LFCR - NASDAQ

Good afternoon, and thank you for joining LifeCor's financial 2025 second quarter earnings call. During the call, all participants will be in a listen-only mode. Now, I would like to turn the call over to Stephanie Diaz, Manager of Investor Relations for LifeCor. Please go ahead.

Good afternoon, and thank you for joining us today to discuss Lifecore Biomedical's second quarter fiscal 2025 earnings results. Hosting the call today from Lifecore are Paul Josephs, President and Chief Executive Officer, and Ryan Lake, Chief Financial Officer. Before we begin today, we would like to remind everyone that certain statements made in the course of this conference call contain forward-looking statements. It is important to note that the forward-looking statements made during this call reflect management's judgment and analysis only as of today, January 2, 2025, and the company's actual results could differ materially from those projected in such forward-looking statements. For a more thorough discussion of the risks and uncertainties associated with any forward-looking statements, please see the disclaimer regarding forward-looking statements included in our fiscal 2025 second quarter earnings release, which was furnished to the SEC today on Form 8-K, as well as our other filings with the Securities and Exchange Commission, including but not limited to the company's Form 10-Q for Q2 fiscal 2025, which was filed this afternoon. With that, I would like to turn the call over to Paul Josephs, Chief Executive Officer.

Thank you, Stephanie. Good afternoon, everyone, and thank you for joining our fiscal 2025 second quarter update. The second quarter was a very productive time at Lifecore. Our achievements during this period span finance, operations, and business development, all of which supported our overall growth strategy. Revenues in the period were strong and in line with our fiscal guide. Gross margins were improved during the period as compared to Q1 margins, reflecting greater leverage over our overhead costs across increased revenues and a favorable sales mix. Our business development team was successful in signing multiple new projects. Importantly, our balance sheet was materially strengthened during the period with the combination of the successful completion of our previously announced PIPE financing and the restructuring of our revolving credit facility with BMO on significantly improved terms for Lifecore. I will provide additional details on business development for the period following an overview of our second quarter fiscal 2025 financial results. For that, I will turn the call over to Ryan.

Thank you, Paul. In conjunction with my comments, I would like to recommend that participants refer to our filings with the Securities and Exchange Commission, which we filed today. I will now go over the results for the second quarter and six months ended November 24, 2024, beginning with results for the quarter. Revenues for the three months ended November 24, 2024, were $32.6 million, an increase of 8% compared to $30.2 million for the comparable prior year. The increase in revenues was primarily due to a $1.9 million increase in CDMO revenues, which increased, composed of $3.8 million of higher sales volume from our largest customer, partially offset by $1.9 million of lower sales volume from our other DMO customers. In addition, manufacturing revenues increased primarily from increased revenue from a customer due to timing, which increased shipments in the second quarter of 2025. Gross profit for the three months ended November 24, 2024, was $11.1 million compared to $10 million for the same period last year. The $1.1 million increase in gross profit is primarily due to a $1.6 million increase in CDMO gross profit as a result of price increases to certain customers, partially offset by a $0.5 million decrease in manufacturing gross profit due to manufacturing variances. Selling, general, and administrative expenses for the three months ended November 24, 2024, were $11.1 million compared to $9.3 million for the same period last year. The increase was primarily due to increases in non-cash stock-based compensation expense of $1.8 million, the majority of which was related to the new hire form stock grants to our principal executive officers. For the three months ended November 24, 2024, we recorded a net loss of $6.6 million and $0.25 of loss per diluted share as compared to net income of $14.2 million and $0.39 of income per diluted share for the same period last year, which had included an infrequently large favorable $20.7 million non-cash fair market value adjustment or debt derivative liability associated with our term loan credit facility. Adjusted EBITDA for the three months ended November 24, 2024, was $6.5 million, an increase of $1.1 million compared to $5.4 million in the prior year period. The increase in adjusted EBITDA was primarily due to the increase in gross profit. I will now review results for the first six months of fiscal 2025. Revenues for the six months ended November 24, 2024, were $57.3 million, an increase of 5% compared to $54.7 million for the comparable prior year. The increase in revenues was due to a $2 million increase in manufacturing revenues, primarily due to higher sales volume from our largest customer, and a $0.6 million increase in CDMO revenues, which increased, composed of $3.3 million of higher sales volume from our largest customer, partially offset by $2.6 million. Gross profit for the six months ended November 24, 2024, was $16.5 million compared to $12.7 million for the same period last year. The $3.8 million improvement in gross profit is due to a $5.1 million increase in CDMO gross profit, which reflected a $3.2 million increase due to price increases to certain customers and a $1.9 million increase due to a favorable sales mix, partially offset by a $1 million write-down on existing inventories to their net realized full value and a $0.3 million decrease in manufacturing gross profit due to manufacturing variances. Selling, general, and administrative expenses for the six months ended November 24, 2024, were $25.9 million compared to $18.5 million for the same period last year. The increase was primarily due to a $4.4 million increase in professional fees, including legal fees related to the civil litigation related to the Yucatan Foods and the stockholder act of the settlement. Additionally, non-cash stock-based compensation expense increased by $2.7 million, the majority of which was related to perform stock unit grants to our principal executive officers. For the six months ended November 24, 2024, we recorded a net loss of $22.8 million and $0.76 of loss per diluted share as compared to net income of $3.5 million and $0.10 of income per diluted share for the same period last year, which had included an infrequently large favorable $20.9 million non-cash fair market value adjustment to our debt derivative liability associated with our term loan credit facility. Adjusted EBITDA for the six months ended November 24, 2024, was $4.7 million, a $1.3 million increase from $3.4 million in the prior year period. The increase in adjusted EBITDA was primarily due to the increase in gross profit, partially offset by increased legal and audit costs. During the second quarter, we reported two additional important financial achievements. First, in October, we successfully closed the previously announced $24.3 million PIPE offering with various new and existing shareholders. These funds significantly improved our liquidity position and have allowed management to focus on opportunities to further grow the business. In addition, in late November, we successfully amended and extended our revolving credit facility with BMO. The terms of the amendment provide, amongst other items, a three-year extension as well as a reduction in interest rate that we believe have further strengthened our balance sheet and overall financial position. We are very pleased with our financial performance during the quarter, which was bolstered by a successful PIPE financing and debt restructuring, which we believe helps to position us well for future growth. This concludes my financial overview. For those interested in reviewing our reconciliations of our non-GAAP financial measures, including adjusted EBITDA, please refer to our 8-K filing or earnings release issued today. I will now turn the call back over to Paul for an update on operations and achievements during the period.

Thank you, Ryan. During the second quarter, our company held its first Investor Day webcast where we outlined our plan for growth in the coming years. I am very pleased to report that we believe the achievements during this period position us well to achieve the ambitious goals that we have articulated. As we discussed during our Investor Day, Lifecore has put into action a three-pronged growth strategy that seeks to drive a 12% revenue CAGR and increase EBITDA margins to over 25% over the next few years. This strategy seeks to maximize our existing customer business, advance programs within our development pipeline towards commercialization, and finally, drive new business to our company through expanded business development efforts. Although this growth program is in its early days, progress was made in each arm of the strategy during the second quarter. With respect to the first strategic goal, the company made great progress to maximize our business with our existing customers in both our fermentation and fill-finish operations. During the second quarter, our team worked closely with our customers on their changing supply chain needs to ensure that they have adequate supply to meet their demand. Recently, after working with one of our customers to meet their near-term challenge, a senior executive at a large multinational pharma company said, "Lifecore support is the strength of our business." This comment represents the trust that we are working to establish with every one of our customer base. This brings us to our second area of focus in achieving our growth, which is the advancement of our development pipeline towards commercialization. We continue to maintain ten late-stage programs, all of which have the potential to achieve commercial approval status by 2028. While there is no guarantee that they will each reach the finish line, even a modest subset of this group could generate substantial and impactful growth for the company in the midterm. I will now move to our third area of focus for growth, which is driving new business to our company through expanded business development efforts. We continue to collaborate with our clients and grew our development pipeline by two programs. As we discussed during our Investor Day, we have deployed a new sales strategy to expand our target market, capitalizing on investments we have made in technology, and creating a more agile organization to support our expanding pipeline. As many of you know, in the past, Lifecore was focused only on complex highly viscous formulations. In an effort to achieve significant growth, our new team is committed to expanding its focus to include other products and formulations across multiple modalities. As a result, our BD project pipeline has grown significantly in recent months, with our team working aggressively to qualify and advance more than fifty new opportunities. In addition, with our expanded business development deployment plan, we have seen an increase in the number of large multinational pharmaceutical companies where we are qualifying leads, being evaluated, and progressing opportunities towards closure. We are confident that our expanded team and increased level of activity will result in an expanded and more diverse customer base that we expect will continue to fuel our pipeline with new and impactful programs for years to come. To further support this effort, our company has adopted a team approach to driving new business, including engagement at the highest level of our organization. I have begun working closely with our business development team to strengthen and expand our BD platform and brand awareness across the market. Everyone at Lifecore sells. This is a philosophy at the heart of all we do at Lifecore, and we are committed to meeting the needs of our customers and working hard to position ourselves for new opportunities as our customers' needs arise. As I mentioned earlier, we signed two new project agreements during the period with new customers. These new programs added to our early-stage pipeline. Earlier this month, we announced one of these deals with Nersum Laboratories. Nersum selected Lifecore to provide CDMO services focused on supporting Nersum's clinical development of its lead development candidate NRS-033. NRS-033 is a novel treatment for opioid use disorder and alcohol use disorder. NRS-033, which is wholly owned and internally discovered by Nersum, is currently entering phase two of clinical development. Pursuant to the newly signed agreement, Lifecore will provide Nersum with filled syringes for use in the clinical development of NRS-033. We are excited to add Nersum to our growing list of customers and appreciative that their team has entrusted us to collaborate with them on these activities. Supplementing these efforts, during the second quarter, the company installed a high-speed multipurpose high-five head isolator filler. This filler, which has the capability to fill vials, syringes, and cartridges, has doubled the company's available capacity and increased our revenue-generating capacity to approximately $300 million annually and expanded the range of project opportunities we can support. The isolator technology is state-of-the-art and provides the capabilities and compliance that the world's leading pharmaceutical companies would expect and demand from a leading CDMO business. Finally, during the second quarter, as part of our leadership team transformation, we added significant talent with the appointment of Thomas Goldegger as our Senior Vice President of Operations. An experienced pharmaceutical industry professional with extensive CDMO experience, Thomas brings a strong operations and finance background, which we believe will help him drive operational productivity within our company's performance-driven culture.

In conjunction with his appointment,

Jackie Klecker has been named Executive Vice President of Quality and Development, a newly created position which will take advantage of her leadership and strong regulatory compliance experience to maintain the company's reputation for excellence in this area. This organizational change strategically bifurcates the operations and quality functions, representing a natural but critically important evolution for Lifecore as we embark on our next phase of growth. This will allow us to leverage the strengths of both Thomas and Jackie in advancing our key sustaining objectives of reducing operational expenses and maintaining exceptional quality. In closing, I would like to reemphasize that we are executing against our transformational plan and that significant changes have been made at Lifecore over the past year, ranging from capabilities to leadership to an enhanced commercial strategy. These changes are designed to maximize the great opportunities in front of us to serve a larger segment of the drug development and commercial manufacturing market. In doing so, we believe that we will be best able to serve our existing customers as well as new customers and achieve the aggressive growth objectives that we are targeting, including significantly increased revenues, as well as improved margins and adjusted EBITDA. We are pleased with our progress in the first half of fiscal 2025 and are increasingly confident that our growth strategy and leadership priorities are tracking the company to its first success in the near, mid, and long term. This concludes our prepared remarks for today. Operator, you may now open the call for questions.

Thank you so much. To ask a question, simply press star one one on your telephone and wait for your name to be announced. To remove yourself, press star one one again. Please standby for our first question, please.

And it comes from the line of Matt Hewitt with Craig Hallum Capital Group. Please proceed.

Good afternoon. Congratulations on all the progress in the second quarter. Maybe first up, if we could dig in a little bit on the Nersum opportunity. A couple of different questions here. First and foremost, how did this come into the pipeline? Secondly, as you look at this opportunity, is there any way to size up? I assume that there are some services in addition to the CMO fill-finish services. Are there also some development opportunities with them, and maybe even beyond the current opportunity, do you see other things in their pipeline that you could leverage?

Thanks, Matt. First of all, and happy New Year. Yes, we are excited about the Nersum opportunity. As I think about it and any opportunity that comes in, it really is our BD team working aggressively to identify potential opportunities to drive new business into our organization. So that is how the lead manifested itself. And then from there, although we have signed a limited scope of work to start the program, the thought and the idea is to contemplate ongoing development over the long term through phase two to phase three and then ultimately the commercialization. We will finalize those agreements as development continues down the way, if you will. As it relates to commercial volumes and numbers, we have not yet quantified those with the customer at this point, but we think it will be meaningful.

Got it. That is helpful. Thank you. And then maybe a more broad question, but over the past couple of months, I assume that you have been having lots of conversations with your pharma customers, those existing and potential new customers. What are you hearing from them as they look at fiscal 2025 or calendar year 2025, either from a budgeting perspective or whether or not they are looking at prioritization pipelines? What is the feedback you are getting from the customers, and how can you be a solution to any bottlenecks that they are coming up against? Thank you.

Great question. So, you know, I see ongoing and continued momentum as it relates to development programs and also the opportunity for late-stage site transfers, which may be heretofore Lifecore has not participated in. The other leading indicator that I take some solace in is the growth in our pipeline related to large multinational pharmaceutical companies. It now represents close to thirty-plus percent of the overall pipeline. When I joined the organization, it was less than ten. So it tells me that not only the combination of the momentum in the market but also our hunting business development strategy is leading to what I would say are indicators of potential future success, which we are very optimistic about.

That's great. Thank you.

Thank you. One moment for our next question. It comes from the line of Jacob Johnson with Stevens. Please proceed.

Hey. Good afternoon. Happy New Year to everybody. Maybe, Paul, sticking on the business development front, you alluded to, I think, maybe trying to win some late-stage customers. I guess, thinking about the fill-finish capacity you have and some of the dynamics in that end market, is it possible for you to go after a commercial tech transfer project? Obviously, it is good to see the early-stage wins, so I am just curious about the opportunities on maybe later-stage or commercial opportunities for fill-finish.

Jacob, thanks for the question, and happy New Year. One hundred percent, I think that is certainly part of our strategy. What I think I may have articulated to you or to others is we want to be strategically positioned to take advantage of late-stage or commercial site transfers, of which we have had now significant opportunities enter our pipeline. So we are working aggressively to close those. We want to be positioned and be top of mind within our customer's mind when those needs arise. That is what we are working hard to do with our expanded business development team. But certainly, we have meaningful ones in our pipeline that we are working on today.

Got it. Thanks for that, Paul. And then maybe for Ryan, just on the margin side of things, obviously, nice top-line beat that flowed through to solid gross margin outperformance, at least versus direct certifications. I am just curious, how should we think about gross margins trending throughout the rest of the year? Is there any kind of benefit from the timing in the quarter that we need to be cognizant of? And I guess the other kind of use of this is the new five-head filler. Is there any impact on gross margin that we need to take into account there?

Thanks, Jacob. So as we have mentioned previously, we have some great opportunities to continue to improve gross margins and adjusted EBITDA as well over time. Sequentially, the primary improvements in the Q2 margins were driven by higher revenues, favorable sales mix, and favorable absorption of overhead costs coupled with lower operating supplies and headcount expenses. We still expect overall margins for the year to be in the low thirty percent range. With the improvement in Q2, I think that makes the gross profit split roughly in the forty percent range in the first half and improving to approximately sixty percent in the second half. I do not think that you will see anything dramatic this year as it relates to the five-head filler in terms of improvement in margins. But as we look out to the future, it is certainly one of the areas where we do expect, as revenues continue to grow in future years, that we are going to continue to experience increased leverage of our overhead costs over greater revenues.

Okay. Thanks, Matt. Anything else we...

Yeah. Go ahead, Paul. Sorry.

I am sorry. I would just add, some of the things that are maybe not revenue-dependent, we are working very hard at. Spending a lot of time on scheduling labor utilization, we want to ensure that we have an efficient indirect and SG&A structure. Those things will positively affect margins over time. Not all of that will manifest itself this year, but those are areas where we are spending significant time and focus on building this organization.

Got it. Thanks for that, Paul. And if I could just sneak in one kind of clerical question. You guys reiterated EBITDA guidance for the year in the press release. I do not think I heard any update on the revenue outlook. Any change in thinking to, I think, the $126.5 to $130 million range for the year?

No changes in the top-line revenue guidance.

Okay. Thank you, Ryan. Appreciate it, guys.

Thank you. One moment for our next question. It comes from the line of Michael Petusky with Barrington Research. Please proceed.

Hey. Good afternoon, guys. A lot is going on. Hey. So let me start real quick with housekeeping. I have not seen the Q hit yet. And, Ryan, I am just curious because I know your debt calculation is a little bit funky, and I think you have to have the debt discount figure to sort of figure out total debt. Can you either give that figure or the total debt figure as of the end of the quarter by any chance?

It should be filed, Michael, but I believe that the total debt figure is around $160 million.

Okay. So in terms of the quarter, the quarter really looks strong, including the adjusted EBITDA. Ryan, did you say that there was some, in addition to favorable mix, that there was some favorable timing that impacted that? I am just curious because I would have honestly, with the historical seasonality of this business, particularly, you know, second half and particularly the fourth quarter, I would have expected you to take EBITDA guidance up unless you felt like there was some, I guess, pull forward in Q2.

Yeah, I mean, we did see some early fulfillment of some orders in the quarter, which is just timing between the quarters. And you are correct. I did mention an improvement in the overall mix of that revenue for the quarter.

Okay. So, I mean, can you by any chance quantify the pull forward? I think it was a few million more than what we had originally anticipated. And how did that flow to EBITDA?

I do not have the specifics of that.

Oh, okay. Okay. Alright. Fair enough. So, hey, Paul, in terms of, you know, now you have been in the chair for a bit. I am just curious about early learnings, conversations with multinationals. Is there anything like, is this sort of, you know, you have talked about the sales cycle for some of these types of conversations maybe being six to eighteen months. I mean, has anything changed in your thinking on that? Have you learned anything about how Lifecore is viewed in terms of the space? Is there more education required in terms of your new capabilities? Can you just talk about early learnings, I guess? Thanks.

Great question, Michael, thank you, and happy New Year. You know, I would say this, that there is a level of ignorance as it related to knowledge about Lifecore. I will say our capabilities are certainly well known for our capabilities in fermentation. But really, the great opportunity is to expand that and open the aperture to our sterile fill-finish capabilities, and I think that has been welcomed greatly by our potential customers. This is directly related to the growth in, I will say, large multinational programs within our BD pipeline and the level of customer visits to Chaska that are planned in the future and that have taken place in the past. So, again, I am optimistic about the opportunity we have based on the early learnings and experience that I have had in the early days.

Okay. Great. And just one quick clarification. I just want to absolutely make sure I heard this right. Did you say, Paul, that you have roughly fifty-ish new opportunities in the pipeline and thirty percent of which involve large multinationals?

Yes, sir. Yes, sir.

Fantastic. Thanks, guys. I really appreciate it.

Thanks. Take care. Thank you. And this concludes our Q&A session, and I will pass the call back to Paul Josephs for closing comments.

Thank you, operator. In closing, again, happy New Year to everyone. I wish to thank our investors who continue to support our growth strategy for the future. I wish to acknowledge our customers and collaborators and our board who continue to entrust Lifecore as a partner of choice. Importantly, I wish to extend my gratitude to our incredibly hardworking and talented team for driving each of the successes at Lifecore. With the support of each of these stakeholders, with our strategic priorities clear and achievable, we believe we are well-positioned to achieve growth and sustainable profitability in the coming years. Thank you very much. That concludes our call today.