Lifecore Biomedical, Inc. ($LFCR)

Good morning, and thank you for joining Lifecore's earnings call for the first quarter ended March 31, 2026. [Operator Instructions] Now I would like to turn the call over to Stephanie Diaz, Manager of Investor Relations for Lifecore.

Good morning, and thank you for joining us. Today, Lifecore Biomedical will provide its earnings for the first quarter ended March 31, 2026, and corporate update. As the company has recently changed its fiscal year-end to align with the calendar year, we will be comparing our results for the first quarter ended March 31, 2026, with the comparable prior year quarter ended February 23, 2025. Hosting the call today from Lifecore are Paul Josephs, President and Chief Executive Officer; and Ryan Lake, Chief Financial Officer. Before we begin, I'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, May 6, 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 8-K and is available on our corporate website at lifecore.com as well as our other filings with the Securities and Exchange Commission, including, but not limited to, the company's Form 10-Q for Q1 2026, 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 would like to turn the call over to Paul Josephs, President and Chief Executive Officer.

Thank you, Stephanie. Good morning, everyone, and thank you for joining us today. During the first quarter of 2026, we continue to execute on each of the 3 pillars of our growth strategy: maximizing our existing commercial business, advancing our development pipeline towards commercialization and adding high-quality new programs to our pipeline through business development. We believe consistent execution across these pillars positions Lifecore for sustained long-term growth, supporting our goal of achieving a 12% revenue CAGR and EBITDA margins above 25% by the end of 2029. We remain confident in our full year expectations and reaffirm our 2026 guidance. Ryan will provide additional details on our financial results following my overview of our Q1 achievements. I will begin today with the progress made with each of our growth strategy pillars, starting with our revamped commercial strategy and priority to add high-quality programs to our development pipeline. I am encouraged by the progress made with regard to this initiative. As previously discussed, we have transformed our business development strategy and team to expand our target market and drive an increase in the number of high-quality customer wins. This effort generated a strong expansion of our pipeline in 2025, and we are encouraged by the continued progress we have seen in 2026. In the first quarter alone, we have signed 3 new commercial site transfer programs. In March, we announced the signing of a manufacturing services agreement for the commercial site transfer of a marketed approved product with a new aesthetics customer. Under the terms of the agreement, we will perform technical transfer activities for a product that is currently manufactured outside the U.S. Our clients' goal is to establish U.S.-based manufacturing for products sold in the U.S. This is an exciting opportunity for us with a customer relationship that we expect to grow over time. Importantly, we believe this product may generate commercial revenue in 2028. In addition, during the first quarter, we announced the signing of 2 CDMO manufacturing services agreements with an existing U.S. biopharmaceutical customer. This customer is a publicly traded U.S.-based pharmaceutical company that has successfully developed multiple marketed products and continues to drive growth in its commercial pipeline. The first of these agreements is a commercial site transfer under which we will assume manufacturing of a currently marketed product produced by another CDMO. This is a new product to Lifecore. We will perform technical transfer services required to support regulatory approval at our site. Upon successful approval of this transfer, the agreement provides for the commercial manufacturing of this product at Lifecore. Consistent with previously discussed commercial site transfers, we believe this product may generate commercial revenue in 2028. The second agreement with the same customer reflects an expansion of our relationship. Lifecore currently manufactures this commercial ophthalmic product in one delivery format and will now begin to manufacture it in a second delivery system. This additional delivery system is currently manufactured in Europe. We believe the secondary -- second delivery system will be additive to our existing commercial revenue for this product. We are motivated to have been selected for all these high-value programs as we believe it reflects the continued progress in becoming a partner of choice for our current and future customers. Our unwavering commitment to best-in-class quality and strong technical expertise are key drivers for those customers that continue to place a trust in us for the development and manufacturing of their important programs. During the quarter, our business development team spent considerable time and effort strengthening our business development pipeline, resulting in a growing number of meaningful meetings with customers and prospects. A meaningful highlight for us was the significant engagement our team experienced with our customers at the recent Drug, Chemical & Associated Technologies or DCAT Association meeting in New York. DCAT is our largest and most important sales and marketing event in North America. This year's engagement was unprecedented for us with our team participating in a record number of meetings with both existing and potential customers. Given the strong engagement and the growing momentum of our business development team is building, we believe we are well positioned to capitalize on the positive market dynamics, including the growth of manufacturing in the United States, and the fact that approximately 50% of the U.S. drug development pipeline are injectable therapies. We believe that this current environment points in our favor and leaves us well positioned to aggressively pursue new business and capitalize on the opportunity in front of us. With respect to our first growth strategy, expanding our existing commercial business, we continue to work closely with our commercial partners during the quarter to deliver outstanding service with a clear focus on readying our organization for the doubling of commercial demand with our largest customer, which is expected to begin in 2027. Concurrently, we remain committed to commercial excellence. And during the quarter, we implemented targeted pricing initiatives to maintain and expand our product margins. Turning to the second growth strategy pillar of advancing development programs to commercialization. We are encouraged about our growing and diverse pipeline. One of the highlights during the quarter was the expansion of our work with Indomo, a clinical-stage therapeutics company. In January of this year, we signed a second agreement with Indomo, having previously been selected to provide formulation and process optimization activities in support of their DT-001 program. Under the terms of our latest agreement, we will be responsible for producing and supplying clinical batches of DT-001, planned studies designed to prepare the product for advancement into Phase II clinical trials in 2026. We also made significant progress regarding our late-stage development pipeline, which includes 13 late-stage programs with the addition of the 3 programs mentioned earlier in my comments. 5 of these programs are commercial site transfers. Unlike development programs, commercial site transfers have existing market demand and are significantly derisked. They do not require additional clinical trials and only require qualification at Lifecore, which gives us greater confidence in their financial projections. Given our quality track record and proficiency in producing similar products, we are confident in our ability to successfully transfer all 5 products to Lifecore. Depending on timing of regulatory approvals, we expect that they will all generate commercial revenue at our site in 2028. It is also important to note that 2 of our late-stage customers nearing commercialization achieved important milestones that support their path towards regulatory approval and commercialization. One of our late-stage ophthalmic customers recently announced positive top-line Phase III results. And after securing funding, another customer has a clear and actionable path toward commercialization potentially in 2028. Beyond the achievements specific to our growth strategy, we made meaningful progress across several key areas of our business, including SG&A, operations and quality. Within SG&A, we continue to identify and act on opportunities for cost reductions and intend to continue to implement changes that we believe will drive sustained margin improvement over time. In addition to our operational achievements, during the quarter, we successfully launched our enterprise resource planning or ERP system in January. To date, this implementation has been smooth, and we ultimately expect the system to improve efficiencies in financial management, cost containment, productivity and inventory control. With regard to quality, our commitment to industry-leading quality was again demonstrated during the quarter. During the quarter, we completed multiple inspections with new business prospects and existing customers. Each of these inspections had a positive outcome, which we believe further validates Lifecore's growing reputation as a leading CDMO and partner of choice for customers seeking high quality. Importantly, these inspections consistently serve as a learning opportunity for us, and allow us to strengthen our quality systems that are the foundation for all our development and commercial manufacturing activities. During the first quarter of 2026, our team successfully executed against each pillar of our growth strategy. Concurrently, we continue to optimize our organization to drive cost reductions and improve efficiencies to support margin improvement, all while continuing to elevate our quality systems. I am energized by our achievements during the quarter, and we remain committed to building on this momentum with discipline throughout the year. That concludes my update. I will now turn the call over to Ryan Lake to provide an overview of our financial results for the first quarter ended March 31, 2026. Ryan?

Thank you, Paul, and good morning, everyone. In conjunction with my comments, I'd like to recommend that participants refer to Lifecore's Form 10-Q filing, which we filed with the SEC earlier today. As a reminder, today, we will compare our first quarter, which ended on March 31, 2026, with the comparable prior year quarter ending on February 23, 2025. Before providing the quarter's financials, I'd like to state that I concur with Paul's optimism for the path ahead, and I'm pleased to reaffirm our 2026 guidance for revenue and adjusted EBITDA. As a reminder, for 2026, Lifecore expects total revenue to be in a range of $120 million to $125 million, net loss to be in the range of $35.4 million to $30.9 million and adjusted EBITDA to be in the range of $20.5 million to $25 million. Turning now to the quarter. Revenues for the first quarter of 2026 were $23.2 million, a decrease of $12 million or 34% compared to $35.2 million for the comparable prior year quarter ended February 23, 2025. The decrease in revenues was primarily a result of the factors we described during our fourth quarter earnings announcement, and we remain on track to deliver our stated revenue guidance by the end of 2026. Gross profit for the quarter was $4.5 million, a decrease of $5.4 million compared to $9.8 million for the comparable prior year quarter ended February 23, 2025. The $5.4 million decline in gross profit was primarily due to decreased revenues. Selling, general and administrative expenses for the first quarter were $7.9 million, a decrease of $2.1 million or 21% compared to $10 million for the comparable prior year quarter ended February 23, 2025. SG&A decreased by $2.1 million, driven by $1.6 million of lower recurring legal and accounting costs, lower compensation and lower credit losses and $0.5 million of lower nonrecurring expenses primarily related to legacy legal matters. The company recorded a net loss of $15 million and $0.43 of loss per diluted share as compared to a net loss of $14.8 million and $0.42 of loss per diluted share for the comparable prior year quarter ended February 23, 2025. Adjusted EBITDA for the quarter was $1 million, a decrease of $4.7 million compared to $5.7 million for the comparable prior year quarter ended February 23, 2025. The decrease in adjusted EBITDA was primarily due to the decrease in revenues and was partially offset by favorable operating expenses. We are pleased with the company's financial performance during the first quarter and remain on track to achieve the guidance that I reiterated at the beginning of my comments. Today, I'm pleased to report that the first quarter of 2026 represents the sixth consecutive quarter of period-over-period declines in SG&A and R&D expenses. Since initiating our expense reduction initiatives in late 2024, Lifecore's SG&A and R&D expenses have been reduced cumulatively by almost $8 million, including substantial reductions in accounting, consulting and legal expenses. These reductions drove the incremental improvements we recorded in EBITDA margins during 2025. And as reflected in our 2026 guidance, we expect continued reductions to support that trend in the future. I'd now like to turn to liquidity, which has improved significantly since late 2024. We ended the first quarter of 2026 with overall liquidity of approximately $38 million, including approximately $21 million in cash and cash equivalents and approximately $17 million of availability under our revolver. Importantly, the first quarter of 2026 marked our fifth consecutive quarter generating positive cash flow from operations and excluding the registration rights payment in the fourth quarter of last year, represents the fourth consecutive quarter of being free cash flow positive. During the first quarter of 2026, we generated $4.7 million in cash from operations and free cash flow of $3.6 million. We are pleased with the improvements we've been able to achieve since late 2024, and we remain committed to further strengthening our financial standing with continued expense reductions and strategic financial management going forward. This concludes my financial overview. I'll now turn the call back over to Paul for his final comments. Paul?

Thank you, Ryan. During the first quarter, we believe that we continue to demonstrate that we are on the right path. We executed against our growth strategy, supporting our clients as they advance towards commercialization, expanding our capacity and capabilities to meet growing demand and addressing new modalities and aggressively pursuing and winning new business opportunities. In addition, we continue to strengthen our organization by driving efficiencies, improving our cost discipline while maintaining exceptional quality as a foundation that supports everything that we do. We believe we are well positioned to achieve our 2026 objectives and have a clear strategy that we have built and are continuing to make progress that give us every reason to look forward to our midterm goals with great optimism. This concludes our prepared remarks for today. Operator, you may now open the call for questions.

[Operator Instructions] Our first question comes from Michael Petusky with Barrington Research.

Congrats on all the progress related to the contract -- new contracts, et cetera. So Ryan, I guess I wanted to take -- get the sort of the numbers and how that connects to the full year guide. Both the revenue and EBITDA came in sort of meaningfully below what we were expecting. And it just feels like the decline in Q1 was considerably above sort of the -- certainly the run rate of the headwinds that you guys identified last conference call, meaning $12 million down this quarter versus I believe it was something like an $18 million headwind for the full year. Can you sort of help me bridge that and just talk about maybe how this plays for the rest of the year in terms of -- are you expecting sequential revenue growth? Like how -- percentage of revenue in the second half versus first half? Can you just speak to some of that?

Thanks, Michael. So I guess maybe to start with the second part of your question first. And as we communicated on the year-end earnings call, we expect revenue to roughly be in the mid-40% range in the first half of the year and then in the mid-50% range in the second half of the year. So that hasn't changed. I think that it's really just timing or split between Q1 and Q2. So I think in terms of the way that you're looking at some of your models, I think it's basically just pushing that, I guess, miss for Q1 and putting that in Q2. We didn't give specific guidance previously between the breakouts, between Q1 and Q2. But I'd say largely, we're still on track for that mid-40% range in the first half and then mid-50% range in the second half. And I would also say just from an EBITDA perspective that we remain kind of committed to that in terms of roughly split in the 40% range in the first half for adjusted EBITDA and 60% range in the second half. As far as some of the items that we communicated at year-end in terms of the headwinds with regard to one of our customer supply chain initiatives as well as the termination of agreement. I'd say a big part of that is really front-loaded into this year in terms of timing and comparison. So I want to say like 50% of that was roughly in Q1. And I think as we look at the first half of the year, roughly 80% of that impact will be kind of bled through the financials.

Okay. All right. That's super helpful. Okay. So Paul, I guess one of the -- I guess, to me, one of the early indicators in terms of future success for you guys is getting folks to Chaska. Can you just talk about potential customer traffic in Chaska to whatever extent you can? I mean, are you seeing sort of a pickup relative to where it was 6, 12 months ago? Is the quality of the projects that are potentially being looked at increasing? Can you just sort of talk, I guess, to traffic in terms of getting folks to travel to Minnesota and just the potential customers you're talking to?

Michael, thank you for the question. Yes, we're very encouraged and energized by the amount of traffic that we're seeing from potential new customers, not only from a business perspective, but a key or a leading indicator of new business is quality audits. So we have a significant increase in the number of audits that we're seeing from prospective customers. And now we're actually into mid-June before we're able to entertain audits from new customers. So that gives me great optimism. And in fact, we'll have the CEO or U.S. CEO of a large multinational in our site this week talking about new opportunities. So the quality of visitors that we're seeing from -- on the business side is up and the increase in the number of audits are up from prospective customers as well, which give us, again, as leading indicators of new business. they're trending in a positive manner.

Our next question comes from Matt Hewitt with Craig-Hallum Capital Group.

Regarding that pipeline and that increasing pipeline, you noted that the aesthetic win, the tech transfer was because they were looking to onshore manufacturing here in the United States. I'm curious, as you look at your pipeline, as you look at the existing tech transfers as well as those that are in the pipeline, how much of that is a function of the tariffs and the desire to repatriate or to add manufacturing here in the States versus how much of it is because of the market that you serve, the sterile injectables and some of the capacity constraints that, that market is facing globally?

Matt, thanks for the question. I think it's meaningful, certainly not the majority, but I'd say maybe low double digits as it relates to reshoring. So it's a meaningful part of it. The other thing that's really manifested itself, if you don't mind me conflating this answer is there is meaningful FDA enforcement or increase in FDA enforcement or actions that is going on in the industry. So when I think about high quality and maybe some of the situations that our competitors are in with regard to warning letters or FDA enforcement, that has also increased the opportunity for a company like Lifecore, which has a high-quality track record. So as I think about the site transfers, it's not only now the reshoring, but it's also the opportunity to take advantage of the regulatory market because we think that's a strong tailwind based on our quality systems led by Jackie Klecker, our EVP of Quality. So it's exciting times for us, and we're energized moving forward.

That's helpful. I guess maybe just to extrapolate on that a little bit. With some of your peers facing [indiscernible] and in some cases, warning letters, does that create an opportunity for maybe some of these or one of these at least tech transfers to accelerate, meaning instead of having to go through the full 18-plus month process, the FDA recognizes, hey, we're going to be in a shortage situation if we don't address this faster and maybe they help move things along a little bit faster. I think we saw that with some [ bags ] a couple of years ago where they basically knocked down some of the barriers to get product to market faster because of some companies that were having issues.

Thanks for the question, Matt. Certainly, it's a possibility. As I think about one opportunity within our pipeline, there may be that opportunity. But that is something that Lifecore doesn't necessarily control. It's on our -- it's really within the control of our customers as we partner with them on their regulatory strategy. So nothing that we could say today that would point to an acceleration of anything within our pipeline, but certainly something that may become a reality in the future.

Our next question comes from Mac Etoch with Stephens.

This is Hannah on for Mac. HA performance was relatively strong this quarter and carries a higher margin profile for you guys. So were there any production inefficiencies, scrap or other dynamics that you would point to that may have impacted this quarter?

Nothing specifically, Hannah, to call out for the quarter in terms of fermentation production, nothing in particular there. I mean I would say, and maybe just to reiterate a prior comment, we do have good visibility in general to our revenue coverage for the year. I think about 85% -- from an aseptic volume perspective, we have firm POs for. And then I think from an HA side, close to 100% PO coverage for the year, which gives us great confidence in the guidance that we've put out.

That's helpful. And then given demand trends across onshoring GLP-1s, et cetera. How do you view current industry capacity for injectable fill/finish?

Hannah, thanks for the question. I would say this that as it relates to prefilled syringes and cartridges, there still remains opportunity where demand exceeds current available capacity for your traditional vials that where you're supported, whether it's your flu vaccine or COVID vaccine, et cetera. There remains a lot of capacity because of the drop in COVID demand. And we're seeing the majority of our pipeline is in the prefilled syringes and cartridges.

Our next question comes from Max Smock with William Blair.

It's Christine Rains on for Max. Ryan, maybe a question for you. You pointed a pretty significant sequential uptick in Q2 revenue, primarily a result of the timing. And I believe you said that half of the impact from the 3 headwinds you announced last quarter impacted Q1. So very helpful context there. But also, I think you said that 80% of the headwind is expected in 1H. So correct me if I'm wrong here, but it sounds like another outsized roughly 30% headwind will impact Q2. So really hoping you can talk through what the offsets from a timing perspective are there on the positive? And what gives you confidence in the sequential growth next quarter?

Thanks, Christine. Yes, I mean, at this point, right, we have all orders in for the quarter, for the second quarter. So we've got really good visibility to that. And I think at the midpoint of the guidance, it's roughly in the $32 million to $34 million revenue range.

Got it. That's helpful. And then congratulations on the new wins. Hoping you can discuss the potential incremental revenue to 2028 from each of -- I believe there was 3 commercial tech transfers that you announced since last quarter.

Yes, Christine, so the 3 that we signed, we believe that they would generate commercial revenue in the 2028 time frame. And those programs, as we think about those, they would be mid-7-figure opportunities for us.

Great. And then just one last one. Last quarter, you pointed to modest revenue growth expectation for 2027, but talked about how this could be impacted either positively or negatively by timing or outcomes of your customer programs. So now that you have another quarter in your belt, hoping maybe you can put a finer point on this or help us frame out a range of possibilities or even just what the most important levers are that are influencing how this outlook ultimately shapes up?

Yes, Christine. So again, we're not providing guidance for 2027 at this point. Certainly, as we get further in the year, I think we'll see some of those things. I think importantly, when you look at our 30-plus development programs, a number of very key important milestones associated with each of those programs this year, where a lot of those customers are either waiting for clinical results or we're doing some very late-stage manufacturing work. So for example, PPQ batches for those customers, we'll get a better sense of timing of not only of success of those products, what their commercial strategies are that will help inform those outlooks for 2027. And I would also say, right, like we do not have some of the forecast from our customers that go out into 2027 and through 2027 yet. So as those become clear and as we start to inflect on the more than doubling of volumes with our largest customer, we'll be able to provide that additional clarity.

Great. That's helpful. I did try to sneak in a guidance...

Our next question comes from Paul Knight with KeyBanc.

Paul, are you having most success in auto-injector pen or a prefilled syringe?

Prefilled syringe, Paul.

What's driving that?

I think it's a lot of the -- just the trend in health care moving more to the patient and away from the hospital and the clinic. But -- so that seems to be where the majority of the therapeutic modalities are going to moving away from your traditional vials that you have to either go to the hospital or the doctor to -- at every point to get your injection. So I think that's really what's driving it. And that's why I think 50% of the injectable pipeline is -- excuse me, 50% of the U.S. drug pipeline is injectables more taking into the more home health care related is how I see it.

And then with the $45 million, I believe, capacity at your facilities, is that a gating factor for some customers is $45 million adequate?

That's a great question. I think that as I think about it, certainly, if somebody has an immediate -- I'll just make -- give you an example, 100 million unit GLP-1 opportunity, Lifecore is not the immediate partner of choice for that. Now we have optionality to grow into what we call Site 3 to meet those growing needs, if necessary, but there would be timing-related aspects to that. I think where we fit a nice role in this market is for boutique, midsized opportunities where somebody -- there's a level of complexity and technical expertise that's required in development and commercial manufacturing in volumes that range from 5 million to 10 million units of market demand. And we're seeing that. There's just a great growth in our pipeline. And Mark DaFonseca, our Chief Commercial Officer and his team are doing a great job of continuing to expand and build upon our current pipeline.

And within your sales group, any changes in that group?

We continue to optimize and upgrade that group, Paul. We want to ensure that we have the best possible talent in those roles to drive meaningful and impactful opportunities into our site. So we've made some minor changes in -- over the past quarter to continue to upgrade our talent.

Thank you. I would now like to turn the call back over to Paul Josephs for any closing remarks.

Thank you, operator. I wish to thank all of Lifecore's 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 success of our customers. We are very pleased with the progress made during the first quarter of 2026 and look forward to future success in the growth ahead. That concludes our call today. Thank you for participating.

Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.