Lifecore Biomedical, Inc.

Good afternoon, and thank you for joining LifeCore's Q3 2025 earnings call for the three months ended September 30th, 2025. 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 LifeCore.

The floor is yours. Please pause one moment. We are experiencing some difficulties.

Good afternoon and thank you for joining us today to discuss LifeCore Biomedical's third quarter 2025 earnings results. The three months ended September 30th, 2025. As we announced in August, the company has changed its fiscal year end to align with the calendar year. beginning with today's Q3 2025 results for the three months ended September 30th, 2025. We will be comparing our 2025 results to the closest comparable period in the prior year. Today, we will be comparing our Q3 2025 period for the three months ended September 30th, 2025 with the period ending August 25th, 2024. Going forward, our fiscal year end will end on December 31st, And we plan to announce results for Q4 and the approximately seven-month transition period from May 26th to December 31st, 2025 in March of 2026. 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, November 6, 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 earnings press release for our third quarter ended September 30, 2025, 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 10Q for the third quarter ended September 30, 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 Joseph, Chief Executive Officer.

Thank you, Stephanie. Good afternoon, everyone, and thank you for joining us for our third quarter 2025 update for the three months ended September 30, 2025. LifeCorps is a differentiated injectable CDMO with a strong foundation in high-grade hyaluronic acid that has served as our entry point into this exciting and growing market. We are well positioned for future growth with a forecasted inflection point with our largest customer in 2027, a promising late-stage pipeline which has significant revenue potential, and finally, a revamped commercial strategy that has expanded our target market and is already delivering impressive results. Collectively, we believe these strengths will drive meaningful growth in the midterm while increasing EBITDA margins. We are thrilled with the progress made during this period as we made advancements in all key areas. Our financial outcomes were strong as we recorded a 26% increase in revenue as compared to the comparable prior year period with other significant improvements in adjusted EBITDA and associated margins. These financial results reflect management's disciplined approach to cost control and the continued improvement in our workforce productivity driven by initiatives we implemented earlier this year. From a quality perspective, following our successful FDA inspection in March, we conducted five customer audits during the period. including a due diligence audit with a large multinational pharmaceutical company. All audits were positive, reinforcing our confidence in the organization's ability to support the growing quality demands of our clients. From a growth perspective, we achieved critical milestones in expanding our commercial business and advancing our late-stage pipeline programs. Finally, we continue to accelerate our business development efforts, and we are seeing progress. During the third quarter, we signed two new business wins and made substantial progress on two additional new projects that were signed subsequent to quarter end. On all fronts, the third quarter was a very productive time at LifeCorps, and I'll now provide a little bit more detail on our achievements during this period. During my initial year at LifeCorps, I spent considerable time learning our business and laying the foundation for our future by recruiting a first class leadership team and building the right culture. Today, we have the right team. We are aligned and we have collectively turned our attention to growth. In the period, we continue to strengthen relationships with our existing commercial customers by delivering outstanding service and support. During the third quarter, we achieved significant milestones in supporting the aseptic fill finish expansion program for one of our key customers. These milestones included successfully producing qualification badges on our new five-head isolator filler. Qualification of our isolator filler was a critical milestone as we prepared to support European and Asian markets for this key customer. This geographic expansion is a key component of an inflection point as this customer is projected to more than double its aseptic fill finished demand in 2027. For this customer, we also developed and qualified our hyaluronic acid to meet the rigid specifications of the Japanese market. Meeting this specification will allow us to utilize our HA as part of the 2027 inflection point contemplated with this customer. We believe that this progress speaks to the trust our existing customers continue to place in our technical expertise and our excellent quality management system. I'll now turn to the progress made in advancing our development pipeline towards commercialization. As I mentioned earlier, we have built a promising late-stage pipeline of 11 programs that have potential launch dates between 2026 and 2029. We believe that commercial success at a modest conversion rate of 50% provides meaningful revenue potential in the mid and long term. During the third quarter, LifeCorps achieved a number of milestones supporting multiple late-stage aseptic customers. The highlights include the installation and operational qualification of automated manufacturing equipment to accommodate the scale-up and commercialization of a large pharma customer's program. We expect to produce validation batches for this customer in early 2026. For another late-stage customer, the company successfully completed critical development work setting the stage for validation batches to be produced in the first half of 2026. During the quarter, we also completed two phase three clinical batches for another late-stage customer and initiated transfer work for one of the latest additions to our late stage pipeline. This refers to the GLP-1 program we announced during our last earnings call. I am pleased with the collective progress we made with our development customers and look forward to sharing additional progress in the future. From a business development perspective, I am pleased to report that during the third quarter, we signed two new customers and we assigned an additional two customers subsequent to quarter end. For clarity, please note that the two customers signed during the current quarter were previously referenced in our August 7th earnings announcement as being one subsequent to the prior Q4 2025 period. This included a late-stage GLP-1 program with a leading specialty pharma company. Those referenced today as one subsequent to the Q3 period ended September 30, 2025, were initially announced on October 29, 2025. One of the programs that closed subsequent to quarter end represented significant development for our organization. This opportunity is a commercial site transfer of a product based on existing commercial volumes will make this large multinational pharmaceutical company one of our top customers once commercialized. This represents our second opportunity with this customer, and we are excited about the future potential of our working relationship. Collectively, these wins continue to speak to the aggressive sales and marketing strategy that we have implemented and the talented professionals we have added to this group. As a result of these enhancements, the quality and number of new business opportunities have steadily increased. In addition, There are a number of tailwinds that we believe support our efforts, including the expected ongoing regionalization of injectable manufacturing in the United States, along with 50% of the drug development pipeline in the United States being injectables. Our talent, strategy, technical capabilities, and high-quality standards combined with these tailwinds give me great confidence that we will continue to drive new and impactful business into our site going forward. Concurrent with the execution of our growth strategy, we are committed to increasing our adjusted EBITDA margins through operational excellence and disciplined cost control. An example of the progress we are making is in the productivity of our workforce and our ability to produce similar production volumes despite a reduction in our manufacturing workforce by more than 20% over the last 18 months. This is a testament to the performance-based culture that we have instilled and the engagement of our entire team. Looking forward, we continue to evaluate opportunities to improve our midterm target of 25% in adjusted EBITDA margins. We see great opportunity to further maximize efficiencies and productivity across our organization with further cost improvement, primarily via improved procurement strategies. We believe that a key catalyst in this effort will be the launch of our new enterprise resource planning system, which we expect to go live in Q1, 2026. We expect this system to strengthen inventory control, support sharper financial management, and help reduce costs as we grow. To further accelerate momentum in this area, we recently hired a seasoned industry professional in the role of head of business transformation. This newly created position will champion our efforts to improve our cost structure, productivity, and efficiencies to maximize the EBITDA opportunity in front of us. In conclusion, we continue to execute according to plan. We've made significant progress related to our growth strategy, including important wins with new customers that have the potential to meaningfully contribute to our revenue growth in the midterm. We believe that these results, combined with our disciplined cost structure and our uncompromising quality, position us well to achieve our midterm objectives and to capitalize on the favorable market conditions for CDMOs here in the United States. That concludes my update. I will now turn the call over to Ryan Lake to provide an overview of our financial results for the Q3 2025 period ended September 30, 2025.

Thank you, Paul, and good afternoon, everyone. In conjunction with my comments, I'd like to recommend that participants refer to LifeCourse Form 10-Q filing with the Securities and Exchange Commission, which we filed today. As a reminder, today we will be comparing our Q3 2025 period, which ended on September 30, 2025, with the period ending August 25, 2024. Revenues for the three months ended September 30th, 2025 were $31.1 million, an increase of 26% compared to $24.7 million for the comparable prior period ended August 25th, 2024. The increase in revenues of $6.4 million was primarily due to a $4.8 million increase in HA manufacturing revenues, primarily from increased demand from a customer due to its supply chain initiatives. In addition, CDMO revenues increased $1.6 million, which was primarily from $2.6 million of higher sales volumes and $0.3 million of pricing and other revenue partially offset by $1.3 million of lower development revenue due to completion of a discrete development project in the prior comparable period and timing of customer project life cycle. Gross profit for the three months ended September 30th, 2025 was 7.8 million compared to 5.4 million for the comparable prior period ended August 25th, 2024. The increase of 2.4 million in gross profit is due to 4.3 million increase in HA manufacturing gross profit due to increased sales volume and manufacturing absorption partially offset by 1.9 million decrease in CDMO gross profit. The CDMO decline was due to lower development revenues of 1.4 million and a decrease in aseptic gross profit of 1.9 million due to product mix and costing partially offset by favorable manufacturing absorption of 1.4 million. Selling general and administrative expenses for the three months ended September 30th, 2025 were 8.9 million compared to 14.8 million for the comparable prior period ended August 25, 2024. The $5.9 million decrease in SG&A expenses included a reduction of $2.2 million in recurring accounting, legal, and consulting expenses and a net $3.7 million reduction in non-recurring expenses primarily related to legacy matters. For the three months ended September 30, 2025, the company recorded a net loss of $10 million and a loss of $0.29 per diluted share as compared to a net loss of $16.2 million and a loss of $0.53 per diluted share for the comparable prior period ended August 25, 2024. In addition to the reasons described previously, the loss in 2025 included a small effect from an unfavorable debt derivative adjustment, while the loss in 2024 included a small net effect from a favorable debt derivative adjustment that was partially offset by registration rights penalty expense. Adjusted EBITDA for the three months ended September 30, 2025 was $3.1 million, an increase of $4.9 million compared to a negative $1.8 million in the comparable prior period ended August 25, 2024. The improvement in adjusted EBITDA was primarily due to the increase in gross profit and the reduction in recurring selling general administrative expenses. In addition to reporting results for the period, we also wish to reaffirm the guidance that we previously provided for the approximately seven-month transition period from May 26 through December 31, 2025. Specifically for this transition period, the company expects revenue to be approximately $74 to $76 million, net loss to range from $18.4 million to $16.4 million, and adjusted EBITDA to range from $12 to $14 million, based on the expectations that LifeCorps would exclude for items similar to its historic definition of adjusted EBITDA. This guidance takes into consideration existing market forces, contracts, and customer order timing, as well as the company's current beliefs and estimations with respect to success and timing related to growing and diversifying the company's new business development revenue. This concludes my financial overview. I'll now turn the call back over to Paul for his final comments.

Thank you, Ryan. In closing, I would like to emphasize our discipline and effective execution over the last 18 months. We have learned a tremendous amount in this period. We have improved our business in a number of meaningful ways, and we have now turned our full efforts to growth of both our top and bottom line. We are energized by the progress we have made today and highly optimistic about the future that lies ahead. This concludes our prepared remarks for today. Operator, you may now open the call for questions.

Thank you. At this time, we will now conduct a question and answer session. As a reminder, to ask a question, you must press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again.

Please stand by while we compile the Q&A roster. Our first question comes from Matt Hewitt from Craig Hallam Capital Group.

The floor is yours.

Thanks for taking the questions and congratulations on your progress. Maybe first up, obviously, with the stub period, it makes it a little bit difficult to run the math here, but I'm trying to get a sense for what the missing month would have been or what that would have implied, maybe even for Q4, just as we're looking at the period-to-period numbers.

Hey Matt, thanks for your question. So the June estimated revenues were about 8.7 million with about 6.6 million of that coming from CDMO revenues and 2.1 million from HA revenues. So year to date through September 30th, the stub period revenue is expected to be approximately 39.8 million. So that leaves for the remaining stub period revenue guidance for Q4, to be in a range of $34 to $36 million or about $35 million at the midpoint, which represents for the fourth quarter about an 8% increase over the comparable prior year quarter. And then for adjusted EBITDA, June estimated adjusted EBITDA was $1.5 million. So year-to-date through September 30th, the stub period adjusted EBITDA would have been approximately $4.6 million. The remaining stub period guidance to be in a range of $7 to $9 million or about $8 million at the midpoint for Q4.

Super helpful. Thank you. And then, you know, just kind of looking and listening to your prepared remarks, you guys have made some substantial improvements on the cost side. I think you mentioned, you know, some pretty significant reductions on the recurring piece as well as some of those legacy improvements. Is there much left to do on that front? Or as we look out, whether it's Q4 or now the new fiscal slash calendar year 26, are there some additional levers to pull there? Or at this point, does it become more about driving incremental volume through the facility? Thank you.

Thanks, Matt. So, you know, I'm really excited to talk about the positive results this quarter that reflects some of the great progress that we've made across the organization. First, I think this represents our fourth or fifth sequential quarter of period over period declines in operational expenses. The operational expenses were down over $6 million, or 36%, compared to the prior year comparable quarter, and over $2 million of that is primarily related to the reduction in the recurring accounting legal and consulting expenses, and $4 million was related to legacy matters. I think that you know, to the second part of your question, there's a lot of hard work left, but I'm even more encouraged than I was earlier on kind of in this journey that, you know, we have the ability to continue to strengthen the foundation of the company and set us up for continued growth. I think overall, over time, as we get past some of these legacy matters, I think we could, you know, see another, you know, million and a half or so a quarter in SG&A that it could come down so that we were at a quarterly run rate of like in that seven and a half, $8 million range.

That's great. Thank you very much.

Thank you for your question. Our next question comes from Matt Eddock from Stevens.

The floor is yours.

Hey, good afternoon. This is actually Hannah on for MAC. Thanks for taking my question. Given the recent manufacturing capacity announcements, can you just talk about how early conversations are progressing given the current macro dynamics and how those might translate to the pipeline over time?

Hannah, thanks for the question. This is Paul. I think that the, I'll call it the regionalization of manufacturing and the investments that have been announced recently are only a tailwind for CDMOs in general and certainly for LifeCorps. We have seen a boy in our pipeline of I would say commercial site transfer opportunities from other regions, whether it's Asia, Europe, Israel, India, that heretofore we haven't seen. I've been in this commercial side of the CDMO business now, had exposure to it for 31 years, and I've never seen this many or this amount or percentage of commercial site transfers become that you have the opportunity to compete on. So I look at it as only buoying the market from a CDMO perspective.

Awesome. That's helpful.

And then on performance and 3Q and then current guidance, it seems to suggest a pretty strong calendar second half compared to normal seasonality. And I believe you had prior expectations for a flat fiscal 2026 using your prior fiscal year. So can you just talk about what's driving the uptick in revenue?

Thanks, Hannah. So we had a very strong kind of back half of what was our fiscal year 25 that ended in May. And comparatively, primarily due to timing and customer ordering patterns, revenue for this seven-month stub period, or essentially the second half, of calendar year 25 are expected to be up significantly. So over 20% or about 14 million compared to an estimate of that same period of the prior year. Because of that nice uptick in revenue for the stub period in calendar year 25 due to the timing and customer ordering patterns, we currently expect the back half of calendar year 26 to be stronger than the first half of calendar year 26 with revenue split probably in that 45% in the first half and about 55% in the back half.

Thanks, that's helpful.

I'll leave it there. Thank you for your question. Our next question comes from Lucas Barnowski from KeyBank.

The floor is yours.

Yeah, this is Lucas for Paul Knight here at KeyBank. You recently won a tech transfer for a commercial product from a large pharma company. I know those types of transfers typically take over a year to complete, but what are you expecting in terms of the timeline for this particular agreement?

Lucas, this is Paul. Thanks for the question. We expect that that commercial site transfer will take approximately 24 to 30 months. We're working with our customer on the exact timeline, but we'll obviously work to accelerate as quickly as we can. But based on current projections, I would anticipate 24 to 30 months.

Yeah, that's good color. You recently also signed a collaboration agreement with a peptide-based CDMO called Polypeptide. Based upon your discussions with them, would you expect the opportunities coming out of that collaboration to be centered around GLP-1, where you got your first win last quarter? Or do you think it could be broader than that?

I think it could be broader than that, Lucas. Certainly that GLP-1s are contemplated as part of that, but certainly it could be broader.

Excellent. That's all I had. Thank you. Thank you for the question. Yes, thank you for your question. Our next question comes from Max Smock from William Blair.

The floor is yours.

Hi, great. It's Christine Rainbaum for Max. So kind of piggybacking a little bit off the last question in terms of the commercial injectable winds, Just hoping if you could give a little bit more context here. So it was helpful that 24 to 30 months potentially as being sort of fully ramped commercially, but wondering if you expect revenues before this full transfer is complete and if you expect to be the sole product manufacturer. And just anything you can give in terms of the scope of the contract in terms of annual revenue expected.

No, great. Christine, thank you so much for the question. We do expect to be the sole manufacturer fully qualified. Based on 2025 revenues, once this product is commercialized, demand remains the same. We anticipate this will be a top five. customer or top five product at LifeCorps and consume, I will say, material capacity within the facility between 5 and 10 percent. We will make what I call or characterize as one-time development revenue. where we qualify and validate the program and product within our facility. And then once we get regulatory approval, obviously, we'll get into that recurring revenue cadence.

Great. Thank you. That was very helpful. So, maybe one for you, Ryan. Echoing kind of what was said before, there's a lot of moving pieces with the transition period. and your financials, so apologize for the bit of the rough approach here. It was kind of already asked on the revenue side, but thinking simplistically in terms of margins, looking at your implied EBITDA margin guide of 17% at the midpoint for the subperiod compared to roughly 10% adjusted EBITDA margin in this three-month period, Hoping you can speak to the factors driving margin expansion in the remainder of the stub period in order to achieve your stub margin target. Thanks.

Yeah, I think, you know, one of the pieces that you're missing and I gave was, you know, the EBITDA for, I guess, the year-to-date stub period, right? And it's pretty, you know, significant. Again, if you add the million and a half or so to the year-to-date stub period from the June period, so about 4.6 million, so leaving that roughly 7 to 9 million or 8 at the midpoint for that. And, you know, again, a lot of that has to do with the improvement in revenue over the period, as well as, you know, all the improvements we've made from a gross profit perspective as well as improvements in the SG&A line. So, you know, overall, I think that the improvements, about a 200 basis point improvement for the stub period to get you to roughly those 17 percent EBITDA margins.

Great. Thanks to you both, and congrats on the progress.

Thank you. Thank you for your question. At this time, I'm showing no other questions, so this concludes the Q&A portion of this program. I would now like to hand it over to Paul Josephs of Management for closing remarks. The floor is yours.

Thank you, Operator. I wish to thank all of LifeCorp's stakeholders and supporters, including our investors, customers, and collaborators for their ongoing support and partnership. I also wish to thank our talented and committed employees for all they do to elevate LifeCorp and maximize our successes. We are very pleased with the progress that made during this period, which we believe puts us on a path to achieving growth and sustained profitability for the years ahead. Thank you very much.

Thank you for your participation in today's conference. This does conclude the program and you may now disconnect.