Pat Mackin
Analyst · Ladenburg Thalmann. Please proceed with your question
Thanks, Ashley, and good morning. Thanks everyone for joining the call today. I am pleased to report that we had a very productive quarter. Today I will detail considerable progress we have made in advancing the future growth prospects for our business that were not readily visible in our reported numbers for the quarter, but which we believe will become more evident in the coming quarters. I will provide you with some highlights from our third quarter results and update you on the progress of our growth drivers that we’ve been communicating for the past year. Following my initial comments Ashley Lee, our CFO will provide a detailed review of our third quarter 2015 financial results and our updated 2015 guidance. I will conclude with an outline of why we believe the business is setting up for a solid 2016 performance and we will then open the line for questions. This morning we reported total revenues of $36.7 million for the third quarter, a 1% decrease year-over-year. We had our second consecutive quarter of growth in tissue processing revenues which were up 1% year-over-year and 8% sequentially. Product revenues were down 3% reflecting the transition to a direct sales force in France, the negative impact of foreign currency in certain markets such as Europe and Brazil, and weaker performance from HeRo than we expected. These items were partially offset by the continued growth of ProCol and PhotoFix. During the quarter, we made meaningful progress on the growth drivers that we’ve been communicating over the past year. This is important as that they are in central components that will drive our future growth. As a reminder, we seek to, one, maximize the opportunity of our new products in ProCol and PhotoFix; two, further increase our global distribution footprint as we did by going direct in France in October 1; three, expand indications of our key products, which include the enrollment of the PerClot Surgical IDE clinical trial in the US and approval for Japan’s new expanded indication for BioGlue; four, to enhance our growth profile through business development opportunities; five, further improve our efficiency and results of the tissue processing operation; and six, to strengthen our leadership team. We believe when we execute on these growth drivers, we will transform CryoLife into a higher growth and more profitable company. In the quarter, we made considerable progress towards delivering on these objectives and I’ll take a few minutes to update you on each. First, we continue to enhance CryoLife’s executive leadership team with the appointment of John Davis as Senior Vice President, Global Sales and Marketing in early September. I had the privilege of working directly with John at Medtronic and can attest to his exceptional track record of driving revenue growth, developing high-performance sales teams and building strong customer relationships. Second, our new product launches are off to a strong start. Customer feedback on PhotoFix continues to be excellent and sales are tracking towards our expectations. We achieved 444,000 of PhotoFix revenue in the third quarter, a 29% sequential increase. We are also working on rounding out the PhotoFix product line with new sizes as well as working on obtaining a CE mark for PhotoFix, which will wed access to the European market. We continue to believe that PhotoFix has the potential of becoming a leading product in the $30 million plus market for biological patches using cardiac surgery. As to ProCol, we achieved $371,000 in revenue during the quarter and 11% sequential increase. We continue efforts to maximize the opportunity for ProCol in the coming quarters. Our effort to expand our global distribution footprint is also going well. The transition into a direct sales model inflect international markets is a key strategic initiative for CryoLife because it enhances our revenue and gross margin mix. It also allows us to implement a more focused sales and marketing strategy and provide a platform for future new product introductions. Earlier this year, we announced plans to transition to a direct sales model in France, which became effective on October 1. As part of this transition, four members of our former French distributor sales team joined CryoLife, giving us an established footprint with strong existing customer relationship. This team’s responsibility is unchanged and they have continued their role of executing sales of CryoLife’s products in France. In addition, we also hired an experienced leader from a major medical device company that will service the country manager for France. I am pleased to report the transition has gone well and our revenue is tracking to our expectations. Looking forward, we plan to add another territory manager to the team further enhancing our direct channel and ability to sell our growing product portfolio in this important European market. Accordingly, we expect to see positive impact to revenue and gross margin beginning this quarter and into 2016. Another key strategy is expanding indications on select products. I will begin with an update on PerClot pivotal trial. To-date, enrollment has been fore than expected as it continues to take longer than anticipated to bring sites to the IRB and contracting process. We currently have only 5 of our 15 sites fully qualified for enrollment. We are working diligently increase the pace of enrollment and are submitting a protocol amendment to the FDA that we believe could be helpful at enrollment. Among other things, it would allow us to increase the number of trial sites from 15 to 25, which should help bring additional trial sites to the enrollment phase as soon as possible. For now, we are targeting to have 15 sites up and running by January 1, 2016. Once we get all of our centers qualified for enrollment, we believe that the trial enrollment will be completed in 2016. With the three month follow-up period, we could potentially gain USFDA approval for cardiac, general and neurological surgery for PerClot in 2018. Also on the new indication front, we recently received regulatory approval for an expanded indication for BioGlue in Japan. We’ve been working closely with our Japanese distribution partner to prepare for the launch which doubles the BioGlue market opportunity in Japan to over $10 million. During the quarter, we collaborated to train their sales team on the expanded indications which allows BioGlue to be used in all aortic, cardiac and large vessel procedures. The launch began on August 1 and in September our partners secured reimbursement coverage which further supports their sales efforts. Another future growth driver is our focus on growing the company through business development transactions. We see this as a highly important area of focus. Our sales platform is highly experienced and poised to drive growth of additional products. We seek products that leverage our well-established customer relationships in cardiac and vascular surgery. We have identified several interesting opportunities, that said, we have a disciplined process and criteria for any investment. We will wait to find the right opportunity if necessary. Moving on, one of the first areas I addressed when I came to the company was to improve the efficiency and results of our tissue processing operations. I am pleased to report that we have made great strides in this area. Following the resolution of the FDA warning letter in the first quarter, we’ve put in place several important initiatives to enhance our tissue processing operations and increased tissue supplies as we have moved through 2015. These efforts began to pay-off in the second quarter and have continued to pay-off in the third quarter. Tissue processing revenues have increased sequentially from $14.4 million in the first quarter to $15.6 million in the second quarter to $16.8 million in the third quarter. The improved efficiency has also benefited tissue processing gross margins, which rebounded in the third quarter and which has positioned us for additional improvements in 2016. We continue to make significant progress on these initiatives and believe that our tissue processing revenues will meaningfully increase in the future. I will now turn the call over to Ashley for a detailed review of our third quarter results and updated 2015 financial guidance.