CryoPort, Inc.

Good afternoon and welcome to Cryoport's fourth quarter and full-year 2025 earnings conference call. All participants will start in a listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require any assistance, please press star zero for the operator. As a reminder, this call is being recorded. I will now turn the call over to your host, Todd Frommer from KCSA Strategic Communications. Please go ahead.

Thank you operator before we begin today, I would like to remind everyone that this conference call contains certain forward looking statements. All statements that address our operating performance venture developments that we expect or anticipate occurring in the future. All forward looking statements. These forward looking statements are based on management's beliefs and assumptions and information currently available to our management. Our management team believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information or future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events, and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include but are not limited to those described in Item 1A, Risk Factors, and elsewhere in our annual report, our Form 10-K, we filed with the Securities and Exchange Commission, and those described from time to time in the other reports which we filed with the Securities and Exchange Commission. As a reminder, CryoPort has uploaded their fourth quarter and full year 2025 in-review document to the main page of the CryoPort Inc. website. This document provides a review of CryoPort's financial and operational performance and the general business outlook. Before I turn the call over to Jerry, please note that because of the strategic partnership that has been established with DHL and related to CryoPDP to DHL, CryoPDP's financials, which were previously a part of CryoPort's Lifesigns and services reportable segments are now presented as discontinued operations. CryoPort previously provided quarterly historical information on this basis for fiscal year 2024 in our first quarter 2025 review document, which remains available on the CryoPort Inc. website. This information is intended to support the financial modeling efforts of those needing this type of information. Please note that unless otherwise indicated, all revenue figures discussed today will refer to continuing operations. This includes Crawford's fiscal year 2025 revenue guidance. It is now my pleasure to turn the call over to Mr. Gerald Shelton, Chief Executive Officer of Crawford. Jerry, the floor is yours.

Thank you, Todd. We have a great report for you today, ladies and gentlemen. But before we begin, with us this afternoon is our Chief Financial Officer, Robert Stavanovich, our Chief Scientific Officer, Dr. Mark Zawicki, and our Vice President of Corporate Development and Investor Relations, Thomas Heinzen. Today, we reported our full year results for 2025, which was a year of strong progress for Crawport. We delivered full year revenue from continuing operations of 176 exceeding the high end of our prior guidance and reflecting continued momentum across our core markets. In the fourth quarter, we again achieved double-digit revenue growth driven by expanding commercial cell and gene therapy activity and revenue from the support of commercial cell and gene therapy, increasing 29% year-over-year to a record $33.4 million for the year. Commercial cell and gene therapy revenue in the fourth quarter represented 20% of our overall revenue, while clinical trial revenue remained solid, growing 14% year-over-year to $47.1 million. We concluded 2025 supporting a record 760 clinical trials and 20 commercial therapies worldwide. Our clinical trial support showed a net increase of 59 over the previous year and represented approximately 70% of total trials for the cell and gene therapy industry. Looking ahead to 2026, based on the information that we have, we anticipate another 13 BLA or MMA application filings, including two of which have already been filed. nine new therapy approvals, and an additional two approvals for label or geographic expansion. In the near term, CryoPort has three customers that are anticipating new therapy approval decisions in March and April of this year. We believe our clinical trial pipeline is spring-loaded with 86 clinical trials in phase three and 361 clinical trials in Phase II. Remember, most of the cell therapies that were approved today were from Phase II. In our opinion, this market-leading base will drive the growth of our commercial revenue in the near and the long term. We continue to execute on our mission of expanding services to the life sciences by broadening our revenue streams and capturing more revenue per client. For 2025, revenue from our life sciences services segment increased 18% year-over-year, including 22% growth in biostorage bioservices revenue. Our performance reflects the expanding scale and scope of the clinical and commercial programs we support and the trust our customers place in our comprehensive end-to-end supply chain solutions. While our primary focus remains on accelerating revenue growth and strengthening our market position, we continue to enhance our operational discipline across the organization as we advance on our pathway to profitability. In 2025, our cost reduction initiatives contributed to our gross margin of 47%, accompanied by a $12 million year-over-year improvement and adjusted EBITDA. With our progress to date, we anticipate achieving positive adjusted EBITDA in the second half of 2026. Turning to our life sciences product segment, revenue grew 7% year-over-year in 2025. MBE Biological Solutions focused on execution and innovation and continues to further enhance its position as the global leader in the production of high-quality cryogenic systems. Recently, MVE launched its integrated condition monitoring solutions for its dry vapor shippers. These novel condition monitoring solutions are integrated with each doer, combining MVE's trusted cryogenic systems with advanced real-time conditioning monitoring technology supplied by Tech4Med, another cryopore company. This system communicates with MVE's new Cryoverse, a cloud-based data capture system and shipment management system. More recently, MBE launched its Fusion 800 series, a revolutionary self-sustaining cryogenic freezer that can fit through a single door, which opens up substantial market opportunities. These revolutionary cryogenic freezers eliminate the need for continuous liquid nitrogen supply, delivering exceptional reliability, safety, and sustainability in a compact footprint that is designed for settings where there is limited space and no readily available sources of liquid nitrogen. At Cryoport Systems, we increased our internal investments to support the traction that we are seeing across our broad portfolio of cell and gene therapy clients. These strategic investments include the completion of our global supply chain center in Paris, France, the expansion of our Belgian operations to accommodate a key commercial client, and continuing the build-out of a global supply chain center in Santa Ana, California, which consolidates three existing facilities into a single expanded campus and enhances our service capabilities. Of course, one topic of the day is AI, and it is certainly a tool we are embracing. As a part of our overall digital strategy, We are actively leveraging generative AI to enhance internal workflows and day-to-day operations. Our focus is on enabling employees to use secure enterprise-approved generative AI tools to reduce manual tasks, accelerate execution, and improve accuracy and consistency of outcomes. This focus... These focused efforts emphasize practical adoption through education, hands-on support, and real production use cases tied directly to current business needs. There's no doubt that AI is reshaping our business and will play a significant role in our future. In 2025, we reported a strategic partnership with the DHL Group, which included DHL's acquisition of Cryo PDP. This action was completed in the second quarter of 2025 and provided Cryoport with a substantial capital infusion. Over time, we expect this relationship to enhance our position in APAC and EMEA regions and strengthen our competitive industry profile by leveraging the global scale and capabilities of this key strategic partner. As a part of our continuing strategic initiatives to embed our market-leading solutions in the cell and gene therapy ecosystem and improve our growth trajectory, we expanded our global partnerships by entering into strategic collaborations with Cardinal Health and Parexcel. Both companies are leveraging Cryoport system supply chain solutions in support of their complementary offerings in the cell and gene therapy space. These partnerships reinforce our position as a market leader in this space and the industry's drive to standardize. As we enter 2026 and consider global macro puts and takes, we believe that our full year revenue guidance of $190 million to $194 million is an appropriate starting point for the year. On a second point, we anticipate achieving positive adjusted EBITDA in the second half of 2026. There's a lot coming into focus for us, and we're very excited about our prospects for 2026 and intend to capitalize on our current momentum leadership position as the only pure play temperature control supply chain integrated platform supporting the life sciences industry's largest portfolio of clinical and commercial cell and gene therapies. This concludes my remarks, and I now will turn the call over to the operator to open the lines for your questions and our discussion.