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AngioDynamics, Inc. (ANGO)

Q1 2016 Earnings Call· Thu, Oct 8, 2015

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Transcript

Operator

Operator

Ladies and gentlemen, welcome to the AngioDynamics’ First Quarter Fiscal 2016 Conference Call. As a reminder, today’s conference is being recorded. At this time, I’d like to turn the call over to Mr. Doug Sherk. Please go ahead, sir.

Doug Sherk

Management

Thank you, operator, and welcome everyone. Thank you for joining us for the AngioDynamics’ conference call this afternoon to review the financial results for the fiscal 2016 first quarter results, which ended on August 31, 2015. The news release that crossed the wire this afternoon is available on the company’s Web site at www.angiodynamics.com. A replay of this call will be archived on the company’s Web site. Before we get started, during the course of this conference call the company will make projections of forward-looking statements regarding future events, including statements about revenue and earnings for the fiscal 2016 second quarter and full year ending May 31, 2016. We encourage 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. Finally, during our question-and-answer period today, we'd like to request each participant to limit themselves to two questions and encourage participants to re-queue to ask additional questions. We appreciate everyone's cooperation with this procedure. With that, I'd like to turn the call over to Joe DeVivo, President and Chief Executive Officer.

Joseph DeVivo

Management

Thank you, Doug. Welcome ladies and gentlemen to our first quarter 2016 this fiscal year conference call. Today, we’ve reported the first of two quarters in 2016 during which we expect to report negative growth, due to tough prior year comparisons. As we’ve guided during our call last quarter, our currency exchange and the impact of withdrawal of the Morpheus PICC line will result in year-over-year revenue declines. At the same time, we expected to generate growth from our four key growth drivers; AngioVac, NanoKnife, BioFlo and microwave. Having just closed the first quarter, for the most part our results are pretty much consistent with what we expected. Our first quarter revenue was within the guidance we provided in August while our adjusted EPS in consensus illustrating what I believe has improved operational execution. I would like to start with our international business where we saw revenues down 17% year-over-year. We expected a weak first quarter internationally and our performance was driven by two factors. The first factor was the currency exchange that we talked about previously. From an overall revenue perspective, fluctuations in currency reduced our international revenues by about 6%. In addition, 60% of all international revenue is from our distribution partners and all of that revenue trades in U.S. dollars. Our business partners have seen currency changes and an inflated dollar. As a result, some saw some very conservative buying in the first quarter. While we believe the capital equipment softness is temporary and came on the heels of a really strong fourth quarter, especially in capital equipment sales, we are working closely with our international distribution partners to review pricing on a market-by-market basis in order to enhance the competiveness of our products. We’re committed to maintaining our market share and are looking at our expense…

Mark Frost

Management

Thank you, Joe, and good afternoon, ladies and gentlemen. As we expected and discussed with you on our last two calls, our business in the first quarter was impacted by two headwinds; foreign exchange FX and the strategic decision to discontinue the Morpheus PICC line. These headwinds impacted our growth by approximately 3% in the first quarter and we anticipate in our planning process that we will have the same impact in the second quarter of fiscal 2016. However, we continue to expect an improvement in the performance in the second half. Given that Joe has discussed the revenue picture in depth, I’ll limit my comments to a few revenue points and then provide more detail on our P&L, balance sheet and cash flow. Total revenue in the quarter was down 4% from the prior fiscal year. However, excluding the impact of FX, the Morpheus discontinuance and the planned wind down of our supply agreement, underlying net sales were 1% down from the prior fiscal year. Continuing down the quarter’s income statement, gross profit totaled 43.2 million or 51.6%. Our operating excellence program contributed a 70 basis point improvement as planned. Our improvement was offset by FX at 60 basis points, the E&L provisions at 50 basis points and negative mix of also 50 basis points. We improved 70 basis points sequentially from fourth quarter but ended down 90 basis points year-over-year. Turning to expenses, operating expenses totaled 42.1 million, including 2.1 million of acquisition integration and restructuring items, of which 1.3 million was related to litigation and 0.5 million for the operational excellence program. Sales and marketing costs increased 0.5 million reflecting our investment in our U.S. sales force offset in part by an FX benefit. G&A costs were flat while R&D decreased 0.5 million primarily because of product…

Joseph DeVivo

Management

Thank you, Mark. So while we have tough revenue comparables in the first half of the year, we’re managing the business and cash well and are poised for both our strong top line and bottom line for the second half of the year. The key growth drivers continue to pay off allowing us to deliver about 60% to 70% more cash than we did last year. Our team continues to do the right things delivering operationally and developing the growth drivers in a meaningful and valuable businesses for our future. So with that, operator, I’d like to open the call for questions.

Operator

Operator

Thank you. [Operator Instructions]. We’ll take our first question from Tom Gunderson with Piper Jaffray.

Tom Gunderson

Analyst

Hi. Good afternoon, guys.

Joseph DeVivo

Management

Hi, Tom.

Tom Gunderson

Analyst

So I want to try and understand Q1 and Q2 better so that we can get a better handle on this inflection that we’re expecting. The minor question, question one, is Morpheus. I think in the press release, it said 2.6 million last year. Should we assume that you recovered or transferred customers to other products of about half of that or did you do a little better or little worse than that?

Joseph DeVivo

Management

Yes, I think the actual number, Tom, is about 45% of customers were converted over, so we lost a little bit more than we had planned.

Tom Gunderson

Analyst

Okay. 45% of customers, was that about the same for dollars?

Joseph DeVivo

Management

Yes.

Tom Gunderson

Analyst

Okay. And then along those same lines, I’m sorry – on the Celerity with no chest x-ray, you’re doing placements, you’re selling some, you’re doing evaluations. I think in the past we’ve talked about evaluations taking a while and then while you’re doing the evaluation, it looks like you’re going to win the competition maybe loading up inventory in that particular hospital and then getting – taking a little bit longer for you to actually get the return that you hope out of winning that evaluation. With that as a too long preface, does that help – is that process something that we’re going to see in Q3 and Q4 and get that inflection upwards moving or is it going to take longer than that?

Joseph DeVivo

Management

First of all, you’re right. It does take time to do evaluations. Now it’s not every situation that a competitor does that but it does take a while. We are asking for our customers to pay more for our products and in order to pay more for our premium products, they would like to feel confident that as delivering its results, and we doing that and that’s a big part of our strategy. So whether – that is a cycle and that does take time. But when we talk inflection, we just have to level set. So without currency and without the PICC headwinds, just on a like-for-like basis we see obviously a much better net performance of this. So by washing out – by anniversarying currency and anniversarying – having to withdrawal product from the market, obviously the year-over-year comparables are going to be much easier to hit, especially with last year. But yes, BioFlo is something that is a continued process. I think even when we look into last year, I have to absolutely commend our sales force. For us to be able to maintain 45% of the revenue to convert over from existing accounts when we’ve had to pull a product from the market is just a tremendous effort on their part. And we’re proud that they’ve gotten very close to that target. With that, when you’re spending that type of energy to sustain business, the efforts that are placed in doing new evaluations and the efforts that are placed in new placements, et cetera, is really challenging. And again, we have a great organization who has weathered this storm and has kept a lot of accounts and a lot of hospitals with our company. So I’m very proud of their activities, but there’s no doubt that we’ve lost some momentum because of this activity. That said, our fundamentals are good. We have our GPL agreements. We are placing a lot of Celerity units out there. We have a significant amount of evaluations. That’s why we’re bullish for the second half of the year, but we knew when we came into the fourth quarter that this was going to be rough. We talked about it on our fourth quarter call. We said, wow, we have to look at the first half of the year without this much revenue in our plan and we have to look at ourselves especially with some pressure internationally. So, we’re not sitting here with a surprise. We’re sitting here with something that we had planned. And our team is committed to continue to get past this and to deliver a better performance in the second half of the year, especially with this asset.

Tom Gunderson

Analyst

Got it, thanks. Those are two. Thank you, guys.

Joseph DeVivo

Management

Thanks, Tom.

Operator

Operator

We’ll go next to Jayson Bedford with Raymond James.

Jayson Bedford

Analyst

Good afternoon. Thanks for taking the questions, guys.

Joseph DeVivo

Management

Hi, Jayson.

Jayson Bedford

Analyst

Just on the access business, I realized BioFlo grew 30% but access was down 7. I’m just trying to reconcile the math there. How big is BioFlo right now?

Joseph DeVivo

Management

You have that in front of you --

Jayson Bedford

Analyst

For the entire – across all three product lines.

Mark Frost

Management

Yes, I’ll answer it, Jayson. It’s about 40% of our VA portfolio now. I think last quarter it was like 30, 35. Now it’s 40% of the whole portfolio. It’s like 70% of PICC and 15 of ports and about 15, 20 dialysis.

Jayson Bedford

Analyst

Okay.

Mark Frost

Management

So the issue is that the PICC legacy business dropped more, which is what caused to be an issue.

Jayson Bedford

Analyst

Right, okay. And to be clear on Celerity, you’ll still be selling this or placing it while you’re working through the R&D efforts on FIREFLY?

Joseph DeVivo

Management

Absolutely. We’ll be placing it for years.

Jayson Bedford

Analyst

And are you placing it or selling it?

Joseph DeVivo

Management

Both. It all depends on the situation but both. But if we’re placing it, it’s under a committed agreement. We don’t give them away. So if we have a committed agreement, then we will place it or if an account would like to purchase it, then they purchase it. But it’s both.

Jayson Bedford

Analyst

Okay.

Joseph DeVivo

Management

So what we’re doing is we’re going to be working with Celerity for several years, but now we’re going to start getting into the marketplace internationally with a bunch of R&D and a lot of work and we felt we wanted to bring illumination to the program, because it’s what we’ve been working on. We acquired a technology a couple of years ago that we knew we were behind in tip location and so we entered into a partnership to kind of quickly close the gap and I think Celerity has done that wonderfully and we’re very excited about launching the Navigation component of Celerity. But we know that in order to win in this market you have to leapfrog and FIREFLY is our entrance that will leapfrog the current systems on the marketplace in leaps and bounds. We’re very, very excited about it. And because we’ll be out in the marketplace more with it, we thought we need to unveil it today.

Jayson Bedford

Analyst

Okay. And then just as my second question here on AngioVac, I thought the growth would be a little bit higher given kind of gen two, let’s call it, of AngioVac. Do you expect the growth to pick up there?

Joseph DeVivo

Management

Yes, I would think so. This particular quarter I think I was a little underwhelmed with the international effort but the U.S. effort was fine. But yes, I think we’re going to see a really good year for the product. We’ve been getting back to the basics on developing very strong education programs, which are completely filled, our usage is strong and I do expect a higher than 11% growth rate.

Jayson Bedford

Analyst

And Uni-Fuse, I was a little unclear to your comments there. You’ve been selling that product or did you reintroduce it? Just remind us – I realize I know the product but I wasn’t sure what was new about Uni-Fuse?

Joseph DeVivo

Management

What we’ve done is in the process of communicating to clinicians about our thrombus strategy with AngioVac, we’ve realized that we have a market-leading catheter directed thrombolysis product that’s been in our portfolio for 20 years. And we are in conversations where we’re not just talking about AngioVac, we’re talking – these conversations talk about other different ways of taking care of the patient and clinicians are likely, well, guys, you have this great Uni-Fuse. This is very synergistic. So in order to even continue our value, we’ve kind of resuscitated a legacy product. We’ve launched 22 new SKUs of varying lengths that are consistent with current practices and anatomies, which make it the most broad catheter directed thrombolysis line in the market. And so we’re pretty proud of our R&D team. They’ve been very busy. They’ve launched – three launches just in the past quarter. And by adding all of these codes to the portfolio, we’re training our sales force to be talking disease state, to be solving problems and identifying ways of helping patients with AngioVac. But also if there’s a case that’s not applicable for AngioVac, we don’t lose it. We go right to Uni-Fuse. And it’s building a very wide broad-based strategy. So because we just launched 22 new codes into inventory, we figured we’d talk about it.

Jayson Bedford

Analyst

Okay, thanks. I’ll get back in queue.

Joseph DeVivo

Management

Thanks, Jayson.

Operator

Operator

We’ll go next to Jason Mills with Canaccord.

Jason Mills

Analyst

Hi, guys. Thanks for taking my questions. Can you hear me okay?

Joseph DeVivo

Management

Yes, Jason. How are you?

Jason Mills

Analyst

Good. Thank you. Mark, good gross margins this quarter. Could you talk about the trends going into the second quarter and through the remainder of the year? And then could you just give us a minute on updating us with your thoughts on the next two or three years based on what’s going on sort of inside the house, what you’re seeing in both from a cost control – reimbursement cost expense control standpoint as well as pricing over the next couple of years? Gross margins has been in my mind one of the more important levers here for bottom line growth and therefore the stocks. So I’m just interested to get an update both on the trends this year and updated thinking in the next couple of years.

Mark Frost

Management

Sure. Okay, I’ll try to – there’s a couple of different questions there but I’ll try to hit the COGS point first. Pricing is a whole different matter and as we get into that, it’s different by each product area. From a COGS standpoint, operational excellence delivered as we expected. We’ve moved 40% of our lines now. We expect to finish that process by January. So you’re going to get an increasing benefit of that in the second half, so you’ll see gross margin improvement rise each quarter as we go through the year. It’s a little muted – the benefit was muted and will be muted a little bit in the second quarter because of FX. Now the FX goes away as we get into the second half. So you’ll see a more pronounced benefit in the gross margin line in third and fourth quarter because the 50, 60 basis point hit from FX goes away, assuming of course there’s not another massive drop in the euro, but we haven’t been seeing that. The euro has actually strengthened in the last couple of quarters. So that’s what we expect in the year. From continuing onward, the plan we continue to expect and we have a pretty well run out plan that we will generate a 100 to 125 basis points in the next two fiscal years as well based on the big benefit coming in fiscal year '17 from consolidation of the plan, but we also expect direct material savings to start kicking in, in both '17 and '18, which will drive that 100 to 125 basis points. So that’s sort of the COGS picture of what’s going to drive performance. From a price standpoint, it is quite a mixed situation. You are on the international side seeing some price degradation, Joe touched on this a little bit, because of in the distributor markets you had a U.S. dollar appreciation. Now we’re going to have to see how that plays out. But we have seen some lower price internationally. In the U.S., it’s quite a mixed bag. Oncology, we continue to get price because of uniqueness of our offerings. Fluid management, it’s been up and down. ELT, there’s been some price but not anything material. I’ll say when you look at the net price impact on the business, it’s still running around 1%. So it hasn’t been a big material impact to the business so forth, and Joe can build on this. On the international side, there’s a little bit of a concern as we go forward. Are we going to have to do something there in our U.S. dollar markets? I don’t know if you want to answer that, Joe.

Joseph DeVivo

Management

The only other comment I’d make for gross margins is as you have mentioned in the past that each of the products that are growing in excess of 10%, 20% are all margin accretive products. And so we’re going to see mix be a pretty positive contributor to gross margins. So it’s our internal cost reduction and it’s our mix improvement. So those are the ways that we get to accelerated and to the gross margin targets that we’ve mentioned. But yes, we have 60% of our international business which is not a huge part of the company but it’s still a meaningful part of our business has seen virtually a 20% or 30% price increase, because of the dollar going up and their inbound price has been higher. And so their orders like this quarter and if it doesn’t change would be challenged. And so we are working with them to ensure that we manage their pricing and cost in order to make sure that they’re competitive. But we have a pretty good plan as far as improving gross margin. I’m very proud of our operations team. We’ve been talking to you about operational excellence for I don’t know four or five quarters. They haven’t missed a beat; every single milestone, product line, time conversion and change they’ve hit. We’ve always said that we’d be done by January and that team is right on it. And by January we’ll see that improvement and those cost come out. So I’m very proud of their execution and across the board, I think the company is going to see improving gross margins over the next several years.

Jason Mills

Analyst

Okay, that’s a lot of detail. I want to make sure just to be clear on a couple of points. Mark, you mentioned 125 basis points next year and then you turned to pricing and we talked a little bit about mix bag. I just want to be clear. The COGS discussion obviously is a discussion broadly about pricing. So is there 125 basis points before we consider pricing and therefore expansion will be less than 125 basis points? And also did you give – I’m sorry if I missed it, a gross margin target for the full year this year, '16?

Joseph DeVivo

Management

Well, let me see if I can help Mark for a moment. Well, first of all, when we run our gross margin targets based upon our cost reduction for the year, we are obviously planning on a certain revenue line which we’re planning on a certain level of pricing. So if pricing changes significantly or if revenue is where our plan, then we’re going to over absorb and our gross margins aren’t going to be as high. But the net cost, the physical one-to-one cost of pulling out of business is what’s happening as far as the headcount, overhead consolidation and whatnot. But of course in that calculation there was changes to the variables and there’s changes to the calculation. But as you know, gross margin is at the bottom line. But as far as we’re concerned based upon the cost reductions that we’re targeting, we expect 100 to 125 basis point improvement gross margin over the next two years.

Mark Frost

Management

Right, and 100 basis points for this year, Jason.

Jason Mills

Analyst

Okay, got it. And then just second line of thinking here on the cash flow side and that’s obviously expansion impedes cash flow. What are your targets, Mark, for free cash flow this year and next year if you can maybe give us a range or directionally?

Mark Frost

Management

Yes, we’ve guided free cash flow to improve pretty significantly this year. I think I mentioned it earlier that it would be – hold on a second just to make sure I don’t misquote – 60% to 70% improvement this year in free cash flow. And that’s generated by operating improvements, working capital improvements and then lower maintenance CapEx in the year. So we have a pretty significant expectation of nice improvement as we get through the manufacturing consolidation. We haven’t really talked to next year numbers. We’ll probably start talking in the next quarter or two on that, but that’s our focus on '16 is trying to deliver that improvement.

Joseph DeVivo

Management

Jason, the good part is for the last couple of years we’ve been using cash. We’ve been using cash for Oracle, we’ve been using cash for planned consolidation, we’ve been using cash in order to increase inventory for all of that and those projects are now being successfully completed. And so our corporate CapEx requirement is not as high as it was for the last several years. Inventory won’t be as high as it was for those obvious reasons. And once it normalizes, that cash is going to flow through for a while. And so we’ll see a pretty significant increase in cash over the next six to nine months and then it should be steady state as the revenue and the business grows accordingly.

Jason Mills

Analyst

That’s helpful. Just a follow-up on that point and I’ll get back in queue. If you’re successful and we see cash up to your guidance this year. I presume that the gross margin expansion next year coupled with not such a bad CapEx environment and you’re hoping I’m guessing for revenue growth next year drives maybe some leverage next year as well to the cash line and that grows. What do you start doing – if you’re successful over the next couple of years generating the type of cash that people have in their models, what do you do with that cash, Joe? And thank you for the answers.

Joseph DeVivo

Management

And thanks for the questions and your involvement, Jason. Right now, our plan is purely to strengthen our balance sheet and pay down our debt. But what we’d like to be able to get back to doing is if we’re going to put some of that capital to work for smaller acquisitions, that makes sense to bolster our product portfolios, we’ll do it. But I think we’ve signaled quite a while ago that we’re really intend on making what we’ve done work and operationalizing the business and getting our top line growing and getting our bottom line growing faster, and then bringing cash out. So we want to return that to shareholders and return it to the company and put it in our balance sheet. But I think ultimately as we sure up our balance sheet, it wouldn’t be inconceivable of that as we’re done with all these projects and we’re ready for more that we not do anything too big but I do think our portfolio is going to always use new technology. And also continue, as we had said, we’re still looking for good international targets to acquire, to build out our international business. So those are probably the two best uses of cash for us.

Operator

Operator

We’ll go next to Matt Mishan with Keybanc.

Matt Mishan

Analyst

Great. Thank you for taking my questions.

Joseph DeVivo

Management

Thanks, Matt.

Matt Mishan

Analyst

On the revenue guidance, you were able to keep that intact for the full year but if I’m looking at it right, I think the cadence changed a little bit where maybe you lowered the first half by about 100 or 200 bps and raised the second half guidance. So I was just curious where are you falling short in the first half, why that doesn’t bleed into the second half and what gives you more confidence in an improving second half environment?

Mark Frost

Management

Sure. I’ll hit it and Joe will probably build on my comments. So in the first half we saw – we came in at slightly below midpoint of our numbers and we had a little bigger – less growth in PICC that we were expecting and international was a little slower start than we would have hoped at the higher end. So that just flows into the second half. That’s why the first half is so – you’re right, it’s about 100 basis points lower. The second half we feel stronger. Joe talked about a number of things. I think particularly the regulatory clearances we have a pretty good line of sight on our number of critical orders, which gives us a lot of confidence that we can recover that 100 basis points of growth in the second half and have a pretty good strong second half. And then clearly as we’ve talked throughout the call and on earlier questions, we don’t have the two headwinds in the first half. So the comps are much easier in the second half, which also gives us confidence. I don’t know if you want to add anything else, Joe.

Joseph DeVivo

Management

Yes, I’ll just add a couple of things. I do not underestimate how not being able to register products for three years impacted our international business. Not having those CFGs and dealing with that, our international team really had their focus on what it had and drive its markets and do a lot of heavy lifting. We have all of our clearances now, we have all of our CFGs now and we’ve been filing for new clearances. There’s markets where we don’t have our 1470 laser register, which is crazy. There’s markets where we don’t have NanoKnife. There’s markets where we don’t have our PICC registered. So we’re now starting in the second half of the year to start seeing some of these key markets get registrations that our distribution partners have just absolutely been waiting for. Probably the biggest second half component is going to be in our oncology business. If we receive and we believe that we will receive NanoKnife clearance in China, China’s a huge ablation market. And there will be we believe within this year a significant capital equipment buy when we receive that clearance and that we have a big launch plan in place. And that’s something that we have a very clear line of sight for. We have a couple of initiatives with other oncology products that we have very high confidence with if we receive those registrations, we’re going to see significant new orders. So we’re now on the beginning tail of benefitting as other companies have as part of their strategy. A lot of the growth you see is not just organic growth, it’s growth due to new product registrations in markets and you keep rolling these new registrations and building these markets, you’re increasing your footprint and increasing your business. We’re starved for that for a couple of years and now that’s happening for us. And so we have again a clear line of sight as to what products, what markets and we know for example and we had mentioned in our comments between $3 million and $5 million of new orders we’re going to see between the third and fourth quarter purely based upon those registrations.

Matt Mishan

Analyst

Okay. And just to follow up – and that was really helpful, just to follow up on the NanoKnife conversation, I think you also said last quarter that potentially some upside to your guidance would be from changes in reimbursement towards the end of the calendar year and you’d have probably some increased visibility into that as the year progressed. Could you give us a little bit of color on potential changes in reimbursement maybe in the U.S. or in overseas for NanoKnife?

Joseph DeVivo

Management

Yes, it’s a great question. So first of all, last year in the January timeframe for the first time we received new codes for NanoKnife in Germany. And if you look at our fourth quarter revenue, we sold 12 NanoKnife systems in the fourth quarter. We had a huge fourth quarter. And our utilization I think going into the end of the last year was up about 30% in NanoKnife worldwide. And that’s a function of a maturing data, that’s a function of – in Denmark and some Scandinavian countries, we’ve started to receive NanoKnife reimbursement. In Germany, we have NanoKnife reimbursement. And now we are actively talking to the National Institute of Clinical Excellence in the UK regarding specific approval and specific guidance on the recommendation of NanoKnife for certain patients. And interestingly if we receive a positive NICE indication – it’s not indication but if we – I guess they give us a positive view on NanoKnife where today NICE has experimental. So all private payors or other government agencies around the world look at that guidance and say, well, we can’t – why would we reimburse this when NICE see this as investigational. We believe that by January we’re going to shed that investigational label. And when we shed that investigational label every market around the world who’s held off on reimbursement we think is going to start coming in line, and we’re very excited. We’ve hired a tremendous executive on healthcare policy reimbursement here at the company and she has really breathed an incredible amount of momentum on our reimbursement strategy. So whether it’s the NICE indication, we’ve also had one-on-one conversations with CMS, there’s 150 clinical publications today on the Internet and there are certain patients who really have a significant medical need and should have this technology. So, I think we’ve held back from talking about NanoKnife for a while but today the data is too advanced and the societies now having AHPBA, the American Hepato Biliary society manage a worldwide registry for NanoKnife is an incredible acknowledgment. The fact that we’re going to do a patient registry for pancreatic cancer patients in the UK with NICE is an incredible accomplishment and these are all early indications now that the technology is on the cusp of its acceptance in reimbursement. So, it’s really – the time for NanoKnife is occurring and to see worldwide growth last year and seeing 38% growth in the U.S. for consumables is a great validation.

Matt Mishan

Analyst

That’s great. I’m just going to squeeze one more in real quick on EVLT just given the volatility in that business over the last couple of quarters. Has the momentum continued so far in this quarter that you saw less?

Joseph DeVivo

Management

Yes, it did. So I think I had mentioned on the last quarter’s call that we saw May, our procedures start returning to our customers. And to refresh everyone’s memory, in the first four months of the calendar year, boy, our same-store sales in patients were just not there and we reported on it as thus we saw it. And yes, they came back in May and they came back throughout the summer. Our U.S. business was up roughly 9%. Now we’re expecting that growth to continue here in the second quarter. And it will be interesting to see if – we’ve asked ourselves openly and publicly whether or not whatever the shortfall was in the first half of the year is made up in the second half of the year, that I don’t know. But my concern for EVLT today is far, far less. And on top of that, if CMS decides to level the playing field for outpatient reimbursement for lasers and RF, it’d probably be game on.

Matt Mishan

Analyst

Got it. Thank you very much.

Joseph DeVivo

Management

Thank you for your questions, Matt, and thanks for joining the team.

Operator

Operator

[Operator Instructions]. We’ll go next to Keith Hinton with Sidoti & Company.

Keith Hinton

Analyst

Hi. How are you?

Joseph DeVivo

Management

How are you, Keith?

Mark Frost

Management

Hi, Keith.

Keith Hinton

Analyst

Doing well. Okay, my first question is regarding the rapid database for AngioVac. I’m curious as to what the sort of timing on that data is going to be? Is that going to be you receive efficacy data regularly on that or is that going to be all at once more like a clinical trial? Can you give a little color on that?

Joseph DeVivo

Management

I don’t know that I have a specific date interval, but I think when there is a meaningful number and a meaningful age and Dr. Moriarty feels like it’s time to – that there is medically necessary or important data that he’ll put it out. I think we funded the STAR registry with Dr. Martin and he chose that certain intervals to do meta-analysis on the data when he felt it was medically necessary. So we don’t control the registry. It is not our registry. We have an unsolicited grant for UCLA and Dr. Moriarty to run the registry as they see fit. And so whenever Dr. Moriarty thinks there’s something of clinical relevance, it will be completely his decision. But one of the things as a company we’ve seen – we’ve funded and gave Dr. Martin an unsolicited grant for the STAR registry five, six years ago. And today we have a publication and he handles the surgery, 200 patients. So that’s why we’re funding the AHPBA registry for NanoKnife. They run it, they do it exactly how they – we don’t determine their protocols, we don’t determine who they include, how they include and when they report. Now we’re funding a registry with CROES for prostate NanoKnife ablation, the same thing. They are completely in control as the same thing as Dr. Moriarty is. So I would expect that whenever they feel it’s medically necessary, it will be out in the public domain and when they present things in the public domain, then we’ll of course draw your attention to it.

Keith Hinton

Analyst

Okay, terrific. And I just have one more. Sales and marketing crept up a little bit as a percentage of sales. I’m thinking that’s probably geographic related as to the weakness in the international. Am I thinking about that correct?

Joseph DeVivo

Management

No. Actually we made a strategic decision that we talked about in the fourth quarter. Our peripheral vascular business in the U.S. has a lot of opportunities and between AngioVac and EVLT, some of our other products haven’t had the appropriate attention. So we made a strategic decision to promote one of our best people to a national business manager role and then some of our best sales people to specialist and sales roles, and we created up a new NAMIC sales force. And that NAMIC organization works through our peripheral vascular organization to basically grow and give new life and energy to our largest product line in the company, our fluid management NAMIC business. So it was an investment. It shows a little bit more cost as a percentage of sales in the quarter and I bless every dollar that we put into it. Our new general manager made a great decision and we’re seeing the activities. If activities are precursors to results, then I expect some good results in the second half of the year.

Keith Hinton

Analyst

Okay, terrific. That’s it from me. Thanks.

Joseph DeVivo

Management

Thank you, Keith.

Operator

Operator

We’ll go next to Charles Haff with Craig-Hallum.

Charles Haff

Analyst

Hi, guys. Can you hear me okay?

Joseph DeVivo

Management

Yes, we can. Charles, how are you?

Charles Haff

Analyst

Good. A couple of questions here, most have been answered, but on the warning letters I understand the CFGs getting lifted here, it helps, but on the warning letters getting lifted, I understand you can pass the re-inspections. Any update that you’ve heard from the FDA? Is there any further steps that are still outstanding before potentially these three warning letters can be lifted?

Joseph DeVivo

Management

I don’t think in our hands. I think right now we’ve asked FDA to review and we’ve asked them to lift it. Obviously, to get into the warning letter we’ve had to have repeat 43s and since that, we remediated and we’re very pleased in the fact that we had repeat inspections of each of the sites. And on those repeat inspections there were no 43s that were repeated, which is a pre-indicator towards lifting of the warning. And hence the real transactional part of it is receiving your certificate to foreign government. That’s where the rubber really hits the road. From a PR standpoint, it’s nice to get rid of the warning letters but from a pure transactional standpoint the fact that we now can register all of our products in foreign markets, that’s where from an operational standpoint we’re there. So to any extent there’s any additional questions, we’ll answer but the ball’s not in our court anymore. We feel we’ve done everything.

Charles Haff

Analyst

Okay. Yes, that’s very helpful. I was kind of thinking more on the PR side getting this news out there is always very helpful. When was the last re-inspection or when was the last communication?

Joseph DeVivo

Management

The last re-inspection was maybe a month ago, maybe – I don’t know, four, five, six weeks. Within four to six weeks, so it hasn’t been --

Charles Haff

Analyst

Okay.

Joseph DeVivo

Management

If I could maybe – don’t really want to assume too much, but I think there is typically a holistic view. I think for us to get a clean bill of health, I think they want to see everything before they would give it piecemeal. So we’ve worked with it, we are very proud of our accomplishments. The amount of cost and the amount of work and the amount of attention of our R&D teams and our quality teams behind the scenes, it’s unheralded. You don’t get credit for that. You don’t get credit for the hours of responses and remediation in CapEx. No one sees that. They see new product launches. But the people at AngioDynamics have worked so hard. They put the customer, they put the patient first and we have been doing such a great job and I am so proud of our quality organization. I’m proud of our R&D team. There’s times when we’re developing, we’re focusing our whole R&D teams and making sure the remediation are there, and again you don’t get credit for that. But so much of that behind us, you’ve seen now just in this last quarter three product launches coming out and we’re going to start – we’ve told everyone that we have a great pipeline and more is going to come. And we’re bullish on our business. Charles, we’re not happy with the fact that we have to live through a couple quarters of down revenue given a product withdrawal and a currency size, but if you look under the hood and our team is executing and delivering and I can’t wait for the PR of the warning letters finally being lifted, because we’ve earned it.

Charles Haff

Analyst

Yes, that’s great. And then on the CFG and being able to get the approval in China for NanoKnife. So you’ve been approved on the NanoKnife generator in China already, right?

Joseph DeVivo

Management

Yes.

Charles Haff

Analyst

Okay. So this would be the needles.

Joseph DeVivo

Management

Yes, from the best of my understanding it’s a two step process. The generator gets approved and the distributor then is allowed to bring the generators in to the top hospitals who do a limited amount of clinical evaluation. And so as a part of the approval process – there are generators that are now in China and no revenue. We are giving them needles and then they’re doing these cases. And as a two step process, so once they approve the needles then we have our complete freedom to market. And we expect that before the end of the fiscal year. We have plans. We know and our partner knows where – who’s in line and where this is going to go. The Asian marketplace is a very big ablation marketplace, especially given the prevalence of ACC and others and 150 papers and clinical publication, this is not an experimental technology anymore. It’s very well established in the scientific community. So we expect that the China launch is going to be material and that’s why it’s in our guidance.

Charles Haff

Analyst

Okay. And then just on the ASP question without getting into specifics, but the U.S. ASP is quite a bit higher than the China ASP on the generators. Would you expect that same ratio for the needles in China or is that still to be determined?

Joseph DeVivo

Management

Yes, I think from our oncology business standpoint, typically our international ASPs are half the U.S. ASPs that goes for generators and needles. That’s a rule of thumb. I’m sure market-by-market might be different but that’s pretty much where it is.

Charles Haff

Analyst

Okay, sounds great. Thanks a lot, guys.

Operator

Operator

That does conclude the Q&A portion of today’s call. I’d like to turn it back over to Joe DeVivo for any closing remarks.

Joseph DeVivo

Management

Thank you everyone for staying with us tonight and thank you for doing your work on the company. We remain very proud of what we are accomplishing here at AngioDynamics. We believe we’re doing the right things in investing for our future. We were hit with a hard blow at the end of last year. We started off the year with great growth and great momentum and we were building this enthusiasm, and we had a rough third and fourth quarter. It’s just excruciating to pull a product off the market. It’s one thing to go through a recall, it’s another thing to just take if off the market. And to try to forecast the effects on your business when your customers have been using that for so long is just tough. We persevere and our team is still out there and we’re driving and we have the absolute best vascular access portfolio in the world bar none, and our competitors are scared of it and they are coming after us hard. We have a fantastic oncology portfolio and we’re building a very, very strong peripheral vascular portfolio. So we’re still as bullish on this business as we’ve ever been and we appreciate your attention and support, so thanks.