Trinity Biotech plc

Greetings and welcome to the Trinity Biotech first quarter 2024 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. 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 a company's annual report on Form 20F 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 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 and EBITDA, so 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 three main priority areas for our new leadership team, which were, one, growing trend screen 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 trendscreen HIV revenue. As I mentioned on our last call, we successfully ramped up production of rapid HIV tests, in particular, trans-screen 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 one was to increase production. so we could meet our trend screen 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 trend screen 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 Prince Green 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 four times as many rapid HIV tests in May this year compared to May last year. Having successfully ramped up production of print-screen 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 trend screen ramp up, we have still seen significant improvement on margin percentage quarter on quarter. As you can see, our previously announced targeted price increases, supply chain optimizations, and headcount reductions all contributed to improve 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 and 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 trans-green 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 receive 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 trendscreen HIV. As you know, before winning business in new countries, there is typically a comprehensive HIV test clinical evaluation program to be completed. Trendscreen HIV is in various stages of these evaluation processes across several countries in Africa. We expect to further grow Trendscreen HRE revenues in 2024 and in 2025 from new wins across many of these evaluation processes. Now, moving on from Trendscreen 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've said out before, we want to drive a step change in financial performance for three main 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 increase our access to capital. And thirdly, we believe that our newly acquired, accessible and environmentally sustainable CGM technology provides 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 three 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, centralized and offshore corporate services. We have made significant improvements in our key objectives across each of these three 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 one, consolidate and offshore manufacturing, we focused on our two largest businesses, being Rapid HIV Test and Diabetes HbA1c testing. In HIV testing, in addition to ramping up production, as I said 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 activities 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 facilities, which will utilise spare capacity created by the offshoring of HIV test assembly, I refer 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 Prince Green 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 reduction. 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 outsource 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 EBITDA 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 CGA. 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 healthcare 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 three months we purchased the biosensor technology of Waveform, including its existing CE mark-approved CGM. As many of you will 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 two 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 solutions. We can see the massive increase in diabetes prevalence, especially type 2 diabetes all across the world. with well over half a billion people now suffering from a diabetic condition, not to mention the many more in a pre-diabetic state. This creates a massive need for a highly effective non-pharma diabetes and pre-diabetes management solution, such as CGM, that can be used alongside or instead of pharmaceutical therapies. That is why we are investing in this exciting and growing area, but decided to enter into it in a de-risked 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 market. For those of you who may be new to this area, our CGM technology is not some unproven, non-invasive solution. Like the two main players, Abena 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 transmits 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 the retractable needle. This leads to the entire plastic and metal applicator becoming non-recyclable biohazard waste. In contrast, our sensor applicator is reusable and lasts for years, with all the sustainability and cost benefits that bring. While this might not sound like a big issue, for every single person using one of the leading products, over two years, they will generate over 11 pounds or 5 kilograms of non-recyclable plastic and metal across 72 applicators. 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 amounts of non-recyclable waste they create. By contrast, over the two-year period, our solution would use just one applicator. Our technology and approach greatly reduces the cost of environmentally harmful waste created by just this part of the solution, thereby solving two major problems with the current market-leading CGM device. 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 two main competitors on market today. This powerful combination of reusable applicators and transmitters 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 products on market. 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 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. Since we last spoke, we have now engaged a world-leading physical and digital product design consultancy based in London in California to lead the design of this next generation solution. This group has designed a broad range of products, from consumer electronic devices to cars, and are renowned for innovative and attractive design. This group has been 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-privileged 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 insight 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-1s, That change is driven by pharmacological-induced responses, with the side effects of GLP-1s becoming more and more understood. They are also very expensive drugs. We believe that CGMs 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 this 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 Pulse AI, with whom we just last week signed a strategic collaboration agreement. We are working with Pulse AI 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 markets, 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 Kail as Continuous Glucose Monitor Program Director. Avinash is already bringing a new level of knowledge and experience in the design and large-scale manufacture 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 global 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 since 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.