BioLife Solutions, Inc.

Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to the BioLife Solutions third quarter 2025 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. Should you need assistance, please signal a conference specialist by pressing star, then zero on your telephone keypad. I will now turn the call over to Troy Witterman, Chief Financial Officer of BioLife Solutions. Please go ahead.

Thank you, Operator. Good afternoon, everyone, and thank you for joining the BioLife Solutions 2025 Third Quarter Earnings Conference Call. On the call with me today is Roderick DeGrief, CEO and Chairman of the Board. We will cover business highlights and financial performance for the quarter and provide an update for our increased 2025 revenue guidance as adjusted for the sale of our EVO cold chain product line. Earlier today, we issued a press release announcing our financial results and operational highlights for the third quarter of 2025, 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 gap to non-gap 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.

Thanks, Troy. Good afternoon and thank you for joining us for BioLife's third quarter 2025 conference call. We delivered another strong quarter and we are raising our full year 2025 guidance as our team continues to execute and build on the momentum we've seen develop over recent quarters. On the top line, cell processing revenue increased 33% year-over-year, driving a 31% increase in total revenue for the quarter. This growth reflects sustained strength across our biopreservation media franchise and broader cell processing portfolio. Importantly, the mix of higher margin recurring revenue continues to translate into improved profitability, with adjusted EBITDA margin expanding 500 basis points year over year to 28%. This demonstrates that the operating leverage inherent in our business model is flowing through to the bottom line, driven by the benefits of our streamlined operations and focused product portfolio. In early October, we announced the sale of our Evo cold chain logistics product line for approximately $25 million in cash. This transaction further strengthens our balance sheet, bringing cash and marketable securities to approximately $125 million. Strategically, the sale allows us to focus entirely on what is now a fully optimized portfolio, which is aligned with our core competencies and operational strengths. advancing our transformation into a leading pure play cell processing company. Over the last two years, our actions have reshaped BioLife into a more focused, high margin enterprise, positioning us to deliver sustainable growth and expanding profitability for the balance of 2025 and beyond, both from continued organic growth and potentially inorganically through the disciplined allocation of capital. Looking at the third quarter more closely, cell processing revenue reached 25.4 million, a 33% year-over-year increase driven by strong growth across our BPM franchise and our broader cell processing tools portfolio. It's important to note that at the request of a commercial customer, we shipped 1.3 million of BPM product in the third quarter that was originally scheduled to ship in Q4. Adjusting for this timing-related pull forward, year-over-year self-processing revenue for Q3 would have come in at 26% and total revenue at 25%. Excluding the early shipment, BPM products represented more than 80% of total self-processing revenue, and our top 20 BPM customers continue to account for approximately 80% of BPM revenue, providing us with the benefit of increased visibility into this critical part of our business. These metrics are consistent with previous quarters and underscore the stability of our recurring revenue base. Staying focused on our BPM revenue, our direct versus distributor mix shifted to approximately 70-30 compared to our historical 60-40 split. This transition reflects continued momentum from our commercial customers, which accounted for nearly 50% of BPM revenues. driving a higher proportion of direct sales relative to distribution. Looking ahead, we expect that our existing commercial customers, together with those advancing late-stage clinical programs, will remain key drivers of future growth into next year and beyond, and that the commercial share of our BPM revenue will continue to increase over time. This increased mix of late stage and commercial customers further highlights the resilience and consistency inherent in our model. This momentum within our BPM customer base is reinforced by the continued breadth and depth of our presence across the CGT landscape. At the end of the third quarter, our BPM products were embedded in 16 approved therapies and utilized in more than 250 relevant commercially sponsored CGT clinical trials in the U.S. representing over a 70 percent share. Notably, this includes more than 30 phase three trials where our share is nearly 80 percent, underscoring BioLife's position as the default partner for later stage clinical programs where success rates are higher and the path to commercial revenue is more clearly defined. Building on this market leadership, we continue to focus on expanding our role within these customer programs beyond biopreservation media. The sales and marketing team remains highly focused on the significant longer-term cross-sell opportunity in front of us to drive adoption of our other cell processing tools across our marquee BPM customer base. As I've previously stated, this opportunity has the potential to increase our revenue per patient dose by two to three times compared to our BPM products alone as customers adopt additional components of our offerings. We look forward to sharing progress on this front on future calls. As we look beyond the near term, our focus remains on the broader market dynamics shaping demand for cell processing solutions, particularly the continued expansion of patient access to cell therapies, as well as expectations of additional unique approvals, geographic expansions, and new indications for existing approved therapies. Because our biopreservation media is embedded in nearly all approved cell therapies and nearly 80% of late stage clinical trials, we have clearer visibility and predictability into future demand trends. More than half our BPM revenue comes from established commercial customers and late stage programs, segments that are growing and less affected by early stage volatility in the broader CGT landscape. In short, As patient access expands and new therapies are approved over time, BioLife will continue to grow with that dynamic, leveraging our market-leading position and trusted customer relationships to capture durable, recurring revenue growth. Finally, given the results through the first nine months of the year and our visibility into Q4 at this point, we're raising our full-year self-processing revenue guidance, which was $91 to $93 million. to 93 to 94 million, representing a 26 to 28% year-over-year growth rate. Total revenue guidance, when adjusted for the sale of EVO, is expected to come in at 95 to 96 million, representing a growth rate of 27 to 29% on a like-for-like basis. With that, I'll hand the call over to Troy, who will provide an overview of our full Q3 results and changes to our total guidance. Troy?

Thank you, Rod. We reported Q3 revenue of $28.1 million, representing an increase of 31% year over year. The year over year increase was primarily related to a 33% increase in our cell processing platform, driven by strong demand from biopreservation media customers with commercially approved therapies. In addition, Q3 included a biopreservation media sales order of approximately $1.3 million that was anticipated to ship in Q4, but based on the customer's request, was shipped in Q3. GAAP's gross margin for Q3 2025 was 62% compared with 63% in Q3 2024. Adjusted gross margin for the third quarter was 64% compared with 67% in the prior year. The decrease in adjusted gross margin percentage compared with the prior year was primarily attributed to a $600,000 one-time inventory reserve we took in Q3 2025, which represented approximately 2% of our Q3 2025 revenue. Additionally, there was a less favorable product mix compared to the prior year. GAAP operating expenses for Q3 2025 were $28.2 million versus $21.8 million in Q3 2024. The increase compared to the prior year can be attributed to increases in cost of sales related to our increased revenues and an increase in stock-based comp expense of $1.8 million over Q3 2024 related to performance-based awards. Adjusted operating expenses for Q3 2025 totaled $16.6 million compared with $14.1 million in the prior year. Gap operating loss for Q3 2025 was $89,000 versus $418,000 in the prior year. The decrease in gap operating loss was primarily due to increased revenue compared to the prior year. Our adjusted operating income for the third quarter of 2025 was $1.3 million compared with an adjusted operating income of $167,000 in Q3 2024. Our GAAP net income was $621,000, or $0.01 per share in Q3, compared to GAAP net loss of $471,000, or $0.01 per share in the prior year. The increase in net income was primarily due to increased revenues compared to the prior year. Adjusted EBITDA for the third quarter of 2025 was $7.8 million, or 28% of revenue, compared with $5 million, or 23 percent of revenue in the prior year. Adjusted EBITDA increased in the prior year primarily due to a $3.9 million increase in gross margin driven by increased sales of biopreservation media and includes a $600,000 one-time inventory reserve. Turning to our balance sheet, our cash and marketable securities balance reported as of September 30, 2025, was $98.4 million, compared with $100.2 million as of June 30th, 2025. Taking into consideration are adjusted EBITDA of $7.8 million in Q3. Cash usage was primarily driven by capital expenditures of $3.7 million, debt principal payments of $2.5 million, and the purchase of the Pluristix convertible promissory note for $2 million. The September balance excludes the proceeds from the sale of our EVO cold chain logistics product line, which occurred on October 6th. The entirety of our $7.5 million SVB debt balance is considered short-term. Our final payment on the SVB debt balance is due June 2026. We continue to expect making quarterly repayments of $2.5 million and have a $1.2 million loan maturity balloon payment due at that time of maturity. Subsequent to quarter end on October 6th, we completed the sale of our EVO cold chain logistics subsidiary for an aggregate sales price of $25.5 million, subject to certain adjustments. In our Q3 earnings release, we are presenting an estimate of key financial results, excluding EVO by quarter for 2024 through Q3 2025. Turning to our 2025 financial guidance, We are increasing our original guidance from our Q2 earnings call, and we are adjusting our four-year guidance to reflect the divestiture of the EVO cold chain logistics business, which occurred on October 6th, and we anticipate will be classified as discontinued operations. Our previously stated revenue guidance from the Q2 earnings call was $100 million to $103 million, which included approximately $8 million of revenue attributed to EVO. Adjusting for EVO, our total revenue guidance would have been $92 million to $95 million. We are now raising our adjusted 2025 total revenue guidance to $95 million to $96 million, which includes our cell processing and ThalStar product lines, representing an increase of 27% to 29% when compared to prior year revenue on a like-for-like basis. Our adjusted revenue guidance includes increasing our self-processing revenue guidance from $91 million to $93 million to $93 million to $94 million, or a 26% to 28% growth rate compared to prior year. Our guidance implies a sequential decrease in revenue in Q4 compared to Q3 due to the $1.3 million media order that was anticipated to take place in Q4, but based on the customer's request, was shipped in Q3. We continue to expect adjusted gross margin for the full year to be in the mid-60s, a reduction of gap net loss, and expansion in adjusted EBITDA margin in 2025 when compared to 2024 due to higher expected revenue partially offset by increases in R&D expenses related to development projects. Finally, in terms of our share count, as of October 30th, we had 48.1 million shares issued in outstanding, and 50.1 million shares on a fully diluted basis. Now, I'll turn the call back to the operator to open up for questions.

Thank you. We will now begin the question and answer session. To ask a question, you may press star, then one on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then two. At this time, we will pause momentarily to assemble our roster. And our first question will come from the name of Paul Knight with KeyBank. Please go ahead.

Hi, Rod. Congratulations on the quarter.

Thanks, Paul.

What's pricing like? What was it in three or nine months, year to date? And what do you anticipate pricing to be in 2021? years ahead.

So I'll take the last part and let Troy address the first one. So we're expecting to increase prices in 26 between 4% and 6% depending on the SKU.

And if you're talking about price growth in year-to-date Q3, we did have price growth that was higher than our list price increases due to those customer contract negotiations we've been talking about.

Okay. And on your direct sales, I know you're trying to sell a variety of products now. What have you been doing with headcount, non-media sales? Could you give us color about, you know, do you continue to increase that direct sales level in the future quite a bit? Where are you with headcount to give us a gauge of kind of what your efforts are, maybe headcount versus a year ago on direct sales?

Yeah, so I'd say that we've added perhaps one that's focused on the cross-selling opportunity that we have, bringing that to a total of about six, right? But until we're confident, Paul, of the return on that investment, we're going to hold fire, although I do suspect we'll add some in 2026. I think what it comes down to is that it doesn't take a lot of people for us to focus on sort of the first, the top 20, of our direct customers who are the key candidates to absorb or adopt some additional technology. So the numbers are pretty small. I think the sales team is also going out and speaking with the sort of 30% of the biopreservation media clinical trials. that we are not known to be SPECT in. We may well be SPECT in some of them, but it's not obvious to us to determine what we can do there. But if I look at the clinical pipeline of our core direct customers that have commercial therapies in the market today, let's call it half a dozen of those, their clinical pipeline is very robust. And the focus is on getting those folks to adopt, whether it's the cryo case, the cell seal, or RHPL or CT5. Those are the four key products that we're trying to cross-sell into that base.

Okay, thanks.

Our next question will come from the name of Matt Stanton. Please go ahead.

Thanks. Rod, maybe one for you. Just in terms of what you saw in 3Q, obviously it sounds like the commercial was chugging along nicely. Would Love to just get a little bit more color. Sounds like trends were solid across the broader cell processing tools portfolio, albeit that's a smaller piece. And then just curious on the clinical side, we've seen a couple months here of a little bit better biotech funding, but we'd love a little more color on what your discussions are like there as well. Thanks.

Yeah. To your point, I think across the board from a customer segment perspective, we had growth, but the rates of growth over these different segments are definitely pretty dramatic with the core commercial customers really driving the overall growth in terms of their own growth rate year over year. Again, you know, we keep in good touch with our key distributors, and at least as of our last quarterly business review with StemCell, our largest distributor, and who would be the most susceptible to the sort of funding issues that you're talking about, there's nothing that they can point to, either good or bad, that would explain sort of the progress that they're seeing this year. So they're not raising any red flags, and they're also not saying, hey, there's nothing to worry about. So it's still a bit of a wait-and-see mode. With the government shutdown, we have not seen anything specific, but if we were, it might be some relatively small amount of revenue that would hit in Q4. And we've built that in. To the extent we believe that's going to happen, we've already built that into the rest of the guidance that we have for the year.

All right. That's helpful. And then maybe just taking a step back and thinking about, you know, the framing around 26. I know it's early days, but you have Evo gone. I think the rest of the portfolio you have pretty good visibility in. If we start to think about 26, you'll have a tougher comp relative to this year. Sounds like there's been nice pricing this year, but you also expect to take pricing next year. Can you help kind of help us frame how you're thinking about 26?

Yeah, I'll do it qualitatively, Matt. You know, we believe we've got really strong momentum going into 26. We expect that a lot of the growth in 26 that we're going to realize will be driven by those commercial customers. But we do expect to see growth across all of our customer segments in the year. We're expecting to receive the full 26 forecasts from these large customers in January. And that's a key part of our our methodology relative to developing guidance. And so we're going to have that by the end of January so that we'll be ready to provide a very specific guidance, which is based on some pretty good visibility on our FY25 call in mid-February. Awesome. Thank you.

And our next question will come from Mac Itok with Stevens. Please go ahead.

Hey, good afternoon. Thanks for taking my questions. I'll add my congrats as well. Maybe just a few from me. You know, now that the EVO platform is gone and kind of removed from numbers, do you anticipate any lingering costs in Q4 and in the FY26? And then secondly, this is essentially the last piece of the strategic review puzzle that's now complete. What are you thinking in terms of capital allocation with the cash that you have on your balance sheet?

Thanks. Roy, you want to take the first one?

Yeah, so as far as your question about lingering costs in Q4, if you look at the earnings release and we provide an estimate of our financial results excluding Evo, so if you look at that Q3 number, that's a good baseline for Q4 as well. At this point, there's really no lingering OPEX in our corporate structure. It's really what's in that results that we've presented in the earnings release is how we see it today.

And on your capital allocation question, Mac, I think that, you know, we are definitely interested in exploring adjacencies relative to not only our existing product line, but things that dovetail with our core competencies. So we're definitely going to be getting a little more aggressive in that exploration activity in 26, now that sort of the the strategic transformation work is behind us. It also dovetails with developing our own three-year product roadmap for the technology we have today. I will say, though, that given the fact that we're going to be pretty disciplined about what we look at and key filter criteria for us when we look at something inorganic would be that there is not a negative or at least materially negative impact on our financial profile. And while there are assets out there that would fit with us, that piece of the criteria is going to make some of these deals just not pass muster. And that's, you know, I'm pretty set on not going backwards from a financial profile standpoint. We've achieved a lot. I think that we have significant margin expansion in front of us, and I don't want to retard that in any way or attenuate that.

I appreciate the context. I'll leave it there.

Thank you.

Our next question comes from Brandon Smith with TD Cohen. Please go ahead.

Hi, guys. Thanks for taking the questions. Apologies if it's a little loud. Nice to see the steady demand across the segment and the new guidance, too. Kind of just piggybacking on some of the earlier questions here, just trying to get a little bit better sense for the really next wave of growth for you all. I guess in conversations with customers, how are you kind of feeling like a potentially more stable funding environment for pharma and biotech might impact their risk appetite to either expand some of these use cases for CNGT or even maybe rotate out of these modalities altogether, just kind of trying to understand some of the puts and takes for maybe the next 18, 24 months?

Yeah, so when you look at the contribution to total revenue that our commercial and our late-stage clinical customers provide, which is in excess of 50% of our BPM revenue, we believe that that's going to continue to grow and accelerate. And so, really, that's what we're relying on for the next 18 to 20 months, 24 months, let's say, for growth drivers. We do believe everything else will grow, but in terms of the growth – stronger growth rate, it's going to come from there. So, you know, the good news is that most of our commercial customers also have a pretty deep clinical pipeline. I mean, we're in 30 phase three clinical trials, and we believe that a good portion of those over the next 24 months will get across the line, which will just be additive to the growth that's coming from our existing commercial therapies.

Got it. Thanks, guys.

Thank you.

Again, if you have a question, please press star, then one. Our next question comes from Thomas Flatton with Lake Street. Please go ahead.

Hey, guys. Appreciate you taking the questions. Ron, on some prior calls, there had been some discussion around you had a customer evaluating the cryo case. Any update on how that project is going?

Yeah, it's going. You know, and I think we're getting closer to a point where we're getting them to make a commitment to us in exchange, as I've talked about before, for doing some development work. We're not going to do the development work on the come per se, but these are large organizations. They've got a lot of things going on. The good news is that, again, deep clinical pipeline, we're not going to be in their commercial therapy, which is going great guns, but they're They definitely have a pain point on bags. They've expressed that to us a number of times. So it's really our product development team working with their process development folks about exactly what changes they want made. I think we're pretty close to that part. And now it's really coming down to the more commercial discussion of, okay, what level of commitment can you make to us for us to go ahead and expend the resources to make this happen. And we could, of course, do it just on the come, but I think it's important to solidify their commitment to adopting the technology into their clinical pipeline before we start spending money on it.

Got it. Got it. And then just to follow up on a prior question regarding the strategic review process being complete. So, FAW is with us, right? FAW is not going anywhere. That was never on the table, just to confirm.

It was never on the table. We feel that thaw is almost a reverse razor, razor blade type of product. You know, we recently, well, recently, I'd say in the last year and a half, we were able to get the thaw unit to work with Celsius vials because the Celsius vials were of a different size that the thaw vial device was set up to thaw. We're now in the process of doing that for our cryo case so that we have an automated thaw device for cryo case. And it's just extremely complimentary relative to those two products. So it's got good margins. We put very little sales and marketing effort into it at this point, and yet it delivers consistent growth at a really attractive rate. So it's definitely a keeper.

Got it. I appreciate it. Thanks, guys. You bet. Thank you.

With no further questions, this will conclude the question and answer session. I would like to turn the conference back over to Roderick DeGrieve, CEO and Chairman of the Board, for any closing remarks.

Thank you, Wyatt. In closing, it's been two years since I returned to the company in an operating role. As I look back, I'm very pleased with the progress the BioLife team has made in executing a fundamental strategic transformation. In the last 24 months, we have solidified and built upon our market leadership position in biopreservation media, driving strong top-line growth and significant margin expansion. We have optimized our product portfolio so that we can focus our efforts on our higher growth and higher margin recurring revenue products. We have also strengthened our balance sheet and have the resources to explore inorganic product portfolio expansion into relevant adjacencies in a measured and disciplined manner. All of this, in combination with what is still a relatively nascent but very exciting market, leaves us confident in our ability to continue to deliver sustainable revenue growth, margin expansion, and shareholder value creation in 2026 and beyond. Thank you for your time today, and I look forward to seeing some of you at upcoming investor conferences.

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.