Aris Kekedjian
Analyst · Sidoti & Company. Please go ahead
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.