Earnings Call Transcript - TRIB Q1 2024

Operator, Operator

Greetings, and welcome to the Trinity Biotech First Quarter 2024 Earnings Call. 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.

Eric Ribner, Investor Relations

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.

John Gillard, CEO

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 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 three main priority areas for our new leadership team. Firstly, let's discuss growing TrinScreen HIV revenue. As I mentioned on our last call, we successfully ramped up production of rapid HIV tests, particularly 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 Q1 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. 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. 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 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-over-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 was 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 additional automation coming online in June through repurposing existing equipment, further supply chain optimizations, and 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 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 2025 from new wins across many of these evaluation processes. 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, 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 three main reasons: firstly, 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 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 onshore manufacturing; two, optimize supply chain; and three, centralize 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 1, consolidate onshore manufacturing, we focused on our two largest businesses: the 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 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 would be 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 the 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 are currently setting up the equivalent manufacturing line here in Ireland and expect to be up and running 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 in building a business of significant value in this area. In Pillar 2, optimize supply chain, this past quarter, 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 focused 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 three 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 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 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 non-pharma diabetes and prediabetes management solution 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 our commercial strategy around CGM and biosensors, and 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 non-invasive solution. Like the two 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 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 a 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 brings. 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 amount 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 reduce the cost and environmentally harmful waste created by just this part of the solution, thereby solving two 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 two main competitors on the 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 the 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 usability, affordability, and sustainability. We believe that by creating a next-generation product around these three 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 is 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 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 are 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 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. 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 wider 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 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 in 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.

Des Fitzgerald, CFO

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 remained below the minimum $15 million for continued inclusion on the Nasdaq Global Select. At that point, we were provided a 180 calendar day period to regain compliance. This 180-day period ended on May 20 of this year, and as expected, yesterday, we received a further notice notifying us 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 a specialist advisor 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 the 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 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 was 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 were $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 considered a loan modification, leading to a one-time non-cash modification gain of $3.6 million in Q1 2024. This gain results from the difference between the loan's existing carrying amount at the modification date and the revised carrying amount. Additionally, the fair value movement of our derivatives related to the term loan and associated warrants was $0.7 million for the quarter, mainly influenced by a fair value movement of the warrants granted to Perceptive. This was offset by an increase in term loan interest expense of $0.4 million compared to Q1 2023, driven by a larger outstanding loan balance, although at lower prevailing interest rates. 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 2024. 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, Operator

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

James Sidoti, Analyst

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

John Gillard, CEO

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

James Sidoti, Analyst

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

John Gillard, CEO

It’s less about one-time costs, Jim, since the capital expenditures have already been made. The focus is really on training the staff and helping them become more efficient. The inefficiency we’re experiencing is related to that aspect. As I mentioned, we’re introducing additional automation in June, which will further improve our efficiency. We are also achieving better pricing on our input materials due to our efforts in the supply chain. So, this is effectively a transition as we shift from the initial scale-up phase to ongoing manufacturing and supply chain operations. We anticipate this will have a significant impact. We were aware that TrinScreen would have a lower margin contribution due to its lower pricing point in the screening market compared to the confirmatory market, so this was expected.

James Sidoti, Analyst

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 the 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?

John Gillard, CEO

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 we sell. It also provides greater stability, requires less calibration, which is a kind of overhead that our users have to incur. 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, but we've also been looking to increase the reliability.

James Sidoti, Analyst

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?

John Gillard, CEO

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 than now than ever. 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 getting regulatory approval.

James Sidoti, Analyst

Okay. All right. And the last one for me, interest expense. I know you had the one-time 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?

John Gillard, CEO

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

James Sidoti, Analyst

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.

John Gillard, CEO

Yes, Jim. Look, 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, it has been really enlightening for us to see the rich partner network that's out there in terms of people that have built or are building already components, both from a physical and digital perspective for this type of industry. Doing this development within an established company like Trinity, where in many cases, we have long relationships 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. We think that will really reduce down the amount of work and spend we need to incur to really move the development project forward.

Operator, Operator

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.

John Gillard, CEO

Thank you, Melissa. And just for me, thank you to 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. 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.

Operator, Operator

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