Joseph M. DeVivo
Analyst · Raymond James
Thanks, Joe. And everybody, just so you know, the release did cross the wire. It is sitting there. I'm sorry, I don't know why it was delayed. But it is what it is. The results and the message are all the same. So now I'm going to take a little bit of time to look forward. Our mission is to become a world-class medical device company, delivering innovative solutions to our customers in Peripheral Vascular, Vascular Access and Oncology/Surgery, while delivering to investors growth, both top line and bottom line, minimum of 10% to 15%, respectively. We will grow in each one of our franchises through research and development, business development and clinical development of data to prove that our technologies are cost effective and clinically valuable. Each business has their investment area, which will drive future growth for the company. For Peripheral Vascular, we are actively developing an automated Fluid Management system to reignite our market-leading Fluid Management business. We are executing on a comprehensive Venous strategy, as much of the growth in new innovations we believe will occur on the Venous side Peripheral Vascularly over the next 5 years. We have active programs in thrombus management in both thrombolysis, as well as thrombectomy, and are actively reviewing plans for next generation of venous ablation to augment our market-leading EVLT laser system. For vascular access, it's BioFlo, BioFlo, BioFlo. I'll review the technology in more detail in a moment, but we intend to make BioFlo a cornerstone for us, and it's the closer we've reviewed technology its one of the gems that come out of this transaction. We are also actively pursuing a tip location technology, which is needed in the marketplace, and we look forward to communicating our progress soon. Through the oncology franchise, our top priority is to develop evidence to establish NanoKnife as a standard of care in pancreas ablation. Add microwave into our thermal ablation strategy, and continue to do talk ins, as well as R&D expenditures to fill out the interventional oncology offering. So as we go to Slide 13, for the first time, we are breaking out the size and growth rates of each of our global businesses. As you can see here in fiscal year 2012, consolidated pro forma, if AngioDynamics and Navilyst were combined, so we can get a real look at the deep rate of our business, we would have done, together, $180 million in Peripheral Vascular, $114 million in Vascular Access worldwide and $41 million in Oncology/Surgery. So of course, without the LC Bead business, combined AngioDynamics and Navilyst, if they were combined in 2012, would have done $344 million together, representing the current deep rate of the business. Next to each of those business numbers, you will see what we believe what those businesses will grow in 2013, given our current portfolio of products. We are increasing our revenue guidance from the $360 million to a range of $360 million to $363 million for fiscal year 2013. Our guidance implies revenue growth of 5% over the pro forma run rate I just described. We will revisit this again at the end of the presentation. So let's turn now to the next slide, so we can share with you another level of detail showing the breakdown of the key product lines and our expected growth rates for 2013. I earlier mentioned Peripheral Vascular business delivered $180 million worth of revenue in pro forma 2012. Our Peripheral Vascular business is made up of 3 categories: Fluid Management, which is now our largest product line, that we expect in 2013 to grow between 2% and 4%; our EVLT business, which is our fastest-growing line, all aside from NanoKnife, of course, but fastest growing in Peripheral Vascular, which is expected to grow 17% to 19%; and our core products, which we anticipate to be about flat to 2%, which in many categories, were declining, so it's a good turnaround. That brings in a blended growth rate, in fiscal '13 for the Peripheral Vascular business, of about 5% to 7%. Now I want to relate a story to you from one of our sellers, which I believe conveys the power of the new -- of new access that Fluid Management gives us into the cath labs. However, our new PB sales representatives went into the cath lab and introduced themselves to an interventional cardiologist as the new Fluid Management rep, and he was given very valuable time to make a new contact. Our rep proceeded to take out our angiographic catheter portfolio and showed it to him, and he was impressed with the new variety of curvatures and lengths and the new things that he hasn't seen before for Peripheral Vascular. And now can you believe that new product line we've had for about 20 years. And our company's named after the line. The interested cardiologist sent the rep to the vascular lab to check which products they currently had in inventory and then discussed which codes you'd like to try on his next case. I thought that was pretty cool. As the call is about to wind up, the rep turned around and said, "Hey, you might want to consider building a venous ablation practice in your office? " And the cardiologist, who was rushing out to another appointment, paused and asked the rep to come back and said, "I've been thinking of doing that for a year. Can you show me how?" Now that cardiologist is now booked into training program for EVLT. And this is not an isolated incident, as cardiologists are now looking to expand their practice more and more into the Peripheral Vascular arena, and just the beginning of our channel strategy proving itself out. It shows that the market position and scale of Fluid Management can help the entire portfolio. So now let's turn to Vascular Access. Currently, our lowest growth business, which in my view, may become the fastest-growing business by the end of 2013. With revenues in our Vascular Access business of $114 million, growing about 3% to 5%, currently. In fiscal 2012, we comprised about $54 million in fixed, $32 million in courts, and $28 million in dialysis catheters. With the consolidation of our 2 companies, we now have a more competitive and more complete offering than ever. Our key objectives for the year are first off, to drive penetration to existing accounts, while identifying key targets for full-line conversions. For the first time, we can do full conversions, because we have the complete offering that we didn't have in the past. Our proprietary PASV valve is the key driver for our PICC business, while Vortex Smart Port offers differentiation in ports. Also, we're actively pursuing, as I mentioned before, a tip location technology, and we'll communicate that process. So now you ask, what's going to turn this business into a 10% plus grower? That growth driver is BioFlo, and after FDA approval and its successful launch in the U.S. Upon that approval, we will focus first on BioFlo for PICCs. Then we will focus on BioFlo for ports. And then we will bring the material into the dialysis business. This passive material will provide AngioDynamics with a truly disruptive technology and help drive share in vascular access. These growth rates, of course, so far do not contemplate the impact of BioFlo. We will deal with that when we -- after we receive our approval. So let me tell you a little bit more about the BioFlo technology. Over the years, many companies have tried to develop coatings to reduce thrombolytic events associated with the use of their devices. Until recently, no anti-thrombolytic catheters had been launched in the market. While infection is believed to be more often caused by clinical insertion techniques and the device itself, Thrombus events are more directly associated to the performance of the device itself. That is what makes BioFlo so special. Because BioFlo is not a coating, and it's not a material, which has some agent impregnated into its pores with a half-life. BioFlo is made with a material called Endexo, a flooring based additive to our existing material, which gravitates to the surfaces of the material it's added to. What it does is create a passivating surface, both inside and outside of the catheter. So what's important about a passivating surface? Well, a passive surface is believed to not get rejected by the body, and doesn't incur the systemic rejection mechanisms. When it comes in contact with the blood, the normal defense mechanisms are not activated, which minimizes platelet formation in the material. Unlike a coating, which will wear in several weeks, the passive surface Endexo brings to BioFlo may be a permanent attribute of the material, and may last the entire time it's in the body. Pretty impressive. It uses no heparin, no antibiotics, no coating, nothing foreign to allude into the bloodstream. So it all sounds good, but now does this really work? From a single site, I'm just sharing with you an early experience from a single site, at one of the earliest customers that we've had in Canada were to product has been actively launched. And in their early clinical experience, they did it on their own, comparing BARD's PowerPICC, which is the market leader, with our BioFlo with a PASV valve, in a single center experience, which was not funded by the company. As you can see, 50 patients were evaluated using BARD and 133 patients with BioFlo. Same nurses, same technique, same clinic. The only thing that was different was the PICC. In this series, patients who had BioFlo experienced 48% reduction in occlusions, 38% reductions in PPA use, 37% reduction in the incidence of deep vein thrombosis. Now I've been around a while, and it's rare to see such an impact in a head-to-head comparison with the market leader. So now we're currently working with the site to get more of this data published, and as soon as possible upon U.S. FDA approval, intend to fund a study that can repeat these results in a controlled perspective environment. Today, we are actively selling BioFlo PICCs in Canada. A late year launch in 2011 from Navilyst, and the first market to use the product clinically. We're on track to grow overall sales by 30% for the country in the year, on the heels of an exclusive health Pro GPO award driven by BioFlo. We are just now launching BioFlo in Europe. So let's shift to oncology. As you can see here with the loss of LC Beads, the business remains with $41 million in overall revenue, and adjusted growth rate, holding the beads out of 2012, of 9%. This comprised of $23 million in thermal ablation revenues, with an expected growth rate of about 6% to 8% in 2013. $12 million in NanoKnife revenues, which we would expect in 2013 to grow about 53% to 55%, and about $6 million in a bunch of other stuff, but including the Embarc catheter and Charter guidewire, which we expect to be flat year-over-year, given some of the atrophy in some of the other legacy products. Overall, we expect our oncology business to grow 17% to 19% in 2013. Before the oncology business, our top priority is to establish NanoKnife as a standard of care for pancreas ablation through supporting clinical evidence and to initiate a major clinical study. I'll review that in a minute. We are adding microwave to sell our thermal ablation strategy and with RF, microwave and NanoKnife platforms to sell in 2013, we will be the clear leader, not only in all ablation, but also in interventional oncology. We intend to market this total solution internationally to our customers. We will also continue, to both organically and inorganically bring new interventional oncology opportunities in the bag [ph]. So let's do a little bit more on NanoKnife. As you all know, we've been working with the FDA for almost a year now for the approval of a safety study for NanoKnife to be used in Stage III inoperable cancer patients. We've been working to answer important questions regarding the application and believe we are near the end of the questioning process, although you can never tell. Given the time that has passed, as well as the recently published data, the company has shifted its strategy from requesting a safety study first, to proposing going straight into a pivotal trial. We believe and hope the amount of the clinical evidence provided the FDA will warrant at direct study, which is scientifically and clinically relevant. We have recently submitted an IDE for a global multicenter, prospective randomized controlled trial comparing the current standard of care for inoperable pancreatic patients to use gemcitabine versus NanoKnife plus gemcitabine, which is -- which we would compare against the standard of care. We proposed 190 patients with confirmed Stage III disease with the primary endpoint of local progression-free survival. We would expect, with approval of the IDE, to start time of the first half of 2013 with an open enrollment of about 24 months. This study would be our pathway to truly comparing a medical device with a drug in a head-to-head survival comparison, and when completed, we hope will prove a landmark study in the initial experiences if all these initial experiences hold true through this trial. It's exactly the study, which needs to be done in the proper way to establish a new standard of care. We hope the FDA agrees and we receive expedited review upon completion of the results. Now that we've told you about our product growth drivers, let's talk about how we will be bringing these products to market. Before I review this U.S. strategy, just a quick nod to our international strategy, with the acquisition, we picked up a direct sales team in Canada, and 51 new distributors worldwide that come to us from Navilyst. We currently do not foresee any major changes, aside from placing greater management attention on our new distribution partners and finding ways to help our new partners grow their businesses. We are direct in several European markets, and maintain focused distribution partners everywhere else in the world. Centrally, we are organized to manage the Oncology, Fluid Management and Vascular distributors with great attention to assist them in any way to grow their business. We are excited to welcome them all to the AngioDynamics family. Now to the U.S. So many of you have asked about our sales force structure, and how we can win going forward. I've had a lot of time to think about this, and a lot of time to test the model with our top sales and marketing executives throughout our integration planning process. I feel very confident in this model. Our model is predicated on a matrix structure, which creates dependency between 3 independent marketing departments, or what I call franchises, with one selling organization in the U.S. led by one VP of sales. One group of area of sales directors and one group of regional managers who are all focused, not only are managing their teams, but creating alignment with their customers. If the organizations in the past solely focused on the practicing clinician, we still have that today, of course, but for the future of a competitive health care environment, our management teams must be able to represent and sell AngioDynamics' value proposition, key stakeholders, at the hospital, the IDN and the GPO level. Having 1 sales management team for all AngioDynamics, we eliminate the silo affect that divisions bring, and create the opportunity to drive synergy and leverage into the relationships. For example, if we have a great relationship in oncology, we should be selling them other AngioDynamics products have to offer. Our prior, silo-ed approach, never really gave us the opportunity going past these synergies. Reporting to the regional manager will be 3 sets of specialists. Each regional manager will have a dedicated peripheral vascular specialist, or several dedicated peripherals vascular specialists, vascular access specialists, as well as oncology specialists. The regional manager will be the key to marshal the local selling resources, to serve the needs of the hospitals, while the sellers service individual clinical customers. Now while the regional managers will be generalists, and the reps specialists, the representatives will also have the support from each one of the focusing -- focused marketing, what I call franchises, to ensure that we don't lose attention or commitment to any one business. This is the key to the matrix organization, the inter-interdependency between sales and marketing. Now this is not an uncommon model. Companies at times put this in place when they want to break the silos in their organization and find ways to extract greater value and revenue synergies. I've managed this model before, and we have implemented it now. At this stage in our company's growth, I'm convinced this is the right thing to do as we've -- as we build scale skilled, it's always an option to divisionalize, but say this is best for us. So now let's move to our 2013 guidance. As we start off, again, we had mentioned the $360 million mark. While we feel a little bit more confident and have upped it to $360 million to $363 million, which represents 5% growth, and that brings our EPS guidance to $0.49 to $0.51 for the year. As you can see on this chart, based upon comparing what the consolidated business would have been, if it was in 2012, we show the growth rate, we show growth in operating income, we show growth in EBITDA. We show growth in EPS. And that's done through driving sales synergies, meeting our cost targets, the new product launches, but BioFlo is not in these numbers. And also, we definitely intend to do additional tuck-in, in-license deals and acquisitions to leverage this new channel that we really, really like. Next slide. What do we want to become in the future? As I have mentioned before, we think that we're going to be a 7% to 9% grower in '14, and then we'll be able to, after that, get to that 10% target to deliver for -- for our investors and also for our customers. We believe we'll be able to at least grow our gross margin 50 basis points every year. And then also improve our operating income and EPS at a minimum in mid teens, and as well, we continue to drive towards making NanoKnife standard of care, introducing new technologies, continue to increase our international expansion and footprint and to continue to realize our long-term operational excellence initiatives. So in conclusion, I feel really good about where we are. Most of this integration is already behind us. And with only the long-term projects continuing, we continue to live up to our Quality Call to Action treatments, our new organization structure's clear and are focus on our sales and marketing teams are enthusiastically in place. Our research and development and business development pipelines are active. And our future looks bright. Today, we enter fiscal 2013 with confidence. Operator, we'd be happy to open up the line now for questions.