Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to the BioLife Solutions Q4 2023 Shareholder and Analyst Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. Please also note today's event is being recorded. I would now like to turn the call over to Troy Wichterman, Chief Financial Officer of BioLife Solutions. Please go ahead.
Thank you, operator. Good afternoon, everyone, and thank you for joining the BioLife Solutions 2023 fourth quarter earnings conference call. On this call, we will cover business highlights, financial performance for the quarter, and 2024 revenue guidance. Earlier today, we issued a press release announcing our financial results and operational highlights for the fourth quarter of 2023 and 2024 revenue guidance, which is available at biolifesolutions.com. As a reminder, during this call, we will make forward-looking statements. These statements are subject to risks and uncertainties that can be found in our SEC filings. These statements speak only as of the date given, and we undertake no obligation to update them. We will also speak to non-GAAP or adjusted results. Reconciliations of GAAP to non-GAAP or adjusted financial metrics are included in the press release we issued this afternoon.
Now, I'd like to turn the call over to Rod de Greef, Chairman and CEO of BioLife.
Thanks, Troy. Good afternoon, and thank you for joining us for BioLife's fourth quarter and full year 2023 conference call. It has been a busy four months since rejoining the company as CEO, and I'm encouraged by our team's ability to navigate one of the more challenging environments for the life sciences industry in recent memory. Not to mention their consistent execution throughout the organizational changes related to our strategic refocusing on higher margin recurring revenue streams. Over time, BioLife has become the industry standard in terms of biopreservation media and has established itself as a leading provider of premium bioproduction tools and services, the critical picks and shovels that support the fast-growing cell and gene therapy industry.
This is our mission, and I'm convinced more than ever that BioLife is in an excellent position to benefit as this space matures, expanding upon our already dominant share of the market and offering diversified exposure to the nascent industry, which we expect to grow at a 20%-25% CAGR through 2033. As we look back on an undeniably challenging year for the CGT industry, we recognize that BioLife was not alone, as companies large and small felt the impact of inventory destocking, a constrained funding environment, and weaknesses in China. Our full year results were certainly impacted by these challenges, but our initiatives to divest the freezer product lines and refocus helped us exit the year with positive momentum.
With encouraging early signs that the macro headwinds facing the industry may have begun to subside, we similarly saw evidence of stabilization and momentum in the CGT industry and our business, as demonstrated by our fourth quarter cell processing platform revenue growing 11% sequentially over Q3, and across our top 50 biopreservation media customers, who account for 90% of total media revenue, growing 14% compared to the third quarter. It is early, and as we have said, we will need to continue to work closely with our customers to manage inventory at normalized levels, which we believe positions us well for what could be a sustained recovery as 2024 progresses. With that, let's take a closer look at our full year 2023 results. Total revenue for 2023 was $143.3 million, an 11% decrease compared to 2022.
Ex-COVID, revenue decreased 4% for the year as there was no COVID-related revenue in 2023. Looking across our platforms, for the full year of 2023, our cell processing platform revenue declined 4% to $65.8 million from 2022, due to a 6% decrease in our biopreservation media revenue, which was partially offset by a 9% increase in our other cell processing tools, which include our CellSeal, hPL, and CT automated fill product lines. In 2023, our top 20 media customers accounted for 78% of media revenue and were up slightly year-over-year by 1%, and our all other category decreased by a total of 26%. In 2023, distributors accounted for 40% of total media revenue, compared to 38% in 2022.
Customers with commercially approved therapies accounted for an estimated 52% of direct media revenue in 2023, compared with 49% in 2022. Keeping in mind that some of this revenue is related to validation, R&D, and other clinical work, in addition to patient dosing. Our full year 2023 biostorage and services platform revenue decreased 2% to $25.9 million. However, excluding prior year COVID-related revenue, this platform grew a strong 61%, as Garrie Richardson's team did an excellent job of replacing the lost COVID revenue. We are currently in the process of consolidating our two Boston area facilities, which we expect will save approximately $500,000 in annual operating costs and which should be completed early in the third quarter.
Our 2023 freezer and thaw platform revenue declined 23% or $15.1 million from 2022, primarily due to a difficult capital equipment environment and the competitive disadvantage generated by the divestiture process. As you know, we have been in the process of divesting the CBS and Stirling freezer entities since August of last year. We recently signed two separate LOIs for the sale of these freezer product lines, and our goal is to close these transactions within the next 45-60 days. All in all, this has been a difficult and time-consuming process, and we expect no net proceeds, and in fact, will realize an initial cash outflow. This initial cash outflow will be offset by the elimination of future cash burn and certain long-term debt, as well as future product warranty liabilities, while materially improving our overall 2024 financial performance and margin profile.
On a more macro industry note, 2023 was a breakthrough year for CGT approvals in the U.S. This momentum continued into the first quarter of 2024, with the recent approval of Iovance's groundbreaking TIL-based therapy, AMTAGVI, an industry first, which we support with two of our biopreservation media products. This brings us to a total of 14 unique approved therapies, which have our biopreservation media embedded, and three of these unique approved therapies also utilize our CellSeal vials. In the next 12 months, we believe there could be up to 10 additional unique therapy approvals, expanded indications, or geographic expansions, which include our proprietary products. In addition to our strong market position in approved therapies, we believe there are currently more than 230 active U.S. commercially sponsored clinical trials, and estimate that our biopreservation media is embedded in more than 70% of those trials.
Looking at these statistics, it's evident that BioLife is the clear industry standard when it comes to biopreservation, and as the industry grows, so do we. We have amassed a class-defining portfolio of products to improve quality and reduce risk in the manufacture and delivery of these novel therapies. We have earned a high level of trust with our marquee customer base and operate in an environment with limited credible competition, specifically in the area of biopreservation. As we look ahead, we're taking a cautious approach toward our 2024 revenue guidance, despite certain customer conversations, which suggest some growing optimism around improving market conditions in the second half of the year.
At this point, we are expecting 2024 revenue, excluding freezers, to range from $95.5 million-$100 million, with our cell processing platform generating between $66 million-$68.5 million, and our biostorage and services platform, which now includes our thaw product line, to range from $29.5 million-$31.5 million. While the total year-over-year growth rate of 2%-7% may seem modest, I would point out that against an annualized second half 2023 run rate, which we believe is a more appropriate baseline given the industry challenges of last year, our guidance for total revenue growth is 13%-18%, with cell processing growing at 17%-22% and biostorage and services at 4%-11%.
As we progress through 2024, we're committed to delivering increases in revenue, gross margin, and adjusted EBITDA, both in absolute terms and as a percent of revenue. At this point, I'll turn the call over to Troy to provide a more detailed review of our financial results. Troy?
Thank you, Rod. We reported Q4 revenue of $32.7 million, representing a decrease of 26% year-over-year, and excluding COVID-related revenue from Q4 of 2022, the decline was 23%. The year-over-year decrease was primarily related to a $6.1 million decrease, or 35% in our freezers and thaw systems platform, and a $5.4 million, or 27% decrease in our cell processing platform, reflecting the industry headwinds and destocking in 2023. However, our sequential growth in Q4 from Q3 for the cell processing platform was 11%. As Rod mentioned, we are starting to see positive indicators for future revenue growth for the cell processing platform. Turning to our biostorage and services platform. Revenue for the fourth quarter was $6.6 million, a decrease of 1% over the same period in 2022.
Excluding COVID-related revenue from Q4 of 2022, revenue in Q4 2023 increased 26%, as the COVID-related revenue was backfilled. Freezers and thaw systems platform revenue for the fourth quarter was $11.4 million, a decrease of 35% over the same period in 2022. Excluding COVID-related revenue from Q4 2022, revenue in Q4 2023 decreased 32%. Adjusted gross margin for the fourth quarter was 35%, compared with 32% in the prior year. The increase in adjusted gross margin was primarily due to product mix related to decreased revenue from our freezer business and lower warranty and scrap expense from our ULT product line. Adjusted gross margin increased approximately 450 basis points sequentially, largely due to increased cell processing revenue and product mix.
GAAP operating expenses for Q4 2023 were $45.9 million versus $93.5 million in Q4 2022. The decrease was largely due to the non-cash asset impairment charge we took during Q4 2022 in the freezer businesses of $40.5 million. Adjusted operating expenses for Q4 2023 totaled $20.4 million, compared with $22.1 million in the prior year. The decrease was largely due to reduced personnel expenses from the reduction in force in Q3 2023, decreased consulting costs, and a reduction in travel expenses. Our adjusted operating loss for the fourth quarter of 2023 was $9.3 million, compared with $8.2 million in Q4 2022. Our GAAP net loss was $13.4 million in Q4, compared with $49.2 million in the prior year.
The decrease in net loss was primarily due to the $40.5 million non-cash intangible asset impairment charge related to Stirling and CBS taking during Q4 2022. Adjusted EBITDA for the fourth quarter of 2023 was $700,000, compared with $1.7 million in the prior year. Our adjusted EBITDA decreased primarily due to lower biopreservation media revenue. Adjusted EBITDA for Q4 increased sequentially by $3.8 million from Q3, largely due to higher revenue from our cell processing platform, reduced freezer R&D costs, and decreased personnel costs, and was the first positive quarterly adjusted EBITDA for the year. Turning to our balance sheet. Our cash and marketable securities balance at December 31st, 2023, was $52.3 million, compared with $42.2 million at September 30th, 2023.
Taking into consideration our adjusted EBITDA of $700,000, our increase in cash during Q4 2023 was primarily related to a $10.4 million PIPE that closed on October 19th, 2023, with an existing shareholder. Our SVB long-term debt balance was $20 million, which is interest-only through Q2 2024, with quarterly repayments of $2.5 million beginning in Q3 2024. Turning to 2024 revenue guidance. Our 2024 guidance is based on expectations for our cell processing and biostorage and services platform, which now includes the ThawSTAR automated thawing devices product line, and does not include any revenue from freezer product lines, which are in the process of being divested. Total revenue is expected to be $95.5 million-$100 million, reflecting an overall growth of 2%-7%.
Our cell processing platform is expected to contribute $66 million-$68.5 million, or flat to 4% growth over 2023. Our biostorage and services platform is expected to contribute $29.5 million-$31.5 million, or 5%-12% growth over 2023, and on a like-for-like basis, growth of 10%-16%. In addition, we expect revenue, gross margin, and adjusted EBITDA growth in 2024. Finally, in terms of our share count, as of February 22nd, 2024, we had 45.3 million shares issued and outstanding, and 48.2 million shares on a fully diluted basis. Now, I'll turn the call back to the operator to open up for questions.
Thank you. If you would like to ask a question, please press star then one on your telephone keypad. If you're using a speakerphone, we ask that you please pick up your handset before pressing the keys. To withdraw your question, please press star then two. Today's first question comes from Paul Knight with KeyBanc. Please go ahead.
Hi, Rod and Troy. Does the LOI allow you to move the freezer assets to discontinued ops for the statements?
Unfortunately, Paul, what we need to do is actually have a signed document, then we can move them into discontinued ops. Obviously, we are, you know, working through the final diligence and in parallel, crafting, the legal guys are crafting the documents, so we're hoping 30-60 days from today, these things will be done, and if we can get it done by the end of March, then they will be considered discontinued operations for the full quarter.
A signed LOI gets you to move them to discontinued?
No, it does not by itself. A deal, a deal does.
Okay. But you have LOIs signed at this juncture or waiting on LOIs?
No, we have two signed LOIs, one for each of the entities. Clear terms spelled out, final diligence is in process with the buyers, and the lawyers are working on the security purchase agreement, and in the other case, an asset purchase agreement.
Then, you know, you had positive EBITDA in the quarter. Rod, could you talk to, you know, steps taken to get to positive EBITDA?
Yeah, I'll let Troy deal with that, Paul.
Yeah, Paul. So as you recall, we did a reduction in force towards the end of Q3. So that reduction in expenses flowed through Q4. In addition, as remarked in my script, we had the increase in cell processing revenue, and then we just, we did a control on discretionary expenses such as consulting costs and travel.
Okay. And then last question on my side is the 10 more potential cell and gene therapies coming in 2024 relative to 13, excuse me, yeah, 13 last year. I know it's not probably correct, but why not almost double the net level of revenue from approved customers that you gave her in the call to get to potential revenue run rate on these approvals? Or what kind of qualifications would you put around that saying, "I can't just double my commercial revenue off CGT's approved?"
Yeah, so a couple of things there. When you're talking about a new unique approved therapy, there's definitely a ramp-up, right? And if you have followed the Iovance conference call, as I did, they were very studious in not saying how many patients they expected to be able to dose over any kind of near-term timeframe. So there's a ramp. That's one thing. The other thing, Paul, is that, you know, we have refined the methodology by which we look at what we call approved therapies, and especially as we look forward to that 12-month number, which is 10. That 10 includes the potential for three unique therapies, three new indications from an existing therapy, as well as four new geographic indications. So, o r sorry, geographic regions. So that means that those are the drivers that actually increase the number of patients that could be dosed, right?
So for instance, Breyanzi could have three new indications in 2024. That's not necessarily a new approval in the way that we're looking at things now. So each one of these three aspects, whether it's an indication, an expansion of indication, whether it's a geographic region expansion, or whether it's actually a unique approval, in addition to whether a therapy moves from, say, a fourth-line treatment to a second-line treatment, those are the variables that make up the patient count ultimately in terms of those being dosed. So it's not a like for like.
The last thing, promise, is as you get these events happening in the year, I would assume they would do some additional stocking in front of it. Are you seeing that at this juncture?
It's difficult to say. What I would say is when we look at a customer like Iovance, who probably had a pretty good heads up that things were going their way, their 2023 purchases were nicely above 2022, and their projected 2024 is also nicely above 2023.
Okay, thanks.
Yep.
Thank you. Our next question today comes from Jacob Johnson with Stephens. Please go ahead.
Hey, thanks. Good afternoon. Maybe, Rod, just, just first on the freezer sale, appreciate the commentary and the prepared comments. Appreciate kinda what you just outlined to, to Paul's question, but I, I guess kinda how confident, y ou, you've got two LOIs. It sounds like this all hopefully be over in two months, but just how confident are you, that this, this will all be concluded, in the next couple of months? And then I heard you mention some maybe outlays related to these transactions. Is there any way to, to quantify that?
Yeah. So I'm not gonna get into any, any details around the specific terms because they're not done yet. With respect to confidence, you know, I, I'm at 70%-80%. One of them, the buyer for Stirling knows the business extremely well. So it's not, we don't believe anything's gonna come and pop out of the woodwork that would be a showstopper for them. A little less so on the CBS side of things, but again, that's a cleaner business at some level, so we don't expect. And it's a sophisticated buyer, so we don't expect anything to pop out of there. So I'd say, you know, 75%-80% confidence that, that we'll get it done in that kind of a timeframe.
In terms of the cash outlay, again, I'm not gonna get specific about it, but what I will say, Jacob, is that there's not, you know, the, the size of it will not impact our ability to operate the company with the cash that we have going forward.
Got it. That, that's helpful, Rod. And then on the, the media side of things, it's good to see it pick up sequentially. You know, you're guiding to kinda single-digit growth year-over-year, but obviously much better growth versus kind of the, the second half trends. I'm just kinda curious, is there any way to, to kinda quantify how much media, what media looks like in the first half of the year versus kind of the back half and kind of the run rate you'll be exiting the year at? Or, or maybe alternatively, kind of how you're thinking about some of the headwinds last year sustaining into this year, just as, we try to think about 2024 and beyond.
Yeah. So, you know, we had a conversation with our largest distributor customer. Literally, they were in our facility here a week ago, and they definitely expressed some confidence in the second half of the year. And I look at them based on the almost 6,000 customers that they sell our media to, as sort of a proxy for just the small commercial, maybe even preclinical customer base. So I think there's good news there that the first half of the year might be a bit flat compared to the second half of last year, but that there could be an uptake there.
Our commercial customers, based on the projections that we're receiving from them and our larger clinical customers, let's say our top 20, they are also suggesting that, you know, the first half is gonna be maybe 45% of the total, for the year, with the back half coming in at 55%. You know, admittedly, Jacob, our, our guidance is a bit cautious because it's early in the year, and last year was a tough year, and I don't want to get ahead of, you know, out in front of our ski tips too much. And we'll be looking throughout the year, every quarter as things change, and our customers give us a forecast, a rolling forecast every three months.
As those change and hopefully become more positive, then we'll share that, and that would be, you know, also shown in our guidance going forward.
Got it. I'll leave it at two and get back in queue. Thanks for taking the question, Rod.
Thanks, Jacob.
Our next question today comes from Steven Mah with TD Cowen. Please go ahead.
Great, thanks for taking the questions. Could you comment on what you're seeing in terms of your comments of macro headwinds potentially subsiding? And they had an 11% sequential growth in Q4 in cell processing. Any sense how you can share on how Q1 is shaping up? And then also, any comments on how the inventory and destocking trends are looking like?
Yeah, let me, let me address the last one first, Steven. I think that, you know, when we looked at Q3 and Q4, we had four and five large customers requesting that we push their orders out, and we're talking about seven-figure orders, right? Which was the, the major reason or, or half the reason that we had such a cliff drop from Q2 to Q3 last year. And in fact, back even in Q4, we still had that three customers asking us to do that. In Q1, so far, we've just had the one customer that has asked us to push things into Q2, and so we, we feel pretty good that that's an indication that from an inventory destocking perspective, things have kind of normalized.
With respect to the larger customer, again, that customer that we just had a meeting with that has sort of 6,000, I would say, smaller customers, they are indicating that what they're seeing is a flattening from the second half of last year, and again, have expressed some optimism toward the back half of this year.
Okay. Yeah, oh, no, I appreciate that. And, talking about the, Q4, you know, the 11% sequential growth in cell processing, can you provide any color on the gross margins in, in Q4? It seemed a bit lighter than we had expected, and also in light of the, the growth in cell processing.
Yeah. So on the gross margin, it did increase about, you know, 450 basis points sequentially. We're not speaking specifically to product line gross margin, but that would be in line with our expectations at those revenue levels, and on a consolidated basis, including the freezer businesses.
Okay. All right. Thanks. And then, let me sneak one more in. Any more cost-cutting efforts contemplated, or do you think the company is right-sized?
Yeah, good question. I think generally speaking, we're right-sized. I think that there are things on the edges that we can still take advantage of. Clearly, we're really focused on any kind of discretionary spending, particularly travel, and putting a pretty fine filter on who goes where and why. And so it's, I think we have some opportunities there throughout the year, but nothing like the sort of RIF that we did in Q3.
Okay, great. Thank you.
Thank you. Our next question comes from Thomas Flaten with Lake Street Capital Markets. Please go ahead.
Hey, good afternoon, guys. Thanks for taking the questions. Troy, in the guidance, you made mention of positive adjusted EBITDA for 2024. Can you quantify that? I know you laid out that 16%-18% adjusted EBITDA margin post-freezer in the middle of last year, but is that a number that's reasonable for us to think about for the second half of the year, or should it be lighter than that?
Yeah, yeah, Thomas, that's a good way to think about it, right? When you keep in mind the media levels of revenue in the first half versus the second half, right, and our guidance is what we're saying, we're still comfortable with those pro forma numbers that we put out once the media revenue grows in the second half.
I would add, Thomas.
Yeah.
That, I would add that once the freezers are divested, we will be in a position to speak to gross margin and adjusted EBITDA ranges for the balance of the year. We're constrained by certain GAAP requirements in doing that right now, but as soon as those things are gone, we will address that.
Got it. And then, given that Garrie's been in post for a little while now, could you just describe a little bit about some of the initiatives he's had ongoing to kind of up your revenue game?
Sure. I think, I think, you know, the, the reality is around media revenue, that the, the opportunity to drive revenue with existing customers is very limited as it relates to media revenue, because they're gonna use what they're gonna use. So the opportunity on the media revenue is to understand where we are not, which when you look at a 70% market share on commercially sponsored clinical trials, as I mentioned, there's, there's some place to go there, right? And, and we are going there to understand what, if anything, they're using. Do they even have a cryopreservation interval at this time, or are they using fresh product? So that there's an exploratory phase going on there.
I think where we do have the opportunity to actually move the needle from a revenue perspective, is the cross-selling of the tools that we acquired from the Sexton acquisition and layering those into the market position that we have on the media side. So there is definitely that going on, where there's a handful of scientifically oriented salesmen taking those products and starting to set up meetings with those media customers to show them, basically introduce them to the Sexton product line, whether it's hPL, whether it's the CellSeal vial line. And I think we're starting to get some traction just based on some meetings that I'm seeing on the calendar, et cetera, with some of our larger customers. So that's an opportunity for growth here as we go through the year.
One quick final one, if I might. Would you be willing to comment on, you know, across the SciSafe facilities, what level of capacity you're currently at?
Yeah, I'd say if you blended it, we're probably in the 75% or 80% kind of range.
Got it. Appreciate you taking the questions. Thank you.
You bet, Thomas.
Thank you. Our next question comes from Matt Hewitt with Craig-Hallum. Please go ahead.
Hi, guys. This is Jack on for Matt. You recently received two approvals in Q4 and have received two more so far this year. How should we think about the ramp of utilization of the biopreservation media? Do customers have inventory on hand in anticipation of the launch, or do they typically wait for the launch to commence and then take on additional product?
No, I think they definitely buy in advance of the approval. I think we saw that just using Iovance as an example, where I mentioned earlier that their 2023 purchases were up above 2022, not just around the clinical trials, but in anticipation of an approval, we believe. We think that what we see from them, projection-wise for 2024, is more reflective of what they think the patient dosing numbers are going to be. It's interesting that when we look at the dosing volume product used per patient, let's say, for sure, this particular application, this therapy, uses the most of anything we have. But they don't give us projections. They've, again, specifically not provided the investment community with any projections about numbers of patients dosed.
But I would say that they keep a safety stock on hand, generally speaking, of between three and six months on the outside, and I think what we saw late last year was a movement from six months to more like a three-month safety stock.
Understood. Thank you.
You bet.
Thank you. Ladies and gentlemen, as a reminder, if you'd like to ask a question, please press star then one. Our next question comes from Michael Okunewitch from Maxim Group. Please go ahead.
Hey, guys. Thank you for taking my questions today. So I guess one of the things that I do want to ask is, as you get towards the removal of the freezer business and returning to EBITDA positive on a full year basis, and with a decent cash pile, do you start the process of looking into additional product lines that you could bring in, or do you look more towards letting things settle and kind of waiting for better clarity on the direction of the market environment?
I think we start by looking at the product line that we have right now, both in terms of products and services, understand the investment required to drive those products forward. Clearly, there are certain external opportunities that we would take a look at, but we're going to be very selective. And just to be general about it, I would say we're early to be looking at those things, and unless something very special comes across our desk, that's probably from a looking outside standpoint, something we would do more in 2025 versus this year. We have a lot of work to do this year, both in understanding how to drive adoption of the current product line, as well as implement systems so that the business runs more smoothly.
All right, thank you for that. And then just one more, and you, you did touch on this a little bit on the, on one of the prior questions, but, I'd like to see if you could provide a bit more color on what the impact of the freezer business looked like on adjusted EBITDA this past quarter.
Yeah, unfortunately, we're a one-segment reporting company, so we don't provide that information. But as Rod mentioned, we do look forward to providing further clarity once the divestiture process is complete.
Fair enough. Thank you for taking my questions.
You bet.
Our next question is a follow-up from Paul Knight at KeyBanc. Please go ahead.
Hey, Rod, I gotta give a shout out to the services group and the 26% growth rate ex-COVID. How is this happening, and why can't this go on, like, for a long time?
Yeah, I think some of it, Paul, had to do with expansion from one of our very large customers and some business that they had and that we were able to get. Not to diminish the other activity that Garrie and his team did, but that was a bit of a one-off that I would say accounts for probably half of that growth. It's one of our larger customers on the storage side. We have an excellent relationship with them and are kind of their go-to when it comes to expanded storage needs.
Okay, thanks.
You bet.
Thank you. Ladies and gentlemen, this concludes our question and answer session. I'd like to turn the conference back over to the management team for any closing remarks.
Thank you, Rocco. In closing, I'd like to say that despite the relatively cautious outlook for 2024 that we're providing at this stage, we do strongly believe that the fundamental thesis remains intact, and that the company is very well positioned to take advantage of the underlying growth drivers of what is still a very nascent CGT market, to drive revenue and profitability not only this year, but in years to come. We believe our biopreservation media is the industry standard and intend to leverage that market position to drive adoption of the other tools and services in our portfolio. Thank you for your time today, and we look forward to updating you on future calls and meeting with some of you at the Cowen Conference in Boston next week.
Thank you. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines, and have a wonderful day.