Joseph M. DeVivo
Analyst · Craig-Hallum Capital Group
Thank you, Joe. So today, we announced in a separate press release issued this afternoon that we've entered into a definitive agreement to acquire Vortex Medical, a privately-held company focused on the development and commercialization of innovative medical devices for venous drainage and the removal of thrombus, or blood clots, from occluded blood vessels. As we detailed in our previous call, venous disease is a core focus of ours, and we believe the acquisition of Vortex significantly accelerates our market presence and solutions in this key target market. Nearly 1 million people encounter venous thromboembolisms each year in the United States. Leading to approximately 300,000 deaths, representing a significant unmet clinical need. Vortex is currently commercializing the AngioVac System, which we believe has the potential to be a real game changer. The AngioVac System is a patented, proprietary design that facilitates on block or whole removal of undesirable intravascular material. Unlike some other options,, AngioVac has the potential to minimize risk of complications associated with major surgery, internal bleeding and/or clot fragmentation. AngioVac is currently cleared by the FDA for venous drainage used during extracorporeal bypass up to 6 hours. An application for an expanded indication to include the removal of fresh and soft emboli and thrombi is currently pending approval for CE Mark and Vortex is currently pursuing an additional 510(k) for the same expanded indications. The product has generated considerable interest among the surgical and interventional communities and more than 350 cases have been performed successfully in the U.S. to date. Vortex, and now us, will also develop next-generation technology aimed at expanding the applications of the device. So why are we so excited? Well, you really just have to see this product in action to believe it. First, I'll give you a brief description. The AngioVac System incorporates a disposable Circuit and Cannula. With these components are combined with a standard hospital equipment such as centrifugal pump and a filter and reinfusion Cannula, they comprise an extracorporeal Circuit that enables drainage, filtration and reinfusion of blood. Unlike other currently available devices, the AngioVac Cannula uses a proprietary, balloon-actuated, expandable funnel-shaped tip to enhance flow and prevent clogging of the drainage Cannula to facilitate en bloc removal of undesirable intravascular material. This funnel device creates a vortex, or a spiraling flow, which facilitates large amounts of material through smaller Cannula, with the suction force provided by a centrifugal pump. The en bloc or whole removal of materials is really key. Thrombolytics are not necessarily required for the use of this device, so the risk of major internal bleeding or many of these patients who've had prior operations can now be treated. There is also potential to minimize risk associated with fragmentation as there is no mechanical maceration employed. And since the procedure is performed in a minimally invasive fashion, the risks associated with major surgery for this type of removal may also be minimized. The outcome which you can see in the image to the right side of the page is simply amazing. In each procedure, whatever is removed from the patient sits in the filter to give immediate feedback on what has been taken out. Other systems simply breakup a clot, and send it downstream. AngioVac has the possibility to take it out whole like surgery but in a minimally invasive manner. By utilizing the AngioVac System, patients may avoid significant time recuperating from major surgery or enduring often suboptimal pharmacological therapies. Not only may this lead to significantly improved outcomes, it has the potential to materially reduce the cost of treatment. With regard to our go-to-market strategy, AngioVac will be carried by our Peripheral Vascular sales force, which will be supported by a newly created group of clinical specialists. We expect limited sales of the product for the remainder of the fiscal year, while we build this dedicated channel and pursue expanded indications with the FDA. The AngioVac System does not require us to sell any capital, has an average per procedure selling price of $11,500 and gross margins are very accretive to AngioDynamics' margins. On this slide, you'll see the terms of the transaction. We will pay $15 million upfront and then $8 million per year for 5 years in guaranteed payment. And then some possible additional payments thereafter for the next 5 years based on sales performance of the product. We will prepare a launch of the technology during the third quarter, and expect fiscal year 2013 revenue for Vortex, as Joe said, to be about $1 million. It has no impact on fiscal year '13 EBITDA and will reduce GAAP fiscal year 2013 earnings by $0.09. For fiscal 2014, we expect revenues to be approximately $10 million in sales, and will be accretive to earnings on a GAAP basis in 2014 fiscal. It can, in my view, be a business of the value of $50 million in revenue in 5 years, with very healthy accretive margins, driving earnings per share accretion as well. All in all, the AngioVac will be a true game changer for AngioDynamics, will help the company power our top line and our bottom line growth as it meets a very important clinical need during the global healthcare environment. So looking forward throughout 2013, our management team is focused on executing to plan. We have a clear line of sight on longer integration activities, expense synergy savings, as well as building momentum on revenues throughout the year. Our revenues came in as expected and as guided in the first quarter. Where there was less disruption, our global oncology and international sales were strong. As we look forward through the year, we affirm our full year guidance of $360 million to $363 million. We do wish to adjust the phasing to 24% in the second quarter and add an extra point in the fourth quarter at 28%, allowing a revenue ramp to occur throughout the year. This has a revised phasing to 23% for the first quarter as we just executed, 24% for the second, 25% of the overall guidance revenue in the third quarter and 28% for the fourth quarter for fiscal year 2013. Moving forward, our structure is clear. We have growth drivers in each major sales force and franchise with NanoKnife for oncology, with BioFlo for Vascular Access and now AngioVac in our Peripheral Vascular business. Growth, growth, growth. We have a strong core in our operations team, we have an experienced and proven management team. We look forward to later in the year adding microwave, as we have discussed before in the U.S., while we accelerate our international sales and continue to pursue a tip location solution as we've mentioned in the past. Now, it's time to execute, to let our plans gel, to rebuild our U.S. revenue momentum and allow our strategies to work. We very much appreciate your support and attention today, and now we open it up for questions.