Bob Leasure
Analyst · Craig-Hallum Capital Group. Your line is open
Thank you, Steve. Good afternoon, everyone. During the second quarter, there were some announcements and events which are likely to impact our industry and our business. Over the last past five years, Inotiv has been evolving and has embraced challenges and changes that we've seen in our business. We believe we are a better company because of the changes we have faced. We also -- we have also made significant investments to better prepare us for the future. These include acquisitions, the businesses that we have started, the RMS site optimization plans and the RMS and DSA site investments. This quarter, we stayed focused on our plans and continue to execute on many of the objectives, including continuing to focus on client satisfaction, client relationships, continued integration of our scientific services and efforts as one company, moving forward and improving upon the next phase of our RMS site optimization plan, and expanding our NHP boarding and colony management services. We also had the opportunity to settle open litigation related to a 3-year-old case in which we were a plaintiff, which we inherited with the Envigo acquisition. We settled this case for approximately $7.6 million and the proceeds were received in March. I'll spend a few minutes on our second quarter results and highlights. For the second quarter of fiscal 2025, total revenue was $124.3 million compared to $119.9 million in Q1 of fiscal 2025 and $119 million in Q2 of fiscal 2024, representing a year-over-year increase of $5.3 million or 4.4%. The year-over-year increase was mainly due to an increase in RMS segment revenue of $6.6 million, partially offset by a decrease in DSA segment revenue of $1.3 million. The RMS revenue growth was primarily due to higher NHP revenue. As I mentioned in our call in February, we continue to see geopolitical and macroeconomic risk and uncertainties for our company as do many other companies and industries do at this time. At this time, we expect to continue to see year-over-year revenue and adjusted EBITDA growth for the next two quarters of fiscal 2025. Our RMS second quarter revenue saw year-over-year growth and some of this was due to a very light Q2 of fiscal year 2024. We believe we do have some momentum in 2025 that we did not see in 2024 and as a result, believe we will continue to see year-over-year RMS growth in fiscal 2025 versus 2024. Our overall RMS operating margins improved and were the strongest operating margins since Q1 of fiscal year 2024. We believe we have further opportunity to drive margins higher as we complete the next phase of the RMS site optimization plan, which we announced in December of 2024. We also indicated this expansion plan was expected to be approximately $5 million investment with the intent to use tenant improvement dollars along with proceeds from the sale of owned facilities to pay for this consolidation project. We originally estimated completion was expected to be before the end of fiscal year 2026. Also, we estimated this plan would have an annual cost savings of approximately $4 million to $5 million a year from reduced repair and maintenance expense on facilities and lower cost of production, along with improved service for clients, while production capacity would be unchanged. We have continued to refine our optimization plan and related timing for this project and have further revised this plan. We now anticipate net annual savings of $6 million to $7 million on a capital investment of approximately $6.5 million, which will be paid for with the use of tenant improvement dollars and a portion of the settlement dollars received this month. In connection with our revised plan, we continue to have two properties under contract to be sold and that proceeds will be used to repay principal on our term loans. This project is now anticipated to be completed by March of 2026, which is approximately six months earlier than our original plan and we anticipate beginning to see savings benefits as soon as Q4 fiscal 2025. As with previous projects, we have executed in RMS, these additional investments will help modernize our existing footprint while allowing us to close older facilities. This revised plan will reduce capacity and we believe will create operating efficiencies and continue to support our animal welfare objectives. Additionally, we believe this plan allows us to remain agile and to increase capacity in the future if needed. We also continue to integrate and improve our North American transportation distribution systems, which we brought in-house in the first half of fiscal 2024. Over the past three years and including the current optimization plan, these initiatives have upgraded our operating facilities, improved efficiencies, decreased expenses, and improved margins, all while enhancing animal welfare, quality, and delivery for our clients. In aggregate, we believe these projects have delivered and will continue to deliver for Inotiv and for our clients and are improving the competitive positioning of our RMS business. Moving now to DSA. Revenue for fiscal Q2 were slightly down versus the prior year quarter and ahead of Q1 2025. We recognize we have had a deterioration of DSA margins over the last two quarters, which we are addressing. We had several expenses that were higher than normal, such as higher cost base NHPs being used in toxicology studies, plus we saw increased overtime and labor costs, additional utility costs and an increase in operating supplies. Some of this margin deterioration can also be attributed to a mix in business and lower general toxicology service revenues and some related to pricing. We will be focused on these variables and efforts to improve margins in future quarters. On a positive note, DSA quoting and awards remain in line with the last nine months as our book-to-bill in the second quarter of fiscal 2025 remained at 1.01:1 and our new orders were 27% ahead of Q2 of fiscal year 2024. Again, the start of this quarter saw strong quoting activity with awards picking up towards the end of the quarter. So far in the current quarter, we remain pleased with the level of quoting and awards. Discovery awards for the first half of the year are still running 6.2% ahead of the six months ended March 31, 2024, and we expect discovery revenue to begin to see sequential and year-over-year improvements in the second half of fiscal 2025. We consider one of our foundational attributes as a contract service and research model provider to be our commitment to our clients having a high-quality experience when they choose us as a partner. Our focus is to meet and exceed our clients' needs and expectations. We believe we accomplished this through scientific talent and speed we can bring to bear on the projects and the care and efficiency which we produce and distribute our feed, bedding and enrichment products, and research models to them. At critical steps along our clients' journeys with us, we monitor metrics of the quality of our product, our delivery, and the satisfaction of our client base. We have been very pleased with the efforts of our teams on all of these fronts and we continue to see improvements in these metrics we use to track the quality of the client experience. We believe this ongoing focus is critical to building confidence for both our new and existing clients and leads our clients to choose Inotiv as a preferred provider. Now, let me provide some comments on what we are seeing in the market today and on recent activities that have generated questions related to our industry. There's no doubt this has been an interesting time for our industry with recent announcements by the U.S. administration on tariffs to be levied on our international trading partners and more recently by the FDA on the future direction of drug development, and the active discussions surrounding changes within the NIH funding and objectives. First, on the FDA announcement, we broadly support the FDA's stated goals of reducing animal testing and the desire to reduce the time and cost required to bring new medications to market. In their recent official statement, the FDA noted the potential critical role that new approach methodologies or NAMs could have in achieving these goals. Such NAMs include technologies such as computer modeling, using cell and organoid-based methods, and the use of human tissues ex vivo as a contributory model for drug safety and efficacy. At Inotiv, many of our acquisitions and investments have been implemented, at least in part, if not sometimes wholly with the intent to help position us for the future, which is in line with the goals outlined in the 2022 FDA Modernization Act 2.0. Examples of some of our current service offerings, which are in line with these goals include predictive computer software, computational toxicology, bioinformatics, proteomics, ex vivo and in vitro cell-based assays, and assays we run in human cells and tissues. I want to remind everyone that we have been building these capabilities over many years and we consider the continuation of development of them to be critical for the future of smarter drug development and our role in this initiative. As we adopt these advanced new technologies, we see these potentially reducing the need for using animals in some circumstances and over some time period, but we do not yet foresee the complete replacement of the use of animals in bringing safe and effective new medicines to humans and animal patients. Indeed, on April 29, the NIH also made an announcement on the future of NAMs and their intent to prioritize the use of human-based research technologies. In their announcement, they made clear their hope that NAMs could enable drug discovery and development to be smarter and more efficient in the future. But they also noted and I quote, "traditional animal models continue to be vital to advancing scientific knowledge". We plan to continue our role helping develop and validate the NAMs alternatives, but until they are sufficiently predictive of complex human biology and are fully accepted as alternatives by regulatory authorities, we believe animal-based safety and efficacy testing will remain critical. Since the FDA announcement, I've also been asked specifically what percentage of our business comes from monoclonal antibodies as they were a major focus of that announcement as the first wave of drugs that would be focused on for NAMs-based testing. We do not track our business at this time in a way that enables us to specifically identify that data. However, from publicly available data, we know that around 15% of all medicines in development are monoclonal antibodies. Moving now to U.S. government's recent introduction of tariffs on virtually all of our international trading partners and the potential for those tariffs to meaningfully increase if the U.S. do not reach specific trade agreements with each of those partners. Let me address the potential direct impacts of the tariffs currently in place. For the majority of our business, the primary components of our products and services are sourced within the same geographies. That is most of what we need to deliver our products and services in the U.S., we source within the U.S. and the same is true for outside of the U.S. A material exception to this rule is the sourcing of NHPs, which we bring into the U.S. from certain Asian and African countries. For these, based upon current tariff levels, we will be paying the 10% tariffs and we will be working with suppliers and customers to mitigate the financial impact of these additional costs. Should the much higher tariff rates that have been talked about previously come to pass, we also expect to work with suppliers and customers to mitigate those potential additional costs as the NHPs are mission-critical to the safety testing of new medicines. If the higher tariffs are put into place and exist for some time, we are not in a position at this juncture to predict if or how our clients may prioritize studies or how our suppliers may prioritize and allocate their supply going forward. Based upon current tariffs announced, we have not yet seen any material change in demand. We believe we are beginning to see some cost inflation that is being linked to tariffs, for example, quotes for certain lab equipment and materials for construction projects. We are working to adapt our sourcing and planning strategies to largely mitigate these costs. Should higher tariffs come into play and/or be imposed for extended periods of time, we will continue to assess the financial impact and consider whether we will try to pass along some, if not all, of these costs to our client base. Overall, we remain confident going into the second half of fiscal 2025 and are also now preparing for '26 and '27. As I said earlier, the geopolitical and macroeconomic condition, risk and uncertainties will remain with us as they do for all companies. We continue to improve and we remain committed to building a business that will create value for our clients, employees, and our shareholders and look forward to our future. I'll now hand things over to Beth to provide a financial overview.