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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2018 - Q4
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Operator

Good day, and welcome to the Trinity Biotech Fourth Quarter and Fiscal Year 2018 Financial Results Conference Call. [Operator Instructions]. Please note, this event is being recorded. I would now like to turn the conference over to Joe Diaz of Lytham Partners. Please go ahead..

Joe Diaz

Thank you, Carrie. And thanks all of you for joining us here today to review the financial results of Trinity Biotech for the fourth quarter and full year 2018, which ended December 31, 2018. With us on the call representing the company are Ronan O'Caoimh, Chief Executive Officer; and Kevin Tansley, Chief Financial Officer.

At the conclusion of today's prepared remarks, we'll open the call for a question-and-answer session. But before we begin with the 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 the Safe Harbor for such forward-looking statements.

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

Investors are cautioned that such forward-looking statements involve risks and uncertainties, including, but not limited to, the results of Research & 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 view 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 remarks, we'll hear from Ronan O'Caoimh, on his review of the quarter. After which we'll open the call to your questions.

Kevin?.

Kevin Tansley

Thanks very much, Joe. Today, I'll take you through the results for quarter four, followed by the results for the full year 2018. You will notice in your release that there's an impairment charge that's being recognized this quarter, which I will disclose at the end of the income statement segment.

But in the meantime, the metrics I will quote exclude the impact of this charge. So I'll begin with an outline of the results for quarter four first. Total revenues for the quarter were $24.5 million, which was virtually identical to last year. As usual, Ronan will provide more details on the revenues later in the call.

So I will move on and discuss the other aspects of the income statement. The gross margin for the quarter was 41.7% compared to 41.5% last year, hence, a slight improvement. This increase is due to the cost savings programs that we implemented earlier in the year.

These savings also served to offset the impact of higher instrument sales which tend to have a lower margin, as well as the impact of adverse currency movements, principally, the Brazilian real but also to a lesser extent, Canadian dollar and the euro.

Moving on next to our indirect costs, our R&D expenses for the quarter were $1.4 million compared to $1.5 million in 2017. Meanwhile, our SG&A expenses have also fallen from $7.6 million to $6.8 million. In both cases, you're very much seeing the impact of our cost savings again.

But I will say, there was a lower level of discretionary expenditure than normal this quarter. And I would caution, again, thinking of the $6.8 million as being the normal run rate for SG&A.

The benefit of the gross margin improvement, and even more so, the reduction and indirect costs has had the effect of improving our operating profits from $800,000 to over $1.9 million. Moving on next to our financing costs, which includes the impact of our exchangeable notes.

Our financial income for the quarter was $158,000 compared to $224,000 last year. And this is due to the lower level of cash deposits. Similarly, financial expenses were also lower at $1 million in quarter four 2018, down from $1.2 million.

This is due to the reduced interest charge on our exchangeable notes following the partial repurchase that we made earlier in the year.

Our noncash financial income, which is disclosed further down the P&L, was just over $400,000, consisting of a gain of $590,000 of the fair value of the derivatives embedded in the notes, partially offset by noncash accretion interest of less than $200,000, again relating to the notes.

You will have seen in the press release that we quote EPS without noncash amounts, and it is these -- noncash amounts totaling to $400,000, which we're excluding here. The profit after tax of the quarter, excluding these noncash items was $800,000. And this compares to $900,000 in the same period last year.

This might sound somewhat anomalous, given our operating profit has improved significantly this quarter, and that our interest expense is lower, which have to be lower profit after tax. As you would've noticed in the release, this was largely due to a swing in the tax charge. This was caused by the reduction in U.S.

tax rates, which are implemented in late 2017, and caused a large one-off tax credit due to the impact on our deferred tax balances at the time. This quarter, we've returned to a more normal tax charge, and hence, you're seeing the impact on our income statements.

For the same reason, we're seeing a basic EPS of $0.038 versus $0.042 last year, and diluted EPS of $0.07 versus $0.077 in quarter four of 2017. However, if you're [indiscernible] here is on a like-for-like basis, profit after tax would have increased from roughly breakeven to a profit of $800,000.

Whilst EPS would've increased from roughly $0.00 to $0.038. Similarly, diluted EPS would have increased from about $0.03 to $0.067. Earnings before interest, tax, depreciation, amortization and share option expense for the quarter amounted to $3.2 million. And the equivalent figure last year was $2.4 million.

I will now make some comments on the full year results. Annual revenues decreased from $99.1 million in 2017 to $97 million for the financial year 2018. As I mentioned earlier, Ronan will deal with this later on in the call. Our gross margins for the year improved from 42.3% to 42.7%.

And in this regard, you are seeing the positive impact of cost savings outweighing the adverse exchange rate movements, plus a less favorable sales mix, particularly, given the lower Point-of-Care sales in 2018. Similar to what we saw in the results for the quarter, we are showing a reduction in the indirect costs.

Our R&D expenses fell from $5.7 million to $5.4 million. Whilst our SG&A expenses fell from $30 million to $28.2 million. Obviously, we're seeing the impact of the cost savings, again.

Though in the case of SG&A, the reduction was partly due to the gain of approximately $400,000 that we recognized on the repurchase of some of our exchangeable notes in quarter 3, 2018.

The net impact of the lower indirect costs and improved gross margin, albeit on lower revenues, is that our operating profits for the year increased from $5.5 million to $6.7 million.

Financial income for the year was slightly lower at $700,000, reflecting the lower levels of cash and deposits, particularly, in the latter half of the year, following the notes repurchase. So this is partly offset by higher deposit interest rates.

Meanwhile, the financial expenses for the year, which essentially the cash interest charge in our exchangeable notes reduced from $4.7 million to $4.4 million with the reason being that interest is no longer required to be paid on the notes which we have repurchased.

This is the effect of reducing our interest charge by just over $600,000 in a full year or $150,000 per quarter, of which close to two quarters of this benefit have been recorded in 2018. In addition to this, there was a separate noncash financial income of $700,000 recorded for the year.

Resulted that the profit before tax for the year has increased from $1.6 million to over $3 million. However, after-tax income has seen a more modest increase to $2.3 million to $2.5 million.

Similar to the case in the quarter's result, the tax charge for the year has swung from being a credit of $700,000 to be a charge for $600,000, of which a significant element is due to the changes to the U.S. Tax Code in 2017. Consequently, basic EPS for the year was $0.114, an increase of 8% versus 2017.

And diluted EPS was $0.26, which is $0.003 higher than the last year. Earnings before interest, tax, depreciation, amortization and share option expense for the year was $12.1 million. I mentioned earlier that I'll provide some more information on the impairments charge of $25.2 million recorded this quarter.

This charge arises as a result of the impairment review that we are required to undertake annually. In so doing, a company is required to assess the current value of its assets from the context of its future cash flows, discounts of the cost capital for the business.

Companies are also required to be mindful of how these values, faced with a prevailing enterprise, value our market capitalization of the company. Consequently, fallen the share price of a company, like we have experienced, can impact the level of an impairment charge taken.

Our lower market capitalization also has an impact on the cost of capital used in the impairments calculations. For example, smaller companies are required to include a small cap premium when calculating their cost of equity. The level of this the small cap premium is dependent on a company's market cap.

That is to say, the lower the company's market cap, the higher that premium applies. Or in layman's term, the smaller the company is, the higher the risk profiler has.

This combines with the increased volatility of our stock and higher prevailing interest rates that propelled our cost to capital forward from approximately 14% last year to over 16% this year.

As you will have also see in the release, the impairment charges also reflected in the latest cash flow projections for the groups cash generating unit, and it's up to date net asset evaluations. Goes without saying that the impairment charge itself is entirely noncash in nature.

Just so that you'll be able to appreciate the impact of the impairment on the balance sheet, I will give you the principal captions, which have been impacted. Goodwill and their intangible assets have been reduced by $19.2 million.

Meanwhile, the reduction in property, plant and equipment has been $6.1 million with other assets being affected by $1.6 million. The charge is then reduced by the tax impact of the -- above the previous adjustments, which amounts to $1.7 million, all of which related to deferred tax.

Before leaving the income statement, I would like to mention that we're going to release our quarter 1, 2019 results in a few weeks' time. But you will see a different looking income statement. This is due to the implementation of IFRS 16, which is broadly equivalent to the American Standard, ASC 842. And which concerns the accounting for leases.

On those new standards, charges, such as rents paid on leases over one year for manufacturing and other facilities will no longer be expensed to the income statement evenly over the life of the lease.

Instead, switch leases will be essentially treated as a financing instrument, whereby, the assets even though not owned by the company will be recognized in the balance sheet as a fixed asset and then depreciated through the income statement over the life of the lease.

But there will also be an interest charge, which will reflect an effective financing charge, and which will appear in the financing section of the income statement. So in essence, these rental charges will be replaced by a combination of depreciation and interest.

And whilst this is largely a wash overall, it will lead to a modest adverse impact in 2019, which will reverse overtime. I just wanted to give you a heads up on this before you see this is on the release, and wonder why this outlay. I will now move on and talk about the significant balance sheet movements since the end of September 2019.

Property, plants and equipment decreased by approximately $4.7 million. This decrease is made up of impairment charges of $6.1 million, depreciation in the quarter of $300,000, offset by additions of $1.9 million with the remainder being translation adjustments. Meanwhile, intangible assets increased by $16.8 million.

In this case, the impairment of [Technical Difficulty] was $19.2 million, amortization was $700,000, and additions were approximately $3.1 million. Moving on to inventories, you will see these have fallen from $32.9 million to $30.4 million.

This reflects the fact that inventory levels tend to fall after the peak Lyme season and also that a large number of instruments were shipped during the quarter. Meanwhile trade and other receivables increased by over $1 million to $24.4 million.

This is due to the timing of sales, which were more back end this quarter, and slower collections as some customer seem to take some extra credit as we got to year end. Meanwhile our trade and other payables, which includes both current and noncurrent liabilities, have reduced from $21.2 million to $17.9 million, a decrease of $3.3 million.

This is been partly driven by a decrease of $1 million relating to the accrued loan interest -- low note interest and the decrease in trade creditors which I flagged on the last call would happen in particular in relation to the fit-out of our new Buffalo facility. Finally, I will talk about our cash flows for the quarter.

Cash generated from operations for the quarter was $3.2 million, which was largely offset by working capital movements. Interest and taxes represented a cash inflow with a significant amount to deposit interest received in addition to a refund our historic taxes in Sweden. Capital expenditure for the quarter amounted to $5 million.

And interest payments on the exchangeable notes amounts to just under $2 million. And this represents 6 months' interest if these payments are made semiannually. The net result is that we have a decrease in cash for the quarter from $35.7 million to $30.3 million, a decrease of $5.4 million.

I'll now hand over to Ronan who'll take you through the revenues for the quarter and year..

Ronan O’Caoimh

Thanks, Kevin. I'm now going to review our revenues for quarter four briefly. And then review the revenues for the year before opening the call to your questions-and-answer session. Revenues for quarter four were $24.5 million. We're in level with our revenues from the current quarter last year.

Point-of-Care revenues were $4 million compared with $3.8 million in the prior quarter, which was an increase of 6%. Clinical Laboratory revenues were $20.5 million compared with $20.7 million in the corresponding quarter, which is a decrease of 1%. And now to look at the year as a whole.

Our revenues for 2018 were $97 million compared with $99.1 million in the prior year, which is a decrease of 2%. Our Point-of-Care revenues for the year were $14.8 million compared with $16.8 million in the prior year, which is a decrease of 12%. Our U.S.

HIV revenues decreased 10% year-on-year, and this decrease is explained by the fact that public health spending in the U.S. on HIV testing continues to decrease. Meanwhile in the Africa, our HIV sales decreased 13% during the year.

This decrease is entirely explained by the fact that one of our large customers in Africa significantly overstocked in 2017, resulting in lower sales levels in 2018. And for the past 15 years, we have held approximately 90% of the African confirmatory market.

And we believe that we will continue to do so given the staff that our product tells is called standard. However, as previously indicated, we have now developed a HIV screening product, which will be launched on the African market at the end of this year.

Given the quality of the product and given that -- given the price at which we can now manufacture this product in our new automated plant in Ireland, and given our long reputation as manufacturer of gold standard, we believe that we can take significant market share in the screening segment of the African HIV market, which comprises 170 million tests annually, and is many times greater than the confirmatory market.

Our new HIV Trin-Screen product is currently undergoing independent trials in Africa, supported to [indiscernible] submission. And it's as anticipated that the products will be approved by year-end.

Given that we now have a high volume, low cost, automated HIV manufacturing capability in Dublin, we believe that this new product will transform our HIV business into a strong growth engine in the future. Moving on to our Clinical Laboratory business. Our revenues for the year were $82.2 million compared with $82.4 million in the prior year.

Our Infectious Disease business decreased 13% year-on-year. Our main line Infectious Disease business decreased 6% year-on-year. And as we have signaled in the past, this is in line with our expectation given the ongoing migration by laboratories from ELISA onto random-access platforms in the U.S.

However, during the year, we also suffered a loss of a significant Lyme confirmatory contract with one of the two major Clinical Laboratory service providers in the U.S. And this loss, which is approximates $2.1 million annually can drive to the overall 13% decrease in Infectious Disease revenues.

On an ongoing basis, we expect shrinkage of our Infectious Disease business to be approximately 5% annually, given that other segments of the business have performed well, particularly, China.

Moving on to our Diabetes and hemoglobin variant business, which has served by the Premier and Premier resolution instruments, they both performed strongly with year-on-year growth of 8%.

We had strong instrument placements in all of our principal markets with instrumentation placement of 96 units in quarter four, and placements for the year of 317 compared to placements of 311 in 2017.

It's important to bear in mind that every instrument we place is new business, and as we are never replacing the existing transient instruments, as we are in the already years of the placement cycle.

Meanwhile, our Premier resolution instruments, which start the hemoglobin variant market for sickle cell anemia and thalassemia performed well in Europe. While we submitted a Premier resolution instrument to the FDA a number of weeks ago and expect a approval within the next couple of months.

A receipt of FDA approval for their resolution instrument will enable us to enter the U.S. market and will also enable us to commence the Chinese regulatory process. These are high-value markets with few competitors. And we believe that with our best-in-class instrument and reagent combination, that we can take significant market share.

Meanwhile, the launch of our new hemoglobin Point-of-Care instruments and tests, the TRIstat adds a significant new business opportunity in our hemoglobin business. Having received FDA approval for the product and the instrument, we are now pursuing Chinese and Brazilian approvals. During 2018, we placed 150 instruments around the world.

And we anticipate significant success with this product, which we believe will quickly grow to constitute a significant percentage of our overall hemoglobin revenue base. Meanwhile, our autoimmune business performed well this year with 7% year-on-year revenue growth. We have consistently grown this business since its acquisition.

The reference laboratory business has been the best-performing part of business with significant growth coming from our Sjogren's test range, and from the growth with the 2 U.S. mega labs.

On the product side -- on the product revenue side of our autoimmune business, our strategy has been to grow our best-in-class immunofluorescence product revenues, while also growing our enzyme immunoassay product revenues around the world with, particularly, in emerging markets.

Meanwhile developing our new automated integrated immunofluorescence processor and reader, which will eliminate the requirement, and for the use of microscopes with our IFA product range. This strategy is working successfully for us. And we have achieved significant success during the year in China with our IFA product range.

At this point, if I could hand back to the operator for a question-and-answer session..

Operator

[Operator Instructions]. The first question will come from Jim Sidoti of Sidoti & Company..

James Sidoti

Great.

Can you just remind me what are the steps left to win a HFO -- WHO approval for the HIV screening test?.

Ronan O’Caoimh

Well, we have to complete our clinical trials, collect all the information and then submit to the WHO. And then they will review that and may or may not inspect our factory..

James Sidoti

Okay.

And how much longer till you submit?.

Ronan O’Caoimh

We're hoping to submit August, September..

James Sidoti

Okay.

And then once you win approval, how long before you think you would see revenue from that product?.

Ronan O’Caoimh

I mean, I think virtually all African countries review their algorithms every 18 months or 2 years. So -- but they're continually being reviewed. So there's a continual flow of applications. So I think it would be fairly immediate..

James Sidoti

Okay. And then Kevin, you mentioned that there's going to be an accounting change for leases that would impact the balance sheet. Now in the past, you've talked about -- I think up to the $3 million of cost savings that you expect to generate from some of the initiatives you're already taking.

Would this be -- would this offset that? Or would this be pretty minor relevant to that?.

Kevin Tansley

Well, the first thing I'd say is that the cost savings are real, they're cash savings. And you're seeing the benefits of those coming through. The changes, I'm talking in relation to the leases are purely bulk entries. And so it's due to a change in how leases are being -- are going to be accounted for in the future.

So in essence, in the past when you would've leased a building from a landlord, you would've just taken an annual rental charge. Now, it's almost as if it looks like you bought the actual building in question. You put it on the balance sheet as a fixed asset, you effectively put an interest charge through and then you depreciate it.

So what's going to happen is, broadly speaking, you're going to see our rent probably going down by the -- the order of about $3 million, which would've gone through partially above the line, partially below the line. And we have -- then we will see an increase in depreciation, a bit lower than that, maybe by about $2.5 million.

And there'll be an interest charge of $800,000 or $900,000. So if you top that off, you're probably going to see a negative impact somewhere in the region over the course of a year of about $400,000 or $500,000. So about $100,000 a quarter. But again, I stress, it's purely book adjustments we're talking about here. And you'll see this for every company.

And it's been implemental drive for us, which obviously impacts the rest of the world. And it's going to be implemented in the U.S. GAAP at the same time, and obviously the two accounting bodies are in league with each other in that regard..

James Sidoti

Okay. And then last one for me.

Do you think in 2019, you both have turned the quarter regarding cash flow? Do you think you'll be cash flow positive in 2019?.

Kevin Tansley

Yes. Our stated aim is very much to be cash flow positive for the year as a whole. I'm not saying it's going to be like that in every individual quarter. For example, obviously with quarter coming up, quarter 1 is typically our weakest quarter. But for the year as a whole we would be -- we are very much targeting a cash flow breakeven.

And that will come from growth, the implementation of our savings. And obviously, we're below our interest charge at the moment as well. So yes, is the answer to your question..

James Sidoti

Okay.

And we're ready to that -- the $5 million in CapEx in the quarter, was that unusually high? And do you expect that comes down?.

Kevin Tansley

You're going to see fluctuations. They are certainly a bit higher on the PP&E side. And as I said, I would have liked that for foreign relations to Buffalo facility, if that's something we did. And the second half of last year and that's not going to replicate the -- in our intangible profits.

But intangible projects you see are more fluctuating cash profiles, so you can see, expect some ups and downs. And also some quarters will be lower, some might be a bit higher depending on third-party costs. So for example, as our trial cost come through, in relation to similar projects. That's going to have an impact..

Operator

The next question will come from Bill Lappe [ph], a Private Investor..

Unidentified Analyst

I have a few follow-up questions. From -- on the Trin and the pre-screening test, how far are you in the tests? In other words, you've already started the clinicals? You think that'll be done, I mean, you're projecting maybe August.

But do you think that'll be done earlier based on your progress going forward? Are you getting all the patients and everything you need?.

Ronan O’Caoimh

Yes. We're working at three different sites in Africa. And we would hope to be finished July, and then place and then submission..

Unidentified Analyst

Okay. Is your product better than the competitors' product? Besides, maybe you can have a pricing competitive? In other words, is your pre-screening product better than what's out -- you'd believe than the one that's out there now.

I mean, you're the gold standard in the other one?.

Ronan O’Caoimh

Yes. I mean, I think the HIV -- I mean, the market leader in screening is Abbott. The market leader in conforming is Trinity Biotech. Virtually, they performed virtually identically. In practical terms, there is very little difference between the screening and the conforming test. I know you would expect one to have higher sensitivity than the other.

But the reality, the levels of sensitivity and specificity are so close to 100%, as in 99.99% and higher that you could regard both our existing tests and Abbott's existing test as virtually flawless. And I think, the same description would apply to the Trin-Screen product. So basically all three are excellent products.

And the performance would be difficult to differentiate between the three, frankly..

Unidentified Analyst

Okay.

And do you anticipate -- is there any other approval besides the FDA -- and it's not like an FDA or Irish approval of selling this product once you get the WHO approval? Is there anything you have to do from a regulatory standpoint to sell it besides...?.

Kevin Tansley

No..

Unidentified Analyst

Okay. Now you haven't ... Go ahead..

Ronan O’Caoimh

The actual approval would -- at this stage is similar to in terms of how onerous it is, it would be similar to FDA..

Unidentified Analyst

Okay. But you've been with them before. I mean, they approved your gold standard test, right? The other test, right? Yes.

You haven't mentioned Syphilis, are you selling much in the Syphilis market? What's going on there? Anything happening with your Rapid test in Syphilis?.

Ronan O’Caoimh

Well, we're the only approved and a clear way to the FDA, and clear way to approved Syphilis Rapid Test in the United States. And we're selling some of the -- around $1.5 million of -- it was just under that level. So it's a significant disappointment in terms of how it's [indiscernible]. But we're working on it.

I think the CDC have been ambivalent in terms of their involvement here. And that hasn't been a help. And in an environment where public health dollars are scarce, and we've seen that with HIV spend, it's proven their disappointment, frankly. I mean I think we had estimated originally that this could be a $10 million product.

And it may grow to be a $3 million product. But we've moved that closer..

Unidentified Analyst

So tell me this one, have you put in -- you own about 10.8% of the company now. And you went out and bought the stock in the old market, which gives us a lot of confidence.

What's your big force right now for the company? Where are you optimistic? What are you excited about going forward in 2019, 2020?.

Ronan O’Caoimh

I think we're in a situation where, clearly, as I've described, we have an Infectious Disease business, which is in decline. But that's never smaller parts of our business.

We have a HIV business, a Point-of-Care business, which diminished last year, but I explained that the reason for that was entirely due to -- in fact, it was a Tanzanian ordering process. And that's -- so basically our 2017 sales were high, and higher than they might have been and then they overstocked. And so '18 was lower as a consequence.

And I think that we have that until of now -- remember, we have now, but if we stopped manufacturing our HIV product, and I'm talking about our existing confirmatory products and as well as, the fact that coming Trin-screen products. We now are -- have stopped manufacturing in China.

And we have developed through -- invested $5 million in a manufacturing facility here. And basically, I have significantly cut back maybe 70%, 80% reduction in our cost base per unit.

And so we basically now have scenario where we can compete in a very real sense and in a very -- with a very efficient factory for both confirmatory tests and the coming screen tests -- screening tests. And we believe that, that would provide a growth engine for us moving forward and a very significant one.

And I'd identified that probably as a single, biggest growth opportunity for us. In addition to that, then you've seen that our autoimmunity business grew 7% last year, that's continued to grow. And we think with various things that I outlined and, particularly, with the advent of the new instruments which is a 2020 phenomenon.

And -- but that we can increase that growth, right? And then, similarly, with our hemoglobins and diabetes business, you saw that we placed 317 instruments this year, 311 last year. And continue to place instruments there. And so the Premier business are doing very well. I think it grew 8% this year.

We believe we -- with the advent now of -- the hit of the resolution instruments and the TRIstat instruments that we can increase those growth rates. So in summary, I think that we are turning the corner. And I think that you're going to see revenue growth. I think that -- we're very disappointed with the current market capitalization of the company.

We think it's over, done. But we accounted -- we're working to basically to increase that by virtue of increased revenues. And again, Kevin has talked about our cash flows. We're determined to maintain our cash flows at a minimum level of $30 million. We're very cognizant of the note. We brought that down to $100 million.

So our net debt, as we stand, is $70 million. We're conscious of that being sort of maturing in three years and two months' time. And we will consider strategic options as we move forward. But for the moment, I think our concentration is on turning -- basically, we believe that we've hit bottom and that we can improve from here.

We can improve, increase of revenues, we can stabilize and increase our cash flows, increase our earnings. And I think, if we do that we'll -- it'll strengthen our share prices. And we can consider our options and moving forward whether would actually have a conductive sale profit or not.

We think at this moment in time, it's a wrong thing to commence that process. And what we need to do is, we need to basically improve the performance and then do that..

Unidentified Analyst

Why don't you put your money where your mouth is? So that's good.

What about the Brazil, did you ever get the manufacturing going there?.

Ronan O’Caoimh

Brazil. We're still waiting for ANVISA, that's the Brazilian equivalent of the FDA. We're still waiting for the -- they've approved the factory, haven't actually approved the product. So we're basically standing, waiting for the approval. And it's imminent. I think the change of government.

Actually, I know that seems like a strange excuse or reason to give. But the change of government resulted in ANVISA being virtually inactive for a period of about 2 months. And that has -- because we had hoped to have had the approval by now, but we haven't. But it's imminent. Basically we're waiting.

As soon as that comes through, we'll have savings, we'll reduce our cost base. And we'll be in a position to recommence instrument placements..

Operator

[Operator Instructions]. The next question will come from Paul Nouri of Noble Equity..

Paul Nouri

Do you think there's a point in time this year, a certain quarter where the growth drivers of the lab business will kind of overcome the drag of the other side of the business, the ELISA business?.

Ronan O’Caoimh

Yes. And -- I mean, well we do. I mean, we expect -- we anticipate that we'll grow revenues this year. We don't tend to give guidance. But I mean if you were to look at Jim Sidoti's numbers, we'd be relatively comfortable with them. They might be under -- marginally demanding side. So they would reflect growth. And we do believe we can do that.

And I mean, I think last year, we were hit with a -- we got a $2 million hit when we locked the Lyme contract. And on top of that, then we had a $2 million hit with the Tanzanian business. So you know if you were -- so that turns $99 million into $97 million. Without them, it would have been a $101 million.

It would have been anemic growth but it would have been growth. So the consequent in the answer is, yes, we do believe so. We will achieve growth this year..

Paul Nouri

And I guess the Brazilian currency was a bit of a drag in 2018.

Do you have any idea what we can expect on that in 2019?.

Ronan O’Caoimh

I mean I think that we can get 14% for that, it'll continue to do so. I mean, I think it has gone a bit weaker, again, still. So I mean it's just as difficult to predict how that will move. But I mean irrespective of how it moves and what we've done is, we have largely now achieved a bouncing -- a situation where we bounce our currencies.

And so with the advent of the factory change -- sorry, with the advent of the ANVISA approval in the factory -- in the new factory. We basically have that, a natural hedge in place..

Paul Nouri

And in terms of gross margin and cost structure for 2019, will it be similar to 2018?.

Kevin Tansley

I've mentioned this before. One of the key drivers of our gross margin is volume. We've a significant fixed cost base. So the more growth we have on our top line, we will get an improvement on our gross margin. And obviously, that will be accentuated by the savings that we've implemented throughout 2018.

But we'll get the full year effect of that in 2019. So I do see an improvement there. I don't anticipate an increase in relation to our SG&A and indirect costs as a whole. So in essence, any growth that we do get from the top line should flow very quickly down to the operating profit line.

And so consequently, that'll drive our efforts, one, to grow our profits, but two, to get to the cash breakeven position that we're looking for..

Paul Nouri

And do you have any open credit line in place?.

Kevin Tansley

We have modest credit lines in terms of some equipment facility, we've got some short-term facilities. So we don't at this point. We do have relationships with a number of banks. But we don't have a form of facility in place. I think the days whereby you can have facilities resting there are largely gone. Just as I -- just in case and everyone has one.

Just in terms of the capital asset in relation to banks now, they typically come with a charge. And therefore, you're only going to basically pull one of those in place if you thought that you needed those imminently. Otherwise, you're basically paying a charge for something that you really don't need..

Paul Nouri

And are you still in the market for buying back your bonds opportunistically?.

Ronan O’Caoimh

No. I don't think so. I think we've -- we decided to maintain our cash balances at $30 million and trying. And then our intention is -- we believe, it's a long time we've achieved cash flow breakeven. And that we, basically, would only buy back in a scenario where we had strengthened their cash balances beyond $30 million.

We might -- So if we got it to $40 million, we might spend $10 million, if you know what I mean. But we've established $30 million as our base..

Paul Nouri

And then going back to the Syphilis tests, I mean there are articles out recently that STD is I think at record in the U.S., and on the rise in underdeveloped nations.

Are you doing anything on the lobbying front to try to get more money allocated towards those?.

Ronan O’Caoimh

No. To be honest, I don't think we are. We've spoken with the CDC who are the biggest influencers here. And so in that essence, we've lobbied it, in the sense that we've tried to persuade them.

And in fact, we ran a trial with them -- with them in essence -- yes, with them basically where we tried to prove to them that there was benefit to -- due to a public health, Syphilis problem. So basically that people would otherwise -- people would be -- HIV, sorry, the Syphilis positive would be detected as part of the public health program.

And basically, who otherwise it wouldn't be -- if I dropped talking about them in place. And we ran quite a big trial. And we proved that we haven't seen it, and I probably -- [indiscernible] a time they were satisfied of that. That's only like 6 months ago. And we thought that might have changed their approach.

But they -- so far, they haven't allocated any resources, either of any sort, financial or otherwise to pushing the Syphilis or Point-of-Care test. So what we're doing meanwhile is we're working....

Paul Nouri

And the -- I'm sorry, the Point-of-Care hemoglobin device that you have, how quickly can that put out a result?.

Ronan O’Caoimh

So it's probably like 12 minutes. And it -- so it's a very quick test. Once you have it up and running, if it repeats every 2 minutes, but the 12 minutes are referred to just a one-off. And so it's -- we're not launching it in the USA, right. There are other providers that serves the U.S.

So our emphasis is mostly Southeast Asia, Brazil and some second world countries. We placed 115 instruments last year. And we'd hoped to place a multiple of that this year. And we're still waiting the Brazilian approval. And that'll certainly -- that would increase the level of activity significantly.

Soon we will see that, we're anticipating getting that in the next 3 or 4 months..

Joe Diaz

Right. I think we have no more questions. And so I think we'll close the call now. Just to say thank you, everybody. And speak to you -- we'll speak, again, at our quarter one results. So good afternoon, and thank you..

Operator

Conference is now concluded. Thank you for attending today's presentation. You may now disconnect. Have a great day..

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