesses, the revenue associated with our new acquisitions that are performing well and then also the great operational excellence tools we have in the background. Although gross margin ticked back slightly this quarter, we showed you why, we feel really strongly about what our supply chain and our quality improvement teams are doing to enhance our gross margin so we feel good about the quarter, Matt.

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Matthew Ian Mishan, KeyBanc Capital Markets Inc., Research Division - VP and Senior Equity Research Analyst [15]

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Okay. You also talked a little bit about timing around NanoKnife sales. Did some sales get pushed from 3Q to 4Q? And then also, can you talk about how you expect NanoKnife revenue to progress through the course of the clinical trial?

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James C. Clemmer, AngioDynamics, Inc. - CEO, President & Director [16]

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Sure. A couple of things. To address your first piece, we don't really push sales, especially capital sales. As you know, in medical device business, I've been doing this 30 years, capital sales really are at the whim of our customers. When they choose a technology like NanoKnife, they have to go through the approvals necessary in their own health care networks to get the approval for capital spend. And sometimes, those approvals and the spend, things come at different pace, so we can't control those. So I think we see sales that we expect in one quarter sometimes come a little earlier, a little late, but we don't actually push or direct that, our customers do that. So yes, a little softer than we thought, but not at all an issue for us.

And secondarily, as far as what we expect for NanoKnife due to the trial, I think what we'll do, Matt, is give you some updated guidance soon. We'll roll out our 2020 plan that you'll have in full detail and even a 3-year look at our strategic plan. We'll give you then a really good, thorough walk-through on how we believe the NanoKnife trial will impact our sales. Steve?

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Stephen A. Trowbridge, AngioDynamics, Inc. - Senior VP & General Counsel [17]

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The one thing I would add to that, Matt, is we will be coming out with those -- with that new 3-year plan, and you'll get some color around revenue as we move forward there. The primary purpose of running this trial is not to generate revenue. Clearly, the primary purpose of running this trial is to generate evidence to prove out to our stakeholders as well the regulatory agencies that we should have an expanded indication and that this technology plays a very important role in treating this very deadly disease.

That being said, because it is a product that we have on the market, because we've gone through the process with the ICD-10 code that we talked about and that we've been able to prove the initial questions of safety and efficacy to end up with a Category B, we do expect that there will be revenue that will help mitigate any of the costs of this trial so that it wouldn't be seen as a typical costly trial in a very linear fashion. So I would expect there will be more color to come out with that 3-year plan in that context.

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Matthew Ian Mishan, KeyBanc Capital Markets Inc., Research Division - VP and Senior Equity Research Analyst [18]

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Then on to OARtrac. Congratulations on getting that through the 510(k) approval. Can you give us a sense of what the expectations for that is as you ramp that over the next 1 or 2 years.

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James C. Clemmer, AngioDynamics, Inc. - CEO, President & Director [19]

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Yes. So Matt, what I'll do is -- joining us on the call, too, we have Brent Boucher, who is the General Manager for Oncology business. I'll have Brent answer that question for you, Matt.

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Brent J. Boucher, AngioDynamics, Inc. - Senior VP & GM of Oncology Business [20]

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Matt, it's Brent. Nice to talk to you again. So the indication that we got, just to clarify for those also listening in, is an expanded indication that enables the OARtrac system, which was previously cleared for both photon radiation and high-dose-rate radiotherapy during cancer treatments, was expanded to include electron radiation, which is the most common radiotherapy treatment in the market today. So certainly expands the capability of the OARtrac system to do real-time dosimetry in the 3 most common areas. So we expect this to expand our opportunity to position the product, which, again, is the first of its kind to deliver real-time adaptive dosimetry reading in all 3 of these areas. So we expect it will impact the growth prospects for the technology going forward.

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Matthew Ian Mishan, KeyBanc Capital Markets Inc., Research Division - VP and Senior Equity Research Analyst [21]

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And just lastly, Jim, can you just give us an update on your efforts with the portfolio transformation and how conversations are going with the ability to maybe get some -- get a couple more M&A deals through?

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James C. Clemmer, AngioDynamics, Inc. - CEO, President & Director [22]

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Sure, Matt. We've talked to our investor base, talked to our employees and our customers about AngioDynamics' need to adapt our portfolio to the changing clinical demands of our marketplace and the way our customers deliver care. So I wish I could announce things more quickly, but as you know, sometimes, these ideas take a bit more time to get over the finish line than you'd want. Again, I think we've shown the ability this current year with our acquisitions of BioSentry and RadiaDyne. When we find unique, differentiated technologies, as both of these were, we're able to act quickly and bring them into our portfolio, and we'll look to do that again going forward.

And we also, Matt, may move some things out that maybe don't work for us as well as they may work for somebody else. So we want to make sure our portfolio is more focused and defined on giving caregivers exclusive technology and tools to deliver care. Matt, I can't wait to share news with you when we have it about how our portfolio gets defined more clearly in our future. But today, this is all the news we have.

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Operator [23]

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(Operator Instructions) The next question is from the line of Jason Mills with Canaccord Genuity.

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Cecilia E. Furlong, Canaccord Genuity Limited, Research Division - Associate [24]

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This is actually Cecilia Furlong on for Jason, and I just wanted to continue on the NanoKnife discussion. Beyond pancreas, what is your current outlook in terms of different organs or potential utilization of the technology?

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Stephen A. Trowbridge, AngioDynamics, Inc. - Senior VP & General Counsel [25]

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Thank you, Cecilia. So NanoKnife has been on the market for a while. We've had our general soft tissue indication. We've been following where the market has been leading us in terms of where this technology has promise. Clearly, we feel that pancreas is the first place to go. There's a pressing unmet need. We understand that the mechanism of action of this technology has a role to play to treat this deadly disease. That being said, we think that NanoKnife is a platform, and we are absolutely looking at the next areas to go into. Outside the United States, there's been a lot of data that we had -- been generated in areas like prostate. I would expect that that's some place that we would look at as we move forward.

We also have a short-, medium- and long-term road map for this technology that includes additional organs. It includes additional changes to the technology and next-generation elements of this technology. So we can think of things like brain, lung, other areas where the mechanism of action could really have a great promise.

Now that being said, we're committed to pancreas. This is a lot of the work that we've done. This is the comprehensive trial that we're embarking on currently. But we do expect to be expanding out into those other areas as we continue to show the promise of NanoKnife.

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Cecilia E. Furlong, Canaccord Genuity Limited, Research Division - Associate [26]

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Okay. Great. And then just turning quickly to AngioVac. Could you provide just a little more color around: one, what you're seeing right now from a competitive standpoint in the market; and then just two, more updates around next-gen products and further color around how you're thinking about building out kind of that middle portion of the treatment spectrum?

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James C. Clemmer, AngioDynamics, Inc. - CEO, President & Director [27]

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It's a good question, Cecilia. So if you look back, as we mentioned today, again, we're really excited with the procedural volume growth. Again, 6 quarters of really, really important growth for us. Our clinical team and our sales team have done a really good job in the conversations with our customers, explaining the value of our technology. We also mentioned back -- last June, when we started this fiscal year, the general manager of that business and the sales and marketing team split the sales force out, so they can have a more direct touch and build those relationships with our customers.

So now that we laid that groundwork, what you just said is important for us. We're coming out with a new version of AngioVac later this summer, which will enable our physicians really to do what they ask. They really designed this product in concert with us to help them navigate it through the channels they want to get it to, to help with care delivery. We have another product in design that will be about a year later, giving, again, more physician treatment and control over how they use our product in more areas.

From there, as identified earlier, we know the space really well. And as we said earlier, we're great on the lower end of acuity with our Uni*Fuse and are great on the higher end of acuity with AngioVac, which does what no other device can do on the market. But there is that significant gap in between, and there are some other good devices out there that we see from competitors that do a good job. But we don't think anything has really solved the exact need to deliver what our physician partners are looking for. So we're looking at using our own research and development to expand the scope of our 2 devices, and we're also looking as well for unique technologies that are available outside that maybe we can bring in-house. So we hope to talk to you in more detail soon, but that's really what we see in the space. We think it's a unique opportunity, and we have a right to be there, based upon the 2 unique technologies we have today with Uni*Fuse and AngioVac.

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Operator [28]

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At this time, I'll turn the floor back to management for closing remarks.

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James C. Clemmer, AngioDynamics, Inc. - CEO, President & Director [29]

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Thanks, Rob. So folks, to close, I want to remind the listening audience today how proud we are of the work that was done here by the AngioDynamics team to get the approval and the IDE that we were able to announce yesterday. This took a lot of effort and work by a lot of really talented people in our company who worked tirelessly and were committed to getting this approval over the goal line. We've added to our team significantly in the past 2 years here, bringing in some really, really talented people who've helped us to get this goal. Now all we want to do is help our physicians treat more people in this area.

And while we've done this, we've also run our business in a really good fashion. We've come closer and closer to what we believe will be a defined company from a portfolio perspective, and we'll share with you news as that changes. And we also do what we do best every day: our really, really strong operations and manufacturing team manufactures and assembles devices every day at world-class, quality levels to help physicians deliver care to patients.

We have really good people at AngioDynamics, and we look forward to sharing our story with you during the course of this year. Thanks for joining us this morning.

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Operator [30]

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