Lifecore Biomedical, Inc.

three earnings results. Hosting the call today from the company are Jim Hall, President and Chief Executive Officer, and John Moorberg, Chief Financial Officer. Before we begin today, we'd like to remind everyone of the Safe Harbor Statement. Certain statements made in the course of this conference call contain forward-looking statements. It's important to note that the company's actual results could differ materially from those projected in such forward-looking statements. Additional information concerning risk factors that could cause actual results to differ materially from those in the forward-looking statements is contained from time to time in the company's filings with the SEC, including, but not limited to, the company's Form 10-K-A for fiscal year 2023 and their subsequent periodic reports. Finally, in light of the company's ongoing exploration of strategic alternatives, management will not be conducting a live Q&A session on today's call. With that, I'd like to turn the call over to Jim Hall, Chief Executive Officer. Jim?

Thank you, Jeff. Good morning, everyone, and thank you for joining us for our fiscal 2023 fourth quarter and year-end update. Today, I'll briefly touch on our fiscal 2023 fourth quarter and year-end results and provide an update on our development portfolio. Before I do so, I want to briefly address the outstanding strategic review process, which remains ongoing. We aren't in a position today to provide any updates, but we remain focused on continuing to execute on our business plan and that the board continues its evaluation of potential strategic alternatives so as to determine the best path forward to maximize value for our stockholders. As you recall from our last call, at the end of May, we took significant step forward with the execution of an expanded supply agreement with significant long-term customer Alcon, as well as completing a comprehensive restructuring of our debt arrangements in which Alcon became our primary lender. These transactions were significant in creating a more stable and sustainable capital structure for LifeCorps These transactions also brought some added complexity to our year-end reporting, which is the primary reason for the delay in providing you with our full year fiscal 2023 update. In the fiscal 23 fourth quarter, LifeCorp generated segment revenue of $31.5 million and segment adjusted EBITDA of $6.1 million, both of which were consistent with our expectations and the cadence that we disclosed during our third quarter call. We believe our business remains very well positioned as a fully integrated CDMO with highly differentiated capabilities for the development, fill and finish of complex, sterile, injectable grade pharmaceutical products. These technical capabilities have been honed from our more than 40 years of experience in building a premier pharmaceutical injectable grade hyaluronic acid manufacturing platform with a focus on complex and highly regulated products. We continue to believe that our unique expertise coupled with ongoing industry trends towards outsourcing of new drug development and our four decades of experience in creating a world-class quality management system positions LifeCorps as a preferred partner to provide CDMO services for new injectable drug applications. In fact, LifeCore is the only major manufacturer of pharmaceutical injectable grade HA with injectable CDMO expertise in the market today. Approximately 55% of all new drug applications are injectables and pre-filled syringe demand is growing at an estimated 13% compound annual rate according to Pharma Projects. Giving the industry's limited specialized injectable drug manufacturing capacity, we intend to continue to take full advantage of this incredible opportunity and deliver much needed capacity that we've been investing in during the past few years. Overall, our development portfolio of active projects advanced nicely in the fourth quarter with the addition of several later stage projects. In total, as of the end of our fiscal year in May, our active development projects increased by five to 29. These five new projects are also with five new customers, which brought our development customer count as of year end up to 27. These projects are spread across early phase clinical development with seven projects, phase one and two clinical development with eight projects, and phase three clinical development and scale up commercial validation activity with 14 projects. We continue to see an active project pipeline and continue to work on the velocity at which we close on new project opportunities. As a result, we expect to add several new projects to our development portfolio by the end of our first quarter of fiscal 24. Our team is doing a great job ramping up commercial presence in the market. As we've discussed several times over the past year, we believe our investments in our business development team are paying dividends in terms of our project pipeline. Our two new isolator fillers remain on track, which broaden our opportunity set in a significant way as a request for usage of that category of fillers for customers' projects are in particularly high demand. Our approach has shifted in response to that. We've continued to evaluate and target our prospective opportunities with the increased capacity represented by those fillers in mind as we look toward the future state with more optimized and balanced capacity. Our targeted and focused sales approach has highlighted and identified 44 prospective projects in our development opportunity pipeline as of the end of the fiscal fourth quarter that are as diverse and impactful as we've ever had at LifeCorps. These opportunities span multiple end markets, classes of drugs and medical devices, and with an assortment of companies, both large and small, which we believe speaks to the attractive CDMO capabilities within LifeCorps' growing expertise that the pharma industry is actively seeking and a CDMO partner. This is especially exciting as we work on leveraging our expanded set of capabilities. We are seeing great interest from potential customers who are working on drug products, which represents approximately half of our current development opportunity pipeline and includes the potential to expand our relationships with some of the larger pharma companies in the industry. But we also continue to see substantial interest from customers who want to utilize our HA expertise for highly viscous products. We are making progress on opening paths to other segments of the market that we previously may not have had the ability to execute and refining our pipeline to focus on opportunities that we believe are uniquely situated to capitalize upon. When combined with our unique expertise working with difficult materials, we feel like we are in an extremely strong position. In terms of our growth and ability to meet customers' needs contemplated in our development portfolio, we continue to invest in capacity. Today, our theoretical filling capacity remains at 22 million units versus demand of 8 to 10 million units that we expect will be fully utilized over the next few years with projects within our existing development portfolio. As such, we need to keep our eye on the near and long term given lead times with installing new capacity and the necessary human capital that's required to operate these higher levels. We have invested in two new isolator fillers, a five head and a 10 head that have been manufactured and are going through the final stages of factory acceptance testing with anticipated delivery dates this fall. Our five head isolated filler and new fill room are planned to be GMP ready by Q1 of calendar 2024. We believe that these fillers will allow us to double our theoretical capacity to approximately 45 million units, putting LifeCore in a great position to meet market needs and optimize our production across our manufacturing footprint. Another capacity investment is related to our fermentation production. We're in the process of moving from a single shift fermentation production staff to hiring a full 24-7 staff to increase our sterile HA capacity by 50% by June 2024 to address the increased HA volume requirements associated with our expanded supply agreement with Elcon. Along with capacity enhancements, we continue to build out our organizational capabilities to attract new talent and develop the team we already have in place. Our life core university training program is a key element of that, as is our lean certification program, which continues to elevate our team. We are proud of the 10 individuals who are granted their lean practitioner certification and have an additional lean certification training group staged to start November. Our operational excellence team continues to focus on creating metrics that matter, enhancing our training program, and creating an efficient environment for enhanced cross-functional communication. With our portfolio of current development projects, and the pipeline of opportunities we are seeing, the new fillers will be very timely to assist LifeCorps in fulfilling our customers' forecasted commercial units, which we see on the horizon. Once again, we believe LifeCorps is well positioned to take advantage of the strong industry fundamentals and customers' projects as they progress through development and into commercialization. We believe this position will translate into significant revenue generating potential in FY24 and beyond. In summary, we are making important progress on preparing LifeCorps for the growth that we see in our development portfolio. I'm extremely pleased with the resilience that our organization has demonstrated and thank each of our team members for their individual contributions. We operate in an exciting and rapidly growing industry, and I believe we are well positioned for significant growth ahead. With that, I'll pass the call to John to discuss LifeCourse Financials.

Thank you, Jim. I'll begin with a brief review of our financial results before transitioning to the balance sheet, the impacts from our recent refinancing, some timing perspectives on our SEC filings, and a brief guide on our fiscal 24 forecasted business. For the fiscal fourth quarter of 23, life course segment revenues increased 14.2% to $31.5 million, driven by a 38% increase in our hyaluronic acid, HA, raw material manufacturing, or fermentation business, and a 9% increase in our CDMO business. The increase in HA raw material manufacturing revenue was primarily due to the higher demand in the current year. The increase in CDMO revenues was primarily due to the timing of customer shipments, as well as a higher mix of earlier phase development projects onboarded at the earlier lower initial revenue stage, but have nevertheless strong runways for future periods. Life course segment gross profit decreased 4.9 million to 8.5 million for the fourth quarter of 23, representing a gross margin of 26.9%, which compares to 48.4% in the prior year period. The gross profit decline was primarily due to a favorable volume variance of 1.9 million due to the increase in year-over-year revenues, offset by an unfavorable rate variance of 6.8 million. The rate variance was driven by the lower volume of higher margin development revenues in the current year period, inflationary impacts of commercial aseptic products on certain legacy contracts, somewhat offset by the higher volume of fermentation revenues. Life course segment adjusted EBITDA was 6.1 million for the fourth quarter of 23, representing an adjusted EBITDA margin of 19.3%. Given the divestment of the remaining curation foods businesses in Q4, I will not comment on those segment results. In the corporate other segment, adjusted EBITDA was negative 1.9 million for Q4 of fiscal year 23, which was consistent with our expectations. And as a reminder, this is the final quarter of reporting the corporate other segment. Beginning in the first quarter of fiscal 24, we will be collapsing this segment into LifeCorp's G&A. We're still in the process of transitioning all remaining holding company back office functions, including financial, accounting, compliance, and IT infrastructure. And once that is complete, we will then be able to finalize our reduction in stranded costs from the legacy Landec holding company structure. Consequently, while we collapse the holding company segment into a single reporting segment, we will still communicate to shareholders the amount that would have been part of the holding company structure, particularly as we remain in the strategic review process so that our shareholders have an apples to apples comparison. While not reflected in our adjusted EBITDA figures, our fourth quarter net income was impacted by $6.9 million in restructuring and other non-recurring charges, net of tax, primarily related to consolidating and transitioning operations associated with the divestment of Curation Foods businesses, advisory costs, audit fees, and transition costs from corporate headquarters, transition to LifeCorps, as well as restructuring and advisory costs associated with our refinancing activities. In terms of outlook, particularly in light of our ongoing strategic review process, we are not in a position to provide formal guidance for fiscal 24 at this time. However, as we have discussed during our fiscal third quarter update, the timing impacts we have been experiencing, including the completion of some larger revenue, late stage development projects, and delays in commercialization of others, The timing and mix of new development projects and smaller earlier stage projects, as well as the inflationary impacts on certain legacy commercial contracts, are expected to continue in our first fiscal quarter of 2024 results. Later in Q2 of fiscal year 24, we expect that those impacts will ease as delayed commercial projects begin shipping in earnest And by January 1st of 2024, we expect to be able to effectuate pricing offsets under existing contracts to help mitigate some of the impacts of the recent inflationary pressures. Consequently, we expect Q1 of fiscal 24 to represent the low point for the year. And on a sequential basis relative to the Q4 that we're reporting today, Q1 revenue and adjusted EBITDA are expected to decrease before re-accelerating across the balance of the year. That said, first quarter LifeCorp adjusted EBITDA is expected to be approximately break-even, excluding the burden of our other segment, which as I noted, we expect to collapse into our consolidated results beginning in fiscal 24 first quarter. In Q2 of fiscal year 24, we expect revenues and adjusted EBITDA to show accelerated improvement following the commencement of commercial shipments that were delayed. Relative to the prior year second quarter, we anticipate FY24 Q2 revenues to grow by nearly 40% and LifeCorp adjusted EBITDA to grow at approximately twice the rate of revenues, which implies some margin expansion due to the aforementioned improvement in revenue mix associated with new commercial shipments strong fermentation revenues, and pipeline development projects that are expected to come online during the second quarter. Then in Q3 and Q4 of fiscal year 24, we expect to generate adjusted EBITDA at more normalized levels, similar to or greater than what we achieved in fiscal year 22 third and fourth quarters. I'd like to emphasize that these quarterly forecasts are being provided without the impact of our other segment, which reflects the corporate overhead that we still carry, and we are sharing this added granularity to help you isolate an apples to apples comparison to our prior segmentation. As for these corporate costs, we believe that there will be ultimately savings to be realized, and for modeling purposes, we believe it is prudent to assume that our current quarterly run rate of approximately 1.8 to 2.1 million continues in the near term. In addition, and excluded from our FY24 adjusted EBITDA expectations, are approximately 2 to 2.8 million in startup costs associated with the HA fermentation capacity improvements that Jim mentioned earlier, including the transition to a 24-7 work shift requiring significant one-time recruiting, hiring, and training costs associated with this approximately 50% capacity increase in HA fermentation. We began incurring these costs during the fiscal first quarter and expect that they should be relatively consistent across the balance of fiscal 24. Now turning to our balance sheet, Note that at the end of fiscal year ended May 28, 2023, our balance sheet reflects the revised capital structure and impact from our recent refinancing. Net term and revolver debt on a reported basis for fiscal year 23 was $147.2 million, including $19.1 million of cash and cash equivalents, which compares to net bank debt at the end of fiscal 22 of 137.2 million. In analyzing the new term debt, we identified and valued certain embedded derivative features totaling 64.5 million that you will see broken out separately on the balance sheet. The embedded derivatives result from certain call and put features associated with the debt that are more fully described in the credit agreement. To be clear, the 147.2 million of reported net debt includes the derivative liability. CapEx was $20.8 million for fiscal year 23, which includes $2.5 million of capitalized interest, which is consistent with our prior expectation. CapEx is focused on supporting LifeCorps' long-term growth initiatives and is earmarked for two multi-use isolator fillers and the associated formulation and process support equipment. For fiscal 24, we expect CapEx to be somewhat moderated to fiscal 23, depending on the timing of payments, and likely in the range of $17 million to $19 million. Included anticipated capitalized interest, similar to FY23 levels, but first half-loaded as we welcome in our two new fillers. Before closing the call, I'd like to comment on our SEC filing process and the timing of our form 10-K filing. It is our intention to file the 10-K as soon as practicable as we finish up the remaining documentation matters in our year-end filings. The final creation foods divestment in Q4 and the accounting for activities associated with closing up the transition services agreements and prior period divestments, including the treatment of discontinued operations and restructuring costs combined with the significant refinancing that closed in the closing days, of Q4-23 has caused significant additional staff and audit effort to complete the year-end processes. On the refinancing side, we had analyzed the embedded derivative features I discussed earlier and engaged specialists to value the derivatives, a very technical and time-consuming effort. Additionally, post-closing adjustments to the sale leaseback included a fair market value study by an appraiser that also took on significant time and effort. Consequently, these areas, when factored into the smaller footprint of a standalone LifeCore segment operation, resulted in lower audit materiality thresholds and significant efforts by third-party specialists. Fortunately, that work is winding down, and we expect to be on file in the near future. In conclusion, I'd like to recognize the great work that the LifeCore team is putting forth. While filing delays in the strategic review process have created some added complexity, to our communications. As you heard today from Jim, our commercial efforts are advancing nicely, our development pipeline is growing in a healthy and diversified fashion, and we have the business gearing up for a significant expansion in the quarters in years to come. That concludes our call today. Thank you for