Jim Walsh
Analyst · CJS Securities. Please go ahead
Thank you, Kevin. I’ll take the opportunity now to update you on our cardiac development programs. In particularly I’ll provide you with a detailed update on our Troponin FDA submission and an overview of our clinical trial data. I’ll also provide a brief update on our Meritas BNP product, which as you know is currently undergoing clinical trials to support the 510(k) and FDA application. Starting with Troponin, you know of course that on December 17 last we submitted a 510(k) application to the FDA for a high sensitive division product. This was the culmination of many months of clinical trial work in United States. To the very best of our knowledge Meritas, is the very first point of care Troponin product ever to be submitted to the FDA under the new guidelines adopted in accordance with the third definition of MI. It is very important to keep this fact in mind later as it will compare our clinical performance in some of the currently approved market leading Troponin products. As the complexity in terms of the new guidelines has lays on clinical performance by many orders of magnitude. The guide line change of course has made the clinical trial very challenging for Trinity, however in the long run it may prove to be a huge advantage to us, as it provides a similar high barrier to our competitors. Following our December submission, the FDA contact does on December 23rd to confirm they had received our application and that they issued - our application with a file number or a KA number at this morning in our industry. We were again contacted in writing by the FDA on January 5th with a number of relatively minor clarification questions. We submitted our response to this questions one week later and shortly after that the acknowledged receipts of our answers. Therefore in about the fourth of week of January with the admission administration process complete the formal review and process commenced and the review actually started ticking from that date. So essentially the first month was involved in administration market and the actual review process starting towards the very end of January. Since then we have had a number of informal communications with the FDA mainly on February 3, February 5 and February 12 and again with relatively minor clarification questions as they work their way through our application. All questions to date have been dealt with and as of today, there was nothing else pending. At the moment therefore we are happy to report that our application has been submitted and that is receiving the careful and serious consideration of the FDA. The actual round of communications, the number of questions and the detail of the questions would indicate that the FDA have treated this application seriously and with the sense of urgency. Some of your application I believe - full review of our application I believe mostly completed by the FDA within the next 90 days, around the last week of April and we received the FDAs comments and questions. However it’s possible that during the process we had to complete it before or then. I’ll move on now to disclose our product clinical performance as determined in our U.S. trials. However in order to put our clinical trial into context, I’m pleased to remind of the scope of our trials. Firstly as you’ll remember by far the most challenging was the ACS or heart attack trial in the emergency room setting. This clinical evaluations was around the 14 trials late, across the USA during 2014 and 2015. The aim of this trial was to recruit after 1,500 patients, presenting in the emergency room with symptoms suggestive of MI and more specifically, at the time at least 150 actual heart attacks amongst this group. Moreover, and I’ll refer to this later, as directed by the new guidelines to all-comers trials by definition must include both type 1 and type 2 MI subjects. The inclusion of type 2 MI significantly the clinical challenge on the product, a hurdle that would not have been nearly as great for the previously approved products. Each of the places were sampled upto four namely admission, otherwise known as time zero, 3 hours, 6 hours and 12 to 24 hours. At each time point, the Troponin level is patient’s blood was measured. The complete patient record was then adjudicated by a panel of three independent cardiologists. The outcome of the adjuration process is ultimately used to determine the clinical sensitive and specificity of the Meritas Troponin product. There is no doubt that no order point of care products presented at the FDA today has ever undergone for stringent, robust and clinically challenging assessment. The second major component of our trials was the result of the upper reference level or the 99 percentile of our product in a population of about 750 normal healthy people. This trial was on a three geographically diverse sites across the USA. The 99 percentile of US population was determined to be 36 people grams in hold lot, which you may remember is exactly is same whether it was determined. European patient are hard cohort markets. The final external component of our clinical trial was a precession study. This was carried out across three U.S. trial sites. The data observed for this study was within the specification that were laid out in the 2012 universal definitional of MI. What I would like to do now however is to observe clinical performance of the Meritas Troponin product in the context for you by comparing our results to two market-leading products, currently approved and widely used in the USA today, mainly the Abbott i-STAT point-of-care Troponin products and the Abbott architect central lab Troponin products. According to the manufacturers package insert, the admission sensitivity of the current FDA approved Abbott Architect Central Lab System is 60% with a corresponding specificity of 95%. In a recent study carried out by Dr. Apple at Hennepin County Medical Center, the added i-STAT Troponin product was determined to have admission center nearly of 32% with the specificity of 92%. In our recent U.S. clinical trials, the Meritas product demonstrates the hope of whole blood sensitivity of 66% and a corresponding specificity of 94%. Thus beating the market leading Abbott i-STAT products by a whopping 35 percentage points in sensitivity, while Meritas also beats Architect Central Lab System by 6 percentage points in sensitivity. However, although these results presented look excellent for Meritas, you need to keep in mind that we’re still not actually comparing like-for-like. Meritas as I have already said, is the first point of care product to be presented to the FDA having put through the new and substantially more rigorous guidelines. For example, 14 trial sites, third party adjudication, and an all-comers trial, which will include substantially more type 2 MIs in the patient cohort than our competitors have encountered. In fact, the Meritas MI cohort consists of 57% type one MIs, 43% type two MIs. If we were to reconclude our clinical performance on type one MIs only, which is much closer to what our competitors would have done, our time zero sensitivity rises from 66% to in fact 75%, which is in fact substantially better than most of the days central lab Troponin systems. In summary therefore we now see the opportunities for either Troponin product is exhibiting market leading clinical performance, not only much better than the performance reported under current market leading point of care products but also matching and even beating some the best Central Lab Troponin products. Moreover as you know Meritas produced these exceptional results in 15 minutes right to their patient’s side, while Central Lab result can take an hour or more to report that. Undoubtedly Meritas will deliver better medicine and certainly save lives. Now I’ll move on briefly to Meritas BNP. As you know BNP levels in the blood stream increase as the severity of heart failure increase as the severity of heart failure increases. Thus BNP has emerged as a principal biomarker in the diagnosis of acute and chronic heart failure. I mentioned in our last call that following discussions with the FDA last year, we agreed to expand the number of U.S. trial sites to 12. The adoption of this strategy we believe would help us smooth review process with the FDA. The aim of this study is to recruit 1,450 subjects approximately 700 of which have heart failure and approximately 700 without heart failure. At this time point with the trial sites actively recruiting we are at 50% point in patient recruitment. As our current enrollment rate patient recruitment expected to be completed in Q2 with submissions of 510(k) appears in Q3 2016. We are quite pleased that the product looks to be demonstrating the same high level performance as observed in our CE marketing trials last year. I conclude and hand over to Ronan and now I’m happy to take questions later. Thank you.
Ronan O’Caoimh: Thank you, Jim. And I’m going to review our revenues for the quarter briefly and then I’ll review the revenues for the year, before the call question-and-answer sessions. Our revenues for quarter four were $24.9 million compared to $26.7 million in the prior quarters as a decrease of 6.5%. Point of care revenues add $5.4 million with the same level as the current funding quarter last year. Clinical Laboratory revenues at $19.5 million were down 8.1% or $1.7 million when compared with quarter four of 2014. The negative impact of currency fluctuations was $1.7 million in the quarter therefore the entire reduction is same by currency. Absent currency movements, our revenues would have been flat for quarter four 2015 compared with quarter four 2014. Within Clinical Laboratory, premier performed well with 6% growth, Immco achieved 5% growth while infectious disease with the weak Lyme season was down 3% and Fitzgerald was down 6%. Now I go look at the year as a whole and where our revenues decrease from $104.9 million to $100.2 million which is a decrease of 4.5%. However when the impact of foreign currency exchange movements due to the strength of the U.S. dollar again the range of currencies is removed, then the entire decrease is erased and the results for the year is an organic growth rate of 2%. Our point-of-care revenues decreased from $20 million to, $18.8 million, which is a 6.1% decrease. Our U.S. HIV revenues were last year-on-year, the overall dynamic is that we are gaining from the advantage of having our new HIV-1, 2 claim in the market which is diminishing slightly with the reduced public health bend. So the overall impact is that we are flat. In Africa, our sales decreased and bear in mind that there is no currency impact here at both revenue and costs are in dollars, but our sales decreased 7% year-on-year. But we do not believe that either the market or indeed our market share have diminished. We believe that this movement is consistent with haphazard nature of NGO purchasing, while the product is still in the funded. Our HIV Uni-Gold product continues to be regarded as the gold standard and continues to be utilized as the confirmatory HIV test of choice across virtually the entire continent, as it has done for the past decade. In addition, funding continues to increase as more and more Africans are put onto antiretroviral drugs with the number now exceeding 20 million people. We are confident of our African HIV business growing into the future. As you know, a year ago we were delighted to receive a clear waiver for our rapid syphilis product. This means we’re the only FDA approved rapid syphilis test and also the only CLIA-waived rapid syphilis test available in the United States. Therefore, this is a totally new market and it’s difficult to estimate the size of the revenues and what they would be. We sell into public health departments and community-based organizations throughout the United States. It’s impossible to say what percentage of this $50 million HIV market the syphilis market will transpire to be. What we can say though is that we are ideally positioned to maximize its potential as we already serve the public health market with our direct sales force. We sell our HIV product to the same target demographic. And secondly, we’ve been in contact with all 50 United States public health departments and virtually all the city and county public health departments. And as best we can tell, all are initiating purchasing plans. However, this takes time. In each case, there is a purchasing decision followed by sourcing of funding, and then we have the establishment of procedures, sometimes the establishment of a pilot and of course training personnel in many cases this can take over 200-day process. Our actual syphilis sales were $10,000 in quarter one, $100,000 approximately in quarter two, and were just over $300,000 in quarter three, and just under $400,000 in quarter four which is the quarter we just completed. As basically, we are gathering significant momentum, particularly in the city and public health departments. We believe that this will be a $10 million product, but it’s difficult to assess at what point in time we will reach that run rate. Moving on to clinical laboratory business, our revenues for the quarter were $81.4 million, down 4.1% from $84.8 million. However, on a constant currency basis, our revenues for the year increased 3%. Fitzgerald revenues were down 7% year-on-year, while our diabetes business performed well during the year with the legacy Premiers business flat. This business will now grow with the pending launch of the Premier Resolution in quarter two and this will make us to grow in hemoglobin vantage market. Coming back to our Premier hemoglobin business, it performed very well. We placed over 300 new Premier instruments around the world in 2015, approximately 20% of all new instruments worldwide. This was obviously, less than the 460 instruments we placed in 2014, but the difference arises due to the fact that we placed 121 instruments in Brazil in 2014 and we made negligible placements in Brazil this year because the Brazilian real currency has basically moved from two to four against the U.S. dollar this has resulted in an effective hardening of the price we receive. We are in the process of increasing our level of manufacturing activity in Brazil thereby saving on import duties and sales taxes and creating a natural hedge. In addition we are seeking price increases against the backdrop of a high inflation environment. We hope to reconnect inflating instruments this year. Meanwhile Premiere placements in the United States and Europe and in China continues strongly. In the report remember of every instrument we place is new business. We are never replacing an existing Trinity instrument as we are in the early years of the placement cycle. Moving on to infectious disease, this business declined 2% year-on-year in a constant currency basis. This arises due to line, which had a weak year due to severe previous winter conditions, line sales in 2015 were down - were $1.2 million lower than in 2014. The balance of the infectious disease business performed reasonably growth 2%. Immco performed well growing 12% year-on-year, sales of children’s during the quarter were approximately $600,000 which is the same as sales in quarter one, quarter two and quarter three. So the loss of children’s sales momentum has risen due to the fact that the ownership of our distribution partner moved from Nicox to Bausch & Lomb, the Valeant subsidiary at the beginning of 2015. The loss of momentum due to transition logistics and training of new sales persons. However the sales force at Bausch & Lomb is 13 times larger than that of Nicox and we believe that Bausch & Lomb will be a much stronger partner than Nicox into the future. Bausch & Lomb have 150 direct sales reps serving optometrists and ophthalmologists around the country. So they have 150 compared to 12. So we’re very, very confident of the momentum being regained and being regained quickly. In general, the strength of the U.S. dollar and the weakness of many of our customer currencies is causing a significant loss of sales. As an example our Russian sales were $1.8 million in 2014. Since then the ruble has depreciated 60% against the dollar and our 2016 sales look like fairly exceeding $100,000. The Turkish lira has dropped 30%, Columbium peso was dropped 43% and of course the Brazilian real has halved and all of these are important markets for us. If we invoice in U.S. dollars than our customer cannot afford our product. If we invoice in lira, real or pesos, then we can’t afford to supply. It’s proving to difficult to growth our revenues with this currency headwind. And at this point in time, I’m going to hand back to the operator for question-and-answer session.