CryoPort, Inc.

Good afternoon and welcome to Cryoport's third quarter 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 immediate 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, events, or developments that we expect or anticipate occurring in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and not on 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 any 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 due information or future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties. They 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 on Form 10-K to be filed with the Securities and Exchange Commission, and those described from time to time in the other reports usually filed with the Securities and Exchange Commission. As a reminder, CryoPort has uploaded their third quarter 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 Group and the related sale of Cryo PDP to DHL, Cloud PDP's financials, which were previously a part of CloudPort's life sciences services reportable segment, are now presented at discontinued operations. CloudPort previously provided quarterly historical information on this basis for fiscal year 2024 and our first quarter 2025 review document, which remains available on the CloudPort page website. This information is intended to support the financial modeling efforts of those needing this information. Please note that unless otherwise indicated, all revenue figures discussed today will refer to continuing operations. This includes CryoPort's fiscal year 2025 revenue guidance. It is now my pleasure to turn the call over to Mr. Gerald Shelton, Chief Executive Officer of CryoPort. Jerry, the floor is yours.

Thank you, Todd, and good afternoon, everyone. With us this afternoon is our Chief Financial Officer, Robert Stavanovich, our Chief Scientific Officer, Dr. Mark Zwicky, and our Vice President of Corporate Development and Investor Relations, Thomas Heinsohn. During the third quarter, we continued our strong momentum delivering double-digit growth in both our life sciences services and life sciences product segments. Notably, revenue from our support of commercial cell and gene therapy grew 36% year-over-year to $8.3 million, driven by the continuing global adaptation of these lifesaving therapies. It is impressive that the growth of the regenerative therapies market which we believe is still in very early stage of developments, has remained resilient despite ongoing challenging microeconomic, political, and geopolitical backdrops. Within life sciences, revenue increased 16% year over year and represented 55% of our total revenue from continuing operations for the quarter. This included a 21% increase in the biostorage bioservices revenue, underscoring the persistent demand for our integrated platform. Driving this growth is the rising prevalence of chronic and rare diseases, prevalence of chronic and rare diseases, coupled with continued advancements in cell and gene therapies, targeting solid tumors and autoimmune diseases. We also are encouraged by signs of stability in our life sciences product market. where revenue grew 15% year-over-year, driven by improved demand for our market-leading cryogenic systems. In the third quarter, we expanded our product portfolio with a launch of MBE Biological Solutions next-generation SC4-2V and SC4-3V vapor shippers. These cryogenic systems models have been redesigned utilizing innovative technologies to offer customers added protection during extended or challenging shipments and include several key advancements designed to enhance the performance and reliability. MBE's newly designed condition monitoring solutions for these doers are integrated with each unit, combining our trusted cryogenic systems with advanced real-time condition monitoring technology supplied by Tech4Med, another Crawford company. These innovations reflect MBE's unwavering commitment to support the life sciences with advanced intelligent connected assets to safeguard vital biological materials. Beyond our core systems and services, we are progressing on a number of other growth initiatives designed to better serve our clients and diversify our revenue streams. These initiatives include the onboarding of our first clients for IntegraCell, our cryopreservation services located in Liège, Belgium, and Houston, Texas. These cryopreservation services are designed to address a critical aspect in optimizing the supply chain for the development and commercialization of cell-based therapies through high-quality standardized cryopreserved starting materials. We're excited by IntegraCell's recent progress as it moves forward to become a significant revenue and profit generator. Additionally, in late October, we opened the logistics portion of Crown Port Systems' new state-of-the-art Global Supply Chain Center at the Charles de Gaulle Airport in Paris, France. This 55,000 square foot facility provides us with increased ability to serve our clients in the European and global markets. It is designed to support complex life sciences supply chain needs, including biologistics, bioservices, and future cryopreservation services. An official grand opening is scheduled to celebrate the launch of this facility, will be held on November 20th, with bioservices opening in mid-2026. In addition, We are also advancing toward opening a global supply chain center in Santa Ana, California, which is expected to come online in the second half of 2026. This facility will consolidate three existing locations and feature next-generation technology to optimize operations and client support. Complementing all of these activities, we have begun implementing our recently established strategic partnership with DHL Group. Due to DHL's size, this strategic relationship will take some time, and when completed, it will enhance our positioning in the APAC and EMEA regions and reshape our competitive profile within the industry by leveraging DHL's global scale and capabilities. Regenerative medicine has been advancing steadily, largely driven by the expanding pipeline of regenerative therapeutics entering the clinical development, and commercialization. Despite any short-term headwinds, cell and gene therapies have continued to enter and move through the clinical pipeline, which should ultimately result in growing revenue from commercially supported therapies. Crawford's temperature control supply chain solutions are supporting the largest portfolio of clinical and commercial gene therapies in the world, with a record total of 745 global clinical trials and 83 of these in phase three, representing approximately 70% of the cell and gene therapy clinical trials. In the third quarter, Four BLA-MAA filings occurred, and three more were filed in October. For the remainder of 2025, we anticipate up to an additional seven application filings, one new therapy approval, and two additional approvals for label or geographic expansions or moves to earlier lines of treatment. Of course, the timing of these filings may be impacted by the current government shutdown of the FDA in the United States. While global trade conditions remain dynamic, Crowdport did not experience any new material impact from tariffs in the third quarter. Furthermore, we have, of course, taken steps to diversify our supply chain to mitigate potential impacts that could come as a result of tariffs. Impacts not covered by these mitigations are covered by surcharges. With strong momentum we have achieved year-to-date and our progress across the board, We are updating our full year 2025 outlook for total revenue from continuing operations to the range of $170 million to $174 million. Our team is dedicated to building long-term value for our shareholders. Cryoport is maintaining and growing its competitive differentiators as the only pure play end-to-end temperature control supply chain platform that supports the largest portfolio of clinical and commercial cell and gene therapies globally. This concludes my remarks, so I'll now ask the operator to open the lines for your questions.