Pat Mackin
Analyst · Jeffrey Cohen with Ladenburg Thalmann. Please proceed with your question
Thanks, Ashley, and good morning everyone. We’re very pleased to report record revenue in the fourth quarter of 2015 capping off what we think was a very productive year for the Company. I will begin today’s call with a brief review of our fourth quarter results followed by a recap of our significant accomplishments over the course of 2015, which have positioned the Company for improved growth and margin expansion in 2016 and beyond. Following my initial comments, Ashley Lee, our CFO, will provide a detailed review of our fourth quarter financial results and our 2016 financial guidance. I will conclude with a review of our key strategic initiatives for 2016 and then we’ll open the line for questions. This morning we reported record revenue of $39.8 million for the fourth quarter, a 7% increase year-over-year. This includes our third consecutive quarter of year-over-year growth in tissue processing revenues, which were up 3% year-over-year. Product revenues were up 10% year-over-year, driven by continued growth of ProCol and PhotoFix and good results from CardioGenesis. Gross margin for the quarter was 67%, which is several hundred basis points better than our historical results in recent years. The main drivers of gross margin of fourth quarter are product mix, and the efficiency and throughput initiatives we’ve implemented over the course of 2015 in our tissue processing businesses, much of which we expect to continue into 2016 and support improved overall gross margin. In addition to these positive financial results, we also announced the acquisition of On-X Life Technologies in late December and the divestiture of the HeRo product line to Merit Medical in early February. I will cover these developments in more detail in my later remarks. Turning now to an operational update, 2015 was a year of significant progress for the Company. When I joined CryoLife in September 2014, I spent my first 100 days, taking a deep dive into our businesses, meeting our customers, our employees and reviewing the state of our operations. Following this review, we entered 2015 with a set of strategic initiatives designed to reposition CryoLife for improved growth and margin expansion. Over the course of the year, we delivered on those initiatives and as a result, we are entering 2016 in a stronger position with significant new growth drivers for our high margin medical device products segment, along with improved opportunities for our tissue processing business. Our key accomplishments for the year include the following: First, we made significant progress enhancing the quality systems and efficiency of our tissue processing operations, which positions this business for mid-single-digit growth and improved margins in 2016. This major accomplishment involved a closeout of the FDA warning with no additional observations in March, followed by the continued investment in new protocols to improve the efficiency of our procurement, processing and customer service operations. As a result, we were able to improve tissue gross margins from 37% in the first quarter to 48% in the fourth quarter, that’s an 1100 basis-point improvement in just one year. Tissue revenue was lower than we forecasted in the fourth quarter caused by inventory constraints on certain tissue products and high demand from our customers. So, the good news is that demand for our tissue remains high and we have the potential in 2016 to leverage the efficiency improvements we implemented in 2015, to increase availability and drive meaningful increase in tissue processing revenue in the future. Second, over the course of the year, we strengthened our executive team with the appointment of several highly experienced leaders. This was highlighted by the appointment of Jean Holloway as Senior Vice President and General Counsel; Bill Matthews as Senior Vice President of Operations, Quality and Regulatory; and John Davis, Senior Vice President of Global Sales and Marketing. These executives have broader understanding of the healthcare industry from their work at much larger medical device companies. As a result, our team is well-positioned to manage the business, as we grow CryoLife. Third, we had several important developments regarding new products in 2015; this includes the January launch of PhotoFix which delivered $1.4 million in sales in 2015. PhotoFix continues to represent a near and midterm opportunity for growth. In 2016, we expect sales will continue to ramp with additional growth potential, driven by the significant increase in our cardiac surgery sales force that’s calling on cardiac surgeons as a result of the acquisition of On-X. We continue to believe that PhotoFix has the potential to become a leading product in the $30 million plus market for biological patches using cardiac surgery. Fourth, we also made important progress in the area of expanding the indications of some key products. In July, we received an expanded indication of approval in BioGlue in Japan and we are now able to sell that product to a much broader cardiac surgery patient population. Since the approval, we have seen very strong increases and adoption in the expanded patient population. Also, in the expanded indication product segment, in November, we reached a resolution on our patent dispute with Medafor regarding PerClot, which removes an ongoing legal dispute that could have taken years and million dollars to resolve. The resolution had minimal impact on our commercial timeline, delaying our U.S. commercial launch to February of 2019. This shift in the timeline also allows us to take a pause with our PerClot clinical trial to work with the FDA to attempt to amend the PerClot pivotal trial protocol, which we believe would support a more rapid enrollment and more robust data collection of the clinical results. We have a meeting with the FDA later this month to discuss these amendments and we’re hopeful of restarting the trial in the second half of 2016. Fifth, we took yet another important step in our international expansion plans by going direct in France on October 1st and expanding our French direct sales team with the addition of our country manager to lead our six-person direct sales team. Transitioning to a direct sales model in selective international markets is a strategic initiative for CryoLife because it carries the potential to enhance our revenue and gross margin and also allows us to implement a more focused sales and marketing strategy, and provides a platform for future new product introduction, such as our On-X valves. Our results in the fourth quarter in France were in line with our expectations. And as we look to 2016, we expect to see a positive impact on revenue and gross margin as we benefit from the ability to sell expanded product portfolio directly to our hospital customers. Sixth, and the final area of key accomplishments in 2015 is in the area of strategy and supporting business development activities. Over the course of the year, we looked at a number of potential transactions while maintaining a strong financial discipline and focusing on deals with the greatest strategic benefit. As a result, in late December, we announced the acquisition of On-X Life Technologies which significantly enhances the size of our addressable market and growth potential. This was followed by the announcement earlier this month of the sale of the HeRo Graft product line, further strengthening our focus on the Cardiac surgery market. This primary focus on the cardiac surgery market will pay off in many ways. This will concentrate our sales and marketing resources as well as our R&D and clinical programs. The cardiac surgery market is a very large market with lots of opportunity to create a unique company that has a novel differentiated technology that carries the potential to improve patient outcomes and reduce cost. We are very excited about the On-X -- of adding the On-X portfolio to CryoLife, given the significant growth opportunities and synergies of the combined company. We closed the On-X acquisition on January 20th and since then we’ve become even more encouraged by what we’ve seen about the potential benefits of the acquisition. First, it allows us to enter a $220 million mechanical valve market with a differentiated high margin product. On a strategic level, the mechanical valve market is highly synergistic with CryoLife’s cardiac surgery business. We believe the transaction will strengthen our focus and critical mass in the aortic and mitral valve repair and replacement segment, creating a more robust platform that we can leverage with additional products in the future. Second, the combination of our direct sales organization and On-X team of direct reps more than double the size of our previous cardiac surgery sale force in the U.S. This combined team is highly experienced and has a broader product portfolio to cross-sell. We see tremendous upside potential for the On-X valves, given the limited sales support these products have received previously. We further strengthened the focus of our commercial organizations in cardiac surgery with the sale of the HeRo Graft business in early February. Outside the U.S., we will introduce On-X products into our direct markets over the course of 2016. As a reminder, these include markets like the United Kingdom, Ireland, Germany, Australia and France. Third, we have learned even more about the robust clinical data supporting the On-X valve and discussed the product with more physicians. In turn, we’ve become increasingly more confident in its potential to take market share. As a reminder, On-X has the only FDA approved mechanical aortic valve that is approved for an INR range of 1.5 to 2.0. As we’ve discussed, a lower INR range is more optimal, as it lowers the risk of patients of having complications from bleeding without at the same time increasing the risk of stroke, which is a major concern of doctors in patients. We believe this is a significant differentiator and will provide us with a distinct competitive selling advantage. Last, the addition of On-X diversifies our business mix, provides additional margin expansion opportunity, and reduces our reliance on the tissue business. Since closing the acquisition, the integration of our On-X team is off to a great start. We have had a meaningful progress combining and training the sales force, optimizing their respective territories. Given the shift in some territories in addition of new products, our sales force is in the process of updating existing relationships and making introductory calls on their new accounts. We have a robust integration plan for both the U.S. and international segments of the business. And once the newly combined teams have had time to further establish themselves in their territories, we anticipate our On-X valve business will grow at a double-digit growth rate between 2016 and 2020 with gross margins in the U.S. close to 90%. Internationally, we expect to drive margin higher as we transition from distributor model to a direct sales model in select geographies over the next few years. Overall, by executing our strategic initiatives for 2015, we have taken a strong first step in repositioning CryoLife into a higher growth and more profitable company. The On-X acquisition is a transformative event for us that we expect will immediately benefit revenue mix and growth trajectory, which should in turn drive gross margin expansion in double-digit compounded growth in adjusted earnings from 2016 to 2020. I will now turn the call over to Ashley for a detailed review of our fourth quarter and full year 2015 results and 2016 financial guidance.