BioLife Solutions Inc (BLFS) 2025 Q4 法說會逐字稿

Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to the BioLife Solutions Q4 2025 Shareholder and Analyst Conference Call. (Operator Instructions) 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 2025 Fourth Quarter Earnings Conference Call. On this call, we will cover business highlights, financial performance for the fourth quarter and full year 2025 and provide 2026 financial guidance. Earlier today, we issued a press release announcing our financial results and operational highlights for the fourth quarter and full year of 2025 and provided 2026 financial 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. Unless otherwise noted, all financial measures discussed reflect 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 2025 Conference Call. 2025 was another strong year for BioLife, delivering double-digit revenue growth, operating margin expansion and improved profitability. Throughout the year, we executed consistently against our key strategic priorities, advanced our efforts to reposition the portfolio and strengthened the foundation to scale the business for years ahead.

We exit the year simpler, more focused and structurally stronger. With the divestiture of our evo product line behind us, we enter 2026 with a strong balance sheet and a fully optimized portfolio that plays to our strengths and positions BioLife to drive sustainable, profitable growth and shareholder value.

Compared to 2024, our '25 results from continuing operations demonstrate our increasingly attractive financial profile, which is driven by the culmination of our multiyear strategic transformation, a streamlined portfolio centered on market-leading consumables and sustained growth from our commercial CGT customers, which reinforces our positioning to benefit from the continued growth and maturity of our end market.

On the top line, total revenue grew 29% to $96 million, landing at the high end of our guidance, which was raised twice in the second half of the year. While gross margin experienced a decline year over year, primarily reflecting product mix and lower bag yields in the second half, operating leverage more than offset this impact and contributed to an increase in adjusted EBITDA to $25 million or 26% of revenue, up from $13 million or 18% in 2024.

In the fourth quarter, total revenue reached $24.8 million, increasing 20% year over year, driven primarily by continued strength in our biopreservation media or BPM franchise, with broad-based growth across our entire cell processing tools portfolio.

Turning to Q4 revenue composition. Our BPM product line accounted for approximately 85% of total revenue with our top 20 BPM customers continuing to account for roughly 80% of BPM revenue. This concentration provides enhanced visibility into demand across this core part of our business. These metrics remain consistent with prior quarters and reinforces the stability of our recurring revenue base.

Staying with our BPM products, direct customers continue to represent the majority of our mix versus distribution and commercial BPM customers accounted for nearly 50% of revenue, up from the low 40s range in '24. Both of these metrics reflect the ongoing shift toward later stage and approved therapies that support both near-term and long-term growth.

Stepping back from the quarter, our position within the broader CGT landscape remains strong. Our BPM products are embedded in 16 approved therapies and utilized in more than 250 relevant commercially sponsored CGT trials in the US, representing over 70% share. This includes more than 30 Phase 3 trials in which our share is approaching 80%, underscoring BioLife's position as the partner of choice for later-stage clinical programs where success rates are higher and the path to commercial revenue is more clearly defined.

Longer term, a key driver of CGT market growth remains the pace of FDA approvals, including unique therapy approvals, expanded indications, geographic expansion and movement into earlier lines of treatment. While 2025 saw fewer approvals relative to '24, we anticipate up to five unique therapy approvals over the next 12 months, along with one new indication and at least one geographic expansion.

We believe that the unique approval funnel is beginning to regain some momentum. This evolving regulatory backdrop supports our ability to capture additional value, especially within the late-stage programs we are already embedded.

Building on our BPM market leadership, we are working to expand our role within these clinical and commercial programs beyond biopreservation media. Our sales and marketing team is actively driving adoption of our broader cell processing tools across our marquee BPM customer base. As we've discussed previously, this cross-sell opportunity has the potential to increase our revenue per patient dose by 2 to 3x relative to our BPM products alone as customers incorporate additional components of our offering into their workflows.

We have numerous product evaluations underway, including several with our largest commercial customers. While adoption cycles are lengthy, engagement remains strong, and we expect to demonstrate some traction in 2026. Complementing our cross-sell strategy, we are also evaluating portfolio adjacencies that build on our scientific and commercial capabilities.

In 2025, we assessed opportunities aligned with our product profile requirements that could broaden our product offering and bring additional value to our customers. One attractive strategic adjacency we identified is cytokines, which represent a natural complement to our emerging hPL product line.

Earlier this month, we entered into a strategic distribution and product development agreement with UK-based Qkine Limited. The agreement provides us with exclusive distribution rights for certain cytokine products and nonexclusive rights for the others within the CGT market. In addition, our product development teams will work together to package and store certain cytokine products in our CellSeal vial line.

Our acquisition of PanTHERA and the investment in Pluristyx last year, together with this new partnership, reflects our strategy to expand the platform through targeted M&A, minority investments and strategic collaboration. These actions broaden our offering and increase our participation in the evolving cell therapy ecosystem.

Turning to our outlook for '26. We issued guidance this afternoon, which included revenue between $112 million and $115 million, representing growth of 17% to 20%. As in prior years, our initial guidance reflects the visibility we have today based on the demand forecast from our key BPM customers. In addition, we see continued operating and adjusted EBITDA margin expansion and expect the company to generate full year GAAP net income for the first time in many years.

Before handing it over, I'd like to comment on some recent developments in the cell therapy space, including encouraging clinical data in larger indications, continued advances in automation and manufacturing scalability and renewed strategic investment by large pharma through multibillion-dollar acquisitions and next-generation facility build-outs, all of which reinforce our confidence in the long-term trajectory of the field and the attractiveness of the CGT market.

BioLife is well positioned as a market leader to benefit as these dynamics translate into durable demand over the long term. With that, I'll hand the call over to Troy, who will provide an overview of our full Q4 and 2025 results and more details of our 2026 guidance. Troy?

Thank you, Rod. Today, we will be reviewing current and prior period financials from continuing operations for Q4 and full year 2025 and providing 2026 financial guidance. Unless otherwise noted, all financial measures discussed reflect adjusted non-GAAP measures.

Before we start with the financials, I am pleased to report we implemented our ERP manufacturing modules in the beginning of February with no disruption to operations. This module allows for greater automated processes and controls for our manufacturing, quality and accounting functions. This in turn, provides a systematic foundation and automated processes to leverage into our planned growth.

As shared in our press release today, we reported total Q4 revenue of $24.8 million, representing an increase of 20% over the prior year and full year revenue of $96.2 million, representing an increase of 29% over the prior year. The year-over-year increase in both periods was primarily related to increased demand for biopreservation media from our customers with commercially approved therapies.

For the full year 2025, we had growth across all product lines, except our hPL media business, which was flat year over year due to certain import restrictions in China, which has since been abated. Adjusted gross margin for Q4 2025 was $15.8 million or 64% compared with $14 million or 67% in the prior year.

Full year adjusted gross margin was $63.2 million or 66% compared with $51.4 million or 69% in the prior year. The decrease in adjusted gross margin as a percentage of revenue in both periods were due to continuing product mix shift towards bags, which carry lower gross margins than bottles, and we had lower-than-anticipated bag yields in the second half of the year. Improving bag yields is a clear operational priority as we enter 2026.

Adjusted operating expenses for Q4 2025 totaled $14.7 million compared with $13.8 million in the prior year and for the full year was $59.3 million compared to $52.9 million in the prior year. Adjusted operating income for the fourth quarter of 2025 was $0.9 million compared with adjusted operating loss of $0.2 million in Q4 2024.

Full year adjusted operating income was $2.9 million compared to adjusted operating loss of $2.6 million in the prior year. Adjusted net income was $1.9 million in Q4 compared to adjusted net loss of $0.1 million in Q4 of the prior year. Adjusted net income for the full year was $6.3 million compared to adjusted net loss of $2.9 million in the prior year. The increase in adjusted operating income and adjusted net income was primarily driven by an increase in revenues year over year, in addition to a decrease in our sales tax accrual of $1.3 million. This was partially offset by increases in R&D expenses from increased headcount and investment in key projects.

Adjusted EBITDA for the fourth quarter of 2025 was $6.9 million or 28% of revenue compared with $3.7 million or 18% of revenue in Q4 of the prior year. Adjusted EBITDA for the full year was $25 million or 26% of revenue compared with $13.3 million or 18% of revenue in the prior year. Our adjusted EBITDA increased primarily due to higher revenue. In addition, we had a $1.3 million gain on the sales tax true-up recorded in Q4, which had approximately a 500 basis point impact on our adjusted EBITDA margin in Q4 and a 100 basis point impact for the full year.

Turning to our balance sheet. Our cash and marketable securities balance at December 31, 2025, was $120.2 million compared with $98.4 million at September 30, 2025, and $105.4 million at December 31, 2024.

Taking into consideration our adjusted EBITDA of $6.9 million, our increase in cash during Q4 2025 was primarily related to the $23.5 million in cash proceeds from the divestiture of SAVSU, partially offset by CapEx spend of $4.4 million, working capital usage of $2.2 million and debt payments of $2.5 million. Our remaining FCB debt balance at December 31, 2025, was $5 million, all of which is short term. We expect to pay off the entirety of the loan by June 2026 in addition to a $1.2 million loan maturity balloon payment due at the time of maturity.

Turning to 2026 financial guidance. Total revenue is expected to be $112.5 million to $115 million, reflecting overall growth of 17% to 20%. The increase is primarily due to expected demand from our BPM customers with commercially approved therapies as well as increased demand for our other tools.

We expect GAAP and adjusted gross margin for the full year to be in the mid-60s. We expect gross margins generally to be in line with 2025 due to favorable higher average selling prices, partially offset by product mix, primarily due to higher growth rates from our other cell processing tools.

As Rod stated, we expect to achieve full year positive GAAP net income and further expansion of adjusted EBITDA margins compared to 2025. The expected improvement in net income and adjusted EBITDA margins from 2025 is primarily driven by expected increased revenue, partially offset by expected increases in R&D and sales and marketing expenses to support our longer-term growth plans.

Finally, in terms of our share count, as of February 19, 2026, we had 48.3 million shares issued and outstanding and 50.2 million shares on a fully diluted basis. Now I'll turn the call back to the operator to open up for questions.

(Operator Instructions) Matt Stanton, Jefferies.

Hey, guys, thanks. Maybe just to kick off for the guide, any more color you can provide in terms of assumptions between commercial and clinical? Rod, I think you said commercial went from low-40s to the mix to about 50%. Can we see a similar magnitude of uptick in '26 on the commercial side?

And then just on the clinical side, are you starting to see some of the positive biotech funding data show up in activity levels or orders from customers? Just a little more flavor on what you're starting to see on the clinical side would be helpful as well.

Sure. So we had a strong increase in our commercial customer revenue as a portion of total revenue. As we mentioned, it's about 20 points, a little less -- actually, sorry, a little less than 10 points. But I think it's going to be not quite that much, and I would expect our commercial customers to be somewhere between 50% and 55% in '26.

With respect to the second half of your question, we're not really seeing any significant uptick. And I think the reason for that is these customers are small, Matt. And so to the extent that they're either constrained or not constrained, the amount of product they buy from us is pretty small in the early stages. So we're really not seeing any major effect of that.

Okay. And then just on the bag yield impact, is there any way to quantify what that was as a headwind in terms of margins in the back half of '25?

And then, Rod, I think you talked about it as a clear priority for '26. Can you just talk a little bit more about timing and logistics in terms of resolving the bag yield headwind you saw in the back half of the year?

Yeah, you bet. I think it's about a 2- to 3-point headwind on the gross margin in the second half of the year. I believe that we have found a solution to the issue. It's a solution that requires a 90-day customer notification. So we've got that piece that's by definition built in from a timing perspective.

And then in addition to that, we have to sell through the higher cost inventory that we have in terms of finished product that's in bags sitting in our warehouse before we'll start to see the impact of the higher yield bags come through, which we expect would be right around Q4 of this year.

Thank you.

You bet.

Anna Snopkowski, KeyBanc Capital Markets.

Hi. This is Anna on for Paul. Congrats on a great quarter. My first question is just around the CAR T market. It seems like we're getting better patient access with the REMS removal.

I was just wondering if you've seen this impact your top line at all or just customers' outlook at all? And then could you just remind us your exposure to CAR Ts at this point? And then I have one follow-up.

Yes. In terms of our commercial exposure, I would say it's at least over 80% with respect to CAR Ts at this point, if not a little bit higher. It's really hard, Anna, to try to parse out the impact of REMS. First, it just happened, right, within the last 6 months or so, and I think it's going to take a while for that to flow through to an increased number of patients being treated.

So while we think it's an excellent move in the right direction because I think patient access is probably the single largest constraint to the overall adoption. I've read where 20% of people who are eligible for CAR T are actually receiving CAR Ts, so I think patient access is a key factor in future growth. But it's hard to try to parse it out to the point of saying we've seen anything or not seen anything.

Okay. And then just quickly following up, on your outlook for 2026, how much would you say is rooted in commercial growth versus dependent on an improving macro conditions in clinical trials? Or would you say most of your outlook is towards the commercial side?

Yeah. I think it's fair to say, Anna, that the primary driver for growth this year is going to be continued growth from the commercial customers that we have.

Thank you.

You bet.

Brendan Smith, TD Cowen.

I actually wanted to follow up on your commentary regarding the cross-selling there just a little bit more. Can you maybe expound a bit on really what ultimate success kind of looks like within that initiative?

And sorry if I missed it, but can you just confirm if any contribution through that is included in some of your '26 guidance assumptions? Or should we think of that more as upside?

Well, we have a base assumption around how much of the growth of our other tools, non-biopreservation media tools, that growth, how much of that is fundamentally related to therapies we're specced into, for example, on the CellSeal vial side versus new business that we're assuming to have come in. So we're pretty clear about that split, although we won't get that granular on this call.

I think the ultimate measurement or metric, Brendan, at this time, at least for most of this year until we get a little bit more rigorous in our own data analysis is the growth rate related to the non-BPM tools versus BPM. And we do expect as a basket that the non-BPM tools will grow at a faster percentage rate than BPM in part because it's a smaller number, smaller base that we're starting from.

But as we put more focus on this and our systems get up to speed, we should be able to start speaking to the number of customers that are using one of our products, two of our products, three or more of our products, and that is definitely a goal internally to pull those metrics together and then figure out a way to report that externally.

Okay, thank you.

Mac Etoch, Stephens.

Hey, good afternoon. And thank you for taking my question. Maybe one on the partnership agreement you signed earlier this year. It's a pretty interesting deal, maybe a little outside of your normal deal structure. But what can you share with us just in terms of maybe the margin profile? I guess first, to start, maybe the adoption potential of that product with your CellSeal vials and all that? And secondly, what could the margins look like for that type of business?

Yeah. So I'm not going to speak specifically to the margins, Mac, just from a competitive perspective. But we certainly got a margin profile that reflects the volume that we anticipate to move.

With respect to the combination of their cytokines in our CellSeal vials, that's probably a 6- to 9-month development project right there, so we wouldn't expect to see much in the way of that revenue in terms of pull-through on the CellSeal vial side of things until the end of this year, early next.

But this is a long-term strategic move for us, right? It's not about generating X amount of revenue in '26, although we will drive some revenue. But really, it's a longer-term market segment, product category that we want to be in and feel we can win there, and that's why we're there.

Appreciate that. And then maybe -- you touched on the bags being an issue in the second half of last year, as it relates to CryoCase, do you see that as a potential opportunity to maybe reduce scrap and improve margins long term as CryoCase is adopted?

Yeah. So it's important to keep in mind that the CryoCase as it's configured today is designed for the final product going from the developer's factory to the patient. The rigid container, or we call it the RCC, is designed and being designed to take 100 mls of our product from our factory to our customer, which is where we have the bag problem, right?

So currently, we're shipping most of our commercial product in bags from our facility to the developer's facility. And then they drain that and they use it in their workflow. The idea would be to replace that bag on the front end, if you will, with the RCC. And we're probably 18 to 24 months away from doing that.

So the remediation that I talked about is really process oriented on our end. And I think that is going to alleviate the -- sort of the higher-than-average scrap that we've realized over the last 6 months.

Matt Hewitt, Craig-Hallum Capital Group.

Good afternoon. Maybe first up, just so I heard you correctly, gross margins are still going to be weighed on a little bit here first half of the year in particular. So should we be thinking somewhat similar in Q1 versus Q4?

Yeah, that's correct. And actually, throughout the remainder of the year, as Rod mentioned, we do have inventory on hand, and it is going to take time to implement our strategies and our customers to adopt the new product format, so if you look at the full year, I would still expect in line with our guidance is what we said.

Got it. And then obviously, the Qkine partnership is unique. It's an opportunity to get into some new areas. Are you looking or exploring for more of those types of partnerships? Or are you still kicking the tires on potentially adding via acquisition?

Yeah. I think it's all three of the things that I mentioned, which would be an outright targeted acquisition, minority investment strategy and/or a strategic collaboration like we've done with Qkine. And that's not to say that what we've done with Qkine is the final end step with them, right? As this relationship evolves into the future, as we understand how to sell that product better, it could very well be that things develop down the road with that particular company.

Thank you.

You bet.

Carl Byrnes, Northland Capital Markets.

Actually, most of my questions have been answered. I'm just wondering if you're seeing any potential acquisitions that would be in the biopreservation area where the valuations have kind of come back to what would be a more normalized attractive level to pull the trigger.

So Carl, other than the PanTHERA acquisition, we keep a pretty close eye on what we consider to be potentially competitive technology in biopreservation.

And while we are pretty rigorous in evaluating what's out there, nothing has come to our attention that would provide us with any sort of competitive advantage or value proposition that we don't already provide. That's why PanTHERA was unique, and that's why we made the move with it that we did.

Congratulations again.

Michael Okunewitch, Maxim Group.

I guess, I would like to ask a little bit about the Qkine collaboration in particular. How comprehensive is this? And are there other commonly used cytokines and growth factors for cell and gene therapy manufacturing that might be the subject of future agreements or M&A activity?

Yes. I think the short answer is yes. The deal as it stands now was specific from an exclusivity perspective to certain of their cytokines that we believe are geared toward the types that are used by our key customers as well as the pipelines that they have, so that's why it's a fairly narrow exclusivity and we do have access to a much broader number of products on a nonexclusive basis.

So again, I would reiterate that this is the first step. We've spent quite some time developing the relationship, primarily through our VP of Sales, who's also located in the UK and has a history with these folks. And so I'd say it's step one of a number of different ways the relationship could continue to move forward.

And then just to follow up on that. As you're saying, there is exclusivity on a limited number of cytokines, but is that exclusivity going both ways as in terms of who else can use CellSeal for those particular cytokines, potential distribution agreements that you may enter or any acquisition? I'm trying to see if the exclusivity is just for you or for them to you as well.

Well, right now, it's one way for us relative to their cytokines. We have a sort of loose intent between the two parties around CellSeal, so we have to pay for that still.

But I anticipate based on the discussions that we've had that it's in their interest and our interest to widely have their products sold through with the CellSeal packaging to wherever it needs to go or wherever they would like it to go because that benefits us and it benefits them, and it's unique to them. We don't anticipate at this point in time, entering into any agreements with other cytokine manufacturers to utilize the CellSeal vial.

This concludes the question-and-answer session. I would like to turn the conference back over to Roderick de Greef for any closing remarks. Please go ahead.

Thank you, operator. In closing, we expect 2026 to be another strong year of revenue growth, operating margin expansion and increased profitability. As the broader macro environment continues to evolve favorably, we remain focused on supporting our core BPM customer base and increasing adoption of our non-BPM products and driving operational excellence across the organization.

We are confident that our market leadership and business model position BioLife to benefit from the secular trends developing across our growing yet still early-stage end markets, enabling us to deliver sustainable revenue growth, expanding profitability and long-term shareholder value creation. Thank you for your time today, and I look forward to seeing some of you at upcoming investor conferences.

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