BioLife Solutions, Inc.

Ladies and gentlemen, thank you for standing by and welcome to Q4 and full year 2021 BioLife Solutions, Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session and instructions will follow at that time. If anyone should require assistance during the conference, please press star zero on your touchtone telephone. As a reminder, this conference call is being recorded. I would like to turn the conference over to your host, Mr. Troy Wichterman, please go ahead, sir.

Thank you, Grace. Good afternoon, everyone, and thank you for joining this call. Joining me on today's call are Mike Rice, Chairman and Chief Executive Officer, and Rod DeGrief, President and Chief Operating Officer. Earlier today, we issued a press release announcing our financial results and operational highlights for the fourth quarter and full year of 2021. As a reminder, during this call, we may make certain projections and other forward-looking statements regarding future events or the future financial performance of the company or its acquisitions. These statements are subject to risks and uncertainties that may cause actual results to differ materially from expectations. For a detailed discussion of the risks and uncertainties that affect the company's business and that qualify as forward-looking statements, I refer you to our periodic and other public filings filed with the SEC. Company projections and forward-looking statements are based on factors that are subject to change, and therefore, these statements speak only as of the date they are given. The company assumes no obligation to update any projection or forward-looking statements except as required by law. During this call, we will 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. These non-GAAP or adjusted financial metrics should not be viewed as an alternative to GAAP. However, in light of our M&A activity, we believe that the use of non-GAAP or adjusted metrics provides investors with a clearer view of our current financial results when compared to prior periods. I'd like to turn the call over to Mike Rice, Chairman and CEO of BioLife Solutions.

Thanks, Troy, and good afternoon, everyone. Thank you for joining our call. After my remarks, Troy will present our financials for Q4 and the full year of 2021 and our initial revenue guidance for 2022. Then Rob will provide an update on key operational initiatives he is managing targeting gross margin improvements, specifically for our Sterling ULT freezer platform. After that, we'll be glad to take your questions. Turning to Q4 revenue and customer highlights, it's clear that our acquisitions of fast-growing assets are complementing stellar growth in biopreservation media revenue. Top-line total revenue was $37 million in Q4. This was up 153% year-over-year and 10% sequentially. Organic revenue growth in the fourth quarter was 64% year-over-year, driven by biopreservation media revenue growth of 64% compared to Q4 2020. Starting in Q4, one large distributor began increasing their inventory power levels to get to a 90-day stock in response to strong downstream demand. We believe this will continue in Q1 2022 and then level off. In Q4, we gained at least 235 new customers across our three product and services platforms, and I'll remind you now what those are. First, self-processing, which includes biopreservation media and Sexton products. Second is our freezers and thaw systems platform, comprised of CBS liquid nitrogen freezers and Sterling mechanical freezers and thaw star systems. And finally, storage and cold chain services, which includes our SciSafe storage services and our Evo cold chain management offering. New Q4 customers by product line included, 15 now using biopreservation media, 7 new Thostar users, 11 new Evo cold chain end users, 17 new cryogenic freezer customers, 159 new Sterling freezer customers, 14 new BioStorage customers, and 12 new self-processing customers now using Sexton products. These 235 new customers in Q4 compare to 213 in all of 2020. For the full year of 2021, we gained at least 700 new direct customers, and we also benefited from very productive distributors, our two largest having sold and shipped our biopreservation media products to more than 4,200 unique end customers in 2021. This is really impressive and should help continue to build brand awareness of BioLife, CryoStor, and Hypothermosol. Based on order volume so far this year, we expect another stellar year for our direct team and indirect distribution partners in driving much broader adoption of our portfolio of buyer production tools and services. Cross-selling to capture revenue synergies is a key focus for us. During 2021, 46 customers purchased at least one additional portfolio solution than they were previously using. We expect to continue to capture revenue synergies by driving broader adoption of our portfolio components at our strategic accounts. Now I'll make some qualitative comments about our three revenue platforms and let Troy speak to revenue for each. For self-processing Q4, we received confirmation that our self-processing media products will be used in at least 17 additional clinical trials for new cell gene therapies. We estimate that our biopreservation media products have been incorporated into more than 530 customer clinical applications, up from 450 at the end of 2020. For biopreservation media, We also remain confident that each customer clinical application, if approved, could generate annual revenue in a range of $500,000 to $2 million, based on the estimated number of doses our customers would manufacture in a year, the volume of our media in each dose in milliliters, and the average selling price per mil. To date, our biopreservation media is used in eight approved therapies, and our sextant cell processing media and vials are used in three approved therapies. Our biopreservation media products are also embedded in at least 10 additional CGT applications for which BLA or other regulatory approval filings are expected to be submitted this year and next year. I'll conclude by saying that our biopreservation media clinical customer base includes most of the CAR T-cell developers, with our products embedded in a majority of the autologous and allogeneic platforms currently in development. We expect to be able to continue to take share from homebrew preservation cocktails as awareness grows of the critical role our engineered media formulations play in reducing risk for CGT companies. Turning to our freezers and thaw systems platform, as noted, we're hyper-focused on improving quality and reducing cost of our Sterling ULT freezer products. The growing pains we're experiencing are a result of customer demand that saw our ULT team more than double unit production in 2021 compared to 2020. We shipped nearly 8,000 freezers last year, and this demand surge strained our supply chain and exposed some latent quality issues that we inherited. Rob will speak in more detail on our recovery and mitigation activities. I can say that while a few ULT customers had to order from our competitors, overall demand remains strong and we're working nearly around the clock to fulfill customer orders. Additionally, we're in discussion of one of our largest ULT freezer distributors to add our CBS liquid nitrogen freezer platform to their BioLife offering. We expect to finalize this amendment to our distribution agreement in the next few months. Specific to our ThawStar product family, one of our largest biopreservation media customers, a distributor, is expected to add our cryobag thawer to their wildlife offering this year. In our final three revenue platforms, storage and cold chain services, which includes EVO cold chain rentals and SciSafe storage services, we gained 25 new customers in Q4. 14 for storage services, and 11 for Evo. Our SciSafe storage services platform continues to grow rapidly, and we remain very optimistic about our ability to profitably scale this platform to meet demand. Our opportunities list to potential new storage services customers as long and robust. With our Evo cold chain management platform, cell and gene therapy companies now have full optionality to access our class-defining offering through our expanded specialty courier partner network. that now includes World Courier, Quick International, Pathiana Thermo Fisher, Marken, and Biocare. We expect to onboard another marquee courier partner for our EVO network in the next few months. Total 2021 EVO shipments were nearly 4,000 to more than 600 unique destinations. Shipment volume was up 81% over 2020. Another highlight for our EVO platform is an ongoing evaluation and validation by a second global pharma company that is successful will support their adoption of the EVO platform for shipping their two existing approved CAR T cell therapies. This and the earlier approved customer we announced have traditionally been served solely by a legacy cold chain logistics services provider. As I mentioned before, we believe most CGT companies will move to validate and approve more than one shipping container and logistics partner over the next few years, and that our EVO platform will emerge as a leading selection. We also recently deployed a new 4G cellular radio across our courier partners' fleets of EVO shippers and can report very solid performance so far in supporting our couriers and end users in the transition from the sunsetting 3G cell towers to the new 4G system. We're also well engaged in our new product development roadmap for the EVO platform and look forward to sharing details when we can. But I can say we're committed to defining the class through innovation, both internal and external. Now I'll turn the call over to Troy to present our financials for Q4 and the full year 2021. Troy?