Trinity Biotech PLC (TRIB) 2021 Q2 法說會逐字稿

Good morning, everyone, and welcome to the Trinity Biotech Q2 2021 Financial Results Conference Call.

(Operator Instructions)

Please also note today's event is being recorded. At this time, I'd like to turn the conference call over to Joe Diaz with Lytham Partners. Sir, please go ahead.

Thank you, Jamie, and thanks to all of you for joining us today to review the financial results of Trinity Biotech for the second quarter of 2021, which ended on June 30, 2021. Joining us on today's call is Ronan O'Caoimh, Chairman and Chief Executive Officer of Trinity Biotech; and John Gillard, Chief Financial Officer. At the conclusion of today's prepared remarks, we will open the call for a question-and-answer session.

Before we begin, I must inform you that statements made in this conference call may be deemed forward-looking statements within the meaning of the federal securities laws. These statements are subject to known and unknown risks and uncertainties that may cause actual results to differ from those expressed or implied in such statements. These risks include, but are not limited to, those set forth in the Risk Factors section of our annual report on Form 20-F filed with the Securities and Exchange Commission. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after today or the occurrences of unanticipated events. With that said, I will now turn the call over to John Gillard, CFO of Trinity Biotech for a review of the results of the quarter, and he will be followed by Chairman and CEO, Ronan O'Caoimh for an update on sales, marketing and revenue. John, please proceed.

Thank you, Joe. Good morning, everyone. Thank you for joining. As Joe mentioned, I will now take you through the results for Q2 2021. You will notice from our press release that a noncash impairment charge has been recognized this quarter and is discussed in the press release. I will give further details on that charge later in the call. The income statement metrics I will quote exclude the impact of that impairment charge. Starting with revenues, total revenues for the quarter were $25.8 million compared with $16 million in Q2 2020. As Joe pointed out and is our typical approach, Ronan will discuss revenues in further detail later on the call. As such, I will move on to discuss other aspects of the income statement.

Gross margin for the quarter was 42.7%, which is broadly similar to the 42.9% achieved in Q2 2020. The small decline in overall margin is driven by a lower comparative margin from VTM products, partially offset by a higher margin from our core products in Q2 2021 when compared to Q2 2020. As ever, our gross margin remains susceptible to product mix changes, geographic spread, currency fluctuations and product level variation. Other operating income increased from $2,000 in Q2 2020 to $2.9 million in Q2 2021. This income relates to loan funding received in 2020 under the US government's Paycheck Protection Program. For Paycheck Protection Program loans received by the company in 2020, totaling $2.9 million were forgiven during quarter 2 2021 and have therefore been recognized as income this quarter. These 4 loans were treated as short-term liabilities at March 31, 2021.

Moving on to R&D expenditure. This decreased slightly to $1.1 million compared to $1.2 million in Q2 2020. Meanwhile, SG&A costs have increased from $5 million in Q2 2020 to $6.3 million in Q2 2021. It is important to note that SG&A expenses were unusually low in Q2 2020 due to the furloughing of employees as a result of pandemic, government payroll support related to COVID-19, which are not available in 2020 -- sorry, in 2021 and other cost savings. In addition, Q2 2021 SG&A costs reflect increased professional fees plus additional sales and marketing team costs, reflecting the expansion of our international sales and marketing team. These resulted in an operating profit for Q2 2021 of $6.3 million compared to $500,000 reported in Q2 2020, an increase of $5.8 million. This increase in operating profit is primarily driven by increased revenues and the forgiveness of the Paycheck Protection Program loans, partially offset by higher SG&A expenses and a slightly lower margin.

Moving on to financial expenses. This includes the quarterly cash interest cost for our exchangeable notes of $1 million and $200,000 related to notional finance charges associated with lease facilities. These notional finance charges are required by the relevant accounting standard, IFRS 16. You will note that the results of noncash financial net income of $900,000, which is made up of accretion interest of $100,000 in the accounting carrying value of the exchangeable notes, less than $1 million fair value adjustment to the derivatives embedded in exchange of notes as required by the relevant accounting standard. Profit after tax before impairments, one-off items and non-cash financial expenses was $4.4 million compared to a loss of $800,000 in Q2 2020.

As in prior calls and as set out in the press release, we quote earnings per ADR effectively our equivalent of EPS on a standard basis and also before the impact of impairments, one-off charges and non-cash financial items. Using that modified measure, earnings per ADR have increased to $0.212 from a loss of $0.036 in Q2 2020. While diluted earnings per ADR have also increased. In this case, the $0.203 from $0.01 in Q2 2020.

I will now provide you with more information on the format and impairment charge of $6.1 million. This charge results from the accounting standard-driven impairment review we are required to carry out under IFRS. There are a number of factors taken into account in calculating the impairment, including the company's period-end share price, calculation of the company's cost of capital and future projected cash flows from individual cash-generating units in the business. In addition, the company examines individual project costs for indicators of impairment. The noncash impairment charge of $6.1 million has been recognized against the following assets. Intangible assets, $3.9 million, property plans and equipment of $1.9 million and current assets of $300,000.

I will now move on to talk about the significant balance sheet movements since the end of March 2021. There was a decrease in property, plant and equipment of $2.1 million. Additions in this quarter were $400,000, and this was offset by depreciation of $600,000 and the aforementioned impairment charge of $1.9 million. In the same period, our intangible assets decreased by $2.3 million. This was made up of additions of $1.8 million, offset by an amortization charge of $200,000 and an impairment charge of $3.9 million.

Moving on to inventories. You would have seen we have decreased -- these have decreased by $2.9 million and now stands at $34.7 million. In Q1 2021, we reduced the level of production of our PCR viral transport media, VTM, in line with projected demand, and this is the main reason for the reduction in inventory this quarter. Meanwhile, trade and other receivables have increased by $0.5 million to $15.4 million, reflecting slightly lower cash collections.

Our trade and other payables reduced by 9.6% compared to March 2021. This reduction was mainly driven by the aforementioned forgiveness of the PPP loans and a reduction in trade credits and accruals as the company paid VTM suppliers for previously supplied raw materials by reducing the level of purchases of raw materials to reflect the reduced demand for new VTM orders as the quarter continued. You will see from the balance sheet that we have presented the exchange of a notes liability and the related embedded derivatives within current liabilities. Previously, this has been recorded within non-current liabilities. The reason for the change this quarter is because the notes have a put option on 1 April 2022 as the company doesn't have a conditional right to defer settlement of liability for at least 12 months after the reporting period, the accounting standards require us to show the exchange notes as a current liability as of June 2021.

Finally, I will discuss our cash flows for the quarter. Cash generated from operations during the quarter was $1.3 million. Non-operating cash outflows during the quarter included capital expenditure of $2.2 million and payments for property leases of $0.7 million. In addition, the company paid $2 million of interest on exchangeable notes. Overall, this resulted in a cash balance of $28.6 million at the end of Q2 2021. Thank you. I will now hand over to Ronan, who will bring you through our revenues.

Thanks, John. I'm now going to review the revenues for quarter 2 and for the corresponding quarter in 2020 before opening the call to question-and-answer session. Our revenues for quarter 2 were $25.8 million compared with $16 million in the corresponding quarter, which is an increase of 61%. Point-of-care revenues in quarter 2 were $2 million compared with $1.3 million in the corresponding quarter, which is an increase of 55%. Despite this increase, our HIV revenues are lower than normalized levels due to delays in the issue of HIV rapid test orders from Africa as a result of COVID-19, and that is further exacerbated by difficulty in procuring air freight transport into Africa. However, we are seeing evidence of these COVID-19-driven delays abating, and we expect that point-of-care HIV revenues will quickly return to normalized levels. In March 2021, we announced that we had submitted our TrinScreen HIV product to the World Health Organization for approval.

This product once approved, will allow the company to enter for the first time the HIV screening market in Africa, which had 170 million tests annually, is a 12-fold bigger market by value and the confirmatory test market, where Trinity Biotech has for many years had a dominant market share with our product Unigold. During the last week, the company received an update from the WHO on the approval process, where the WHO confirmed that the final assessment phase is now well advanced. The company is confident of receiving an approval over the next number of months and then quickly leveraging the quality of its product given its advantages over the competition, given also its experienced sales and marketing team on the ground in Africa, given also our reputation for excellence with Unigold and also given our high-volume automated production capability in Ireland, and we believe that all of these factors will enable us to quickly take market share in screening HIV African market.

Moving now on to our Clinical Laboratory business. Our revenues for quarter 2 were $23.9 million compared with $14.8 million in the corresponding quarter in 2020, which is an increase of 62%. This increase is primarily explained by strong COVID-19-related product revenues with our PCR viral transport media product being the most significant contributor. We have developed and continue to develop a strong suite of COVID-19 related products. As just mentioned, our FDA-approved PCR viral transport media products performed well during the quarter. It's a simple -- it's a sample collection device for COVID-19 PCR molecular testing, which is used to store the nasopharyngeal swab, which contains the patient sample, allowing it to be transmitted in a stable environment.

The transport medium stabilizes the sample and prevents bacterial growth and maintains its integrity until such time as the test is run in the laboratory. In addition, the company has developed a COVID-19 Elisa-automated antibody test, which is available for sale in the United States, which sells in modest volume. The company also developed another antibody test, which is a COVID-19 point-of-care antibody test. And in June, it made an emergency use authorization application to the FDA for the test. However, disappointing that the FDA informed the company that given the volume of EUA requests that it is not prior to prioritizing this type of tests for review.

Given that the rapid adoption of COVID-19 vaccines and the focus on using evidence of vaccination rather than the presence of antibodies as proof of immunity, we believe that the use of antibody tests in this pandemic would be very limited, and we will, therefore, make no further investment in antibody testing. Moving on then as previously announced, the company is well advanced in the development of a COVID-19 rapid antigen test. Now that's an antigen test as opposed to an antibody test. It uses a nasopharyngeal swab which will run in 12 minutes. The test will be manufactured in our automated manufacturing facility in Ireland with the cassette, which is virtually identical to that of both HIV Unigold and HIV TrinScreen. The test, which is largely developed is demonstrating excellent analytical results and the focus for the remainder of the development process will be on transfer to automated manufacture and to capital validation.

We now expect that we will have achieved CE mark during quarter 2 2022, thereby enabling sale of the product throughout Europe. While we do expect to launch the product in the US, the regulatory path for such products remains fluid and but the company will continue to assess what may be the most appropriate regulatory approval pathway to allow a US launch of the product. However, we do expect that, that will be achieved within a short number of months after European approval. Given the evidence of breakthrough infections for those vaccinated and a continuing stress -- given the evidence of breakthrough infections for those vaccinated and a continuing threat of new variants, we believe that rapid antigen testing will have a continuing place in the overall public health response to COVID-19 and that this will be a significant market for Trinity into the future.

As previously stated, our increase in revenues is mainly due to strong revenues from our COVID-19 PCR viral transport media product. The company noted a significant reduction in demand for new orders of VTM during quarter 1 and quarter 2 of 2021. And despite fluid situation, given delta and the fact that over the past few weeks, we are seeing increased interest in the product, we believe that our VTM sales in quarter 3 will be significantly lower than the prior quarters. And now moving back to our core business. The comparison between this year's revenues and quarter 2 of 2020 is meaningless, given that there was a virtual total shutdown during quarter 2 of 2020.

Moving to our hemoglobin A1c business. We continue to have low instrument placements with just over 30 instruments placed during the quarter, which is less than 50% of normal placement levels. This was expected as hospitals and clinics are unlikely to purchase new capital equipment during the pandemic. However, we are confident that these placements will fully recover in a post-pandemic environment. Meanwhile, hemoglobin reagents -- meanwhile hemoglobin reagent revenues and by assuming the number of tests being run in our diabetes business are running at about 90% of normal, again, due to the fact that patients are less likely to perform discretionary tests during the pandemic. Meanwhile, we anticipate launching our new midsized hemoglobin A1c instrument in early 2022. This instrument will enable us for the first time to target thousands of smaller hospitals and diabetes clinics around the world, mostly outside of the US and EU.

Previously, we had been unable to service this market as the processing capability of our premier instrument and also with its cost was too large for their requirements. Although we have designed and developed instruments in Kansas City, it will be manufactured in China, thereby enabling us to make the instrument available in the market at a very attractive price. And lastly, our autoimmune business generated revenues approximately 7% lower than in the pre-pandemic environment with reference laboratory volumes down approximately 10% and product revenues marginally down. We believe that this is entirely due to the pandemic as many patients prefer doctor visits and that's absolutely necessary, and we are confident that these revenues will fully recover post pandemic. But I'll now open the call to a question-and-answer session, please.

(Operator Instructions)

Our first question today comes from Jim Sidoti from Sidoti & Company.

Ronan and John, can you hear me?

Hi Jim, yes.

So it sounds like you're in the final stages with the WHO for TrinScreen. Is the WHO similar to the FDA in that you're not allowed to talk about the test with potential customers until the approval is received? Or can you start to market the device now ahead of the approval?

You could start to market the device ahead of the approval. But I don't think you'd be taking very seriously in the individual countries without the approval being in place. So I mean, you can kind of warn people up a little bit, but you can't really seriously market it as such.

So how should we think about the ramp in sales for this new test? Is this something that's going to take a couple of quarters to get going? Or do you think you'll be able to get orders within the first quarter or so after you received the approval?

Jim, unfortunately, it's not as simple as that. In order to have any meaningful sales, we will have to basically be put on to the algorithm for a particular country, right? So basically, each individual African country, despite the fact they don't actually pay for the test and sales, they actually decide what products they'd like to use. And after that, then the Americans and Europeans actually make the payments. So basically, what happens is that the individual countries will decide or test normally just one test would be to confirm -- it will be the screening test, although they can split it. And then they'd also decide what tests would be the confirmatory test. And some countries review that every year, but typically, it's every 2 years.

But it's not a kind of end of year December thing. It's the varying times they review it. So in order to actually basically sell in meaningful volume, you need to basically be put on the algorithm as the screener of choice for a particular individual country. So that will take time. But those algorithms are being reviewed all the time. There's always algorithms in the melting part and whatever. And in each individual country, we have a distributor, and we are involved with opinion leaders, and we have technical people on the ground. So we'll be working the system all the time as each other algorithm comes up for review. But it's not a straight -- it's not like a 100 meter rate. It's not like you're straight out of the blocks.

Understood. And then how will you handle ramping up production? Have you started to build some inventory yet? Or are you going to wait until you actually receive some of these orders before you build up your inventory?

Yes. So primarily, Jim, we'll wait until we receive orders or at least have, I suppose, a significant line of sight. It's a -- as Ronan suggested, it's a relatively long sales process, but we're lucky to have a very experienced team at both from Unigold and also some kind of key people we've got on board. So we have the team that are able to make those kind of judgment calls in terms of how solid orders are. What we have been spending a lot of our time is optimizing our manufacturing process here in Ireland to make sure that we can efficiently reach the level of volume that we expect. So to Ronan's point earlier, the screening market is a much larger market, it's a much, much larger volume market. So in terms of our efficiency and the level of volumes from our plant here is really a step change for us, and that's really where we're putting our focus to make sure that when those orders are ready, we are ready to be able to fulfill them.

So is it reasonable for us to assume that you'll have some level of orders in 2022, assuming you get the approval in 2021?

Well, absolutely. We believe we will get moving very quickly. And we believe a couple of the bigger countries may actually decide to split the algorithm as in for the screening to take to basically put us in the long side avert.

Okay. And then a similar question for the for the hemoglobin device, the new A1c tester. Do you think you'll have some revenue from that product in 2022? Or is that going to be further out?

Yes, that will be. But I mean, it's difficult to estimate when we'll have the instrument fully approved. But I mean I think mid-2022 would be optimistic. It's that order of time frame.

Got it. And then the last one for me -- can you tell us -- I'm sorry.

Sorry, go ahead, Jim.

Okay. Can you tell us what the VTM sales were in the second quarter and how they compare to a year ago?

Well, I mean, I think our total COVID product sales would have been around 7% and change in this quarter.

And where were you a year ago with that product? Were there any sales in June 2020?

Yes. I think about $3.5 million.

(Operator Instructions)

Our next question comes from Paul Nouri from Noble Equity.

Did you say towards the end of your formal remarks that the COVID sales will be down for the third quarter?

I did, Paul, yes. I mean I think you're seeing this right across -- I think you're possibly seeing this right across all diagnostic companies that basically as more and more people are vaccinated, I mean, despite the fact that the Delta variant is proving very problematic reality is that the total volume of testing is actually is dropping. And what you'd also seen, I think we've signaled is that it was almost like panic buying towards the end of last year of VTMs and in general, other COVID products. And so, there's a element of stockpiling that has to be kind of watched to a system. So having said that, on a positive -- so despite the fact that we said that, I also indicated that we were seeing renewed levels of interest just in the last short number of weeks. Again, so a very fluid situation. But yes, we have said that quarter 3 will be down.

Paul, I think what you've seen is a -- we're obviously towards the end of the quarter. As Ronan said, we're seeing increased interest. To what extent that interest manifests itself into significant orders towards the end of this quarter is just unclear at this point, but we clearly don't have a full quarter of that renewed interest.

Okay. And then for the autoimmune panel that you guys are running out of the lab, is that posting any significant sales yet?

You mean actual COVID sales like long COVID sales? That's only at the commencement stage Paul. And then just remember, I said you that, in general terms, our autoimmune laboratory volumes are probably down about 10%. And that's just because, again, if people have a choice, they're going to stay away from a hospital or a doctor. So the problem is pressing and tend to get deferred. I was going to say the long COVID product side we have a very interesting range of products, but they're very much just being rolled out as we speak.

Yes. What's going to be your strategy in terms of creating awareness about it among physicians. I mean it seems like the type of physician that could order through that might order this kind of panel is just so wide ranging. So how might you go about marketing it?

Bob, I mean we have a US sales team involved in marketing those products. I mean, what we do is we do papers on it. We -- academic papers, we try and talk to your opinion leaders, get them interested, direct sales efforts as well. That's the kind of message we're using.

Okay. And I think you said earlier on the call that the sales team expanded. I was just wondering, is that in anticipation of the WHO approval? Or is that for your current product on the market?

No. When we said that we were referring only to Africa. So what's happened there basically is that -- so the Alere had basically had a dominant position within African HIV screening. And they were acquired by Abbott a number of years ago, fairly recently. And basically, what's happened is that we have managed to basically recruit the senior management team that developed the business for Alere. So we have a really good team in place. So senior people of that team now work for us, and they are the people that basically manage to have a kind of -- who built that 85% market share for Alere now Abbott.

So our argument is that we have a very experienced the perfect arguably, the perfect marketing team, we have a good reputation with Unigold. The product itself is performing excellently and is quicker than the Abbott test. I mean the WHO ran their own trials, and they got -- we've got 100% sensitivity and specificity on large sample sizes. And on top of that, we have this very sophisticated automated system in Ireland for manufacturer, which can be -- will be very easy, will respond easily to demand at any level. I think to put all those factors together, we're confident of taking meaningful market share. We only -- the slide is kind of surprising. We will come in marginally below the #1.

(Operator Instructions)

Our next question comes from [Bill Lappe].

I got just several questions, Ronan. What is the pricing on the alert product right now for the test in Africa?

It recently moved from $0.80 to $0.90. So basically $0.80 for about 12 years, and it moved in the last year to $0.90.

Okay. All right. Well, that sounds good. And you say there's $117 million of those tests a year.

Yes, 170.

170, not 117, better. Thank you for the clarification. I have another question on the rapid -- on the COVID rapid antigen test. Now you've expanded going forward for the antibody test, but you're still pursuing the antigen test. And it seems to me, if you go to Target or some of these stores in the United States, you can get that test for $23 without going to doctors. Now they're talking about on TV yesterday at CNN about this guy from Harvard that's pushing that you should get it quicker. In the United States, I believe, is going to really wrap is going to really accelerate the testing. So I mean, you have to go to a doctor to do your rapid test to get it done? And how are you going to compete? You're not even going to be in the ballgame until 2022. If you get there, you'll be in Europe, but you won't be in the United States. What's the thinking on this antigen test? I mean you're already almost there, but your approval in the U.S. will be at least a year away, correct?

Yes, probably about a year away. I think by the time we get in and the only reason we can put a firm data on Europe because exactly what the regulatory pathway is. But in the USA, we're just being more cautious because the rules pertaining to the EU, the merge use authorization and then the notification status have changed and have changed and changed regularly. And for example, like we're in a situation where on EUA notification basis, we can sell our antibody test, but when we submitted the rapid antibody test, they said that they didn't want to review it.

So we're just being cautious when we say we're just saying we don't -- we're not certain of what the pathway is because the pathway is tending to change. But there's a huge market in Europe for us for the antigen test. And we believe, although we're coming late to market, we're coming with something of really high quality. In terms of pricing, we can manufacture it arguably around $0.50. And therefore, there will be a very strong margin on it. Whether the product is run by a doctor or individually, but I think it's kind of almost like a side shows in some jurisdictions, you can do some, but typically, it doesn't have to be run by a doctor. But there are many instances where it can be run from home. As you know, many employers are doing -- my own daughter is working in London in Goldman Sachs, she's tested 3 times a week with an antigen test every week from month and end.

So I think COVID is with us, we could debate, the characteristics of COVID, how long it will endure. But I do believe -- we believe within this company that androgen testing is going to be with us for an extended period of time, extended that into years. And although we're coming to the party late, we believe that we have an excellent test.

Okay. And is it 12 minutes fast enough? I mean that's pretty fast test, but it doesn't have to be administered in a doctor's office, so you now tell me I could buy that kit and administer at home or the employer can you don't need a clinician to do it?

It depends on the jurisdiction. It depends on the rules. I mean, obviously, there's lots of antigen tests available for home use. And then there's tests where you take the swab and you post it and then the result is running a lab and then you -- so there's various ways of doing this. But it's suffice to say, there's a very big market for antigen testing. I mean they're selling the millions and millions of mins.

And they currently selling antigen rapid tests in Europe quite a bit?

Yes. I mean I was just instance in Goldman Sachs and London 8,000 employees, and they're all tested 3 times a week.

24,000...

Many employers doing that. Plenty of example.

What are they using for their antigen tests? Are they just -- do you know what tests they're using? Is it...

Okay, these test, mostly Chinese tests. And remember, all flights in and out of the UK require antigen tests now. But from an out of Europe, it requires an antigen test when you turn back into return back into the country. So there's a lot -- believe me, antigen test requirement.

I think the way we think about it, Bill, is the position has shifted again somewhat given the level of breakthrough infections -- vaccination is no longer the strong signal that it was expected to be in terms of out somebody not having COVID. And that can be either in terms of comfort from yourself, comfort to your employer, comfort to your coworkers, comfort to your co-travelers around being free from infection. And I suppose the antigen test, we've seen lots of examples of employers pushing in, et cetera, is a way for people to get a level of comfort that they are not infectious or the people around them are not infectious. And I suppose just a short time ago, we thought that vaccination was probably going to give that level of comfort. But with the Delta variants and the level of breakthrough infections, that doesn't seem to be the case anymore. That's probably the key driver as to why we think there will be greater longevity in this test, these types of tests than we would have just a short while ago.

Just some other examples, Bill, like, for example, in Dublin, Google and Facebook or an salesforce.com, as are all testing their employees weekly -- And for example, also, I'm sure you're reading about this. I'm not sure so much on top, but like, for example, in the US -- sorry, in Europe, admittance to concerts and to all sorts of social events require antigen test.

So I mean it's still -- it's something that's more of a bonus, but your real excitement is the WHO, you said that's your most exciting thing you got going, I mean, besides other things that could really make a change.

I think we're excited about both.

Okay. Okay. That's good. All right. And there's nothing you can say further on the refinancing of the $100 million loan at this point, right? Is there anything further you can add?

Well, we've appointed professional advisers, and we're confident there are a number of options available to us to deal with the matter. But as you can imagine, it's very much in our thoughts and then talk to the Board, and we're working diligently on it. There appears to be no more questions. So I think maybe we'll close the call and thank you, everybody, and thanks for your support and your interest, and talk to you soon.

Ladies and gentlemen, the conference has now concluded. We do thank you for attending today's presentation. You may now disconnect your lines.