Jerrell W. Shelton
Thank you, Todd. Good afternoon, everyone. With us this afternoon is our Chief Financial Officer, Robert Stefanovich; our Chief Scientific Officer, Dr. Mark Sawicki; and our Vice President of Corporate Development and Investor Relations, Thomas Heinzen. Today, Cryoport reported strong double-digit revenue growth across all revenue streams in our Life Sciences Services for the second quarter. Service revenue increased 21% year-over-year, accounting for 54% of total revenue from continuing operations. notably, revenue from our support of commercial cell and gene therapies increased by 33% and BioStorage/BioServices grew 28%, underscoring the growing demand for our integrated temperature control supply chain platform. This growth continues to be fueled by the increasing adoption and scaling of cell and gene therapies, a positive trend, we believe, will continue for years to come. Turning to our Life Sciences products. We posted a solid performance with 8% year-over-year revenue growth, driven by improved demand, particularly from animal health customers during the quarter, we made -- we also continued to expand our product portfolio with the launch of our next-generation MVE SC 4/2 and SC 4/3 vapor shippers, which offer medical and animal health professionals, improve safety and reliability for transporting and preserving sensitive biological materials at cryogenic temperatures. During the second quarter, we also recorded revenue in accordance with plan from sales of MVE's high-efficiency 800-seat cryogenic storage system, which was released earlier this year. This compact form factor freezer was designed for facilities with limited space that require high capacity and security. These innovations demonstrate our continued commitment to addressing the evolving needs of our clients globally and expanding our future revenue potential. For the second quarter, we had an overall 14% increase in total revenue from operations, and we delivered an increase in gross margin, along with a meaningful lift in our adjusted EBITDA and as a result of our pathway to profitability initiatives. Given the strong execution across all our business units, we are reaffirming our full year 2025 revenue guidance as we move toward our goal of sustainable long-term profitability, which will accelerate as our capital projects mature. I'm pleased with all the progress of all of our business units but I would be remiss if I didn't highlight 1 of the most significant achievements for the second quarter, which was our launch of our strategic partnership agreement with the DHL Group and DHL's acquisition of CRYOPDP in a transaction that included cash payments of approximately $200 million to Cryoport. Aside from a strong infusion of capital, this strategic partnership provides for enhancing our global biologics capabilities -- bio logistics capabilities and effectiveness by leveraging DHL's competencies scale and reach in Asia Pac and EMEA, we will be increasingly well positioned to expand our life sciences business and deepen our leadership in the rapidly growing global regenerative medicine market. This strategic partnership is an initial step as we continue to work to develop a strong global partner network that complements our core capabilities through discussions with various global companies. Before we take your questions, I want to briefly address a unique situation with 1 of our clients that has received some immediate attention. 1 of our gene therapy clients temporarily pause the distribution of their commercial therapy for about a week in July. The therapy is now back on the market and shipping to patients. However, that company anticipates treating fewer patients than originally forecast in 2025. We do not expect this to have a material impact on our business. Our guidance that we reaffirm today considers an estimated revenue impact of approximately $2 million from this client for the remainder of the year. As of June 30, Cryoport supported a record 728 clinical trials which is approximately 70% of the industry cell and gene therapy trials. For the remainder of 2025, we anticipate up to an additional 20 application filings, 1 new therapy approval and an additional 3 approvals for label or geographic expansion. Also, we want to note that during the quarter, 5 of our clients that had filed for approval earlier this year or late last year, received negative opinions from the FDA or MAA, all these clients have requested meetings with the regulators to find a pathway forward to bring their therapies to market. Given the need for these therapies, along with the recent changes within the FDA, many analysts are thinking more positively about their chances of gaining approval later this year or early in 2026. The strength and resilience of Cryoport's performance in the second quarter despite these challenges faced by a few of our clients by largely in the broad number of clinical trials we support and the scaling of the current commercial therapies we are supporting on a global basis. Our commercial revenue is expected to drive our growth for years as it is boosted by additional Cryoport-supported therapies as they reach commercialization, including the new cell therapy from our customer, Aviano -- Aviana Therapeutics that was approved by the FDA during the second quarter. I probably mispronounced that, and I think it's Abeona. In summary, our second quarter was marked by strong revenue growth, improved margins and the beginning of the execution of a transformative strategic partnership agreement. We are entering the second half of the year with strong momentum and a clear focus on driving long-term shareholder value as we support the growth of the global regenerative medicine markets and the life sciences in general. As the regenerative medicine industry accelerates, the complexity and precision required to safely deliver personalized often life- saving therapies has never been greater. Our global platform of temperature control supply chain solutions, coupled with real-time informatics and regulatory compliant processes enable 728 active clinical trials and 18 commercial therapies worldwide. Whether supporting first in-human studies or globally scaled commercial treatments, Cryoport ensures end-to-end integrity from the manufacturer -- from the laboratory to the manufacturer, to the points of care, to the patient's bedside, our advanced packaging systems, BioStorage and Bioservices capabilities, biologistics and cryogenic infrastructure have become mission-critical to the industry's leading biopharma companies, CDMOs and researchers alike. In short, we formed the connected tissue between researchers, manufacturers and the patients enabling the secure preservation and movement of living regenerative therapies with real-time data and systems and a global reach. We do more than support the life sciences ecosystem, we make it responsive, resilient and ready for the future of medicine. This concludes my prepared remarks. So now I'll ask the operator to open the lines for your questions.