Earnings Labs

AngioDynamics, Inc. (ANGO)

Q3 2008 Earnings Call· Mon, Apr 7, 2008

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Transcript

Doug Sherk

Management

This is Doug Sherk with the EVC Group. Thank you for joining us this afternoon for the AngioDynamics Conference Call to review the financial results for the third quarter of 2008, which ended on February 29, 2008. The news release announcing the third quarter results crossed the wire this afternoon shortly after the market closed. If you haven’t received a copy of the release and would like one, please call our office at 415-896-6820 and we’ll get one to you immediately. Additionally, we’ve arranged for a taped replay of this call, which may be accessed by phone. The replay will become available at approximately 6:30 PM Eastern Standard Time this evening and remain available for seven days. The dial-in number to access the replay is 800-405-2236 or for international callers 303-590-3000. Both numbers will need the passcode of 11110709 followed by the pound sign. This call is being broadcast live and an archived replay will be also available. To access the webcast, go to AngioDynamics’ website at www.angiodynamics.com. Before we get started, during the course of this conference call, the company will make projections or other forward-looking statements regarding future events, including statements about the sales and the company’s beliefs about its revenues and earnings for fiscal 2008. 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. In addition, management will be reviewing various non-GAAP measures during today’s call. Investors should consider these non-GAAP measures in addition to, not as a substitute for or superior to, financial reporting measures prepared in accordance with GAAP. During today’s call, the company will discuss non-GAAP measures, adjusted income and adjusted EPS. Adjusted income and adjusted EPS exclude certain expenses relating to the acquisition of RITA Medical, stock-based compensation expense, litigation damages and others, including the cash benefits from the use of acquired net operating losses and assumed taxes on net income where applicable. Management believes these measures provide investors with useful information in comparing the company’s performance over different periods, particularly when comparing this period to periods in which the company did incur any expenses relating to these activities or items. A reconciliation of all GAAP measures used during today’s call was provided in the news release distributed this afternoon and is available on the company’s website. Finally, during the question-and-answer period today, we request each caller to limit themselves to two questions and then encourage re-queue to ask additional questions. In advance, we appreciate everyone’s cooperation with this procedure. Now I’d like to turn the call over to Eamonn Hobbs, President and Chief Executive Officer of AngioDynamics.

Eamonn P. Hobbs

Management

Thank you for joining us today to review our third quarter results for fiscal 2008. With me is Joe Gersuk, our Chief Financial Officer. Our third quarter revenue of $40.7 million was in line with the preliminary results we provided four weeks ago. While revenue grew 14% on a pro forma basis as compared to the third quarter of fiscal 2007, we didn’t grow as rapidly as we had expected. Our growth was limited in the quarter by a combination of several factors. We believe that we have already successfully addressed some of these factors. The others should be addressed through a five-point strategy we have put in place as part of a very focused effort by our team during the last few weeks to generate consistent predictable growth as we move forward. I will discuss this strategy at the end of my opening remarks, before turning the call over to Joe. The third quarter revenue shortfall was not something that we took very lightly here in AngioDynamics. As I just mentioned, there were several factors that combined to impact our quarter. The first factor was that we continue to experience the pricing pressure in the dialysis product market that we have seen for the last two years. Our plan to address this has been to introduce new and very innovative dialysis products that will allow us to drive a much more compelling value proposition for our customers. As we mentioned during our last call with you, we had anticipated beginning commercial shipments of our very innovative and feature-rich Centros hemodialysis catheter in early Q3, but unfortunately this was delayed due to start-up manufacturing issues, which have now been resolved. I am now happy to announce that commercial shipments of Centros have begun. Centros is a major part of our…

D. Joseph Gersuk

Management

Following our March 6 sales pre-announcement, today we’re reporting final financial results for our fiscal third quarter. While third quarter sales were below original Wall Street and company expectations, we performed well on a number of other financial metrics this quarter, including our highest ever gross profit margin, record cash flow from operations in the fiscal quarter, and good operating expense management. In addition as Eamonn just noted, we are pleased to report that we have settled the patent litigation with Diomed. Before I review our financial performance for the quarter, let me briefly summarize the positive financial impact of the settlement of this litigation. Following the March 2007 jury verdict and subsequent monetary judgment award, AngioDynamics recorded a $9.6 million litigation provision in its fiscal third quarter of ‘07. And the provision had increased to $10.2 million, primarily as a result of interest accrued on the award. Under the terms of the settlement, we will make a single payment of $7 million to Diomed. The resulting $3.2 million reversal of the unused litigation provision is shown in the income statement this quarter. The after tax impact on net income is $2 million or $0.08 per share. As operating performance, third quarter net sales increased by $14 million or 52% to $40.7 million. $11.2 million of the increase was attributable to the sale of products acquired from RITA Medical Systems and the balance or $2.8 million was in AngioDynamics products. This represents a 12% growth rate in AngioDynamics product sales, while sales of RITA Medical products grew by 17% on a pro forma basis. You will recall that our fiscal third quarter result a year ago included slightly more than one month sales of RITA Medical, following the closing of the acquisition on January 29, 2007. Total company sales then…

Operator

Operator

(Operator Instructions) Our first question will be coming from Phil Nalbone - RBC.

Phillip Nalbone - RBC

Analyst

First question relates to the IRE clinical development effort. Eamonn, what exactly do you mean by reportable clinical outcomes by the June timeframe, what exactly do you expect that we will have learned about the utility of this technology and what sort of real world use do you think that those insights will enable?

Eamonn P. Hobbs

Management

Our pilot trial that began this week in Florida and we expect to have wrapped up by the end of the month; will demonstrate the ability of the IRE technology to ablate malignant prostate cancer in humans. It’s a small series, it really isn’t going to generate statistically significant data, but it will present to us very compelling data that we can follow up with a much larger study that will generate statistically significant results. The end points are needle biopsy of 14 days to confirm that the cancer has been ablated and completely ablated, followed by routine and continuous PSA blood test for basically the life of the patient, to make sure there is no recurrence. So, we are optimistic that this pilot trial is and subsequent pilot trials are going to present pretty compelling evidence that IRE does in fact translate to humans very effectively, from the extensive pre-clinical animal work that we’ve conducted, and are going to initiate more specific clinical trials with the idea of obtaining more specific indications, past our current FDA approval for the general indication of soft tissue ablation.

Phillip Nalbone - RBC

Analyst

My second question relates to fixing what went wrong during the third quarter. I think you were very clear that the fix is in on the first two of the four issues, the Centros and the NeverTouch manufacturing issues. I’m not as clear on what the fix is for the challenges that you faced in the conventional port access business and the slowness in the angiographic product set. Can you talk about your responses to those issues?

Eamonn P. Hobbs

Management

On the port side, we saw really superb growth in Smart Port CT sales. It really exceeded our expectations. We did see some concern or have some concern about the sales of the standard ports. Standard ports were not a focus at all during Q3, and all eyes were on the Smart Port CT sales. We’ve modified the sales force commission plan for Q4 to hopefully address that by enticing the sales people to pay more attention to the maintenance business of the standard port business as well as drive the Smart Port CT business forward. The angiographic catheters, we’re in a situation there where we are the clear market leader and the market is only growing at mid single-digits. We’re basically growing at the market rate right now, at 5%. So, our challenge there is to figure out how to change the value proposition so we can grow our revenues there with new product introductions, and higher priced products, higher margin products, because it’s a clearly an issue of diminishing returns to look for more market share, because we have such commanding lead already. So, a bit of a victim of our own success with that product line, and are looking to do all of the above plus as I mentioned, for the first time as a company looking at product lifecycle management. And, we’ve really never had to do that in the past. But, we’ve matured to the point and some of our products have matured to the point where it makes sense to now look at the right strategy for those types of things.

Operator

Operator

Our next question is coming from the line of Christopher Warren - Friedman, Billings, Ramsey.

Christopher Warren - Friedman, Billings, Ramsey

Analyst

Can you talk to us about how much R&D dollars went into the IRE, and how that spending should progress through the next couple of quarters?

Eamonn P. Hobbs

Management

Well, the IRE investment to-date would be measured I would say between $5 and $10 million, which has happened over the last seven years, far more closely weighted towards the more recent years. Five of that was a deposit with Oncobionic in the $25 million buyout of Oncobionic, that’s a stage file. And the other, I don’t have the exact figures, but somewhere in the neighborhood of between $2 and $5 million that we’ve invested ourselves in the development of the IRE system in close collaboration with Oncobionic. How things should pan out is that we expect that although we have the FDA approval for the soft tissue ablation, we are going to be looking to expand that or I should say, refine that indication to more specific indications like organ specific liver, lung, kidney, bone, prostate, etc. And those trials are going to be significant expenses and we haven’t actually finalized our budget for next fiscal year. So, I couldn’t tell you what the R&D expenditures are going to be, because that hasn’t been decided yet. But, IRE is going to be a big part of where we’re going to be putting our money.

Christopher Warren - Friedman, Billings, Ramsey

Analyst

Could you just talk a little bit about the rationale for in sourcing manufacturing, and maybe line out the months to come or what inning you’re in there relative to where you want to be?

Eamonn P. Hobbs

Management

Well, one of the more recent vertical integrations was the NeverTouch, which we mentioned. And, we’re having that made outside. In Q1 and Q2, we sort of had parallel manufacturing in and out, and Q3 we’re solely manufacturing in-house. And we did that really for the usual reasons, control and gross margin improvement or lower cost. The dialysis catheters, we’ve been systematically vertically integrating those over the years, weaning ourselves away from outside manufacturing where it made sense. So the real driver there is, just blocking and tackling of good operational manufacturing business and trying to reduce our costs and gain control. And we look at the vast majority of our products are manufactured internally but where we leverage outside manufacturing we always look to vertically integrate that over time.

Christopher Warren - Friedman, Billings, Ramsey

Analyst

Do you think we could see more of that in the months to come?

Eamonn P. Hobbs

Management

Definitely.

Operator

Operator

Our next question is coming from the line of Jayson Bedford - Raymond James.

Jayson Bedford - Raymond James

Analyst

Anyway you can quantify the impact of the VenaCure shipping delay and then are you on a backorder situation right now?

Eamonn P. Hobbs

Management

Well, Q3 was hand to mouth throughout the quarter. We were backordered in VenaCure NeverTouch really throughout the quarter. And really put our sales force in a tight spot in that, they had to spread inventory around as judiciously as possible to keep all of our existing customers immune to the inventory tightness. It’s hard to quantify what that could have been, as far as the impact, but north of seven figures is very realistic. Because there was no clear air at all, there was no way to drive the VenaCure NeverTouch sales during the quarter, quite the opposite. We were scrambling all quarter. We are in clear air now, and we’re sitting on a very solid inventory position in our NeverTouch product and expect that to end and definitely focus the sales force on going after business once again. So, it was a very material part of our shortfall in Q3.

Jayson Bedford - Raymond James

Analyst

And so it sounds like it was at least $1 million impact in the quarter?

Eamonn P. Hobbs

Management

Yes.

Jayson Bedford - Raymond James

Analyst

The more rapid R&D conversion, it seems like that’s aimed more in improving manufacturing efficiencies. Are there any new initiatives in place there that you plan on implementing to stimulate new product flow?

Eamonn P. Hobbs

Management

There are a number of new initiatives. The ink isn’t quite dry on many of them. But what we’re trying to improve upon is the predictability of new products coming out of the pipe so that we can be much more consistent in our ability to generate revenues from them in a predictable fashion. And that’s blocking and tackling scenario where new product development and research and development is notoriously hard to predict. The best way of making it more predictable is to not forecast new product sales until you have the product in the bag so to speak. It would be far more conservative on new product sales, because of the inherent delays associated with new product development, so and the nature of the beast. So I think we’re paying a tremendous amount of attention to that. I think it is going to have a very positive effect on our ability to predict where our business is going to be.

Operator

Operator

Our next question is from the line of Jason Mills - Canaccord Adams.

Jason Mills - Canaccord Adams

Analyst

Joe, your guidance for earnings this year, fiscal 2008 was GAAP guidance. The pro forma guidance I presume would just to be to subtract the $0.08 or so from the Diomed gain, is that correct or are there other moving parts there?

D. Joseph Gersuk

Management

Yes, that would be a $0.08 on the gain.

Jason Mills - Canaccord Adams

Analyst

So, similar on $0.50 to $0.53 pro forma.

D. Joseph Gersuk

Management

Correct.

Jason Mills - Canaccord Adams

Analyst

Eamonn, on the national account business, which is one point for the five-point plan for predictable accelerating growth going forward. I was curious how you will measure success. You mentioned perhaps somewhat surprisingly to me that you think that that part of the business will be driven or focused or that area of business will be contingent on service and quality as opposed to price and we hear in many other medical device markets that national accounts or GPOs are focused on price. So, I was just curious whether you’ll be focused more in judging success of that part of your five-point plan in terms of revenue or gross profit dollars and is there perhaps an impact down the road to gross margins? Would you give up gross margin for a bit bigger piece of that pie, I guess is what I am asking?

Eamonn P. Hobbs

Management

Well with regard to national account business we don’t anticipate that there is going to be any gross margin impact. In analyzing the contract pricing of products that are most amenable to national accounts, such as vascular access products and dialysis products, we were very pleasantly surprised to find out that the pricing was very competitive. It wasn’t competitive with market prices that we’re used to. So, that didn’t scare us off. And I would say as, with the advent of national accounts, and although there is certainly a lot of rhetoric about how they’ve driven prices down. If you look at medical device companies overall, in the last 10 years, their gross margins have certainly not gone down or suffered because of national accounts. So if you do lower price, you pick up so much incremental volume that you can make it up with lower cost and maintain your gross margin or you don’t have to lower your price.

Jason Mills - Canaccord Adams

Analyst

What are your plans for fresh iteration within your angiographic catheter division? You touched on briefly it being an impact to the quarter and you also touched on in Jayson’s question new R&D initiatives, those two things match up over the course of the next handful of quarters?

Eamonn P. Hobbs

Management

Our angiographic products are a very, very broad line of products on to themselves and we have a number one market position in peripheral vascular angiographic catheters. But the range of products in that line range anywhere from $17 up to hundreds of dollars. And we are looking at initiatives to potentially convert customers to a higher value platform that has a much higher ASP, and similar or better percent gross margin to where they are now. So we’re looking at up selling opportunities in that product segment because there is no way we’re going to drive the market growth past the 4% or 5% or 6% that depending on which study you read right now, that it’s growing at today. It is what it is. But if we can convert a customer who is buying a $17 catheter to a $35 catheter that would obviously be very, very accretive to our growth in that segment.

Operator

Operator

Our next question is from the line of Greg Brash - Sidoti & Company. Greg Brash - Sidoti & Company: Eamonn, do you think maybe you could run down, besides IRE and the Centros, some of the new products in the pipeline that you are pretty excited about and how important are these new products to reach your goal? I know you’ve stated a goal in the past of 20% revenue growth, and is that goal still achievable in light of some of the slowdown in growth this year?

Eamonn P. Hobbs

Management

We don’t talk about specific things in our pipeline for competitive reasons, but I’m very excited about our pipeline. We do have a broad range of product development opportunities and projects that we are working on. With regard to our ability to drive growth back up to the 20% level, new products play a huge, huge part of our ability to do that. And the way we look at our business is every year, half of our growth would come from legacy products, and the other half of our growth would come from brand new products recently introduced. So if we falter on the new products our 20% growth would be 10% growth and so new products are very, very important. Of the new products that we have disclosed, certainly next fiscal year, the Smart Port CT product line we are expecting that’s going to be continued to a big growth driver, Centros is going to be a big growth driver. And then IRE, we are planning to commercially roll out in Q2, and that’s a blockbuster product. That’s revolutionary technology that can really raise the bar and make a very material impact on our growth rate once it gains traction. So, because we are going into multibillion dollar markets ultimately with that product, so even small market share attainments will move the needle quite a bit. Greg Brash - Sidoti & Company: Joe, one of things that jumped out at me was the G&A it was down to around $3.4 million in the quarter. It had been up a little over $4 million the prior two quarters. What’s going on there, and is this a level we can expect to see going forward?

D. Joseph Gersuk

Management

One part of the decline was on the legal expense side, we had our lowest quarter of the year, legal expense. We only spent a couple of hundred thousand dollars, and so that was a benefit in the quarter. And apart from that, we’ve been working hard to eliminate a few non-essential expenses. So we’re squeezing it as much as we can in order to invest elsewhere in the business, primarily in R&D. Greg Brash - Sidoti & Company: So we may begin to see an uptick next quarter, because of the VNUS litigation and have it come back down, or how should I be looking at that?

Eamonn P. Hobbs

Management

Yes, it will certainly uptick a bit next quarter, but still be less than $4 million. Greg Brash - Sidoti & Company: You mentioned plans to add sales reps. I don’t recall if I heard you mentioned a number. You are at 53 right now in the interventional side, is there a goal in mind?

Eamonn P. Hobbs

Management

We’re currently at 57 on the interventional territory, IPG territories. And 28 on the OPG side, plus field managers, and other managers and clinical specialists and all that. So just to make sure we’re talking apples-to-apples. We intend to add 8 to 10 people, 8 to 10 territories on the IPG side in the Q1 timeframe. So we’re out looking right now.

Operator

Operator

Our next question is coming from the line of Jeff Jonas - GAMCO Investors.

Jeff Jonas - GAMCO Investors

Analyst

I was wondering if you would quantify the impact of taking some of those manufacturing in-house.

D. Joseph Gersuk

Management

Well, we don’t quantify it exactly Jeff, specifically as Eamonn said, we’ve had a transition from the outside vendor over the course of three quarters. And we’re paying a higher price when it was outsourced as well as the transition cost of sending people back and forth. So we don’t break it out explicitly, but it’s certainly inherent in the improvement in gross margin that we saw this quarter from the prior.

Jeff Jonas - GAMCO Investors

Analyst

When you talked about tuck-in acquisitions, are these going to be specific products? Are these going to be much smaller scale than the RITA deal?

Eamonn P. Hobbs

Management

Yes, our anticipation is that it would be smaller scale than the RITA deal. We are looking for products that can fit right in the current sales force’s bag and really leverage their ability to use the relationships that they’ve already established more effectively. So I don’t anticipate any broad-based company acquisitions as we did with RITA. Although we’d never want to rule one out if a gem popped up. But I think it’s far more likely that we would be looking at products and product lines that are really tuck-ins right into the bag with not too much stress.

Operator

Operator

The next question is from Ronald Goodson – Goodson of Malibu. Ronald Goodson – Goodson of Malibu: RITA shareholders were looking at a lot of buzz for the share product for breast RFA. We haven’t heard any of that since the merger.

Eamonn P. Hobbs

Management

Well, we have conducted a number of trials on the Assure program and just a little background on Assure. Assure is a development program that RITA was conducting and that AngioDynamics has continued to evaluate the potential to utilize radiofrequency ablation to create an assurance margin around an excisional breast biopsy. With the idea being that every surgical excisional breast biopsy is conducted with a very, very poor idea about the margin being clear and frozen sections were done and makes the surgery a lot more laborious. And the concept of actually using an RF probe to ablate a margin around the excisional cavity, made a tremendous amount of sense, and it still does. It’s a very, very appealing idea. We have been impressed with the clinical data we’ve received and generated. The biggest challenge we face with that development program is reimbursement. We’re looking at avenues of achieving and obtaining a compelling reimbursement. It is difficult to do because although it’s intuitive that ablating a margin around an excisional biopsy in a breast is a really good thing to do. It’s very, very hard to quantify how much is that worth. So the powers that be that set reimbursement levels are struggling with that. And have set the bar much higher than we think is attainable for us to show data to in order to achieve compelling reimbursement. So as they say, life is a negotiation, and we continue to negotiate. Ronald Goodson – Goodson of Malibu: Is there any chance of like a celebrity patient or an Oprah event or something that could jumpstart that process?

Eamonn P. Hobbs

Management

Yes, on the reimbursement side, that would potentially have a very positive effect on cash payment. But on the reimbursement side, compelling CMS for instance to establish a reimbursement level that would make it compelling or worthwhile for surgeons to actually perform the procedure post lumpectomy, that’s a different kettle of fish. They are not very impressed by any publicity unless it’s a leading politician who regulates the CMS, that might have a very positive impact actually, but we’ll work on that.

Operator

Operator

Next we have a follow-up from Jason Mills – Canaccord Adams.

Jason Mills - Canaccord Adams

Analyst

I just wanted to get a sense for some products we’ve talked about in the past and have for the last couple of quarters, which include Sotradecol and the new balloon product, the new PTA Profiler product. How are those going? And what do you see for prospects, specifically for Sotradecol, maybe an update on the Kennedy Bill, if it’s still in process?

Eamonn P. Hobbs

Management

Well, Sotradecol is doing very, very well. We are very pleased with its progress, and it’s still racking up growth rates that are multiples higher than our corporate growth rate, so all is well there. We see no end in sight there. All the traction we’ve been looking for is coming. It’s really, we’re going to keep beating the drum there and hopefully, keep getting the benefit of that. With regard to the Kennedy Bill and Sotradecol, the Kennedy Bill is stalled in committee. The compounding pharmacies have mobilized with scare tactics to get constituents to write their Congressional representatives, and there is a lot of debate going on about it. So we don’t think that Bill is going to go away by any stretch of imagination, but it’s not anywhere near being passed either. We have seen enforcement actions from the FDA pickup significantly with regard to compounding pharmacies. So, compounding pharmacies are based on the FDA’s actions, on the FDA’s radar screen and that helps quite a bit. The Profiler is doing well. We are pleased with its performance. We are putting more emphasis on it. We have been pleased with the performance of the product in the marketplace. We’ve had certain territories do extremely well with it and then others not focus on it enough. So we’re tweaking our sales management to make sure that everybody spends enough time on that product, but it’s growing at a very, very high rate.

Jason Mills - Canaccord Adams

Analyst

On Sotradecol, when would we get to the point that you would consider buying that business from your partner? And then secondly, not corresponding with Sotradecol, but with respect to the sales reps, I believe, when you acquired RITA you acquired somewhere in the mid-30s range in terms of quota carrying sales reps. At that point in time I think it got you to over 90, and now you’re at 25 quota carrying. So have you pared back primarily on the oncology side or have you seen some departures on the interventional side? It looks like where you are today is perhaps five or six less than where you were a year ago when you bought RITA, is that correct?

Eamonn P. Hobbs

Management

Yes, when we bought RITA there were 32 territories in the RITA sales force and we pared it back to 28, but having said that we took a few of the RITA people who are actually ex-Horizon sales people and moved them over to our IPG sales force. Our current numbers are 28 territories on the OPG side and 57 on the IPG side. So, 85 plus which is the same number we had for a year.

Jason Mills - Canaccord Adams

Analyst

So you pared that back pretty quickly, then it’s been constant with no add since?

Eamonn P. Hobbs

Management

That’s right. And as we said we’re looking at for the first time since 2006, 8 to 10 territories on the IPG side in Q1.

Jason Mills - Canaccord Adams

Analyst

On the Sotradecol follow-up, Eamonn, just where would it get to the point where it makes economic sense to buy that business?

Eamonn P. Hobbs

Management

We’ve got ways to go, I think.

Operator

Operator

There are no further questions at this time.

Eamonn P. Hobbs

Management

I would like to thank you all for your attention today. We look forward to updating you on the progress and appreciate your interest in AngioDynamics. Have a great evening.