Bob Leasure
Analyst · Lake Street Capital Markets. Please proceed with your question
All right. Thank you, Devin, and good afternoon, everyone. We appreciate you taking time to join us today and appreciate your patience with respect to the delay in announcing of our results for the fourth quarter and full year. Following a very strong third quarter, total revenue for the fourth quarter of fiscal 2022 rose fivefold to $150.5 million from $30.1 million in last year's fourth quarter. For the full year 2022, revenues improved to $547.7 million from $89.6 million last year, with the increase across our DSA and RMS business segments reflecting approximately 31% organic growth plus the contribution from acquisitions. Adjusted EBITDA for fiscal Q4 improved to $18.3 million or 12.1% of total revenues from $4.3 million or 14.4% of total revenues in last year's fourth quarter. For the full year, adjusted EBITDA grew from -- grew to $90.5 million or 16.5% of total revenues from $9.3 million or 10.4% last year. This was a very solid year of continued growth and was reflective of our ongoing evolution into a comprehensive provider of non-clinical CRO services and research products to the global pharmaceutical and biotech industries. During 2022, we consummated several acquisitions that enhanced both our geographic footprint and portfolio of service offerings. We began the integration and optimization of our acquired operations and created a path to what we believe will be sustainable growth in sales and expansion of margins. We're pleased with the progress we made in fiscal year 2022 and have entered '23 with specific plans to continue to improve our overall business model while addressing what we estimate will be a temporary disruption in our NHP business, which I'll discuss in greater detail shortly. During the fourth quarter, we did experience unexpectedly higher operating costs related to company-wide recruiting and the validation of new DSA services, as well as certain non-recurring costs related to restructuring charges, legal fees for closures of facilities, and consolidation expenses to move operations from Dublin, Virginia to other facilities; we also began the preparation for moves from Haslett and Boyertown; we had acquisitions integration costs, including expenses from terminated M&A deals, which we will not close, and financing transactions and the discontinuation of a capital project. Let's move to a brief discussion of our DSA and RMS business segments. Overall, our DSA business had an exceptional year, generating revenue of $165.3 million, an 84.5% increase from 2021. Organic DSA revenue growth in 2022 was $49.6 million, representing incremental growth of approximately 66%, supported by $26.1 million of incremental revenue from strategic acquisitions. For 2023, we've already added new capabilities and capacity in Rockville, Maryland to conduct Good Laboratory Practices, or GLP, studies for in vitro, cytogenetics and bacterial mutation assays as components of the standard battery of genetic toxicology studies required to support first-in-human evaluations of novel therapeutics. We continue developing our suite of genetic toxicology services and look forward to seeing continued growth in Rockville as we also complete the facility buildout and launch our biotherapeutics business. We are completing other projects to build out the capacity and capabilities across our existing enterprises, specifically completing a project in Boulder, Colorado. This expansion was initiated in early fiscal 2022 and will be coming online during fiscal '23. We are expanding operations as well in Fort Collins, Colorado, but we'll be narrowing the plan which was scheduled for 2023. Once completed, these expansions will increase our DSA facility capacity by 30% and our DSA revenue capacity by an estimated $50 million. These expansions will also improve the overall quality and efficiency of our service offerings, while reducing our reliance on third-party outsourcing for certain services. We are reprioritizing some of our capital plans that we believe can generate quick returns and overall reducing our spend in fiscal '23. Conversely, we will delay our previously-announced expansion activities at our ILS facility in North Carolina, which we acquired in January 2022. The slowdown of our expansion does not impact our near-term growth prospects and we will evaluate these needs and investments in the future. Our RMS segment contributed $382.4 million of revenue in the year, reflecting strong incremental revenue well above the run rate when we entered the RMS market with our Envigo acquisition in November 2021. Organic revenue growth in 2022 was $91.3 million, representing incremental revenue growth of approximately 24%. This was our first year in the RMS business. We've had a chance to gain further knowledge of this business, have taken significant actions to improve the operations and enhance future margins through site optimization plans, enhanced pricing across the product portfolio and other significant operational changes. We have also made significant progress in our comprehensive site optimization master plan. In June, we announced the closure of two RMS facilities in Virginia. The closure of Cumberland, Virginia facility was completed by the end of fiscal 2022. Cumberland revenue was less than 1% of our total revenue and did not contribute to adjusted EBITDA. The operations at our Dublin facility in Virginia ceased in November of 2022, and the customers were transferred and are now being served from other locations. Since the closings, the Dublin property has been sold and the Cumberland facility is in the process of being sold. The previously-announced facility closures in Haslett, Michigan and Boyertown, Pennsylvania are now in process and should be completed by March of 2022 -- or March of 2023. We recently announced the closure of two facilities in Indianapolis. The activity of these Indianapolis facilities will be relocated to other existing facilities and should be completed by June of 2023. We also introduced the proposed consolidation plans of Gannat, France and Blackthorn, U.K. into existing facilities, which if approved, we hope to complete in 2023 and 2024, respectively. Now, I want to move to give a little bit more detail on our non-human primate business. As stated on our November 16, 2022 release, out of an abundance of caution, we have not initiated any shipments or imports of NHPs from Cambodia, although we do continue to sell and import NHPs from other countries. Cambodia is a critical supplier of NHPs to the U.S. In absence of imports from China, Cambodia represented over 60% of the NHP imports, according to CDC statistics. We continue to work with external and internal resources to review our current NHP inventory from Cambodia and we'll begin shipments of these NHPs only after such time that we can reasonably determine the NHPs in our possession are purpose-bred and not wild caught. While we are not currently aware of any outside constraints on importing NHPs from Cambodia, Inotiv will not import from Cambodia until we can complete satisfactory on-site audits of our suppliers. We are in communication with our Cambodian suppliers and we expect that we will be able to be on-site in Cambodia to complete these audits during this quarter. We do understand Cambodian officials have stated that they will be shipping NHPs. Even in a significantly-constrained market, we believe the DSA business will have -- our DSA business will have ample access to NHPs to meet our clients' needs. Having access to the supply, along with our desire and ability to have a positive impact on this industry, was a critical factor in the decision to purchase Envigo and Orient BioResource. We believe the current situation shows the need to implement changes within our industry, and we look forward to working with others in our industry and with the government to continue to lead changes to this industry. With respect to broader market conditions and commentary, during the fourth quarter 2022, an increased level of quoting activity translated into a higher backlog at year-end. As a reminder, when we report new awards, they are net of cancellations. Despite the growth in backlog, we also continued to experience a high level of cancellations, due primarily to molecules not being ready as expected for projects that were awarded 12 to 18 months ago and the abandoning of projects which were seen as risky. We have seen some market commentary that the industry is seeing a downturn in the biotech funding and spending. We have experienced a few occasions recently where this has been the case with our clients. We continue to monitor market conditions closely. The operational investments we made in 2022 in areas such as recruiting, internal processes, facilities, technology, personnel have been significant. We have allowed -- and it has allowed us to further integrate our acquisitions and begin to achieve synergies. We invested over $36.3 million in internal projects during 2022. We believe these investments will allow us to broaden our service offerings, improve margins, enhance our overall level of customer service and maintain a high level of animal welfare. Within our RMS business, specifically, the investments will allow us to implement our comprehensive site optimization plan, which currently includes closing nine of the 24 sites we acquired with the RMS business. In addition to the operational investments in 2022, we've also had an opportunity to review our cost and pricing. As a result, we have been able to amend customer contracts and pricing. Many of the pricing changes began to go into effect in January of 2023. These will help offset inflationary cost increases, which we experienced in 2022 and during Q1 of fiscal 2023. During the 12 months ended December 31, 2022, we hired approximately 860 people, which is over 35% of our current workforce. This was a significant investment and was needed to support our growth and improvements last year. We've seen our retention rate increase and we're able to successfully reduce our turnover rate. At present, critical operational leadership positions are all filled. Overall, in 2023, expect employment to stay consistent with our current levels, and we expect a growth -- to support our growth in 2023 from efficiency gains. As a result of market conditions and what we have been able to achieve over the last four years, in 2023, we expect to be less focused on acquisitions. As stated earlier, we have also delayed and reduced certain expansion activities we had previously announced related to our DSA business. We believe that this course of action is prudent given the current state of capital markets and our desire to focus on integrating and optimizing the businesses we acquired and have built over the past two years. We believe our strong organic growth for fiscal 2022 has exceeded the industry average of low double digit growth for Discovery Services and mid to high single digit growth for Safety Assessment, which speaks to our ability to increase market share. As per guidance for 2023, for fiscal year end -- year ending September 30, 2023, we are providing guidance of at least $580 million of revenue and at least $75 million of adjusted EBITDA. Due to the recent disruption of our NHP supply chain, the guidance of $580 million of revenue includes a range for Q1 fiscal 2023 revenue from $118 million to $122 million, and approximately $460 million of revenue during the nine-month period of Q2 through Q4 of 2023. The guidance of $75 million of adjusted EBITDA includes an expected negative adjusted EBITDA margin in Q1, and adjusted EBITDA margins of approximately 17% during Q2 through Q4. We will continue to focus on organic growth and market share gains with our expanding service offerings in the DSA business. With the strong backlog growth through 2022, we have good visibility on DSA revenue heading into 2023. We look for efficiency improvements to leverage our fixed cost structure on increasing sales to enhance DSA margin. Our RMS business will benefit from the price increases implemented in January of 2023 and the expected market share gains, while further margin expansion will be driven by our site optimization plans. We also continue to invest in enhancing our animal welfare programs. Our guidance does assume a reduction in the number of NHP sales from last year. Although we've experienced a short-term disruption, we are not aware of any importation ban from Cambodia and NHP sales could increase throughout the year from our guidance level if we are able to resume full importation levels. We hope to get further knowledge and comfort on 2023 importation levels based on additional supply audits that are expected to take place during this quarter. Even if the total volume of NHPs is lower than 2023 -- '22, we expect to benefit from price increases for NHPs, which could range between 65% to over 100% throughout this year in this highly supply-constrained environment. Although we were impacted by the NHP supply issue in Q1, we believe the business is well positioned to achieve above market revenue growth rates and expansion in margins. As stated previously, for 2023, we are focused on optimizing organic revenue growth and improving margins, and less focus on acquisition opportunities. We continue to guide long-term revenue growth of high single to low double digits and long-term EBITDA margins of 18% to 22%. With that, I'll turn it over to our Chief Financial Officer, Beth Taylor. Beth, please go ahead with the financial overview.