D. Ashley Lee
Analyst · Jeffrey Cohen with Ladenburg Thalmann. Please proceed with your question
Thanks, Pat. This morning we reported our results for the fourth quarter and full year of 2014. The following factors influenced our fourth quarter and full year performance. Total company revenues increased 5% to $37.2 million for the fourth quarter driven by 12% year-over-year revenue growth from our higher margin product segment. Our fourth quarter international revenues were $9.2 million, up 20% compared to the fourth quarter of 2013. For the full year, international revenues were $34.1 million, an increase of 8% year-over-year. International revenues accounted for 25% of our business in the fourth quarter and 24% for the full year. The increase in international revenues were driven by strong sales of BioGlue, PerClot and HeRO. Our domestic revenues increased 1% for the fourth quarter of 2014 and full year of 2014 compared to the prior year periods. The full year increases were driven primarily by an increase in BioGlue and HeRo revenues, partially offset by a decrease in tissue processing revenues. Worldwide BioGlue revenues in the fourth quarter were up 11% year-over-year. International BioGlue revenues were up 19%, on an 18% [ph] increase in volume. Domestic BioGlue revenues were up 5%, on a 2% increase in volume. For the full year 44% of our BioGlue revenues were generated in international markets, up from 43% in 2013. HeRO Graft revenues increased 10% to $1.8 million in the fourth quarter of 2014, compared to $1.7 million in the fourth quarter of 2013. The increase was primarily driven by increased adoption of the HeRO Graft in international markets where we are still in the early stages of the product rollout. PerClot revenues increased 52% for the fourth quarter of 2014 compared to the fourth quarter of 2013. The increase was due to continued growth in European markets where revenues increased 21% and the opening of new markets in South America and Asia Pacific. The quarter included a nominal amount of revenue from the US where we launched PerClot Topical just before Labor Day. Revenues from our TMR product line increased 1% for the fourth quarter of 2014 compared to 2013, which resulted primarily from a 17% increase in hand piece volume mostly offset by a decrease in laser console sales. Tissue processing revenues were down 4% for the quarter compared to the prior year, while our tissue processing gross margin also decreased year-over-year for the fourth quarter. Tissue processing revenues were down due to the processing changes resulting from our efforts to enhance our quality systems. These changes have resulted in a temporary decrease in processing capacity and reduced availability of certain high demand tissues. The net result is that our revenues decreased due to the lack of availability and our cost have increased which is reflected in our lower tissue processing margins in the fourth quarter of 2014 as compared to the fourth quarter of 2013. However, we have not seen any significant change in customer demand for our tissue products. General, administrative, and marketing expenses were $18.6 million for the quarter and $73.8 million for the full year, up from $16.7 million and $68.1 million for the comparable periods in the prior year. The fourth quarter and full year increases were primarily due to the cost associated with executive management changes in our patent infringement lawsuit with Bard. During the fourth quarter we wrote-off our $2 million note receivable from ValveXchange which was mostly offset by a reversals of a $1.4 million liability for contingent consideration related to our Hemosphere acquisition, which we no longer expect to have to pay, and a gain of $530,000 related to the sale of our investment in Medafor, all of these items are reflected in other income and expenses. The carrying value of the investment in ValveXchange, the note receivable from ValveXchange and the contingent consideration payable to Hemosphere are now all zero. We had a tax benefit for the fourth quarter of 2014 and our effective tax rate for the full year was 16%. The tax rate for the fourth quarter and full year benefited from reductions in uncertain tax positions, non-taxable gains related to the reversal of the contingent consideration labiality, favorable deductions taken on the company’s 2013 tax return and R&D tax credits recorded in the fourth quarter. As of December 31, 2014, we had $39.3 million in cash, cash equivalents and restricted cash and securities. We had several large outlays of cash during the year. These included $5.6 million for share repurchases, $3.3 million for dividends, $2.1 million for PerClot inventory purchases pursuant to minimum purchase requirements, $2.1 million related to business development activities, in particular for ProCol, and $1 million for development milestone payments for PerClot. Despite these uses of cash, our balance sheet remains very strong. We continue to carry no debt and expect to continue to generate operating cash flow. Now for our initial guidance for 2015. There were several items affecting 2015 guidance that are transient in nature and we believe will not recur in 2016, positioning the company for improved, top and bottom line growth after 2015. I'll discuss each of these items in detail as I talk about the 2015 guidance. We expect total revenues to between $151 million and $153 million. This represents annual total revenue growth of 4% to 6%. We expect revenues from our higher margin product segment to increase in the mid single digits on a percentage basis for the full year of 2015. This guidance includes the anticipated FX of the following factors. One, we estimate that FX will adversely affect our top line in our product segment by approximately $1 million. Two, as Pat mentioned, we plan to move to a hand [ph] market beginning in October, which we believe will adversely affect our top line by approximately $2 million in the first three quarters of 2015. In 2014, we generated approximately $2.8 million in sales to our distributor in this market, as our distributors sales down their existing inventory, we expect to have no sales in 2015 in that country until we go direct in October. However, for 2016 we expect that our new direct sales force will generate significantly more end user revenue in 2016 than we did from our distributor model in 2014. We expect tissue processing revenues to grow low single digits on a percentage basis for the full year of 2015 compared to 2014. This reflects continued customer demand for our tissue products, offset by lower processing capacity as we implement and refine new quality programs and processes. We expect our gross margins in 2015 to be around 60% comparative with 63% in 2014. There are a couple of factors contributing to the margin decrease for 2015. First, the cost associated with improving our quality systems, including consulting fees and process changes have temporarily resulted in decrease capacity and other inefficiencies in our tissue processing operations. As a result, we expect the gross margins in our tissue processing operations to be in the upper 30% range versus the mid 40% range historically. However, we've already identified many opportunities for improvement and expect that barring any unforeseen issues, tissue processing gross margins could return to historical levels in 2016. Second, recall that we have recently launched three new products, both ProCol and PhotoFix which we are currently distributing have gross margins in the 50% range. However, we have the right to purchase both of these product lines in the next couple of years and bring the manufacturing to Atlanta. If and when we do so, we expect the gross margins on both of those businesses to be in the 70 plus percent range. Additionally, we recently launched PerClot Topical here in the US. Unlike PerClot that we distribute in international markets which we source from our partner, PerClot Topical is manufactured by CryoLife in Atlanta. At low levels of production, our gross margins are close to zero. However, once we receive PMA approval for the surgical version of PerClot in the US, we have the right to begin manufacturing all PerClot both US and international in our facilities in Atlanta and we expect very attractive gross margins once we directly distribute these products. Considering all of that, we expect gross margins on our product business will be in the mid 70% range for the year. We expect our G&A expenses to be affected by few items in 2015. We've included a significant amount in legal fees related to our patent case with Bard. If we are able to conclude the case in 2015, a significant amount of legal fees won't be recurring in 2016 and depending upon the timing of any resolution, the actual amount incurred in 2015 could change materially from our estimates. Also, we have the cost of additional sales reps related to our direct sales strategy in a major European market beginning in October 2015. We think the annual cost of carrying this direct sales force is just over $1 million on an annual basis. That I've talked a little already about the positive impact that we expect from going direct – to have on our business beginning in 2016. We expect research and development expenses to between $13 million and $14 million in 2015, primarily reflecting our investment in our US clinical trial for PerClot which we estimate to be around $5 million in 2015. Depending upon the rate of enrollment in the trial, a substantial portion of that $5 million would not be repeated in 2016, although you should not assume that we won't be investing in another trial or other development activities in 2016. The net effect of tissue processing, European distribution elimination, lower margin new products, litigation expenses in the PerClot IDE trial is that we expect earnings for the full year of 2015 to be anywhere from a loss of $0.03 to breakeven. It is important to note that our guidance is not reflective of any activities related to business development which are difficult to predict. That concludes my comments, and now I'll turn it back over to Pat.