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8/7/2025
and thank you for joining LifeCorps' fiscal 2025 fourth quarter and full year earnings call. During the call, all participants will be in a listen-only mode. Now, I would like to turn the call over to Stephanie Diaz, Manager of Investor Relations for LifeCorps. Please go ahead.
Good afternoon, and thank you for joining us today to discuss LifeCorps Biomedical's fourth quarter and full year fiscal 2025 earnings results. Hosting the call today from LifeCorps are Paul Josephs, President and Chief Executive Officer, and Ryan Lake, Chief Financial Officer. Before we begin today, we'd like to remind everyone that certain statements made in the course of this conference call contain forward-looking statements. It is important to note that the forward-looking statements made during this call reflect management's judgment and analysis only as of today, August 7, 2025, and the company's actual results could differ materially from those projected in such forward-looking statements. For a more thorough discussion of the risks and uncertainties associated with any forward-looking statements, please see the disclaimer regarding forward-looking statements that is included in our fourth quarter and fiscal year 2025 earnings press release, which was furnished to the SEC today on Form 8K and is available on our corporate website at lifecore.com. as well as our other filings with the Securities and Exchange Commission, including but not limited to the company's Form 10-K for the fiscal year ended May 25, 2025, which was filed this afternoon and is also available on our website. In addition, our earnings press release includes a discussion of, and during this call we will reference, certain non-GAAP information. You can find relevant non-GAAP reconciliations in our earnings press release. With that, I'd like to turn the call over to Paul Josephs, Chief Executive Officer.
Thank you, Stephanie. Good afternoon, everyone, and thank you for joining our fiscal 2025 fourth quarter and full year update. Fiscal 2025 was a strong year for LifeCorps Biomedical. As you may recall, I joined the company in May 2024 and immediately began to tackle a number of challenges. I am pleased to report with a new strategic plan and proven CDMO leadership, we were highly successful in achieving a number of important goals during this transition year. Key among these is upgrading our business development and marketing strategy. During the year, we signed multiple new development agreements with new and existing customers, including nine new programs with nine new customers. and multiple wins subsequent to the end of the fourth quarter, including a late-stage clinical GLP-1 program. These wins will help to drive our near-term momentum and have us excited about our performance in 2026. Additional achievements from fiscal 2025 include right-sizing our workforce, significantly improving our productivity, raising capital to strengthen our balance sheet, and meeting our stated financial guidance for both revenue and adjusted EBITDA for the fiscal year. We are very pleased indeed with Lightcore's performance during fiscal 2025, as we remain on track to achieve our stated goals of achieving a 12% revenue CAGR and increasing EBITDA margins to more than 25% over the midterm. During the company's first investor day presentation in November 2024, We outlined our strategic plan for achieving these goals, which focuses on the following three growth strategies. Maximizing our existing customer business, advancing programs currently within our late stage development pipeline towards commercialization, and finally winning new and impactful business that will continue to fill our project pipeline from early stage work to commercialization. During the fourth quarter and full year, LifeCorps made significant progress in executing against each of these growth strategies. I will first address our efforts to maximize our existing customer business. Existing customers are advancing programs and expanding aseptic business at LifeCorps. These companies are a rich source of potential new business, and we have dedicated significant effort to growing with each of our current customers. To that end, we remain on track to realize a significant inflection point related to one of our current customers in 2027. This inflection point contemplates a significant increase in the minimum pay commitments from this customer and an expansion in regions supported by LifeCorps to include Asia Pacific markets. This expansion in geography is only possible due to LifeCorps' strong, multi-compendial quality system and regulatory compliance framework. We are very pleased to have the confidence of this customer who is choosing to work with us as their development and manufacturing needs grow. And we continue to view all of our existing commercial customers as an important part of our growth strategy. I will now turn to our efforts to advance programs currently within our late stage development pipeline as they move towards commercialization. As previously disclosed, many of our late-stage pipeline programs are poised for potential regulatory approval and commercialization by 2028. And while there is no guarantee that they will all reach the finish line, even a modest subset of this group could generate substantial and impactful growth for the company in the midterm. We recently announced that we have signed a new 10-year commercial manufacturing and supply agreement with one of our late-stage customers, that is planning for commercialization of their novel ophthalmic therapeutic drug. In addition to the commercial manufacturing and supply agreement, LifeCorps has also signed a multimillion-dollar statement of work detailing a range of CDMO services that will further advance this program towards potential regulatory approval and commercialization. Under the terms of this new statement of work, LifeCorps will be responsible for manufacturing a variety of batches of the drug candidate including multiple process performance qualification or PPQ batches. As a reminder, PPQ programs are particularly important milestones as they are a pre-commercialization requirement. And while we caution that the execution of a PPQ campaign is only the beginning of a one to two year journey towards a potential commercial approval and associated recurring revenue and demand, These multimillion-dollar programs reflect our customers' ongoing trust in our capabilities and team. For the year, we have successfully supported the advancement of other late-stage programs towards commercialization, including a significant statement of work with a large multinational customer progressing its injectable medical device product, reflecting what we believe is their ongoing confidence in this program. This customer also made a multimillion-dollar investment in a dedicated production equipment. We are very pleased with the progress we've made in advancing programs, this program and other late stage programs. And we look forward to supporting those that achieve commercial launch. The third area of focus that we believe is critical to our ability to reach our financial goals is winning high value programs with new customers in various stages of development. And with each of the previous efforts, we made progress towards this goal. We continue to add new programs across a variety of development stages. And during the fourth quarter, we signed three new early stage programs in respiratory disease and ophthalmology. One highlight is our agreement with Human Edits, which is focused on the company's Bio 300 program. Bio 300 is a novel and highly selective modulator of inflammation that is currently in development for multiple indications. We believe the program may expand as it advances towards commercialization, supporting not only LifeCore's growth, but also our capacity utilization. Under the terms of our agreement with Humanetics, LifeCore will be responsible for conducting tech transfer of the existing fill and finish process for Bio 300, including formulation development, gap assessment, and filling of a pilot batch. This will be followed by analytical method work, including feasibility assessments, which will help estimate future development work for the product candidate. In summary, we have added a total of nine new programs during the fiscal year 2025. These programs span a broad spectrum of modalities and add meaningful revenue potential to our development pipeline. I'm thrilled to announce that subsequent to the quarter end, we signed multiple new customer agreements. These include a late-stage product with a leading developer of GLP-1 therapeutics for obesity and a Phase II dermatology program. Both programs are in the process of being onboarded by our project management team. The GLP-1 program will be an addition to our late-stage pipeline, and we look forward to collaborating with both of these new customers going forward. We are encouraged by the momentum that we've been building within our business development team and the talent within that team. Led by Mark Delfonseca as our new chief commercial officer, we have rebuilt our sales organization with industry professionals, including the recent addition of a proven business development veteran with more than 20 years of pharmaceutical experience. Equally as important, we have aligned our internal organization to maximize our business development selling time, and to ensure that our team has the support necessary to pursue new opportunities. In FY25, in addition to making meaningful progress in executing our strategy, we also made important changes to the organization to facilitate our success. During the year, LifeCorps appointed a number of seasoned and successful leaders to elevate the company's operations, including Ryan Lake, a highly experienced CFO, Thomas Goldegger, our new Senior VP of Operations, Tom Salus, LifeCorp's first Chief Legal and Administration Officer, and as I mentioned earlier, our newest appointment, Mark Delfonseca, the company's Chief Commercial Officer. This new team working with me and Jackie Klecker, our Executive VP of Quality and Development Services, has upgraded processes and implemented changes across our company to create a more efficient, productive, and customer-oriented organization. We have accomplished this while reinforcing our proven quality management system, ensuring that we maintain quality as we grow. I am very pleased with these organizational enhancements, which have resulted in measurable improvements across our company. demonstrating the effectiveness of our quality management system and expertise of our quality team. The Food and Drug Administration conducted a general audit of our quality systems and processes during the fourth quarter. The audit was spanned over two weeks, resulted in a highly favorable outcome for our organization. And feedback regarding the audit results from our customers and prospective customers has been overwhelmingly positive. As we turn to our operations, I'm pleased to share that we have made meaningful improvements across the board. Over the past year, our HA fermentation, aseptic, and packaging teams have delivered consistent gains in productivity, each contributing to the stronger, more efficient organization we're building. One standout, our fermentation department achieved record output for our fiscal year at LifeCorps. That milestone is a powerful example of what happens when strong leadership and engaged workforce and a mindset of continuous improvement come together. It's a reminder that performance follows culture, and we're seeing the impact. Our commitment to customers remains unwavering. We closed the fiscal year with an on-time, in-fold delivery rate of 97%, an improvement over FY24, and a direct reflection of the pride we take in delivering high-quality products on time, every time. Looking ahead, I'm especially encouraged by the progress we've made towards launching our new enterprise resource planning system, which remains on track for our Q1 2026 go live. This isn't just a technology upgrade. It's an enabler of our long-term strategy. Once implemented, our cloud-based ERP will enhance efficiency, strengthen our inventory control, support sharper financial management, and help reduce costs as we grow. And finally, I want to recognize the team's continued focus on safety, our most important responsibility. We maintained a recordable injury rate well below industry average this year, and that's not by chance. It's a result of intentional, proactive work to ensure that every associate feels confident and safe in the work they do every day. We're building momentum, and these operational achievements give me great optimism in our future. I'm extremely pleased with the cohesiveness and speed with which our team has identified areas of improvement and implemented value-added solutions. In a short amount of time, we have achieved measurable increases in efficiency and productivity across our organization, and we plan to continue this effort to realize our overarching growth strategies. That concludes my update. I will now turn the call over to Ryan Lake to provide an overview of our fourth quarter and fiscal 2025 financial results. Ryan?
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