8/7/2025

speaker
Operator
Conference Operator

Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to the BioLife Solutions Q2 2025 Shareholder and Analyst Conference Call. At this time, all participants are in a listen-only mode. After today's presentation, there will be a question-and-answer session. This conference is being recorded. And now I'll turn the call over to Troy Wichterman, Chief Financial Officer of BioLife Solutions.

speaker
Troy Wichterman
Chief Financial Officer

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 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. 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. I'd like to turn the call over to Rod DeGrief, Chairman and CEO of BioLife.

speaker
Roderick DeGrief
Chairman and Chief Executive Officer

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, self-processing revenue increased 28% year over year, driving a 29% increase in total revenue for the quarter. With strong performance and self-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 Pluristics, 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 and self-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 an 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 models. anchored to later stage and improved 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 four 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 two to three 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 Pluristics, a local early-stage but revenue-generating developer of innovative IPSC-based products for the cell therapy market. Floristics has a strong scientific team with a deep expertise in cell therapy, and their 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 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. Troy?

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-