TRIB

Greetings. Welcome to the Trinity Biotech Third Quarter 2024 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now pleasure to introduce Eric Ribner, Investor Relations. Thank you. Eric you may begin.

Thank you very much. Before we begin, please note that statements made during this presentation may be deemed forward-looking statements within the meaning of federal securities laws. These statements are subject to known and unknown risks and uncertainties that may cause actual events to differ from those expressed or implied in such statements. These risks include but are not limited to those set forth in the risk factor statements in the company's annual report on Form 20-F filed with the SEC. Trinity Biotech undertakes no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after today or the occurrence of unanticipated events. I will now hand the call over to John Gillard, President and CEO of Trinity Biotech, who will give an overview of Q2 performance and a business update. John will be followed by the company's Chief Financial Officer, Louise Tallon, who will give further details on third quarter financials. John, I'll turn it over to you.

Good morning, everyone and thank you for joining today’s call. It has been an exciting time for our company. I have a lot to share with you today. Our company has been significantly transformed over the past year and we are now looking into the future and growth drivers that will create meaningful value to our shareholders. On our call today, I want to focus on three key elements. One, planning for long-term growth, which we believe will be driven by our continuous glucose monitor or CGM for diabetes management. As we progress towards commercial launch of our next generation solution, we are incredibly excited about the opportunity our innovative and pioneering approach presents in this fast market, a market that is already worth over $10 billion a year and projected to grow rapidly. In addition, in order to provide shareholders with more opportunities for value accretion, we are building out our pipeline of high-growth potential products through the acquisition of innovative prostate cancer and preeclampsia test technology, plus a strategic investment in a sepsis diagnostic technology. Moving on to two, I will also update you on our continued strong execution of our comprehensive transformation plan, which is establishing the profitability infrastructure for our existing and future business lines. This will support R&D for growth and balance sheet strengthening, as well as increasing the value of many of our existing business lines. And finally, three, I will speak to how we have strengthened the company by successfully addressing NASDAQ listing deficiencies, removing an important overhang from our stock. Before I address each of those three areas, let me first speak to our Q3 performance. As you saw in today's press release, we are continuing to grow our revenue base while at the same time reducing costs. We saw 3% year on year revenue growth, driven by TrinScreen HIV revenues. Our TrinScreen revenues were lower in Q3 compared to Q2, but this is only as a result of different ordering patterns quarter-on-quarter, which are a feature of the rapid HIV test market. We expect higher revenues in Q4 of this year for TrinScreen HIV, and as set out in today's press release, we are reiterating our guidance of 2024 sales revenue for TrinScreen HIV of approximately $10 million. Our Q3 2024 hemoglobin’s revenues from A1C testing products were lower than Q3 2023, primarily due to Q3 2023 having unusually high revenues compared to the normal run rate due mainly to uneven ordering patterns from certain customers during 2023. Continued disciplined execution on our profitability enhancing initiatives contributed to a decrease in the operating loss before restructuring and impairment charges to $2.2 million from $4.5 million in Q 2023, a 51% improvement. As I will speak to later, while we have spent this year planning and executing on the many profitability initiatives in our comprehensive transformation plan, most of them were scheduled to be completed at the end of this year or early in 2025, and as such are not yet very significantly adding to our profitability. However, I am happy to confirm that in line with our plan, many are due to be executed by the end of this year or very early 2025. And as such, we expect that we are on the cusp of a near-term step change in our profitability performance. Louise will bring you through our Q3 financial results in more detail later on the call. Now let me walk you through some of our key achievements and provide more details across the three main priority areas for our new leadership team, beginning with driving long-term growth from our CGM solution and recently acquired lab-based innovative diagnostic tests. With respect to our next generation CGM for diabetes management. As I mentioned, we are incredibly excited about the progress we are making in the design of this breakthrough solution. The opportunities this innovative solution presents for the company in this vast and rapidly growing market are game changing. Having consulted with a broad range of commercial and clinical stakeholders globally, we know that reducing the cost per day of CGM solutions is a critical need in both established and developing markets. This is a need that the current main products do not satisfactorily address given their products are built around entirely or mainly disposable components. We are specifically designing our next generation solution to address this market need. To remind you, our next generation solution capitalizes on our proprietary glucose sensor technology to reduce down the amount of non-reusable components. As a result, our new breakthrough design boosts a reusable applicator and transmitter paired with a simplified low-cost disposable sensor patch, all designed to give a great user experience. This modular approach significantly reduces both cost per day and waste. Our new design also allows our solution to capture additional physiological data points beyond glucose, similar to many of the data points captured by smartwatches and other wearable devices. We believe these data points will provide key insights to users and further strengthen and differentiate the value proposition of our solution. I suppose you could say, rather than trying to get a smartwatch to accurately measure glucose, as we understand some companies have tried, we are developing an accurate continuous glucose monitor that incorporates many of the data collection functions of a smartwatch and other wearables. We believe this is a much more achievable solution. We are moving quickly to capitalize on this incredible market opportunity and as we previously reported, we successfully completed the first pre-pivotal trial of our updated sensor technology. This week, we are starting a second, larger pre-pivotal trial which will provide extensive data on further developments of the sensor technology, which would feed into our sensor design choices. We are confident that the steps we are taking supported by our impressive partners with an emphasis on: One, a great user experience. Two, enhanced data capture and insights and three, reduced cost through more reusable components will lead to a differentiated product and a higher value proposition. We believe this will allow Trinity Biotech to take a leading position in the global CGM and diabetes management markets. Additionally, as we have mentioned previously, we are receiving significant inbound interest in our CGM technology from both commercial and strategic partners alike. We continue to build and nurture these solutions to create strategic optionality for our assets as well as create shareholder value. Finally, I'm pleased to report that we are establishing strategic manufacturing and supply chain relationships with large-scale premium market players to prepare for efficient and rapid scaling across the globe upon launch. Now, let's turn to our recent new lab-based technology acquisitions, which form an additional vertical to our long-term value creation and growth strategy. The catalyst for these acquisitions is the recent set of changes by the U.S. Food and Drug Administration, the FDA, to the rules regarding the introduction of new lab developed tests or LDTs. We expect that these recent FDA changes will limit the ability of reference laboratories that are not New York State Department of Health certified to bring new laboratory developed tests such as epiCaPture prostate cancer test and Metabolomics preeclampsia test to the market in the U.S. As our Immco lab is New York State Department of Health certified, this provides us with a competitive advantage, which we have sought to capitalize on with these two acquisitions. Trinity Biotech's strategy was to leverage our New York State laboratory to attract new innovative technologies and products and combine those with Trinity's established capabilities to address large-scale urgent and important clinical issues. We believe that this FDA rule change provided us with attractive and capital efficient opportunities to acquire companies with new technologies and products and support their route to market. As we evaluated these new opportunities in this area, our criteria were focused on: One, large and important disease areas. Two, diagnostics that lead to differentiated treatment paths for patients and three, utilization of sophisticated next generation technology platforms. For example, prostate cancer is the most common non-skin cancer among men in the U.S., with about one in eight men diagnosed during their lifetime. And the cost for diagnosis and treatment is estimated at over $100 billion annually. The ability to accurately monitor prostate cancer progression is critical as the disease can often be slow growing and unnecessarily invasive interventions, such as prostate biopsies can lead to significant complications. The epiCaPture test could significantly reduce the frequency of these interventions, thereby improving the quality of life for patients. The epiCaPture test offers a breakthrough approach to monitoring disease progression by using epigenetic analysis. This technology is innovative and new to Trinity Biotech, thus allowing us to move up the technology and value curve in a large-scale disease area and introduce our company to the high value oncology market. Similarly, our other new acquisition, Metabolomics Diagnostics, addresses the large-scale issue of preeclampsia, which impacts up to 5% of pregnancies in the U.S. and which can cause serious illness or death in affected mothers and babies. The Metabolomic Diagnostics proprietary PrePsia technology has been shown to deliver improved prediction of preterm preeclampsia risk at week 12 of pregnancy. Early detection of preeclampsia would allow for the prescription of effective medication, which can significantly reduce the risk of often serious health issues for mothers and their babies. The Metabolomics test uses mass spectrometry combined with machine learning powered bioinformatics, which again is a new and innovative technology to Trinity Biotech. This increases our exposure to and capabilities in machine learning, which is increasingly becoming a critical aspect of modern healthcare and in particular diagnostics. Regarding Novus Diagnostics, in which we have made a 12.5% strategic investment, our strategic rationale is to leverage our existing capabilities to support the development and commercialization of Novus' groundbreaking technology. This is a rapid 15-minute sepsis test that can provide life-saving information to physicians to enable faster diagnosis and timeline treatment. Novus' platform addresses key limitations in current sepsis diagnostics, such as the delay in results. This rapid point-of-care solution is expected to significantly improve sepsis outcomes by enabling faster diagnosis and timely treatment, potentially saving lives and reducing the over $50 billion estimated annual cost of sepsis related hospitalization in the U.S. Now turning to the second of the three key areas I want to focus on today. Our comprehensive transformation plan on which we continue to make significant progress and remains on track. Our aim with these initiatives is to enhance the value of our existing business lines by transforming operations to address the root causes of historical inefficiency and pave the way for profitability growth on a larger scale. Under this plan, we have several objectives to accomplish. First, reduce costs through consolidation and offshore of manufacturing. In this regard, we have now successfully completed the transfer of our second rapid HIV product manufacturing process to our offshore manufacturing partner. In a significant milestone, we have made submissions to the relevant international regulator to commercial production of both rapid HIV tests with our offshore partner. We expect offshore production of both products to begin in Q1 2025. We expect this shift will be gross margin accretive and provide meaningful working capital benefits. We are also beginning to transfer some of the more technical aspects of production of both of our rapid HIV tests to our offshore partner. In fact, we already have a team on-site for the next two weeks with our partner. Once in place, this change should support further gross margin and profitability enhancements. We have continued to make significant progress in consolidating our main hemoglobin manufacturing activities currently carried out at our Kansas City plant into two of our other existing plants. We remain on track to seize the main manufacturing activities at our Kansas City site by the end of 2024. We have recently also informed staff at our autoimmune test manufacturing site at Buffalo, New York of our intention to consolidate its main manufacturing activities into our Jamestown, New York plant. We expect to see some main manufacturing activities at our Buffalo site by the end of Q1 2025. We are also focused on optimizing our supply chain. In this regard, we've continued to identify further material saving opportunities in our rapid HIV test supply chain and expect to have them in place by the end of Q1 2025. Lastly, we plan to centralize and offshore many of our corporate services to drive both efficiency and agility. As planned, our offshore corporate services site is now live with a number of functions operating from this site. We expect to add additional functions through the end of 2024 and into Q1 2025. These changes will support improved profitability. Our comprehensive transformation plan is ambitious and wide ranging, impacting almost every aspect of our business. I would like to take this opportunity to thank our staff, including those that are set to leave the business as part of the transformation for their support and cooperation during this important journey. Once completed, I believe we will have a much more efficient and modernized operating model. With just two main manufacturing sites, focusing on the more complex aspects of our products, one in the U.S. and one in Ireland, with less complex manufacturing activities either offshored or outsourced. This simplification is expected to drive significant efficiency and profitability enhancement. In addition, our centralized and offshore corporate services side should give us a more efficient and effective platform to support the business. Given our continued strong execution on our wide range comprehensive transformation plan, we are today reiterating our guidance to achieve approximately $20 million of annualized run rate earnings before interest tax depreciation and share options cost or EBITDASO, excluding impairment charges and once off items, and annualized run rate revenues of approximately $75 million by Q2 2025. And we will continue to execute towards this. Finally, and thirdly, I'm extremely pleased to be closing out a difficult period for the company over the past year. One of my top priorities when I took on the CEO role in December 2023 was to address the company's pre-existing NASDAQ listing requirement deficiencies. We have now regained compliance with NASDAQ listing requirements and removed an important overhang on our stock. We are grateful for the continued support of our shareholders, partners and employees during this process. So to conclude, overall, I am very satisfied with the significant progress we have made over the past few months on our ambitious priorities. We will remain focused on disciplined execution in our comprehensive transformation program, so that we as rapidly as possible transition to profitability, while at the same time preparing the company for significant future growth with our exciting programs in CGM, prostate cancer and preeclampsia. I would like to thank you all for your attention, and I will now hand you over to Louise Tallon, our Chief Financial Officer, to discuss the Q3 financial results in more detail.

Thanks, John. I'm delighted to go through our Q3 results and highlight some of the progress the company has made during the last quarter. Starting with our revenue, our revenues for Q3 2024 were $15.2 million which is just over 3% higher than Q3 2023. Our point-of-care revenue continues to have a large impact on growing our business, increasing by $2,7 million to $4.3 million. This is an increase of 60% compared to Q3 2023 driven by our TrinScreen product which has sales of approximately $2.4 million. We have reiterated our guidance for TrinScreen sales of approximately $10 million for the full year 2024. Our clinical laboratory revenues were $10.8 million which is a decrease of 9% compared to Q3 2023. Included in these revenues was a strong performance from our clinical chemistry portfolio, which grew by almost 80% year-on-year. This increase in revenue was offset by a revenue decrease in our hemoglobin business, which was 70% lower year-over-year. This occurred due to decreased instrument sales during the period combined with higher consumable sales in Q3 2023, which as John noted was influenced by the phasing of hemoglobin revenues from certain customers throughout the prior year. Moving on to our gross profit for the quarter which was $5.3 million and represented a gross margin of 35%. This was broadly consistent with the margin for the comparative quarter in 2023 when you exclude the stock obsolescence costs that were included in 2023 results. Within our gross margin, there are two pieces of key businesses that affect the results. Firstly, we have positive margins with our hemoglobin’s business. We're now manufacturing costs through supply chain initiatives and from our revised and highest manufacturing process. Secondly, in offsetting this, the Trin Screen HIV sales are currently diluting our overall gross margin percentage. We we're expecting this to improve incrementally over the next three quarters due to the increased operational efficiency through automation and expected transfer of assembly activities to a lower cost location which begins Q1 2025. We have some favorable movement in expenses year-on-year. Within research and development expenses, they were $200,000 less than the comparable quarter. We also capitalized $2.1 million for the quarter in relation to our biosensor development as we continued our development activities post the Waveform transaction we completed in January. Our SG&A expenses were $6.5 million in the quarter compared to $7.7 million in Q3 2023. This is a substantial decrease of $1.2 million and is a clear indication of our journey on cost reduction where we've lowered overall employee remuneration costs. This quarter, we've also incurred restructuring costs of approximately $300,000 related to the comprehensive transformation plan, which John described earlier. This brings total costs year-to-date to $2.3 million with further costs expected in Q4 as a result of our ongoing transformation plan. These costs mainly comprise of termination payments, factory closure costs and costs associated with the transfer of activities to the offshore service provider. The majority of the cash outflow related to these restructuring costs will happen in Q4 2024 and Q1 2025. Overall, we now reported an operating loss of $2.6 million in the quarter compared to an operating loss of $4.5 million in Q3 2023. Our net financial expense in the quarter increased by approximately $200,000. This increase is due to our term loans, a result of the additional loan drawdowns related to the Waveform transaction earlier in the year. This brings us to a net loss post tax and interest position of $4.8 million in the quarter compared to $6.7 million loss in the same quarter last year. The adjusted EBITDASO was one of our primary KPIs and represents the loss before depreciation, amortization, impairment charges, restructuring costs, tax, interest and share-based payments. For the quarter, we report adjusted EBITDASO of $1.4 million loss compared to $3.5 million loss in the equivalent period last year, while our basic loss per ADS was $0.46 compared to $0.88 in Q3 2023. Finally, I'll talk about our cash for the quarter. The cash balance decreased from $5.3 million at June 30 to $2.8 million at the end of September. Cash used by our operations was $3.6 million in the quarter, an improvement of $1 million compared to Q3 2023. Although there was improvement on the prior year, I note the working capital outflow in the quarter. Trade and trade receivables have increased relating to large receivables associated with our TrinScreen product. We expect to show improvements here in Q4. We had investment cash outflows of $3.1 million which mainly related to our R&D capital expenditure for CGM and hemoglobin products as well as cash related to the acquisition of Metabolic Diagnostics. Cash inflow from financing activities were $4.2 million in the quarter. During the quarter, the company entered into an aftermarket offering agreement, which resulted in a positive net cash flow of $7.1 million. Now I'll hand you back to Eric for any questions.

Thank you. And I guess we'll take questions now. Yes.

Thank you. [Operator Instructions]. Our first question is from James Sidoti with Sidoti and Company. Please proceed.

Hi, good evening. Thanks for taking the questions. It's nice to see earnings coming out before the quarter -- the next quarter has ended. So it seems like you're back on track that way, which is nice to see. So regarding the third quarter, you said you still expect the TrinScreen sales around $10 million. So it sounds like you're looking for a little over $3 million of revenue from that in the Q4. Does that sound right?

Hi, Jim. Good to talk to you. Thanks for your question. Yeah, I think that's fair. As we've seen over many years with HIV rapid sales, there can be quarter-on-quarter variation in ordering patterns and because the order sizes for TrinScreen are much larger typically than we would have for Uni-Gold that leads to I think it was a higher overall impact in terms of our revenue. And yes, we would expect about $3 million for Q4.

Okay. And with regard to the Premier Instruments, it sounds like those sales were a little lower this quarter as some customers waited for the new column to come out. Do you think that business comes back in the Q4 or do you think that business is lost or do you think it comes back in 2025?

Yes, I think the core revenue for consumables there is broadly consistent quarter-on-quarter, which we would expect, right, given the nature of that business where you've got typically instruments placements and a consistent level of throughput in terms of those instruments. I think that variation was more really got to do with 2023. There was some high variation in ordering patterns across particularly one customer and we took steps earlier this year to kind of normalize their demand because it creates operational challenges where you're having very high spikes in demand over particular quarters. So we've kind of more smoothed it out. In terms of the other differential revenue predominantly down to instrument placement sales being reduced as we've been consistent, I think throughout the year, we're not pushing them as hard as we will be in the past because we think the new column proposition is a much better proposition given the higher level of tests that those columns do and the lower level of calibrations etc. required for customers. So while we're rolling out the new columns and betting in that value proposition, we're not pushing instruments as much as possible because as you know instrument sales for us typically have been quite gross margin dilutive and in some cases significantly cash flow negative. So we think that the value proposition is better with the new column and we prefer to sell on the basis of that. We also have made some significant supply chain changes in our supply chain for instrumentation which allows us to have a much reduced cost of instruments. And we are also waiting for that to fully come through before we start pushing again. So a temporary reduction I would say Jim, but in terms of our instrument placement revenues, but overall our level of throughput and consumables revenues is consistent.

Okay. And it sounds like you're making some pretty significant progress on the cost reduction side. Did I hear you say you think that these first phase of initiatives they should be complete by the end of Q1 of 2025?

Yes, Jim. And look I appreciate completely that it is somewhat frustrating for investors hearing about these initiatives, but not seeing a huge, huge impact in terms of financials as yet. We operate in a highly regulated environment as people know and changes in terms of our operating structure require significant planning and execution, right? And I do believe and I know from other people who are very experienced in the industry, we are moving at a very fast pace, a controlled but very fast pace. There is nobody beyond myself and Louise that would like to see this happen much quicker. We would like this to be done as quickly as possible. But the truth is it just takes time in this industry for all the various steps with checks and balances that are properly there to be carried out. And so for that reason we had always expected most of these changes to be affected by the end of Q4 this year or very early in 2025. And that's where we expect the real profitability and cash flow benefits associated with those to come on stream. So as I mentioned in my prepared remarks, we do expect we are on the cusp of a step change in financial performance and that should build throughout the rest -- from early 2025 towards the end of the year.

Okay. And then just a couple more. What's the timeline for the two tuck-in deals you did, the PSA test, the preeclampsia test? What's the timeline do you think to commercialize those tests? And will they be sold throughout the United States or are they just New York test?

Yeah. So if I take the Metabolomic test, the preeclampsia, we expect that to be revenue generating in the second half of 2025. They will be sold initially as lab developed tests. We would expect that we will be able to provide that testing service all around the U.S. because our lab is New York State certified which basically gives the right to be able to provide testing services to people in 50 states. And so that is the way that we will initially roll out that test is as a service. And as Immco has done for many, many years, we will then look to get traction for that test in the market through interaction with KOLs, so key opinion leaders, physicians, etc., Jim. And then assuming that we get the level of traction that we expect from providing that test as a service, we would then typically look to get an FDA approval as a 510(k) for example on that test and then sell it as a test kit to other laboratories all across the U.S. and possibly internationally. With regards to the prostate cancer test for Metabolomics, again we're very excited with that opportunity and the opportunity to get into the oncology space. There is more work to be done on that in order to get us into the necessary kind of stage in order to start offering testing services out of our New York State certified lab and expect that will be revenue in 2026. But given the nature of the test and the market that it focuses on, I believe there's an opportunity for us to create very significant value in the short-to-medium term by further developing that test. So our plan would be to roll it out in the same way but I think we can add a lot of value given the nature of the test, the type of technology, what it does for patients and in line with its intended use and the space that it operates in.

All right. And the last one for me is, what do you expect the share count to be in the Q4 as a result of these two acquisitions?

I don't have that number right now. We can go back to you on that, Jim. We can go back to you on that.

Okay. Okay. Thank you.

Thanks, Jim.

Our next question is from Paul Nouri with Noble Equity Funds. Please proceed.

Hey, good morning. I guess the looking at these goals for the second quarter of next year, I guess pretty much calls for a sales increase of 20% and EBITDA. So quarterly turnaround of $6.5 million. So maybe -- I know all the initiatives you have and it's great that you're drilling into the details publicly, but what are the biggest maybe two or three items that will get you there in the next few quarters?

Yes. Thanks, Paul. Look, for commercial reasons as you can imagine, we're dealing with partners. So I don't want to give particular details around the savings we get from different initiatives. But I think it's safe to say the ones that we have noticed are the biggest ticket items that we have, right. The drains on profitability per our analysis has been significant number of factories operating not at full capacity and because we're in a very highly regulated industry that comes with a significant amount of overhead, right? So reducing down from three in the U.S. to just one will have a big impact, right? And then offshoring some of the less complex aspects of our operations to a lower cost location and to a partner who's also manufacturing other products and that was effectively spread a lot of that overhead. So they are each the biggest contributors. The offshoring and consolidation of corporate services has an impact. It's probably on the lower side than the physical infrastructure ones in terms of manufacturing, but again does add. I think the key benefit around that would be modernization of our processes and further agility and ability to scale particularly as we push out the CGM product. So that is a cost save move but also further agility focused as well. Does that make sense?

Yes. Thank you. I guess looking at TrinScreen and the revenues for next year are – are most of the revenues for next year on TrinScreen expected to be from new tenders or building on the existing tender from this current year?

Yeah. Thanks, Paul. Good question. So a mix. So we are in a number of valuation processes for TrinScreen. I know as a long-time investor in the company, Paul, you know as well as anyone there is uncertainty around the timing of those tenders and those evaluation processes. And they can move from quarter to quarter depending upon different priorities within the health organizations, government changes, etc., right? And that's something that we need to be agile on and ready to react. And I think our outsourced manufacturing will allow us to be more agile and to react to shorter notice in terms of scaling up for big wins, right? And that was one of the drivers in addition to cost savings. So we would hope to win and do expect to win additional tenders and evaluations for 2025. And when exactly they will come in, we don't know. We have an idea. That's not something we will go into publicly. But as you know, it can shift around. But we've done what we needed to do this year on TrinScreen, which was supply the market at a very, very big volume from the off. So we've proven that we can manufacture and supply a very high volume of product on time to the highest levels of quality.

Okay, great. And then final question, how much capacity is remaining on the ATM?

I think there's about less than a million on the current ATM filing.

Okay, thank you.

Thanks, Paul.

We have reached the end of our question-and-answer session. I would like to turn the conference back over to management for closing remarks.

Thank you, Sherry. Thank you everybody for your attention. We appreciate your interest in the company and your support as we continue with this transformation journey. And we look forward to speaking with you over the next coming weeks.

Thank you. This will conclude today's conference. [Operator Closing Remarks].

Welcome to the Trinity Biotech Second Quarter 2024 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I will now turn the call over to Eric Ribner. Thank you. You may begin.

Thank you. And before we begin, please note that statements made during this presentation may be deemed forward-looking statements within the meaning of federal securities laws. These statements are subject to known and unknown risks and uncertainties and may cause actual events to differ from those expressed or implied in such statements. These risks include but are not limited to those set forth in the risk factor statements in the company's annual report on Form 20-F filed with the SEC. Trinity Biotech undertakes no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after today or the occurrence of unanticipated events. I will now hand the call over to John Gillard, President and CEO of Trinity Biotech, who will give an overview of Q2 performance and a business update. John will be followed by the company's Chief Accounting Officer, Simon Dunne, who will give further details on Q2's financials. John, I'll turn it over to you.

Shortly after I took over as company's [technical difficulty] I set out a plan [technical difficulty] revenues in the short-term due to training TrinScreen HIV production; two, deliver a sustainably profitable business by transforming operations to deal with the root causes of historical inefficiency; and three, build an exciting and truly scalable new business in wearable biosensors starting with a meaningfully different continuous glucose monitor. This is an ambitious plan. It is a plan with bold steps. We are now taking those bold steps at speed. This quarter, we are pleased to report that again, significant advances are being made across our entire business and the plan is working. We are growing our revenue base while at the same time, reducing costs. We have had over 50% quarter-on-quarter revenue growth in point of care revenue, driven by the continued successful scaling of rapid HIV test output. This was accompanied by a 45% improvement in operating profitability before impairment charges and restructuring costs quarter-over-quarter. We are enthusiastic that the ambitious and aggressive comprehensive transformation plan, we developed and set out earlier this year is working and delivering results. Given our team's success in executing against this plan, we are now even more confident that we are on the cusp of significant step changes in our financial performance and profitability. We remain on track to achieve annualized run rate revenues of approximately $75 million by Q2 2025 with approximately $20 million in EBITDASO that is earnings before depreciation, amortization, tax and share-based compensation costs from our existing business. Now let me walk you through some of our key achievements and provide more detail across the three main priority areas for our new leadership team, which to remind you were: one, growing TrinScreen HIV revenue; two, aggressively executing on the key initiatives underpinning our comprehensive transformation plan; and three, progressing our main long-term growth strategy based on our newly acquired continuous glucose monitoring or CGM technology. Firstly, let's discuss growing TrinScreen HIV revenues. As I mentioned in our last two calls, we've been focused on successfully ramping up production of rapid HIV test, in particular, TrinScreen HIV, and this continued to scale from Q1 into Q2 2024. As you can see in today's results, the financial impact of that increase with the quarter-over-quarter increase of over 50% in our point of care revenue which itself is an increase of almost 120% year-over-year and is a testament to our current team ability to execute. Our current focus is to continue to ramp production, whilst also significantly increasing the profitability and margin contribution from this new product. We successfully implemented further automation of our manufacturing processes as planned, which reduces the net cost of manufacturing. In addition to increasing efficiency through automation, we are running a twin-track approach of outsourcing the less complex aspect of our rapid HIV production to a lower-cost offshore location as part of our comprehensive transformation plan, and I will speak to that further a little later. Outside of scaling production to meet incoming orders and focusing on manufacturing efficiency. Our technical and sales teams continue to be very active in pursuing new commercial opportunities for TrinScreen HIV. They met with many key stakeholders at the recent International AIDS conference that took place in Germany. There is significant interest from many key stakeholders in sourcing a high-quality test such as TrinScreen HIV from an established and trusted partner such as Trinity Biotech. As I've mentioned before, TrinScreen HIV is in various stages of evaluation processes across several countries in Africa. We expect to further grow TrinScreen HIV revenues from new wins across many of these evaluation process. Now moving on to our comprehensive transformation plan that I set out earlier this year. To recap, this plan is designed to deliver a much lower manufacturing and SG&A cost base, which will drive significant profitability from the growing revenues from our existing business, and importantly, provide an efficient, scalable platform to facilitate the next stage of the company's growth. The new management team continues to be united in our vision that we can fundamentally improve upon the prior commercial and financial performance of our existing business through series of ambitious and aggressive incremental changes. With the significant progress in execution and successes we have already had, we are very excited about the opportunity and believe we are on the cusp of near-term significant step changes in our financial performance. To recap, the transformation plan has three main pillars to optimize the existing business and prepare the company for our next stage of growth. One, consolidate and offshore manufacturing; two, optimize supply chain; and three, centralize an offshore corporate services. We have again made significant advancements in our key objectives across each of these three pillars since I spoke with you last, with a key focus on executing against our plan. As I did last quarter, let me take a few moments to give you some examples of the key objectives we achieved in this period. With respect to pillar #1, consolidate and offshore manufacturing, we continue to prioritize on our two largest businesses, being rapid HIV test and diabetes HbA1C testing. In HIV testing, I am very excited to report that we have successfully completed the technical transfer of one of our rapid HIV product manufacturing processes to our offshore manufacturing partner. This was a very significant achievement by Board team. It is a complex process. We set out audacious time lines and we have been successful. I believe that this is a critical milestone in our comprehensive transformation plan and further increases our confidence in reaching our ambitious financial performance target. Our team is now preparing the data to support our upcoming submissions to the relevant regulator to permit commercial manufacturer with this outsourced partner, and we expect this to be received later this year. In diabetes HbA1C testing, as we previously announced, by the end of this year, we are ceasing main manufacturing activity at our Kansas City facility. Since our last earnings call, we have made further significant progress in executing on this closure. We are currently moving many parts of the manufacturer of these products to our Irish facility, which will utilize spare capacity created by the offshoring of HIV test assembly, I referred to earlier while allowing us to maintain the highest quality of product. As part of this move, we have had teams from our Irish facility in Kansas City being trained on these manufacturing process. We are also moving less complex manufacturing process currently carried out in Kansas to lower-cost offshore locations. This is building on our previously announced manufacturing and supply chain optimization in our hemoglobin's business. And with further support us building a business of significant value in this area. In Pillar 2 optimized supply chain. This past quarter, we successfully transitioned a significant proportion of our hemoglobin instrumentation supply chain to lower cost providers. As we set out in today's press release, we expect this shift to be gross margin accretive and provide meaningful working capital benefits. This is a project that has been ongoing for some time and I believe takes away a significant proportion of cost of our instrumentation and allows us much greater agility commercially as we move forward in that business. In Pillar 3, we have substantially progressed the setup of our centralized and offshore corporate services function. This is designed to provide us with an efficient and highly scalable corporate services platform to support growth while reducing our SG&A costs. We have identified the functions that will transfer to this new centralized location and these are currently being recruited for. Our current focus is ensuring a smooth transition of these functions to this new location and maximizing the operational benefits and ongoing efficiencies that can be delivered by this change. To conclude, we are excited by the very real progress we are making on all major fronts in delivering this step change in financial performance and that continues to give us the confidence to reiterate our previous guidance of approximately $20 million of annualized run rate EBITDASO and annualized run rate revenues of approximately $75 million by Q2 2025. Now moving to our long-term growth driver, continuous glucose monitoring or CGM. As I said before, in addition to strengthening our existing business, we aim to build a global business in wearable biosensors, initially, with the focus on CGM. Since we made the acquisitions, we've been, a, further developing our commercial strategy around CGM and biosensors. And b, advancing the design and development of the next-generation CGM device. Now let me take you through our main activities in these areas since we last spoke. With respect to commercial strategy, we attended the American Diabetes Association Conference in Florida, where we met with several key global industry participants. It is clear from these discussions that there is a real desire in the industry for our CGMs key differentiators of being a more affordable and sustainable CGM that delivers a great user experience and that the product development direction we are taking will realize that vision in an exciting and compelling way. That has further increased our confidence that our unique technology provides a great platform on which to develop a next-generation CGM that can truly disrupt the diabetes care market. For those of you who may not -- who may be new to this area or have not heard me speak on this before, our CGM technology is not some unproven noninvasive solution. Like the two main players, Abbott and Dexcom, it uses a minimally invasive sensor wire or filament. I think it is important that I take a moment to again explain the importance of some of the technical differences in the Trinity Technology and the valuable differentiated product features they facilitate. Like the other CGMs I mentioned, in the Trinity Solution, an ultra thin sensor wire or filaments is inserted a few millimeters into the skin and this transmits live data about the level of blood glucose in the body to smartphone. However, a critical distinction and benefit of our technology is that the sensor wire can be inserted into the body without the use of a needle. What this means is that our sensor is inserted using a reusable sensor applicator. The others I refer to require a single-use applicator that punctures the skin with the retractable needle. This leads to the entire plastic and metal applicator becoming nonrecyclable biohazard waste. In contrast, our sensor applicator is reusable and lasts for years with all the sustainability and cost benefits that brings. While it may not sound like a big issue for every person using one of the leading products, over 2 years, they will generate about 11 pounds or 5 kilograms of nonrecycled plastic and metal across 72 applicators, which is not insignificant, especially when it is multiplied by the number of global users of these devices. This drives two big problems with the main CGM solutions on the market today. One is cost, which creates a barrier to broader adoption of this life saving technology and the second problem is the massive amount of nonrecyclable waste they create. By contrast, over that 2-year period, our solution would use just one applicator. Our technology coupled with our design philosophy, greatly reduces the cost, environmentally harmful waste created by just this part of the solution, thereby solving two major problems with the current market-leading CGM devices. But we are not stopping there. As part of our modular solution, we are combining this reusable applicator with a reusable transmitter, encompassing a rechargeable power stores and electronics to further reduce the cost and harmful waste of our solution compared to the two main competitors on the market. This powerful combination of reusable applicators and transmitters dramatically reduces the cost of our solution. And we believe we can provide a CGM solution at a daily cost that is at least 40% less expensive than the current main products are market. We believe this gives us a very significant competitive advantage and a great opportunity to disrupt the market and this view was confirmed at our recent meetings with key opinion leaders within the industry. We understand that this is a very large market opportunity for a company of Trinity's current size. And that is why since the acquisition, we have continued to be focused on creating a team of world-class designers and engineers to develop and design the next-generation CGM solution, focused on: a, usability; b, affordability; and c, sustainability. We believe that by creating a next-generation product around these three teams, we can reach as many people as possible with this life saving solution. This is similar to the way that the company has supported accessibility to HIV health care for over 25 years. We have substantially moved the project forward over the last quarter, and we are now entering a new and advanced stage. We now have designed two prototypes that showcase the key advantages of our technology and design philosophy. We plan to road test [ph] these prototypes with representative user groups over the coming weeks and months. Given our strong focus on usability and accessibility, this engagement is important to us in guiding the finalization of these designs. We are also working with a hyperscale contract manufacturer to optimize these designs for high-quality and efficient automated manufacturer scale. We have designed prototypes of the next-generation key digital interfaces and we are working with digital health care company on the development of the overall digital technology stack that can support our vision of delivering key data-driven health care and wellness insights. Again, the digital prototype designs are focused on true differentiation and usability. Since acquisition, we have also made a number of enhancements to the sensor technology itself and we've begun a prepivotal clinical trial, which we expect to conclude in early September. We have also applied for approval to begin a second pre-pivot clinical trial in quarter 4 2024 and we expect to receive Competent Authority approval to commence the trial in the coming weeks. These prepivotal clinical trials will give us insights into the sensor optimization pathways. On overall timing, we remain on track to enter pivotal clinical trials by summer 2025 with EU regulatory approval targeted by the end of 2025. We expect regulatory approval for further global markets will follow the initial approval in the EU. With all these developments, we are more excited than ever of the opportunity CGM represents for Trinity Biotech and we are rapidly building the team and technology to deliver on that opportunity. To conclude, overall, I am very satisfied with the significant progress we've made over the past few months on our ambitious priorities and believe that the company is now at a very exciting point of transformation and opportunity with significant financial benefits set to be realized in the near-term. We have again had some key wins gaining our TrinScreen HIV, which provides us with growth and additional profitability. We have further executed on our comprehensive transformation plan, which will support us shortly delivering step changes in profitability. Finally, we've made real progress on the realization of a highly impressive both differentiated CGM solution that can disrupt this massive market, help millions of people globally and deliver very significant growth to Trinity Biotech. As Eric said, today, I'm joined by Simon Dunne, our Chief Accounting Officer. We are excited that our new group CFO, Louise Tallon, joins within a few weeks. And I am thankful to Simon for supporting us on this call during this transition period. I would like to thank you all for your attention, and I will now hand you over to Simon to bring you through the Q4 financial results in more detail.

Thanks, John. Our revenues for quarter 2 2024 were $15.8 million, which was 14% higher than in quarter 2 2023. Our point-of-care revenues more than doubled with revenues increasing by $2.5 million to $4.6 million, equating to an increase of 119% compared to Q2 2023. This increase was driven by our HIV screening test, TrinScreen HIV, which had sales of approximately $3.1 million. Our clinical laboratory revenues were $11.3 million, which is a decrease of 4.6% compared to Q2 2023. There was a strong performance in the quarter from our clinical chemistry portfolio, which grew by over 20% year-over-year. This increase was offset by lower hemoglobins revenues, which were down 10.8% year-over-year primarily as a result of lower instrument sales in the period. We expect the decline in instrument sales to be a temporary one as we are in the process of repositioning our instrument offering in line with our new improved diabetes column system, which is currently being rolled out. Our gross profit for the quarter was $5.7 million, representing gross margin of 36.2%, which is consistent with the gross margin for the comparative quarter in 2023. There are two main trends in our gross margin, one favorable and one unfavorable, which are currently offsetting each other, resulting in the gross margin being flat year-on-year. Firstly, in our largest division, hemoglobins we are seeing improved gross margins. We succeeded in lowering our manufacturing costs through supply chain initiatives and from our revised in-house manufacturing process. Secondly, the TrinScreen HIV sales are currently diluting our overall margin percentage, but we are expecting this to improve incrementally over the next three quarters due to increased operational efficiency through automation and the expected transfer of assembly activities to a lower cost manufacturing location by the end of 2024. Research and development expenses for Q2 2024 were $1 million, down $200,000 versus Q2 2023. Following on from our acquisition of the waveform assets in January of this year, we continue to progress the development of our CGM offering in line with our previously communicated plan. Our overall capital expenditure in the quarter relating to our CGM Biosensor division was $2.8 million for the quarter. SG&A expenses were $6.4 million in Q2 2024 compared to $7.9 million in Q2 2023, a decrease of $1.5 million. The majority of the reduction in SG&A expenses is due to lower employee remuneration costs, comprising salary costs and share-based payment charges. The cost saving here is due to the headcount optimization activities during 2023. These SG&A savings were partly offset by an unfavorable movement of $0.5 million in foreign currency retranslation charges. This quarter, you will see from our release that we've incurred restructuring costs totaling $1.9 million related to our comprehensive transformation plan, which John described earlier. These costs mainly comprise termination payments, factory closure costs and costs associated with the transfer of activities to the offshore service provider. The majority of the cash outflow related to these restructuring costs will happen in the second half of 2024. We've recorded a noncash impairment charge of $0.4 million this quarter compared to an impairment charge of $10.8 million in quarter 2 2023. The impairment test performed as of June 30, 2024, identified that the value and use of some of our cash generating units was below the value of the carrying amount of their assets, other than inventories, accounts receivable, cash and cash equivalents and deferred tax assets. All of what I have described so far led to an operating loss of $4.1 million in the quarter compared to an operating loss of $14.9 million in quarter 2 2023. Net financial expense reduced by approximately $900,000 from $3.8 million in quarter 2 2023 to $2.8 million in Q2 2024. In Q2 2023, we incurred a penalty of $905,000 for the early settlement of a portion of our senior secured term loan. And this charge did not repeat in Q2 2024 and this is the main reason for the decrease in net financial expense year-on-year. You will see from the table in our earnings release that our term loan interest has increased to $3.1 million in Q2 2024, up from $2.5 million in the comparative period. And this increase is mainly due to the additional loan drawdowns related to the Waveform acquisition. Just over $800,000 of these incremental borrowing costs have been capitalized to the CGM intangible asset this quarter as required by IFRS accounting standards. Net loss from continuing operations was $6.8 million in the quarter compared to $18.3 million in the same quarter last year. The adjusted EBITDASO for the quarter, which is the loss before depreciation, amortization, impairment charges, restructuring costs, tax, interest and share option charges, was $1.4 million compared to $2.6 million in the equivalent period last year. Basic loss per ADS was $0.71 compared to $0.78 in Q2 2023. Finally, I'll talk about our cash flow statement for the quarter. The cash balance decreased from $5.8 million at March 31 to $5.3 million at the end of June. Cash used by operations was $1.1 million in the quarter, an improvement of $3.3 million compared to Q2 2023. We had investing cash outflows of $3.2 million, which mainly related to our R&D capital expenditure for CGM and hemoglobin products. Cash inflow from financing activities was $3.9 million in the quarter primarily driven by the drawdown in April of $6.5 million from our lender perceptive, offset by our quarterly interest payments. Now, I'll hand you back to the operator for questions.

[Operator Instructions] The first question comes from the line of James Sidoti with Sidoti & Company.

Hi. Good afternoon. Thanks for taking the questions. I start with TrinScreen, which was very strong in the quarter. I think you said it was $3.1 million that compares to $1.2 million in the first quarter. How does that compare to your internal expectations? And do you still think that TrinScreen will be about $8 million in revenue in 2024?

Yes, look, it meets our expectations the two greatest uncertainties as we came into this year, Jim, was the ordering pattern for that, we've have received it before and how that would pan out in terms of quarter-over-quarter variability. And then the second, obviously, was around frankly, our ability to be able to scale up manufacturing to meet those types of volumes. And so it certainly has met our expectations. In terms of the full year outlook, I think we are on track for that $8 million, and we are currently kind of looking at the landscape for the rest of the year and we are assessing whether there's potentially some upside around that number. And that's something we'd hopefully be able to bottom out on in the short-term.

All right. And then moving on to clinical chemistry that was up very nicely in the quarter. Can you give us some color on what drove that and if that is something that you think will be sustainable?

Yes. I think the driver that was price increases we were able to put through and for one of our products, which the market was able to bear and that's likely to be sustainable, certainly in the short to medium term. And there also has been some challenges in the market more broadly in terms of availability of product and that has allowed some switching in which we'd be able to benefit from.

Right. And then moving on to the Premier instruments. You indicated those were down in the quarter as the market waits for the new instruments come out? When do you expect those new instruments to be available?

Yes. It's less around the new instrument [ph]. I suppose it's more about the new column, the new column system. So that is currently being rolled out, that's active at the moment. We have literally people in the field, putting through the changes required to the instrumentation to use that new column system. And the reason that we held off on instrument placements and sales during the quarter is that, as I said previously, a key driver for us around that new column system is that its higher level of test per column allow us to be more aggressive on pricing for growth and should allow us to attack parts of the market for A1C testing that we historically have not been able to get into and given pricing pressures. And obviously, you can imagine, we make most of our sales outside of the U.S. and Brazil to distributors. And they look at the overall package in terms of cost of the instrument, cost of the consumables and then how much they can get paid from the health care system per test. And so it's an overall package. And I would also say in the past, there have been placements that we probably would have liked to optimize the level of consumable revenue from further, and that's where we make our money. Selling instruments is not our business. We sell instruments in order to facilitate our business, which is selling HbA1C test. So because of that combination, we are very much looking at the column and the instrumentation as an overall commercial package. And that's I suppose while that's being rolled out, and distributors, in particular, are coming up to speed with the features around the new column system and the revised economics that allows and we not push instrument sales as much as we have in the past.

If we assume that the growth in the clinical chemistry business continues because of the price increases and that the Premier business improves as the new columns come out. Should we expect the overall clinical laboratory business? Do you expect those numbers to be positive in the -- by the fourth quarter of this year?

In terms of growth, Jim?

Yes.

Yes, yes, absolutely. No, I would expect so.

Okay. All right. And then moving on to CGM. It sounds like you'll have the two pivotal trials completed. The two prepivotal trials completed in the next couple of quarters. When do you think you'll lock in the design and how does the final trial, how does that compare to some of the other trials you've done at Trinity?

Yes. So I'll take -- I'll answer both questions separately. So in terms of locking in the design, look, it's obviously [indiscernible] process. So we're very, very happy with the progress we have made to date. I'm very, very excited about the designs that we've developed. I think the additional utility that brings to users is very significant and the advantages we could have in terms of cost, et cetera, is very exciting, right, and sustainability. And as we said, they are prototypes. We now need to get user feedback and that's both from people who wear the devices, clinicians, et cetera and that would feed in further to design. And then our manufacturing advisory partners will also feed into. So these are evident, right, these are evident. And we will continue and continue to narrow the scope for change as we get towards the end of the year and early into next year. And then I'd expect us to be very much honing in the final products, probably by the end of Q1, early Q2 next year just before we go into trial. And in terms of the trials, it's not too dissimilar from previous trials we would have run. And I suppose the differences in -- normally, in our case, the tests are outside the body. In this case, there's something going into someone's body and so there's different protocols around that and different safety requirements. But that's something that our team has experience in. And I would say the scale of the trial is the other unknown at this stage. We have not decided whether we would do what's called a global trial that we would look to gather data from a large number of different sites around the world and use that to support regulatory submissions in a number of different countries and regions or whether we would do individual trials. And that's probably one of the main unknown at this point, Jim. And we will make an incision on that as we progress forward based upon what the regulatory environment at that time and the cost difference associated with those options.

Okay. All right. And the last one for me. I'm not sure it was end of last week, earlier this week, you announced a new distribution partner for the clinical chemistry products. How do you expect that to impact your business?

Yes. Look, in short, we expect it to be positive. We've been impressed with our interactions and work with that partner to date. And they have got boots on the ground in the U.K. and they have a strong desire to grow that business. So that allows us in that more kind of simplified organization structure that we are striving for to deliver profitability to also have the opportunity to have more resource -- more trained resource and more focused on those sales. So we expect that to be margin -- gross profit and revenue accretive over the term.

So does that give you access to new geographies?

It's U.K. focused. So I won't say gives access to new geographies, it gives us access to new sales contacts, okay, where we wouldn't have had access before. And because they have a sales force on the ground in the U.K., and that gives us a greater opportunity to target new hospitals and clinics, et cetera.

Got it. All right. Thank you. Thank you. It seems like you're making a lot of progress.

Thanks, Jim. Appreciate it.

Thank you. [Operator Instructions] The next question is from Andrew Mei, who is an Investor. Please go ahead.

Hey, John. Thanks for taking my questions. Very excited for the future. But as a long-term investor here, we just were curious if there's still a relationship with MiCo.

And so MiCo made a public filing that they had disposed of their investments, I think, late last year or earlier this year. So that's the status on that.

Thank you very much.

Thank you.

Thank you. Ladies and gentlemen, as there are no further questions, I would like to hand the conference over to John Gillard for closing remarks.

Thanks, everybody, for your attention. We continue to be excited about the progress that we are making and we appreciate your support, and we look forward to updating you and around the time of Q3 results. Thanks very much. And again, thanks to Simon for your support today.

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Greetings, and welcome to the Trinity Biotech First Quarter 2024 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Eric Ribner, Investor Relations for Trinity Biotech. Thank you. You may begin.

Thanks very much. Before we begin, please note that statements made during this presentation may be deemed forward-looking statements within the meaning of federal securities law. These statements are subject to known and unknown risks and uncertainties that may cause actual events to differ from those expressed or implied in such statements. These risks include, but are not limited to, those set forth in the risk factor statement in the company's annual report on Form 20-F filed with the Securities and Exchange Commission. Trinity Biotech undertakes no obligations to publicly update or revise these forward-looking statements to reflect events or circumstances after today or the occurrence of unanticipated results. And with that, I will turn it over to John Gillard, CEO of Trinity Biotech.

Good morning, everyone, and thank you for joining today's call. We appreciate your interest in the company. This quarter, we are pleased to report significant advances are being made across our entire business. We are growing our revenue base while, at the same time, delivering higher profit margins. We had almost 40% quarter-on-quarter revenue growth in Point-of-Care revenues driven by the successful scaling of rapid HIV test output. This was accompanied by a 360 basis point improvement to gross margins quarter-over-quarter. We remain on track to achieve annualized revenues of approximately $75 million by Q2 2025 with approximately $20 million in EBITDASO. That is earnings before depreciation, amortization, tax and share-based compensation costs from our existing business. Now let me walk you through some of the key achievements and provide more details across the 3 main priority areas for our new leadership team, which were: one, growing TrinScreen HIV revenue; two, moving from the planning to the execution phase for the key initiatives underpinning our comprehensive transformation plan; and three, progressing our main long-term growth strategy based on our newly acquired continuous glucose monitoring or CGM technology. Firstly, let's discuss growing TrinScreen HIV revenue. As I mentioned on our last call, we successfully ramped up production of rapid HIV tests, in particular, TrinScreen HIV in Q1. You can see in today's results the financial impact of that increase with an almost 40% quarter-on-quarter increase in our Point-of-Care revenue. A key priority of mine in quarter 1 was to increase production so we could meet our TrinScreen orders and therefore, prove to our customers, partners and indeed competitors that we could be a real player in the large volume HIV screening market as we roll out our new TrinScreen HIV product across multiple markets. I'm delighted to report that we have done just that. And as we set out in our recent press release, we have been successful in securing more orders and increasing our 2024 revenue guidance from TrinScreen HIV. I have no doubt that our successful ramp-up provided us with the credibility to obtain those additional orders. And we are now further increasing production to meet these volumes and are on track to manufacture 4x as many rapid HIV tests in May this year compared to May last year. Having successfully ramped up production of TrinScreen HIV, now our focus moves to increasing the efficiency of manufacture and driving further margin contribution. I was delighted that even with the margin percentage dilutive effect of the TrinScreen ramp-up, we are still seeing significant improvement on margin percentage quarter-on-quarter. As you can see, our previously announced targeted price increases, supply chain optimization and headcount reductions all contributed to improved gross margins this quarter as did our in-house HbA1c consumer production. These initiatives are working. As with any new production ramp-up in the earlier stages, investments in training were required as the new staff were trained. We added approximately 70 team members to our Irish site since January this year to facilitate this ramp-up. These staff are now fully embedded into the organization. We expect TrinScreen HIV margin contribution to improve significantly with a, additional automation coming online in June through repurposing existing equipment; b, further supply chain optimizations; and c, the move to offshore downstream assembly, which is planned to be implemented and received regulatory approval later this year. Outside of scaling production to meet incoming orders, our technical and sales teams are also very active in pursuing new commercial opportunities for TrinScreen HIV. As you know, before winning business in new countries, there are typically a comprehensive HIV test clinical evaluation program to be completed. TrinScreen HIV is in various stages of these evaluation processes across several countries in Africa. We expect to further grow TrinScreen HIV revenues in 2024 and in 2025 from new wins across many of these evaluation process. Now moving on from TrinScreen to our comprehensive transformation plan that I set out on our last earnings call. This plan is designed to deliver a much lower manufacturing and SG&A cost base, which will drive significant profitability from the growing revenues from our existing business and also importantly, provide an efficient, scalable platform to facilitate the next stage of the company's growth. This new management team is united in our vision that we can fundamentally improve upon the prior commercial and financial performance of our existing business through a series of incremental changes throughout 2024. As I set out before, we want to drive a step change in financial performance for 3 main reasons. Firstly, the obvious point. Cash-generating businesses are generally more valuable, which increases value for our shareholders. Secondly, better-performing businesses strengthen our balance sheet and increase our access to capital. And thirdly, we believe that our newly acquired accessible and environmentally sustainable CGM technology provide a tremendous opportunity for significant future growth and that a strong balance sheet will permit us to capitalize on this opportunity more rapidly. The transformation plan has 3 main pillars to optimize the existing business and prepare the company for our next stage of growth: one, consolidate an offshore manufacturing; two, optimize supply chain; and three, centralize an offshore corporate services. We have made significant improvements in our key objectives across each of these 3 pillars since I last spoke with you and have very much now moved from the planning stage to the execution stage. Let me take a few moments to give you some examples of the key objectives we achieved in this period. With respect to Pillar 1, consolidate an onshore manufacturing, we focused on our 2 largest businesses, being rapid HIV test and Diabetes HbA1c testing. In HIV testing, in addition to ramping up production as I set out earlier, we also completed training of our identified offshore manufacturing partner staff in the downstream assembly of our rapid HIV test. This allows them to prepare to take over these downstream assembly activity for our rapid HIV test, which will reduce our cost of manufacturing. In Diabetes HbA1c testing, I announced on our last earnings call that by the end of this year, we were ceasing the main manufacturing activities at our Kansas facility. Since that announcement, we have made significant progress in executing on this closure. We are currently moving many parts of the manufacturing of these products to our Irish facility, which will utilize their capacity created by the offshoring of HIV test assembly I referred to above while allowing us to maintain the highest quality of product. As part of this move, we are currently setting up the equivalent manufacturing line here in Ireland and expect to be up and running on that by the end of this summer. We are also moving less complex manufacturing processes currently carried out in Kansas to lower-cost offshore locations. This is building on our previously announced manufacturing and supply chain optimizations in our hemoglobin business and will further support us building a business of significant value in this area. In Pillar 2, optimize supply chain, this past -- we prioritized optimization of our rapid HIV supply chain with increased volumes from TrinScreen HIV creating opportunities to negotiate with supply partners, resulting in double-digit percentage reductions in cost of goods. We also identified and engaged with a number of alternative suppliers that could facilitate further cost reductions. We're confident there is further margin accretion in this area. In Pillar 3, we have substantially progressed the setup of our centralized and offshore corporate services function. This is designed to provide us with an efficient and highly scalable corporate services platform to support growth while reducing our SG&A costs. We have signed an implementation agreement with a third-party outsourced partner, who is already hiring to staff up that offshore location. To conclude, we are making very significant progress on all major fronts in delivering this step change in financial performance. And that gives us the confidence to reiterate our previous guidance of approximately $20 million of annualized run rate EBITDASO and annualized revenues of approximately $75 million by Q2 2025. Now moving to our long-term growth driver, continuous glucose monitoring or CGM. As I've said before, in addition to strengthening our existing business, we aim to build a global business in wearable biosensors, initially with a focus on CGM. It is important to recap the context for this strategy. When I took over as CEO in late December, I was aware that Trinity's new product pipeline was insufficient to drive the kind of organic growth investors expect. It was, therefore, imperative to execute on a viable growth driver for the business that leveraged our existing strengths and resources. We know today that data digitalization and artificial intelligence will play an increasingly important part in our health care and wellness management as they are beginning to in virtually all other parts of our lives. As such, for those of you on today's call that may not be aware, just over 3 months ago, we purchased the biosensor technology of Waveform, including its existing CE Mark-approved CGM. As many of you would know, CGMs have been shown to be very effective in helping people with diabetes manage their conditions, and their usage is growing rapidly. For example, the 2 main leading players in CGM, Abbott and DexCom have combined revenues of over $8 billion from CGM, and they are growing. We are already a significant player in the global diabetes management market, supporting over 10 million people with diabetes annually with our quality HbA1c testing solution. We can see the massive increase in diabetes prevalence, especially type 2 diabetes all across the world with well over 0.5 billion people now suffering from a diabetic condition not to mention the many more in a prediabetic stage. This creates a massive need for a highly effective nonpharma diabetes and prediabetes management solutions such as CGM that can be used alongside or instead of pharmaceutical therapy. That is why we are investing in this exciting and growing area but decided to enter into it in a derisked way by building on an established product. Since we made the acquisition, we have been prioritizing progressing, a, further developing our commercial strategy around CGM and biosensors; and b, the design and development of the next-generation CGM device. Now let me take you through our main activities in these areas. With respect to commercial strategy, since our acquisition, we have received a double-digit number of expressions of interest from potential commercialization partners across the globe. This is in addition to our existing relationship with Bayer for China and India. It is clear that there is significant appetite in the industry for a more affordable and sustainable CGM that still delivers a great user experience. That has made us more confident than ever that our unique technology provides a great platform on which to develop a next-generation CGM that can truly disrupt the diabetes care markets. For those of you who may be new to this area, our CGM technology is not some unproven noninvasive solution. Like the 2 main players, Abbott and DexCom, it uses a minimally invasive sensor wire. I think it is important that I take a moment to explain the importance of some of the technical differences in the Trinity technology and the valuable differentiated product features they facilitate. Like the other CGMs I mentioned, in the Trinity solution, an ultra-thin sensor wire is inserted a few millimeters into the skin. And this transmit live data about the level of blood glucose in the body to a smartphone. However, a critical distinction and benefit of our technology is that the sensor wire can be inserted into the body without the use of a needle. What this means is that our sensor can be inserted using a reusable sensor applicator. The others require a single-use applicator that punctures the skin with a retractable needle. This leads to the entire plastic and metal applicator becoming nonrecyclable biohazard waste. In contrast, our sensor applicator is reusable and lasts for years with all the sustainability and cost benefits that brings. While this might not sound like a big issue for every single person, using one of the leading products, over 2 years, they will generate over 11 pounds or 5 kilograms of nonrecyclable plastic and metal across 72 applicators. This drives 2 big problems with the main CGM solutions on the market today. One is cost, which creates a barrier to broader adoption of this life-saving technology. And the second problem is the massive amount of nonrecyclable waste they create. By contrast, over the 2-year period, our solution would use just one applicator. Our technology and approach greatly reduces the cost, environmentally harmful waste created by just this part of the solution, thereby solving 2 major problems with the current market-leading CGM. But we are not stopping there. As part of our modular solution, we are combining this reusable applicator with a reusable transmitter, encompassing a rechargeable power source and electronics to further reduce the cost and harmful waste of our solution compared to the 2 main competitors on market today. This powerful combination of reusable applicator and transmitter dramatically reduces the cost of our solution. And we believe that we can provide a CGM solution at a daily cost that is at least 40% less expensive than the current main product on markets. We believe this gives us a very significant competitive advantage and a great opportunity to disrupt the market. We understand that this is a very large market opportunity for a company of Trinity's current size. And that is why since the acquisition, we have been focused on creating a team of world-class designers and engineers to design and develop a next-generation CGM solution focused on: a, usability; b, affordability; and c, sustainability. We believe that by creating a next-generation product around these 3 themes, we can reach as many people as possible with this life-saving solution. Since we last spoke, we have now engaged a world-leading physical and digital product design consultancy based in London and California to lead the design of this next-generation solution. This group has designed a broad range of products from consumer electronic devices to carriers and are renowned for innovative and attractive designs. This group is being supported by our internal technical team and our external international technical consultants, who have also been progressing technical developments and extending the stability of our glucose sensor wire while maintaining its high level of accuracy. Since acquisition, we have made a number of enhancements to the sensor technology, and we've applied for ethical approval to begin a pre-pivotal clinical trial in June 2024. This pre-pivotal clinical trial will give us insights into the sensor optimization pathway, and we expect to receive ethical approval to commence the trial in the coming weeks. We intend to be providers of a digital health and wellness service to users, similar, if you like, to a subscription model technology company, an area I'm very familiar with. We do not want to be just a hardware supplier to other commercialization partners. We believe that strategy will allow Trinity to capture a much greater share of the value chain, not just in the diabetes space, but also the broader health and wellness markets, including obesity and weight management. That is why we are not just focusing on the physical product development. As part of our design focus on usability and differentiation, we are also concentrating on the insights the digital aspects of the solution can deliver to users. As we can see with GLP-1 drugs such as Ozempic, people with diabetes and prediabetes can benefit massively from behavioral changes. However, in the case of GLP-1, that change is driven by pharmacological-induced responses. The side effects of GLP-1 is becoming more and more understood. They are also very expensive drugs. We believe that CGM can be used to deliver key insights that can drive behavior changes that people with diabetes or prediabetes can really benefit from but without the need for long-term use of powerful drugs like GLP-1s and as part of an overall diabetes management program. Conscious that our ambition for the CGM project goes much further than just monitoring and with the huge potential we see in AI around this whole area, we are partnering with advanced software companies like PulseAI with whom we just last week signed a strategic collaboration agreement. We are working with PulseAI in developing data-driven software solutions to support users, as I said, not just in the diabetes space, but also the broader health and wellness market, including obesity and weight management, developing the broader digital health and wellness solutions as part of our overall platform is a key focus for us over the coming months. We have also strengthened our team with the appointment of Avinash Kale as Continuous Glucose Monitor Program Director. Avinash is already bringing a new level of knowledge and experience in the design and large-scale manufacturer of advanced medtech devices to this project. For those of you who wish to get further insights on our product vision for CGM, I invite you to visit our new CGM microsite that we just launched today at cgm.trinitybiotech.com. That's cgm.trinitybiotech.com. We have also put that link up on our LinkedIn page. This microsite is designed to keep stakeholders updated on our product development progress. On overall timing, we remain on track to enter into pivotal clinical trials of our next-generation CGM by summer 2025 with EU regulatory approval targeted by the end of 2025. We expect regulatory approval for further builder markets will follow the initial approval in the EU. On the cost of development, I'm delighted to let you know we are reducing our expected development spend for 2024 to less than $2 million per quarter between now and the end of 2024. Over the past few months, we have realized significant efficiency benefits by leveraging Trinity's established medtech business structure in developing the CGM platform. This allows us to use existing resources in the business to support development. In addition, we have also found a very rich partner network with many of our existing suppliers and some large electronics and digital solution partners having developed components to support wearable medical devices. This is lowering the amount of work and spend we expect is necessary to develop this next-generation project. We are more convinced than ever of the opportunity CGM represents for Trinity Biotech and are rapidly building the team and technology to deliver on that opportunity. So to conclude, overall, I am very happy with the significant progress we have made over the past few months on our ambitious priorities. We have had some key wins on TrinScreen HIV, which provides us with growth and additional profitability, which really helps stabilize our financial position. We are now executing at pace on our comprehensive transformation plan, which will support us delivering a step change in profitability in the coming quarters. And we can already see the beginnings of the impact of these and other profitability changes we introduced in late last year in driving increased financial performance. Finally, we are really pushing ahead in developing a highly impressive but differentiated CGM solution that can disrupt this massive market, help millions of people globally and deliver very significant growth to Trinity Biotech. I would like to thank you all for your attention, and I will now hand you over to Des to bring you through the Q1 financial results in more detail. Thank you.

Thanks, John. Before I speak to our financial results for the period, I want to take a moment to mention the most recent correspondence we received from Nasdaq around our continuing Nasdaq listing. On November 21 last year, we received a deficiency letter from Nasdaq notifying the company that for the preceding 30 consecutive business days, the market value of our publicly held shares remains below the minimum $15 million for continued inclusion on the Nasdaq Global Select. At that point, we were provided a 180 calendar days to regain compliance. This 180-day period ended on May 20 of this year. And as expected, yesterday, we received a further notice notify enough that we have not regained compliance. We intend to seek a hearing from Nasdaq. And that will put a stay on any further action until that year. We have appointed specialist adviser to support us in this manner, including the preparation of a comprehensive and compelling compliance plan. The Board has determined that the company will remain Nasdaq listed. And I know from speaking with our top investor that they're supportive of the company maintaining the listing. We'll update shareholders throughout the process. Now I will speak to our financial results for the first quarter of 2024. Our revenues for the first quarter of 2024 were $14.7 million compared to $14.8 million for the first quarter of 2023. Our Point-of-Care business experienced a strong performance in the quarter with revenues increasing by $0.8 million or 38.5% to $3 million. This increase was driven by our HIV screening test, TrinScreen, which had sales in the region of $1.2 million as we shipped further products to Africa following our more initial shipments in December 2023. In addition to this, we have received substantial orders for TrinScreen HIV post quarter end with our revenue for the year expected to be in the region of $8 million. Our clinical laboratory revenues decreased by 7.6% to $11.7 million compared to $12.7 million in the same quarter last year. Despite this drop, there is a strong performance from hemoglobin business, which experienced a 6.4% year-on-year increase in revenue. This, however, was more than offset by decreases in our lab services revenue due to previously reported -- due to the previously reported loss of our transplant testing activity at our Buffalo lab in early 2023. Our gross profit for the quarter was $5.5 million, representing a gross margin percentage of 37.6%, in line with gross margins in the same quarter last year. We recorded improved margins in our Hemoglobins business in the quarter on the back of the optimization of our instrument manufacturing supply chain and our revised in-house manufacturing process, which we fully implemented by the end of last quarter. Offsetting this was the impact of our TrinScreen HIV test, which were achieving lower gross margins than our other products. Increasing sales of TrinScreen over the remainder of 2024 will continue to dilute our overall gross margin percentage, although we do expect TrinScreen HIV to contribute additional gross profit as we progress through the year due to the various cost-saving initiatives that are underway as detailed by John. Additionally, we expect to realize further financial benefits of the previously announced cost-saving initiatives across our business throughout this year and into 2025, again, as John detailed earlier. Research and development expenses for the quarter were broadly flat. Following on from our acquisition of the Waveform assets in January, we continue to progress the development of our CGM offering, in line with our communicated plan. Our overall spend in the quarter related to our CGM biosensor division, including what was capitalized in line with IFRS accounting standard was $1.3 million for the quarter with ongoing spend per quarter expected to be less than $2 million. SG&A expenses for the quarter were $7.5 million, $1.1 million lower than the $8.6 million we incurred in Q1 2023. Key drivers of this improved SG&A expense include lower recurring salary and contractor costs in the last quarter versus the comparative period driven by headcount optimization activities in the latter half of 2023, together with other cost savings across our SG&A base due to the benefits of our cost-saving initiatives across the nonsalary expense base over the last 12 months. All of the above led to an operating loss of $3 million in the quarter compared to $3.9 million in Q1 2023, a decrease in loss for the period of $0.9 million or 23%. Net financial expenses in Q1 2024 was $0.2 million compared to $2.4 million in Q1 2023, a decrease of $2.2 million. The reduction in financial expense this quarter is as a result of the renegotiation of the terms of our term loan with our main lender, Perceptive Advisors, in January 2024. We obtained a 2.5% reduction in the base interest rate for the term loan. The amendment of the term loan is treated as a loan modification resulting in the recognition of a once-off noncash modification gain of $3.6 million in Q1 2024. This gain was based on the difference between the existing carrying amount of the loan as at the modification date and the revised carrying amount. Additionally, the fair value movement to our derivatives associated with our term loan and associated warrants was $0.7 million in the quarter primarily driven by a fair value movement of the warrants granted towards [indiscernible] Perceptive. Offsetting the above was an increase in the term loan interest expense of $0.4 million when compared to Q1 2023, this was driven by a higher outstanding loan balance, albeit at a lower prevailing interest rates in [indiscernible] earlier. Net loss from continuing operations was $3.3 million in the quarter compared to $6.3 million in the same quarter last year, an approximate 47% reduction. Loss before depreciation, amortization, impairments, tax, interest and share option charges, i.e. EBITDASO, was $1.5 million for the quarter compared to a loss of $2 million in the equivalent period last year, an approximate 25% improvement. Basic loss per ADS was $0.37 compared to $0.76 in Q1 2023. Our cash balance increased from $3.7 million in Q4 2023 to $5.8 million at the end of Q1 '24. Cash used by operations was $4 million in the quarter. Our sizable core operations, during the quarter, the company had an investing cash flow of $14 million, the largest element of this related to the outflow for the acquisition of the Waveform assets at $12.5 million. Cash inflows from financing activities were $18.8 million in the quarter primarily driven by net proceeds from the January 2024 drawdown from our lender of $21.7 million. This is offset by our quarterly interest. Now I will hand you back to Eric for questions.

[Operator Instructions] Our first question comes from the line of Jim Sidoti with Sidoti & Company.

Can you talk a little bit, let's start with the TrinScreen sales? Is everything of the 8 -- is all of the $8 million in 2024, is that all to Kenya? Or do you expect to be -- start shipping to other countries in 2024?

Jim, thanks for the question. For commercial reasons, we're not going to give that level of detail at this point, right? But what I will say is we do expect to be shipping to other countries outside of Kenya in 2024.

Okay. All right. And it sounds like there was a considerable amount of onetime on the costs in the quarter as you ramp up production. Can you give us -- can you quantify that at all, the onetime costs to ramp up production for TrinScreen?

It's less onetime cost, Jim, in terms of -- like the CapEx is already spent. It's really around training the staff and then them getting up to speed. The lack of efficiency, I suppose, comes from that space. As I said, we're introducing further automation in June, right? That will further increase our efficiency. And then we're also getting much better pricing on our input materials as part of the work we've done in the supply chain. So it's really just a kind of transition as we move forward from initial scale up to kind of run rate manufacturing and run rate supply chain. But we do expect it will have a significant impact. And we always knew TrinScreen would have a lower margin contribution because of the lower pricing point in the screening market rather than the confirmatory market. So that was nothing that was not new to us or it's not known to us. But really what's happened here is we've had to ramp up so quickly, which is a great sign of success, but that also brings our challenges as we would have expected it takes time for that to bed in. The flip side is these much greater volumes, not just in TrinScreen but across our rapid HIV products generally give us more leverage to negotiate with suppliers and get better pricing. So overall, we'd expect better profitability contribution from our rapid HIV business as a result of this increase. And then obviously, with the move later in the year to assembly in an offshore location going live, we'd expect that to deliver further increases in margin contribution. So overall, we do expect our margins to increase and not just in Point-of-Care but across the organization and our main revenue lines through the various initiatives that we're putting through. And I think as I said in the last call that we would expect our margins to be 50%-plus in 2025, and we still expect that to be the case.

Okay. All right. If we move over to the hemoglobin business, it sounds like you've made significant progress on shifting production and lowering the cost for that product. How about on product development side? Do you have everything in the market now that you expect to have in 2024? Or do you expect to have new versions of your premier system out there this year?

So our key next product development is around the new column and buffer combination. And that's really what gives a higher number of injections per column, and the column is the main consumable that we sell. It also provides greater stability, requires less what's called calibration, which is a kind of overhead that our users have to incur. So it has more usability, lower cost, lower consumption of key raw materials. So that, I suppose, Jim, is our next key innovation that we're now bringing to the market. In terms of the instruments, we have been making changes in the background on that. As part of our supply chain optimization, we've not just been looking to reduce the cost of those components. We've also been looking to increase the reliability. So we carried out an analysis of what were the main parts of that component -- the main part of that system that failed. And we've looked to change those out either through supplier changes and/or engineering design changes. So that's really, I suppose, Jim, what we're doing to drive innovation within that. We continue to look at the medium throughput -- low to medium throughput device, which we typically call the T-10 or the T-20, and that's something we are continuing to look at in terms of the appetite for throughput through that instrument if and when we bring it to the market. And -- but for now, our focus is really around rolling out the column and rolling out those changes in the [ 90 to 10 ] from a reliability perspective.

Okay. All right. And then on the CGM side, you said development costs this year should be less than $2 million a quarter. Going forward, do you think that number ramps up in 2025 as trial activity continues? Or do you think that $2 million per quarter that stays relatively flat going forward, maybe not 2025, but in general going forward, should that number stay around that level?

Yes. So look, what I indicated in the past is we continue to spend on CGM while we continue to see real progress, right? And believe that we have a disruptive product that we can really make a significant contribution to the market. As I set out in my prepared remarks, we're more confident that now than ever, right? You're absolutely right, Jim. I think in 2025, as we move to pivotal clinical trials, that will increase our expenditure. But we'll only do that if we have a very high degree of confidence that the product would perform well in those trials and will support to getting regulatory approval. What are the benefits of doing this within Trinity is we have a large, large degree of experience in taking products through regulatory approval processes, both from the Trinity team that have been here a number of years and also some of the more senior people we've brought in over the last couple of years. So I think from our perspective, we wouldn't -- we would only go into that process, as I said, with a high degree of confidence. And from an investment and return perspective, Jim, that will be a very compelling proposition I would expect considering the size of the market and the opportunity we believe we have to disrupt it.

Okay. All right. And the last one for me, interest expense. I know you had the onetime adjustment in the quarter this quarter. So going forward, though, for the remainder of 2024 with the new debt level and the new interest, what should we assume a good number is for interest expense?

It's about 2.5 a quarter, I suppose, Jim, based upon that debt level, yes.

Okay. All right. Well, it definitely sounds like you've made a lot of progress on the cost side. So that was good to see. And especially with the increasing revenue from TrinScreen, it should lead to much better operating results. So that's very good to see. So I guess we'll just have to stay tuned to see how development goes on CGM.

Yes, Jim. Look, we're -- as I said, we're very happy with the progress we've had. We're very happy with the team that we've built, and actually, to reiterate a point I made in my prepared remarks, was to be really enlightening for us is the rich partner network that's out there in terms of people that have built already components, both from a physical perspective and a digital perspective for this type of industry. And I suppose doing this development within an established company like Trinity, where in many cases, we have long, long relationship with these customers means that we're much more credible than a startup in fostering those relationships and getting to a real point of traction with them. And we think that will really reduce down the amount of work and spend we need to incur in order to really move the development project forward. So outside of the work we've done over the last couple of months, reiterating the significant market opportunity and how our differentiated solution can really help capture that, the partner network and our credibility within that has been very, very positive, both from a timing perspective and a cost perspective.

[Operator Instructions] Thank you, ladies and gentlemen. This concludes our question-and-answer session. I'll turn the floor back to Mr. Gillard for any final comments.

Thank you, Melissa. And just for me, thank you for everyone for your continued interest in the company and joining today's conference. We continue to be focused on execution on those key priorities that we set out. And I look forward to updating you all over the next coming weeks and months in terms of our further progress. Thank you so much, and have a great day.

Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

Greetings! Welcome to the Trinity Biotech’s Fourth Quarter and Full Year 2023 Earnings Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. [Operator Instructions]. Please note that this conference is being recorded. At this time I’ll now turn the conference over to Eric Ribner, with Investor Relations. Eric, you may now begin.

Good morning everyone. And thank you for joining us on today call. Before we begin, please note that statements made during this presentation may be deemed forward-looking statements within the meaning of Federal Securities Laws. These statements are subject to known and unknown risks and uncertainties that may cause actual events to differ from those expressed or implied in such statements. These risks include, but are not limited to those set forth in the risk factor statement in the company's annual report on Form 20-F filed with the Securities and Exchange Commission. Trinity Biotech undertakes no obligation to publicly advise, update or revise these forward-looking statements to reflect events or circumstances after today, or the occurrence of unanticipated events. And with that, I’ll turn the call over to John Gillard, CEO.

Thank you, Eric. Good morning everyone. And thank you for joining today's call. We really do appreciate you taking the time. This morning I will take you through some key business updates, including new financial guidance, our progress in our recently acquired biosensor business, and our comprehensive transformation plan, that I set out to investors in early March at the Emerging Growth Conference. I will then hand you over to Des to bring you through the financial results for Q4 and fiscal year 2023. Right now, Trinity Biotech is an experience diagnostic company that under new leadership and with fresh thinking plans to transform its existing business into a high-performing cash-generative enterprise. This morning we are pleased to introduce financial guidance which is predicated solely on growth from the existing businesses, including haemoglobin and HIV testing, and planned improvements to operating margins. This does not include any contribution from the newly acquired biosensor platform technology. We are targeting approximately $20 million of annualized run-rate EBITDASO, so earnings before interest, tax depreciation, amortization, impairment, and share-based compensation costs, by Q2, 2025. This is based upon targeted annualized run-rate revenues of approximately $75 million by Q2, 2025. We believe that this guidance is achievable, based on our comprehensive transformation plan for the business which we will review in more detail today. Additionally, 2024 is already off to a strong start, which increases our conviction in our outlook. In addition to strengthening the base business, we aim to scale the company by building a global business in wearable biosensors, initially with a focus on continuous glucose monitors or CGMs. We believe that this product can be a real game changer for the company. This represents the key growth driver for Trinity Biotech into the medium term. As many of you will know, just over two months ago, we announced the acquisition of the biosensor technology of Waveform Technologies. Waveform had an established and proven biosensor technology with a European Regulatory Approved CGM product. In addition to acquiring this technology and product rights, we have hired a number of key individuals who created this technology at Waveform. Using this established technology, we intend to update Waveform's existing product and launch a more affordable, high-quality CGM into a broad number of markets globally. Since the acquisition, we have been progressing this plan across a number of areas, including, one, building out our biosensor team, with a number of key appointments from established medical device and diabetes technology companies, such as Phillips, Johnson & Johnson and Lifescan. Two, we have re-established CGM manufacturing capability. This greatly assists us in planning and executing sensor design improvements. This work is based on the existing CGM product design, and has been carried out with the assistance of world-class, external technical and design consultants. Three, the team is also initiating enhanced data analysis on Waveform’s large existing data bank of clinical trial results and we are very excited by the potential outcomes of that analysis. In addition to this technical work, we are progressing discussions and agreements with potential commercial partners, such as Bayer for the launch of our CGM products. Finally, we are establishing a scientific and user advisory group for CGM. This is to ensure that strong clinical outcomes and user needs remain at the forefront of our thinking. As you can see, there are a broad range of activities ongoing, and we will keep investors appraised of our progress on this business as we advance our plan forward. Now I would like to transition over to discussing Trinity's comprehensive transformation plan for our existing business. This transformation plan is a key pillar of our new management team's fresh vision and strategy for the company. As I have said previously, this is a vision and strategy that builds on the past, but also breaks from the past, toward a future of more ambitious growth. As part of our near-term transition plan in 2024 and 2025, we will drive a step change in our financial performance. By building on our existing revenue base and eliminating unnecessary overhead and complexity, my immediate priority is to dramatically improve the financial performance of the company's existing business. As such, we are totally focused on getting us to a position where Trinity's existing business is delivering substantial free cash flow. I believe this is critically important for three key reasons. Firstly, the obvious point, cash generated businesses are generally more valuable which increases value for our shareholders. Secondly, better performing businesses strengthen our balance sheet. And thirdly, we believe that our new and future biosensor technology provides a tremendous opportunity for a significant future growth and that a strong balance sheet will permit us to capitalize on this opportunity more rapidly. Looking at our transformation plans for the existing business, it had several key components that we believe are rapidly achievable, in most cases by mid-2025. The three main components are, one, reducing complexity and cost through consolidation. Two, reducing cost of goods through negotiation and supplier changes. And three, further simplifying our internal operations through consolidation in lower cost locations. Let me expand on these. In the first of these, we are considerably reducing complexity and cost by consolidating our main manufacturing operations into a considerably smaller number of main sites, and also moving to an outsource model for a significant amount of our less complex manufacturing activities. As part of this initiative, we are today announcing that we will cease manufacturing at our Kansas site before the end of 2024. This site has traditionally supported our diabetes HbA1c testing and hemoglobin variant tests. We believe that we can create multi-million dollar annualized operational efficiency by absorbing much of this activity into our other manufacturing footprint and outsourcing other aspects of operation. These additional efficiencies, coupled with the $4 million annualized savings from other projects in our diabetes HPA1c business are a game changer in terms of this business's profitability and cash flow generation profile. This will create a recurring revenue business of significant value. This change is part of a broader strategic objective to centralize our most complex and valuable manufacturing activities so as to maximize quality and intellectual property protection while outsourcing less complex manufacturing activities so as to drive efficiencies and reduce complexity. By using this strategy, we believe we can significantly reduce our cost while maintaining the high quality of our products and protecting our intellectual property. In the second element, we are also considerably reducing the cost of goods of many of our products by changing suppliers and negotiating new deals with existing suppliers. This is an area where we have already achieved millions of dollars of annualized savings and I believe there is even more we can do here over the coming quarters. In the third element, we are further simplifying our internal operations and centralizing business support functions in lower cost locations. As such, today we are announcing a project to move a significant portion of our business support functions to a lower cost and centralized location. This should drive a significant reduction in our SG&A expenditure, plus and very importantly, provide us with a cost efficient and highly scalable platform that can efficiently and rapidly support our expansion to the growth of our wearable biosensor business. We are currently well advanced in working with our partners and our staff on these changes, and we expect to have these changes complete by Q4, 2024. While many of these initiatives are focused on cost optimization, they are within our realm of control. As a result, I have a high degree of confidence that these will deliver the financial benefits we have targeted. In my prior role as CFO, before I took over as CEO in late December last year, we began planning and executing on many of these initiatives, and as a result we are already beginning to realize some of the financial benefits. As you can see from today's announcements, we have clear steps underway to deliver the remaining benefits to the base business between now and Q2, 2025 when we are targeting approximately $20 million of annualized run rate EBITDASO. This is on targeted annualized run rate revenues of approximately $75 million. We plan to give further details on these initiatives and their progress during our future earnings announcements and presentations. As I had said before, we recognize that in this we are taking some big bets. But we believe these are necessary to deliver the fundamental change in financial performance that will emerge from a more streamlined and nimble organization. We have mitigated execution risk in the following ways. (A), putting in place a highly skilled and experienced team who have come from large and sophisticated organizations, and have a significant experience in driving and delivering these types of changed projects. (B), careful selection of our transformation partners. We have selected highly capable and reputable outsourcing and supply chain partners who have a strong track record in our industry. And (C), developing a strong culture of change execution in the business. Our strong start in 2024 is a testament to the effectiveness of our efforts and the strong culture of execution we are building within Trinity. Let me share some examples. I am delighted and very proud of our team's performance in successfully scaling our rapid HIV testing manufacturing capacity in Q1, 2024 to meet the additional output requirements for TrinScreen HIV screening algorithm win in Kenya. Our ability to scale manufacturing output fourfold required some major changes in the business and the way it operates. This was critical for us in demonstrating our capability and commitment to be a strong and reliable partner to our TrinScreen HIV testing partners, just as we have been for many years in our to our Uni-Gold HIV testing partners. We were also very pleased this week to receive a further purchase order for an additional 2 million TrinScrees HIV tests for the Kenya market. We expect to supply this in Q2, 2024. We receive this order in spite of another legal challenge against the Kenyan government, HIV testing algorithm, this time from the manufacture of a competitor product. We will be monitoring this case against the Kenyan government for any impact on orders for TrinScreen HIV for Kenya. But at this stage our focus is on delivering the quality tests that have been ordered by our customers to support the critically important HIV screening program in Kenya. Outside of HIV we have continued to execute on our key change initiatives in our existing diabetes HbA1c testing group. We have now completed the development and testing of our new diabetes HbA1c Column System on time. As set out in today's press release, the results of this development program have exceeded expectations with our new Column System now delivering up to 4 times -- excuse me, the number of injections compared to the existing product. As planned we are now executing on the commercial launch of these new products. This new Column System is more convenient for many of our users and reduces our cost of goods to service these customers. We expect to see the financial benefits from this rollout to accrue from quarter two this year. We have also now completely brought in house the manufacturing process of our key diabetes HbA1c consumers and see startling any further product from our external provider. Again this project has been delivered on time and as planned. Finally we are now using lower cost components in our Hemoglobin Instrument business. This is as a result of our supply chain optimization focus. These three initiatives are expected to deliver approximately $4 million of annualized savings and significantly benefit the profitability and value of our hemoglobin business. So, to sum up from me, a recent strategic acquisition gives us a foothold in a vast and rapidly expanding CGM market, into which we plan to introduce a highly competitive offer that we believe can successfully disrupt the market and capture significant value for our shareholders. We are pleased to be progressing on target with our initial plan for the business. Trinity Biotech, as I said, is an experienced diagnostic company that under new leadership and with fresh thinking can transform its existing business into a high-performing cash-generated enterprise, and we are very focused on executing on this plan. With that, I will hand you over to Des Fitzgerald, our CFO, who will bring you through the financial results for Q4 and fiscal year 2023. Thank you for your time.

Thank you, John. I will now speak to our financial results for the four quarter of 2023. And following that, I will briefly discuss our full year 2023 financial results. Our revenues for the four quarter of 2023 were $13.4 million, compared to $15.7 million for the same quarter in 2022, a decline of $2.3 million. This movement was driven by, firstly, declines in our hemoglobins business of $1 million quarter-on-quarter, as we defer year-end shipments of products at suboptimal pricing as we renegotiate the contract terms, terms that are now agreed as of Q1, 2024. Secondly, a decline of $0.6 million, quarter-on-quarter in our autoimmune business, due to the already communicated ceasing of our transplant testing activity in our Buffalo Lab business, and thirdly, lower period-over-period revenue from our COVID-19 VTM products, leading to a decline of $0.2 million in that product segment. Additionally, in our point of care business, we experienced a decline of $0.5 million, driven by lower sales in our Uni-Gold test, due to regular ordering patterns in that business. That decline is partially offset by revenue from our TrinScreen test of $0.4 million. This quarter was the first quarter we recorded revenue from our sales of our TrinScreen product to Africa, and we expect this test to be a key growth driver for us going forward. Our gross profit for the quarter was $4.6 million, representing a gross margin percentage of 34%, which was broadly in line with Q4, 2022. Other operating income decreased from $0.3 million in Q4, 2022 to zero in Q4, 2023. Other operating income in Q4, 2022 comprised government grants in relation to R&D activities, and there was no equivalent in the fourth quarter of 2022. Research and development expenses were $1.1 million for the quarter in line with Q4, 2022. SG&A expenses were $6.9 million in the quarter, $2.8 million lower than the $9.7 million incurred in Q4, 2022. Key drivers of this reduction were a lower share-based payments expense of $2.3 million when compared to the same period in Q4, 2022, primarily due to the reversal of cumulative share-based payments expenses for unvested options related to our former CEO's resignation in this quarter. Additionally, included when SG&A spent this quarter was $1.8 million of non-product development legal, audit, and professional advisory fees. These fees were elevated in the quarter with the main driver being due to our acquisition of the CGM assets of Waveform in January 2024. Our expected level of non-product development advisory, audit and consulting fees going forward is expected to be broadly a quarter of the Q4, 2023 level. We recognized an impairment charge of $0.3 million in Q4, 2022, which compared to a charge of $3 million in the same quarter last year. In the quarter, we recognized $0.3 million impairments across our cash-generating units, Immco and Trinity Biotech Do Brasil as their value in use was below their current value. We are seeking to implement profit initiatives in both units. All of the above led to an operating loss of $3.8 million in the quarter compared to $8.2 million in Q4, 2022, but the key drivers for the lower loss being lower impairment charges and lower SG&A expenses offset by lower revenue. Financial income, representing movements in the derivative liability related to warrants granted to Perceptive Advisors our main lender for the period was $0.6 million compared to $0.3 million in Q4, 2022. Financial expenses in the fourth quarter of 2023 were $2.3 million compared to $2.4 million in Q4, 2022, with a slight decrease due to a lower principal amount over the quarter offset by higher prevailing interest rates. Loss before depreciation and amortization, impairments, tax interest and share option charges was $4 million for the quarter, basic loss per ADS of $71.8 compared to $132.3 in Q4, 2022. Our cash balance decreased from $6.3 million in Q3, 2023 to $3.7 million in Q4, 2023. Cash generated by operations was a positive $0.3 million in the quarter, in cases of net movement in their networking capital of $4.4 million. In January 2024, the company entered into an amended credit agreement where it's existed with our existing main lender, Perceptive Advisors. Under the amended term loan and additional $22 million of funding was made available to us, with $12.5 million being used to acquire the Waveform assets. The remaining $9.5 million is available for general corporate purposes, including for the further development of the CGM of biosensor technologies. In addition, the loan provides for additional liquidity of up to $6.5 million that may be drawn down by us between April and December 2024, which can be used for general corporate purposes, again, providing further liquidity to fund the development of the CGM and biosensor technologies. The amended term loan, also immediately reduced the annual rate of interest on the loan by 2.5% to 8.75% plus the greater of the term Secured Overnight Financing Rate or SOFR or 4% per annum, and allows for a further 2.5% reduction in the base rate to 6.25% once the outstanding principal loan under the amended term loan falls below $35 million. Additionally, the term loan reduced the early repayment penalty from a range of 8% to 7% down to 4% to 3.5% depending on the timing of early repayment and also reduced the revenue covenants. The amended term loan matures in January 2026. Now I will move on to the full year 2023 results and give a brief overview of the financial performance of the year. Revenue for the full year was $56.8 million, a decrease of an approximately 9% on revenues for 2022. The key drivers of the decrease were firstly lower COVID revenues of $1.8 million year-on-year as COVID testing programs scaled down. Secondly, lower autoimmune lab services revenues of $1.8 million as we lost the key transplant testing service contracts. And thirdly, declines in our hemoglobin business due to their predicted decline in sales related to our Ultra II instrument, and also, as discussed earlier, lower sales in the fourth quarter as we deferred shipment while we renegotiated contract terms with the key customers. Gross margin for the year amounted to $19.5 million representing a gross margin percentage of 34.2%. This was 6.6% higher than 2022. This increase was due to a significant inventory obsolescence charge of $4.7 million that we experienced in Q3, 2022. Our SG&A selling, general and administrative expenses in FY’23 increased by $4.2 million to $31.2 million versus FY’22, an increase of nearly 16%. Significant elements of this increase relate to an increase of $1.6 million in technical advisory, legal and professional fees primarily due to the acquisition of the biosensor assets of Waveform, which was complex in nature as we turned up with an asset deal. Together with other corporate developments and corporate finance activities as we continue to assess our strategic opportunities and balance sheet optimization initiatives. We also experienced higher FX losses largely related to the revaluation of euro-denominated lease liabilities. We experienced impairment charges of $11.1 million in FY’23, largely driven by an impairment to Immco due to the loss of revenue relating to the transplant testing activity together with a write down of our investments in imaware. Our operating loss for the year was $27 million. Our financial expenses for the year were $11.1 million compared to $24.7 million in FY’22, was the decreased primarily driven by two material items. Firstly, we experienced a loss of $9.7 million in FY’22 relating to the disposal of exchangeable notes, and secondly, we incurred a larger period-on-period earlier repayment penalty relating to a re-payment of the Perceptive term loan in FY’22 of $3.5 million versus a similar penalty of $0.9 million in FY’23 related to a smaller repayment during the financial year. Profit from discontinued operations totals $12.9 million in FY’23, largely attributable to the gain of $12.7 million arising from the divestiture of Fitzgerald Industries. Loss on continuing operations before interest tax, depreciation and amortization, share-based payments and impairment charges was $12.1 million. Cash use by operations was $11.9 million in the year, inclusive of the negative net movement in working capital of $2.7 million. To finish, as CFO and as part of this new management team, I will reiterate that we are fully focused on the implementation and execution of the transformation plan that was laid out by John earlier in the call to transform Trinity into a hype forming, cash-generative enterprise, and I am excited to be part of this company as we plan to disrupt the rapidly expanding CGM market on the back of our recent strategic acquisition of Waveform. Now I will hand you back to the operator for questions.

Thank you. [Operator Instructions]. Thank you. Thank you. Our first question is from the line of Jim Sidoti with Sidoti & Company. Please proceed with your questions.

Hi, good morning, and thanks for taking the questions. First one on the diabetes business, are all these -- the new products that you have, the new consumables, are those all approved and ready for market or are there approvals that you need to get before you can start to sell those devices?

There may be local registrations required, but they are effectively a variant on the existing approved product. So, we don't have to go for a new 510(k) or something like that, Jim. So they're available to roll out immediately in certain markets and other markets, there is just registration requirements. We've finished all the testing, all the trials, there's no regulatory risk at this point around that.

So, that applies to the fact that you've changed manufacturing locations for the consumable and the instruments that's all been worked out with the FDA?

Yeah, so they go through what's called a variation change process, and you need to show basically comparable performance. So, without boring everyone on the call with some of the regulatory issues, but effectively Jim, there are requirements that the various facilities need to have, and then they have to operate a specific type of quality system, and we need to carry out testing to show that the products that we manufactured in a particular place or in a particular way previous is comparable to the product that we manufacture now. And I suppose that's why it's very important for us to have an experienced and highly specialized team that can plan and execute on those types of initiatives. As they set out, there's very significant savings associated with this and that's one of the reasons that over the last two or three years we have been making these senior hires to give the company the capability to number one, identify these opportunities and then number two, to be able to execute on them and execute on them efficiently and quickly. I think that's something as a business we have developed very significantly over the last two to three years, and we're now seeing the benefits of having those people in place, and I suppose having the management focus and discipline around executing on it.

And so it sounds like by this current quarter you should be in the market with product that has similar results, but significantly lower manufacturing costs. So, I would assume you'd be able to compete on price more effectively starting the second quarter of 2024. Is that correct?

Yeah, exactly, Jim. So the reason that we push these changes are really twofold. Number one, to reduce down our cost in manufacture and that should give us higher revenue and higher cash flows from that business. And then secondly, to allow us to compete in different parts of the market especially, A1c testing that traditionally haven't been really that open to us. I would categorize that in two ways. So, by updating our Column System and now allowing a higher number of injections, that opens us up to labs that run a higher number of tests, and that wouldn't really have been practically available to us in many markets. So, that kind of increases our time across the number of labs that are potentially open to our type of solution. And then secondly, by reducing down our costs, it allows us to target maybe lower price markets, where we traditionally have either not sought to compete or have been able to effectively compete. And very much what goes hand in hand with that is the work that we've done to reduce down the cost of building the instrument, and now what we're doing around outsourcing more aspects of the manufacturing of that instrument. So, by reducing down the cost of the consumables and reducing down the cost of the instrument, you reduce down the total cost of ownership, either to the distributor or the lab themselves of our solution, and we think that would give us a more competitive offering in those other parts of the market that we haven't been able to aggressively attack in the past.

All right, and then if we switch over to TrinScreen, it sounds like you've made progress getting that manufacturing up and running. You've got the sales already in Kenya. Are there other markets in Africa where you can sell the product?

Yeah, because we have WHOPQ approval, there are many markets effectively open to us for a regulatory perspective. As you know, Jim, the way that this testing happens in Africa is through national algorithms. That's effective via a list of approved products or selective products, I should say, to be used in the national testing programs. You typically have a screening test, which what TrinScreen is for. You have a confirmatory test, which is Uni-Gold, and you maybe have a second line confirmatory test, which again could be Uni-Gold. So we cover off the screening and the confirmatory test markets with both products. Those algorithms come up for change every so often. That is both a positive and a negative. It is a negative when you're trying to get into new countries, but it's a positive when you're getting selected from that algorithm, because typically it doesn't change that terribly often, provided you continue to provide the quality products. So, it takes some time to build a business within that, but as we've seen with our Uni-Gold business for the last 20, 25 years, that can provide a very stable recurring business. So there are a number of countries that the team is working hard at getting the product into. It's a competitive market and we will not release the names of those countries until we have to for competitive reasons, but we have a senior team that are very experienced, both within Trinity and from other companies that are highly successful in this market, working for us on these initiatives, and we do expect to win further countries as we move through. And as I said, it doesn't happen overnight, but the flip side of that is that it does give you some recurring revenue and some predictability, and it's both an asset once you win some of those countries.

So, it sounds like nothing may happen in the near term, but by 2025 you do think that you'll be selling the product to other countries in Africa? Is that the ..

I think that’s -- exactly. I think that's a fair way to categorize it, Jim. I would agree with that.

Okay. All right. And then I just want to be clear, the guidance you gave for revenue and EBITDA for 2025, that includes no revenue from CGM, is that correct?

Yeah, exactly. So that's really built upon the existing business. We would expect continued growth from TrinScreen through Kenya and winning some of those other countries as we spoke about, and then also some growth within our hemoglobins business from those changes that we already spoke about, in terms of the lower costs and our ability to grow. Like we typically see year-on-year growth in our hemoglobins business, but we do expect these changes to really position us for stronger growth in the second part of this year and onwards. As we roll out the more efficient instrument from a cost perspective and our new Column System. So, I think we fairly expect additional growth there, and that's really where we expect to build over time to that $75 million run rate number that we talked about earlier.

And when do you think it’s reasonable to assume that you’ll start your underwriting revenue from CGM?

At this point we are not seeing a huge amount on that. We are very much looking at the data from the wave Waveform existing device. The Waveform device has been through a number of clinical trials over the years. So, there is a rich vein of data for us to work with there. We're also speaking with commercial partners, and that would inform what we will do in terms of commercial launch. What we've previously said is, with regards to the next generation device, we expect to be in clinical trials summer 2025, and we'd expect to be in the market, ideally within six months after that. Depending on the outcome of the various data analysis that we're doing right now and conversations with commercial partners, we may change that. We may take a different approach, but I don't want to say too much about that now until we decide what we're going to do based upon further data analysis and further discussions and feedback from the market. What I will say is, we have been very positively influenced and happy with the feedback from some commercial partners in terms of the desire to have a product on the market as quickly as possible. People recognize the unique benefits of the Waveform device, particularly in terms of cost of care and reducing down that daily cost of this critical technology and solution for people who have diabetes. So, we're confident the demand is there, and we just need to decide which way we can best meet that demand in a way that allows us to build a very successful business and brand for the future going forward.

All right. Then some general modeling questions. What should we use for an effective share account for 2024?

I think we're at about $9 million ADSs now. That's after our reverse share split a number of weeks ago. So, I think we're at $9 million.

Okay. And that includes the shares that were used to complete the divestures [ph].

Yeah, the Waveform acquisition, Jim.

I'm sorry, complete the acquisition. Right?

Yeah, yeah, exactly.

And do you think with the cash on hand and the $6 million cash available, do you think you have enough cash to make the changes in 2024 that you want to make?

We're running fast to do that. The benefit of improving the cost basis of the business is twofold, Jim, right. The quicker we do it, the less cash we need to get there. Then each initiative that we successfully execute on provides further positive cash flow to fund the other initiatives. That's, we're running very, very fast. We're being aggressive here. We think it's necessary and we think it's warranted, and so I would be hopeful that that would be enough to get us to where we need to get to within the changes around the existing business, and we'll obviously keep that under review. But like I said we're working hard to make sure that's the case.

Okay. All right. And then you mentioned a couple of times that 2024 is off to a strong start. Can you give us any guidance on that first quarter? Or would you rather wait a couple of weeks for that?

Well, only four days post-quarter in. So, what I will say is we do expect revenues to be stronger in Q1, 2024 than they were in Q4, 2023. So, certainly some positive momentum there, and yeah, so for us, look at the focus is on executing on these initiatives to change our cash generation profile and our cost profile, and then to build that revenue base. So, I think, we've been a strong start on both sides of the equation.

All right. Seems like there's quite a bit going on. Appreciate all the color. Thank you.

Thanks, Jim.

Thank you. Our next question is from the line of Paul Nouri with Noble. Please proceed with your questions.

Hey, good morning. Thanks for taking the questions.

Hi Paul.

So, do you have a target gross margin for 2025 that you could share, a range?

We hadn’t really planned on going that deep Paul. I think we'd expect it to be – 50% would be kind of where we would be hoping to get to, are targeting to get to, and that’s really from the procurement efficiencies that we're talking about, the outsourcing of some of the less complex aspects of our manufacturing right, and the consolidation of the manufacturing site. I mean they will have a significant impact on that gross margin. And then I suppose – so that we turn that into a higher degree of cash generation, that's the reason we are focused on our SG&A and very much focused on reducing down the cost of complexity that we have within the business. I know from speaking to shareholders that you know people have I think rightly to be concerned about the extent of SG&A. Some of the key drivers for that are, we have a broad breadth of products, we are operating in a highly regulated industry and we also sell to a large number of countries globally. And all of those drive complexity, and we have traditionally been managing that complexity across a number of different sites, usually typically co-locations with our manufacturing facilities and our manufacturing facilities are not in low-cost locations. Our manufacturing facilities in the whole are in Ireland and they are in the US. That leads to a situation where you have a high degree of complexity, you need to resource that complexity and do it in a distributed way, reduces down the efficiency, and do it in higher cost countries, increases the cost and amplifies the costs of that inefficiency. And that's really why we're focused on centralizing a lot of those functions into a lower cost country, where we can get those efficiencies and we can also reduce down the cost of servicing that compliance burden. So no, that's not a little bit longer than gross margin, but I think I want to make it clear, we're targeting all areas of the P&L really, to try and get back to that very positive EBITDASO number. So it's a comprehensive view we're trying to take it.

Okay, and in terms of the source of the growth, because it's pretty dramatic, the expected growth. Do you see it evenly between point-of-care and the lab business or should it be more weighted towards one or the other?

It's probably a bit more on point-of-care Paul, but not usually so. As I said, we normally see year-on-year growth with our hemoglobins business anyway. So within that, as I said, because of the changes in the product, we do expect to have a more competitive product to go to the market and we do be able to expect to have core market share over time. We also have the Premier Resolution within that. As you know that type of sales process and installation process is a slow burner and it's not a high volume type of play, but it’s very sticky when you get it into a lab. So I think both of them will drive some hemoglobin growth, but obviously the point of care especially with TrinScreen, because that is designed for the screening market, they are generally much, much higher volume than the HIV confirmatory testing markets that we've been in previously. So the example I always give is, if someone – if 10 people go for a screening test, maybe only one person goes and gets the confirmation test right, because you got a positive on the screening test, it might even be less. So in that example the screening market from a volume perspective is 10x the size of the confirmatory test market. So that's why a win, especially in a reasonable size country right, can have quite a big impact in terms of revenue for a company of our size, and that's why it's a little bit of a game changer for us to be into that space. So to take your point, there is growth within that, but I suppose you know we have built in wins in terms of Kenya and then just growth from a hemoglobin, from particularly that new product growth.

And I know in hemoglobin, you have a presence in China, you have a presence in Brazil, but going forward the next couple of years, do you see more of your growth in the U.S. or in some of those international markets?

No, I think it's more in the international markets. Like, the reality is HbA1c testing in the U.S. is typically now on the larger chemistry systems, where we continue to have a strong presence either in your research areas or some of the more high quality, lower volume type labs, right, that are very focused on – very, very focused on the quality of the test and very focused on accuracy. And we know our product delivers that very well, especially in populations where there is a significant amount of hemoglobin variance, right, so we continue to hold a position there. If you look where diabetes is going, it is growing – it's still growing in the U.S., but it's growing very much internationally, right, and a lot of the countries that have high degree of hemoglobin variant, where there's arguably a greater benefit from using our technology is in Asia, is in Africa, in those types of countries. So I expect a good chunk of our growth to come from those more, as you would call it, international markets, rather than the U.S. and probably rather than Western Europe. They are just using a different type of technology.

And then just two more quick ones. Did the Sjogren's test continue to grow?

Yes, that continues to grow and continued growth in terms – I think post-COVID we've all kind of forgotten about that, thankfully. But we're still seeing autoimmune issues arise from that, and so it's an area we are focusing on. And we think that the autoimmune space, particularly around kind of esoteric tests and our screening tests that have a prognostic value can be very, very beneficial. So look, that continues to be a good performing part of our business in terms of the Sjogren's test, and we think it is maybe a good model for growth going forward, without a huge amount of capital expenditure, which is helpful.

And then the last question, the EBITDA guidance, that includes the spending you are doing in the CGM segment?

No. So we capitalized that Paul under IFRS. We capitalize that expenditure as we typically would have with product development spend, and so look, what I would say about that is the CGM spend is optional, okay. We will only continue to spend on developing that product if it is developing results for us right, and we're confident with the technology direction and the market direction. I think we've no question over the market direction. We know that this market is exploding, and we know from speaking with market participants that there is a strong desire for a lower cost solution, right. The technology piece, I think we have substantially de-risked by acquiring a technology that's already proven and has European regulatory approval. What we're really doing is looking to tweak that, change the form factor, improve the manufacturing process as an experienced high-scale medical device manufacturer ourselves. You know we're confident we can do that. So that's not a built-in ongoing drain on cash resources. We will only continue to invest in that business Paul, while we are very confident that we will see returns in that. And my own personal view would be we'll see very, very significant returns on any investment in that area.

Okay. Thanks a lot.

Thank you. At this time, we've reached the end of our allotted time for question-and-answer sessions today, and that will also conclude today's conference. Thank you for your participation and have a wonderful day.

Thank you, everybody.

Greetings, and welcome to the Trinity Biotech corporate update call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, [ Eric Rebner ]. Thank you, Mr. Rebner. You may begin.

Thanks very much and thank you for all for joining us today to review Trinity Biotech's entry into the wearable biosensor market and associated intended partnership with Bayer and its amended credit agreement and strengthened investment relationship with Perceptive Advisors. We will also touch on the company's Q3 2023 results. Joining us on today's call are John Gillard, Chief Executive Officer; and Des Fitzgerald, Chief Financial Officer. Before we begin, please note that statements made during this conference call may be deemed forward-looking within the meaning of federal securities laws. These statements are subject to known and unknown risks and uncertainties that may cause actual events to differ from those expressed or implied in such statements. These risks include but are not limited to those set forth in the risk factor statement in the company's annual report on Form 20-F with the Securities and Exchange Commission. Trinity Biotech undertakes no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after today or the occurrence of unanticipated events. Please also note that description of the transactions on today's call do not purport to be complete and is qualified in its entirety by reference to the transaction documents which will be included in Form 6-K to be filed with the U.S. Securities and Exchange Commission. With that said, I will now turn the call over to CEO, John Gillard, after which we will open -- after which we will let you know that you can ask us questions by using the e-mail associated on the press releases. John, the floor is yours.

Thank you, Eric. Hello, everyone. I'm very excited to speak to you today in my first investor conference as CEO about the recent Waveform transaction, which we believe marks the beginning of Trinity's transition into a global leader in wearable biosensor technology. Behind the scenes, we've been spending a significant amount of time evaluating options to drive the company's future and I'm eager to tell you about our vision and plan moving forward. We have engaged a group of industry-leading consultants with whom we have collaborated to assess markets, conduct extensive technical due diligence and map out development and commercialization scenarios. We have combined this work with Trinity's 30-year health care industry experience and the insights that our new management team bring from other industries and companies to develop our reinvented vision for Trinity, a vision built around the modern technology and health care landscape. This vision is ultimately focused on developing a range of wearable biosensors to deliver analytically driven health and wellness insights based upon what is happening in, on and around the body. Compared to sporadic and/or infrequent lab testing that combine disjointed small and often analyzed datasets, biosensors have the capability to regularly and frequently capture large enriched and digital datasets. We believe this will be critical in training and fueling the next generation of diagnostics and wellness insights, which in our view will be powered by artificial intelligence. Of the 3 pillars required to build artificial intelligence-powered diagnostic and wellness insight models, 2 of them being software and computing power are relatively broadly available through cloud computing services. It's the third access to large accurate data models that we believe is likely the largest constraint to development and where we believe biosensors can play a critical role. On this call, we will explain why we found the opportunity so compelling and why we think that Trinity can succeed in this large, developing and important market. Those who have followed Trinity's story know that we have been providing accessible high-quality HIV diagnostics throughout the world since 1996 and currently manufacture over 30 million diabetes HbA1c tests annually. Leveraging these strengths, we are now reinventing and repositioning our company towards a future and wearable biosensor technology and artificial intelligence-driven insights. We've acquired a wearable biosensor technology platform from Waveform that offers a proprietary needle-free, reusable and affordable Continuous Glucose Monitor or CGM. We believe that this Trinity biosensor technology will initially allow us to launch a state-of-the-art CGM that delivers a lower annual cost of care compared to the current main market participants. This should allow us to bring this important care solution to the vast number of potential users who currently don't have access to this technology due to the cost of care of existing solutions. These people can be, one, users in low or middle income countries where public or private peer resources are insufficient to provide broad access to CGM. As I will talk through later, many of the countries where diabetes is growing at its fastest rates are lower middle income countries, meaning this is an ever increasingly important problem to solve. And two, diabetics in high income countries where public or private payer budgets are exhausted by paying for the current CGM solutions across only a portion of the diabetic population. Frequently, this shortfall is attributed to financial constraints and many countries only cover insulin-dependent diabetics rather than offering the solution to non-insulin-dependent or pre-diabetics who could use CGM to manage and prevent the progression of their condition. As we all know, prevention is better than cure. The acquisition of the Trinity biosensor technology was made on what we believe are attractive terms and I will walk you through those specific shortly. Our development and commercialization of this new technology will be supported by existing capability in high-volume, high-quality medical device manufacturing and global regulatory and distribution expertise. We expect to kick-start our scaled commercial launch of this new technology through commercial partnerships, the first of which with Bayer in China and India, we are delighted to also announce today and which we will speak more about later in this call. Trinity has a long history of working as a key partner with some of the largest health care industry participants globally and we look forward to building a strong and mutually beneficial relationship with Bayer. As I mentioned, in the Trinity biosensor technology, we have acquired an innovative wearable biosensor technology, which we believe has applications beyond CGM in being a key data capture component in the move towards artificial intelligence-driven diagnostics and wellness insights. At an industry level, going forward, we expect that developments and artificial intelligence, including machine learning, provide immense opportunities to deliver personalized, visible and actionable health and wellness insights to users. This is where we believe diagnostics is going. However, a foundational requirement to capture such insights will be the convenient capture of accurate multifaceted data points about what is happening in, on and around people's bodies. As such, we believe that the delivery of an accurate, multipurpose wearable biosensor technology can unlike existing solutions that arguably only offer a pinhole view of what is happening, instead effectively be a window into people's health and will be absolutely key to unlocking the value from these broader technology revolutions and we intend to build that data capture technology in tandem with developing a sophisticated and multipurpose analytical platform that can deliver insights to digital devices including smartphones, smart watches, et cetera. The Trinity biosensor CGM has a number of attractive points of differentiation versus the current market-leading devices. Notably, it features proprietary needle-free insertion of the wearable biosensor, which reduces pain and tissue trauma at the injection sites and also offers more user comfort. All other major marketable wearable CGM devices require a needle which creates trauma at the injection site by puncturing the skin and this needle is then withdrawn and needs to be disposed of together with its applicator. In contrast, the Waveform device allows for reusability of the applicator as there is no needle for disposal. In addition, all of the components of the CGM solutions offered by the current main market participants must be discarded in their entirety after use, i.e., 10 days to 2 weeks. This includes the battery, electronics and plastic housing. In contrast, the main components of our new technology including the battery, electronics and applicator are reusable for up to 2 years, resulting in a lower cost of goods in terms of an annualized cost of solution and substantially less waste from an environmental perspective. The reusable nature of our electronics allows for the cost-effective incorporation of additional sensor technology details of which we will keep confidential for now given commercial sensitivities, but we will update the market on these in due course. These features make the product ideal for low-to-middle income countries where cost sensitivity can be a gaining factor to scale CGM adoption and should significantly reduce the cost of care to both patients and payers alike in higher income countries allowing for a broader adoption of CGM as a standard of care for diabetics. The generally accepted measure of CGM accuracy is Mean Absolute Relative Difference or MARD. The Waveform device achieved CE mark approval in 2019 and published clinical studies have demonstrated a MARD of less than 10%, which is brought in line with the published MARD of the main market participants. While the Waveform device was commercially launched in a limited number of European countries, we are not going to continue sales of the current device as we believe it would benefit from upgrades in its feature set, considering today's user expectations including in terms of calibration frequency, look and feel plus manufacturing process improvements to facilitate manufacture at high volume. After our extensive technical due diligence and development road mapping in partnership with an internationally recognized technical consulting house, we have identified a discrete number of product and process improvements. In particular, we as an experienced and high-volume manufacturer of quality medical devices have identified manufacturing improvements that can improve real world performance and user experience. These enhancements should fundamentally upgrade the product feature set and performance and deliver a more consumer-friendly and compact product. Our immediate plan, which we have already started, is to execute on these enhancements and confirm their impact in a clinical trial, which we aim to begin in 2025. In order to drive this program, we have hired a number of senior Waveform leaders and are engaging internationally recognized external experts to augment our internal resources. We will update the market on our progress in due course. It's important to note that we are not starting from scratch. Although we are not continuing sales of the current version of the Waveform product, we are going to build on that significant prior investment foundation on earlier device development. We understand that over $100 million has been spent to-date on the Waveform technology. We expect to complete final improvements through commercial re-launch with a relatively modest incremental outlay compared to the size of the financial opportunity that exists for this technology. This investment allows us to reinvent Trinity by better utilizing our existing platform of capabilities in the medical devices space to bring cutting-edge technology through to its final stages of development and commercialization in high value in expanding markets. We believe that an opportunity like this to acquire well-progressed but not yet market-optimized technology on attractive terms provides an exciting and compelling opportunity for our investors to benefit from significant capital value growth. The market for CGM is clear and proven with the 2 largest players in the market Dexcom and Abbott both currently generating revenues of greater than $1 billion a quarter based on recently disclosed information. As I've mentioned, we believe that the reusable nature of the sensor applicator, battery and electronics has a significant impact in terms of the cost of goods of an annual solution using our technology. This can translate into a lower cost of care solution and a significantly lower environmental impact. Trinity's reusable applicator is extremely environmentally friendly when compared to the disposable technology of market-leading devices. Our competitors discarded approximately 50 to 70 applicators for every one applicator discarded by Trinity's acquired CGM system depending on the use life of the competitor products. In addition, by discarding batteries, transmitters and circuitry with each sensor, our competitor solutions generate significant pollution and cost. Our reusability is a strong differentiator as it reduces pollution and waste while also allowing a lower cost solution to users. Additionally, as we look to expand our biosensor capability across other areas, the reusable device should allow for the cost-effective incorporation of additional sensing capability into the device to make it multifunction and increase its measuring capabilities. We are very excited about this prospect. The global diabetes market continues to grow. According to data produced by the International Diabetes Foundation, disease prevalence is expected to grow from 537 million adults in 2021 to approximately 640 million in 2030 with approximately 80% of those based in low-to-middle income countries where our independent market research indicates the rate of CGM adoption is lower than established markets like North America. All of these markets need an affordable and high-quality CGM device and the growing prevalence of diabetes in established high income countries, combined with the trend of consumer spend on wellness technologies such as smart watches leads us to believe there is a substantial and growing market for CGM into the future. For example, our market research studies have shown that CGM use is in its infancy in Brazil, a country where we currently have a market leading position in providing diabetes HbA1c tests. Brazil has a significant and growing diabetic population with approximately 16 million diabetic patients. We believe that providing an affordable CGM to markets like Brazil can increase accessibility and more broadly, our market research suggests that an affordable device will increase usage globally. As such, MARD rather than merely competing with the main market participants head-to-head in the same regions and at the same price points. We believe that our CGM device can drive geographic growth through increasing penetration of CGM devices in these markets by tackling the cost of care barrier to broad adoption of CGM. Our established brand as a global provider of quality diabetes tests should be a powerful tool to drive commercialization of our CGM and global markets. Our partnership with Bayer is designed to further unlock these opportunities in China and India and I will speak further on that shortly. Through market analysis and feedback with key opinion leaders, we've confirmed that we are pursuing an attractive and growing market where in addition to the established global level of Type 1 diabetes, the global prevalence of obesity and Type 2 diabetes is growing. We also appreciate that in the established markets, payers have significant influence in the CGM industry and often use costs to select regulatory approved devices for reimbursement. Our research suggests that CGMs are currently used primarily by Type 1 diabetics and Type 2 diabetics who are insulin-dependent and/or who have a history of hypoglycemia. However, as utilization further advances to more of the Type 2 diabetic population and governments continue to broaden the reimbursement patient base, we expect to see more price sensitivity from patients who are paying copays as well as from government programs that purchase these devices. Additionally, there is an increased uptake of CGMs being used in everyday life outside of the current reimbursement bodies with increased non-insulin based on dependent Type 2 diabetics, people with pre-diabetes and even non-typical users who have no history of diabetes beginning to understand the health and wellness benefits of continuous are sporadic CGMs users. In this regard, the current CGM offerings are generally too expensive for wide adoption by these users. By developing a low cost reusable CGM through our acquisition of the Waveform assets, we believe we can increase the affordability and accessibility for these users. With the cost of care of the main existing market participants, it is difficult to see how widespread adoption of CGM can be achieved in the short to medium term, if ever, especially in low-to-middle income countries and non-insulin-dependent cohorts. We believe that this technology is too important to just passively rely on time to drive adoption. We want to be a catalyst for enabling access to this critical technology in the same way we have for HIV testing technology. The inherent lower costs of care of our solution should collapse the time line for broader adoption across 2 vectors, one geographically; and two, penetration to other user cohorts. By driving adoption across both growth vectors, we believe we can drive significant market expansion for this technology. These tailwinds make us extremely enthusiastic about the opportunity for Trinity and its shareholders. Critical in our search for new product opportunities was a recognition that many of Trinity's existing and well-developed capabilities as a 30-year-old global diagnostic company could provide a higher return to our investors if they were directed to new technology areas with true potential to scale to an extent appropriate for a modern public company. As I already mentioned, Trinity has built significant expertise in the diabetes area over the last decade or more, growing our diabetes HbA1c testing business to over 30 million tests per year. As such, we know diabetes. We have numerous products approved by health care regulators across the globe, including the FDA, World Health Organization and CE mark approval in the EU to name but a few. As such, we know regulation. Finally, we know how to consistently deliver critical medical devices to aid the management of epidemics globally. Trinity was established in the midst of the AIDS crisis to develop and deliver an affordable quality medical device that has played a critical role in the management of HIV across many countries for well over 20 years, something our company is rightly very proud of. Today, diabetes and obesity are some of the most pressing health care challenges facing populations globally and we believe that with the acquisition of the Waveform Technology, Trinity is again well-positioned to make a very meaningful contribution to the management of an epidemic this time on a global scale. While recognizing and appreciating the importance of those who have contributed to Trinity's capabilities to-date, we have also recognized the need to bring in fresh talent in key senior positions. Over the past 3 years, we have hired senior individuals with track records of achievement in some of the largest life science and technology companies globally. These people were hired so we were well-positioned to execute on a high growth potential opportunity such as this. We believe that the combination of the new Trinity team with key hires from Waveform and internationally recognized external experts has created a formidable and motivated team who can drive this vision to success. We have today also announced that we have entered into a non-binding letter of intent with Bayer to establish joint partnerships with Bayer in China and India, which we are very, very excited about. The China joint partnership intends to leverage Bayer's significant and well-established presence in the Chinese health care market, particularly diabetes and is intended to lead to the launch of a low-cost, high-quality CGM device designed to increase affordability and accessibility of diabetes care. Diabetes is a major health concern in China with a significant and rapidly growing diabetes prevalence rate. In addition to the proposal to enter the Chinese market, the letter of intent includes a framework for the intention to launch a CGM device in India. India faces a significant public health challenge with over 100 million people living with diabetes and a rise in both Type 1 and Type 2 diabetes. To-date, CGM use in India is not widespread, but has been trending higher recently with increasing awareness about self-care. Bayer Pharma India has a strong presence in the diabetes market with brands like Kerendia and Glucobay. With a low cost offering, this partnership intends to increase access to CGM technology across India providing a innovative and affordable path to high-quality health care. We believe that the combination of Bayer's strong local commercial presence and Trinity's ability to manufacture a low cost and innovative CGM device on the back of the Waveform asset acquisition can drive our collaboration to a market-leading status in China, aiding both patients and physicians with the management of diabetes in a data-driven and scaled way. In addition, Bayer's established presence in the diabetes market in India provides an ideal partnership for us to drive adoption of CGM in this strategically important and expanding market. I believe that this development demonstrates the value that can be created for Trinity shareholders through the company's revised strategy. Now let me walk you through the attractive terms for this transaction. We believe that it was important from a capital structure and risk perspective that we used a balanced mix of equity and debt to fund the acquisition. As such, we have made an upfront cash payment of $12.5 million plus issued 9 million Trinity Biotech American Depository Shares or ADSs in exchange for all the assets related to Waveform biosensor business. This includes all intellectual property including a number of patents in this field and manufacturing and development equipment. Waveform is part of a portfolio company of our current principal lender Perceptive Advisors and the 9 million ADSs being issued by the company as partial consideration for the acquisition of the Waveform assets will be issued to Perceptive. As set out in the press release, additional contingent consideration may also apply. We are also very pleased to have strengthened our investment relationship with a large scale and specialist health care investor such as Perceptive Advisors with Perceptive now becoming our largest investor with an almost 20% equity holding and significant debt investment. We have also updated our credit agreement with Perceptive to provide greater liquidity and lower cost of borrowing to our company. Under the amended credit agreement, we have immediate access to an additional $22 million of funding and are deploying $12.5 million of this to acquire the Waveform assets. The remaining $9.5 million is available for general corporate purposes including the further development of the CGM and biosensor technologies. We can also draw down on another $6.5 million of borrowings for general corporate purposes and further development of the CGM and biosensor technologies at any point between April 2024 to December 2024 thereby providing further liquidity to fund the CGM and biosensor technologies. The amended credit agreement also immediately reduces the annual rate of interest in the loan by 2.5% to 8.75%, plus the greater of the term Secured Overnight Financing Rate or SOFR or 4% per annum and allows for further 2.5% reduction in the annual interest rate to 6.25% plus the same terms once the amended term loan falls below $25 million. In addition, the amended loan has the early repayment penalty, thus reducing the cost of early repayment. The amended term loan continues to mature in January 2026. In addition, in connection with the amended term loan, Perceptive will receive new warrants to purchase an additional 2.5 million ADSs and the company has agreed to price these additional warrants and reprice the warrants to purchase 2.5 million ADSs previously issued to Perceptive under the regional term loan to an exercise price of USD 0.44. The amended term loan significantly reduces the company's revenue covenants, which will enable the management team to focus on profitability rather than an over-focus on pure revenue growth. We're excited to have strengthened investment to have a strengthened investment relationship with the specialist health care investor of the caliber and scale as Perceptive. Before I hand you over to Des to discuss Q3 2023 results, I will take a few moments to update everyone on the new management team strategy and priorities for the company outside of our move into wearable biosensors. We are also very focused on meeting our both opportunities in our rapid HIV testing business and much improving its cash generation profile. We are working to scale and optimize our rapid HIV testing manufacturing capacity in light of the successful launch of our TrinScreen HIV product in Kenya with the team at our Irish manufacturing site aiming to at least triple manufacturing output for 2024, so we meet the expected 2024 TrinScreen orders. However, I am very conscious that we do this in as cost and cash efficient manner as possible. We do expect this to be initially margin percented dilutive as we scale given the price point of TrinScreen HIV. However, in conjunction with scaling production, we are actively pursuing a location move of some aspects of our rapid HIV products, which should very significantly improve the margin EBITDA and cash generation profile of our rapid HIV business. We are aiming to have these in place by the end of 2024. We continue to focus on significantly improving the cost structure of our existing diabetes HbA1c testing business, which we would expect will improve the profitability, cash generation, ultimately the value of that business. The 3 initiatives we set out in our October 2023 press release are progressing well and we remain on track to deliver approximately $4 million of annualized recurring cost savings from these initiatives and we believe that these initiatives will also allow us to deliver an increasingly cost competitive diabetes HbA1c solution, putting us in a stronger position to grow market share over time. We also continue to critically examine other aspects of the manufacturing structure of our overall hemoglobin business with a view to further significantly reducing the cost of operations. We are also seeking ways to identify the most value accretive use for our other smaller businesses and have engaged external consultants to support our examination of the optimal path to value accretion for these businesses. This review remains ongoing and there are some potentially exciting paths available. We will update shareholders in due course as we solidify plans for these businesses. Overlaying each of our business segments is a key focus on profitability through optimizing our revenue and cost cycles. This new management team is focused on discipline and relentless execution on these priorities. I will now hand you over to Des who will walk you through preliminary results for Q4 2023 and Q3 2023 financial results.

Thanks, John. Before I get into the details of the third quarter results, I'd like to take the opportunity to express how excited I am to be joining the executive management team of Trinity Biotech at this juncture. Today's announcement of our acquisition of the Waveform assets, our non-binding letter of intent with Bayer and our amended credit agreement and strengthened relationship with Perceptive really marks what we believe is the beginning of an exciting transformation of Trinity Biotech as we aim to become a global leader in wearable biosensor technology. Firstly, I will briefly speak to our preliminary Q4 2023 results. We expect revenues for the fourth quarter 2023 to be between $13 million and $14 million with growth margin percentage to be broadly in line with the reported growth margin percentage for Q3 2023. Our Q4 margin is expected to be negatively affected by a raw material supply issue, which reduced the amount produced for inventory over Uni-Gold HIV test. This issue has been resolved, but had a negative impact on our absorption of cost in the quarter, thereby negatively impacting gross margin. Our reported revenues are expected to be broadly in line with Q3 2023 for the majority of our product lines with expected reductions in our hemoglobins division and HIV division. In our hemoglobins business, we are expected to be lower than Q3 2023 as year-end shipments of products at suboptimal pricing were deferred as we renegotiate contract terms with a key customer. In our HIV business, shipments over a Uni-Gold HIV tests are expected to be lowered in Q3 2023 due to typical irregular quarter and quarter ordering patterns. Now I will move on to our Q3 2023 results starting with revenues. Revenues for the quarter were $14.7 million compared to $15.7 million for the same quarter in 2022, representing a decrease of $1 million. This decrease was primarily driven by a reduction in revenue in our autoimmune business with the largest contributor being the previously announced loss of the transplant business -- transplant testing business in our reference laboratory in Buffalo. Our VTM business and [ Clinical Chemistry ] businesses experienced small declines of $0.2 million each in the quarter compared to Q3 2022, which was offset by an increase in our diabetes HbA1c business of $0.3 million and increases in our point of care business of $0.2 million driven by higher sales of Uni-Gold. Gross profit margin percentage for Q3 2023 was 29.2%. However, this was inclusive of an excess inventory obsolescence charge of approximately $0.9 million in the quarter. This obsolescence charge was driven by write-offs in our COVID VTM business as demand in the latter half of 2023 was weaker than expected together with small write-offs relating to our Tri-Stat instrument as we sunset that product. Excluding these write-offs, our gross margin would have been 35.5%, 350 basis points higher than gross margin in Q3 2022 measured on the same basis of excluding excess inventory obsolescence charge. Moving on to R&D expenditure of $1.2 million for the quarter, which was marginally higher than the same quarter in 2022 as we capitalized fewer costs into product developments and tangible assets. Our SG&A expenses of $7.7 million in the quarter increased by $2.5 million when compared to Q3 2022. This increase is due to a number of factors including higher share-based accounting charges of $0.6 million, lower foreign exchange gains of $0.4 million, restructuring costs of $0.2 million associated with our previously announced head count reductions and higher than expected consulting fees. Our professional advisory and consulting fees, which were $1 million in the quarter were $0.5 million higher than Q3 2022 and we also expect elevated fees in Q4 2023. These higher fees are driven by higher legal and financial advisory costs as part of our acquisition of the Waveform assets, which as an asset deal was complex and time-consuming and external consulting fees were incurred as we continue the examination of the optimal path to value accretion for some of our smaller business lines as detailed by John earlier in the call. We expect these fees to reduce through 2024 to a quarterly level of half of Q3 2023 expense unless we engage in additional transactions. I will make the point that we recognize that professional fees associated with the Waveform transaction are relatively large when compared to the deal side. As we structured this as an asset deal rather than a share deal, this drove a higher degree of complexity. However, it also brought increased benefits of significantly reducing the risk of the transaction. This all led to an operating loss for the quarter of $4.5 million compared to an operating loss of $8.1 million in Q3 2022. The lower loss was primarily due to an impairment charge recognized in Q3 2022 of $2.3 million and higher excess inventory obsolescent charge of $3.8 million in Q3 2022. Financial income for the quarter was $0.4 million compared to $0.3 million for Q3 2022 related to fair value adjustments to warrants granted. Financial expenses in Q3 2023 of $2.4 million were slightly higher than Q3 2022 due to higher interest rates in the period. The loss after tax for continuing operations for the quarter was $6.7 million compared to a loss of $10 million in Q3 '22. The key drivers of the movement being the previously mentioned impairment charge and higher inventory obsolescent charges in Q3 2022. Loss before depreciation, amortization, tax, interest and share option charges was $3.5 million for the quarter. Basic loss per ADS was $0.18 compared to $0.24 in Q3 2022. Finally, I will discuss our cash flows for the quarter. Our cash balance decreased from $14.2 million in Q2 2023 to $6.3 million in Q3 2023. Cash used by operating activities is $4.7 million, which was inclusive of a net working capital investment of $2.3 million. I will now hand you back to John.

Thank you, Des. To revisit for a few moments the broader opportunity from our acquisition of our new biosensor technologies. Our longer term aspiration is to pursue platform expansion into adjacent wearable biosensor technologies to measure other important biomarkers and health metrics and provide essential data and artificial intelligence-enabled health and wellness insights. We do intend to expand this technology beyond CGM. We believe that some of the differentiated features of the acquired biosensor technology lend themselves very well to more comprehensive data capture and analytical solutions. We will reveal more about these plans as we advance them, but we are very excited about coupling this platform biosensor technology with broader technologies including machine learning to develop products and services that give valuable insights based upon what is happening in, on and around people's bodies. To wrap up, we are extremely enthusiastic about our plans for this wearable biosensor technology and the broad opportunities that lie ahead for Trinity. We are delighted to be partnering with Bayer in this important endeavor and finally, to our strengthened investment relationship with Perceptive Advisors, we have secured the financing to immediately execute on our vision. I'd like to take this time to thank you for your attention and engagement and I'll now hand you back to Eric. Thank you.

Thanks, John, and thanks, everyone, for listening to our call. If you do have any questions, please e-mail them at [email protected] or you can call us at (646) 751-4363. I will now turn it back to the operator.

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Good day, and welcome to Trinity Biotech Announces Second Quarter Financial Results. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. Please note that this event is being recorded. I'd like to turn the call over to Mr. Joe Diaz of Lytham Partners. Please go ahead.

Thank you, operator. And thanks to all of you for joining us today to review the financial results of Trinity Biotech for the second quarter of 2023. Joining us on today's call are Aris Kekedjian, Chief Executive Officer, 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, please note that statements made during this conference call may be deemed forward-looking statements within the meaning of 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 factor statements in the company’s annual report on Form 20-F filed with the Securities and Exchange Commission. Trinity Biotech undertakes no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after today or the occurrence of unanticipated events. With that said, I will now turn the call over to CEO, Aris Kekedjian for opening remarks. He will be followed by CFO, John Gillard for a review of the financial results. After which we will open the call your questions. Aris, the floor is yours.

Thank you. Good morning. As usual, I will discuss the summary highlights for the quarter and John Gillard will discuss the detailed financial results. In addition, we took the opportunity this quarter to take you through the in-depth details of our operational initiatives surrounding our core diabetes franchise. We think these are critical for our shareholders to understand as it’s critical to unpivot and transformation. Total revenue for fiscal Q2 2023 was $13.9 million, Fitzgerald Industries, which was disposed of in April 2023. Excluding our COVID focused PCR Viral Transport Media or VTM products and Fitzgerald, revenue for the quarter was $13.7, which is comparable -- properly comparable given the changes. This was 3% lower than in Q1 2023. Our core franchise diabetes consumables revenues increased 10% over Q1 2023. This is a critical financial growth metric that is key to the transformation of the company. Recurring diabetes consumables revenue rebounded strongly in Asia in the quarter, increasing approximately 70% over Q1. This was led by demand recovery in China. Our expectation is that, this level of demand will continue for the rest of 2023 in one of our most important markets. In addition, diabetes revenue grew by over 10% collectively over the quarters in our direct distribution markets, namely the U.S. and Brazil. In other product lines, Clinical Chemistry, Chromsystems and Syphilis product lines continue to show positive revenue momentum despite key raw material backorders in some Clinical Chemistry product lines. I'll reflect on that as we continue the dialogue. These revenues were gains -- sorry, these revenue gains were offset by lower infectious disease revenue compared to Q1 2023 and reflects the irregular order cycle in this business line. In addition, we phased out our non-core and difficult to scale transplant activity at our Buffalo, New York laboratory during the quarter. Revenue outlook for Q3 is expected to be approximately $14 million to $15 million. Based on our current perspective on what we're seeing coming in and the fact that we more or less closed the quarter, we think that might be closer to the upper end of that range. In addition, order backlogs have increased substantially to approximately $1 million which is broadly double the run rate for the first half of 2023. I want to give you further perspective on the outlook for the rest of the year, especially around our Haemoglobins franchise. Significant commercial reorganization, customer engagement initiatives and service quality improvements have positioned the core Haemoglobins franchise for a strong second half 2023 revenue performance. We have made strategic instrument placements and focused on maximizing instrument utilization, these are gaining traction toward building an expanding, recurring revenue profile for the business. Diabetes consumables are expected to increase over 20% in the second half of 2023 versus the first half. In addition, diabetes instrument placements for the second half of the year are accelerating and are expected to be up to double those placed in the first half of 2023. Now I'd like to turn our attention to some strategic highlights with respect to our key product lines. First on Haemoglobins. In August, Trinity Biotech received U.S. FDA 510(k) clearance for the Premier Resolution System, the automated analyzer for accurate and precise quantification of haemoglobin variants. Our intention is to retake the market leadership position in haemoglobin variants with this modern successor to the highly regarded Ultra2 platform. The Premier Resolution System builds on our Ion Exchange technology reputation of excellence and a market leading combination of accuracy, speed and value. We expect this important clearance from the FDA to actually drive further penetration and increased utilization of the Premier Resolution System in key global markets, including Brazil, where there is substantial scale in the blood screening market, and allow us to begin the regulatory process to roll-out the product in China. The redevelopment of our flagship diabetes HbA1c platform, the Premier 9210, is on track for a phased roll-out in 2024. The final redeveloped system is expected to feature an improved, backward compatible column and reagent formulation that should feature up to 3 times the current injection capacity, reduced calibration frequency, improved user interface and better lab system integration. The launch of the new column and reagent will be the first step in a multi-generational product development plan aimed at expanding the target market into higher throughput segments, driving lower service downtime and cost, while significantly expanding operating margins. Our improved design, combined with significant overhaul of supply chain strategy are expected to yield significant reductions in instrument cost. Cost of goods sold related to test volume, and cost of service and repair are all on the priority list. These cost competitive actions are aimed at significantly expanding our total addressable market in the high growth diabetes space. We have initiated a program to manufacture a version of our core diabetes instrument in China, the 9310. In addition to optimizing supply chain benefits, we believe this will enable us to double our reach in a very significant proportion of the Chinese hospital market that is limited to domestic manufacturers. We plan to -- we plan to obtain regulatory approval for domestic market entry by late 2024. Now I'd like to take a moment to discuss our strategy to leveraging and scale our Reference Lab in Ney York. Efforts are at an advanced stage to significantly reposition and scale the commercial focus of our 50-state certified lab in Buffalo, New York. The company continues to see significant potential in its proprietary Sjogrens bio-marker lab developed tests, despite limited commercialization activities to date, with have had 20% average annual growth since 2020. Annual revenues are approaching $4 million, we think we can significantly scale this number. A serious Autoimmune complication of the broader dry-eye market, studies indicate that Sjogrens syndrome may affect over 3 million individuals in the US or about 1% of the population. In conjunction with this opportunity we are entering into a strategic revenue-sharing partnership with Trusted Health Advisors to lead our commercial and business development activities aimed at maximizing the Sjogren’s opportunity. The team, comprising of ex-senior executives from Quest and Mayo Clinics, brings decades of experience and extensive network in the industry. We as partners intend to explore the opportunity to leverage the Reference Lab’s Autoimmune capabilities to jointly expand beyond Sjogrens and look at proprietary biomarkers library expansion opportunities. This may give us the opportunity to develop this platform into a center of excellence for therapeutic drug monitoring and companion diagnostics across multiple Autoimmune diseases. I’m very happy to have a team with caliber working with us on such an important initiative. Next, I would like to update you on the status of our TrinScreen HIV launch in Kenya. The company is focused on executing the launch and distribution of its TrinScreen HIV screening test, this follows the announcement by the Kenyan Ministry of Health last year of the adoption of this new HIV rapid testing algorithm. This algorithm establishes Trinity Biotech’s TrinScreen HIV as the standard screening test in Kenya under World Health Organization guidelines. We have completed field evaluation of the algorithm in June, the Ministry of Health has communicated procurement and use specifications to the agencies that are directly aimed at placing the orders and we have shipped kits for training purposes. We, along with the Kenyan government are addressing legal challenges to the HIV testing algorithm and related process changes introduced. We are anticipating resolution of the court challenges in hearings being held in early October. Our expectation, and the government's actions indicate that we will receive significant orders in the fourth quarter upon resolution of these legal matters. The Kenyan HIV screening program is one of the largest in Africa, with up to an estimated 10 million screening tests annually. Now I'd like to take a moment to discuss in a little bit more detail our operating initiatives. John and I thought it will be worthwhile sharing with you the status of the extensive Operational Transformation and Cashflow Improvement activities that have been underway for much of this year, we believe many of those activities are actually reaching an inflection point and we'd like to share those with you now. We are very focused on driving significant operational transformation and optimization to improve cashflow and allow our key products to gain a cost competitive advantage in certain market segments. As the company operates in a highly regulated healthcare sector, significant operational changes are typically subject to complex technical validation processes that can create time lags between initiation of the change and final implementation. In that context, many of the key operational transformation programs we initiated over the past 12-24 months are now starting to deliver significant benefits and we projected to deliver increased and recurring cashflow benefits while allowing us to target growth in certain lower price markets, all while maintaining target margin. To look some of the key operational transformation projects include the following. First, Headcount Optimization. This has been an ongoing effort, but in Q2 and Q3 2023 management accelerated headcount reductions as a result of process simplification initiatives that have been ongoing for the past number of quarters, the implementation of new software tools in quality/regulatory compliance as well as production planning, and to reflect the lower than expected revenues, particularly in light of the delays around the Kenyan HIV roll-out. Excluding the impact of the disposal of Fitzgerald and limited hiring to support TrinScreen HIV manufacturing, these changes are expected to deliver an approximately net 20% reduction in headcount by the end of Q4 2023 compared to Q1 2023, with a resultant annualized cashflow saving of over $4 million. Overall, this would represent an over 35% reduction in headcount compared to Q4 2020 when we originally started this optimization journey. The majority of these 2023 reductions are in back-office functions such as Finance, Quality Assurance/Regulatory, Supply Chain, etcetera, reflecting the impact of modernization and simplification projects lead by senior functional leaders we have hired over the past couple of years. We expect the financial benefit of these reductions to make a meaningful impact from Q4 2023. To support TrinScreen HIV manufacturing we have hired approximately 15 staff. I'd just like to reflect that in light of these numbers I indicated to you. We are highly focused on revenue per headcount as a key KPI for management and we intend to continue to transform and optimize our operations to improve this KPI overtime. And we will keep you posted on how we progress. Beyond headcount we are also focused on optimizing the entire Haemoglobins operation to enhance price competitiveness and profitability. We see significant opportunity to truly refine this platform, specific actions are as follows. Number one, with respect to our Diabetes A1C Consumables Manufacturing Optimization Efforts, we are now at the final stages of our revised manufacturing process for our key Diabetes A1C testing column. It's the key consumable for 9210 instrument platform. Bringing this process in house is an -- in an optimized manner is projected to reduce the cost of goods sold of our Diabetes A1C testing column by over 30%. Based upon current run rate of production, this is estimated to deliver over $1.5 million recurring annualized cash flow savings once we have fully transitioned to the revised manufacturing process and should allow our Premier 9210 A1c testing system to be more competitive in lower price/high volume segments of the market. We expect the financial benefit of these reductions to make a meaningful impact from Q4 2023 with an increased savings level in 2024 as we transition completely away from the legacy manufacturing process. Initiative number two with respect to our core Haemoglobins platform. Diabetes A1c Instrument Supply Chain Optimization. Over the past12 months we have initiated a supply chain optimization program for this instrument, with the intent of reducing cost and optimizing the quality of the instrument by moving to more competitive supply chain environment. This program has progressed significantly, we have already commenced securing materials savings of 20% per instrument. Given the success of this program to date, we are now targeting savings of 40% to 50% in materials costs for our Premier [9210] (ph) instrument which is based upon our expected production run rate and would deliver based on that run rate annualized cashflow savings of over $1.5 million when fully completed. These changes are already delivering a working capital benefit in terms of lower inventory costs and expected EBITDA impact to begin in late 2023 or early 2024 as inventory is converted into sold product. In addition, this lower cost of production should allow us to competitively target growth in segments of the Diabetes A1c testing market that are lower price but much higher volume than our traditional focus segments, this would allow us to significantly scale our business in terms of revenue while maintaining target margin. There is also significant component commonality between our Premier 9210 and our Haemoglobin variant instrument the Premier Resolution that recently achieved FDA clearance. This means that many of the savings achieved for the 9210 instrument can also carry into a meaningful lower cost of production for the Premier Resolution. The third key initiative I'd like to highlight with respect to this platform is the fact that we are rebuilding and repositioning the Diabetes A1c reagent column system core to our 9210 instrument. As previously discussed, we are developing an improved backward compatible reagent column system. This system is expected to feature up to 3 times the injection capacity of our current system. This program is at its final stages of development and technical validation. Subject to this validation, we expect to launch this new reagent column system in early 2024 and estimate that this system should deliver recurring annualized incremental cost of goods cashflow savings of over $1 million, while again facilitating us more importantly to competitively targeting growth in segments of the A1c testing market that are lower price but much higher volume than our traditional focus segments. The ability for us to maintain volumes is because our reagent business is much higher margin than our insurance business. This is a razorblade model and high volume is a critical way to scale. We are applying the same thinking now with all of this discussion about our Haemoglobins business to our HIV product manufacturing as well. We have initiated a program to optimize the location and cost of certain downstream manufacturing and supply chain activities related to our HIV products, namely Uni-gold and TrinScreen. Our initial assessment indicates that such a program could well deliver several million of annual cash flow savings while providing the company with additional manufacturing capacity to meet the increased and expected demand for TrinScreen as we roll the product out in additional countries. We expect this key product -- this key project to start to deliver recurring savings in 2024, and we will provide further updates on this program as it progresses over the next couple of quarters. These initiatives have combined to increase -- these initiatives have contributed to some increased SG&A expenditure over the last 12 months. And we will continue to require some further investment over the coming quarters. Management believes that the future profitability and growth of the company is significantly dependent on optimizing our cost structure and cost competitiveness which makes these investments key to delivering significant returns over the medium term. We are prioritizing investing and the delivery of recurring savings or recurring revenue as they should deliver increased sustainable EBITDA and thus increase capital value within each of our core business areas. Before I turn it over to John, I'd like to address ongoing balance sheet optimization and the development of new growth opportunities. As can be seen from the results over the past few quarters, our SG&A has increased. A major driver of this increase is expenditure on third party market research, technical assessment consultancy services, and other related costs as we seek to identify next generation biotech opportunities for the very significant growth market segments within our total addressable market. We are trying to position Trinity and its capabilities where the TAM is significantly larger, especially as it relates to adjacencies around our diabetes franchise. As a result of this work, we have now identified and are pursuing a select number of investment areas and associated targets. In conjunction with pursuing these targets, we're also closely working with our existing lenders, Perceptive Advisors, to both improve the terms of our existing financing, considering our lower debt levels, and to gain their support and investments in these high growth opportunity areas. These discussions are going well. We continue our strategic review of some of our noncore business lines for potential capital reallocation, to lower debt or reallocate capital to higher growth opportunities. Our approach to improving cash flow through operational transformation and organic growth in our core business areas should also play a key role in providing cash flow for investment and availability to incrementally improve financing. With that, I would like now to turn it over to John Gillard, who will provide you a more detailed review of the financial results for the quarter. Following that, we will take your questions. Thank you.

Thank you, Aris. Good morning, everyone. Now I’ll take you through the results for the second quarter of 2023. As you may be aware, we sold our Fitzgerald Industries business in April this year. So on our income statement for Q2 2023, the results of Fitzgerald have been reported separately within discontinued operations. As was the case in our Q1 earnings, the revenue, gross profit and operating loss numbers are stated without Fitzgerald for both Q2 2023 and the comparative period. Starting with revenues, total revenues for the quarter were $13.9 million compared with $15.4 million in Q2 2022. Gross margin for the quarter was 36.2%, which is the same as for Q2 2022. Here we are seeing the sales price and cost saving initiatives that we have implemented in the last year have been offset by lower revenue over a significantly fixed and semi-fixed cost base and by an unfavorable sales and exchanges. In particular, the loss of the transplant testing services at our Buffalo lab has had a negative gross margin impact. As I will speak to later and as Aris has already disclosed we are taking significant action to address our cost base. R&D expenditure increased from $1 million in Q2 2022 to $1.2 million in Q2 2023 mainly due to lower capitalization of payroll costs into the product development of intangible assets as key products came to the end of their development cycle. Meanwhile, SG&A expense in the quarter increased by $2 million compared to Q2 2022, mainly due to the effect of three different cost increases. Firstly, $0.9 million of the increase was due to higher share based payments expense. This is a non-cash accounting charge related to performance share based compensation awards, which are intended to closely align the goals of our team with those of our shareholders in the creation of shareholder value. Secondly, there was an increase of $0.6 million due to external technical advisory, legal and professional fees. The board of the company is committed to our corporate development and corporate finance activities as we continue to assess strategic opportunities for inorganic growth and balance sheet optimization. In particular, we are seeking to identify next generation biotech opportunities for very significant growth in market segments with total addressable markets of real scale that can fuel Trinity Biotech's growth into a much larger scale company. As such, we have invested in market research, technical advisory and other professional services to assist us in successfully mapping our way to these key areas. Thirdly, within SG&A there was an FX loss of $26,000 for Q2 2023 compared to an FX gain of $0.6 million in Q2 2022, resulting in an unfavorable variance of approximately $0.6 million. This mainly relates to lease liabilities for our rented premises. We have recorded an impairment charge of $10.8 million this quarter compared to an impairment charge of $0.5 million in Q2 2022. The impairment test performed as of June 30, 2023, identified an impairment loss in two cash generation units, namely Immco Diagnostic and Trinity Biotech Do Brazil with the majority of the impairment charge relating to Immco. Immco's laboratory has for a number of years provided transplants testing services to a local healthcare provider. However, in early 2023 that health care provider informed the company that it was moving to a different service provider and this resulted in lost revenues for the laboratory since the beginning of quarter two 2023. Secondly, the expected level of additional laboratory services revenue arising from our partnership with imaware, Inc. has not materialized. As a result, Immco’s value in use has fallen below the carrying amount of its relevant assets. Similarly, Trinity Biotech's Brazil value in use as end of June is below the value of its relevant assets. Included within the Immco impairment is a full impairment of the financial assets associated with the company's $1.5 million investment in imaware. To date, the company has paid $700,000 of this $1.5 million investment to imaware, but as the investment agreement provides us our total potential investment of $1.5 million, this amount was recognized in our balance sheet in Q1 2023. Given the uncertainty over the future of imaware’s performance and thus the value of this investment, management have decided to impair the entire $1.5 million of committed investments. We have not to date paid the additional $800,000 to imaware, which remains in our balance sheet as an accrued payable. However, we have contested whether we have a valid obligation to pay the additional $800,000 and expect discussions on that matter to continue with imaware. The aforementioned items have resulted in an operating loss for Q2 2023 of $14.9 million compared to an operating loss of $1.9 million reported in Q2 2022. Moving on to net financial expenses of $3.8 million in Q2 2023 compared to $8.3 million for Q2 2022. The decrease of $4.5 million is mainly due to the comparative period, including a penalty for early settlement of the senior secured term loan with Perceptive in Q2 20.22 of 3.5 million, whereas in Q2 2023, there was an early repayment penalty of $0.9 million. Additionally, early partial settlements of the term loan results in an acceleration of the accretion interest expense under the applicable IFRS accounting provisions. This accelerated interest expense was $2.1 million in Q2, 2022 and $0.5 million in Q2 2023. These variances account for $4.2 million of the decrease, while the remaining decreases accounted for decreases in the fair value of derivatives of $0.4 million and an increase of $0.1 million convertible note interest as the note was issued midway through the comparative period. Although our borrowings are now significantly smaller following our repayments of debt, the interest cash expense is broadly similar to the comparative period last year as our main borrowing accrued interest have a significantly higher interest rate than during Q2 2022 due to base interest increases in the interim. The profit on discontinued operations was $12.4 million in Q2 2023, comprising a gain on disposal of Fitzgerald Industries of $12.7 million, offset by trading loss of $0.3 million for discontinued operations. The gain on disposal was made up of proceeds of approximately $30 million, offset by associated transaction costs of $1.3 million and the net assets limited on disposal of $16 million. The trading loss of approximately $300,000 mainly comprises the results of Fitzgerald on 1 April to the date of sale on 27 April 2023. In Q2 2023, the loss per ADS is $0.16 compared to $0.29 loss per ADS in Q2 2022. I will now move on to address some of the main balance sheet movements we have seen since quarter one 2023. PPE decreased by $3.6 million in Q2, of this $3.5 million relates to the impairment charge for Immco. Intangible assets decreased by $5.6 million with $5.8 million relating to impairment of Immco's intangible assets, the remainder is made up of amortization of $0.2 million offset by asset additions of $0.4 million. The majority of the additions to intangibles relate to product development in our Haemoglobins business and some of this expenditure contributed to gaining FDA 510(k) clearance of our primary resolution instrument in August. As I mentioned above, financial assets have decreased by $1.5 million as a result of our impairment of the investments in imaware. The senior secured term loan liability has decreased by $9.4 million during the quarter as we repaid $10.1 million of the senior secured debt held by Perceptive Advisors from the proceeds of the Fitzgerald [indiscernible]. The remaining movement is made up of accretion interest. Finally, to briefly mention our cash flow for the quarter, our cash balance increased by $10 million in Q2 2023 from $4.2 million at the end of Q1 to $14.2 million at the end of quarter two. And including the cash balance of Fitzgerald in the Q1 number of $4.2 million, although you will note that this balance was reported on March balance sheet with an assets 10% rather than in the cash balance. Now turning to the operational transformation issues as we outlined in today's press release and as discussed by Aris. As I said out in previous earnings calls, driving recurring operational cost savings has been a key priority for Trinity over the last few years and indeed since I've joined and has been a major driver in us hiring some of the senior function leaders that have joined the business over the past three years. As Aris said and as you will note from today's press release, in Q2 and Q3 management initiated a significant headcount reduction program. As a result of this program, net of limited hiring for TrinScreen production, we expect a headcount reduction of approximately 20% by the end of 2023 compared to our headcount in quarter one, 2023 with an expected annualized saving of $4 million. We expect that the financial benefits of these reductions will really start in Q4 2023 and will reach full run rate savings in early 2024. We've also focused on reducing the cost of our core products through manufacturing and supply chain optimizations, including the $4 million of cost of goods saving expected in our diabetes business, from the key three initiatives being moving a key manufacturing aspect of our main diabetes test consumable, our column in house, changing the sourcing of key components of our Premier 92 and Premier Resolution instruments, and the launch of a new diabetes column and reagent system. All of these, as I said, are expected to deliver combined $4 million annualized run rate savings. And these initiatives should lead to a significant improvement to the operating margin and cash flow generation profile of our Haemoglobins business. The savings are now starting to come through but we expect it will be mid to late 2024 until we see the full $4 million impact of those savings. We're also focused on improving the cost of our HIV tests, Uni-gold and TrinScreen as Aris set out, we've identified opportunities to change some downstream manufacturing activities which we believe could save several millions of dollars per year, allow us to effectively scale production to meet the increase demands as we roll out TrinScreen HIV to new markets. This is a very exciting opportunity and we expect it will deliver savings from May 2024 and is now a key priority for the operations team. We are focused on delivering recurring annual savings. That in turn increases sustainable EBITDA of our businesses. This in turn should increase the capital value of these businesses and ultimately our shareholders' equity. As a simple rule of thumb, if we assume a 10 times EBITDA valuation multiple, which is broadly what we saw with Fitzgerald, each $1 million of annualized sustainable savings is worth $10 million in capital value. In addition, if these savings can also allow our products to become more cost competitive and deliver growth through accessing new market segment, that then delivers an additional benefit to shareholders. Finally, we are in advanced discussions where our current lender is Perceptive, regarding an update to our existing credit facility and we expect to access improved interest rates recognizing our progress in lowering debt compared to when we initially took over the dash, plus access to additional capital to fund the key strategic investments in next generation biotechnology areas. I expect we'll have further updates on that for shareholders in the short term. With that, I will hand it back to Aris. Thank you.

Thank you, John. I appreciate the thorough update. I think you can all appreciate that we endeavor in this call to be a bit more in-depth and specific about our initiatives and efforts. As John mentioned, some of these things take time. We are in a regulated industry, but we felt both the combination of positive momentum from a commercial standpoint and improvements that have been -- had been implemented over the last 24 months from a COGS standpoint, we believe we're actually approaching an inflection point. Now, we don't want to get ahead of ourselves but we do feel very confident about the progress we're making and we wanted to share that with you. With that said, we'd like to hand it over to questions.

Thank you. We’ll now begin the question-and-answer session [Operator Instructions] First question is from Jim Sidoti of Sidoti & Company. Please go ahead.

Hi. Good morning. I'll have to go over this morning. But let's start with the business that you lost in Buffalo, the transplant services testing business. On an annual basis, how material is that for you?

Hi, Jim. It's John here. It's probably about $2 million of revenue. We had seen some declines in this, so it's not hugely material. It was a difficult business to scale. So the vast majority of our business at that lab is focused on autoimmune disease, in particular, our proprietary Sjogrens test. The transplant business required kind of 24/7 365 staffing. And so there was some additional costs associated with that. I'm not saying we were happy to lose that business, but it was not core to us and did add complexity as we set out in the press release, it was not easy to scale, because inherently the transplant business you have to be within a certain geographical distance, typically to where the transplant activity is happening. So you're limited in a geographic sense.

I think you have to be within 30 miles typically. So you're basically covering two hospitals. You can't scale. And as John mentioned, the standby requirements, and frankly, we had a chance to try to win that business or maintain that business, we actually bid it pretty low, but we felt at some level it didn't make any sense anymore, because long term, we couldn't scale it. And so at the level it went at, I think we felt confident we had better opportunities. To be honest with you, we have a chance -- if you look at the margins in Sjogrens compared to the margins of transplants, they're not even close. And we have a chance here to partner with the team that people know what they're doing to really scale the Sjogrens business. So that's the right focus right now.

Okay. All right. And you did give guidance for the third quarter, which is higher than the second quarter, despite the fact you bought this business. Should we take that as saying, maybe the second quarter is -- I know you don't want to give long term guidance, but do you think this second quarter was a low water mark to you and that you'll see revenues from your other businesses continue to grow to offset business and some of the other -- some of the COVID type businesses. So that revenue should sequentially be climbing for the next several quarters?

Again, I think, your premise here is actually pretty much why John and I wanted to spend the time on this call to baseline people, okay? We feel like we bottomed on all of the changes we had to make on the revenue run rate. We feel confident about our sequential revenue profile going forward, both -- and not only that, but we also feel confident about our COGS profile going forward. So I think we're at an inflection point. That's our view.

Okay. And now if we switch over to the Premier business, it was down overall in the quarter, but that was -- it sounds like that was all on instruments that consumables business continues to grow. Is that correct?

Yes, look, the thing you got to look at in this core business in the Premier business. And eventually, as we get into rolling out the resolution product in a more extensive way is really about consumables. That's where all the money is, right? We generate greater than 50% margins in the consumables, its recurring revenue, the instruments are there to largely drive that consumable profile, revenue profile. So we've been focused very much on being strategic about where we're placing instruments, making sure that -- and I can tell you, John -- a stickler for this, making sure that we've got recurring revenue profiles associated with those instrument placements around the world so that the payback makes sense. And that is a big change in terms of how we've been running the place historically versus where we are today. Okay? So this is where the franchise scales. And this is our number one focus.

And Jim, just to augment that, as we reduce down the cost of us manufacturing the instruments, right? That will allow us to be more competitive in terms of placing instruments, which should ultimately allow us to have a greater footprint, which again will drive revenue in the consumables, right? So really reducing down the cost of the instrument is reducing down a barrier to market entry in certain segments. And coupled with that is, we can reduce down the cost of goods of our consumables, in particular, our column, will allow us to be cost competitive while also maintaining margin. So there's a comprehensive strategy here to grow. We've had some market research done on the A1c testing business and that [indiscernible] cost is critical and that kind of validates the path we've been on for the last 12, 18, 24 months and trying to get these cost reductions through. To Aris’s point, we are going regulate the market. This is not stuff you can just flick the switch on. But the flip side of that is, once you've made those changes, those regulatory barriers that slowed you down can become somewhat of a competitive moat around your business.

Okay. And that's actually what I was going to ask next, the regulatory hurdles. Now you've overcome a big one, I think, when you got resolution approved, but it's a separate 510(k) for the new column and then for the 9210?

No. Well, let's put it this way. The changes we're anticipating at the end of the year into 2024 don't require any significant regulatory approval. They've been going -- they've been undergoing validations and testing, which are required, but we don't need any regulatory approval. Are there regulatory approvals planned in the updates later in 2024 and 2025? Yes. But for the initial launch of these improvements, the things John's talking about, the 3 times improvement in column performance, etcetera. That's all within the purview of what we've got going on right now. And look, one of the other things I think I want to expand on with respect to John's point. The cost competitiveness is a huge factor here in scaling the volume and volume is the game. But the other thing you got to keep in mind is, if we can actually increase throughput of our system, which is what we're working on with the column, we start getting to higher volume segments in general. That's not just price driven, but it's the fact that we can actually drive into higher volume segments. So we're trying to scale this thing by driving costs down and driving throughput up. That's how you make money in this business. It's not very complicated.

Okay. And so you don't need any -- you can launch the new column when you're ready. And then I do -- I would assume you would need some kind of 510(k) for the 9210 in 2024?

Well, we're looking at next generation changes, which would significantly potentially increase the [column] (ph) the number of column -- test for column. So like I said, John and I have been talking to you about increasing the column test numbers right now by 3 times in the current generation. We feel confident that's all within our purview. We are looking at strategies to increase that even more potentially to double that. That would probably require regulatory approval. And that's why we are concurrently, in addition to the changes we're about to roll out in the fourth quarter, concurrently working on that longer term process. And we think that'll be late 2024 before we get the kind of progress we need from a regulatory standpoint.

All right. And then can you just give us some kind of sense on what the legal challenges are left in Kenya? I mean, are you confident that you'll have this resolved in 2023 and that you'll be able to start shipping the units by the end of the year or test systems?

Look, I'm not going to -- I'm not going to opine on legal matters necessarily, but I will say, when you look at the actions being undertaken by the government, and the progress being made and our assessment of the situation, we believe that these matters should be resolved in early October. There are a couple of hearings coming up. And in principle, our view is, those hearings should all rule in the favor of the government and ourselves and should be able to move forward, okay? I am not -- I'm not going to give you a prediction on that other than to say we're confident that we feel that these matters should be resolved and that we will move forward at least with the expectation that the government has and ourselves. Our expectation in terms of all the activities is that, we're moving forward.

All right. And then lastly, you ended the quarter with about $14 million in cash. Do you think that's sufficient? I know you expect cash flow to improve in the -- over the next few quarters as some of your initiatives start to take effect. But do you think the cash –

I just want to be clear. I don't think it's sufficient. And John and I are working with our lenders to make sure we have plenty of liquidity going forward. It’s everyone’s best interest for us to have the appropriate runway and that what we're working on. Liquidity is a high priority for me in this kind of environment.

Right. Okay. But you -- I would think that when these initiatives such to kick in, you do expect to be cash flow positive over the next 18 to 24 months?

We expect significant improvement in both our HIV franchise as these orders for TrinScreen come in and the initiatives John kind of outlined, play through. And clearly, all these activities on the Haemoglobins business are aimed at making that a really kind of world class business. It should be running around 20% operating margins. That's where we're targeting that business. That's cash flow positive and it should be on a recurring basis.

All right. Thank you. That was it from me.

Thanks, Jim.

Thank you. [Operator Instructions] And we have no further questions. I'll turn the call back over to Mr. Aris Kekedjian for closing remarks.

Well, thanks everybody for attending our earnings call today. I think John and I specifically wanted to give you a bit of a deep dive and more insight and transparency in terms of what we're doing. We intend to continue this with you in the coming quarters as we make progress around these initiatives. And we look forward to following up with you as we have announcements to make in the coming month or two. With that said, thank you for the time. We'll see you again soon.

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

Hello, and welcome to the Trinity Biotech First Quarter Fiscal Year 2023 Financial Results. [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.

Thank you, MJ, and thanks to all of you for joining us today to review the financial results of Trinity Biotech for the first quarter of 2023. Joining us on today's call are Aris Kekedjian, Chief Executive Officer; 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, please note that statements made during 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 Statements in the company's annual report on Form 20-F filed with the Securities and Exchange Commission. Trinity Biotech undertakes no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after today or the occurrence of unanticipated events. With that said, I will now turn the call over to CEO, Aris Kekedjian for opening remarks. He will be followed by CFO, John Gillard, for a review of the financial results. And Mr. Kekedjian will provide additional background and we'll open the call for your questions. Aris, the floor is yours.

Thank you, Joe. Good morning, everybody. I'd like to take a few minutes to update you on the summary highlights for the quarter and some of the strategic initiatives that we have underway. John will go through more detailed financials and then we'll open up the call for questions. With respect to the quarter, starting with the revenue discussion. Revenues for the quarter for Q1 2023 was $17.2 million, excluding our COVID-focused PCR products and Fitzgerald industries revenues, which was disposed in April of 2023. Revenue for the quarter in terms of what is an ongoing business was about $14 million, about 2% higher than this period last year. Our performance in the quarter was led by year-over-year growth of approximately 35%, 15% and 10%, respectively for autoimmune clinical chemistry and the diabetes HbA1C consumable products. Strong demand from key accounts and a focus on clearing order backlog drove an increase of over 80% in revenues for the U.S. autoimmune business compared to Q1 2022, and an approximately 45% increase in deliveries for diabetes consumables in Brazil compared to Q1 of 2022. These were partly offset by revenue gains that we had last year on instrument sales [were] to China that were at a significantly lower margin. Those sales did not repeat this year, and that sale differential offset some of the benefits I just spoke to you about. Gross margin, excluding Fitzgerald, was broadly flat compared to Q1 2022, but we've had a approximately 4-point improvement over Q4 2022 as we increase prices and stabilize our manufacturing and supply chain processes. I'd like to take a moment to talk about our hemoglobin product activities. We continue to work closely with the FDA to gain clearance of our 510(k) submission for the Premier Resolution hemoglobin variant instrument. In addition to a U.S. market introduction in the second half of the year, we expect FDA approval will drive significant global order activity as many of our distributors await approval. We are repositioning technical sales capability for the post-FDA rollout. The development of the next generation of our flagship diabetes HbA1c instrument, the Premier 9210, is also on track for an expected rollout in early 2024. The instrument is expected to feature an improved backward compatible reagent column system that should feature up to 3x the injection capacity and stability limited calibration and an improved user interface. This is the first step of a multi-generational product development plan aimed at expanding the target market, driving lower service downtime and cost while significantly expanding operating margins. These improvements we expect will have a significant improvement -- impact in terms of COGS on our core diabetes franchise business. So that's one of the most important priorities we've got going on in the company. In addition, with respect to hemoglobins, both China and Brazil our markets are particular focus for both product line expansion as well as footprint expansion in both markets, both to drive cost competitiveness, streamlined regulatory pathways and expand market access. We already do some reagent activity, manufacturing activity in Brazil. We're looking at optimizing that platform and potentially looking at some opportunities for assembly in China. I'd like to take a moment to talk about our TrinScreen HIV product, which is ready to be launched. We are focused on executing on the launch and distribution of this test, following the announcement by the Kenyan Ministry of Health of the adoption of our new rapid testing algorithm. The algorithm establishes Trinity Biotech as the HIV screening standard to testing Kenya under World Health Organization guidelines. There have been some delays as the government currently is addressing some legal challenges to the HIV testing algorithm changes and we expect to receive significant orders in the second half of 2023 upon resolution of these legal matters. The Kenyan HIV screening program is one of the largest in Africa, there's a potential of up to 9 million tests a year. And the intention is to immediately ramp up to deliver several million tests in initial orders in the coming months. I'd like to take a moment to discuss portfolio transformation initiatives and our capital structure. In April, the company completed the sale of Fitzgerald Industries, generating approximately 30 million of proceeds that were partially used to further reduce debt by approximately $10 million. This exit is the first of several strategic moves aimed at focusing the current portfolio around our core hemoglobins and HIV franchises, streamlining our cost structure, reducing debt and providing firepower for M&A. Our pipeline of attractive M&A opportunities is aimed at disruptive adjacencies where the total addressable markets are TAMs, are significant and matter. They also potentially provide us access to next-generation diagnostic product platforms and provide us an opportunity where we can leverage our global manufacturing and distribution footprint. In February, the company secured a $20 million flexible term facility, specifically to provide the ability to move quickly when opportunities or transactions arise. I'd like to take another moment to highlight and give an update on our structural and operational initiatives. Multiple initiatives are underway to significantly reduce cost of goods sold in our core hemoglobins and HIV franchises. These include instrument and consumables design updates to supply chain optimization, outsource and localized manufacturing as well as overall streamlining of processes that support these businesses. All these initiatives are aimed at driving significantly higher operating margins in these platforms. We are pushing both platforms to have gross margins at or around 50% -- 40% to 50% and operating margins in the 20% range. Those are our targets. Those are what we're working toward, and these initiatives will help us get there. As a final reminder, I'd like to let everyone on the call know that Trinity Biotech will be participating at the American Association of Clinical Chemistry, otherwise known as AACC Annual Conference, taking place in Anaheim from the 23rd to the 27th of this month. We hope to see some of you there. With that summary, I'd like to pass it on to John to give you a more detailed review of our financials, and I'll be back at the end of the call.

Thank you, Aris. Good morning, everyone. Now I will take you through the results for Q1 2023. I would like to start by talking about the sale of our Fitzgerald Industries Life Sciences supply business, which was completed on April 27 [last]. We consider that life sciences supply was no longer core to the group's refined long-term strategy and pursued this transaction as part of our plan to transform into a high-growth innovator in diabetes care and decentralized diagnostic solutions. As Aris mentioned, we achieved cash proceeds of approximately $30 million which represented a multiple of approximately 10x Fitzgerald EBITDA on a historical basis. Fitzgerald generated revenue of approximately $12 million in fiscal year 2022. In our income statement for quarter 1, 2023, the results of Fitzgerald have been reported separately as discontinued operations. Therefore, the revenue gross profit and operating loss numbers I will talk about today are stated without Fitzgerald for both the Q1 '23 and comparative quarter. Moving on to our results for Q1. Starting with revenues, as Aris outlined already, total revenues for the quarter were $14.8 million compared with $15.7 million in Q1 2022. Gross margin for the quarter was 36.7% compared to 38.2% in Q1 2022. The reduction in gross margin is largely due to changes in sales mix and the lower sales activity. I would point out that gross margin in Q1 2023 is substantially higher than Q4 2022 margin of 33.4%. And here, we are seeing the benefit of price increases and cost optimization initiatives implemented in mid to late 2022. Moving on to R&D expenditure, which was $900,000 in the quarter, down by $100,000 compared to Q1 2022. Meanwhile, SG&A expense in the quarter were $8.6 million, up $2.4 million compared to Q1 2022. Of this increase, half of it or approximately $1.2 million was due to higher share-based payments expense. This is a noncash accounting charge relating largely to performance share-based compensation awards, which are intended to closely align the goals of our team with those of our shareholders and the creation of shareholder value. The majority of these options granted in Q4 2022 and in Q1 2023 are performance share options and are structure such that they're exercisable only if the company's ADS price increases to certain levels, $3, $4 and $5 per ADS during the life of the option. None of these performance share options are currently exercisable. The remaining increase in SG&A expense was largely due to higher travel and expenses following the [lifting] of COVID travel restrictions, higher salary costs filing or senior leadership team appointments in late 2022. And lastly, foreign exchange loss largely related to the accounting-driven requirement to mark-to-market euro-denominated lease liabilities for right-of-use assets. This resulted in an operating loss for Q1 2023 of $3.9 million compared to an operating loss of $1.2 million reported in Q1 2022. Moving on to net financial expenses of $2.4 million in Q1 2023 compared to $12 million in Q1 2022. The decrease of $9.6 million is because the comparative period included a loss on disposal of exchangeable notes of $9.7 million. Excluding this nonrecurring financial expense, financial expenses for Q1 2022 were $2.5 million compared to $2.6 million in Q1 2023. Although our borrowings are now significantly smaller following our payments of debt, the interest expense is broadly similar for Q1 as our main borrowing accrued interest at a significantly higher interest rate than [during] Q1 2022 due to base interest rate increases. Given our repayment of debt on for the Fitzgerald transaction, we should see a reduction in those interest costs assuming stable interest rates in the following quarters. Profit for the period in discontinued operations was $0.5 million in Q1 2023, down from $0.8 million in Q1 2022 due to lower profitability of the now disposed Fitzgerald's business. In Q1 2023, the loss per ADS is $15.2 compared to $0.50 loss per ADS in Q1 2022. I will now move on to address some of the main balance sheet movements we have seen since quarter 4, 2022. The Assets and liabilities attributable to Fitzgerald industries have been separately presented within assets included in disposal group held for sale and liabilities included in disposal group held for sale separately, in the balance sheet at 31st March 2023. Intangible assets decreased by 13.9 million. This is made up of the Fitzgerald Industries intangible assets of $14.1 million, which are now shown in assets included a disposal group head for sale. Amortization was 0.3 million, and this is partly offset by additions of $0.5 million, which mainly comprises capitalized R&D expenditure. Financial assets have increased by 1.5 million. This relates to our investment in imaware which we announced in January 2023. At March 31, '23, 0.7 million have been invested with the $0.8 million balance recorded in current liabilities on the consolidated balance sheet. I must note that the convertible [note] investment, which represents an investment in unquoted equity instruments is presented as a financial asset on the consolidated balance sheet. As the instruments do not have a quota price in an active market for an identical instrument, the determination of fair value involves use of appropriate valuation methods and certain unobservable inputs requires significant management judgment and destination and may change over time. I would highlight that the valuation of this asset may be subject to a wide range of possible fair value measurements and may fluctuate significantly due to changes in market variables as well as available entity-specific information. The senior secured term loan liabilities increased by 4.9 million during the quarter, following the drawdown of an additional $5 million facility from Perceptive Advisors in February 2023. Also in the quarter, the company secured from our lenders a new $20 million facility to fund potential acquisitions, as Aris mentioned. None of this 20 million facility has been drawn down to date, although as we've discussed, we are actively looking at potential acquisitions. Finally, I will discuss our cash flow for the quarter. Our cash balance, including cash [indiscernible] by Fitzgerald decreased by $2.4 million to $4.2 million in Q1 2023. Cash used by operations for the quarter was $2.7 million, an increase of about 1.2 compared to Q2 2022. Capital expenditure cash outflows comprising PP&E and R&D spend and the investment in imaware were $1.3 million, a reduction of $400,000 compared to the comparative period. Interest payments in the quarter were $2.6 million. I will now hand it back to Joe. Thank you.

Thank you, John. We will now go ahead and begin the Q&A session. MJ, please set up.

[Operator Instructions] Today's first question comes from Jim Sidoti with Sidoti & Company.

Can you break out what the COVID, the VTM revenue was in the quarter? I think it was about 2 [indiscernible]. But is that right?

Just a second, I got that. I believe, I believe it was for the quarter 780, [ 700,000 ] which was just slightly higher than last year, about a couple of hundred thousand.

But down about $1.2 million from a year ago?

From a year ago, yes, definitely down by 1.29 last year. We -- I mean our expectations on COVID right now are very hard to predict, and nothing we're relying on.

Okay. You talked a little bit about Kenyan [indiscernible] is another legal hurdle you have to get past. When do you think you'll start shipping product in Kenya?

Well, look, all I know is that the government is confident that this challenge is going to get ruled in their favor. They're putting significant pressure on us to be ready and available to deliver there's like millions of [tests] between now and the end of the year. They've indicated they'd like to start with $1 million order immediately. So we're sort of 1 million test order immediately. So we are literally gearing up and ready. And I believe -- there's a key court date. John, I believe it's the second week in July, if I'm not mistaken, next week.

I think 10th of July.

Okay. So it sounds like you do expect revenue in 2023 from Kenya?

Yes, definitely. I mean at least from the standpoint of what we are gauging from the government's actions, activities, expectations. And at the end of the day, this is their battle, right, at some point. So -- and they're feeling confident. So based on that, what we are getting is feedback and we've got guys on the ground, who are in contact on a regular basis. The view is that there's no merit behind the case, and they will prevail, and this will go through. It's not unexpected. You would expect an incumbent who's had this business for a while to push back as hard as they can.

Got it. And then with the new diabetes instrument, can you give us a little color on when you think those products hit the market?

Well, look, we've done -- I believe a large number of reviews of the FDA around the primary resolution. I think those have been concluded now is our understanding. And so we are expecting some news imminently from them. And we are gearing up our team appropriately to be prepared at AACC to highlight the product and we are gearing up our technical sales resources to be ready to go immediately. So those are all in place. And our expectation is to be ready for this coming quarter.

And then on...

As on the hemoglobin variants in on the diabetes instrument on the 9210, our core product. We are in stability testing around the columns. We are in the process of the key redesigns are almost done with this -- with the testing that will significantly improve the service quality and maintenance aspects and costs of the product. And John will probably give you a little context around some of the supply chain initiatives and the in-sourcing activities that are underway. But my expectation is that we will be in the market with the column updates and the quality redesigns in terms of the Phase I improvements in early '24. And I think the supply chain improvements and those COGS benefits should start trickling in by second quarter -- is that fair?

Yes. So in terms of the in-sourcing of the column, which we expect to significantly reduce down our cost of production of our consumable and that's towards the final stage in terms of quality review and technical review. We've given notice to our existing supplier that we will be moving away from them. So that's very real, and we would expect that accreting financial benefit to us probably towards the end of Q3. And then in terms of the supply chain around our instrument business we are very much looking at outsourcing and off shoring certain aspects of those instruments to much lower-cost locations in terms of supply chain. We are well advanced in Phase I on that and are currently testing samples and prototypes in terms of these modules. And then we're also actively examining supply chain changes for Phase II. Our core objective around that is to make our instrument cheaper to produce, which then should allow us to supply that to our customers and distributors at a lower cost which should effectively increase the total addressable market for our instruments. And that, coupled with the increased injection per column, and the increased reliability that we're also pursuing, we think we'll give this another lease of life and allow us to compete at a lower price point while continuing to deliver healthy margins.

Okay. On the autoimmune business, which I believe you said was up about 35% in the quarter. Is that the business in upstate New York, the lab business?

It's the associated test manufacturing business connected to the lab, yes. And a lot of that activity was a rebound in our U.S. order book and clearing of some backlogs.

So it sounds like you have multiple areas where you expect things to improve. You just reported Q1 around $15 million, I would imagine you have a pretty good handle on what you think revenues are for Q2. Can you give us any kind of range where you think revenues come in for the year? Or is it still too early to provide guidance?

I think it's too early to give you guidance for the year. This is -- I think revenues for this quarter for Q2 will be [ramped on] around close to $14 million, something like that, I would imagine $14 million. But we're still closing the books. But in terms of how the profile plays out, a lot of what we're talking about here, the inflection points play out in the second half, okay? So Kenya and TrinScreen and scaling of that business plays out in the second half. All of the changes that John and I talked about with respect to both the hemoglobins product launch, sorry, the launch of the hemoglobins product is also a second half play and all the changes around the 9210 are happening in the next 6 months. And should be in the market in 2024. So I don't expect an immediate rebound of these things, but I do expect key milestones that you'll be able to see in the coming quarters that we can point to where we get traction around orders and we get traction on the COGS benefits. And we'll highlight those as we go here in the coming months.

All right. Thank you. That was it for me.

[Operator Instructions] Being no further questions in the queue. I would like to turn the call back over to Aris Kekedjian for closing remarks.

Thank you for attending our call today. I know it's a bit of a tight holiday day week for a number of people in the U.S. I will say that I will apologize ahead of time. I've said the people we will report on a more timely basis. This quarter was on me. We got caught up on a number of corporate development initiatives in travel, and I'll take blame for that and ensure it doesn't happen again. But that being said, thank you for being on this journey with us, and we will keep you posted as developments [are out]. Have a good day.

The conference has now concluded. Thank you for your participation. You may now disconnect .