Lifecore Biomedical Q4 2025 Earnings Report

Lifecore Biomedical EPS Results

• Actual EPS: N/A
• Consensus EPS: -$0.09
• Beat/Miss: N/A
• One Year Ago EPS: N/A

Lifecore Biomedical Revenue Results

• Actual Revenue: N/A
• Expected Revenue: $35.36 million
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Lifecore Biomedical Announcement Details

• Quarter: Q4 2025
• Date: 8/25/2025
• Time: Before Market Opens
• Conference Call Date: N/A
• Conference Call Time: N/A

Lifecore Biomedical (NASDAQ:LFCR), together with its subsidiaries, operates as an integrated contract development and manufacturing organization in the United States and internationally. The company engages in the manufacturing of pharmaceutical-grade sodium hyaluronate (HA) in bulk form, as well as formulated and filled syringes and vials for injectable products used in treating a range of medical conditions and procedures. It also provides services, such as technology development, material component changes, analytical method development, formulation development, pilot studies, stability studies, process validation, and production of materials for clinical studies to its partners for HA-based and non-HA based aseptically formulated and filled products. The company was formerly known as Landec Corporation and changed its name to Lifecore Biomedical, Inc. in November 2022. Lifecore Biomedical, Inc. was founded in 1965 and is headquartered in Chaska, Minnesota.

Lifecore Biomedical Q4 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Company signed nine new development agreements this fiscal year, including a late-stage clinical GLP-1 program, boosting near-term momentum for 2026.
• Positive Sentiment: Met fiscal 2025 guidance by rightsizing workforce, improving productivity, raising capital, and remain on track for a 12% revenue CAGR and >25% EBITDA margins midterm.
• Negative Sentiment: Q4 revenues decreased 4% to $36.4 million and the quarter’s net loss was $1.1 million compared to a $7.1 million loss a year ago; fiscal 2025 net loss was $38.7 million with adjusted EBITDA at $19.5 million.
• Neutral Sentiment: Provided seven-month transition period guidance (May–Dec 2025) of revenues at $74–76 million and adjusted EBITDA of $12–14 million as it aligns its fiscal year to the calendar year and gears up for ERP implementation.
• Positive Sentiment: Advanced its late-stage development pipeline to 11 programs targeting approvals by 2028, including a new 10-year commercial manufacturing and supply agreement for an ophthalmic therapeutic.

Presentation

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

Thank you, Stephanie. Good afternoon, everyone, and thank you for joining our fiscal twenty twenty five fourth quarter and full year update. Fiscal twenty twenty five was a strong year for Lifecore 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 that with a new strategic plan and proven CDMO leadership, we were highly successful in achieving a number of important goals during this transition year.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

Key among these is upgrading our business development and marketing strategy. During the year, we signed multiple development 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-one program. These wins will help to drive near our near term momentum and have us excited about our performance in 2026. Additional achievements from fiscal twenty twenty five include rightsizing 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 Lifecore's performance during fiscal twenty twenty five 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.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

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, Lifecore 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 Lifecore. These companies are a rich source of potential new business, and we have dedicated significant effort to growing with each of our current customers.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

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 take or pay commitments from this customer and an expansion in regions supported by Lifecore to include Asia Pacific markets. This expansion in geography is only possible due to Lifecore's strong multicompendial 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.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

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 ten 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, Lifecore has also signed a multimillion dollar statement of work detail 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, Lifecore will be responsible for manufacturing a variety of batches of the drug candidate, including multiple process performance qualification or PPQ batches.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

As a reminder, PPQ programs are particularly important milestones as they are a pre commercialization requirement. And we 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 competence in this program. This customer also made a multimillion dollar investment in a dedicated production equipment.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

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 as we 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.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

One highlight is our agreement with Humanetics, 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 of the existing fill and finish process for BIO three hundred, including formulation development, gap assessment, and filling of a pilot batch. This will be followed by analytic analytical method work, include including feasibility assessments, which will help estimate future development work for the product candidate.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

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 one therapeutics for obesity and a phase two dermatology program. Both programs are in the process of being onboarded by our project management team.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

The GLP one 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 of of a proven business development veteran with more than twenty 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 of the nest support necessary to pursue new opportunities. In FY '25, in addition to making meaningful progress in executing our strategy, we also made an important changes to the organization to facilitate our success.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

During the year, Lifecore appointed multiples a number of seasoned and successful leaders to elevate the company's operations, including Ryan Lake, a highly experienced CFO, Thomas Goldeger, our new senior VP of operations, Tom Salas, Lifecore's first chief legal and administration officer, and as I mentioned earlier, our newest appointment, Mark Delfonseca, the chief the company's chief commercial officer. This new new team working with me and Jackie Clecker, 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'm very pleased with these organizational enhancements, which have resulted in measurable improvements across our company. Further demonstrating the effectiveness of our quality management system and expertise expertise of our quality team, The Food and Drug Administration conducted a general audit of our quality systems and processes during the fourth quarter.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

The audit would span 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 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 Lifecore.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

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 full delivery rate of 97%, an improvement over FY '24 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 q one twenty twenty six go live.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

This isn't just a technology upgrade. It's enabler 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 help reduce costs as we grow. And finally, I wanna recognize the team's continued focus on safety, our most important responsibility. We maintained an injury a recordable injury rate well below industry average this year, and that's not by chance.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

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 and implemented value added solutions. In 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.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

I will now turn the call over to Ryan Lake to provide an overview of our fourth quarter and fiscal twenty twenty five financial results. Ryan?

[Ryan Lake, CFO at Lifecore Biomedical]

Thank you, Paul, and good afternoon, everybody. In connection with my comments, I'd like to recommend that participants refer to Lifecore's Form 10 ks filing with the Securities and Exchange Commission, which we filed today. I'll now go over results for the fourth quarter and twelve months ended 05/25/2025, beginning with results for the quarter. Revenues for the three months ended 05/25/2025, were $36,400,000 a decrease of 4% compared to $37,900,000 for the comparable prior year period. The decrease in revenues was primarily due to a $5,600,000 decrease in CDMO revenues, which was primarily impacted by $4,400,000 of lower development revenue, primarily due to completion of a discrete development project in the prior comparable period and timing of customer project life cycles.

[Ryan Lake, CFO at Lifecore Biomedical]

In addition, hyaluronic acid manufacturing revenues increased $4,100,000 primarily from increased demand due to our largest customer supply chain initiatives. Gross profit for the three months ended 05/25/2025, was 14,000,000 compared to $17,300,000 for the same period last year. The decline of $3,300,000 in gross profit is primarily due to a $6,000,000 decrease in CDMO gross profit, which was primarily impacted by sales mix, including lower development revenue and aseptic manufacturing volumes. The decline in CDMO gross profit was partially offset by a net $2,800,000 increase in manufacturing gross profit due to increased volumes and manufacturing variances. Selling, general and administrative expenses for the three months ended 05/25/2025 were $9,000,000 compared to $12,200,000 for the same period last year.

[Ryan Lake, CFO at Lifecore Biomedical]

The $3,200,000 decrease in SG and A expenses was primarily due to a $1,600,000 of lower legal, personnel and finance and accounting consulting expenses as a result of focused efforts to reduce operational expense and bringing in new leadership. Also included in SG and A expenses is $2,000,000 for the current period and $3,600,000 for the prior period related to legacy matters. For the three months ended 05/25/2025, the company recorded a net loss of $1,100,000 and $06 of loss per diluted share as compared to a net loss of $7,100,000 and $0.19 of loss per diluted share for the same period last year. The decrease in net loss also included a couple other non operating income or expense items detailed in our filings. Adjusted EBITDA for the three months ended 05/25/2025 was $9,100,000 a decrease of $1,300,000 compared to 10,400,000 in the prior year period.

[Ryan Lake, CFO at Lifecore Biomedical]

The decrease in adjusted EBITDA was primarily due to the decrease in gross profit, partially offset by favorable recurring selling, general and administrative expenses. I'll now review the results for the twelve months of fiscal twenty twenty five. Revenues for the twelve months ended 05/25/2025 were $128,900,000 an increase of 0.5% compared to $128,300,000 for the comparable prior year period. The increase in revenues was due to a $7,100,000 increase in manufacturing demand, primarily due to our largest customer supply chain initiatives. The manufacturing revenue increase was partially offset by a $6,500,000 decline in CDMO revenues that is primarily due to a $6,200,000 of lower development revenue due to completion of a discrete development project in the prior comparable period and timing of customer project life cycles as well as various other offsetting customer fluctuations detailed in our Form 10 ks.

[Ryan Lake, CFO at Lifecore Biomedical]

Gross profit for the twelve months ended 05/25/2025, was $40,300,000 compared to $41,900,000 for the same period last year. The $1,600,000 decrease in gross profit is due to a $5,900,000 decrease in CDMO gross profit, which was primarily impacted by sales mix, including lower development revenue and aseptic manufacturing volumes and was partially offset by a net $4,300,000 increase in HK manufacturing gross profit due to increased volumes and manufacturing variances. Selling, general and administrative expenses for the twelve months ended May compared to $40,500,000 for the same period last year. The increase in SG and A expenses was primarily due to a $3,700,000 increase in noncash stock based compensation, the majority of which was related to new higher performance stock unit grants to the company's executive officers. Also included in SG and A expenses is $11,600,000 for the current period and $11,900,000 in the prior period related to legacy matters.

[Ryan Lake, CFO at Lifecore Biomedical]

For the twelve months ended 05/25/2025, the company recorded a net loss of $38,700,000 and $1.27 of loss per diluted share as compared to net income of 12000033¢ of income per diluted share for the same period last year. The loss in 2025 included a $7,700,000 loss on the sale or disposal of assets as compared to the same period in 2024, which included a favorable $39,500,000 noncash fair market value adjustment to the debt derivative liability. Adjusted EBITDA for the twelve months ended 05/25/2025 was $19,500,000 a $700,000 decrease from $20,200,000 in the prior year period. The decrease in adjusted EBITDA was primarily due to the decrease in gross profit. As Paul stated earlier, we are very pleased to have met the company's stated guidance for both revenue and adjusted EBITDA for the fiscal year.

[Ryan Lake, CFO at Lifecore Biomedical]

Fourth quarter adjusted EBITDA was the strongest of the year. Further, subsequent to quarter end, the company's balance sheet was significantly strengthened through the receipt of the remaining $10,000,000 in proceeds from the sale of the non core assets, which took place earlier this year to align our capital assets with operational and commercial needs. In other financial news, I'm pleased to announce that the company will be moving its fiscal year end to align with the calendar year effective for the 12/31/2025 calendar period. In the coming months, our internal finance and accounting team will be working closely with our public accounting firm to prepare the financial statements and disclosures needed to meet the reporting requirements under the new fiscal calendar. Concurrently, we'll be working to recast financial statements for a 2025 fiscal year that will end on 12/31/2025, and to prepare supporting documentation to bridge the statements filed today to the recasted 2025 statements that will be filed following the 12/31/2025 year end.

[Ryan Lake, CFO at Lifecore Biomedical]

This decision to move our fiscal year end, which had been based on the legacy business' seasonality, will allow Lifecore to report in a timely manner with the majority of our peer companies, customers and other stakeholders, which we believe is an important factor in evaluating operating and financial performance and also aligns with the launch of the new ERP system and expected associated benefits that Paul discussed earlier. The company will provide additional updates on this transition in the coming months. As a result of the communicated change in fiscal year, we are providing financial guidance for the approximately seven month transition period from May 26 through December 2025. For this seven month transition period, we expect revenue to be between approximately 74,000,000 to $76,000,000 and adjusted EBITDA to be in the range of 12,000,000 to 14,000,000 We wish to reiterate that we are only providing guidance at this time with respect to the seven month transition period, and we caution against extrapolating quarterly results or this guidance to estimate full year results. This concludes my financial overview.

[Ryan Lake, CFO at Lifecore Biomedical]

I'll now turn the call back over to Paul for his final comments.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

Thank you, Ryan. In closing, I would like to reiterate how thrilled I am with the company's achievements during this transition year. We have restructured our organization and implemented numerous upgrades and enhancements across our company. We've improved efficiency by rightsizing our headcount and reducing expenses as a percent of revenue, all while increasing revenue per direct labor employee. Our stronger, more productive organization made substantial progress.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

This concludes our prepared remarks for today. Operator, you may now open the call for questions.

[Operator]

Our first question will be coming from Max Schmuck of William Blair. Your line is open, Max.

[Max Smock, Research Analyst - Healthcare at William Blair]

Hey, good afternoon, guys. Thanks for taking our questions. Maybe just starting with one on your commentary here around your largest customer supply chain initiatives, a two parter for me. I know when we talked in the past, you mentioned about $20,000,000 of incremental revenue as part of those annual minimum commitments. Is that still the right number to think about here?

[Max Smock, Research Analyst - Healthcare at William Blair]

Or has that gone up at all? And then you also previously mentioned the potential for volumes to ramp ahead of that minimum volume commitment kicking in, in 2027. Are you seeing that happen given the noise out there around tariffs? Or are volumes going to remain more or less the same until we get closer to or get into 2027? Thank you.

[Ryan Lake, CFO at Lifecore Biomedical]

So, Max, maybe this is Ryan. Thanks for the question. So, you know, I I guess I would first just mention that the increases that we're seeing from an demand perspective, you know, we think one of our customers' strategic supply chain initiatives is to move away from another third party, and that's bringing that additional aseptic manufacturing volumes to both Lifecore and in house with this partner. And we believe it's part of their overall strategy to increase Lifecore's aseptic production in the coming years.

[Max Smock, Research Analyst - Healthcare at William Blair]

Okay. Understood. Thanks, Ryan. Maybe one quickly on the new GLP one agreement you signed. Can you just frame out for us what that agreement looks like in terms of size of engagement, the potential timeline for approval, and then just the role that you all have been engaged to play, assuming that drug does eventually reach approval at some point in the future?

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

Thanks, Max. This is Paul. Appreciate the question. At this point, we're not in a position to disclose all the terms of our agreement, but I can tell you we're extremely excited to collaborate with our client on this opportunity. GLP-one market is projected to triple over the near term as I think about towards 2030, and we're looking to towards driving meaningful impact with our client as they work towards commercialization.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

I would say in that 2029, 2030 period is where it's

[Max Smock, Research Analyst - Healthcare at William Blair]

Okay. That's helpful. Thank you, Paul. And then maybe one last one for me, and then I'll I'll hop back in the queue. On the margin side, Ryan, I appreciate it's a little tricky here because of the seasonally weak fiscal first quarter historically.

[Max Smock, Research Analyst - Healthcare at William Blair]

The 17%, I mean, a pretty big step down relative to the back half of the year here. But again, you're you know, disproportionately reflecting the soft margins in q one. So can you just walk us through or give us some sense for maybe what margins look like over the next twelve months just so we have a better frame of reference to how that compares to what you all just posted for fiscal twenty twenty five?

[Ryan Lake, CFO at Lifecore Biomedical]

Yeah. So, maybe just to touch on the the quarter. I mean, from a margin perspective, this was, a pretty significant step up. This was our highest quarter at about 38% margins for the quarter, and that was due to the timing of the manufacturing. We also had good absorption of our fixed costs.

[Ryan Lake, CFO at Lifecore Biomedical]

I think as we look out, kinda oh, we've only provided guidance for the seven month stub period, but I think, you know, overall, we expect gross margins for the seven month stub period to be in the low 30% range, but improved, from the overall 31%, gross margins that we experienced in fiscal year twenty five. And then with some variability between quarters based on products mix, volume, and timing of the shipments, we expect a pretty even split of of that expected gross profit, about 45% of of that gross profit to come in the first four months, and then about 55% of that to come, in the in the last three months of counting the year '25. So over the comparable prior year period, that represents about a $6,000,000 improvement in gross profit. And then just to take that a little bit further in terms of the adjusted EBITDA margins in roughly 15% that we had for for fiscal year twenty five, we'd expect the the adjusted EBITDA for the seven months stub period, to be in that range of 12 to 14,000,000, and that's split between kind of the four months stub, about 40% of that, and then the other 60% is really in the last three months of calendar year '25.

[Max Smock, Research Analyst - Healthcare at William Blair]

Got it. Super helpful. Thank you again for, taking our questions.

[Operator]

Thanks. And our next question will be coming from Matt Hewitt of Craig Hallum Capital Group LLC. Your line is open.

[Matthew Hewitt, Senior Research Analyst at Craig-Hallum]

Good afternoon. Thanks for taking the questions. Maybe another way to ask the question is if you were not going through the calendar year change here, what would your FY twenty six guidance have looked like?

[Ryan Lake, CFO at Lifecore Biomedical]

Hi, Matt. Thanks for the question. So had we not changed the reporting calendar, we would have expected fiscal twenty twenty six ending in May 2026. Revenues to be probably in a similar range as fiscal twenty twenty five despite some potential headwinds on volumes going down. But from an expense side, I think what's important here is that'll be the first mover.

[Ryan Lake, CFO at Lifecore Biomedical]

We expect to see improvements in adjusted EBITDA due to all the efficiencies and cost cutting measures that we've implemented over the past year. So just a a reminder, a large portion of those cost savings and efficiencies were realized in our f y twenty five results. So they're not as pronounced in those forward looking results, but we continue to strive for for more. And an example of this is the reduction in force that we had at the beginning of fiscal year twenty five. So we realized the benefit of that in fiscal year twenty five.

[Ryan Lake, CFO at Lifecore Biomedical]

So you won't see that incremental benefit from that action in the comps because it's essentially savings in both periods. And then similarly, as you can see with our s g and a expenses, they came down almost $6,000,000 in q four compared to q one of fiscal year twenty five. So, you know, I think another important fact is that we we've we've previously communicated the key inflection point to the ramp and us achieving our financial goals over the midterm is really based on that expansion project that Paul mentioned with one of our largest multinational customers and the associated contractual minimums that are expected to begin in calendar twenty seven. Also crucial to this is achieving, the goals is is ongoing progression of our late stage development pipeline, and we remain confident in achieving that 12% CAGR for revenue over the midterm, which at that time we had defined as kind of the next three to four years or approximately calendar year '27 or '28. And then in addition, we continue to make material progress as we discussed on reducing costs as a percentage of revenue, and we believe we'll reach our EBITDA margin targets in a similar time frame.

[Matthew Hewitt, Senior Research Analyst at Craig-Hallum]

That's very helpful. Thank you. Shifting gears a little bit, there's been a lot of noise here over the past month or so with tariffs on imported pharmaceuticals. I think initially, was big was the term used. And then I think just this past week, there was talk of 150% to two fifty percent tariffs in eighteen months.

[Matthew Hewitt, Senior Research Analyst at Craig-Hallum]

I'm just curious how your conversations have been evolving as those kinds of numbers have kind of thrown out. Obviously, it sounds like you've had some success already here in this quarter, signing some new deals. Is that a function of those tariff threats? Or is there still more to come on the new development side? Thank you.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

Matt, thanks so much for the question. This is Paul. You know, I can't tell you how many texts I get, emails I get about tariffs and poll and policy going up and happening in Washington. And and, personally, I I consider that just noise. I don't think anybody in the industry really believes that we'll have tariffs at the 20 250% level.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

With that said, it's undeniable, really undeniable that pharmaceutical manufacturing here in The United States is cons is incredibly strong. The you see it in the recent announcements about investments large multinational players are making. Like, I think about g J and J, Eli Lilly, AstraZeneca, Novartis come to mind. But they can't manufacture anything, and not every organization is gonna be able to make those types of investments. And it is clear that the most economical and efficient way to onshore manufacturing demand is is utilizing a CDMO.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

And I truly believe that Lifecore is strongly positioned to maximize on the opportunity, and that's why we're playing offense. We're making significant increases in our investment in sales and marketing for FY '26, our transition period and on into '26. And we're seeing the it manifest itself in our pipeline. I think about my review with the team earlier this week. We have we have opportunities that we're looking at at a Asia Pacific market, European market, out of Israel, all a part of potential onshoring.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

So, you know, again, we're gonna really play significant offense with regard to our sales and marketing team. I expect, personally, I'll spend an inordinate amount of time working with that team, hopefully, complementing their efforts. And we're really excited about the opportunity that's in front of us. And then if I think about how we manage the business internally, just building off Ryan's comments in before, you know, we're gonna continue to manage the business aggressively as it relates to cost so that we are don't see any significant impact due to tariffs. So, again, great tailwinds for the market.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

50% of the programs that get FDA approval are injectables. We believe we're strongly positioned to maximize our potential success in this area.

[Matthew Hewitt, Senior Research Analyst at Craig-Hallum]

Well, that's great. Happy hunting.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

Thank you.

[Operator]

Thank you. And our next question will come from Michael Petusky of Barrington Research. Your line is open, Michael.

[Michael Petusky, MD & Senior Investment Analyst at Barrington Research Associates]

Hey, good evening, guys. Paul, if I could just sort of follow-up on that last question. When conversations or your senior people are having conversations with drug manufacturers, I mean, are these guys like genuinely viewing this as like a catalyst for near term action? Are they kind of sort of like you are with the 250% tariffs sort of rolling their eyes and saying, well, we'll see where this heads and we'll see over time and we'll sort of make like I'm trying to get a sense of how much of this is real within the industry, you know, where it could drive near term results, say, over the next twelve to eighteen months for you guys. Thanks.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

Well, I I think it's thanks, Mike. Appreciate the question. I I I just believe it's part of the overall momentum. You know, if I think about where we were a year ago when I when my first earnings call as part of Lifecore, and we had a farming type mentality from a sales and marketing perspective, our pipeline was weak, clearly, but we rebuilt our sales and marketing team. And now with Mark on board, I I couldn't be more excited and optimistic about where we're going.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

I just think the overall quality of our pipeline is better. Tariffs play a part of that, but we're just seeing more opportunities based on our our our strategic shift in with regard to how we build this business by taking a very aggressive hunting approach to that. With that said, again, as I mentioned, we have real intangible opportunities that are we see in our in our pipeline coming out of Europe that maybe heretofore we didn't see out of Asia Pacific and Israel. So not all of that's tariffs. Some of it is political unrest as as a example of it out of Israel, but the momentum is clear. There is US manufacturing momentum within the pharmaceutical industry.

[Michael Petusky, MD & Senior Investment Analyst at Barrington Research Associates]

Fair enough. Two, more, I guess, quick quicker questions. Paul, I didn't hear it if you mentioned it. What's what's the current number of late stage projects that you guys have?

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

To go now, as of today, 11, Mike, late stage programs that we have from 10 that we announced pre or have communicated previously.

[Michael Petusky, MD & Senior Investment Analyst at Barrington Research Associates]

Okay. Great. And then one for Ryan real quick. I didn't catch it if you mentioned it. Did you mention what cash flow from ops and CapEx was in the fourth quarter?

[Ryan Lake, CFO at Lifecore Biomedical]

No. I didn't. So we had positive cash flow from operations for the fourth quarter of a little over 5,000,000 and free cash flow of over 3,000,000. And I just remind you that that's despite having some one time kinda nonrecurring legacy expenses of about $2,000,000 in the quarter. So it would have been $2,000,000 better had that not been included.

[Michael Petusky, MD & Senior Investment Analyst at Barrington Research Associates]

Okay. And then let me sneak one one more quick one in for you, Ryan. The ERP, any, estimate in in terms of, the time to implement and the the cost of implementation? Thanks.

[Ryan Lake, CFO at Lifecore Biomedical]

Yeah. Thanks, Mike. So, in terms of timing, we're targeting 2026 of calendar twenty twenty six. It's roughly a 600,000 to million dollar ERP investment. I think what's what's important, to mention about that is, you know, we've we've had, you know, over a dozen subject matter experts that have been directly engaged in all phases of the design and development of that.

[Ryan Lake, CFO at Lifecore Biomedical]

We've had third party validation testing that's aligned with FDA and g GMP standards that executed months in advance of the go live. We're we've also been engaged with, SOX kinda tech testing from a SOX testing perspective months in advance of the go live. You know, we've got defined go, no go criteria and rollback plans, and the new ERP will run parallel with our legacy, ERP system as well. And then we are planning to go live during, a planned manufacturing shutdown as well to minimize any any risk with that.

[Michael Petusky, MD & Senior Investment Analyst at Barrington Research Associates]

Okay. Awesome. Thanks, guys.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

Thanks, Mike.

[Operator]

And I would now like to turn the call back to Paul Josephs for closing remarks.

[Paul Josephs, President, CEO & Director at Lifecore Biomedical]

Thank you, operator. I wish to thank all Lifecore's stakeholders, including our investors, customers, and collaborators for their ongoing support and partnership. I also wish to thank our incredibly hardworking and talented team for driving each of the successes here at Lifecore. We are very pleased with our progress made in fiscal twenty twenty five, and we remain optimistic regarding our potential to achieve growth and sustainable profitability in the coming years. Thank you.

[Operator]

And this concludes today's conference call. Thank you for participating. You may now disconnect.

Participants

Executives

• Paul Josephs, President, CEO & Director
• Ryan Lake, CFO

Analysts

• Max Smock, Research Analyst - Healthcare at William Blair
• Matthew Hewitt, Senior Research Analyst at Craig-Hallum
• Michael Petusky, MD & Senior Investment Analyst at Barrington Research Associates