Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to the BioLife Solutions Q2 2025 Shareholder and Analyst Conference Call. This conference is being recorded. I'd now like to turn the call over to Troy Wichterman, Chief Financial Officer of BioLife Solutions. Please go ahead, Mr.

Thank you, operator. Good afternoon, everyone, and thank you for joining the BioLife Solutions 2025 Second Quarter Earnings Conference Call. On the call with me today is Roderick de Greef, 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. Earlier today, we issued a press release announcing our financial results and operational highlights for the second 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 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 Second Quarter 2025 Conference Call. We delivered another strong quarter as our team continues to execute and build on the momentum established over the last several quarters. On the top line, cell processing revenue increased 28% year-over-year, driving a 29% increase in total revenue for the quarter. With strong performance in cell processing revenue, coupled with meaningful adjusted EBITDA margin expansion, which is up 400 basis points to 24%, we're seeing the operating leverage play out in our financial results, realizing the benefits of our optimized product portfolio and streamlined operations. With over $100 million in cash and marketable securities at quarter end, we're operating from a position of strength, enabling us to invest in our strategic priorities. This includes advancing targeted growth initiatives as evidenced by our recent investment in Pluristyx while continuing to drive market share in our core cell processing business. We remain highly focused on operational execution and disciplined capital allocation to ensure we're deploying resources where they can generate the greatest return. Our strategy is working. With a sharpened focus, a leading product portfolio and an enhanced financial profile, we believe we're well positioned to deliver sustainable growth throughout the balance of 2025 and beyond. This confidence is reflected in our decision to raise our full year revenue guidance, driven by continued strength in cell processing, even as broader macro uncertainty persists. I'll speak more to this later in my prepared remarks. Looking at our second quarter more closely, cell processing revenue reached $23 million, a 28% year-over-year increase and up 6% sequentially, making this our seventh consecutive quarter of cell processing revenue growth. Performance was led by continued strength in our core biopreservation media, or BPM product line, which represents approximately 85% of our Q2 cell processing revenue. In Q2, our top 20 customers continue to account for approximately 80% of BPM revenue, which provides us with the benefit of increased visibility to a critical portion of our business. As in prior quarters, approximately 60% of our BPM revenue came through direct sales and 40% through distribution. Consistent with our last report, roughly 40% of total BPM revenue was generated by customers with an approved commercial therapy, representing more than half of our direct channel BPM revenue. While a portion of that demand supports clinical trials and process development rather than specific patient dosing, we continue to view these commercial customers as a key growth driver in the quarters ahead. I highlight this because it reflects the resilience and consistency inherent in our model, anchored to later-stage and approved programs that are less susceptible to funding constraints. Overall, these metrics remain broadly consistent with what we saw in the first quarter of 2025, reinforcing the stability and recurring nature of our cell processing business. BioLife has become the default partner for later-stage clinical programs where success is more likely and the path to commercial revenue is more defined, and the data continues to support this position. At the end of the second quarter, our BPM products were embedded in a total of 16 approved therapies and used in more than 250 relevant commercially sponsored CGT trials in the U.S., representing over a 70% share. Notably, this includes more than 30 Phase III clinical trials, bringing our estimated share in this phase to nearly 80%, underscoring our leadership in late-stage clinical development. Harnessing this momentum, our sales and marketing team is spending the majority of their time visiting customers, and they remain focused on deepening relationships with our key BPM accounts, both commercial and clinical, in order to unlock cross-sell opportunities to drive broader adoption of our full cell processing portfolio. Today, our CellSeal and hPL products are utilized in 4 approved therapies in the U.S. and internationally, in addition to being used in over 35 commercially sponsored clinical trials in the U.S. We believe there is a significant long-term potential to scale these products over time. As we've shared before, each additional product integrated into a commercial therapy has the potential to materially increase revenue per dose, often by 2 to 3 times compared to our BPM products alone. Our commercial team is highly focused on advancing this cross-sell strategy. And today, we have a growing number of BPM customers, including large pharma, who have adopted or are evaluating at least one additional product. While this opportunity will play out over the mid- to longer term, early traction reinforces our confidence in its potential as a future growth lever for BioLife. In July, we made a strategic investment in Pluristyx, a local early-stage but revenue-generating developer of innovative iPSC-based products for the cell therapy market. Pluristyx has a strong scientific team with deep expertise in cell therapy, and the recent launch of a biological assay for organoid manufacturing aligns with our interest in exploring biological assays more broadly as a potential adjacency to our core cell processing portfolio. This investment demonstrates our commitment to exploring inorganic product portfolio expansion into relevant adjacencies in a measured and disciplined manner. We remain optimistic about the long-term fundamentals of the CGT industry but acknowledge persistent near-term uncertainties, whether from tariffs, NIH budget pressures, or ongoing leadership changes at the FDA. We are actively monitoring these dynamics from both a supplier and customer perspective, but do not expect any material impact on our financial outlook for the balance of 2025. That said, there have been some positive developments, which should lead to enhanced patient access to cell therapies over time. Specifically, we view the FDA's recent decision to remove the REMS requirement as an encouraging signal for the broader CGT landscape. This update reflects growing regulatory confidence in this class of therapies backed by years of real-world safety and efficacy data. By reducing patient monitoring burdens, this change should expand patient access, streamline clinical workflows, and ultimately drive increased referrals and uptake. Finally, given our strong first half performance and clearer visibility into second half demand, we're raising our full year cell processing revenue guidance to $91 million to $93 million, reflecting an increase of 24% to 26% over last year. With that, I'll hand the call over to Troy, who will provide an overview of our full Q2 results and changes to our total guidance.

Thank you, Rod. We reported Q2 revenue of $25.4 million, representing an increase of 29% year-over-year. The year-over-year increase was primarily related to a 28% increase in our cell processing platform, driven by an increase in biopreservation media revenue. GAAP gross margin for Q2 2025 was 62% compared with 64% in Q2 2024. Adjusted gross margin for the second quarter was 65% compared with 67% in the prior year. The decrease in adjusted gross margin percentage compared with the prior year was primarily attributed to fleet repair and maintenance costs at our evo operations and a less favorable product mix as a percentage of revenue. Despite the decrease in gross margin percentage, we had an increase of $3.2 million or 25% in gross margin dollars, reflecting strong revenue growth compared to the prior year. GAAP operating expenses for Q2 2025 were $42.1 million versus $21 million in Q2 2024. The increase compared to the prior year was largely due to a $15.5 million noncash IPR&D expense incurred in connection with the PanTHERA acquisition. We fair valued the IPR&D asset at $15.5 million, and in accordance with U.S. GAAP, the fair value of the asset was immediately expensed. For clarity, this is not an impairment and is treated as an expense under U.S. GAAP, and we are excited about the potential future of IRI technology. In addition, stock-based compensation increased by $1.9 million over Q2 2024. Adjusted operating expenses for Q2 2025 totaled $16.9 million compared with $14 million in the prior year. GAAP operating loss for Q2 2025 was $16.6 million versus $1.3 million in the prior year. Our adjusted operating loss for the second quarter of 2025 was $0.5 million compared with an adjusted operating loss of $0.8 million in Q2 2024. The increase in GAAP operating loss was primarily due to the $15.5 million IPR&D expense incurred in connection with the PanTHERA acquisition and an increase of $1.9 million in stock compensation. Our GAAP net loss was $15.8 million or $0.33 per share in Q2 compared to $5.6 million or $0.12 per share in the prior year. The increase in net loss was primarily due to the $15.5 million IPR&D expense we incurred, which had a $0.32 impact on EPS during the quarter. Without the impact of the IPR&D expense, our GAAP net loss per share would have been $0.01. Adjusted EBITDA for the second quarter of 2025 was $6.1 million or 24% of revenue compared with $3.9 million or 20% of revenue in the prior year. Adjusted EBITDA increased from the prior year, primarily due to the $3.2 million improvement in gross margin, driven by increased sales of biopreservation media and includes $220,000 of OpEx from the PanTHERA acquisition. Turning to our balance sheet, our cash and marketable securities balance reported as of June 30, 2025, was $100.2 million compared with $107.6 million as of March 31, 2025. Taking into consideration our adjusted EBITDA of $6.1 million in Q2, cash usage was primarily driven by the $11.5 million cash outflow for the purchase of PanTHERA, debt principal payments of $2.5 million, and capital expenditures of $1.9 million. The entirety of our $10 million SVB debt balance became short term at quarter end. Our final payment on the SVB debt balance is due June 2026. We expect to continue making quarterly repayments of $2.5 million and have a $1.2 million loan maturity balloon payment due at the time of maturity. Turning to our 2025 financial guidance, we are increasing our original guidance from our Q1 earnings call. Total revenue is now expected to be $100 million to $103 million, reflecting an overall growth of 22% to 25%. This is an increase from prior guidance of $95.5 million to $99 million. Our cell processing platform is now expected to contribute $91 million to $93 million or 24% to 26% growth over 2024. This is an increase from prior guidance of $86.5 million to $89 million. We did not change our revenue guidance under our evo and Thaw platform, which is still expected to contribute $9 million to $10 million or 3% 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&D expenses related to development projects. We do not expect any material revenue from PanTHERA in 2025. Finally, in terms of our share count, as of July 31, which includes shares issued from our PanTHERA acquisition, we had 47.9 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.

And the first question comes from Matt Stanton with Jefferies.

Maybe just first one on the guidance. The updated guide seems to suggest kind of a 6% ramp in the back half versus what you did in the first half year. Can you just talk about your level of visibility into that given some of the macro you called out? Is that all tied to commercial ramps? Are there any kind of later-stage clinical items you hope to see move further along? And then just maybe one quick one in terms of phasing. Any more color in terms of what you expect to see between 3Q and 4Q? I assume maybe there's a bit of seasonality in 4Q, but Troy, any more color on that would be appreciated.

Matt, it's Rod here. Yes, you're correct in the percentage increase first half to second half. And it's based on pretty good visibility with respect to the 80% of biopreservation media revenue that's made up of the 20 largest customers, including distribution, which we have decent visibility on as well. So we feel pretty confident. Based on what we're seeing, there may be some lumpiness between Q3 and Q4, but we're highly confident in the overall second half number and therefore, the full year number.

Yes. And to address your seasonality question, we really don't experience seasonality in our business. But as Rod mentioned, it really depends on the orders placed by our largest customers that influences that sequence.

Okay. Great. And then, Rod, you talked a little bit in the prepared remarks, but I would love to just hear a little more color from you on updates around the team's focus on cross-selling dynamics. I know you and the team have been focused on that. I think you talked about kind of early traction. Just any more color in terms of proof points? Is that trialing products? Is that early indications on orders, parts of the funnel? Just any more color you can kind of provide on the cross-selling dynamics and maybe just a little more color in terms of what's maybe near to midterm and then what's more mid- to long term?

Yes. So we look at it as a percent of our media customers that are purchasing and utilizing other technologies or tools that we have. That's sort of the framework that we look at it within. And we have some baseline numbers that we're working with coming out of '24 and then applying that same filter to Q1 and Q2. We're internally figuring out the best way to report that out and expect to be able to report it out in Q3 so that we have that be part of the periodic metrics that we report. But I think anecdotally, it's fair to say that we're definitely seeing some traction, and there are a couple of larger accounts that can provide some significant revenue opportunity with respect to adopting, for example, our CT-5 automated fill device with one of our largest customers that has two commercial therapies in the market and they're pretty close to making a decision on that. So all in all, I think things are going well. What's also helped is the fact that we finished up our clinical trial drill down in terms of really understanding what are the commercially sponsored clinical trials in the U.S. that we're in. And we talked to that both in the press release and in my prepared remarks. And so that really gives the sales team a roadmap to go out and talk to, call it, 70% of customers or clinical trials, I should say, that are using media and introducing the other products that we have. And then with the 30% that we can identify their use of media, the opportunity there is to understand what is going on there. And the team is working on it. We have a relatively small number of team members in the sales force. But at the same time, the absolute number of clinical trials that they need to go touch are also relatively small. So give us another quarter, and we'll be able to get more specific around that, Matt.

And maybe I could just sneak one more in. Just on the CryoCase, just any update on the timeline? I think you had talked about previously kind of a couple of quarters to make some tweaks in relation to a larger customer that gave you some feedback. And then any update on the status of kind of locking them in on the other side of making those tweaks as it relates to the CryoCase?

Yes, that's the key is that, yes, we have a large commercial customer, probably #3 or #4, and they're highly interested in adopting CryoCase for their clinical pipeline. As you noted, they've asked us to make some changes. However, these changes are pretty material with respect to the mold that we have. So what we're asking them to do is give us a commitment, and we're in the process of that conversation right now. Once we get that commitment that they will adopt the CryoCase, assuming that we make the changes they want, then we're going to go ahead and make those changes. I will say that I'm pleased when I did my last check-in on CryoCase evaluations that we have well over 30 customers that are currently evaluating the CryoCase within our media customer base.

And the next question comes from Chad Wiatrowski from TD Cowen.

Just wanted to touch on Pluristyx a little bit. The company also has sort of this PluriFreeze, cryopreservation product. Do you view that as a competitor today? Obviously, you have a huge moat and are the incumbent in commercial therapies. Would a future acquisition of Pluristyx allow you to enter any other parts of the market?

Yes. So we're clearly aware of their PluriFreeze product. And again, we have respect for what their capabilities are. We do not see them as any kind of competitive threat from a cryopreservation perspective. Their focus with respect to cryopreservation has been specifically around iPSC cells and trying to gain some incremental benefit. So that's kind of a side tangential part of it all. The real big focus for us is this idea that they're starting to develop some assays, which is an area that we're interested in looking at more closely. And that's really what the focus of the investment was about.

That's helpful. Can you provide any updates on PanTHERA, particularly regarding the next-generation combo formulations? Are these the products we can expect to be launched next?

Yes. In terms of de novo products in the media category, I would say, yes. So from an update perspective, you recall that we closed the transaction in early April of this year and we stated that we expected to have commercial product flowing in 18 months, which kind of puts that in the back half of next year. So we remain on track to meet that objective. And right now, the focus is the scientific work associated with identifying which of the three Gen 2 molecules will ultimately end up with in terms of combining that with our CryoStor product. We do have one of the Gen 2 molecules in the hands of two customers who have commercially available therapies, and they're experimenting with that to see what sort of impact that has on cryopreservation efficacy from their perspective. So it is in the hands of two sophisticated real-world large customers. So we're looking forward to getting that feedback in the next couple of quarters.

And the next question comes from an unidentified analyst with Stephens Inc.

It seems commentary lately has just been more recently focused around the cell processing segment, obviously, a priority just given where it's at. But I'd like to take your temperature on expectations around evo and Thaw and just given your comments around Pluristyx, just how that segment fits into the portfolio longer term?

Evo and Thaw are presented separately, but combined. We are still evaluating the Evo product line to see if it aligns with BioLife's long-term strategy. However, we are committed to keeping Thaw in our product portfolio due to its strong and consistent quarterly revenue generation, making it a valuable product line for us.

I think that answered it pretty accurately. I appreciate that. And then focusing on the early clinical stage portion of the business within media. Just given the continued funding challenges and headlines from a regulatory perspective and things of that nature, what are you seeing in terms of demand trends there?

Yes. Good question. So I would say that in Q2, it's fair to say that all of our customer segments were up year-over-year. But from a percentage increase, I would say the lightest of those would be what we call our other clinical customers, which are the smaller earlier stage Phase I and Phase II customers. So clearly, we're seeing a little bit of softness, but nevertheless, they're still up year-over-year, and we expect that to continue for the balance of 2025.

And the next question comes from Anna Snopkowski with KeyBanc.

On the quarter. Maybe first, you called out strength in both your direct sales and distribution network. And I know distribution is often exposed to more uncertainty. So is there anything you would call out there in terms of visibility? Or has anything changed there from the first quarter?

No, you're right in pointing out the visibility issue. So in our last call, I think we stated that to the extent that we expected to see any ramifications of in particular, NIH funding that we would likely see it through our distribution channel, which sells primarily to small labs, etc. We have not seen that, certainly not in Q2. And based on the forecast that we received for the second half of the year, we're not seeing any weakness there either. So at least as we sit today, we're confident that, that distribution line is going to continue to have some strength to it throughout the rest of the year.

Okay. Perfect. And then my next question is just on the M&A front. I know you acquired the remaining PanTHERA business. Maybe if you could just touch on how you see this business advancing your existing portfolio, maybe boosting your market share? And then how do you view your M&A strategy going forward?

Yes. So with respect to PanTHERA, really, the fundamental driver there was to really underscore our market leadership within the area of biopreservation. So by adding IRI, which has some unique characteristics relative to our core product line, in addition to bringing on several very accomplished cryobiologists to beef up our staff and scientific expertise in that area. Really, I think it puts us without question between that and the market leadership that we have from a clinical trial standpoint and from an approved therapy standpoint. It's hard to debate that BioLife is the market leader and gold standard in biopreservation. So that was a strong driver for doing that. What we expect to come out of it is a line of products sort of in the second half, and it will probably be one product first with several others that come behind it. And the opportunity there with these products are to have better cryopreservation efficacy when combined with our standard CryoStor product. It has the opportunity to have the same cryopreservation efficacy, but with a lower concentration of DMSO. And then the real, I think, home run for us would be to be able to allow these cell therapies to be shipped not at LN2 196 temperatures, but more at minus 80. And I think that's a much longer term but potentially significant alteration to the way that cold chain logistics works in today's marketplace.

And the next question comes from Yi Chen with H.C. Wainwright.

Could you give us some comment on the rationale behind the $2 million convertible note and also whether you will eventually acquire that target company? And also in general, your M&A strategy going forward?

Yes. So I'll speak to the second part of your question with respect to the Pluristyx investment. We did structure the investment similar to that of PanTHERA and Sexton, thank you, Troy. And so in that case, we do have an opportunity to have some rights relative to an acquisition down the road. But what will determine that are two things. One is our conclusion that assays are a place that we want to be from a product adjacency and that the uptake or the revenue growth that Pluristyx is going to realize over the next few years is going to be sufficient to make a difference to us. So relative to Pluristyx, that's sort of how it works. In terms of the overall M&A strategy, I think it really is focused on a disciplined approach to make sure that whatever we do has a strategic rationale to it with respect to where we already are from a product portfolio. So again, in the simplest terms, it's between the walls of the cell manufacturing facility. It's products that are adjacent to products we already have. And whether that, as in the case of PanTHERA, solidifies our market leadership position or some other opportunities that we're looking at, which would take an existing product line that we have and move us into the market leadership position. Those are the kind of things we're looking at.

And this concludes our question-and-answer session. I would like to turn the floor back over to Roger Degree for any closing comments.

Thank you, Keith. In closing, the first half of 2025 positions us well for the balance of the year. We remain confident in our ability to navigate any uncertainty with minimal impact to our financial results. Thank you for your time this afternoon, and we look forward to updating you as we move through the remainder of the year as well as seeing some of you at upcoming investor conferences.

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