Mark T. Frost
Analyst · Jayson Bedford with Raymond James
Thank you, Joe, and good afternoon, ladies and gentlemen. Building on Joe's commentary, we have continued to drive improvements to our performance, overachieving on the revenue front and meeting adjusted earnings and cash generation targets. I will start with our quarter results and then move to guidance for both the third quarter and the fiscal year. Starting with revenue, total revenue was up 2% from prior year, but excluding the impact of the planned wind down of supply agreement, we were 3% higher than prior year. This has improvement from the 1% growth in quarter 1 and a better measurement of our sales performance. Consistent with our strategy to bring faster growth, higher margin products to the market, our growth drivers continue to increase through impacting the overall business. AngioVac delivered $2 million in sales, while BioFlo's market penetration reached 35% of global PICCs now sold with this disruptive technology. During the quarter, we had also launched BioFlo ports, which Joe mentioned, which helped drive growth in this product line for the first time while contributing to the overall improved performance in Vascular Access. Microwave, again, doubled revenue in the quarter. Turning to product performance, Peripheral Vascular increased 7% to $48.9 million, reflecting over 20% growth in EVLT and a larger contribution of AngioVac. EVLT's results were driven primarily by exceptional U.S. performance and the conversion of a competitive customer, as well as the benefit of the new NeverTouch, a next-generation product. Fluid Management, again, was essentially flat, reversing its past negative results as they came in above our expectation. Vascular Access was down to $25.6 million compared to the prior year, but a sequential improvement from this year's first fiscal quarter. PICCs is expected to continue to be impacted by the lack of tip location, and sales were down 5%. Ports, however, grew 1%, reversing the erosion experienced over the last 2 years driven in large part by new product introductions as well as the previously mentioned launch of BioFlo ports. Oncology surgery growth improved to 5%. Growth was lower than we expected, reflecting mixed performance within NanoKnife which experienced positive growth in the U.S., but a tough quarter internationally as a number of NanoKnifes did not close despite the strong pipeline. On the thermal ablation front, driven by strong U.S. microwave results, growth came in at 11% for the quarter. From a geography perspective, U.S. revenue increased 3%, while the international markets demonstrated slight improvement with 1% growth. While we did show positive growth, we are disappointed with our international performance, and we believe we have significant potential to improve revenue and its profit contribution. Some of our current issues relate to regulatory delays in registering new products, as well as the indirect impact of the warning letter which has prevented our ability to file CFGs in some of our core products, not yet registered in all of the countries around the world. As you're aware, we have operated under a warning letter for the past 2 years at our Queensbury site and are awaiting the FDA to perform their final audit, which we believe should result in the letter being lifted. We recently announced a leadership change which we expect will be a catalyst to improve our performance. In addition, as previously discussed in our prior earnings calls, we are assessing further M&A options to accelerate our growth in the international front. Now continuing down the quarter's income statement, gross profit totaled $44.9 million or 50.7% of sales, flat with prior year's second quarter results. Our gross margin return was lower than expected, reflecting a product mix impact in Oncology which is our highest-margin business, as well as an increase in royalties because of the stronger performance of EVLT. Now while our broader product portfolio and national account efforts have led to new GPO/IDN wins and contributed to our sales growth, our admin fee rebates have increased, reducing the margin return. All these points are expected to flow through to our full year results, which I will touch upon when I discuss our guidance. Now turning to expenses. Operating expenses totaled $43.4 million, including $2.7 million of acquisition, integration and restructuring items, of which $1.6 million is associated with the Navilyst acquisition, including some start-up costs related to our recently announced operational excellence program which is designed to generate significant savings over the next 3 fiscal years. In addition, we had costs related to our refinanced prior litigation with Bard and the Clinical Devices acquisition. Now sales and marketing expenses did increase $2.4 million from the last year as a result of the planned increase in sales territories leading into 2014, as well as our investment in AngioVac clinical specialist team, which we have previously discussed on past calls. An important point to also remember is that we experienced significant sales attrition during the first half of fiscal year 2013, which artificially reduced the run rate, particularly for quarters 2 and 3. Now lower G&A offset some of the sales and marketing increase. We also incurred $1 million of medical device tax and $0.9 million of contingent costs, which are basically new costs in the first half of fiscal 2014. Now as announced in December, we have become the next phase of integration on the operations side of our business. Our operations excellence initiative is expected to generate savings of $15 million to $18 million within the manufacturing supply chain areas and improve our gross margin return by 400 to 500 basis points, with the improvement starting in fiscal year '15. These activities are envisioned to take 3 years to fully implement, and will involve a $5.4 million CapEx investment, most of which will occur in fiscal year '15 and '16. We also anticipate $4.7 million in restructuring charges, with $1.5 million being cash and $3.2 million, noncash, reflecting cease-use accounting for the Queensbury facility. We expect $1.6 million of these charges to occur in fiscal year '14, with $0.9 million being cash and $0.7 million noncash. GAAP results were breakeven, were $0.06 in the fiscal 2013 second quarter. Pro forma adjusted EPS, excluding amortization was $0.14 per share or $0.17 in fiscal 2013's comparable quarter. Adjusted EPS, excluding amortization, was reduced by $0.02 of medical device tax as well as the higher sales and marketing costs which offset our gross margin improvement. We also started to see the benefit of a refinance transaction. We expect to realize the full impact starting in the third quarter. The GAAP to non-GAAP reconciliation items are detailed in the earnings tables in the quarter's news release. EBITDA was $7.8 million or $0.22 a share versus $11.4 million or $0.32 a share in the prior year's second quarter. Adjusted EBITDA was $12.7 million or $0.36 a share versus $15 million or $0.43 a share in the prior year. A detailed reconciliation again is provided in our news release. We generated $8.2 million of operating cash and $4.2 million of free cash flow in the second quarter, and year-to-date, we have generated $15.8 million of operating cash and $8.6 million of free cash flow versus operating cash of $5.5 million and free cash flow of $0.7 million in the prior year's first half. We did invest slightly more than planned in CapEx because of the timing of the ERP project, which is expected to go live, as Joe mentioned, in the next quarter. Our cash balance was reduced to $17 million, reflecting the first Vortex earn-out payment of $8.4 million, and we ended the quarter with $140.2 million of debt outstanding. I'll now turn to a discussion of our guidance for fiscal year 2014. For fiscal year 2014, we are raising the lower end of our revenue guidance from $347 million to a range from $349 million to $353 million, representing 3% growth at the top end of the range. Our change is driven by the stronger results we have seen in the first half of our fiscal year 2014. As I will discuss in a minute, when speaking to third quarter guidance, we continue to anticipate revenue growth to gradually increase over the fiscal year, as our growth drivers become more significant contributors and, therefore, have a larger impact in the back half of the year. However, it will be uneven by quarter and not linear. On the earnings side, we are reiterating our full year guidance and expect adjusted EPS, excluding amortization, to range from $0.63 to $0.67. However, we are going to achieve this outcome in a different fashion than previously communicated. As a result of the gross margin headwinds mentioned earlier, we are expecting the pro forma gross margin to improve by 50 to 75 basis points versus 75 to 100 basis points indicated at the beginning of the year. We expect leverage in G&A, R&D and our refinance benefit to offset the lower gross margin rate. For cash guidance, we have slightly reduced our expectations for operating cash improvements, and expect operating cash to improve by 40% to 45% from $27 million in the prior year. The lower expectation incorporates an interim inventory build as we begin to undertake our facility rationalization at the start of the summer calendar 2014. The free cash flow range is accordingly being reduced to $25 million to $28 million from the previous $28 million to $30 million, based on the inventory build, and CapEx at the higher end of our range of $8 million to $10 million. On the adjusted EBITDA front, we continue to expect we will be in the $56 million to $59 million range. Now turning to fiscal year third quarter guidance, we are guiding to a revenue range of $85 million to $88 million, 4% to 8% at the top end of the range and 5% to 9%, excluding the wind down of the supply grid. The growth is higher in quarter 3 as we have an extra day, and last year's fiscal year's soft third quarter represents an easier comparison. In the fourth quarter, we will have 1 less day, so doing the math, you will see that our growth rate is anticipated to be 2% to 3% and 3% to 4% without the supply agreement. I will reinforce a point we have made in the past few calls, we do not expect to see a dramatic increase in our revenue growth rate, but a more gradual improvement as we continue to build our growth drivers and improve the execution on our core products. Adjusted EPS, excluding amortization, is expected to improve from quarter 2 and be in the range of $0.15 to $0.18. So with that, I'll turn the call back to Joe for his final comments. Joe?