Good morning, and thank you for joining Landec's fiscal 2023 first quarter earnings call. During the presentation, all participants will be in a listen-only mode. Afterwards, we will conduct a question-and-answer session. At that time, I will provide instructions on how to ask a question. Now I would like to turn the call over to Jeff Sonnek, Investor Relations at ICR. Thank you. Please go ahead.
Good morning, and thank you for joining us today to discuss Landec Corporation's first quarter fiscal 2023 earnings results. On the call today from the company are Jim Hall, Chief Executive Officer and President of Lifecore, and John Morberg, Chief Financial Officer. Before we begin today, you should have received a copy of our earnings release, which is also available on the company's website, where we also post our investor presentation.
In addition, we'd like to remind everyone of the Safe Harbor statement. Certain statements made in the course of this conference call contain forward-looking statements. It is important to note that the company's actual results could differ materially from those projected in such forward-looking statements.
Additional information concerning risk factors that could cause actual results to differ materially from those in the forward-looking statements is contained from time to time in the company's filings with the SEC, including, but not limited to, the company's Form 10-K for fiscal year 2022. Copies of those filings may be obtained from the company's website. With that, I'd like to turn the call over to Jim Hall, Chief Executive Officer.
Thank you, Jeff. Good morning, everyone, and thank you for joining us. I'll begin today with a brief update on our strategic initiative that we unveiled just eight weeks ago to transform the focus of the company to a standalone Lifecore business. In terms of the formal timing of the transition to the Lifecore corporate branding and ticker switch, we are working through those legal processes and are targeting November for the formal change.
When we have a greater precision, we will be sure to update the market accordingly so everyone is prepared. With respect to our efforts to monetize the remaining Curation Foods assets, those activities are well underway. However, we are not in a position yet to communicate any potential outcomes. That said, I want to continue to emphasize the importance of this work by our team and our commitment to getting this done as soon as possible.
With that, I'll provide a summary of Lifecore's fiscal 2023 first quarter performance, provide some additional updates on our business and commercial efforts, and then pass the call to John to discuss the financials and the fiscal 2023 outlook, which we are reiterating today. In the fiscal 2023 first quarter, Lifecore grew revenue by 8% to $23.7 million, generating an increase of 8.1% in Adjusted EBITDA to $2.5 million, both of which were consistent with our plan and the cadence that we disclosed at the beginning of the fiscal year.
As a reminder, the first quarter is our seasonally lowest quarter of the year in terms of revenues and EBITDA due to the idling of our manufacturing lines for annual required clean room certification and facility maintenance.
Nonetheless, we're off to a solid start for the year and remain excited about the business development activity that we are generating, which I'll cover in a moment. Our business remains very well-positioned as a fully integrated CDMO with highly differentiated capabilities for the development, fill and finish of complex, sterile, injectable-grade pharmaceutical products.
These technical capabilities have been honed from our more than 40 years of experience in building a premier pharmaceutical injectable-grade hyaluronic acid manufacturing platform with a focus on complex and highly regulated products.
Our unique expertise, coupled with the ongoing industry trends towards outsourcing of new drug development, means Lifecore is ideally positioned as a preferred partner to provide CDMO services for new injectable drug applications. In fact, Lifecore is the only manufacturer of pharmaceutical injectable-grade HA with injectable CDMO expertise in the market today.
Approximately 55% of all new drug applications are injectables, and prefilled syringe demand is growing at an estimated 13% compound annual rate. Given the industry's limited injectable drug manufacturing capacity, we will continue to take full advantage of this incredible opportunity and deliver much-needed capacity that we've been investing in during the past few years.
On the development front, our project portfolio remains robust with 24 active projects from 21 different customers. These 24 projects are dispersed across various stages of our portfolio as follows. Early phase clinical development with five projects, Phase 1 and 2 clinical development with 11 projects, and Phase 3 clinical development and scale-up commercial validation activity with eight projects. We continue to work closely with all of our customers in progressing their products through the various stages of development and eventual FDA approval. These efforts are now paying off.
Three of the late-phase projects are nearing FDA approval. One is a drug with a PDUFA date before the end of calendar 2022, and the other two are medical device programs, both of which have anticipated approvals within this calendar year. As I mentioned last quarter, we are preparing for pre-approval inspections to support these projects and are working closely with these customers to support their product launch plans.
As it pertains to the forecasted value of the projects in our active portfolio, we currently believe the revenue potential from the development activity is in the range of $50 million-$80 million in development revenue over the life cycle of the projects, which we expect will continue to grow as we expand our active development project portfolio.
Looking at the potential commercial value for the eight late-stage projects in our active portfolio, we believe that the commercial revenue opportunity is in the range of $45 million-$120 million annually as these products receive FDA approval and are successfully transferred to contracted commercial supply agreements.
CDMO activities represented nearly 80% of our revenue mix this past fiscal year, 2022, with the balance of our revenue generated from HA raw material sales. HA remains a critical component of our business and is the foundation by which we've developed our CDMO expertise in complex and highly viscous products over the past 40 years. Approximately 50% of the revenue produced in our CDMO business is generated from products utilizing HA, and within our current active project portfolio, that mix is approximately 70%.
HA is viewed as an ideal excipient for injectable therapies in that it is a naturally occurring substance in the human body, and its highly viscous characteristics allow for optimized targeted drug development. Thus, we continue to see a meaningful activity among the biopharma community in utilizing HA, and nearly 40% of our prospective project opportunities are utilizing HA, which is a good segue to updating you on our commercial strategy to convert new potential engagements.
We now have the complete team in place that we set out to establish from our investments in people that we announced last year. Our team is doing an impressive job ramping up our commercial presence in the market, and we are seeing immediate returns on our investment in people, which spans marketing, sales, business operations, and process development.
In the fiscal first quarter, we added 14 new prospective opportunities to our development opportunity funnel for a total of 63 projects that are in various stages of diligence and discussion. These opportunities span multiple end markets, classes of drugs and medical devices, and with an assortment of companies, both large and small, which we believe speaks to the attractive CDMO capabilities within Lifecore's growing expertise that the pharma industry is actively seeking in a CDMO partner.
While the number of potential projects will shift over time as we convert some and dismiss others, we aren't seeing any slowdown in the number of opportunities. On the contrary, we continue to believe that our expanded commercial strategy will support an increasing trend well into the future. On the operational front, our company continues to prepare for a multi-year acceleration of growth.
As I mentioned, it is imperative that we continue to push our organization forward with the implementation of best practices and new capabilities. Our team is in place, and they are diligently working to raise our profile. We've bolstered our marketing approach, which is supported by enhanced branding, awareness, and greater reach to communicate Lifecore's differentiated capability to the market.
Last fiscal year, we made great advancements in optimizing our facilities in anticipation of adding new capacity in the coming years. With this complete, we are now focused on creating operational efficiencies across the entire company. We are modernizing systems and automating wherever possible. For instance, our Laboratory Information Management System, or LIMS, has been integrated, and we've qualified our first product on LIMS in late June, with a series of other products transitioning to LIMS in the coming months.
This platform provides rapid visibility to data and enhanced analytics that replaces manual and inefficient processes. We are also isolating additional areas of savings and efficiency through our focus on pharmaceutical elegance. These opportunities include enhancing our sustainability and energy management, our supply chain, and working capital requirements.
Further, our team is laser-focused on resource planning across our entire organization to prepare us to add new manufacturing lines and shifts, and to do so with an efficient workforce as capacity and demand requires. In fact, we just recently added an additional weekend shift to support increased manufacturing activity across our organization.
While there is always more to do, Lifecore is very well prepared for our anticipated robust growth. Looking ahead, our future expansion continues to be driven by our strong development project portfolio, expansion of our prospective development pipeline, and conversion of these projects into our active development portfolio.
We remain focused on driving towards a multi-year acceleration of annual revenue growth into the mid to high teens based upon our current project portfolio characteristics and favorable industry tailwinds. While we continue to concentrate on maximizing the revenue-generating capacity of our current infrastructure, we also must balance the known future capacity requirements within our project portfolio with the multi-year lead times on the specialized equipment that is manufactured to our specifications and must also undergo rigorous testing, customer acceptance and regulatory approval.
Our four decades of experience in creating a world-class quality management system provides us the confidence to directly meet these challenges as we plan to deliver this multi-year acceleration in our revenue growth trajectory, which is supported by known projects within our existing project portfolio and will be further enhanced by new opportunities with the prospective projects in our development pipeline.
Now, I would like to turn the call to John for his financial review.
Thank you, Jim. I'll start with a review of Lifecore's financial performance and our fiscal 2023 outlook before shifting to some updates around the financial aspects of the transition plan that we shared in August. Our first quarter is our seasonally lowest quarter in terms of revenues. This seasonality results from idling our manufacturing lines for annual required clean room certification and facility maintenance.
This slows shipment volumes and causes first quarter to be our lightest quarter of the year. For the first quarter of fiscal 2023, Lifecore total revenues increased 8% to $23.7 million, consistent with our expectation for the first quarter growth to be in the single-digit range. This growth was driven by a 31% increase in our HA raw material manufacturing business and a 3% increase in our CDMO business.
The increase in the HA business is primarily due to reduced shipments in the prior year period due to excess channel inventory during the global pandemic and its impact on elective procedures. Lifecore gross profit increased 6% to $6.1 million for the first quarter of 2023, representing a gross margin of 25.7%, which compares to 26.3% in the prior year period.
The 60 basis point variance versus prior year was primarily due to higher depreciation, partially offset by improved revenue mix. Lifecore Adjusted EBITDA increased 8.1% to $2.5 million for the first quarter of 2023, with an Adjusted EBITDA margin of 10.4%, which was consistent with the prior year.
Shifting to our fiscal 2023 outlook for our Lifecore segment, we are reiterating revenue guidance in the range of $122 million-$126 million, which implies growth in the range of 12%-15%, and Adjusted EBITDA guidance in the range of $31 million-$32.5 million, which implies growth in the range of 7%-12%.
While we are no longer providing formal guidance on our Curation Foods segment due to our strategic actions to monetize those remaining assets, for modeling purposes, we are assuming no contribution from Curation Foods for the full fiscal year. Additionally, we are reiterating our full year guidance for our other segment, which reflects the ongoing corporate costs of the organization, which we continue to expect in the range of $7 million-$7.5 million.
On this point, I'd remind everyone that while our intent is to formally transition to Lifecore, our organization is in the process of establishing the corporate infrastructure that we carry at Landec. As this transition progresses, we will be making those changes. In the near term, we think it's most appropriate to expect those expenses to continue.
Longer term, we believe there will be some modest savings as we manage the smaller and less complex Lifecore organization. On a consolidated basis, we expect Adjusted EBITDA net of corporate costs and assuming no contribution from Curation Foods, to be in the range of $23.5 million-$25.5 million for the full year fiscal 2023. With respect to Lifecore, there are a few modeling considerations of note.
We continue to anticipate gross margins to decline by approximately 100 basis points in fiscal 2023 to approximately 39%, which is very consistent with fiscal year 2020 and fiscal year 2021 performance. This is due to an expected mix shift towards higher commercial revenues, which on a relative basis, have lower margins than our other revenue streams.
Additionally, we will continue to invest in the sales and marketing functions as we drive an acceleration of top line growth, taking advantage of the favorable industry tailwinds. As a result, we anticipate a similar to slightly higher level of operating expenses versus prior year.
Perhaps by approximately 50 basis points as a percentage of revenues for the full year. In terms of Lifecore's quarterly cadence, we continue to expect sequential revenue growth from first to second quarter and second to third quarter, and then similar revenue in both third and fourth quarters. As a reminder, third quarter of fiscal 2022 revenues were higher than expected due to shipment timing.
Therefore, we would expect this year's third quarter to be approximately flat with the prior year. Adjusted EBITDA is expected to increase sequentially from the first through the third quarters, but then flatten out in fiscal fourth quarter, which is expected to be similar in size to that of the third quarter. Now turning to Landec balance sheet, which still reflects our remaining Curation Foods assets and liabilities, and the impact of the segment's cash flows.
Net bank debt on a reported basis for the fiscal quarter ended August 28, 2022 was $138.3 million, which was essentially flat with the net bank debt at the end of fiscal 2022 of $136.5 million. In fiscal 2023 first quarter, Lifecore spent $2.9 million in capital expenditures, which is consistent with our fiscal year 2023 CapEx guidance of $34 million-$38 million, which is earmarked for two multi-use isolator fillers in the associated formulation and process support equipment, which will be ready for acceptance testing next summer. As a reminder, included in this estimate is approximately $3.4 million of CapEx carryover from fiscal 2022.
This keeps us on track to expand our operational filling capacity from our current 10 million units to 22 million units and beyond to meet expected growth and capacity demand, driven by projected growth in our base commercial business and commercialization of products in the late phases of development in our active project portfolio. With that operator, please open the call for questions.
Thank you. The floor is now open for questions. If you would like to ask a question, please press star one on your telephone keypad at this time. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Again, that's star one to register a question at this time. The first question is coming from Jacob Johnson of Stephens. Please go ahead.
Hey, good morning, Jim and John. Congrats on a nice start to the year at Lifecore. Maybe kicking off with a higher-level question. Jim, you talked a little bit about the state of the fill finish market, but maybe just to flesh it out some more, can you just talk about kinda where fill finish supply and demand is for the industry? It sounds like capacity is still tight there. Just a follow-up there, maybe just a couple of comments on how you differentiate yourself versus other fill finish providers.
Sure. Good morning, Jacob. Listen, based on the activity that we see coming in from the field and what we're hearing from our sales people out on the streets, I think you can see there's no end in the opportunities that are coming our way. We increased our opportunities that we're evaluating by 14 projects, and I know there's more knocking on the door. I think a lot of that is based on our ability to provide capacity.
People know that we have additional capacity coming on board over the next couple of years, which also says there isn't a lot of unused capacity out there. People are looking for it, right? That's part of it. The other part is, you know, the niche that we provide and the complex formulations of products and the fact that Lifecore has the HA manufacturing capability and the importance of that HA to our business that I discussed earlier in the call also plays into it because a big chunk of what's coming our way contains HA and which answers part of your question on the differentiation of Lifecore.
You hear people talking about reduced funding in biotech projects. I think that's probably true. I think in our experience though, what's not getting funded is earlier phase projects that you know would probably wouldn't be funded in a typical situation except that there was a lot of funding available out there. We're not seeing a slowdown.
Far from it. We still see the limited capacity out there that's helping drive the additional opportunities for Lifecore. You know, listen, the work we've done to put the organization in place from a targeted marketing and sales approach is really starting to pay off. And now the focus is on converting those opportunities into active projects to continue to drive things moving forward.
Got it. Thanks for that, Jim. That segues to my next question. You know, you've got this kinda funnel of 63 projects and people you're talking to there. Can you just talk about how selective you are in terms of who you work with and that kinda decision-making process as you take those leads and then kinda convert them into the development pipeline?
Yeah, sure. Listen, Lifecore's got a very experienced, and amazing team that's got a lot of industry experience, and really has a lot of experience and works hard to evaluate and identify low probability projects and tries to eliminate those sooner rather than later. Really, it's one of our core competencies that's been driven by our 40 years of experience trying to identify what we should and shouldn't work with.
What really sparked that is, historically, Lifecore didn't have a lot of capacity, and we wanted to make sure we picked the right projects that had a high probability of success, to get there. That's really, you know, what we bank on as we pick and work through the ideas to get through the funnel.
The other thing is we're spending a lot of time on our new marketing effort, getting Lifecore's unique capabilities out to the marketplace. For the first time ever, we've, you know, upgraded our website, doing Google ads, updating our social media content, enhancing our trade show presence. Really what's more important is we're paying attention to what that's telling us and where we need to go target to get more opportunities into the pipeline.
There's still more work to do there. The opportunities are showing up now. It's a matter of getting them onboarded as quickly as possible, and that's what we're doing now with the organization to make sure we're set up and can get these things onboarded. Because several are out for proposal and, you know, it's just a matter of working it through the process.
Got it. Just last one from me. Jim, you mentioned, I think, some kinda operational initiatives. I think last quarter you talked a little bit about Lifecore University and I think a bunch of Lean and Six Sigma people who've been kinda educated on those. Can you just talk about the key areas for operational improvements? If John wants to chime in on how we should think about that from a financial perspective, that'd be great too.
Yeah, sure, Jacob. It's actually across the entire organization and impacts every corner of the company, right? Obviously we wanna optimize and get the most out of our processes as we can. We look for efficiencies, and there's a lot of lean projects centered around that. As well as, you know, our business operations processing to help get things identified and onboarded, and making sure that the organization's set up not only from a project management and business op standpoint, but from a development and manufacturing standpoint to support the increased manufacturing capacity.
LIMS is another example, our laboratory information management system, to allow us to manage data and look at it quicker and get it out to our partners quicker as well. It's across the entire organization and something that is ingrained in our culture at Lifecore. One of the reasons, you know, that we implemented what we call Lifecore University is to get people onboarded, our employees onboarded and operational as quickly as possible. You have anything you wanna add?
Hey, Jacob, from a financial perspective, really, you know, impacts two areas, our gross profit margins and operating leverage and operating expenses. All these things that Jim's talking about are, you know, we wanna be able to keep our gross profit margin in that high 30s%-low 40s%. Secondly, over time, leverage the operating expense to drive EBITDA margins. That's where we're very focused on these efforts.
Got it. Thanks for that, John and Jim. Thanks for taking the questions.
Thanks, Jacob.
Thanks, Jacob.
Once again, ladies and gentlemen, that is star one if you would like to register a question at this time. The next question is coming from Mark Smith of Lake Street Capital Markets. Please go ahead.
Hi, guys. Just wanted to look at the pipeline, just a little bit more. Can you just talk about kinda conversion from prospects into projects? Kind of generally how you feel about your pipeline and then really that conversion process.
Sure. Good morning, Mark. Obviously, we have a lot of things in the pipeline that we're analyzing, 63 that we're in discussion with now. The way we look at those is how they run through the funnel, is what converts to leads. Then we monitor qualified leads, and then they get to the proposal stage. Not all of them are gonna make it into that process.
We have a lot of experience and a pretty good set of criteria we look at to gauge opportunities before we would even consider them part of that funnel or part of the 63 projects. I don't have a set percentage of how many of those will be onboarded over the next period of time.
A lot of it depends on, you know, what phase they're in and how it fits into our niche of capabilities. Our track record and historical rate is pretty high. Will that continue as more come through? It's our intent to have as many of those come through as we can. It's difficult to judge how many of those. The one thing I can tell you is the majority of those 63, you know, fit what we look for. Now it's just gonna be, you know, picking the best ones that utilize our skill set and we can provide the most value to.
Okay. Then a couple kinda model questions maybe for John. Just cadence of the revenue guidance. You know, it sounds like you guys are looking for, you know, a really solid growth here in Q2. You know, is some of that just a function of seasonality and then just how well, you know, Q3 was, how solid Q3 was last year that really drives that higher year-over-year growth here in Q2?
Yeah. Mark, I think what we're really seeing is the back half of the year is probably where the biggest, you know, growth is gonna be occurring. Again, it's just kind of a, the lineup of projects that are out there and a timing of orders from customers. We actually see, you know, a bigger growth in the back half of the year. Not dissimilar than last year actually as well.
Okay. Similarly, just as we think about CapEx, you know, very little spend here in Q1, these projects that are coming online, what's kind of the cadence or expected timing of this larger spend in CapEx this year?
Yeah. I'll start, and I'll ask John to weigh in a little bit as well. Listen, Lifecore works very hard to be good stewards of our capital. This is a timing and within what we expected Q1 will be, and really focuses on, you know, progress payments for a lot of the capacity-related spend we have. It's obviously gonna pick up through the rest of the year.
We're still maintaining the spend guidance that we gave earlier. Nothing really to call out here other than this is the timing. Q1 was light as we projected and, you know, Lifecore is gonna do whatever it can to manage the spend and not spend until we need to.
Yeah. The only thing else to add to that is that, you know, most of our CapEx, you know, or 85% of it is, you know, growth related and primarily focused on the filler isolator equipment, and which we hope to arrive next summer. As a result, it just kind of pushes a lot of the progress payments, you know, later into the year or the back half of the year.
Okay. Great. Thank you, guys.
Thanks, Mark.
Thank you. The next question is coming from Mike Petusky of Barrington Research. Please go ahead.
Hey, good morning. That actually was a perfect lead into the question I wanted to ask. One of the questions I get, you know, most about Landec is CapEx and, you know, in terms of sort of a longer term normalized CapEx. Can you guys. You know, you sort of alluded to a lot of the current year spend being growth capital. Could you guys just speak to what's a normalized figure or a normalized range after you sort of get through, you know, what I think is a period of elevated investment?
Yeah. John, you wanna take that?
Yeah. Hey, hey, Mike. Good morning. How are you?
Hey, good.
I think as we've shared a few times, you know, we've had our CapEx needs, you know, could be somewhat lumpy and not necessarily perfectly linear. We certainly are looking at our capacity needs and we need to place orders for, you know, filling equipment. The couple of years it takes to get it here, and then you've got time to get it validated before it starts, you know, really earning some revenue.
That's a big part of what we look at from a CapEx perspective. Primarily, I would say that our CapEx is gonna be growth focused. We should be 85%+ of our CapEx spend is always gonna be focused on that and not focused on maintenance CapEx.
You know, the other part is you can see that we're transitioning to really a growth company. You know, we intend to really, at least the next couple of years, is to reinvest, you know, our EBITDA at Lifecore back into CapEx, because we're really focused in on is growing our EBITDA out into the future. We think with these investments, you know, the annual increase in EBITDA is very worthwhile.
We think this, you know, $34 million-$38 million, for instance, ought to be able to generate, you know, an additional $5 million-$10 million of EBITDA on an annual basis. As a result, that turns into a very nice ROI when you look at, you know, valuation multiples in the CDMO space.
Is it then fair to say that maybe this really isn't an elevated range going forward, maybe this is more of like a normal range going forward?
Yeah. Just, you know, we just, you know, not in a position yet today to probably give, you know, guidance on that other than what we're giving guidance on for this year. Again, I again would think that we would be trying to reinvest for the most part, our EBITDA back into CapEx going forward. By the way, once you get through a couple of years of that, you know, you eventually turn around to a, you know, pretty nice free cash flowing, you know, business. In the short term here, the focus is on being a growth company.
I know you don't wanna comment a lot about the Curation assets, but is there an expectation that sort of process of monetization will be complete either by calendar year-end or fiscal year-end? I mean, can you know, sort of speak to that?
Yeah, sure. I mean, the first thing is we said, you know, obviously, we're in a process, you know, to sell those off. When we say that, by virtue of being in the process, you know, we've hired the appropriate advisors to help represent our interests.
They're very much underway. You know, we've kinda created our own, you know, Jim and I, our own self-imposed goal of a sale by year-end. You know, what I hope you take away from that though, is that we're really committed to making something happen, but we're also realistic as to the amount of time things like this take.
You know, we do appreciate our shareholders who would like to see this done quickly, and we're aligned with that completely. But we've been working through projects really in the midst of unprecedented circumstances between the pandemic, extreme inflation, labor shortages, and all those variables really complicate this exercise already, which we've done each time for each asset that we've had to sell.
I will say we are focused on it, work on it every day, and we know this is important for this company and we intend to get it done as quickly as we can, and we'll update obviously the market as soon as we are able to.
Okay. All right, great. I just wanted to confirm that I heard one thing I think that Jim said earlier. PDUFA date before the end of the year and two devices likely approved before the end of the calendar year, correct?
That's correct, Mike.
Okay. Awesome. Thanks, guys. Really appreciate it.
Thanks, Mike. Talk soon.
Thank you. Our final question today is gonna be coming from Mitch Pinheiro of Sturdivant & Company . Please go ahead.
Yeah. Hi. Good morning.
Morning, Mitch.
Hey, one thing I wanna understand, you talk about tight capacity in the syringe fill finish area in the industry. You know, isn't that capacity kinda constrained company to company where, you know, new drugs, new therapies are, you know, the manufacturer is sort of already embedded into that process at the beginning.
I'm not sure why there's a lack of capacity that you can take advantage of in any immediate sense. Wouldn't you have to go through the whole FDA process again to get approved into that new therapy? Could you talk about that a little bit?
Yeah, Mitch, I think where you're a little bit confused. I'll clarify your last part of your question. If somebody is gonna transition from an already approved CDMO to another one, that would require, you know, the qualification at the approval, the whole process again. What we're finding, there's a lot of drug development going on, and the majority of that is being outsourced.
What we're seeing is people trying to identify CDMOs that have capacity that can build with them in the future. They have a product platform, several products. They project what kind of capacity they're gonna need for the next, you know, two, three, four or five years, and try to lock that up with somebody that's got the ability to grow with them.
That is part of the qualification process for a drug would be an NDA, where Lifecore, in this case, would be qualified as they develop the product and process. A lot of the things in our pipeline are companies looking for that capacity, and who has capacity available, and to lock that up for what they see as their future demand.
When you talk about your own capacity as you expand it, so that capacity that you are building over the next couple of years here, I had thought it was mostly earmarked to people, you know, to companies that you're already connected with. Is that, A, true? And B, if not, are you, I mean, are we gonna see a ramp-up in CapEx to further expand your theoretical capacity?
Right. You're right that we have a good chunk of that capacity earmarked with things we're already working on. We also know and are planning additional capacity above and beyond what we think we're gonna need, because in the world of an injectable-grade CDMO, you need capacity to continue to grow and expand, and that's what we're planning on.
Not all of the capacity we're planning is taken up. We're trying to sell additional capacity. At some point down the road, Lifecore will need to expand beyond the two additional fill lines. We've talked about that. We're constantly evaluating what kind of capacity we think we'll need to support that pipeline, and we'll make sure the investment aligns when the time is right to make sure we have that capacity moving forward.
I wouldn't say there's gonna be a ramp-up in capital spend. I think we just need to evaluate when we need it. Like we've talked about, Mitch, you know, it's a 3+ year timeline to get a fill line in place now. The art of this is determining what kind of capacity you need and making that investment early enough. The other thing we're seeing, like I just mentioned, from our people out in the field is that there are people looking for future capacity and willing to help invest in that, and that's something we're looking at as well.
Yeah. I mean, you know, I mean, you know, it must be difficult to, I mean, you know, to sort of figure out your capacity needs as, you know, most of those 24 projects in your pipeline, you know, just by definition of, you know, of drug approval, you know, most of those will fail. So how to know what your capacity is, your capacity needs will be against the prospects of successful, you know, drug development, I mean, it seems to be quite a challenge.
It is a challenge, and you're right, not everything will make it through. It's why we, you know, once things make it into the late phase and we start to see some successful data coming out of phase three trials, we have a little more assurance that, you know, it typically is not a matter of if, but a matter of when an approval will happen.
Not everything will make it through, even though it's in its Phase 3 trial. The other thing is, you know, not everything and that's why we pay attention to the late phase and the eight projects that are really driving, you know, the next three to four years of commercial capacity requirement.
The other game and thing we need to model, and we pay a lot of attention to, is how much, you know, a clinical capacity we'll need to support that portfolio as it moves forward. Qualification batches, validation batches, that kind of thing. It's not all a commercial volume puzzle. Listen, our team does a phenomenal job working through this and understanding and working with our partners of what is expected as they move through and as we move to the commercial contract that we have, what we need in place to support them.
Okay. One more question, and it just concerns leverage. You know, you're a growth company, but a growth company with high leverage, you know, is obviously less attractive than perhaps the alternative. You know, we're here at 5x leverage.
I know that there's gonna be some asset sales down the road, but as you come out of that, I mean, the asset sales sort of have to play into your capital spending plans for Lifecore. I mean, you don't wanna emerge as, you know, Lifecore Biomedical with a highly leveraged balance sheet because you can't get the asset sale, you know, pricing that you want. How do you think about that?
Are you confident that you can, you know, that your asset sales will be enough to keep yourself at a, whatever you deem as reasonable leverage? Or, does that slow down your capital spending plans? Can you talk about that a little bit?
Yeah. You know, obviously, you know, improving our capital structure, it's been a common thread behind Project SWIFT and, you know, since we introduced it, you know, a couple of years ago. It's no secret that it's unsustainable, the leverage level that we have, and hence the hard work to preserve cash, optimize our assets, and extract value.
As you've seen, we've directly redeployed that cash towards debt retirement, and we've been consistent in our intent to improve the balance sheet. You know, while I'm not in a position to provide you a forecast of what standalone leverage will be, you know, suffice it to say, you know, we wanna improve it, you know, going forward.
We're gonna do it in two ways, you know, continuing to sell off assets to improve the balance sheet with our EBITDA growth will also really help to de-lever the business. You know, we are constantly in great communication with our banks, always looking for, you know, what's the next, you know, bank deal we could do going forward once we're a standalone Lifecore business. We still believe that there's a great way forward for us to make this make our growth plans work.
I know, you know, as you look forward, I mean, is there a leverage target that you think Lifecore Biomedical can operate comfortably? Is it three times? Is it two times? Any idea?
I mean, you know, my personal sense is I'd love to be in the 3x range. We recognize for a short period of time, we might have to be above that. Ultimately, we think we can be, you know, more comfortably in that type of range. We look, you know, kind of mid-range timeframes.
Okay. All right. Very helpful. Thank you, guys.
Thanks, Mitch.
Thank you. At this time, I'd like to turn the floor back over to Mr. Hall for any additional or closing comments.
Thanks again, everyone for your interest. These are very exciting times for Lifecore. We'll look forward to talking with you again when we release our fiscal second quarter results. Thank you and have a good day.
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