AngioDynamics Inc (ANGO) 2012 Q3 法說會逐字稿

Good day, ladies and gentlemen, thank you for standing by. Welcome to the AngioDynamics' third-quarter fiscal 2012 financial earnings conference call. During today's presentation, all parties will be in a listen-only mode. Following the presentation, the conference will be opened for questions. (Operator Instructions) This conference is being recorded today Wednesday April 4, 2012. I would now like to turn the conference over to Mr. Bob Jones of the EVC Group. Please go ahead.

Thank you, Alicia, and thank everyone for joining us today for the AngioDynamics' conference call to review the results of the fiscal 2012 third quarter which ended on February 29, 2012. The news release announcing the results crossed the wire this afternoon after the market closed and they are available on the AngioDynamics website. The call is being broadcast live on the web at www.angiodynamics.com. A replay of the call will be also archived on the AngioDynamics' website. To access both the website and the archived replay, go to the investor section under events and presentations.

Before we get started, during the course of this conference call, the Company will make projections and forward-looking statements regarding future events including the statements about revenue and earnings for fiscal 2012. 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 actual results or events to differ materially from those described in forward-looking statements.

Finally, during the question-and-answer period today, we'd like to request each caller to limit themselves to two questions and encourage callers to reque to ask additional questions. We appreciate everyone's cooperation with this procedure. And now I'd like to turn the call over to Joseph DeVivo, President and Chief Executive Officer of AngioDynamics.

Thank you, Bob. Good afternoon, everyone, and welcome to our call. With me on this call is Joe Gersuk, our Chief Financial Officer.

During the third quarter we embarked on a course to transform AngioDynamics into a global world class medical device leader by creating a platform for stronger future growth. AngioDynamics is a Company who has innovated for years with customer intensity at the core of its business. It's grown and has seen success. In order to set the Company up for future success, and quite frankly put the past several years behind us, we chose a catalyst to get us there, the acquisition of Navilyst Medical. It's not a bolt-on or a tuck-in, it's a combination. A reset, a realignment of the best of two successful companies to create an enterprise which will sustain above market top line growth and expanding margins through ongoing efficiencies. That's a Company that investors want to invest in and I intend to get us there.

And looking at our third-quarter results, as you see, sales came in as we expected in the range of $51.6 million with a gross margin a little less than we expected at 57% and earnings of $0.09 per share excluding special items. I'll let Joe review our results in detail in a moment, but let me touch on our strategy behind the investments that we made during the quarter. It wasn't an easy quarter for Angio, and to get to the world-class organization we intend to be, we must continue to invest. As I mentioned to you on prior calls, delivering quality at every level of the organization is our top priority.

As you're aware of, we received a warning letter last year in May. In my first month I reviewed the letter and was unimpressed with the extent of our progress in remediation. As I mentioned to you on calls since then, I knew we needed to get better fast. We made changes at the top, pulled resources from many departments and launched the Company's Quality Call To Action, or QCTA. Everyone in the Company learned of our commitment to quality and what we all need to do is to reach these objectives. We created QCTA work streams for each area and we felt that we needed to fix, but not just fix, systematically improve. I'm very proud of this early effort and the scope, depth and breadth of project we laid out for ourselves.

Following the notification of a NeverTouch recall you all heard about last quarter, the FDA came in for a follow-up inspection. With our QCTA program in its infancy, the program has not yet impacted the outcome of the inspection. The audit lasted more than two months, was extensive and ultimately resulted in some observations at Queensbury as well as our Fremont location, some of which were repeat. The good news is while the audit continued in parallel, our teams were aggressively building new processes along the lines of the observations, making progress even before the observations were formally delivered. During the quarter we brought in a significant amount of offsite expertise and have made and continue to make a significant amount of progress. We committed to the FDA in our response we would have remediations in place with key milestones identified, I am pleased to say we've hit all of our commitments to date and are well on the way of the process improvement remediation and implementation. As you will see in the third-quarter costs and fourth quarter guidance, we are committed to get this right.

You all know companies in the medical device space who have been through this before. The biggest names all have and you've seen them emerge stronger for it; that will happen to us, too. The majority of QCTA will be completed prior to the acquisition. We will still have work to do in early fiscal 2013, and it is factored into our integration planning and execution. In many ways, Navilyst will help us accelerate this progress allowing us to implement systems that are already in place, fair and battle tested. In no way do I believe our QCTA will hinder integration or vice versa. Our proactivity, I believe, has put us in a better place. As you know, I believe the quality and experience of our sales teams remains one of our greatest strengths. The global sales force demonstrated solid performance in the quarter despite challenges they faced. I'm very confident that we will leverage this strength as we continue to build our product portfolio through innovation, acquisitions and distribution agreements.

Our proposed acquisition of Navilyst Medical and recently announced relationship with Microsulis Medical are great examples of our focus on leveraging our sales teams. Microsulis is a market leader in microwave ablation therapy. We believe Microsulis' technology is the most innovative microwave system on the market today and their flagship product, the Accu2i pMTA system for percutaneous use, delivers significant advantages to clinicians and patients including faster and larger soft tissue ablations. We have exclusive distribution rights to market and sell the ablation system in all markets outside the US up to December of next year. We also have the exclusive option to purchase all of the company's global assets which include its microwave ablation technology and worldwide distribution rights. The combination of RF, microwave and IRE creates the most comprehensive set of ablation options for clinicians who are treating inoperable lesions, continuing AngioDynamics' leadership position in the interventional oncology market.

Now, let's turn to some recent clinical developments with the NanoKnife System. Notably, the NanoKnife System was highlighted at three conferences in March. I've mentioned to you on prior calls, that this March would be an important month for us and it delivered as billed. I'll highlight two experiences. First of all, the paper from Dr. Raj Narayanan at University of Miami Miller School of Medicine entitled The Electrical Pulse Treatment Gives Pancreatic Cancer Patients New Hope was not only presented at the SIR Conference, it was used by SIR for their own public relations to expand the society's reach.

The findings within this work reflect the treatment of eight patients with inoperable locally advanced pancreatic cancer who failed conventional therapies. At the treatment was the NanoKnife System, two of the original eight inoperable individuals were successfully down staged to have surgery. Both had surgical resections and remain cancer free months following the treatment. This is a significant development for patients who had no option prior.

During the Society of Surgical Oncology Conference in March, Dr. Robert Martin from the University of Louisville reported on a 54 registry patients treated with IRE for inoperable pancreatic cancer as well and compared them to 84 patients in a similar disease group. The experience reported a significant improvement in local progression-free survival, 14 versus 6 months. Improvement was also reported for distant progression-free survival, 15 versus 9 months. Overall survival increased 20 versus -- from 20 months versus 13 months. This data are significant as it is the first series reporting of survival benefit for a traditionally option less patient population failing conventional therapy. We are excited about this early indication of efficacy with the use of IRE and look forward to the opportunity to repeat this experience in a controlled regulatory study. Early indications thus far remain exciting.

As I mentioned at the beginning of my remarks, we took significant action this quarter to set the Company up for sustained value creation for years to come. Our acquisition of Navilyst is a big move, one I believe in at my core. It is clear to me our investors yet realize the value of Navilyst, its great people and technology. I assure you they will. At every level in this organization, the combination of AngioDynamics and Navilyst will deliver a stronger more competitive and efficient Company. We can't wait to get this deal done, integration completed and show the world what this team will deliver. We're on track to close the acquisition by the end of our fiscal year. Integration work is underway and we are on schedule.

We are increasingly excited about adding new products like BioFlo, PASV and NAMIC to our portfolio while building scale in our other products. Our sales organization alignment is close to being finalized and our sales reps will have a clear line of sight to be in a great competitive position coming out of the gate. On completion of integration, we will have focused sales channels, focused product portfolios, and either a number one or number two market position in each of our four key markets we play in. As well as a world-class operation which will deliver leverage for the foreseeable future. Also, we will continue to do strategic transactions aimed at leveraging our new sales channels, adding even more growth for the Company in the future.

Now we plan to offer specific guidance on fiscal year '13 during our fourth quarter year-end conference call. We continue to see the shape of the Company being $360 million in sales, $60 million in EBITDA while generating approximately $50 million of free cash flow. With that, I'd like to turn the call over to Joe Gersuk to discuss our third-quarter financial results in more detail. Joe?

Thank you, Joe, and good afternoon, ladies and gentleman. Following two consecutive quarters of solid revenue growth to start the fiscal year, our third-quarter sales of $51.6 million were affected by the end of the LC Bead's distribution agreement on December 31, the decision in late January to stop shipping NanoKnife products to customers in the US and by some disruption in the supply chain in our Vascular business. Nonetheless, the sales quarter-- the quarter sales were within the range of our recent guidance. The $3 million lower sales result this quarter was primarily attributable to having one month of Bead sales in the quarter as we had $4.2 million in Bead sales this quarter and $6.7 million a year ago. We have long anticipated the end of the line with LC Bead and have sought to find alternatives to take advantage of our excellent Oncology/Surgery sales force. Our recent announcement about a strategic partnership with Microsulis Medical was the first step in that direction.

Elsewhere in the Oncology/Surgery business, NanoKnife sales were essentially flat on a year-over-year basis as strong international growth in new systems offset the impact of the shipment halt in the US. We are pleased that 12 hospitals became commercial sites in the third quarter with six purchasing NanoKnife generators and the others added under loaner program. Most of the new sites are international customers as you would expect. Meanwhile, net sales in our Vascular division declined by $400,000, or 1% in the quarter with supply outages in several products in the aftermath of our recent voluntary recalls limiting our sales this quarter. We estimate that approximately $700,000 in third-quarter sales were lost due to the disruption of the supply chain.

There are two positive factors worth noting this quarter. The first is the strength of our laser vein ablation business which more than doubled-- with more than double digit revenue and strong unit volume growth. We've indicated before that our recently introduced 1470 laser and the 97 -- 90-centimeter NeverTouch disposable kit are fueling market share gains in this important product line. The second positive is that pricing pressure eased somewhat this quarter as ASPs in the Vascular division declined by only 2% year over year. This is the slowest rate of price decline we have seen in more than two years. From a geographic perspective, international sales grew 26% from the prior year on a reported basis and 27% on a constant currency basis as our international sales team delivered yet another strong quarter.

Continuing down the income statement, gross profit totaled $29.4 million, or 57% of sales in the quarter with $900,000 in cost of the Quality Call To Action Program and $400,000 in product recall cost reducing the margin by 2.5 percentage points. We continue to make progress with the material cost reduction program and actions to improve manufacturing utilization which benefited gross margin by 2 percentage points in the quarter.

Operating expenses totaled $32.2 million in the third quarter as we incurred $5 million of acquisition, restructuring and other items this quarter, of which $3.8 million is associated with the pending Navilyst acquisition and three other items professional fees for the recently announced Microsulis relationship, the transfer of laser manufacturing from the UK to our Queensbury, New York facility and executive transitions, each amounted to $400,000 in costs in the quarter. The low spending in R&D this quarter is primarily due to the temporary reassignment of engineers to support the Quality Call To Action program. The cost of which is recorded in the cost of sales section of the P&L. In addition, the increase in sales and marketing costs this quarter is primarily attributable to the planned expansion of our international business including a direct sales group in the Netherlands and additional sales commissions in the US in an effort to keep the group intact as we prepare for a sales force integration.

Non-GAAP earnings were $0.09 per share if we exclude our Quality Call To Action program, product recall costs and acquisition and restructuring costs which reflects the true operating performance of the business absent special items. On a GAAP basis, we're reporting a $0.07 loss per share.

Turning to the other financial statements, cash flow from operations was $6.8 million in the third quarter and $12.5 million year to date compared with $22 million last year to date. This year's lower level of cash flow from operations mainly reflects the lower net income as a result of the acquisition and restructuring charges as well as the cost associated with the Quality Call To Action program and product recall. To date we have spent $2.1 million under the stock purchase program purchasing 142,000 shares of stock. We did not purchase any shares during the third quarter and do not intend to repurchase additional shares under the program in contemplation of the Navilyst acquisition closing during the fourth quarter.

We ended the third quarter with $143 million in cash and liquid investments, an increase of $11.5 million since the fiscal year began. Earlier this week the HSR waiting period expired with no government action and we filed a definitive proxy statement regarding the issuance of 9.5 million shares of AngioDynamics common stock in support of the acquisition of Navilyst Medical and to that end we have set May 15 as the date for the special shareholders meeting to consider the matter. Assuming the share issuance is approved, we will then proceed to close the transaction on or about May 22.

The fourth quarter guidance shown in the tables in today's earnings release does not reflect the Navilyst acquisition or any of the costs associated with the transaction, or the restructuring of the Company that will commence immediately upon the closing. The special items that account for the difference between the GAAP and non-GAAP fourth quarter guidance are limited to $1.5 million for the Quality Call To Action program, and $300,000 for the closure of our UK facility. Finally, we plan to report fourth quarter financial results on July 12 after the market closes, and as Joe indicated, we will issue financial guidance for fiscal year 2013 at that time. And now, Alicia, we're ready to open the call for questions.

(Operator Instructions) Matt Hewitt with Craig-Hallum.

Question, you've provided kind of a framework for what AngioDynamics can look like post the Navilyst acquisition, and I'm wondering if you could maybe provide a little bit more color, specifically what could the combined entity look like say two quarters post the closing and then what could it look like maybe two years down the road? Not so much-- I'm not looking for specifics, but from a gross margin perspective, an operating margin perspective, maybe a top line growth, could you provide some color on those metrics?

Well, it sounds, Matt, like you're looking for 2013 guidance and we're really not prepared to give that guidance. What's that?

Not necessarily, Joe, what I'm looking for is okay you've got a Company that's let's call it a 6% operating margin Company, where do you think that you can take this Company a couple years down the road? I mean can this become a 10% operating Company? Obviously, we can do math and kind of figure out what that means, but is that kind of the direction you're taking the Company, or hope to?

Well I guess putting me in a corner, Matt, the answer is yes. I think we can double our operating income. I think we can get ourselves to a Company that's growing at or above the market in the markets that we serve. And I think we can continue to see operating leverage at the gross margin line as we see the longer-term benefits of the operations coming together. We're -- the end of our fiscal year 2013 is a long way away. And so for us to really give guidance and get the shape of the -- or not just the shape, but get the trajectory of the business, it's just too soon. But we're going to have three sales forces that are focused. We haven't had that before. We're going to have growth drivers in each one of our sales forces.

We're going to have -- in our peripheral vascular sales force, our growth driver will be our EVLT system, which everyone knows is a market in venous ablation that's very underpenetrated. There's a lot of patients that suffer from that disease who could be treated and that's why our growth rates are driving so far-- so strong. So now having a focused sales force there is going to accelerate that growth.

I believe we're going to get FDA approval for BioFlo this summer, and BioFlo will be the only product that has properties proven to reduce thrombus formation. And if that prediction comes true, our Vascular sales force will be focused on that segment and will drive market share and we're going to be queued for growth. In the Oncology business, our NanoKnife product will come back on the market this quarter and we'll manage that pent-up demand and will continue to see our clinical efficacy rise.

So each one of those businesses I intend to grow, I don't intend this to be putting a couple of companies together, I do intend to see this thing grow. In the first year, it's going to take -- it'll take some time for us to get the sales teams in order and for them to see that growth. We're going to focus on ensuring that we drive the cost out at the bottom line and that we create a better P&L going forward. So in the first several quarters, you'll probably see the results more on the P&L, and then several quarters following you'll start seeing those sales numbers kicking in with the type of focus that I mentioned to you. So I'd like to ultimately in a couple years to see a Company that is seeing above market top line growth and is seeing continued operating leverage on the bottom line.

That's great, and I do appreciate the color. I think it helps paint a picture going forward of what this Company can look like, so thank you for that. Second follow up, you mentioned it sounds like NanoKnife you expect back this quarter, what other -- obviously you just had some fantastic data presented at a couple different conferences, but I'm wondering what are the next signposts there that we should be watching for?

Well first of all, obviously, what our revenue is going to occur in the fourth quarter. We've -- we were very concerned when we had our recall of EVLT in the third quarter and didn't expect it to recover as quickly. We need to see how quickly NanoKnife recovers, but at the end of the day, it's still a long-term story in my view and even though we've had this hiccup in the third quarter, my view doesn't change. I think we'll continue at our revenue trajectory, but until we get into a protocol and until-- if we can have the results that we just saw manifest in the controlled protocol, then I think we will get the type of responses that other companies get when they put those results out. So the catalyst is going to be, hopefully, sometime this summer we start our IDE for pancreas and let it go. Does that answer your question?

Yes, absolutely. Thank you.

Jason Mills with Canaccord.

Hello, guys, this is Jamar Ismail calling in for Jason. My question is on just the quality programs that you guys are embarking on. Did you find things wider in scope than the FDA had noted and are there any deadlines that the FDA has it to remediate any issues?

Well, it kind of comes the other way around. We've identified -- the items have been identified by ourselves and the FDA, we set our own deadlines and commitments to the FDA on how and when we'll have them remediated. When we look at the grand spectrum of where we're at, we are not dealing with significant patient injuries and all kinds of issues that these products are-- the sky is falling. It has more to do and we've been fortunate, knock on wood, that any of the issues that we've identified in the quality system has not translated into any issues with patients. These are systemic checks and balances that need to be in place to ensure our quality going forward. These are things that are -- take time in building processes and then systems to automate those processes and the redundancies to ensure that they execute and then the manpower and the training and then the backup.

So it's-- each of these things might seem on a surface level, mundane or not as elegant, but when you break it down, it takes a lot of effort and energy to put them in place. And when the Company is running fast, sometimes people don't do it. So we are looking at something across the Company. We have a broad program and we don't intend to visit this again from a construction standpoint after we're done. We intend to automate, maintain and continue to get better.

Okay, thanks. And just one more, have you built up sufficient inventory levels in Access so that you won't have any supply problems in Q4?

Inventory levels? No, we haven't. We're working to do that, now. But we haven't done so yet, but it's one of our business objectives is to build inventory in a particular with regard to our NeverTouch product line given the very strong demand that we've seen in some lost sales this quarter. So we have an aggressive program to build inventory and to actually end Q4 with more inventory than we need and to not suffer any more outages there.

Okay, thank you.

Jayson Bedford with Raymond James.

Good afternoon, thanks for taking the questions. I guess just following up on that Access business, I realize it was a tougher comp but it was down year over year. It seemed like pricing was not as bad. I don't think it was impacted by any recall. So can you give a little bit of commentary on why the business was down year over year, does that reflect volumes, is that share loss? Any additional granularity would be great.

Yes, actually the Access lines we're affected by recalls. Both the Morpheus PICC and the DuraMax products experienced recalls. So they did feel impact there, so that was part of it. And ASPs also were down on the Access products by about 3% a bit more there actually than the peripheral vascular product which were only down 1 percentage point, so a bit of pricing as well. We're also in the midst of a product transition with our-- the DuraMax and our new Dura-Flow product that we build ourselves. So several different factors there were at play Jayson.

So the $700,000, how did-- you lost out because of recalls, how does that break out between Access and then VenaCure?

About a bit more than half of it would have been in the VenaCure line, in the peripheral vascular line. And the rest of it would've been in the in Access products, roughly.

Okay and then on gross margin, it looked like third quarter gross margin guidance was 58% to 59% on a non-GAAP basis, it came in at 57% I guess why the weakness? And then it looks like you raised your fourth-quarter guidance quite a bit, so wondering kind of what is going on there? Thanks.

So the third quarter would have been impacted by the QCTA program as well as additional recall costs. And we don't think that we're going to have the heavy recall costs in Q4 repeating that we just saw in the third quarter. And in the fourth quarter, there will be no healthy Beads at all, they will be completely out of the revenue mix, so that alone also improves gross margin.

Okay, I'll get back in queue. Thank you.

Thank you.

Charles Croson with Sidoti & Company.

So quick one on international growth, can you just kind of run through what's driving that continued high upper 20s growth there?

Sure, so the two driving factors were NanoKnife, very strong sales there, they nearly tripled from a year ago. And then the other factor was the direct sales operations in the Netherlands that we now have. This will be the last quarter with that being the case of it not being in the prior year period. So we have the full benefit of that this quarter.

Yes, okay. Then a couple more quick ones here then, and I might have missed this I'm sorry if you said this I just jumped on, what were the overall ASP declines for the overall business?

Overall for the business it was 2%.

2%, okay thank you.

2% in Vascular, as well.

Okay, okay, I got you. All right last quick one here then, for the Microsulis, what-- does that have any I imagine you guys are giving guidance out for 2013, but does this imply some upside potentially for that $360 million number you guys gave out?

I think in the first year, since we're going to go through international distribution first and since there's a lot of capital to be sold, we didn't-- we're not expecting a real significant pop in the first year in international. When we acquire the business, and bring it over to the US, I'm sure we'll be happy to give guidance, but it'll take some time to get that ramped up overseas.

Okay, I got you. All right, thanks, guys, that's all I've got.

Thank you, Charles.

Robert Goldman with CL King.

A couple of questions on the quality control initiatives. First on Fremont, California, and I apologize for my own ignorance here, but do you have a 483 or a warning letter pending against that plant?

The -- in Fremont, there's not a plant, it's a design house, and we just were issued a couple 483s, yes.

Okay, and what can you say relative to the 483s as far as what they're cited or the number of citations?

Well the-- I don't have them broken out between Queensbury and Fremont. The Fremont ones would be some observations on improving our design, history files, and some complaint handling, some items as such in the R&D process.

And what is being designed in Fremont?

All the Oncology products.

And then on Queensbury, and I again apologize because I know you gave some metrics up front on the call and I did not catch them all, but you spoke about a reinspection of that plant. When did you say that occurred?

Well we had an inspection last January and then the -- another inspection that began in November of 2011. So January 2011 and November 2011.

And it ended in November of 2011?

No, it ended sometime in January 2012.

And you mentioned that there were some citations that were the same as the prior citations?

Yes, and that's where we've created a sense of urgency and ensure that we come up with some remediation, because we don't want to have -- we don't want to be told the same thing twice and we currently are well on our way to remediating those.

And you do have the warning letter relative to Queensbury but you do not have a warning letter relative to Fremont?

No, not at this point in time. I wouldn't doubt that we would get another one given the most recent citations and observations that we've received. That is why we're preparing to get ahead of the game. And that's why we've taken the action that we have and by the time even we believe a complete review of our responses you will have so many of these already taken care of. They should have been taken care of before at a much more detailed pace and much more in depth. One of the first things I did when I came here is realize that we have to do a better job. We've mobilized and we'll get there.

Okay. And then, Joe, since there are issues now on a couple plants, and I don't wish on anybody, but what's your quality control or legal folks suggesting is the risk relative to consent decree?

Well the-- if the FDA does not believe a Company is making the sufficient progress, they have all kinds of options at their fingertips. We don't intend that to happen and we've taken action, significant action, to get ourselves to where we need to be.

Okay, thank you very much, Joe.

Thanks, Robert.

Larry Haimovitch with HMTC.

Two questions, one on the buyback, you mentioned you've stopped buying the stock back; just curious if you could comment on that at all. The stock continues to languish down here, I would think it would be a good buy in here but I'm just curious what your thinking is.

Yes, we certainly think it's a good buy and it's merely the fact that we anticipate using a substantial amount of cash and borrowing a lot to close the acquisition and therefore have decided to put the buyback on hold and the authorization was only through May 31. So when it was put in place, so essentially that will be it. And we'll work on the integration and as things settle out in the future, our Board may consider authorizations down the road at some point.

Okay. And then, for Joe DeVivo, Joe with the Microsulis acquisition, which I agree with you looks like a nice tuck-in and gives you three energy sources for Oncology, I just wonder how much bandwidth does the Company have now to continue to do that? You've got a lot on your plate, you've got FDA issues, you've got a massive integration issue, you got some enormous opportunities ahead. Is there bandwidth in the organization to do more of these tuck-in acquisitions or do you think you're going to be pretty quiet for a while to try to get all these other issues resolved?

Well, Larry, it depends on what kind of deal it is. If it's something that we can rely on an external-- the partner to provide products for us to sell within one of our channels, then I think it's easily doable. I think given the Microsulis transaction, we have the option to close that whenever we choose. Doing an integration of their facility on the back of the current deal, we do not think is wise and chose not to do an acquisition at this point. Our international distribution team is not as focused on the type of issues as we are given here in the States, so we thought it was a safe bet to get them started with those products. We'll continue to look at opportunities as they come up and be very mindful as to which bandwidth is consumed and which is not.

Okay, one other quick question and I'll jump back in queue. On the IRE, obviously some of the data was encouraging and hopefully will continue to be very, very good. Of the data that we saw in March, Joe, what paper or what approach to pancreatic or liver cancer was most encouraging to you from these recent papers?

Well, as I mentioned in my comments, I think the discussion that Dr. Martin put together was significant. I mean looking at 43 or I think it was 54 or 44.

It was 44.

Yes, 44 yes -- I'm sorry I think I got that wrong -- 44 different cases and then coming up with a prospective or a control group. We're talking about patients who have -- who are failing existing therapies who have a very short survival curve and to be able in the early experience with the learning curve that exists and all the startup, to show any kind of benefit is encouraging. But we still have a lot of work to do, Larry. We-- getting these type of results under a protocol I think is what we need for this business to inflect, but this is an indication that we're doing the right things. It's an indication that we believe the technology can add value. The clinicians clearly believe it can add value and it gives us the fortitude to continue on.

I have another question, but I don't want to be a hog here, should I jump back in queue, is there other people waiting?

That's fine.

Okay. The application for IRE in the US, my understanding is only for pancreatic cancer and I'm wondering why you're not also going after liver cancer?

For what now?

The IDE application that you're working on in the US, my understanding is it's solely for pancreatic cancer. My question is wouldn't there be a reason to also pursue liver cancer in the US at this time?

Well, yes. I think that there are a lot of applications within liver where IRE is applicable. That said, we need to focus. We need to go deep. And I think the Company historically has been a little bit thin in that area. We need to drive one application to standard of care, and we can't do two concurrently. So we've chosen the one disease state where we think we can make the greatest impact clinically and help patients and get the biggest return for our efforts especially given how quickly unfortunately these patients expire. Liver, like prostate, is a very well served organ with many different technologies from catheter-based therapies to drug delivery to energy cold and hot and IRE and this and that in Beads. So we decided that the greatest impact we can make clinically and the economically and also to patients would be to focus on pancreas first.

We did do a study in Europe, 26 patients was presented on at SIR as a primary therapy for liver cancer patients. It showed in several patients complete disappearance of the lesion, which we were stunned because normally with RF there's a scar that's left behind. Some of the artifacts on follow up, they couldn't even identify if there was a tumor in place. So there are some very encouraging early clinical signs, but we think the greatest return and the greatest way to drive adoption is to drive pancreas.

Okay, great, thank you, Joe.

Thank you. There are no further questions at this time I will turn it back over to Mr. Jones.

Okay, let me just have Joe DeVivo is going to make some concluding remarks.

First of all one point of clarification, excuse me, can't get rid of this cough. One point of clarification, is when I mentioned we have observations in Queensbury and Fremont. The repeat observations were solely in Queensbury, there were no repeat observations in Fremont and there's no risk of another warning letter in Fremont. But, regardless, our efforts are significant and we're going to show the FDA that we've listened, that we have great processes in place and that this will be a great platform for us. We've-- we're investing not just in Queensbury, we're investing our Quality Call To Action is a Corporate program, Company-wide which is not only process but culture, infrastructure, talent realignment and execution. So we're very, very committed, very, very committed.

That said, everyone on the call and for those who follow AngioDynamics, we're in the process of transition. And when you make these moves, and we're intent to get to a different level as a Company, there may be some bumps in the road. But we have a great team, we have great people, we are excited about our future. Every day that goes by that we see what this Company is going to become with the combination of great people at Angio and great people at Navilyst, boy, we get excited. We walk around the halls of the businesses and you can just palpate the excitement of what our future holds.

Last week we are at the Society of Interventional Radiology meeting, we met customers who are customers of Navilyst and customers of Angio. On both sides of the business, those customers are excited. They see the vision. They understand why these Companies should come together. They see how we can serve them better. They see how we can become more competitive. And we will successfully integrate these businesses. We will create a platform for growth. We will drive better earnings performance on our P&L as a percentage of revenue. We will generate cash. We will continue to acquire and bring on technology and we will be a great Company. I thank you for your time and attention and look forward to talking to you next quarter.

Ladies and gentlemen, this does conclude the conference call. You may now disconnect and thank you for your participation.