Evan Smith - FTI Consulting, Managing Director Howard Donnelly - Chairman of the Board Jim Clemmer - President & CEO Mike Trimarchi - Interim CFO.

Matt Mishan - KeyBanc Jeff Chu - Canaccord Genuity Charles Haff - Craig-Hallum Jayson Bedford - Raymond James.

Welcome to the AngioDynamics 2016 Fiscal Tear Third Quarter Earnings Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Evan Smith. Please go ahead, sir..

Thank you and welcome, everyone. Thank you for joining us for the AngioDynamics conference call this afternoon to review the financial results of the Fiscal 2016 third quarter which ended on February 29, 2016.

The news release detailing the third Quarter results crossed the wire this afternoon and is available on the company's website at www.angiodynamics.com. A replay of this call will be archived on the company's website.

During the course of this conference call, the company will make projections or forward-looking statements regarding future events, including statements about revenue and earnings for the FY '16 fourth 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.

[Operator Instructions] And with that said, I would like to turn the call over to Howard Donnelly, Chairman of AngioDynamics Board of Directors..

Thank you, Evan. I would like to welcome everyone on the call to AngioDynamics' third fiscal quarter of 2016 conference call. I am joined today by our Interim CFO, Mike Trimarchi; and our new CEO, Jim Clemmer. We're very excited to welcome Jim to AngioDynamics. This is a key appointment at an important time for our company.

With near term regulatory challenges behind us and some growth products across our business segments providing a foundation for the future, it is critical that we're able to capitalize on our opportunities to drive the next leg of growth for AngioDynamics.

In saying that, we wanted to bring in an experienced leader who has managed successfully in a highly competitive and global marketplace.

With over 25 years of industry experience, Jim brings a wealth of knowledge and proficiency in leading a global medical device business, having most recently served as president of the medical supply segment at Covidien.

In Jim, we have found a well-rounded executive with both the industry and global experience that was important to us as we considered our next phase of leadership. I firmly believe that Jim's wide range of experience and track record of delivering results will be valued by shareholders, customers and employees.

We're confident he is the right person to lead us through an exciting new growth period in the company's history with a priority on driving growth and innovation, improving margins and ultimately maximizing shareholder value. Myself and the Board are very excited about Jim joining the Angio team and we look forward to working closely with him.

I will ask Jim to say a few quick remarks and Mike will then provide a review of key business updates from this quarter, cover the financials, as well as an overview of our financial guidance for 2016. With that, I would like to hand the call over to Jim Clemmer, AngioDynamics' new President and CEO..

Thank you, Howard and greetings to everyone on the call. I'm excited to join AngioDynamics and enthused to be participating in my first earnings call as CEO. Before assuming my new post, I have known great things about AngioDynamics and the people who work here.

Even in my brief time spent on the ground this first week, I've seen the commitment and energy of the employees that will help us take this company forward to where it should be.

Over the course of my career and in particular most recently at Covidien where I ran the medical supply segment, I've had success driving growth by understanding and adapting for the ongoing market dynamics and the needs of customers focusing on driving efficiencies, expanding margins and working across the organization to drive innovation and expanded product offerings.

AngioDynamics has a strong reputation. I believe the company has the potential for future growth across all three segments with opportunities both in the U.S. and globally. I look forward to sharing my thoughts and our strategy for driving our next phase of growth in the coming months. Thank you for giving me the opportunity to lead this great company.

Now I'll turn it over to Mike for the financials update..

Thank you, Jim and welcome to the team. During the third quarter, we continued to make progress on multiple fronts including delivering solid revenue growth in several key products, enhancing profitability and executing on our promise to improve free cash flow which we use to deleverage our balance sheet.

These advancements were made while continuing to experience headwinds related to competitive dynamics and challenges in getting reimbursement and our regulatory approvals for certain products. In the third quarter, we generated net sales of $87.4 million, an increase of 1%.

On a constant currency basis and excluding the impact of the Morpheus product discontinuance last year, sales were up 3% compared to the third quarter a year ago. EPS was $0.02 compared to a net loss of $0.12 per share in the third quarter of FY '15.

Excluding the items shown in the quarterly non-GAAP reconciliation table, adjusted EPS was $0.15 compared to $0.12 per share from the year-ago third quarter. EBITDA was $9.5 million compared to a loss of $1.5 million a year ago. Adjusted EBITDA was $14 million compared to $13.3 million in the year-ago comparable period.

Adjusted gross margin for the third quarter was 49.8% compared to 49.5% in the prior-year period.

Cost reduction efforts, including our operational excellence program and changes in inventory reserves, contributed 100 basis points of improvement which was largely offset by 50 basis points of price headwinds and 30 basis points of foreign currency headwinds. Similar to our second quarter, the pricing headwinds were split evenly between our U.S.

and OU.S. businesses. As a brief update on the manufacturing footprint consolidation, in the quarter we made the decision to temporarily pause the final transition of manufacturing from Queensbury to Glens Falls.

As noted last quarter, we have already started the benefit from reduced operations management spending in advance of finalizing the consolidation. In this quarter, we continued to consume the inflated levels of inventory built in preparation for the move.

Since the end of the quarter, we have resumed the consolidation effort which we will finish in FY '17. Operating expenses were flat to last year. We continue to incur $750,000 per quarter associated with the investment in our sales force. This investment has been offset by other cost reductions year over year, including currency benefits.

The third quarter included one month of medical device tax expense totaling $435,000. As a discussed in our last call, this tax has been suspended for calendar 2016 and 2017.

As outlined in the supplementary tables to our release, total acquisition, restructuring and other expenses of the quarter was $3 million which was primarily $2.8 million of legal expenses related to our ongoing DOJ matters in previously disclosed litigation. Amortization expense was $4.5 million in the quarter.

We had lower M&A costs in the third quarter compared to the prior sequential quarter. As previously stated, we evaluate opportunities as they arise, however at this time, we do not have any imminent M&A transactions planned or in the pipeline. In the third quarter, we generated $12.4 million in operating cash flow, slightly up from prior year.

Free cash flow was strong at $11.7 million as compared to prior-year free cash flow of $8.7 million. Working capital improved from reducing our inventory levels, partly generated by the facility consolidation progress to date.

We used the recent cash performance to pay down an additional $5 million on our credit facility, above and beyond the scheduled term loan amortization. At February 29, 2016, cash and investments were $23.6 million and debt was $126.4 million. I'll now share some additional color on each of our franchises beginning with peripheral vascular.

PV delivered another strong quarter growing 8% to $49.8 million in sales, driven by growth across all categories, led by significant increases in thrombus management and venous. AngioVac sales grew 28% year over year, a strong quarter but in part benefiting from a below average prior-year comparative period.

At this point, we do not anticipate growth at this level to be sustainable in the near term as we continue to develop the market. On a positive note, the sales were supported by a corresponding increase in procedures indicating true utilization in the marketplace. From a year-to-date perspective, AngioVac sales are up 13%.

Within the venous category, we saw nearly $1 million of Sotradecol revenues in the third quarter we had anticipated in our Q4. This timing shift was the result of a focused sales initiative to reduce our inventory of the product as we end our distribution relationship and prepare for our launch of Asclera.

As we have previously mentioned, we entered into an agreement with Merz North America to serve as the exclusive distributor of Asclera, a polidocanol injection within the vein market in the U.S. as a treatment of spider and varicose veins. In addition to those product drivers, our U.S.

PV sales force investment made at the outset of the fiscal year continues to deliver returns with 7% growth in fluid management and 30% growth in venous laser sales compared to the third quarter of 2015. Overall, our PV business continues to build momentum.

Now, moving to vascular access which generated $24.9 million in revenues during the quarter, down 6% from the prior year with sales down across all product segments excluding the Morpheus discontinuance, VA sales declined 2%. We saw continued strong growth in BioFlo sales across all product categories.

BioFlo grew 21% in PICCs, 33% in ports and 68% in dialysis. From an overall percentage of sales, BioFlo now represents 42% of total VA and is 73% of all PICC revenues, 17% of ports and 19% of dialysis. We continue to struggle with declines in non-BioFlo products and challenges with delivering a competitive tip location system to the market.

While discussions with the FDA continue, we no longer expect to receive FDA approval of Celerity with navigation during the FY '16. We know that we have work to do in the vascular access business and we understand that we have not properly executed.

To grow our business in the difficult competitive market, we need to better perform commercially by building additional data on the economic outcomes of BioFlo, continue to demonstrate the value of BioFlo to clinicians and decision-makers and create more advantageous relationships with GPOs.

In parallel, addressing our tip location technology gap is critical for our PICCs business. Now, moving to oncology/surgery, net sales were $12 million in the third quarter, down 8% or $1.1 million compared to the third quarter last year. The decline is due to lower capital sales for NanoKnife and Microwave.

Once again, utilization of our products was up, a metric we believe is a better indication of the overall health of the oncology surgery business. NanoKnife disposables rose 10% worldwide including 14% in the U.S. and Microwave disposables were up 16% worldwide, 21% in the U.S. Capital sales of NanoKnife continue to be a challenge this quarter.

To address this challenge and drive procedural growth, we continue to place evaluation units in hospitals globally which we believe will ultimately translate into capital purchases. We continue to have discussions with NICE and CMS with the hopes of favorable outcomes which we expect to increase market adoption of this disruptive technology.

Recent procedural growth trends combined with the opportunity to expand NanoKnife registrations into international markets and our ongoing discussions with regulatory and reimbursement bodies around the world continue to give us optimism about the future for our oncology/surgery business.

Turning to guidance, as you recall, during the last quarter, we revised our net sales range for the FY '16 to $353 million to $359 million, mainly as a result of the slower than expected turnaround in our VA business and the reduced level of capital sales related to NanoKnife.

Our prior guidance for the year included approximately $3.5 million of sales in the Asian market that are dependent upon regulatory clearances in China and Japan. As we currently move through the fourth quarter, we're still waiting for the necessary clearances.

While our timing expectations for these approvals remain unchanged, Jim and I philosophically agree that at this time, removing registration contingent sales from our guidance would be a more prudent approach.

In addition, despite our efforts to account for and minimize the risk of ongoing headwinds, our vascular access business performance continues to be negatively impacted by competitive pressures and the delay in Celerity with navigation approval further tempers our expectations for that business through the balance of the fiscal year.

The impact of last year's currency movements which resulted in a price increase for our international distributor partners continues to be a case-by-case management effort and the cause for uncertainty in some of our OU.S. markets.

Lastly, the revised guidance contemplates near term NanoKnife capital sales to be below historical run rate levels for the rest of the year and the potential for increased competitive pressure in our EVLT business as customers shift procedures to alternative modalities that have higher reimbursement.

These various execution and market-driven headwinds contributed $4 million of the decrease to our full-year 2016 revenue expectations which we announced in our press release. We now anticipate fourth Quarter sales in the range of $87 million to $90 million and adjusted EPS of $0.14 to $0.18.

For the full year, the revised sales range is $347 million to $350 million and adjusted EPS of $0.54 to $0.58. We continue to anticipate free cash flow of approximately $30 million for the year. With that, I will open the call up to questions..

[Operator Instructions]. We will take our first question from Matt Mishan with KeyBanc. Please go ahead. Your line is open. .

My first question is, why now for the management change? And can you walk us through how this evolved over like the past maybe three to six months?.

Like we said, Joe left to pursue other interests and fortunately for us, Jim was known to several members of the Board and the process that we used sort of came together rather rapidly. We got very fortunate that Jim was available.

And with that, the leadership that Jim brings to the table was just what the Board felt this company needed at this point in time to drive us to that next phase of profitability and growth..

And then just one more, why the pause in the facility consolidations? And then the reason why the Celerity navigation didn't go through, if you have any color on that..

Yes Matt, as far as the pause in the facility consolidation, there were a number of factors internally that we evaluated and ultimately determined that pausing temporarily was the right decision.

But as I mentioned, we have now recommenced the facility consolidation and look forward to having that behind us and benefiting further from the opportunities.

With respect to Celerity with Navigation, we continue to work actively with the FDA, responding to questions but as you are very familiar with, the process with the FDA is not entirely in our control or not in our control and so we continue to work hard to do our part and at the end of the day, we just need to be patient with the process and we don't have an ability to force this any faster than we're..

[Operator Instructions]. We will go ahead and take our next question from Jason Mills with Canaccord Genuity. Please go ahead. Your line is open..

This is actually Jeff Chu filling in for Jason.

A question for Mike, just wondering what does the FDA need with regard to Celerity in order to get that approved in the U.S.?.

Yes, we don't provide that kind of visibility into the back and forths, but as the FDA has questions across a variety of facets of the technology, we continue to answer it and feel confident that we're answering it effectively and to the best of our abilities. From there it's in the FDA's court..

Okay. And a question for Jim, I was wondering if you could walk us through, objectively if you can, where you see possibilities for acquisitions or divestitures.

I know it's a difficult subject and perhaps there's not as much as you would be willing to say at this point but I'm wondering what you can say at this point with respect to where the company is today and relative to where you expect it to be about a year or two from now?.

It's actually not a difficult subject, it's just difficult timing. This is my fourth day. What we will do is initially my thoughts are, I want to make sure the underlying business is performing at the rate it should be. So, most of my focus will be there initially so I can understand the dynamics affecting AngioDynamics in the marketplace.

So once I have a better grasp on that, the second look I will take beyond that then is to what you just mentioned, external M&A opportunities, potential divestiture opportunities here. I'm sure they will come into play, but I think right now I'm better served by spending time looking at the underlying business potential here first.

And we'll get back to you with more transparency in the future..

And we will go ahead and take our next question from Charles Haff with Craig-Hallum. Please go ahead. Your line is open. .

First question on AngioVac, did you say, Mike, that grew 28% this quarter?.

Yes, Charles. It did..

And you're forecasting kind of flattish growth next quarter, but I thought we had a new generation of product there, so just trying to reconcile your comments that you have to do more on the sales and marketing side. I thought with a new product you had some good momentum there.

Can you just clarify that?.

Yes. I don't think we said it would be flat in Q4. We didn't give a specific number other than to say it wouldn't run at 28% which is clearly inflated if you go back to where we were in sales Q3 of last year. At the end of the day, we did launch a second-generation of AngioVac.

There was certainly improvement in that and recognition of that in the medical community. But there's more work to do to develop the market for AngioVac.

Reimbursement, indications, ability to market, all go into play in making this a successful long term product and capturing the opportunity and we continue to plug away at those efforts and look forward to hopefully capturing the value we see in AngioVac long term..

Okay.

And just to confirm, you have an easier comp for AngioVac next quarter, right than you did this quarter?.

No. Q3 was the low point if you look back at last year..

And then my other question was in terms of NanoKnife and Celerity units that were placed in the quarter, do you have those numbers?.

Yes, we don't provide that kind of granularity but we continue to do as much as we can to drive procedures on the NanoKnife side, for sure. And on Celerity, we recognize the competitive landscape and are doing everything we can to generate momentum in the PICCs business. So, we're not going to give out the specific numbers, but that's the philosophy..

Okay. Well, since you didn't want to answer that, maybe I will take the liberty of asking one more then.

So for gross margin guidance embedded in the fourth quarter, I don't think you shared that but can you help us understand gross margin and what you're thinking that's embedded in that $0.14 to $0.18 of guidance?.

Sure. And if you go back to where we were in the second quarter and with the much higher revenue expectation embedded in our fourth quarter, we talked about 100 and 200 basis point year-over-year improvement for the fourth quarter.

As we sit today with the adjusted guidance and pulling out those registration-based revenues which are all in the oncology space with high margins, I would tell you that given what we look like in the third quarter and where we would end up in Q4 within the guidance range, similar to slightly up margins is the way to think about it..

And that's year over year or quarter over quarter?.

Sequentially..

[Operator Instructions]. And we will go ahead and take a follow-up question from Charles Haff with Craig-Hallum. Please go ahead. Your line is open..

So on peripheral vascular, you last quarter talked about a more focused sales force for AngioVac and I think EVLT.

I'm just wondering how that process is going so far having the new focused salesforce?.

Yes. Just to connect the dots again, Charles, on this, the focused sales force that we created was actually a subset of the sales force and dedicated to fluid management.

The comment we talked about was the remaining sales force once you pull that out has the bandwidth capacity to dedicate their efforts more directly to the growth driver opportunities in AngioVac and EVLT. I think in the end, the new sales force was FM oriented but overall, the focus is created across the PV business.

I think the transition of those reps away from the fluid management and toward the remaining growth drivers. We've done several internal efforts at this point to better educate them in the areas they are going to be focused.

We've talked about in the past, we created a role of a national sales leader for the EVLT business and I think you're seeing the benefits of that come through in the capital sales that we've delivered over the first nine months.

So, overall it's still early stages to see the success build on that sales force becoming more focused, but I think the health of the PV business and the momentum you're seeing over the last few quarters demonstrates that we're starting to see some of the benefit..

Okay. And then one more question on EmboMedics.

Can you give us an update there? Are we still looking at a calendar year end of FY '16 where we may get an update and just refresh our memory on the bead business that you have going with EmboMedics?.

Yes, Charles. Nothing new from the last time we talked about this. This is very early stage from a development perspective and obviously with Jim coming on board we're going to want to go through and get him up to speed on every project and understand where we're.

Nothing new to provide from an investment perspective and we continue to look forward to long term benefiting from that relationship, but it's still in the very early stages from a development standpoint to talk about specific timelines..

[Operator Instructions]. Our next question is from Matt Mishan with KeyBanc. Please go ahead. Your line is open..

I know you've only been here four days, Jim. I'm just trying to get a sense, when I look at the guidance, as a question is you actually did nice organic growth and decent constant currency sales in the third quarter, international was up, AngioVac was up and as you look into the fourth quarter, the FX headwind is waning.

You don't have the comparison of the Morpheus PICC anymore but you're also indicating with your guidance that on a constant currency basis, sales are going to be down.

If I'm looking at it they are going be flat to 2% or so, I'm just trying to understand whether or not you guys are indicating that the business is deteriorating a little bit or if there is just some implied conservatism given the newness of your tenure..

Yes, I'll start and then Jim, obviously feel free to layer in. Obviously, Jim has only been here a few days. We had an opportunity to spend a little time on the forecast and talk about the business trends and talk about some guidance philosophies.

And I think as we talked about, as we walk through the guidance, a good example of that is taking out the registration-based revenue where we just think that's the better approach as we talk through it.

From a Q4 expectation standpoint, one of the things I did mention between Q3 and Q4 was a little bit of a timing of $1 million on our Sotradecol business. Again, you can move those dollars between quarters if you wanted to get a more reflective view of the run rate.

The other thing to point through as we go back to Q4 last year, we did have a pretty big Nano capital order come through in Q4 last year, that as we said on the call for our guidance range we have today, isn't contemplating that type of recurrence. Broadly, across the business, you heard us talk about the areas we're seeing challenges.

VA in particular and there's a lot there between PICC location and as we all know, a very challenging competitive landscape. I think we're seeing PV's momentum and look forward to that continuing.

And from an oncology/surgery standpoint, capital does really distort our overall growth numbers, but I think we're expecting to see the disposables continue to run at double-digit growth rate..

And Matt, beyond that, once I get my arms around the business a bit more, what I think you'll see from us is we're focusing primarily on first performing at higher rates with our business and then providing you hopefully transparency into the consistency of how we've done so. So when I have more details around that, you will get that.

At this point, it's just hard to give you a lot more detail..

And then AngioVac grew 28% in the quarter but obviously you indicated that's not a sustainable number.

What do you think is a sustainable number on the AngioVac for the next several quarters?.

Yes, obviously we'll come out with FY '17 guidance in the summer. I think what we've said is near term, if you look out a few quarters, I think we feel like it's probably prudent to think of it as a double-digit grower but over the long term, that certainly we want and expect better performance out of the product..

[Operator Instructions]. And we will go ahead and take our next question from Jayson Bedford with Raymond James. Please go ahead. Your line is open. .

I have a couple questions. First maybe for Howard, you mentioned growth products providing the foundation in growth and maybe you can just walk us through the components of growth going forward.

What are those growth products to identify?.

Jayson, I think it's some of the ones that we've been talking about for several quarters now. Obviously, in the vascular access business, we still have our BioFlo product line that as Mike mentioned with hopefully some additional economic and data that allows us to drive that business even more.

It's doing well already but we would expect more out of it. AngioVac which we just talked about near term being a double-digit growth product and hopefully with some additional focused selling and driving that product in the market clinically, that we will see that sort of drive the business in peripheral vascular.

And we still have our NanoKnife business that the Board and management is still very solidly focused on that that can be a significant driver of growth for us in the future..

Okay. So it's BioFlo, AngioVac and NanoKnife are the keys. Okay, the 7% growth in fluid management, clearly the market's not growing that quickly.

What's the right level of growth in fluid management going forward?.

Yes, I agree. We're obviously outpacing the market and we think the dedicated sales force has certainly created a pop over the last couple of quarters.

I think it's a bit premature for us to provide a level of expectation of what that might look like but I would say from a modeling standpoint until you hear something different from us, let's look at it as a market growth rate and let's assume we're able to keep pace with the market.

And if we're able to keep this momentum and continue to see a sustained level that we see confidently exceeds it, then Jim and I will come back and talk about the drivers of that and give some clarity and comfort but I think as of now we certainly don't expect to drop back to flat in Q4, but I think we just need to continue doing what we're doing and from a modeling standpoint, think of it as market movement..

And just for context, market growth is--..

Yes, I think that market has been, for as long as we've been with it, been a flat market broadly. So, it's up 1%, down 1%, it doesn't move meaningfully. I think assume that that business is flat and let us prove that we can sustain something better than that..

And then I guess just the last one here. Where are you with your next-gen RF product? I think you talked about that in the past..

The only RF product that we've been talking about is an RF product specific to the Japanese market, but beyond that I know we have probably communicated the microwave..

Right, sorry. On the microwave, sorry..

I think from a microwave standpoint, we've talked about that being this calendar year and I think we still anticipate towards the end of the calendar year having that available and out on the market..

Thank you. It does appear we have no further questions at this time. I will now hand it back over to our speakers for any additional or closing remarks..

Folks, thank you for your interest in AngioDynamics. I look forward to the upcoming quarters when I'll have more knowledge, I can share more transparency, but with the efforts we're making here at AngioDynamics, to outpace the growth rates we've talked about today.

Our goal is again, to get our core markets growing the rate they should be and finding ways to expand the profitability of the company. I'm happy to be here at AngioDynamics and I look forward to talking to you soon. Thanks..

And that does conclude today's program. We would like to thank you for your participation. Have a wonderful day and you may disconnect at any time..