image
Healthcare - Medical - Diagnostics & Research - NASDAQ - IE
$ 1.37
-7.43 %
$ 15.6 M
Market Cap
-0.51
P/E
EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2015 - Q1
image
Executives

Joe Diaz – Investor Relations, Lytham Partners, LLC Kevin Tansley – Chief Financial Officer, Secretary Jim Walsh – Chief Scientific Officer Ronan O'Caoimh – Chairman and Chief Executive Officer.

Analysts

Bill Bonello – Craig-Hallum Larry Solow – CJS Securities Jim Sidoti – Sidoti and Company Bill Nasgovitz – Heartland Funds Paul Norrie – Novel Equity Fund.

Operator

Good morning and welcome to the Trinity Biotech First Quarter Fiscal Year 2015 Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions]. After today’s presentation there will be an opportunity to ask questions. [Operator Instructions]. Please note this event is being recorded.

I would now like to turn the conference over to Joe Diaz with Lytham Partners. Please go ahead..

Joe Diaz

Thank you, operator, and thank all of you for joining us to review the financial results of Trinity Biotech for the first quarter of fiscal year 2015, which ended March 31, 2015. With us on the call representing the company are Ronan O’Caoimh, Chief Executive Officer, Kevin Tansley, Chief Financial Officer; and Dr.

Jim Walsh, Business Development Director. At the conclusion of today’s prepared remarks, we will open the call for a question-and-answer session. But before we begin with prepared remarks, we submit for the record the following statement.

Statements made by the management team of Trinity Biotech during the course of this conference call that are not historical facts are considered to be forward-looking statements subject to risks and uncertainties. The Private Securities Litigation Reform Act of 1995 provides a Safe Harbor for such forward-looking statements.

The words believe, expect, anticipate, estimate, will, and other similar statements of expectation identify forward-looking statements.

Investors are cautioned that such forward-looking statements involve risks and uncertainties, including but not limited to, the results of research and development efforts, the effect of regulation by the United States Food and Drug Administration and other agencies, the impact of competitive products, product development, commercialization and technological difficulties and other risks detailed in the company’s periodic reports filed with the Securities and Exchange Commission.

Forward-looking statements reflect management’s analysis only as of today. The company undertakes no obligation to publicly release the results of any revision to these forward-looking statements. With that said, let me turn the call over to Kevin Tansley, Chief Financial Officer for a review of the results.

After Kevin’s results, we will – after Kevin’s remarks, we will hear from Dr. Jim Walsh on development issues and Ronan O’Caoimh will ramp up the prepared remarks which his perspectives on the quarter.

Kevin?.

Kevin Tansley

Thanks so much, Joe. Today I will take you through the results for quarter one 2015. Beginning with our revenues, total revenues for the quarter were $25.2 million, this compares to $25 million in quarter one of 2014. However revenue of this quarter particularly impact us by currency movements.

The recent strengthening of the dollar has also reduced the dollar equivalent of our Euro, Sterling and Brazilian revenues. As you will see from the press release and we were stated the quarter one revenues on the constant currency basis which show the growth of 6% quarter-on-quarter.

The impact with the currency movements is not inline such to revenues, you all have heard as I mentioned before, from our profitability point of view we are broadly neutral from the currency point of view. This is because we have a natural hedge where by our foreign currency denominated revenues and expenses offset each other.

Thus far revenues are lower, so too our costs and this is relevant from considering growth process and SG&A movements this quarter. Deferring with them to this quarters gross margin, as you all seen from the press release we are showing gross margin 47.9% this quarter.

Marginal reduction on the 48.6% in quarter one last year due to the currency issues I just mentioned, it is higher than the – it is actually higher than the 47.5% reported in quarter four 2014. We are now beginning to see the beginning of the improvements in our gross margins, something I would have alluded to on our most recent earnings call.

Moving on to our indirect expenses our R&D expense remain constant this quarter at approximately $1 million, meanwhile our SG&A expenses also remain consistent with the equivalent quarter in 2014 at $6.3 million.

However in this case we are seeing a reduction of these costs, due to the currency movement I mentioned earlier, but this is offset by higher sales and marketing costs largely associated with our Meritas business, which is currently not generating matching revenues.

Operating profit for the quarter was $4.3 million compared to $4.5 million in quarter one 2014, which represents an operating margin of 17.2%. And we on to our net financial expense this quarter we had net financial expense of $23,000 which represents some notional charge in long-term liabilities.

Meanwhile our tax charge for the quarter was just over $300,000 this represents an effective rate of 7%. And the previous quarter to continue to receive the combined benefit some very competitive Irish corporation tax rate and tax credits arising in ardent USA, and Canada.

Overall point has retired than the unusually low raise of less than 2% recorded in quarter one 2014 which obviously has impacted profits this quarter. The Net results of all that I have spoken up so far is that profit for the period was $4 million. This equates to a basic EPS of $17.04 on a diluted EPS of $0.17.

I’ll however, repeat, we are carrying significant Meritas cost and these remittent our earnings for the quarter would have been over $0.20. In meanwhile our earnings before interest tax depreciation and amortization and share option expense for the quarter increased to $6.2 million versus $6 million in 2014.

I’ll now move on and talk about the significant balance sheet movements since the end of December 2014. Property, plants and equipments remained largely consistent with last quarter this is due to additions of $1.2 million being offset by combination of depreciation of about 300,000 and retranslation movements of 700,000.

In the same period our intangible assets increased by $2.5 million and this was made up of additions of $3.7 million offset by amortization charges of $0.7 million and retranslation movement of $0.5 million moving onto inventories you will see these increase from $33.5 million to $37 million this is due to a number of timing issues.

Firstly we build up inventory of our rapid Syphilis product it has down to the expected growth in sales in the months and quarters ahead. That was also the normal increase in the levels of Lyme inventory in preparation for the peak Lyme season of December month, predominantly seeing in quarter one every year.

In addition we continue to build premier inventory levels inline with growth methods. And finally there is a normal fluctuation encourage you to ordering the production schedules for example I’ll remind there is a little slight fall in inventories in quarter four versus the previous quarter and now receiving the offset effect this quarter.

Meanwhile trade and other receivables have increased by $1.6 million to $27.6 million which reflects the longer payment cycle with respect to instrument sales and the timing of some receives. Meanwhile our trade and other payables including both current and non-current have decreased slightly from $23.6 million to $23.3 million.

Finally, I’ll discuss our total cash flows in the quarter cash generated from operations for the quarter was $1.8 million. In meanwhile capital expenditure were $4.1 million it’s lower than the previous quarters though this is in somewhat ways explained by timing factors affecting the fact that quarter fall is unusually high.

That was relative to payment of the licensee of $1.1 million you will recall this relates to the license fee associated with the HIV-2 license which has taken as in 2013 and which has been paid over five equal payments three of which still remains to-date.

Net results since that we had a decrease in cash for the quarter of approximately $3.3 million with quarter ends balancing $5.7 million in terms of the loan rates the cash outflow will point out have insights cash inflow in quarter four 2014 is $300,000 and both the average cash outflow for each of the last two quarters is effectively being $1.5 million per quarter.

I will now hand over to Jim, who will take through the latest developments with regard to cardiac..

Jim Walsh

Thank you, Kevin. I'll take the opportunity now to update you on the progress on our cardiac market development programs. In particular, I will provide you with a detailed update on our Troponin clinical trials, which I'm delighted to say, it’s progressing very satisfactionally and according to plan.

I'll also update you on our Meritas BNP product, which as you know, obtained European CE approval last year which also submitted the FDA later this year. Nothing, said with us, the company announced the relationship products to the USA for the recommends in our U.S clinical trials on our Troponin point of care products.

The trial is now running and approach trial size across the USA, and its currently recruiting team 60 to 70 patients per week. On our last call, since we hope excuse me – for a recruiting team of 72 patient per week, so therefore traffic very close to our expectations.

Furthermore, the actual way of AMI this is currently tracking slightly higher than expected, which of course is very encouraging.

The project therefore remains of course have data collections and subsequently adjudication during the month of July with 58 submission found [indiscernible] Since the recommend to the clinical trial the line report that the product continues to exhibit the same excellent chemical performance demonstrated in both our European CE trials, and indeed in the independent clinical evaluation carried out by Dr.

Apple, at Hennepin County Medical Center, in Minneapolis last year. Furthermore European evaluations whether are where now along with product registrations at the team of advancing in another concept including China and Brazil.

So in summary, we are happy with the quality also Troponin products and the clinical evaluation progressing very well and the quality plan. And I'll move on now to the Meritas BNP. About six months ago, the company announced that we had received European approval for our BNP heart failure test.

As you know, BNP levels in the bloodstream increase, as the severity of heart failure increases. Thus BNP has emerged that’s a principle biomarker for the diagnosis of acute and chronic heart failure. For our CE approval, the BNP product was tested on a predominately U.S.

population of more than 1,000 healthy individuals, and 665 patients, which had been diagnosed with heart failure.

On the population by example, the Meritas BNP product demonstrated sensitivity on procession which is at least comparable to much larger or far more expensive clinical laboratory systems, while delivering results in 10 minutes right at the point-of-care. We’re delighted that [indiscernible] which is owned by Dr.

Apple, as it reach to the except the presentation at AACC Meeting in Atlanta. It will take place in July next. With regard to our U.S.

approval, I mentioned on our last call, that in a conversation with the FDA in last January, the FDA made a strong recommendation to us that on bank samples would not be optimal support our application and suggested that we our strategy towards fresh perspective U.S. samples only. I also mentioned that we had been an overview U.S.

clinical trail by work to those collect to necessary data. I mentioned 54, but the good news is that BNP – that the BNP trial is seems a little more straightforward in the Troponin trial. Firstly, only one blood sample of a patient is required as compared to four for Troponin.

Moreover, heart failure patients are generally not in an emergency situation. So obtaining patient consent to take a blood sample is much easier proposition. And of course, finally, cardiologist adjudication is not required.

In summary, therefore, we believe the data collection of BNP will be complete in September for the 55 – 510k submission to the FDA. We believe that’s due to the less complex each of the BNP to review process should be somewhat more straightforward than the Troponin. And U.S. approval is expected sometime ahead of Troponin in 2016.

I’m happy to answer and detailed questions you have later on in the question-and-answer, but for now, I’ll hand over to Ronan..

Ronan O'Caoimh

Thanks, Jim. I’m going to review our revenue for the quarter, before opening the call for question-and-answer session. Our revenue for the quarter were $25.24 million, up from $25.03 million in the corresponding quarter, which is an increase of 1%.

However, when the impact of the strengthening dollar is excluded and the actual increase in the revenue for the quarter is 5.7%, which is all organic growth at the Immco and blood banking acquisitions were completed in 2013. And our current features of HIV revenues for the quarter were $4.7 million, up from $4.5 million, which is an increase of 4.4%.

African sales performed well, showing growth of 5%. In the U.S., our HIV sales increased 3% over the prior quarter with hospital sales performing strongly aided by the fact that we are now selling HIV-1, HIV-2 combination products since we got the HIV-2 FDA approval last year.

Public health HIV spend continues to be depressed, with sales flat when compared with the prior year. In December, as you know we were delighted to receive a CLIA waiver for our Rapid Syphilis product. This means we have 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 total new market and it's difficult to estimate the size revenues will be.

The most obvious comparison and really the only comparable product is the CLIA waiver rapid HIV products and that is sold by synergy OraSure and combined where we share the market of $15 million of CLIA waived HIV revenues, which sell mostly to the public health departments and community-based organizations throughout the United States.

And its probably to say a half percentage of this HIV market and syphilis market will transfer to be, but we can’t 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 and sell our HIV product to the same target demographic.

And secondly, we have been in contract with all 50 public United States public health departments and most city public health departments. And especially can tell all our initiating of purchasing plan. And however, this takes time.

As in each case its almost purchasing decision is needed followed by the sourcing of funding, and then we have the establishment of procedures, sometimes establishment of the pilot, and of course training of personnel. Basically, we estimate 120 to 150 day process. And our current indications are that all of the states will buy.

In addition, we have been inundated with approaches from community-based organizations, Planned Parenthood, health clinics, and community health centers; we are receiving by the way huge support from the CDC in all our efforts. And in summary, this is going to be very significant, but it is too early to quantify.

And moving onto our clinical laboratory business increased from $20.5 million to currency adjusted $21.7 million, which is an increase of 6% our diabetes business grew 13% over the prior corresponding quarter; and given the quarter we placed an excessive 100 premier instruments with all of our key markets Menarini in Europe, Brazil, China and U.S.

performance strongly. Last year, we placed 460 instruments and their expectations as we will match are modestly be that placement during 2015 moving onto our infective disease business, excluding Immco this business grew 3% from currency and impacted exclude this.

The Lyme confirmation component of the business was down $400,000 compared with the prior year due directly to last year’s severe winter. But all of the other components of the business performance strongly but most stronger than the U.S.

business continues to benefit from the advantage of having the Immco autoimmune business added to it while China continues to grow strongly. Moving now onto Immco sales, we acquired 20 months ago and we are pleased to report that we grew the business over 20% over the past year.

The business has been successfully integrated and the Immco autoimmune products range is helping us to grow our existing infective disease business as I just mentioned.

The highlights at Immco has been success in our Sjogrens test, which is a dry eye test, which we do not sell to laboratories around the country, we run this in our own laboratory in Buffalo. Sales of this test during the quarter exceeded $600,000 following its launch last June.

Finally, as Jim said, relating to Troponin the trial is going very, very well and we’re confident the significant wonderful product to the FDA.

And lastly before I hand over to questions and answers I just like to address our recent one-time item, as you aware we raised $115 million just over $110 million after the full service fees in the form of a 4% exchangeable senior note we had about and up to 30 years the purpose of rising the 20 was to allow us to cardiac acquisitions.

The company has a long history and significant experience intensifying high quality acquisitions and integrating them efficiently and effectively. Also at this stage in the company developments we all have been major building blocks required for growing a diagnostic company, either through acquisition or organically.

In particular we have an excellent sales channel with the long established and significant direct sales organization in the USA. And we’re now also direct in the Brazil and UK. On top of this, we have a formidable network of distributors, which allows us to reach further 100 additional countries.

Meanwhile, we have a number of high quality FDA approved manufacture. This is highly skilled in structural workforces. After this our regulatory quality marketing and finance functions as well as our experience management team. And we believe that we’re well position to take on new acquisitions.

While we have no particular acquisition in mind at present, we are very clear to the type of acquisition that we would like to make. The acquisition must be growing business, which operate to the growing markets. The earning enhancing and cash deposit from day one either in side the normal short-term integration cost.

And also must be synergistic with the rest of the company’s business, all at the same time leveraging in terms of sales and operational strength. In this context, we will think to make high quality acquisitions at lower evaluation multiples.

And then by leveraging transition here in strength, I’m realizing synergies enable them to trade at a higher multiple markets to strengthen your own multiple. We’re confident that we can identify companies could see exciting growth products. And which are capable of becoming significant there is in attractive niche markets.

We already have experience in this card. I’ll point out that our Immco acquisition exactly fits this profile, I’ll talk premier business is an example of how well to the small company can become a significant participants in a high growth niche markets of huge potential. So we’re now actively seeking acquisition opportunities.

Their concept of the need to move quickly, but not so quickly but we would buy badly. So if I could now hand back to Gary and to the question-and-answer session guys..

Operator

We will now begin the question-and-answer session. [Operator Instructions] The first question comes from Bill Bonello with Craig-Hallum. Please, go ahead..

Bill Bonello

Hey, good morning, guys, or afternoon for you. Just take up a little follow-up questions. First of all, Kevin, do you expect to be cash flow positive this year. As we think about operating cash flow less normal capital expenditures for in the full year or would you expect to kind of keep earning at sort of the $1.5 million rate..

Kevin Tansley

I think fairly, as we go throughout the year, we’re going to see a number of things. From probability point of view, as the revenues grow and our gross margins improve, you are going to see more cash thing turn out by operation research.

And at the same time you are going to see lower expenditure once particularly gets through this phase in relation to components to a lesser extent BNP. You are going to see a diminishment ban in the amount of capital expenditure. So as the time goes on, we are going to move to two points where we return from cash flow negatives, cash flow positive.

So I’ll expect yes, we will ship over to being cash flow positive before the end of the year and a quarterly basis. And whether that result and absolute cash flow positive overall and that’s circumstances spend in the timing flows will be helpful in that regards.

The real point I was at this quarter really need to looked at in the context of the previous quarter.

With the slight uptick in the previous quarter, this quarter was down, more substantially obviously and really, there is timing issues in there and the year-end particularly strong collections for example at the end of quarter for which more normally would have been expected to help into quarter one.

So looking us quarter one in isolation is little bit misleading..

Kevin Tansley

Sure..

Bill Bonello

Okay, so that makes sense. And then just on that gross margin point, you said you think you are beginning to see the expected improvement in gross margin.

Is that or do you saying that’s the trend you would expect to continue as the year progresses and maybe just tell us a little bit, is that just yes, leverage on the revenue you are getting or are there other factors that are driving better margin?.

Kevin Tansley

The few factors the wholesale one year, you are absolutely right leverage driven by higher revenue, the certainly one. The fact that are constantly each quarter from now on, we are done again more to more favorable mix as regards instruments versus reagents from the premier business, and obviously reagents for a higher margin.

[indiscernible] again that’s a good gross margin products, we would expect given the effect we own that markets. So yes, I do expect our gross margins will continue to improve.

I will say there is always fluctuations of that anyway, which demands on product mix and more have you purchase, we have turned the corner by going from 47.5% in 2014 quarter for back up to 47.9%, which is coincidentally equivalent pretty much to what we did in quarter three 2014.

And obviously you will – as the quarters go on you will see the trends also demonstrating itself, quarters go on you will see the trends also demonstrating itself..

Bill Bonello

Okay. And then just one last question as I can just in light of the money, you have raised in the focus of acquisitions. Can you just give us is there any quantification that you can give us for Immco right now, in terms of how that’s going. I think when you originally took it on. It was getting on the $0.10 or $0.12 of EPS contribution.

Just curious if it is actually contributing to net income right now and sort of the what pace and where you think you can go just we can kind of engage how the acquisition experience has been recently?.

Kevin Tansley

Yes. Bill we are happy with the progress with that particular acquisition, you’re right, we just have to prepare that it would generate profits and met those expectations and as we continue to grow the revenues we continue to expect those profits to continually..

Bill Bonello

Okay, thank you..

Operator

The next question comes from Larry Solow with CJS Securities. Please go ahead..

Larry Solow

Thanks, good afternoon.

Quite frankly touch on the sort of the interest for Joe you need offering, Ronan and you realized acquisitions are always has been part of your strategy a bit seems like you are sort of taking out of sense of urgency and in terms of booking that offering this is you see like there is a lot of opportunities out there and that’s why you did it or any color on that would be very helpful thanks?.

Ronan O'Caoimh

Well, Larry I think we had I mean actually we sold our coordination business we had a $170 million we spend about $10 million buyback and we bought into that but if we only and we also have blood banking business in the Immco so we have – we had spend some money and we are clearly happy to raise money for nearly a decade and we thought it was time to do so.

And we also didn’t want to - we didn’t want to raising money and rise in the middle the sample of the next year, so the machine relating to troponin and balance of this has which is right about the right time. Clearly we were in excess and unusual enough situation for a company like ours and sensitive if long to integrate money.

And we actually didn’t have a life start registration and so that also added to mention to the whole thing and sort of how we look the approaches. And so in many events and we talked about for all the reasons that our clients are already and we are a company that’s grown largely by acquisition side that the time was right to do so..

Larry Solow

Okay. Fair enough.

I know you said the nothing even if on the table which you’ve probably can tell us if there was anyhow but are there – looking out do you see opportunities that are maybe still not historic you speaking with people yes, but do you see bunch of opportunities and that’s why you went out and rise money or is it just you something that do you expect to do something within the next 6 to 12 months is that your intention..

Ronan O'Caoimh

Yes. Thanks for the question.

Larry I mean we didn’t specifically you re-categorized by we did not raise money with any particular acquisition or acquisitions in mind right so therefore we didn’t raise the money but that sort of the whole we didn’t potentially so with – we didn’t raise the money with the whole and potentially in mind first at specific one.

So by having said that since the acquisition we have been extremely does the and since the found the way I think we have been extremely looking in terms of looking for something..

Larry Solow

Okay..

Ronan O'Caoimh

The concept is, as I mentioned trying to get kind of straight the right balance, between, spending the money likely and spending it quickly. We don’t want the money to burn the whole pockets, but I say to I’m extremely conscious of the cost of making the money set variety.

And I will talk about a situation, we would like to end, we would imagine that we would by a sort of one valuation and try to have another..

Larry Solow

Great..

Ronan O'Caoimh

And then I talked about the synergies and the capabilities of the company and their experience in terms of identifying executing its pricing and all of that process. I don’t look feature for, but then throughout taking that’s the whole process..

Larry Solow

Okay. Just touch on the free cash flow question, I think you spend $21 million last year in total of CapEx and mostly capitals R&D. I know this is schedule on the 20 of that.

I think this is remaining cost base program, but do you have sort of a target who not spend this year and do you expect that to sort of start to slow down over the next couple of years..

Ronan O'Caoimh

Do you expect the slow down Larry, I mean those, because of the two aspects which is sort of the development work in the normal PPE and expect the amount PPE industry trial and the interim placement side. We have invest in the lot of equipment in the last 12 and 18 months and expect that to reduce in relations of the product development side.

You will see it in the first half of the year, but I expect that to start coming down as well, but particularly as it gone through the trial period of such. And particularly, this own trial what's Jim mentioned there as more intrigues and I’m trying to more expensive trial. BNP is less costly and that a little bit of the later.

So I do expect the reduction that was in BNP, so as expect overall to see a reduction and combined capital expenditure during the year..

Larry Solow

Okay. In related to on the operating side, I mean you referred to Meritas in particular, I think you spend $2.3 million last year and, you called up $0.6 million of expense of the SG&A, R&D this quarter was in that.

Do you that sort of a good run rate number about 2.5 million per year, do you expect that to go higher this year?.

Jim Walsh

Well, obviously as we come to your point, we’re getting closer and closer to launch..

Larry Solow

Right..

Jim Walsh

We will be putting for the building asking rate sort of to launch and we’ll be just in relation of thought process will obviously be promotional, literature, et cetera..

Larry Solow

Absolutely..

Jim Walsh

Yes, marketing plans, we put in place what have you, so as you can imagine the closer we guess to launch date you can expect that to take all purchase..

Larry Solow

Okay. And did you give a premier placements number, I know, wasn’t in the release. I don’t think, did you talk about that on the review, could you give that number out or you are not giving that anymore..

Kevin Tansley

No, we just said that we’ve done an excess of hundred..

Larry Solow

Okay, I missed that..

Kevin Tansley

Yes, what we said that I think we get to 101 on the corresponding quarter last year, we placed over 100 this year was actually more than 101. And what we just said, what we said in this is that was that we did - we take 460 instruments last year..

Ronan O'Caoimh

Yes..

Kevin Tansley

The prior estimate by 23% of all worldwide patients. And we expect as we will meet that and somewhat we make at the 500 and we probably won't quite get there. So I think it will be somewhere between 460, 490 that kind of order up size. And but I think there is – yes, I think that’s about for you can mature.

What we would hope to do, as we hope to continue they get placed on that raise for the period of cycle, which is sort of 7.8 to 8 year cycle. So its all new business for the next five years and half to that of course we are replacing our own..

Larry Solow

Got you. I just in terms of premier I know you talk about gross margin seems like we’ve seen the bottom, premier by itself, is that accretive to I mean to gross margins today or not yet with the royalties on the….

Kevin Tansley

No, we are not added, still drag Larry I mean,.

Larry Solow

Okay..

Kevin Tansley

We’re still replacing very, very significant quantities of instruments, which is you know we had a very low margins as of many color in the industry. To take care all with this own says comes in relations to pull through and that comes to a higher margin..

Larry Solow

Right..

Kevin Tansley

The ratio was moving in our favor all the time, are you getting a great portion of reagents..

Larry Solow

Right..

Kevin Tansley

As a percentage overall, we haven’t reached the sweet spot where we kind of move halfway average gross margin..

Larry Solow

Okay. You haven’t actually reached inflection plan for premier lease, but do you think your gross margin has bottom or close to..

Kevin Tansley

I believe we turn the corner, yes, with that….

Larry Solow

Right. And I assume that do you have all the cost cuts really to the asset of lot 21 that’s all now, in there..

Kevin Tansley

All that – yes, all that’s true..

Ronan O'Caoimh

The gross margin for quarter one is higher than quarter four..

Larry Solow

Right, right, okay.

Just last question maybe for Jim on Meritas, I know you had given your backup and running some of these evaluation trials in Europe, what sort of the expectation of that into the generally have to run for all several months even a full year or what are – how long do you expected these things to run before maybe you can get some commercial sales in Europe..

Jim Walsh

Yes. In terms of the – we have been backing we’ve been doing evaluations in there in Europe now for the last sort of 2.5 months I guess okay we have some new products, we have obviously product for amortize the U.S.

for availability on if you like new product, we’re back in Europe for the last 2.5 months and just today for instance, we got the results back to back trials that was carried out, in a lab called [indiscernible] in Germany, its got some very nice results in Brazil. So what I'm saying each country is different I guess, okay..

Larry Solow

Right..

Jim Walsh

So some of your – someone wanted in very detail index so try to get one perfect samples and so if you take ages quite frankly. So that’s for example, other countries are happy to do some bank samples. But all in all, good results back in Germany, and yesterday, quite frankly okay.

And one boards of trial are to finished, I’m not some sure, because there is still another bit to go on that would, I think you are going to see that over the coming start at second half of the year.

You are going to see, slowly but surely, country by country, probably first maybe Scandinavia then, maybe Germany then perhaps France, then perhaps in UK or maybe that’s not the order, because we will have start to copying all over to carry to be year..

Larry Solow

Right. I just want to get couple hopefully to our built upon sales….

Jim Walsh

That’s obviously not at all, but you know once you get like to keeping leader in Germany sample things,.

Larry Solow

Absolutely..

Jim Walsh

That thing keeping a leader in France hopefully..

Larry Solow

Absolutely, okay, great. Thanks, Jim. I appreciate it..

Operator

The next question comes from Jim Sidoti with Sidoti and Company. Please, go ahead..

Jim Sidoti

Good afternoon, can you hear me?.

Jim Walsh

Yes, Jim. Hi..

Jim Sidoti

Great.

So I believe you said the diabetes this was up by 13% where as premier units were flat, so I assume the growth is mostly from the reagents?.

Jim Walsh

Yes, that’s absolutely..

Jim Sidoti

And is there a particular region where you saw strong growth is it across the board or is it more in the U.S., North America, China?.

Jim Walsh

It’s across the board, having said that in Brazil has been the star and I talk about I mean really and probably down in the U.S. and then that so in China, because although its facing a lot of insurance as I mentioned before. And as of yes the amount of reagent puts running in niche some to the modest.

And I expect, that’s what we expected and we are going to see that, because remember hey, we may on see reimbursement is a 30 weeks and phenomenon in China. And so you need to keep its tune into so - and that’s gradually happening.

So over the course of the next number of years, each Chinese instrumental become progressively busy year, but at the moment they are lagging in terms of reagents and all the other contributing very well..

Jim Sidoti

Alright.

And then in terms of the offering, you said the rate on the bunch was 4%, but what rate do you actually – will you do you point out on actually reporting on the income statement?.

Ronan O'Caoimh

Okay, that’s a fair enough, Jim, be – as you know there are two elements today.

The actual normal rates, which is effectively the cash interest associate with the 4% and then on top of the last there is the notional interest charge effectively reflect the value of the embedded revisions which form parts of the instruments which is effectively are recovered over the time of the bonded sales of such it’s difficult to very precise at this point as to how much that is going to be it requires a very intricate evaluation to using binomial models which would have to be custom bills for the specific purpose of valuing the particular embedded derivatives and the expectation can be the little urge somewhere in the region of 1% to 2% on top of the 4% so when you look at our P&L in quarter two you’ll see the 4% charge going through but you know to expect a notional charge which will breakout for you but that will be somewhere between 1% and 2% on top of that so in that’s something effective rate from a gap point that you will be somewhere between 5% and 6% typically to say or precise at this point I think the model is actually constructed until it has doesn’t what have you but I will take and that we will say that was the impact with us just from comparability point of view but in that sense it is in the precisely meaningful number….

Jim Sidoti

Okay but for our purpose we should assume somewhere between $6.50 million to $7 million a year of annual interest charges that’s kind of a rate?.

Jim Walsh

Probably been high there..

Kevin Tansley

I mean if you take our we’re talking about $5.75 to….

Jim Walsh

6.3...

Kevin Tansley

6.3 yes..

Jim Sidoti

I think the – great respect to accounting profession if you remember I think that it’s really here or there I mean it’s meaningless that notional number..

Jim Walsh

It’s also a number by the way which you have to chew up each quarter so which is a further complication and you will see that at each quarter the embedded derivatives are mark to market tends to be depending on prevailing market conditions, you will get a change in valuation which could be interestingly up or down to obviously again will be is there anything else thus..

Jim Sidoti

Okay. And then finally on the troponin test as you get closer and closer to submission and you start to talk with the FDA when do you expect to actually ramp up the sales force or do you, will you wait for approval before you actually hire sales people for troponin or will you just sell it through your existing sales force..

Kevin Tansley

Well, Jim the answer is that we will wait until we get approval because of the fact that we already have currently sales at 1,000 so there is no need for us to do that basically we’re prepared and in fact that process is already long commenced, and I think we’re probably at somewhere between 7 and 10, as we believe we wait until the approval comes early and that’s ready until they come before we do that and during the model but you don’t know as exactly when it was coming, so but the bottom line is we already have over 75% of the sales force in place..

Jim Sidoti

Great. All right, thank you..

Kevin Tansley

Thank you..

Operator

The next question comes from Bill Nasgovitz with Heartland Funds. Please go ahead..

Bill Nasgovitz

Good day guys.

Could you talk a little bit about the dry eye, how big is that market and what’s going on there and what do your expectations over the next couple of years?.

Jim Walsh

Bill, dry eye and, it takes about 6% of that really people, so it’s a condition that – haven’t gotten a lot of attention until more recent years, and they only begin to three therapeutics basically and going through the approval process.

But it is an extremely habilitating condition and so it basically because we’re off to our values which is come from the eye and kind of that as shifts our condition of that is of course dry them out, which attract the biosimilar proportionate people and it taking more to penetrating and to succeeding to basically have a intensely try [indiscernible] that’s where to sleep in fact so these are real big problem and I think for long term people its associated with actually it is – is it a disease that can be treated.

So I think the diagnoses of it is going to go significantly just in the context of our products.

And in traditionally but if all our characteristics you would submitted to the FDA and you would make it available to the hospitals all over in the United States and we might take a look as well as the $10 in fact we did took the approach there to actually runs in our own laboratory and that runs through the FDA.

And given that we have a clear approved laboratory we don’t need FDA approval for own test. So we partnered with Baush & Lomb it’s a part of volumes and th 150 sales reps out on the road carrying the product and is only got launched last June.

And if choose to complicate the matter our original deal with the company called Nicox we sold out their interest to Baush & Lomb. So Baush & Lomb basically paid a considerable some of money deploy side outside of contract.

And are very committed to it and as part of the volume – and are expecting to have therapeutics approval for, so in the fairly recent very soon and so I think its got this product has got a lot of potential. As I mentioned in call, $600,000 last quarter, so its running at $2.5 million now.

Also how far control difficult to say for them given that it only had it’s launch in June and by the way, for the first number of months it was only been sold by sales force of after 12 nice stock sales reps.

And now, end of the last two months we introduced to 150 plus in num sales reps, who are specialist going to the up town and be a up commercials. And I think that – it’s got really, really significant potentially most of traits to kind of fair number, but it’s a lot higher than where we are at now.

And so I think this is going to become a very important product for us. But it’s actually generally difficult to quantify its potential..

Bill Nasgovitz

What is it sale for in it is just a 50/50 relationship..

Jim Walsh

Yes, it sales are 50/50, and it sales 50/50 and not actually 50/50. But the price at sales are actually $300 seems to be really, really high drive. And so….

Bill Nasgovitz

Okay. Alright..

Jim Walsh

You can very quickly build very big numbers. But if you go back – if you just go back to your actual growth in 6% of the elderly population will have this problem..

Bill Nasgovitz

Okay, thank you..

Jim Walsh

Thanks [indiscernible]..

Operator

The next question comes from Paul Norrie with Novel Equity Fund. Please, go ahead..

Paul Norrie

There is about $1 million paid out for the – you paid for the two license, is that going to be a perpetual cash outflow as you sell more of the test..

Jim Walsh

You might recall back in 2013, we negotiated a licensee. The licensee at that time was about $5.5 million. And we paid the first fiscal battlefront and now we paid the first of for subsequent annual trenches. So there are three more to come and that would be either in quarter four, if I can actually we do very closely in the quarter four.

So it can fall in quarter four or quarter one just depending on notifications, et cetera..

Jim Walsh

But that’s it, sorry, the run overall is they are after that..

Paul Norrie

Okay, thanks..

Kevin Tansley

It stated we are not paying it – but the actual payment in deferred over the period of time..

Jim Walsh

Okay.

Are there any more questions?.

Operator

[Operator Instructions].

Kevin Tansley

Okay. It seems that we don’t so…..

Operator

Pardon me. We do have a question from a Private Investor..

Jim Walsh

Yes..

Operator

David Schneider, please go ahead..

Unidentified Analyst

Yes, I joined in the call little bit late. You may have already answered this it all in the transcript, but can you explain why you did a convertible bond offering instead of just straight debt..

Ronan O'Caoimh

Well, I think there is a variety of reasons. I think that – which have been difficult - I would have been possible to just say it as at that level. I think we have our own bank was willing to probably meant, so it’s around $30 million. So that would have been the extent of [indiscernible].

Does that answers your question?.

Unidentified Analyst

Yes.

I just also think if you’d waited until the troponin was filed your stock price obviously as you get closer to the troponin of that shouldn’t be higher in the rational market you may have gotten better terms?.

Ronan O'Caoimh

Yeah, I think that’s – that’s the point that some other investor have made. I think that the issue that to bear in mind was that – was that if we were closer to the troponin approval and we went into the market and rose money and as it was possible that we would have been – into the market and raise money.

As it was possible that we would have been very severely criticized for diluting so close to such a positive events. So it [indiscernible] and yes, at the same time – as is always uncertainty about the timing of an event like a FDA submission of – of troponin all the way that we’re extremely confident about its ultimate success.

I mean the timing is uncertain. And therefore you could enter the situation where [indiscernible] enable to basically participate in any acquisitions opportunities for an extended period of time. So it – all that together [indiscernible].

And I think we were confident that the management now can – spend this money wisely and can make this whole experience and learn….

Unidentified Analyst

Okay thank you..

Ronan O'Caoimh

Thanks very much. I think there’s no more questions and operator could we just close the call at that stage and let’s say thank you to every body and talk to you soon..

Operator

The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect..

ALL TRANSCRIPTS
2024 Q-3 Q-2 Q-1
2023 Q-4 Q-3 Q-2 Q-1
2022 Q-4 Q-3 Q-2 Q-1
2021 Q-4 Q-3 Q-2 Q-1
2020 Q-4 Q-3 Q-2 Q-1
2019 Q-4 Q-3 Q-2 Q-1
2018 Q-4 Q-3 Q-2 Q-1
2017 Q-4 Q-3 Q-2 Q-1
2016 Q-4 Q-3 Q-2 Q-1
2015 Q-4 Q-3 Q-2 Q-1
2014 Q-4 Q-3 Q-2 Q-1