Greetings. And welcome to Inotiv’s First Quarter Fiscal Year 2024 Earnings Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Bob Yedid. Thank you. You may begin.

Great, Camilla, and thank you everyone for joining today’s quarterly call with Inotiv’s management team. Before we begin, I’d like to remind everyone that some of the statements management will make on the call are considered forward-looking statements, including statements about the company’s future operating and financial results and plans. Such statements are subject to risks and uncertainties that could cause actual performance or achievement to be materially different from those projected. Any such statements represent management’s expectations as of today’s date. You should not place any undue reliance on these forward-looking statements, and the company does not undertake any obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise. Please refer to the company’s SEC filings for further guidance on this matter. Management will also discuss certain non-GAAP financial measures in an effort to provide additional information for investors. Definitions of these non-GAAP measures and reconciliations to the most comparable GAAP measures are included in the company’s earnings release which has been posted to the Investors section of the company’s website and is also available in the Form 8-K filed today with the Securities and Exchange Commission. If you haven’t obtained a copy of today’s press release, you can do so by going to the Investors section of Inotiv’s website. Joining us from the company today are Bob Leasure, President and CEO; and Beth Taylor, Chief Financial Officer. Bob will begin with some opening remarks, after which Beth will present a discussion of the company’s financial results and then we’ll open the call for your questions. With that said, it’s my pleasure to turn the call over to Bob Leasure, CEO. Bob, please go ahead.

Thank you, Bob, and good afternoon to all of you joining us on our call today. As you saw from today’s financial news release, Inotiv began its fiscal 2024 making progress against important financial and operational metrics while continuing to develop and solidify its business model. As noted in our year-end conference call last quarter, our promise to shareholders, customers, and employees has been to guide Inotiv toward becoming a leading midsize CRO in the marketplace through transformative acquisitions and build-out of new services, which will ultimately expand our contract research service capabilities. We continue to enhance and build an organization delivering innovation and solutions for drug discovery and development. It is significant that in the past 18 months, we have optimized our operational footprint from 33 to 23 locations by closing down nine RMS facilities and one DSA facility, transferring the work to existing facilities, which have been recently renovated and expanded, while simultaneously expanding three DSA existing facilities. This will allow us to better service our customers’ demand for new complementary services and create a platform that will support growth and allow us to leverage our fixed cost structure and enhanced margins. Further, as noted in our prior quarter, we have also been restructuring our transportation services and logistics operations. As a result of all these initiatives, once they are completed, Inotiv will have eliminated $20 million of annual operating expenses from the business. Approximately $5 million of these reductions were realized in fiscal 2023 and the remainder should be completed in the fourth quarter of this year. In addition to the decrease in operating expenses for the site optimization and restructuring of our transportation, we have seen reductions in G&A expenses as well. We have also expanded our service offerings and capacity. As we near the completion of these infrastructure projects, we have shifted to a renewed focus on sales and marketing by adding additional salespeople and focusing on improving our brand awareness. We believe that our strategic efforts will enable us to broaden our customer base and better serve these customers through innovation and the development of nimble solutions and custom offerings. We have remained focused and accomplished significant transformation while our industry has faced headwinds over the past two years. As we go forward, we are focused on executing our plan to become a stronger company by increasing sales and margins. Now let us turn to the highlights of our financial results. Beth will go through these in more detail shortly. We are pleased to report revenue of $135.5 million for Q1 of fiscal 2024, up 10.3% compared to the same period a year ago. It’s worth noting that all year-over-year growth is now organic, as we have not completed an acquisition in the past 18 months. These topline results consisted of DSA revenues of $44.7 million, roughly 8.8% in Q1 2024, compared to $41.1 million in the prior year period. Revenue from RMS was $90.8 million in Q1, an increase of 11.1% from the prior year period. Overall adjusted EBITDA was $9.6 million, as compared to consensus $8.3 million. Adjusted EBITDA improved $15.1 million, compared to a negative adjusted EBITDA in Q1 fiscal 2023, which was primarily driven by the initial negative impact on revenue and gross margins from the company’s decision to refrain from selling or delivering any of its Cambodian NHPs in the U.S. in Q1 2023 until our staff and external experts could reasonably determine those NHPs and inventory from Cambodia for purpose-bred. The year-over-year improvement in adjusted EBITDA of $15.1 million is important as our bank loan covenants are calculated on a trailing 12-month basis, and therefore Inotiv has further improved its financial flexibility for the quarter starting January 1, 2024. Our net book-to-bill ratio for DSA business for the first quarter of 2024 was 1.46 to 1 as net new order bookings were up to $63.8 million versus $40.7 million a year ago. This represented a 57% year-over-year increase in net new business signings. Cancellation rates in Q1 2024 were less than half of what we observed in the immediately prior quarter and the lowest we have seen since Q3 fiscal 2022. We are still seeing some projects get delayed, which can impact our quarterly revenue. Inotiv’s conversion rate was up to 32.5% in Q1 fiscal 2024 versus 27% in Q1 of last year. Our backlog at December 31, 2023 was $152.3 million versus a prior year backlog of $147.9 million and a September 30, 2023 backlog of $132.1 million. Our DSA operating income was down for the quarter compared to the same quarter in 2023 due to increased costs associated with the development of new services. These new services are not yet seeing positive gross margins and therefore have created a headwind for overall margins. As revenue for those services increases, we expect to see an associated margin improvement. For research model services, revenue increased over Q1 2023 mainly due to pricing in the NHP business. In the first fiscal quarter of 2024, the total number of NHPs we sold was down 20% compared to the same period a year ago. However, pricing for NHPs was still much stronger so overall NHP sales and margins, and therefore RMS sales and margins remained higher than a year ago. In last quarter’s conference call, we indicated that NHP prices were expected to come down from the highs we saw in Q4 of fiscal 2023. We did see NHP pricing on average come down roughly 18% in Q1 of fiscal 2024 versus Q4 of fiscal 2023, with Q1 of 2024 closer to the average unit price for all of fiscal 2023, including the first fiscal quarter of last year. We believe it is important to understand that we expect to see a transition in the marketplace by customers seeking more long-term supply contracts for NHPs versus buying on the spot market as we experienced last year. This means that over time, we could sell fewer NHPs on the spot prices and more under fixed contract pricing. We believe this shift would be favorable for our NHP business as we could increase the predictability of our NHP revenue and improve the management of our working capital. However, in the near term, we may experience some variability in our NHP revenue quarter-to-quarter. We believe the level of these fluctuations will depend on our customers’ current inventory of NHP, changes in the amount of their preclinical work, and when they transition to these supply agreements. For our SG&A in Q1 of 2024, we did see the benefits of some of the changes we have implemented, such that G&A expenses were $3.7 million fewer in Q4 of fiscal 2023 and approximately 16% expense reduction sequentially, and $18.4 million or approximately 30% less than the same quarter a year ago. Controlling our SG&A in line with our overall revenue is another significant area of focus as we integrate and improve our business model. Last year, we made substantial efforts towards increasing our focus on execution, site optimization, and integration. Additionally, the planned closures of 11 facilities over the last 18 months created substantial severance costs, significant startup costs related to transfer of production between sites, starting new services and expanding facilities. However, these are vital projects to our future. We were pleased with how these projects were executed, generally in line with the original budgets and timeframes. We look forward to completing the last major consolidation and expansion efforts still in process. We believe we are now positioned more strongly for the current macro environment and well-positioned to participate in a wider recovery in our industry, which will allow us to further accelerate our growth and improve margins on an incremental basis. To briefly update on the recent major projects activity from the end of fiscal 2023 spilling over into fiscal 2024, these projects include the sale of our French and Spanish facilities, which were completed in the quarter ended December 31, 2024. Our facilities in Haslett, Michigan, Dublin, and Cumberland, Virginia, and Blackthorn, U.K. are now currently all under contract to be sold. Our original Hillcrest expansion is in process and is on track with our original timeframe. However, we are pleased to have entered into two new customer contracts, which will require further expansion at Hillcrest operations. In order to accommodate one of these customers in early fiscal Q3 of 2024, we are planning to move the transfer of work from Blackthorn to Hillcrest to fiscal four of 2024. We estimate that once the expansion of Hillcrest, with the consolidation of Blackthorn and the renovations for the two new customer contracts are complete, we expect a small research model and services in Europe to see annual revenue growth of approximately 15% and approximately 15% improvement in our margins. We have now completed the expansion of our Fort Collins facility. We did experience some delays during Q1 in completing this expansion and validating this new facility. We also experienced client delays and studies for this facility, and therefore did not realize any revenue from the expanded facility in fiscal Q1 of this year. We anticipate beginning to realize revenue from this facility during fiscal Q2 of this year. We have continued to complete new assays and are pleased with the continued growth and startup of our new genetic toxicology and biotherapeutics business in our Rockville, Maryland facility. Although these startup services still carry negative margins, these new services help drive our growing backlog in fiscal Q1. At the end of fiscal Q1, we also announced we entered into a transition service agreement with Vanguard Supply Chain Solutions, the company’s main outsource provider of transportation services, to enable the in-house integration of Inotiv’s North America transportation operations. We have now completed this transition. By taking direct control of our transportation operations, we expect to further reduce costs and achieve key efficiencies to strengthen internal operations, improve our outgoing supply chain, and further improve service quality for clients. In fiscal 2024, we’ll continue with critical improvement projects. These include the conclusion of our site optimization plan, continuing site infrastructure and animal welfare improvements in our RMS business; continuing to evaluate and improve our RMS transportation operations and service based on our new site footprint, which should allow us to further reduce expenses and improve client services; further expand our NHP supply and customer base; focus on expanding our customer base while continuing to improve and provide exceptional client services; and continuing to further leverage our scale and capabilities to reduce outsourcing costs, enhance our competitive profile, and increase the speed of innovation for the discovery and development process for our customers. We see our ability to expand our service business and take advantage of recent expansion efforts and leverage our fixed cost structure as one of the biggest opportunities for future margins and earnings improvements. We have put in DSA capacity to accommodate approximately a 40% increase in DSA revenue or up to $70 million in additional revenue compared to our current run rate annualized. In fiscal 2024, we will continue to grow our DSA sales team by dedicating resources to increase our market share. As I said on our last call, with the recent capacity and new services added, we are growing our customer base by increasing our sales effort in chemical and crop protection markets, recently adding a medical device salesperson, increasing our discovery and translational sciences services sales team, and building our drug development and safety assessment sales team. While we believe we are in a much better position than we were a year ago, we feel we can continue to make further improvements. We believe we are well-positioned to increase our sales volume in 2024, driven by greater cross-selling to our existing customers, expanding our sales team, focusing our market efforts, and building our brand recognition. Our first quarter saw some very good awards and positive momentum, and the improvements in the DSA backlog exceeded our expectations. We expect some of this may reflect pent-up demand after a slow summer, but we do remain encouraged. We look forward to our future and seeing the next two quarter trends. And with that, I’d like to turn the call over to Beth to review Inotiv’s financial results in detail.

Thank you, Bob. For the 2024 first quarter, total revenue increased 10.3% to $135.5 million from the $122.8 million recorded during the prior year period. DSA revenues increased by 8.8% to $44.7 million when compared to the prior year period of $41.1 million. As previously mentioned, the higher revenues experienced in our DSA segment were primarily driven by new services related to genetic toxicology and the mix and pricing of general toxicology services, which were partially offset by a decrease in medical device surgical services due to cancellations we experienced in the fourth quarter of fiscal 2023 and delayed projects. RMS revenue for the fiscal first quarter was up 11.1% to $90.8 million compared to the same quarter last year, mainly due to favorable pricing across several products, particularly NHP. These increases are partially offset by lower volume of NHP sales and a decrease in revenue for small research models due to lower demand. Consolidated net loss attributable to common shareholders in the first quarter of fiscal 2024 totaled $15.4 million or a $0.60 loss per diluted share. This compared to consolidated net loss attributable to common shareholders of $87.3 million or a $3.41 loss per diluted share in the first quarter of 2023. For the quarter, adjusted EBITDA improved $15.1 million compared to the prior year period to $9.6 million or 7.1% of total revenues from a negative $5.5 million or a negative 4.5% of total revenues in last year’s first quarter. Operating loss for the first quarter of fiscal 2024 was $9.4 million, compared to a loss of $90.6 million from last year’s first quarter, which included $66.4 million of goodwill impairment loss. Additionally, the current quarter had lower G&A and other operating expenses, which was partially offset by higher selling expenses and higher depreciation and amortization expenses compared to Q1 of 2023. The decrease in G&A of $8.4 million and other operating expenses was driven primarily by decreases in compensation and benefits, acquisition and integration expenses, bad debt expenses, and a decrease in other third-party expenses, which was partially offset by higher restructuring expenses related to site closures, site optimization costs, and the announced transition of transportation for our RMS business in North America. Non-GAAP operating income for our DSA segment in the first quarter decreased to $6.9 million or 15.5% of segment revenue from $7.9 million or 19.1% of segment revenue in last year’s first quarter. DSA non-GAAP operating income in Q1 of fiscal 2024 was unfavorably impacted by the increased costs at our new facility in Rockville, Maryland, as this facility is close to being fully operational and general price increases seen for research models, operating supplies, and compensation and benefits. As our new services start to come online and we begin to fill newly added capacity, we believe we will be able to boost our DSA margins from the mid-30% range in 2024 to a level in line with our long-term targets of going consistently into the upward 30% range. The net book-to-bill ratio for DSA in the first quarter was 1.46 to 1. Coming off weaker net awards in Q4 fiscal 2023, this brought our trailing six-month net book-to-bill to 1.03 to 1 and our trailing 12-month net book-to-bill also returned to slightly over 1. The higher net book-to-bill in Q1 fiscal 2024 was primarily due to higher awards, and we saw about half the cancellations in the first quarter of fiscal 2024 compared to previous quarters. DSA backlog was $152.3 million at December 31, 2023, compared to $147.9 million at December 31, 2022. Additionally, our conversion rate, which is our ability to convert our backlog to sales, has improved over Q1 fiscal 2023. Non-GAAP operating income for our RMS segment in the first quarter of fiscal 2024 was $16.9 million or 18.6% of segment revenues, compared to $5.6 million or 6.8% of segment revenues in last year’s period. The increase in RMS revenue was due primarily to favorable pricing, particularly for NHPs, partially offset by the negative impact of lower volume of NHP sales and lower sales of small animal models due to lower demand. We also saw a decrease in costs as a result of site optimization. Interest expense in Q1 2024 increased to $11.4 million, up from $10.5 million in last year’s first quarter due to higher interest rates. Our balance sheet as of December 31, 2023 included $22 million in cash and cash equivalent, as compared to $35.5 million at September 30, 2023. Total net of debt issuance costs as of December 31, 2023 was $379.3 million, consistent with the $377.7 million at September 30, 2023. The balance sheet also includes assets held for sale of $1.9 million as of December 31, 2023. Net cash used in operations for the first quarter was $6.5 million, compared to cash used in operations of $7.4 million in the same period last year. The decrease in cash used in operations was primarily driven by a lower operating loss in Q1 2024 versus Q1 2023. Cash provided by operations for the trailing 12 months was $28.7 million. Capital expenditures in the first quarter were $5.6 million or 4.1% of total revenue and reflected investments in completing our DSA capacity expansions in Fort Collins, Colorado; infrastructure improvements in NHP facilities; renovations in the U.K. in order to complete the expansion of Hillcrest for the new customer contracts; and the consolidation of Blackthorn, enhancements in laboratory technology, and improvements for animal welfare. Regarding our guidance, we are reiterating our fiscal 2024 revenue guidance. We expect revenues to be in the range of $580 million to $590 million. We expect increases in DSA revenue and flat to decreasing RMS sales based on a possible reduction in NHP sales. Adjusted EBITDA is expected to be in the range of $75 million to $80 million. The increase in adjusted EBITDA over fiscal 2023 is expected to be driven by increased margins from the DSA segment and cost reductions we initiated in fiscal 2023, offset by the projected reduction in future NHP margins. We expect to continue to remain in compliance with our financial covenants for the fiscal year. We expect capital expenditures to be approximately 4.5% of revenue in fiscal 2024, as compared to an annual average of 10.3% over the last five years as we expanded sites and grew the DSA service capacity. We are pleased that we were able to improve adjusted EBITDA by $15.1 million over the last year’s quarter and with the progress that was made to complete the capacity expansions for the DSA segment to increase revenue and improve margins, and the significant progress made on the site optimization plans for the RMS segment. And with that financial overview, we will turn the call over to our Operator for questions.

Operator, this is Bob. One clarification. My friend, Bob Yedid, pointed out that when I referred to the SG&A expense reduction year-over-year, I referred to an $18.4 million reduction. It is an $8.4 million lower in Q1 2024 versus Q1 2023. That’s $8.4 million, not $18.4 million. I want to make sure I make that clarification, as Bob Yedid said, it was not clear when I read that the first time. But thank you.

Thank you. Our first question comes from Frank Takkinen with Lake Street Capital Markets. Please proceed with your question.

Great. Thanks for taking the questions and congrats on all of the progress. I was hoping I could start with a question around the book-to-bill. It looked really solid. Maybe take us a little bit deeper into where some of this business came from, if there were any particular customer profiles that were bright spots. And then I heard the cautionary statement around kind of pent-up demand after a slow summer. Maybe explain the reasoning behind this, as well as we start to move into 2024.

Thank you, Frank. It was a strong quarter, with last quarter at 0.65 and this one around 1.46 or 1.4 plus. While I knew we had momentum last quarter, we didn't secure the awards until this quarter. Our trailing six months average is over 1. I didn't find last quarter as poor as 0.65, and 1.47 seems a bit high compared to the market, which is why I’m looking to balance those two quarters. Regardless, I’m quite pleased. The conversion rate is improving, and the backlog is shortening. We’ve seen increases in some new services, especially at the Rockville, Maryland site, which currently has negative margins. If we exclude Rockville's sales and margins for this quarter, our sales would still show an increase and improve our DSA margins. We're aware that we're currently operating at about 25% capacity at that site, but we're happy with its progression, validating the assays, and the backlog growth last quarter is encouraging for the future. We hope to maintain these trends, and while 1.46 was an unexpected and pleasant surprise, the six-month average is just over 1, which we need to build on.

Got it. That’s a good color. Maybe moving on to the cadence of revenues expected for the year. Fiscal Q1 typically is a seasonally slower quarter, but seems you performed ahead of expectations. Maybe walk through how we should be thinking about getting to the guided ranges for 2024 on the revenue line and EBITDA line, given this stronger than anticipated fiscal Q1 performance?

We have seen steady growth in the DSA business and I am pleased with our backlog and current position. However, delays may affect our results on a quarterly basis. Overall, we will maintain our guidance. The small animal and diet business remains stable for us. The NHP market, on the other hand, could experience significant fluctuations. Last year, that market shifted significantly from contracts to a spot market. Demand was high, and pricing remained stable with increases. This year, supply is much improved compared to last year, and I believe customers have learned from this experience, opting for long-term suppliers over multiple years. This approach will provide us with better predictability and more manageable working capital needs. However, the market must revert to this strategy from where it was a year ago, and we are currently engaging with various customers, which is encouraging. Looking ahead over the year and into 2025, we are in a solid position. Nevertheless, the NHP market remains less predictable, as we saw last year with fluctuations of $10 million to $15 million between quarters due to the number of NHPs being released from quarantine and other factors. That’s why we prefer to provide annual guidance rather than quarterly guidance, as we could see considerable variability in NHP results from one quarter to the next.

Okay. One more quick one for me. What’s your split of contracted NHPs versus spot market NHPs today and where do you see that going?

If you look back two years, we were primarily dealing with contracts, including those inherited from previous years. One challenge with those contracts was that they were fixed-price agreements, yet we were purchasing on the spot market towards the end of last year, which contributed to a slight decline in margins late in 2022. Currently, less than 15% of our business relies on contracts as we shifted away from that last year, focusing mostly on the spot market. I believe this trend will change and by the end of this fiscal year, we might see a reversal to 80% contracts and 20% spot. This change would significantly enhance predictability and address various management issues within the business.

Got it. That’s helpful. Thanks for taking the questions and congrats on the quarter.

Thank you.

Thank you. Our next question comes from the line of Matt Hewitt with Craig-Hallum. Please proceed with your question.

Good afternoon. I appreciate the questions and want to extend my congratulations. We've made significant progress over the past year. I would like to delve deeper into the book-to-bill ratio. It seems you had a strong quarter with new customer signings. How much of that can be attributed to pent-up demand from the summer, and how much is due to improved visibility from your customers regarding their balance sheets and the programs they want to initiate and advance this year? Is it possible to differentiate between these two factors?

I’ll do my best here, Matt. First, we closed a significantly higher percentage of our quotes last quarter compared to previous quarters, indicating we’re improving our quoting processes. Second, we saw much more quoting activity than last year, particularly in October, November, and December, which is very encouraging. Several factors may be contributing to this. Last year at this time, we didn’t have a discovery translational sciences sales team, which we've developed over the past three to four years, with some recent hires in the last eight weeks. Additionally, we established a chemical crop business in the last few months, and we didn’t have a medical device salesperson, but we’ve added that role within the last four to five months. We also increased our safety assessment sales team and have been better at promoting our brand and enhancing brand recognition. All of these efforts are coming together, and we’re improving our cross-selling tactics. That said, I believe we are still in the early stages of our potential, as many of these initiatives have been launched only in the last three to four months, with some just in the last two months. These new team members require time to acclimate to the market, understand our company, and receive training. I can't pinpoint a single factor; I believe it’s the combination of all these elements and our improved engagement with our operations and scientific teams during the sales process. I’m genuinely pleased with the collaborative efforts we initiated nine to twelve months ago. As we primarily sell to biotechs, we are aligning our business design with their needs.

That’s very helpful. Thank you. Additionally, where does your current sales and marketing headcount stand today? I know you plan to add a few more people, but what do you expect that number to be by the end of the year?

I don't have an exact number of people involved because our team is quite broad, including our sales, marketing, client services, and scientist engagement teams. It's not just a small sales team; we operate as a comprehensive organization. There are likely over 100 people actively engaged in selling and collaborating with other scientists on a daily basis, possibly even more than 150. Additionally, project managers, pathologists, and toxicologists are all partaking in the sales process, along with our leadership team. Hence, it's more than just a typical sales team; it's an entire organization focused on serving the biotech customer.

Understood. And then maybe one last one and I will hop back...

...on the DSA side. On the RMS side now, we’re developing relationships with universities, CROs, large pharma and that’s a whole other sales and marketing team.

Got it. Understood. And then maybe last one. Regarding Rockville, obviously, you’re seeing some nice early returns from that expansion. When does that get to profitability? Is that later this year? Do you think it may take a little bit longer? Is there kind of a threshold or a sales amount when it kind of gets to that break-even level? Thank you.

That's a great question, and for me, it's not going to happen soon enough, because we are still investing in startup costs there, and the margins are negative at the moment. I think we're currently about 25% of our capacity. We need to be closer to 40% or 45% of capacity to break even. So, we may still have a couple of quarters to go. If we have a couple of quarters like we did last quarter, we will get there very quickly. However, even when we ramp it up, I must say that we’ve taken on so much work that, despite having the capability, we sometimes outsource just to avoid being late with customers. We want to increase our capacity, and while we’ve made progress, I believe we are more than halfway there. Last year at this time, we were just getting started. Now we are at 30%, and if we can reach 40% over the next quarter or two and achieve at least break even on the margins in the next three to four months, that would be significant.

That’s great. Thank you very much.

Thank you. We’ve reached the end of our question-and-answer session and I would like to turn the floor back over to CEO Bob Leasure for closing comments.

Thank you everyone for joining today’s call. I look forward to updating the market on our progress regarding our strategic objectives during what I hope will be an exciting year for us. Having laid the critical operational groundwork over the past 18 months, we strongly believe we will see success in our initiatives aimed at improving efficiency, which will positively influence our top and bottom lines. Additionally, we will continue to work on enhancing our reputation to become the preferred midsize CRO provider. I’m also pleased to know many of our employees are listening to these calls. They have done an incredible job, and I greatly appreciate their efforts. Thank you again for your support as Inotiv embarks on this new stage of growth and opportunities. Have a good afternoon, and we look forward to our next call.

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