Joseph M. DeVivo
Analyst · Tom Gunderson with Piper Jaffray
Thank you, Bob. Good afternoon, ladies and gentlemen, and welcome to our conference call for our company's first fiscal quarter of '14. With me is Mark Frost, our Chief Financial Officer, who will review our financial information following my opening remarks. So very pleased with the progress that we're making as a company. We transitioned from a negative 2% growth last quarter to returning to growth here in the first quarter, net the supply agreement. I believe the contributors to our turnaround are: our U.S. sales force improvement and maturity, acceleration of our growth drivers that we've been talking about, as well as stability that we are gaining in our core business. I feel, as a business, in many ways, we've turned the corner. We have a very solid foundation across each of our 3 franchises and are now fully focused on execution: execution of continual operating efficiencies, execution of our growth initiatives and execution of our international channel build-out strategies. This quarter, we've delivered operating results at the top end of our guidance, which is a good start to the year. Mark and I anticipate that as we progress through the year, we will see improving growth, gross margin expansion and cash generation. While progress is being made, there are still areas in the business we are focusing on. It's not time for a victory lap yet. And today, we're pleased that the integration year of '13 is behind us. We're off to a good start to this new fiscal year. We have many highlights this quarter. Our Peripheral Vascular business started the year with momentum. We delivered over $1.4 million of AngioVac revenue, up 30% over last quarter and ahead of the plan that we've set for ourselves during the slowest procedure quarter of our year this first quarter. We see this accelerating to over $2 million in sales in the second quarter in the U.S. alone. Many of you have seen the coverage of the UCLA case, which chronicled a 2-foot long clot that was removed from the inside of a patient's heart and inferior vena cava. This patient had no other course except for major surgery as every other therapy had failed, and then they choose AngioVac. Exciting procedures like this are happening now every day as doctors become aware of the possibilities. This is truly an exciting and disruptive technology. We did, though, expect CE marking for AngioVac earlier in the calendar year, but our notified body reclassified AngioVac, raising the bar on its clearance. We've conducted animal studies in order to meet their needs. That said, we are expecting CE clearance shortly, which will allow us to broaden the market opportunity for AngioVac in the second half of '14. The other PV products also did quite well, primarily due to the improving productivity of our Peripheral Vascular sales force. Prior to the integration, we had double-digit growing EVLT business and a stable Fluid Management business. Both were affected by a learning curve this time last year, resulting in some loss of share in Fluid Management and almost elimination of EVLT growth through '13. Today, our sellers feel more comfortable with the whole bag, and we're seeing the results. Our average daily sales have been increasing for the last 3 quarters in a row, and we're regaining share. Our Fluid Management growth, I believe, is ahead of the negative 1% to 3% interventional cardiology market, and I'd not be surprised to see the full year Fluid Management business grow in what we are seeing as an overall declining market. EVLT had a nice rebound this quarter, buoyed by increased procedure growth in a favorable time of the year for EVLT, plus a more effective sales force, coupled with pretty significant market share gains. Overall PV growth should continue through the year, and this is all before we launch the NAMIC Duet automated power injector in early fiscal year 2015. When we do, in my view, our PV franchise should be killer. Vascular access is still a work in progress. BioFlo has proven to be everything we had hoped for, and the clinical data is better than we expected. At this past AVA meeting, many clinical experiences were presented, which consistently, hospital to hospital, experience to experience, supported the clinical effectiveness and economic impact of BioFlo. It's the real deal, and I think few who attended walked away from AVA thinking otherwise. Today, BioFlo represents now 30% of our global PICC revenue and climbing. This quarter, we announced the partnership with Medcomp, who's been a long-term partner of AngioDynamics in many of our product segments. And our new relationship is for their excellent, recently approved in Canada, Celerity system, which is a tip location system. And our hopes is that we will see a U.S. market soon. Celerity is an EKG-based system in an open platform, which can be used with anyone's PICC product. It gives hospitals choice while being very cost effective. With Celerity in our seller's bag, combined with BioFlo, we believe it levels the competitive landscape from a technology perspective. We currently expect Celerity to be approved in the U.S. prior to the end of the calendar year and full commercial launch by January of 2014. In my view, at that point, future PICC conversions will more greatly value thromboresistance. Tip location, while a necessity, will no longer be proprietary to our competitors artificially who force them -- force customers to use one or the other. The launch of Celerity tips the scale to open systems, giving freedom to the customer to purchase what they wish. Bundling will be seen in the future as a negative, greedy tactic. Also this quarter, we were pleasantly surprised to see how quickly we received approval from the FDA for BioFlo on our complete Xcela portfolio. This competitive offering should be launched by December 2013 in the U.S. On the dialysis front, we expect now BioFlo to be cleared for use with our dialysis catheters by March of calendar 2014. Having a complete vascular access offering following integration, coupled with BioFlo in each of our product segments by the end of this year and early next year and enhanced with the Celerity system, our Vascular Access franchise, I believe, will transition from a business in decline to one beginning to grow again in the second half of the fiscal year. Also going forward, we are pleased that we secured the rights for BioFlo for, now, the entire CVC catheter category worldwide, as we are developing some new products there to launch in the future. Lastly on Vascular Access, I've mentioned to you in the past that a key rationale for our acquisition of Navilyst was to have a full breadth of product offering in the combination of Navilyst with AngioDynamics. Today, we are a more valuable player in vascular access, and we will grow simply through the creation of new contracts and relationships. Now what I've mentioned to you in the past, today, is working. Moments ago, we announced a major sole-sourced IDN win in the U.S. for our core products that will go into effect this November 1. A subset of the purchasing group Premier, called Large Integrated Delivery Network, LIDN, is comprised of 8 independent chains with 130 members. This LIDN does approximately $4 million in port sales annually. We received approval today to publicly discuss the agreement, and the names, if you are interested in each of the networks, are in our press release. Today, we are seeing clear execution of our GPO and IDN strategy, which is core to the business, and look forward to letting you know of other major wins that will come. So now let's shift to oncology. We made positive strides with our Oncology franchise as well this quarter. We enrolled our first patient in the European CROES safety study, which is the clinical research office of Endourological Society for the treatment of focal prostate cancer. This commences an important effort to validate the safety of NanoKnife for focal prostate ablation. In the U.S., we are setting up our sites for the prostate safety IDE we announced earlier and are readying for the initiation of enrollment. Also, several investigator-initiated studies for NanoKnife's use in the prostate are currently underway internationally. We look forward to the reported data. Overall, procedures are progressing, and we are consistently selling new capital, establishing new centers worldwide. Until we complete many of these clinical efforts, I do not see NanoKnife accelerating above current levels. I do see it maintaining the current contributions to the business. Our microwave launch of Acculis is meeting all of our expectations also, as we now have the most competitive ablation offering in the world. Thermal ablation, we anticipate, will be a positive growth driver for the company throughout the year and into the future. Shifting to international. International sales were a bit slower than we expected for the first quarter. I'm not really concerned as we have a great team who closed last quarter quite strong. Capital for us normally in the first quarter of the fiscal year, given the summer period, is usually a bit fickle, and we recognize that. Our pipeline is still rich. In the U.S., we are launching an internally branded financing plan to help our domestic capital sales, while we're architecting a similar plan for certain international markets later in the year, and that should help. Regarding EVLT, an exciting development for the thermal varicose vein ablation market internationally was a decision made by NICE, which is the National Institute of Clinical Excellence in the U.K., that was their guidance decision that they recently sent to recommend thermal ablation therapies as standard of care over vein stripping. We think that's a pretty big deal. We expect, over time, for this to increase the market size for thermal vein ablation and growth for our international EVLT business in those markets who heed NICE guidelines. Lastly, on the PV front, we closed the acquisition of a Netherlands-based company called Clinical Devices, a small deal, who is also our Netherlands-based distributor of our Fluid Management business, and owner, interestingly enough, of a very novel, next-generation wireless tip-location system. This system, which is currently in development, empowers AngioDynamics beyond our current tip location distribution relationship, which we're very happy to have, to develop next-generation technology across a broad range of vascular access products. We are pleased to welcome the Clinical Devices team to the AngioDynamics family. So with that intro, I'd like to turn it now over to our Chief Financial Officer, Mark Frost. Mark?