3/16/2026

speaker
Operator
Conference Operator

Good day, and welcome to the LifeCorps Biomedical Fourth Quarter 2025 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. Instructions will be given at that time. Please note this call is being recorded. I would now like to turn the call over to Stephanie Diaz, Manager of Investor Relations. Please go ahead.

speaker
Stephanie Diaz
Manager of Investor Relations

Good morning, and thank you for joining us. Today, LifeCore Biomedical will provide its earnings results for the fourth quarter and transition period ended December 31st, 2025 and a corporate update. As the company has recently changed its fiscal year end to align with the calendar year, we will be comparing our 2025 results to the closest comparable period in the prior year. Today, we will be comparing our fourth quarter ended December 31st, 2025 with the previously reported quarter ended November 24th, 2024. We will be comparing our seven-month transition period ended December 31st, 2025, with the unaudited seven-month period ended December 31st, 2024. Hosting the call today from LifeCorps are Paul Josephs, President and Chief Executive Officer, and Ryan Lake, Chief Financial Officer. Before we begin, we'd like to remind everyone that today's conference call will 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, March 16, 2026, 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 which was furnished to the Securities and Exchange Commission this morning 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 10KT for the transition period ended December 31st, 2025, which was filed with the SEC this morning 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 financial 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, President and Chief Executive Officer.

speaker
Paul Josephs
President and Chief Executive Officer

Thank you, Stephanie. Good morning, everyone, and thank you for joining us today. 2025 was a highly productive year for LifeCorps Biomedical, during which we strengthened our pipeline capabilities leadership, and our standing as a differentiated CDMO. During the year, we continued to successfully execute against our strategy to position LifeCorps for sustained growth through which we aim to achieve a 12% revenue CAGR and improved EBITDA margins to above 25% in the midterm. Our many achievements during the year included maximizing our existing commercial business, advancing our development portfolio towards commercialization, adding multiple new programs to our pipeline through our revamped business development strategy, and implementing key initiatives throughout the organization that have improved our margins and will continue to drive improvement towards our EBITDA goal. Our financial performance was also strong during the transition period. During the fourth quarter of 2025, we recorded revenues of $35.7 million, a 10% increase as compared to the most comparable prior year quarter. And for the approximately seven-month transition period from May 26, 2025 through December 31, 2025, we recorded revenues of $75.5 million, an increase of 20% compared to the prior year comparable period. Gross margin and adjusted EBITDA also improved during the 2025 fourth quarter and transition period as compared to the prior year comparable periods in 2024, reflecting the growth in our fermentation business as well as the benefit of the many efficiencies incorporated throughout our organization in 2025. Ryan will elaborate on these financial results as well as guidance for 2026 following my overview of our 2025 achievements, beginning with the successful expansion of our commercial business. As noted previously, our company is preparing to support a significant increase in aseptic fill finish demand from our largest customer that is expected to begin in 2027. In 2025, LifeCorps achieved several milestones in support of this anticipated event. In particular, the company successfully qualified our five-head isolator filler to supply the European and Asian markets for this customer. Expansion into these markets is expected to help drive a more than doubling of this customer's aseptic fill finish demand, and we are pleased to have achieved this key milestone. Another milestone supporting this expansion is the successful qualification of our hyaluronic acid for supply to the Japanese market. Meeting Japan's strict HA specification requirements is difficult to achieve, and we believe our success in meeting this challenge speaks to our expertise and capabilities. With these hurdles achieved, we believe that we are well positioned to support this critical expansion and financial inflection point. We continue to work closely with this important customer as we approach this inflection point, and we are grateful for their continued trust that they have placed in LifeCorps. The impact of our revamped business development strategy was demonstrated as we recently added several new high value programs to our late stage pipeline, including two commercial site transfers in 2025. Unlike development programs, commercial site transfers have existing demands and are substantially de-risked as they do not require additional clinical trials and only require qualification at LifeCorps. Based on our quality track record and expertise in producing similar products, we believe that both products will be successfully transferred to LifeCorps and generate commercial revenue at our site in 24 to 30 months. These two products represent important additions to our late stage pipeline, strengthening a growing portfolio of programs that we are actively advancing towards commercialization. As we have previously disclosed, the company has a promising late stage pipeline. In prior quarters, we have stated that we expect launch dates for these programs to take place between 2026 and 2029. And while the company has made substantial progress with many of these programs in 2025, we are adjusting the expected launch timeline to between 2027 and 2030. The shifting of these timelines is not due in any way to LifeCore's performance, capabilities, or capacity. Rather, they are due to matters outside of LifeCore's control, including typical changes in customers' development plan strategies, and the impact of financing challenges in 2025 that two of our customers experienced. We remain optimistic that the 10 late stage programs in our 30 plus program development pipeline will continue to advance and have the potential to reach commercialization before or during 2030. And while we cannot provide assurances that all programs will achieve regulatory approval, we believe that even the commercial success at a modest conversion rate of 50% of these programs could drive a significant increase in revenue in the years ahead. LifeCorps continued to make strong progress in 2025, successfully advancing key initiatives despite external headwinds. Notable advancements of our development pipeline during 2025 include the installation and operational qualification of an automated manufacturing equipment to accommodate the scale-up and commercialization of a customer program. This particular customer is a large pharma company, and we are currently preparing to produce validation batches for this project in 2026. We expect this program to be a meaningful growth driver upon regulatory approval, having the potential to contribute more than half of the commercial revenue we anticipate for our late-stage pipeline by 2030. Several other programs met key advancement milestones in 2025, paving the way for continued progress in 2026. These include the completion of development work in advance of the production of validation badges for another late-stage customer, the successful completion of two Phase III clinical badges for a separate late-stage program, And finally, the onboarding of a late-stage transfer work for the company's GLP-1 customer. We believe that we are on track to achieve our financial goals and reiterate our expectation that a significant number of programs in our late-stage pipeline will launch within the midterm window, specifically between 2028 and 2029. The advancement of our development pipeline remains central to our mid- and long-term growth strategy. And in 2025, we successfully delivered multiple key customer milestones that meaningfully advanced these programs towards commercialization. The third pillar of our growth strategy is the addition of new programs to our pipeline. In 2025, the company revamped its business development strategy and team in an effort to expand our service market and increase the number of high-quality customer wins. In 2025, LifeCorps expanded the strategy from a primary focus on supporting complex, highly viscous formulations towards a strategy of promoting our strong technical capabilities and our ability to support products across multiple modalities. This effort is being executed and led by a new team of seasoned industry professionals, and the successes achieved in our first year were impressive. Employing an aggressive hunting model, the momentum achieved by this team over the last year has resulted in five new programs in the transition period, including the aforementioned two commercial site transfers and a late-stage GLP-1 program. Our business development pipeline has not only grown in its number, but in the quality of new business wins has improved significantly. Given the value and opportunity presented by commercial site transfers and the growing trend of regionalized manufacturing in the United States, our team is strategically and aggressively pursuing additional commercial site transfer programs, and we are optimistic regarding the potential to add more in 2026. We believe other factors may positively impact our ability to further grow our pipeline and customer base in the midterm. Among these, We believe we will continue to benefit from the fact that approximately 50% of the drug development pipeline in the United States is injectables, a trend that is expected to grow in the coming years. We believe that LifeCorps' exceptional track record in compliance and quality distinguishes us and so gives further support for our business development efforts with existing and new customers. In early 2025, the company successfully completed an unannounced FDA inspection. During the transition period, we also conducted 10 customer audits and one regulatory inspection. All were positive, reinforcing our confidence in the organization's ability to support the high-quality demands of our customers. Given the strength of our revamped business development organization, the successes achieved in 2025 and the quality standards that LifeCorps employs throughout the organization, I am highly optimistic for continued growth in the future. In addition to supporting revenue growth, we continue to improve our adjusted EBITDA margins through the implementation of cost improvement initiatives throughout the organization. We believe that targeted cost control and optimized procurement strategy provide other opportunities to improve EBITDA margins in the near term. A key tool in this effort will be our Enterprise Resource Planning System, or ERP, for which substantial preparatory work was completed in 2025, enabling a successful launch in January 2026. LifeCorps expects this system to strengthen inventory control, support improved financial management, and help reduce costs in 2026 and as the company grows. Another key factor that we believe will drive LifeCorp's growth in the midterm is the company's current and anticipated capacity utilization. As we look forward, our capacity in aseptic fill finish is 45 million units. During the last year, we utilized approximately 20% of our available capacity. As we scale our production towards our goals in 2029, we expect our utilization to reach an estimated 60% of our current installed production capacity. Our long-term plan is to fill the remaining unused capacity, which we expect will drive revenues to over $300 million and further improve EBITDA margins. Importantly, reaching this long-term capacity utilization plan is tied to commercializing wins that already exist in our development pipeline, the expansion of our existing customer relationships, and adding new programs to our pipeline. In conclusion, 2025 was a strong year for LifeCorps. We executed effectively across each pillar of our growth strategy. This manifested in strong revenues and improved EBITDA margins for the period. At the same time, our organization today is leaner, more efficient, and more productive than at any time in the recent past. Our quality track record remains strong, and our business development team is aggressively pursuing and winning the projects that we expect to fuel our future growth. I'm very pleased with our progress in 2025, and I believe it has created a strong foundation for us to achieve both our mid and long-term goals. That concludes my update. I will now turn the call over to Ryan Lake to provide an overview of our financial results for the fourth quarter and the seven-month transition period ended December 31, 2025, and to provide calendar year 2026 guidance. Ryan?

speaker
Ryan Lake
Chief Financial Officer

Thank you, Paul, and good morning, everyone. In conjunction with my comments, I'd like to recommend that participants refer to Life Corps Form 10-KT for the transition period ended December 31st, 2025, which we filed with the SEC earlier today. As a reminder, today we will be comparing our fourth quarter, which ended on December 31st, 2025, with the most comparable prior year quarter ending November 24th, 2024. For the seven-month transition period ended December 31, 2025, we will be comparing to the unaudited seven-month period ended December 31, 2024. Before I jump into the numbers, I'd like to echo Paul's sentiment. We are very pleased with the company's 2025 performance, and I'm happy to share our financial results with you today. Revenues for the quarter ended December 31, 2025 were $35.7 million. an increase of 10% compared to $32.6 million for the most comparable prior quarter ended November 24th, 2024. The increase in revenues of $3.1 million was due to a $5.6 million increase in HA manufacturing, primarily due to timing of revenues from LifeCorp's largest customer supply chain initiatives. TDMO revenues decreased $2.4 million which was primarily from the absence of take-or-pay revenue in the comparable period and lower aseptic sales volumes, partially offset by higher development revenue driven by timing of project work for two major customers. During the seven-month transition period ended December 2025, revenues were $75.5 million, an increase of 20% compared to $63 million in the comparable prior year period. This increase in revenues of $12.6 million was primarily due to a $10.1 million increase in HA manufacturing, primarily due to timing of revenues from LifeCorps' largest customers, supply chain initiatives. In addition, CDMO revenues increased by $2.4 million, which was primarily from overall higher sales volumes. These increases were partially offset by the absence of $1.6 million of take or pay revenue recognized in the prior comparable period. Gross profit for the quarter ended December 31st, 2025 was $12.8 million compared to $11.1 million for the most comparable prior quarter ended November 24th, 2024. The increase of $1.7 million in gross profit is due to a $3.2 million increase in HA manufacturing due to increased sales volume, partially offset by a $1.5 million decrease in CDMO gross profit. The CDMO gross profit decline was primarily due to a decrease in aseptic gross profit of $3 million, which included the absence of a prior period taker pay, partially offset by an increase in development gross profit of $1.5 million. During the seven-month transition period ended December 2025, gross profit margins improved to 31% compared to 26% in the comparable prior year period. The 5% increase in gross margin was primarily due to an increase in HA manufacturing from increased sales volume and manufacturing absorption. Selling general administrative expenses for the quarter ended December 31st, 2025, were $7.5 million compared to $11.1 million for the most comparable prior quarter ended November 24, 2024. The $3.6 million decrease in SG&A expenses is primarily due to a $2.8 million decrease in non-recurring expenses primarily related to legacy matters and prior period restructuring, and a $1.2 million decrease in stock-based compensation. During the seven-month transition period ended December 2025, SG&A expenses were $19.5 million compared to $30.8 million for the same period last year. The $11.4 million decrease in SG&A expenses is primarily due to a $6.6 million decrease in non-recurring expenses primarily related to legacy matters and prior period restructuring, a $2.5 million decrease in recurring professional fees, and a $1.8 million decrease in stock-based compensation. For the quarter ended December 31st, 2025, the company recorded a net loss of $5.1 million and a loss of 16 cents per diluted share as compared to a net loss of $6.6 million and a loss of 25 cents per diluted share for the most comparable prior quarter ended November 24th, 2024. In addition to the reasons previously described, The non-cash debt derivative adjustment contributed $1.1 million to the net loss in 2025 while partially offsetting $1.2 million of the net loss in 2024. During the seven-month transition period ended December 2025, the company recorded a net loss of $18 million and a loss of 54 cents per diluted share as compared to a net loss of $30.6 million and a loss of 99 cents per diluted share for the same period last year. In addition to the reasons described previously, the non-cash debt derivative contributed $1.6 million to the net loss in 2025, while partially offsetting $1.9 million of the net loss in 2024. Adjusted EBITDA for the quarter ended December 31st, 2025 was $8.6 million, an increase of $2.1 million compared to $6.5 million in the most comparable prior quarter ended November 24, 2024. The improvement in adjusted EBITDA was primarily due to the increase in gross profit. During the seven-month transition period ended December 2025, adjusted EBITDA was $13.1 million, a $10.5 million increase from $2.6 million in the prior year period. The improvement in adjusted EBITDA was primarily due to the increase in gross profit and the reduction in recurring, selling, general, and administrative expenses. We are very pleased with LifeCore's strong financial performance in 2025 as we met 2025 transition period financial guidance for revenue, net loss, and adjusted EBITDA. A critical part of our strategy to strengthen the company's financial standing has been expense reduction. Since announcing our growth strategy in late 2024, we have worked aggressively to streamline and reduce the company's operating expenses, and we are pleased to report that the fourth quarter of 2025 represents the sixth consecutive quarter of period-over-period declines in operating expenses. For the seven-month transition period ended December 2025, operating expenses decreased $11.1 million compared to the prior year seven-month period. Cumulatively, over the past 18 months, LifeCourse operating expenses have been reduced by over $7 million, including substantial reductions in accounting, consulting, and legal expenses. These reductions are driving the initial improvement we are now seeing in margins. With EBITDA margins improving from 15% during fiscal 2025 to 17% in the seven-month transition period ended December 2025. I'd now like to turn to liquidity. As with other financial measures, LifeCorps' liquidity has improved significantly over the last 18 months. As we ended the year with overall liquidity of approximately $39 million, including approximately $17.5 million in cash and cash equivalents, and approximately $21 million under our revolver, all of which remains available. It is noteworthy that the fourth quarter of 2025 marked our fourth consecutive quarter generating positive cash flow from operations, and excluding the $4.7 million preferred stock registration rights payment in the fourth quarter, it represented the third consecutive quarter of being free cash flow positive. During the seven-month transition period ended December 2025, we generated $7.3 million in cash from operations and free cash flow of $3.6 million. Over the past 18 months, our capital structure has also improved, including the pay down of approximately $20 million in debt and the reduction of other obligations. including the full satisfaction of the $4.7 million preferred registration rights payment. Overall, I am very pleased with the successful achievement of our financial objectives for 2025 and the resulting improvement in LifeCourse financial structure and standing. For the past 18 months, our team has executed an expense reduction strategy designed to eliminate costs without impeding growth or progress, and we are very pleased with the outcome of this strategy. We continue to work with leadership throughout the organization to optimize spending, and we expect continued benefit from these ongoing efforts. I now wish to address our transformation strategy outlook and guidance for 2026. For the full year, LifeCorps expects total revenue to be in the range of $120 to $125 million, net loss to be in the range of $28.9 million, to $33.4 million, and adjusted EBITDA to be in the range of $20.5 to $25 million. This 2026 guidance reflects several variables within our customer base. These are, one, the anticipated loss of a customer due to a change in that customer supply chain strategy. Two, a customer decision to build excess hyaluronic acid inventory in 2025. to affect its transition of aseptic volume demand to life core in 2027. And third, a commercial launch that was targeted for 2026 but has been delayed due to customer funding challenges. As noted in our press release, our outlook does not contemplate any redemption of shares of our outstanding Series A convertible preferred stock or any prepayments of outstanding debt. We expect to generate modest revenue growth in 2027 with significant revenue growth continuing into 2028, driven by expansion of existing customer programs, including a planned doubling of aseptic demand from our largest customer, along with increasing revenue contributions from development programs and the commercialization of our late-stage pipeline. During this period, we also expect to broaden and diversify our customer base, to include additional specialty pharma and large pharma companies to generate a more balanced revenue mix, increase our capacity utilization, and reduce our dependency on any one customer. Through 2029, we expect our strategies to achieve sustained growth, resulting in a targeted 12% revenue CAGR for the 2025 through 2029 period, and reaching our targeted EBITDA margins of greater than 25%. We continue to expect significant revenue growth in future years based on management's visibility to leading revenue indicators, such as identified contractually committed volumes of one of our key customers, expansion opportunities in our commercial business, growing traction in the number of customer deals and technology transfers, commercialization of our late-stage pipeline, and an increasing number of deals at later stages of development. Our outlook regarding revenue growth is based on current expectations regarding the likelihood of success in the expected launch timelines from the late-stage development portfolio. However, in light of current customer and program concentrations, projected growth starting in 2027 may be impacted, positively or negatively, by changes in the timing or specifics of expected customer programs. Throughout this entire period, we intend to continue executing our transformation initiatives and anticipate making substantial progress in improving EBITDA margins through efficiency gains across all areas of the business. We reiterate that we remain highly optimistic for the midterm and long term, and as I hope we have demonstrated to date, we are building a strong and stable business that can withstand the fluctuations caused by hurdles in the financing markets supply chain, and other issues. There is a natural pipeline erosion that occurs with every CDMO, and the strongest among us possess the financial stability and the organizational agility to respond without detriment to our mid- or long-term goals. We believe LifeCorps has the ability to do exactly that. Bolstered by our strong relationships with large and long-term customers, expert CDMO leadership an enhanced business development effort, and an optimized and highly efficient organization. We are confident that our midterm and long-term goals remain on track. This concludes my financial overview. I'll now turn the call back over to Paul for his final comments.

speaker
Paul Josephs
President and Chief Executive Officer

Thank you, Ryan. In closing, I would like to address our recent path, as well as our roadmap we see ahead for the next several years. Since my start with the company in 2024, Through calendar year 2026, LifeCorps has been in a period of stabilization. From 2024 to its present, we have brought in new leadership, improved efficiencies and productivity, significantly lowered expenses, including headcount, expanded our technical and service capabilities, and reorganized our business development infrastructure, leading to multiple new customer wins last year, and we expect additional wins on the horizon. In the 2027 into 2028 timeframe, we expect our growth to primarily be driven by an increase in commercial demand, as well as the development revenues and the commercialization of late stage portfolio projects. We believe that we are well positioned to achieve our midterm objectives in 2029. We look forward with confidence and optimism, supported by a clear strategy for a strong future. This concludes our prepared remarks for today. Operator, you may now open the call for questions.

speaker
Operator
Conference Operator

Thank you. If you'd like to ask a question, please press star 1-1. If your question hasn't answered and you'd like to remove yourself from the queue, please press star 1-1 again. Our first question comes from Max Smock with William Blair. Your line is open.

speaker
Christine Raines
Analyst, William Blair

Great. It's Christine Raines on for Max. Thanks for taking our questions. So, hoping you can talk a little bit about your strategy for targeting customers in Asia. I think at recent conferences you've talked about an increase in conversations from customers from the region, given the trend in regionalization and manufacturing. And you also talked about today your steps that you've taken in terms of allowing the use of HA as well as finished product in the region. So wondering if these investments are due to LifeCore already being approached from potential promising customers or sort of a more proactive approach to go out and win clients in the region.

speaker
Paul Josephs
President and Chief Executive Officer

Christine, thanks for the question. Hope you're well. The majority of inquiries we get from Asia are in, well, they are all inbound, taking advantage of the regionalization of manufacturing. As LifeCore's brand continuously great, broader and broader knowledge across the market. We expect that trend to continue. But most of the, again, all of the inquiries that we received to date from Asia have been inbound. We have no intent or plans of putting, figuratively speaking, feet on the street in the Asian markets.

speaker
Christine Raines
Analyst, William Blair

Great. That's super helpful context. And then, In your outlining of the three factors impacting your 2026 guide, one of them you notice the delay in the commercial launch that was targeted for 2026 due to funding challenges. So just hoping you can unpack this a bit in terms of the incremental revenue impact as expected to have for the year and just how confident you are that this program is just being pushed out to 2027 and not canceled.

speaker
Paul Josephs
President and Chief Executive Officer

It's a great question. So it is already a commercialized program in other markets, which gives us great confidence that it will move forward. This is a smaller company. It was, I would say, a small launch for us in 2026 that has now been moved to 2028. We expect to have more granularity and visibility to the customer's future plans in the summertime period.

speaker
Christine Raines
Analyst, William Blair

Great. Thank you so much for taking our questions.

speaker
Paul Josephs
President and Chief Executive Officer

Of course.

speaker
Operator
Conference Operator

Thank you. Our next question comes from Matt Hewitt with Craig Hallam Capital Group. Your line is open.

speaker
Matt Hewitt
Analyst, Craig Hallum Capital Group

Good morning, Paul and Ryan. Thanks for taking the questions. Maybe first up, so obviously last year and since you guys joined, there's been some pretty heavy lifting on the operational side of things to drive efficiencies, to increase margins. Is there still some lifting to do there? Or at this point, is the margin expansion largely going to come from volume growth?

speaker
Ryan Lake
Chief Financial Officer

Hey Matt, thanks for your question. So as we've previously stated, we still believe expenses will be the first mover. We've seen that now and we expect to see continued improvements and adjusted EBITDA due to all those efficiencies and cost cutting measures that we've implemented. over the past 18 months but yes there are further opportunities in particular in procurement in our strategic investments and organizational efficiencies as well as systems and processes that will help us achieve those further reductions got it and then regarding the the commercial tech transfers um i think today you mentioned 28 to 30 months for those to kind of flip over in

speaker
Matt Hewitt
Analyst, Craig Hallum Capital Group

Pardon me. I mean, I feel like historically it's 18 to 24 months. Is there something unique about these specific candidates? Is it the regulatory environment that things are just taking a little bit longer? Maybe walk us through or provide a little bit of color on these specific targets. Thanks.

speaker
Paul Josephs
President and Chief Executive Officer

No, great question, Matt. I can take that one. So what I stated, I believe, was 24 to 30 months. These are products that LifeCore certainly has proven capability to manufacture, but the overall overriding environment is really focused around safety and reliability when it comes to sterile injectable programs. So we believe based on timing, discussions with our customers, and the regulatory environment that it will take 24 months because it will require what they characterize as a pre-approval inspection. And by the time the customer files, we expect it would be a nine to 12 month approval process of LifeCore. So that's what ultimately drives that 24 to 30 month timeframe.

speaker
Matt Hewitt
Analyst, Craig Hallum Capital Group

Got it. That's super helpful. Thank you.

speaker
Operator
Conference Operator

Thank you. Our next question comes from Paul Knight with KeyBank Capital. Your line is open.

speaker
Paul Knight
Analyst, KeyBank Capital

Hi, Paul. Could you talk about your sales force changes, and are you done with this change in what you've done for distribution?

speaker
Paul Josephs
President and Chief Executive Officer

Thanks, Paul. Thanks for the question. Yes, we're done, I would say, structurally. We've brought in a very experienced leader, Mark Duff on SECA, to lead our business development efforts. He has over 20 plus years of sales leadership. experienced within the cdmo industry we have a well-experienced marketing leader within the team and a very well-experienced business development team with with a grounded and experienced in sterile injectables so we feel really good about the team we have in place and it's all about continuing the momentum that we built within 2025 and then we expect to have more meaningful and impactful programs close in 2026.

speaker
Paul Knight
Analyst, KeyBank Capital

And then the other macro question I would have would be, what's the status of the fill finish capacity globally right now? Is it an advantage that's tight, or is it not that tight? If you could talk about what's the status of fill and finish. It seems like some firms are adding a lot of capacity, but where are we right now?

speaker
Paul Josephs
President and Chief Executive Officer

I would say that's a very good question, and we talk about this a lot. I would say on your traditional vials that you would go and get your flu vaccine from CVS or Walgreens on an annual basis. There is an adequate amount of capacity in the market for that dosage form or delivery system. But when it comes to pre-filled syringes and cartridges, there's available, there is a dearth of capacity at this point. Ultimately, capacity will catch up. But LifeCorp continues to differentiate itself based on our technical capability and quality, and I think that's what will sustain us and help us grow over the long haul.

speaker
Paul Knight
Analyst, KeyBank Capital

And then last question would be regarding insuring. I mean, there's a lot of numbers being thrown about, but does it make you reconsider that 12% long-term CAGR, or is it just too early to tell?

speaker
Paul Josephs
President and Chief Executive Officer

I think too early to tell, Paul. I would say right now the leading indicators are strong. Christine asked a question about Asian markets. We have Asian late stage programs within our pipeline, programs from Europe. I've mentioned this in the past, programs from Israel as well, and complex injectables from India. So I believe the regionalization trend is real and something that we're certainly working very hard to capitalize on and I don't see it changing anytime soon. Okay, thank you.

speaker
Operator
Conference Operator

Thank you. Our next question comes from Mac Etoc with Stevens Inc. Your line is open.

speaker
Mac Etoc
Analyst, Stevens Inc

Hey Paul, Ryan. Thanks for taking my questions. Maybe just a couple from me. Maybe double-clicking on the 2026 guidance. the customer decision to build excess HA inventory in 2025. I think previously you had mentioned that there's a customer moving away from an external third party and bringing manufacturing in-house. So I guess my question is, did you all see a benefit in 2025 from that stocking? And yeah, I'll leave it there and follow up.

speaker
Paul Josephs
President and Chief Executive Officer

Mac, thanks for the question. Yes, from an HA perspective, it's really been a two-year... strategic initiative by one of our customers as they look to bring more aseptic volume to LifeCore. And as they transitioned away from, they've always been dual source with regard to HA, and they were moving away from one source and also building stock within their existing site, their other existing site as they transition volume to LifeCore, which led to a 24-month, I would say, increase with regard to our HA demand. You see a leveling out of that starting in 2026 with approximately a $10 million reduction, which Ryan articulated. And then you'll see a further leveling out as we move into 2027, and you can see that in our earnings presentation or investor presentation. We see that leveling out moving forward from 2027 forward.

speaker
Mac Etoc
Analyst, Stevens Inc

I appreciate the color there. And then given the dynamics that you highlighted for 2026, how should we think about the revenue and margin cadence throughout the course of the next year?

speaker
Ryan Lake
Chief Financial Officer

Yeah, thanks for the question, Mack. From a revenue perspective, we currently expect the revenue split to be roughly in the mid-40% range in the first half and the mid-50% range in the second half. From an operating expense or gross margin perspective, we expect margins to be in the 30% range. with some variability between quarters based on the product mix, volume, timing of shipments. That's going to result in an anticipated split similar to revenue. R&D expenses, we expect R&D to remain at a similar run rate as Q4, so about in that $1.5 million to $2 million a quarter. And SG&A for calendar year 26, we expect to be in a range of approximately $28 million, and that will represent approximately a $6 million decrease compared to the prior year comparable period. Because of all those cost-saving initiatives, the legacy matters and efficiencies that we've realized, and we expect the cadence of the SG&A expenses to be split approximately a little over 50% in the first half and slightly south of 50% in the second half. So, you know, the goal, and as we've talked about too, it's, you know, currently expecting that that run rate to be approximately $7 million a quarter exiting the year. And then just from an EBITDA margin perspective, you know, in the $20.5 to $25 million, that'll be split about 40% or in the 40% range for the first half and 60% in the second half. And that's you know, really shows that continued progression of adjusted EBITDA margins, as we mentioned previously, from 15% to 17% to now between 17% and 20% or 18.5% at that midpoint.

speaker
Mac Etoc
Analyst, Stevens Inc

I appreciate the color. Thank you for taking my questions.

speaker
Operator
Conference Operator

Thank you. Our next question comes from Michael Patesky with Barrington Research. Your line is open.

speaker
Michael Patesky
Analyst, Barrington Research

Hey, good morning, guys. Thanks for all the information information. I guess, Paul, I just wanted to talk a little bit more about the site transfer success that you guys have had here recently. Just in terms of the impact, and I know you're not going to give like super specific guidance, but, you know, if you could look at each of these site transfers, I mean, how meaningful in terms of top line, you know, incremental contribution Is it a few million? Is it north of 10? What are we actually talking about in terms of the upside of these site transfer things?

speaker
Paul Josephs
President and Chief Executive Officer

Mike, thanks for the question. We've risk-adjusted these accordingly in our forward-looking projections, but if you look at our late-stage pipeline slide, both at, I would say, peak sales, have the opportunity to be in, I would say, eight figures of commercial revenue. So they're exciting and impactful programs for us. We think they'll be very sticky because of the technical nature of them and proud to win both of those programs with relatively new customers for LifeCorps.

speaker
Michael Patesky
Analyst, Barrington Research

Okay, terrific. And then, Brian, I guess in 27, I had assumed maybe a little bit more than the modest revenue growth you guys sort of put out there in the press release. I'm just curious, what sort of the puts and takes on that modest revenue growth or the biggest puts and takes on that modest revenue growth? And then I guess in terms of just what that means, is that low single digits, is that mid single digits? What does modest revenue growth in 27 actually mean in your view?

speaker
Ryan Lake
Chief Financial Officer

Yeah, thanks for the question, Michael. So, you know, I think, you know, as we talked about, you know, some of the puts and takes in revenue for calendar year 26 with the loss of the customer, that has an expected annualized impact of about $7 million. And then, you know, what Paul talked about with regard to HA and the impact of 26, you know, there's about another $10 million impact to that in 27. So that mutes that growth a little bit, but also in 27 is when you have those contractual commitments beginning from our largest customer as well as some of those commercial launches that are anticipated.

speaker
Michael Patesky
Analyst, Barrington Research

Okay. All right. Great. And just in terms of when you talk about modest revenue growth, what are you guys actually envisioning if you can arrange?

speaker
Ryan Lake
Chief Financial Officer

Yeah, I mean, those are just goals right now. We haven't provided, you know, that outlook for 27 yet.

speaker
Michael Patesky
Analyst, Barrington Research

Okay. And then just the last question, you provided some historical information, which I really appreciated on the free cash generation, obviously. And I'm just curious, you didn't give formal guidance, I don't believe, around free cash and capex expectations. Is there anything you can sort of say on that just to be helpful in terms of our models? Thanks.

speaker
Ryan Lake
Chief Financial Officer

Thanks, Michael. So beyond the operational expense improvements and continued reduction and the non-recurring costs from legacy matters, those all have a real cash impact. So we expect cash flow to continue to improve. There are a number of puts and takes for our cash outlook for calendar year 26, but I expect our base case will be generating free cash flow in excess of $10 million. but that could be impacted and dependent on a number of items, including future expenses incurred related to legacy matters, timing of CapEx, and as I mentioned in my opening remarks, any potential redemptions of our convertible preferred stock or prepayments of our debt.

speaker
Michael Patesky
Analyst, Barrington Research

Is there a ballpark estimate around CapEx?

speaker
Ryan Lake
Chief Financial Officer

Yes, it's in the $8 million range.

speaker
Michael Patesky
Analyst, Barrington Research

All right, great. Thank you so much, guys. Really appreciate it, especially some of the out-year commentary. Thank you.

speaker
Paul Josephs
President and Chief Executive Officer

Thanks, Michael.

speaker
Operator
Conference Operator

Thank you. I'm showing no further questions at this time. I'd like to turn the call back over to Paul Josephs for closing remarks.

speaker
Paul Josephs
President and Chief Executive Officer

Thank you, Operator. I wish to thank all of LifeCourse stakeholders and supporters, including our investors, customers, and collaborators for their ongoing support and partnership. I also wish to thank our dedicated employees for their commitment to our success as well as the successes of our customers and the patients they serve. We are pleased with the progress we made in 2025 and look forward to future growth ahead. That concludes our call today. Thank you for participating.

speaker
Operator
Conference Operator

Thank you. You may now disconnect. Everyone, have a great day.

speaker
Paul Josephs
President and Chief Executive Officer

Thank you.

Disclaimer

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