BioLife Solutions, Inc. Price & Performance (BLFS)

Good morning, everyone.

Thank you for joining the BioLife Solutions twenty twenty four fourth quarter earnings conference call. On this call, we will cover business highlights, financial performance for the quarter and full year 2024 and present 2025 revenue guidance. Earlier today, we issued a press release announcing our financial results operational highlights for the fourth quarter and full year of '20 is available at biolifesolutions.com BioLife. 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 Degrief, Chairman and CEO of BioLife BioLife. Thanks Troy. Good morning and thank you for joining us for BioLife's fourth quarter and full year twenty twenty four conference call. Twenty twenty four was a pivotal year for BioLife. Over the last twelve months, we strategically reshaped our portfolio establishing BioLife as a leading pure play enabler of cell and gene therapies.

Strengthening our long term growth trajectory and unleashing the attractive financial profile of our streamlined operations. We executed in our core business evidenced by quarterly sequential cell processing revenue growth including Q4. Exceeding the high end of our already raised full year guidance for that platform. In parallel, we repositioned the company divesting non core product lines to drive gross margin By completing the sale of two freezer product lines, in our biostorage business, we not only emerged much more focused operationally, but also with a stronger and cleaner balance sheet which when combined with positive cash flow from operations makes us self sufficient. I believe we are better positioned today than at any other time in our long history. A summary look at our 2024 results from continuing operations. When compared with our as reported results in 2023, highlights the positive and material impact to our go forward these divestitures have had. Although total revenue in 2024 was $82,000,000 compared with $143,000,000 in 2023, Due to divestitures, [indiscernible] Our GAAP gross margin doubled from 31% in 2023 to 62% in 2024. Generated absolute GAAP gross margin dollars of $51,000,000 compared with $44,000,000 in 2023. Our adjusted EBITDA in 2024 was positive 16,000,000 or 19% of revenue compared with negative $5,000,000 in 2023.

We also doubled our cash balance with the sale of non core assets ending 2024 with $109,000,000 in cash. Compared with $45,000,000 in 2023. While also paying down $5,000,000 of principal on our $20,000,000 year end 2023 bank debt. We have a strong foundation in place ourselves sufficient and well positioned strategically and financially moving into 2025. Moving to the fourth quarter results, our cell processing platform revenue was $20,300,000 up 7% over Q3 and a year over year increase of 37 For the full year, cell processing revenue totaled $74,000,000 a record high increasing 12% when compared to '23 driven by high single digit growth in biopreservation media, or BPM and higher percentage growth in our other tools, BPM revenue versus 60% direct. Approximately 36% of total BPM revenue came from those with the caveat that a portion of that demand is likely going to clinical pipeline programs and process development validation versus patient dose [indiscernible] These metrics are in general consistent with what we saw in 2023. At the end of twenty twenty four, our BPM was utilized in a total of 17 combined total of 17 unique therapy approvals, geographic expansions, additional indications or earlier lines of treatment.

As we have previously stated, we believe our BPM products are utilized 70 plus percent of relevant commercially sponsored CGT trials in The U. S. And at this point, we have not been able to identify any commercial freeze media used in this set of clinical trials. So homebrew formulation could To drive sustained growth in our cell processing business, a key commercial priority this year is to continue to deepen our relationship with existing While leveraging those partnerships to create cross sell opportunities and increased adoption of our broader cell processing portfolio. For instance, while our CellSeal vials are already incorporated in an established commercial therapy, and utilized in numerous clinical trials there is a significant opportunity to scale these products over time. We see this as a significant mid to long term growth lever as additional products integrated into commercial therapies can materially enhance our revenue potential. Said differently, if these products are specked into a commercial therapy, they can increase our revenue per patient dose. By a factor of 2x to 3x compared to our BPM products alone. As we enter 2025, we are cautiously up optimistic that the modest improvement in the underlying industry fundamentals that emerged in 2024 will continue.

Respect to the 2025 guidance we issued this morning, we anticipate an acceleration of growth when compared to the 8% We expect total 2025 revenue of $95,500,000 to 99,000,000 representing growth of 16% to 20% compared to 2024. With growth primarily driven by our cell processing platform. To $86,500,000 to 89,000,000 largely due to projected increases in BPM sales to our commercial CGT customers. We expect this in turn will drive solid adjusted EBITDA margin expansion for the full year. Now I'll hand the call over to Troy who will provide an overview of our full 2024 results and 2025 guidance. Troy? Thank you, Rod. Today, we will be reviewing current and prior period financials from continuing operations. For Q4 twenty twenty four. Which excludes financial results from Sterling, Sysafe and CBS. We reported total Q4 revenue of $22,700,000 representing an increase of 31% year over year The year over year increase was primarily related to a 37% increase in salt processing platform. EVO and SAW platform revenue for Q4 $2,400,000 a decrease of $200,000 or 8% from the same period in 2023. GAAP gross margins for Q4 twenty twenty four was 60% compared with 53% in Q4 twenty twenty three.

Adjusted gross margins for the fourth quarter was 63% compared with 63% in the prior year. Adjusted gross margin was in line with prior year due to an increase in revenues offset by product and customer mix. GAAP operating expenses for Q4 twenty twenty four were 24,800,000.0 versus $24,400,000 in Q4 twenty twenty three. Adjusted operating expenses for Q4 twenty twenty four totaled $15,000,000 compared with $15,400,000 in the prior year. GAAP operating loss for Q4 twenty twenty four was $2,100,000 versus $7,600,000 in the prior year. Our adjusted operating loss for the fourth quarter of twenty twenty four was $700,000 compared with 5,100,000.0 in Q4 twenty twenty three.

Our GAAP net loss was 2,000,000 or or $0.04 per share compared to $7,200,000 or $0.16 per share in the prior year. The decrease in operating loss and GAAP net loss was primarily due to increased revenue, and decreased personnel costs. Including stock based comp. This was partially offset by an increase in performance based bonus accrual in addition to increased accounting fees related to divestitures and SOX. Adjusted EBITDA for the fourth quarter of twenty twenty four was $4,000,000 compared with 3,700,000.0 in the prior year. Our adjusted EBITDA increased primarily due to higher revenue, partially offset by $900,000 increase in SOX consulting, and accounting related fees due to divestitures. Which we expect to be lower in future periods after Q1 twenty twenty five. Turning to our balance sheet. Our cash and marketable securities balance at December 31, 2024 one hundred and nine point two million dollars compared with $34,100,000 at 09/30/2024 and $52,300,000 at 12/31/2020 Taking into consideration our adjusted EBITDA, of $4,000,000 Our increase in cash during Q4 twenty twenty four was primarily related to the divestitures of Sisafe CBS. Our SVB long term debt balance at 12/31/2024 was $15,000,000 compared to $20,000,000 at December 31, 2023, with quarterly repayments of 2,500,000.0 moving forward.

Turning to 2025 revenue guidance. Total revenue is expected to be $95,500,000 to $99,000,000 reflecting an overall growth of 16% to 20% over 2024. Our cell processing platform is expected to contribute 86,500,000.0 to $89,000,000 or 18% to 21% growth over 2024. Our EVO and THAAD platform is expected to percent to 15% growth over 2024. We expect adjusted gross margin for the full year to be in the mid-60s. A reduction in GAAP net loss and expansion in adjusted EBITDA margin in 2025 due to higher expected revenue partially offset by increases in R and D expenses related to development projects. Finally, in terms of our share count, As of 02/24/2025, we had 47,000,000 shares issued in outstanding and 49,000,000 shares on a fully diluted basis. Now, I'll turn the call back to the operator to open up for questions.

Thank you.

Will now begin the question and answer session.

And today's first question comes from Matt Stanton at Jefferies. Please go ahead. Hey, thanks. Maybe first one, just on the margins. Particularly the EBITDA margins, any kind of finer point you can put around the continued expansion? I think you talked about the improving top line and mix dynamics there, but also some investment dollars into R and D. So just talk a little bit about the pacing of that continued expansion through the year and then color maybe where we might look to exit the year here in 2025 on the EBITDA margins? Thanks. Yes, sure, Matt. I'll take that one.

So if you look at some of the commentary we made in the the earnings call, There was abnormal, I'd say, more onetime in nature type costs in G and A. Being related to stocks and the divestiture accounting costs thereof which we'll see some leakage of that in Q1. But if you take that Q4 number as a good jumping off point for 2025 for SG and A, that would be a good jumping off point. And then for R and D, we didn't mention some development projects we're working on. So if you take that Q4 twenty twenty three baseline for R and D, that would be a better baseline than Q4 twenty twenty four due to those development projects. And then as far as EBITDA margin, expansion, yes, we would expect that pretty steady throughout 2025 as far as increasing compared to 2024. Into that mid-20s. That we mentioned Okay. Thanks. That's helpful. And then Rod, you talked about the revenue opportunity to increase 2x to 3x by cross selling the portfolio beyond just media. Obviously, that doesn't happen overnight. It sounds like it's a big focus in 2025. Can you just kind of talk about either the products or the customers where you're seeing the most potential to do that and when we can maybe start to see some of the the benefits of that cross selling of the portfolio over time here.

Sure. Well, thanks for recognizing that it definitely takes some time, right, because Our media market position is so strong and so large that for us to start to come close to that is going to take multiple years. That said, we have a commercial customer, large company that utilizes both CryoStore and our CryoSeal vials in their approved therapy And that's to us the poster child of of what something should look like. On top of that, they are evaluating our automated fill system as they're focused on automating in a closed system, they're [indiscernible] really drives a lot of consumables as well. So it's really about targeting the clinical trial customers that we have, directing the half a dozen sales force salespeople that we have to those accounts and put a focus push on introducing those products. We do have and the one I mentioned is one example. There's another one where we have good traction on a cryo case evaluation, which again was introduced last year, not for their commercial product because as with the media, as you get further down the clinical development chain to a commercial product, then you end up making it extremely difficult and costly to make a switch like that, particularly on a container for the end product for the final drug product.

So we are in discussions with them about introducing Cryostore into their into their clinical BioLife, which is not insignificant. So we're going to attack it from both sides, the early stage where it's less less expensive and easier to switch and on the pipeline for the commercial therapy customers. And just to clarify, Rod meant to say Cryo Case not CryoStor for the VINCE. Thank you.

Cryo Case.

Yes.

Okay. Thank you.

That makes sense. Yes, that's helpful. Appreciate it guys.

Great. Thank you. And our next question comes from Anna Snobkowski with Hi. This is Anna on for Paul Knight.

I want to ask on the momentum you are seeing in cell processing platform. You mentioned this is the fifth quarter of consecutive growth. So maybe just a little bit into what is driving this growth and increased visibility Is it any one specific approved therapy or is it the overall health of the industry improving?

You bet, Anna. Thanks. So we're seeing on the start with the non approved therapy. So the clinical trial group of customers is slightly ahead and we expect slight growth there. Distribution, we expect to see some growth, but the fundamental driver we see for biopreservation media and cell processing general in 2025 is that group of 17 commercial customers that we have in our base. That's where the bulk of the the revenue growth is going to come from in '25.

Perfect. And then, could we get an update on your outlook over the long term in terms of adjusted EBITDA margins? Now that we've moved past certain product lines and the pro form a business is coming into focus, Yes, sure. So like we said, for the full year 2025, we'd expect mid-20s for adjusted EBITDA and then going outward it's really highly dependent on media growth. As you know, there's a term flow through on the revenue for media. So we could model out media growth at certain percentage points with that flow through of, call it, 65% on revenue, to get to an expanded EBITDA margin with not huge increases in OpEx. So you do model that out, you can get to the 30s call it, in 2026 timeframe towards the end of twenty twenty six, middle of twenty twenty six. Thank you. And our next question comes from Chad Wojtowski with TD Hey, guys. Yes, just wanted to dig in on sort of media growth and maybe less so over 2025 as you're mentioning it's going to be approved therapies driving growth, but just like at a higher level, when you look at like catalysts and clinical trials as some of these newer modalities are expanding into larger indications, Could you just speak to maybe how media is used differently between like a gene therapy, a CAR T or like Till based therapy and kind of how BioLife is positioned to benefit [indiscernible] Yes, it's a good question.

I think that [indiscernible] the product works [indiscernible] most cell types. In some instances better in some than others. That said, I think that the difference between the modalities and the cell type really comes down to the amount of CryoStore used [indiscernible] And so when you look at Iovance's Amtagvi, which I think specifically states that they use kraft store. I would say that they are the largest user per dose [indiscernible] Versus a CAR T which would use less So it really comes down to the volume per dose And we're Many of our customers seem to think that that's really confidential information. So it's sometimes difficult to get exactly how much of our products is used per dose, which is why I made the comments I did there earlier. Whereas Amtagb for instance in their FDA insert pretty well you can back into how much cryostores use Got it. And then just on the non media, so If homebrew is really the only alternative for media which has just created this dominant brand. Could you speak to sort of the competitive profile of some of these other products And what dynamics do you expect to come across just when trying to cross sell?

Thanks for the questions guys.

Sure. I think on the let's talk about seltzeal vials. So the vials, there are competitive vials out there. West comes to mind They're a larger company Our files have certain attributes with respect to the materials used, the freezing profile, etcetera. When you have that frozen down with the final therapy. On the cryo case side, that's clearly a direct competitor to cryo bags. And they are very well established and no doubt the most used final dose container And in that regard, it comes down to the benefits of our cryo case, which include an easier to work with form factor particularly prior to freezing, And reduction or mitigation of a shattering the dose if it's dropped in a frozen state. So there's no question that we're up against some well entrenched I guess products, product lines, and we feel pretty comfortable that the benefits that our products yield in combination with the push toward automation which is another nice benefit that the Cryo Case has relative to automating versus a bag. We think that those things over time will drive adoption in addition to the fact that we are a credible supplier to these large commercial therapy companies as well as a lot of earlier stage companies.

Thank you. Our next question today comes from Matt Hewitt at Craig Hallum Capital Group. Good morning and congratulations on a strong finish to the year.

Maybe first up, when you when you're talking about the growth this year, how much of that if any, is related to some pricing [indiscernible] couple of weeks talk about implementing some price increases, call it CPI adjustments whatever. Are you including some of that into your model?

Yes, we do have our base price increase, which sort of mid single digits. Lower than previous years, baked into that. And in addition to that, we've been on a a push to alter some of the distribution and direct relationships that we have from a pricing standpoint given that they're legacy Those won't really kick in until the back half of the year into '26. So pricing is definitely a factor, but the bulk of it is coming from from the demand side in terms of volume.

That's great. And then maybe kind of a follow-up to that. As you look to to grow the vials and the rest of the product portfolio, given your strength with the media products, is there a way for you from a pricing perspective to kind of bundle the whole portfolio to together and maybe you're giving a little bit here, but you're taking more there and ultimately it's a win win for everybody?

Yes, it's a good question as well. I think that those opportunities exist. I think that the decisions around, for example, utilizing Cryo Case it really goes beyond just the price. Because the benefits of using it would outweigh any kind of real price increase. And the fact of the matter is it may even be equal to or lower ASP per, let's say, per final dose on the container by switching to us. So we don't really feel the need to be discounting. In fact, what we're trying to do is go the other way and have the pricing that we have on our product line reflect the premium products that they truly are.

That makes complete sense. Congratulations again on the strong year and must feel good looking out to this year in not necessarily having some of the distractions you're dealing with last year. So congratulations. Thank you, Matt. Thanks, Matt. Thank you. And our next question today comes from Thomas Flaten at Lake Street.

Please go ahead.

Hey, guys. Appreciate you taking the questions. Rod, just keeping in mind all the things you've noted about potential growth opportunities particularly with the cross selling. If you were to look at that 18% to 20% growth rate, guided for 2025, where do you think that can go maybe not in an ideal world, but do you see that to accelerating beyond that 21%? I think over time, it can. It's going to depend [indiscernible] It really is going to be driven for the next few years at least The bulk of the growth is going to be driven by biopreservation media and that really is to dependent on the cadence of approvals and the overall demand for these therapies down the road. So that's number one. And that's really not in our control. What's in our control is to make sure that we're in as many clinical trials as we can be as they come online. I think with respect to Sexton, the growth there will be higher over time. And really, it is going to take us I would say, twenty four to thirty six months to to get well established to the point where as these therapies move through the clinical journey, and the volume increases not just for media, but for these other tools, then you're going to start to see an acceleration of revenue growth rates beyond I think where we are today.

So I still I think we're about twenty four to thirty six months away from kind of any material change growth rate would be Got it. Appreciate that. And then just on the business itself, now that you've been here a couple of months past the the deals in November, any more [indiscernible] the middle of the P and L that we should anticipate either positively or negative No, the comments I made earlier still stand Thomas. Because those financials, as you know, are all continuing basis, right? So does strip out any of the divestiture entities from those financials as well as some people that went with those divestitures. So it's a good BioLife, as I mentioned, for Q4 twenty twenty four annualized for SG and A And then R and D, we will be putting more money into R and D this year compared to 2024. Got it. Appreciate it. Thank you. Thanks, Thomas. Thank you. And our next question comes from Yi Chen at H. C. Wainwright.

Please go ahead.

Good morning. This is Eduardo on for Yi. I guess related to customer expansion, I had a question regarding any potential catalysts from your clients. Naturally, massive approvals or label expansions that would be really relevant for your guys' projections.

Correct. It's really from the clinical trial customer base that we have, it's movement through the from Phase one to Phase two, etcetera, right? On the commercial side, once they're commercial, it's it's both time in terms of adoption let's just say in The United States, but then there are those other factors geographic expansion around the world, movement of the line of treatments, those things are equally important to us in terms of the overall growth rate and adoption of those therapies as time goes by. Also a lot of therapies end up several years later getting additional indications using the same drug and that also opens up that pool of patients. Right. And do you guys have visibility on whether or not any of those milestones or inflection points are happening in 2025 for your clients?

Yes. We think right now that we're we have visibility to what we believe are about eight of those of any one of those things happening in 2025. We track that as well as we can. The information is a bit opaque. And we're actually working with a third party consultant to try to more formalize a review of that on an every six month basis as opposed to trying to track it internally, which I think has given us less than fulsome data. So I think we'll get better at that. But right now, what we're seeing is about eight over the the next twelve months or the year of 2025, I should say. So Got it. That's really helpful.

And I know the clinical trial component of revenue isn't that significant, but just curious if you guys anticipate any complications with grant funding freezes potentially know if any of the clinical trials that you're customers are running are dependent on government funding, but if you anticipate any complications associated with funding freezes Yes, not at this point. We're aware of the uncertainty around that IH funding I think that to the extent that there could be an impact of that, I would say that it shows up on the distribution side of our business We have two large distributors. I think they're very much focused on academic and early research Those folks might have might be impacted by all of this, but in terms of our overall revenue, when we talk to those two distributors, we don't get any sense that they're concerned about it at this point. That may change throughout the year. But right now, I think it would would come from a bit of a softening of demand on the distribution side versus the direct side. Most of our direct customers are privately funded.

Got it.

That's helpful.

And then finally, I'm curious, [indiscernible] for EVO and SAU and if there's any potential if you have bundling products, talked a little bit previously about bundling packages with cell processing. I'm curious if these two would also fit into a strategy there to kind of increase your footprint with those products and services as well?

Yes. So on the THAW side, our thaw device definitely could be viewed as almost a reverse razor razor blade in the sense that it is designed now and has been modified to accept a cell seal vial product line, our own product line for automated saw. So you could look at it almost as a a it's a nice add on if you're using our cell seal vials. It could be in yet another just benefit of doing so. And it could also use be thought of as a razor razor blade scenario in terms of if it gets placed, It can drive in some way although I would say it's a pretty soft indirect way the utilization or the adoption of the cryo seal. On the EVO side of things, very little chance. The people that are making decisions around utilizing EVO are very different than the people that would be utilizing the the Cell Seal or other products, including thaw, the decision makers are very different. So there's very little opportunity to do that.

Got it. That's really helpful. Thanks. [indiscernible] Thank you. And our next question comes from Michael O'Connor Lynch with Maxim Group. Hey, guys. Thank you so much for taking my questions today. Congratulations on all the progress. Thank you.

I just would like to see if we could drill down a little bit. You mentioned that you're looking at a bit more R and D spend going forward versus the fourth quarter. So could you provide just a little bit more color on how you're planning to allocate additional spend? Is this more is this for new products or more just continued improvements on your existing product line?

Yes, it's really about expanding the consumable set of products that we have and acquired from Sexton. That would be the crowd case to do some additional work on that relative to some customer feedback. It would be modifying the cryo case for our own internal use on the front end. In other words, shipping our cryo store product out in a cryo case There are various benefits to that. It's about increasing the consumable line of products that are associated with our CT5 automated fill device. So it's really I would say product line expansion as opposed to new products per se.

Okay. Thank you for that. And then just want to see if you could remind us of your involvement with any any mesenchymal stem cell based products. I know that Mesoblast historically hasn't been a customer, but there has been a lot of gains of traction in that space. So any additional color with your involvement could be helpful. [indiscernible] Yes. I don't know if I can give you any in real time, but I can certainly follow-up with you on that after the the fact. I'll sit with our folks that have managed the clinical trial side of things and have a chat with them and come back to you on that, my Mike. Certainly. Thank you very much for taking my And once again, congrats on the progress. Thanks very much.

And this concludes our question and answer session. Would like to turn the conference back over to Rod Degreed for closing remarks. Thank you, Rocco.

In closing, 2024 was a year of strategic transformation and solid operational execution for BioLife.

We see 2025 as an opportunity to solidify and leverage our market leading position as an enabler of CGT therapies and position the company for long term sustainable growth in both revenue and profitability. Thank you for your time this morning and we look forward updating you as we move through the year.

As well as seeing some of you at the Cowen Conference this week and other conferences. Throughout the year. Thank you.

Thank you. This concludes today's presentation. You may now disconnect your lines and have a wonderful