Cryoport, Inc. (CYRX) Business

Item 1. Business

Overview

We are a leading global provider of integrated, temperature-controlled supply chain solutions for the life sciences, with a strong focus on supporting the rapidly growing cell and gene therapy (“CGT”) market. Our solutions are purpose-built to support a broad range of global life sciences markets, including biopharmaceutical and pharmaceutical companies, the animal health markets, reproductive medicine, academic institutions, research, and government agencies. Our solutions help our customers ensure the safe, compliant storage, handling, and delivery of high value, temperature sensitive biological materials, including cell and gene therapies and immunotherapies.

We place particular emphasis on the CGT market, our fastest growing market, by delivering highly specialized, end-to-end supply chain solutions that support cell and gene therapy programs from preclinical research, through clinical trials, and ultimately to the global commercialization of approved therapies. As of December 31, 2025, Cryoport supported 760 clinical trials, and 20 commercially approved cell and gene therapies.

Our integrated temperature-controlled supply chain solutions combine advanced logistics, biostorage, kitting and labelling, clinical sample management, collection and cryopreservation services for cell therapies starting materials, cryogenic systems manufacturing, and an industry-leading informatics platform that integrates all our solutions. Our capabilities for supporting cell and gene therapies enables our end-to-end Chain of Compliance® which includes chain-of-custody, chain-of-condition and chain-of-identity for some of the most complex therapies in development, clinical trials, and commercialization today.

Our solutions are designed to maintain the viability, identity, and quality of these patient-specific and high-value therapies playing a critical role in enabling timely treatment, reducing the risk of therapy failure, and supporting positive patient outcomes.

The Company delivers its integrated life sciences services and products through three operating units:

Cryoport Systems provides advanced temperature-controlled BioLogistics, BioServices, and cryopreservation solutions, supporting clinical and commercial workflows through specialized transport, cGMP storage, kit production, labeling, packaging, and commercial therapy fulfillment.

CryoGene delivers long-term temperature-controlled BioStorage and related value-added services for preclinical and early-stage clinical programs for biopharmaceutical products.

MVE Biological Solutions (MVE) designs and manufactures industry-leading cryogenic systems, including freezers, dewars, and transport systems used globally for the storage and movement of biological materials for the life sciences.

Together, these businesses form an end-to-end, digitally integrated supply chain solution that supports the safe, regulatory compliant, handling of critical biological materials from pre-clinical through commercially approved products.

During the second quarter of fiscal year 2025, we completed the divestiture of our specialty courier CRYOPDP business to designated affiliates of DHL Supply Chain International Holding B.V. (“DHL”) for $133.0 million. The transaction also included the repayment of approximately $77.2 million of outstanding intercompany loans owed by CRYOPDP to us. We also entered into certain related agreements in connection with the transaction, including a master partnership agreement. The divestiture and strategic partnership with DHL are expected to enhance our ability to develop our business, particularly in the Europe, the Middle East, and Africa (EMEA) and Asia-Pacific (APAC) regions, and to provide differentiated and high-value services aligned with our long-term growth strategy. The CRYOPDP business is classified as discontinued operations and, unless otherwise noted, the description of our business in this Form 10-K relates solely to our continuing operations. See Note 5 – Discontinued Operations to our consolidated financial statements included under Part II, Item 8 “Financial Statements and Supplementary Data” for additional information about the divestiture of the CRYOPDP business.

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Our Reportable Segments

We report our financial performance in two segments that include five core areas:

See Note 19 – Segment Reporting to our consolidated financial statements included under Part II, Item 8 “Financial Statements and Supplementary Data” for additional information about our segments.

Life Sciences Services

Our strategy for the Life Sciences Services segment is developed around three pillars that serve as the foundation for the Company’s fully integrated temperature-controlled supply chain solutions: our Cryoportal® digital logistics management platform, our Chain of Compliance® and quality principles, and our Global Supply Chain Center Network.

The Cryoportal Digital Logistics Management Platform. This platform serves as the digital ‘nerve center’ for the Company’s fully integrated temperature-controlled supply chain solutions. From the collection of patient- or donor-derived starting material through biostorage, transport, distribution, and final delivery, Cryoport’s solutions work together to reduce risks and complexity, improve visibility, and enhance reliability for clients operating in highly regulated environments. The Cryoportal combines advanced temperature-controlled logistics and informatics by integrating with clients, partners, and vendor systems through application programming interfaces (APIs), enabling seamless data exchange and consistent execution across global temperature-controlled supply chains.

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As the scope and importance of digital capabilities expanded, Cryoport established its Enterprise Technology Group (ETG) in 2024 to unify its digital platforms, monitoring, intelligent packaging, Internet of Things (IoT)-enabled monitoring, automation, and data analytics into a single, cohesive digital framework and ecosystem. This evolution aligns with Cryoport’s technology-led growth initiatives, including global infrastructure expansion and the introduction of new advanced solutions and platforms such as IntegriCell®, CryoVerse, Bioservices and our Global Supply Chain Network.

Cryoport continues to expand the foundations for its fully integrated solutions through ongoing enhancements to the Cryoportal, broader deployment of its Smartpak® Condition Monitoring System and Tec4med IoT-based monitoring solutions, and deeper integration of quality systems such as Chain of Compliance. We plan to further support these capabilities through the development and application of artificial intelligence (“AI”) and advanced analytics to aggregated platform data, enabling the Company to manage and anticipate network risks, improve operational performance, and support predictive, data-driven decision-making across the temperature-controlled supply chain.

By embedding digitalization, data intelligence, and automation across its solutions, Cryoport aims to continue to enhance its scalability, further strengthen its regulatory integrity, and support the continued growth and commercialization of the CGT market as these lifesaving cures are developed.

Chain of Compliance and Quality. Our Chain of Compliance framework is integrated throughout our services to ensure that critical biological materials are handled, stored, and transported in full accordance with applicable regulatory, quality, and procedural requirements throughout the entire temperature-controlled supply chain. It extends beyond traditional chain-of-custody and chain-of-condition by embedding more compliance, documentation, and process control into every physical and digital touchpoint including storage and distribution equipment management.

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Through the integration of validated temperature-controlled supply chain systems, standardized operating processes and procedures, continuous condition monitoring, chain-of-custody tracking, chain-of-condition monitoring and real-time informatics, our Chain of Compliance provides end-to-end visibility and traceability of every component and every process from initial material collection through final delivery to points of care. This approach supports our adherence to ISO 21973:2020, ISO 9001:2015, global regulatory standards, including Good Manufacturing Practice (“GMP”), and applicable international transport and quality requirements.

Enabled by the Cryoportal and supported by highly trained staff, the Chain of Compliance captures and aggregates environmental, shipping, biostorage, and handling data into a unified record that supports audit readiness, deviation management, and regulatory reporting. By proactively managing risk and ensuring consistent execution across complex, global supply chains, the Chain of Compliance helps protect biological material integrity, reduce variability, and support reliable patient treatment outcomes.

All our operations are also certified to ISO 9001:2015 for quality management systems, ISO 13485:2016 for medical devices, where applicable, and ISO 21973:2020 for the transportation of cells for therapeutic use. These certifications support standardized processes across our Global Supply Chain Center Network demonstrating our commitment to risk management, traceability, and continuous improvement. In addition, our quality framework incorporates Good Distribution Practice (“GDP”) and GMP principles, validated equipment and processes, supplier qualification, and ongoing training and auditing programs. Together with the Chain of Compliance framework, these standards are intended to ensure the integrity, safety, and compliance of biological materials throughout storage, handling, and transportation.

Global Supply Chain Center Network. We operate a Global Supply Chain Center Network through which we provide our BioLogistics, BioStorage, BioServices, and Cryopreservation services, supporting the end-to-end requirements of the life sciences industry. This integrated network is purpose-built to manage the complexity, regulatory requirements, and time- and temperature-sensitive nature of cell and gene therapies, regenerative medicines, and other biological materials.

Our global infrastructure includes strategically located Global Supply Chain Centers across the Americas, EMEA, and APAC regions. These facilities are further complemented by a qualified partner network of transportation providers that extend our reach while operating under Cryoport’s qualification, monitoring, and compliance standards. These transportation partners include integrators, life sciences specialty couriers, and local service providers, enabling reliable coverage across major clinical, commercial, and research markets worldwide.

On this foundation, we provide the following core solutions in the Life Sciences Services segment:

BioLogistics Solutions. Our BioLogistics solutions provide highly specific, temperature-controlled transportation services for CGT and other critical biological materials. These services are designed to meet the stringent requirements of advanced biologics, where deviations in temperature and other variables, shock, handling, or timing can compromise product integrity and patient outcomes. Our BioLogistics solutions are ISO 21973:2020 certified—the first standard to specifically address, in detail, the requirements for the CGT supply chain, with a focus on transportation, and that recognizes CGT products are significantly more fragile and valuable than most small molecule and biological therapies.

Through purpose-built Cryoport Express® and Cryoport Elite® shipping systems, continuous condition monitoring and tracking, customs and trade compliance support, integrated temperature-controlled logistics management and consulting services, we deliver reliable global temperature-controlled transport while maintaining full visibility, intervention capability, and compliance throughout transit. Our BioLogistics capabilities are tightly integrated with our BioServices and Cryopreservation services through the Cryoportal, which provides a unified, end-to-end solution for our clients thereby reducing risks that come from disjointed or discrete point services.

In November 2025, we commenced BioLogistics services at our new Global Supply Chain Center in Paris, France, with BioServices operations expected to commence in the fourth quarter of 2026. In late 2026 another Global Supply Chain Center is scheduled to be opened in Santa Ana, California.

BioStorage Solutions. Our BioStorage solutions provide temperature-controlled biostorage and value-added services that support life sciences researchers’ requirements for pre-clinical studies and programs across the life sciences. These services are primarily focused on longer-term storage and related services in support of preclinical and early-stage clinical trials. These services are delivered through our CryoGene operations in the Americas, with facilities in Houston, TX and San Antonio, TX that are registered and accredited

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to applicable U.S. Food and Drug Administration (FDA), International Organization for Standardization (ISO), GMP, and tissue-handling standards. CryoGene is scheduled to open its third biorepository in Tampa, FL in mid 2027 with a primary purpose of supporting Moffitt Cancer Center.

BioServices Solutions. Our BioServices solutions provide temperature-controlled storage and value-added services, such as biostorage, kitting, and fulfillment,  that are integrated directly into clients’ workflows to support clinical and commercial activity across the life sciences, globally. Our BioServices infrastructure is designed to scale alongside our clients as cell and gene therapies advance from clinical development to global commercialization. BioServices includes solutions such as sterile and cGMP kit production, qualified person (QP) drug product release services, labeling, secondary packaging, order fulfillment, storage, clinical sample management, and related value-added services. These services are delivered through our Cryoport Systems operations in the Americas and EMEA, with facilities registered and accredited to applicable FDA, ISO, and GMP standards.

Cryopreservation Services (IntegriCell). Our Cryopreservation Services, offered under our IntegriCell platform, providing standardized, scalable cryopreservation and cryo-processing services for cellular starting materials, is our newest services offering. This platform addresses a critical industry challenge related to the collection and preservation of leukapheresis material, which is the starting input for most cell-based therapies. By standardizing and automating this cryopreservation process, IntegriCell is intended to reduce variability in starting materials, improve consistency, enhance quality across the clinical spectrum and provide clinical collection and commercial manufacturing flexibility, alleviating logistical and manufacturing bottlenecks.

The IntegriCell platform integrates apheresis collection through qualified partners, cryogenic transport, cryo-process optimization, cryopreservation, and associated BioServices into a single, harmonized solution. Introduced in late 2024, the platform currently operates from two purpose-built facilities located in Houston, Texas, and Liège, Belgium, to support global clinical and commercial cell therapy programs. During the second half of 2025, IntegriCell began onboarding biopharma companies.

IntegriCell is expected to function as an integral part of Cryoport’s broader ecosystem, complementing our BioLogistics and BioServices offerings to support the evolving needs of the cell therapy market.

Life Sciences Products

Our Life Sciences Products segment includes our cryogenic systems manufacturing solutions.

Cryogenic Systems Manufacturing. We are a leading global manufacturer of cryogenic systems for the storage and transportation of biological materials, through MVE Biological Solutions (“MVE”) and its portfolio of cryogenic freezer and dewar systems. MVE has manufacturing facilities located in the United States and China.

MVE, with more than 65 years of experience designing and manufacturing cryogenic storage and transport systems, offers a broad portfolio of cryogenic systems and accessories in multiple sizes and configurations designed to meet a broad range of capacity, workflow, and application requirements. MVE’s cryogenic systems are utilized by biorepositories, clinical laboratories, biopharmaceutical companies, research institutions, animal breeding and IVF clinics for the cryopreservation, transport and storage of biological materials.

MVE’s product offerings include:

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In October 2025, MVE launched its integrated condition monitoring systems for dewars to provide real-time monitoring of their cryogenic environments to provide for the monitored and recorded safety and integrity of stored materials. These condition monitoring systems are powered by Tec4med®, a Cryoport company providing IoT technology that specializes in real-time condition monitoring and data-driven traceability in the regulated life sciences, distinct from the Cryoportal and SmartPak.

In 2026, MVE plans to introduce a proprietary connected platform, the MVE CryoVerse™ Ecosystem, delivering real-time monitoring and cloud visibility to protect critical biological materials while simplifying operations and strengthening compliance.

MVE is a foundational company. Our manufacturing capability represents a critical component of our integrated Life Sciences Services core solutions, ensuring reliable access to the highest quality, purpose-built cryogenic systems and equipment, supporting our scalability as the CGT market grows worldwide.

Our Life Sciences Markets

We serve a broad range of global life sciences markets, including biopharmaceutical and pharmaceutical companies, the animal health markets, reproductive medicine, academic institutions, research, and government agencies. We ensure the safe, compliant storage, handling, and delivery of high value, temperature sensitive biological materials across their entire respective lifecycles. The range of these materials include cells, tissues, DNA, RNA, plasmids, blood, bodily fluids, clinical specimens, cloned materials, oligonucleotides, lentivirus, retrovirus, adenovirus, pathogenic microorganisms, microorganisms, eggs, sperm, embryos, cell and gene therapies, immunotherapies, etc. We have a particular emphasis on cell and gene therapies, our fastest growing market. These cell and gene therapies represent some of the most complex and sensitive products in modern medicine, requiring digital data driven, integrated, advanced technology-supported supply chain solutions—an area where we have established industry leadership.

The Global Cell and Gene Therapy Market

The global CGT market is thought to be entering a phase of accelerated commercial expansion, supported by a continuously maturing clinical pipeline and a favorable regulatory environment. Global sales in the CGT market increased to approximately $14.5 billion in 2024, up from $4.2 billion in 2019, representing a historical 28% compound annual growth rate (“CAGR”). Industry analysts project continued momentum, with the CGT market expected to grow at an estimated 34% CAGR through 2028. Regulatory approvals are accelerating, increasing from one to two annually between 2018 and 2021 to a record seven to eight approvals in 2023 and 2024, respectively, and an additional 5 approvals in 2025. In June 2025, the FDA eliminated Risk Evaluation and Mitigation Strategy (“REMS”) requirements for approved BCMA- and CD19-directed autologous CAR-T therapies, which is a change expected to reduce administrative and logistical barriers, thereby expanding patient access. The clinical pipeline remains robust, with over 1,100 active cell and gene therapy clinical trials globally, excluding China, in 2025, increasingly weighted toward late-stage Phase II and III programs as sponsors are prioritizing cell and gene therapies closer to commercialization.

Strategic industry trends include growing interest in allogeneic, or off-the-shelf, therapies, which now represent roughly one-third of our global clinical pipeline, as well as increased demand for standardized, scalable, and compliant supply chain solutions to support the specialized storage, handling, and transportation requirements of cell and gene therapy products from clinical development through commercialization.

The growth in our clinical trial pipeline has driven increased demand for specialized infrastructure and services, including temperature-controlled BioLogistics, BioStorage, BioServices, Cryopreservation services and cryogenic systems, which support the complex requirements of cell and gene therapy products.

The CGT market is characterized by a high degree of regulatory oversight and operational complexity due to the sensitivity of biological materials and the need to maintain product quality and integrity from collection through delivery to patients. The growth in demand for supply chain services in the CGT market is driven by the personalized nature of many therapies, the requirement for precise

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temperature and condition control, and the complexity of coordinating multi-step manufacturing and delivery processes. As a result, we believe our cryogenic systems, advanced informatics, temperature-controlled logistics solutions, critical bioservices and cryopreservation services offerings and global networked operational capabilities, that we are well positioned to continue to benefit from these industry trends.

Key Accomplishments in 2025

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Customers and Distribution

We believe that our platform of integrated temperature-controlled supply chain solutions, expertise, and geographic footprint enables us to take advantage of the growing demand for effective and efficient global transport and biostorage of temperature sensitive life sciences commodities. This is especially the case for cell and gene therapies that require tightly controlled temperatures through the development, biostorage, transportation, and delivery processes to maintain efficacy and safety.

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Our major customer types include biotechnology and pharmaceutical companies, contract research organizations, contract development and manufacturing companies, central laboratories, fertility clinics, animal health companies, universities and research facilities.

During the year ended December 31, 2025, one customer in our Life Sciences Services reportable segment accounted for 10.2% of our total revenue. During the years ended December 31, 2024 and 2023, no single customer accounted for over 10% of our total revenue.

Our geographical revenue, by origin, for the years ended December 31, 2025, 2024 and 2023, were as follows:

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Sales and Marketing

We serve clients across the life sciences industry, with a particular focus on the rapidly evolving CGT market. Our global sales and marketing efforts are centered on addressing each customer’s unique challenges and anticipating their future needs through our specialized temperature-controlled supply chain solutions. Our marketing teams create and execute targeted digital campaigns that align with our commercial strategy, showcasing our innovative portfolio of solutions and capabilities. These initiatives are designed to fuel business development, program management, and consulting activities, while also enhancing awareness of our advanced temperature-controlled supply chain solutions.

Competition

We believe Cryoport is unique in its services and product offerings. Collectively, Cryoport’s specialized expertise in providing advanced temperature-controlled supply chain solutions for the Life Sciences including, but not limited to, proprietary technologies, regulatory expertise, global infrastructure, embedded customer relationships, and a data-driven operating model create substantial competitive advantages. Our deep proficiency in supporting the Life Sciences with an emphasis on the CGT Market for over 12 years, operational knowledge, compliance track record, and extended customer validation cycles required to compete at scale reinforce Cryoport’s durable competitive advantage in the Life Sciences and especially the rapidly growing CGT market. However, we do have competition in various segments of our business from companies that offer services and/or products that could be considered competitive to certain components or elements of our platform of temperature-controlled supply chain solutions for the Life Sciences. Life Sciences Services competition is primarily with specialty couriers, who fall into the category of coopetition and include companies such as World Courier (a Cencora company), UPS Healthcare, Quick (a Kuehne+Nagel company), and Biocair. In addition, life science companies may develop their own in-house temperature-controlled supply chain solutions, systems, and/or procedures to cover their specific needs. Competition for our cryopreservation services in particular includes companies such as the American Red Cross and Gift of Life Biologics. Life Sciences Products competition is with companies offering cryogenic systems products such as Azenta Life Sciences, Phase 2, and IC Biomedical. Cryoport is a leader in both its Life Sciences Services and Life Sciences Products reporting segments.

Engineering and Development

Our engineering and development activities are focused on advancing our integrated, temperature-controlled supply chain platform through the development of proprietary digital systems, intelligent packaging, condition monitoring, automation, and data analytics. Our Enterprise Technology Group coordinates platform architecture, Internet of Things–enabled monitoring, and informatics capabilities that support real-time visibility, chain-of-custody and chain-of-identity, and regulatory compliance across global operations. These efforts include ongoing enhancements to the Cryoportal® digital logistics management platform, deployment of Smartpak® and IoT-based monitoring solutions powered by Tec4med, and the integration of advanced analytics and artificial intelligence to improve operational performance, risk management, and scalability. We also apply engineering resources to product development within our cryogenic systems manufacturing operations, supporting the design, validation, and continuous improvement of cryogenic freezers, dewars, and transport systems. Collectively, these engineering and development initiatives are intended to strengthen the reliability, traceability, and efficiency of our solutions as we support the expanding global CGT Market and other parts of the Life Sciences.

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Manufacturing and Raw Materials

Manufacturing - We source components for our products from multiple suppliers, including those that manufacture to our engineering specifications, using, in part, proprietary technology and knowledge to mitigate supply chain risks. We also use “off-the-shelf” products, which we may modify to meet our requirements. For some components, there are relatively few alternate sources of supply and the establishment of additional or replacement suppliers may or may not be accomplished immediately. When this occurs, we endeavor to mitigate risk by locating an alternative qualified supplier and, as appropriate, increasing our inventory level.

Our vendor/partner relationships allow us to concentrate on further advancing and expanding our platform of systems, products, and solutions for the life sciences to meet the growing and varied demands for validated temperature-controlled solutions in the life sciences industry. We endeavor to keep our supply structure up to date and agile as it provides us the opportunity to rapidly scale to support our client’s commercialization, systems, products, and solutions requirements; however, we are ever mindful of the work we must do to improve our current sourcing and to continue to mitigate risks therein.

Raw Materials - Various raw materials are used in the manufacture of our products and in the development of our technologies. Most raw materials are generally available from several alternate distributors and/or manufacturers. Where we have experienced significant difficulty in obtaining these raw materials, we have established alternative global sources or work with existing suppliers to overcome any deficiencies.

Patents, Copyrights, Trademarks, and Proprietary Rights

To remain competitive, we develop and maintain protection on the proprietary aspects of our platform of technologies. We rely on a combination of patents, copyrights, trademarks, trade secret laws and confidentiality agreements to protect our intellectual property rights.

We file patent applications to protect innovations arising from our research, development and design. As of December 31, 2025, we owned approximately 74 issued patents and have more than 110 pending patent applications throughout the world. Our patents generally protect certain aspects of our products and related technology. We also own common law and registered trademarks in the U.S. and in certain foreign countries to protect the names of our company, certain products, and key service brands. We own certain copyrights relating to certain aspects of our systems, products and services.

Our success is influenced, in part, by our ability to continue to develop proprietary products and technologies. It is desirable to obtain patent coverage for these products and technologies; however, some are protected as trade secrets. We intend to file trademark and patent applications covering any newly developed products, methods and technologies. However, there can be no guarantee that any of our pending or future filed applications will be issued as patents or registered as trademarks. There can be no guarantee that the various patent and trademark governmental agencies from around the world or some third party will not initiate an interference proceeding involving any of our pending applications or issued patents. Finally, there can be no guarantee that our issued patents or future issued patents, if any, will provide adequate protection from competition.

Patents provide some degree of protection for our proprietary technology. However, the pursuit and assertion of patent rights involve complex legal and factual determinations and, therefore, are characterized by significant uncertainty. In addition, the laws governing patent issuance, and the scope of patent coverage continue to evolve. Moreover, the patent rights we possess or are pursuing generally cover our technologies to varying degrees. As a result, we cannot ensure that patents will issue from any of our patent applications, or that any of the issued patents will offer meaningful protection. In addition, our issued patents may be successfully challenged, invalidated, circumvented, or rendered unenforceable so that our patent rights may not create an effective barrier to competition. We must also pay maintenance fees at set intervals for our patents to not expire prematurely. The laws of some foreign countries may not protect our proprietary rights to the same extent as the laws of the United States. There can be no assurance that any patents issued to us will provide a legal basis for establishing an exclusive market for our products or provide us with any competitive advantages, or that patents of others will not have an adverse effect on our ability to do business or to continue to use our technologies freely. As with all patents, we may be subject to third parties filing claims that our technologies or products infringe on their intellectual property. We cannot predict whether third parties will assert such claims against us or whether those claims will hurt our business. If we are forced to defend against such claims, regardless of their merit, we may face costly litigation and diversion of management’s attention and resources. As a result of any such disputes, we may have to develop, at a substantial cost, non-infringing technology or enter into licensing agreements. These agreements may be unavailable on terms acceptable to such third parties, or at all, which could seriously harm our business or financial condition.

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With respect to our trademarks, we file and pursue trademark registrations on words, symbols, logos, and other source identifiers that clients use to associate our products and services with us. Although our registered trademarks carry a presumption of validity, they can be challenged and possibly invalidated and as such, we cannot guarantee that any trademark registration is infallible.

We also rely on trade secret protection of our intellectual property. We attempt to protect trade secrets by entering into confidentiality agreements with employees, consultants and third parties, although, in the past, we have not always obtained such agreements. It is possible that these agreements may be breached, invalidated, or rendered unenforceable, and if so, our trade secrets could be disclosed to our competitors. Despite the measures we have taken to protect our intellectual property, parties to such agreements may breach confidentiality provisions in our contracts or infringe or misappropriate our patents, copyrights, trademarks, trade secrets and other proprietary rights. In addition, third parties may independently discover or invent competitive technologies, or reverse engineer our trade secrets or other technology. Therefore, the measures we are taking to protect our proprietary technology may not be adequate.

Government Regulation

Globally, Cryoport is subject to regulations in numerous country jurisdictions and international regulations relating to manufacturing, shipments, customs, import, export, safe working conditions, environmental protection, and disposal of hazardous or potentially hazardous substances. In addition, we must ensure compliance with economic sanctions and/or restrictions on individuals, corporations, or countries, and other government regulations affecting trade that may apply to our international cross border business activities.

The shipping of biologic products, biologic commodities, diagnostic specimens, infectious substances, and dangerous goods, whether via air or ground, falls under the jurisdictions of many country, state, federal, local and international agencies. The quality of the packaging that protects such commodities is critical in determining successful shipping conditions and to ensure a commodity will arrive at its destination in a satisfactory condition. Meeting stringent regulations such as Dangerous Goods Regulations, ISTA, and IATA, as applicable, Cryoport has demonstrated compliance and adhesion to these requirements. Many of the regulations for transporting dangerous goods in the United States are determined by international rules formulated under the auspices of the United Nations. Dangerous goods are typically one-time shipments and are not a part of our routine services. When called upon to ship dangerous goods, Cryoport follows strict and stringent guidelines. International Civil Aviation Organization (“ICAO”) is the United Nations organization that develops regulations (Technical Instructions) for the safe transport of dangerous goods by air. If shipment is by air, compliance with the rules established by the IATA is required. IATA is a trade association made up of airlines and air cargo couriers that publishes annual editions of the IATA Dangerous Goods Regulations. These regulations interpret and add to the ICAO Technical Instructions to reflect industry practices. Additionally, the Centers for Disease Control (“CDC”) has regulations (published in the Code of Federal Regulations) for interstate shipping of specimens.

Our Cryoport Express® and ELITE™ Shippers meet Packing Instructions 602 and 650 and are certified for the shipment of Class 6.2 Dangerous Goods per the requirements of the ICAO Technical Instructions for the Safe Transport of Dangerous Goods by Air and IATA. Our present and planned future versions of the Cryoport SmartPak™ Condition Monitoring Systems are subject to regulation by the Federal Aviation Administration (“FAA”), Federal Communications Commission (“FCC”), FDA, IATA and possibly other agencies which may be difficult to determine on a global basis. Additionally, our Chain of Compliance™ processes comply fully with ISO 21973:2020 guidelines.

Storage of biological materials that are classified as drug products for human therapeutic use (either for investigational use or commercially approved) or materials used in the manufacture of drug products for human therapeutic use, is regulated by the FDA under Title 21 Code of Federal Regulations (“CFR”) part 210 & 211. Facilities must be compliant with current GMP regulations which are enforced by the FDA through registration and audit. When drug products are exported to other countries, biostorage upon receipt must meet relevant local regulations.

Our MVE Biological Solutions cryogenic stainless-steel freezers and aluminum dewars are certified to the Medical Device Directive (MDD) in the EU. MVE is compliant with current GMP regulations which are enforced by the FDA through registration and audit of compliance with 21 CFR Part 820 and GMP. This FDA registration and product listing is in addition to MVE’s existing ISO 13485:2016 certification.

Additionally, registrations for import are in place for various countries with these requirements.

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Cryoport’s advanced integrated temperature-controlled supply chain solutions platform is designed to support the global distribution of high-value commercial biologic and cell-based products and therapies regulated by the FDA, the European Medicines Association (EMA) and other international regulatory bodies. Cryoport’s solutions are also relied upon for the support of pre-clinical, clinical trials, Investigational New Drug Applications (IND), Biologics License Applications (BLA), and New Drug Applications (NDA) with the FDA, as well as global clinical trials initiated in other geographies, where strict regulatory compliance and quality assurance is mandated.

For additional information, see “Part I, Item 1A — Risk Factors—Risks Related to Regulatory and Legal Matters” in this Form 10-K.

Employees

We refer to our employees as our “team.” They are critical to our success, and we are in constant communication and training. We believe that we have assembled a strong management and leadership team with the experience and expertise needed to execute our business strategy. As of December 31, 2025, we had 738 employees: 684 full-time, 8 part-time, and 46 temporary, of which 448 are located in the Americas, 148 in EMEA and 142 in APAC. We anticipate hiring additional personnel as required to support our global growth strategy.

Corporate History and Structure

We are a Nevada corporation originally incorporated under the name G.T.5-Limited (“GT5”) on May 25, 1990. In connection with a Share Exchange Agreement in March 2005, we changed our name to Cryoport, Inc. and acquired all of the issued and outstanding shares of common stock of Cryoport Systems, Inc., a California corporation. Cryoport Systems, Inc., which was originally formed in 1999 as a California limited liability company, was reorganized into a California corporation on December 11, 2000 and converted into Cryoport Systems, LLC, a California limited liability company, on September 17, 2020, and remains one of our operating companies under Cryoport, Inc. Our principal executive offices are located at 112 Westwood Place, Suite 350, Brentwood, TN 37027. The telephone number of our principal executive office is (949) 470-2300, and our main corporate website is www.cryoportinc.com. The information on or that can be accessed through our website is not part of this Form 10-K.

Information about our Executive Officers

The following are our executive officers as of the filing date of this Form 10-K:

Jerrell W. Shelton. Mr. Shelton, age 80, became a member of our board of directors in October 2012 and was appointed President and Chief Executive Officer of the Company in November 2012.  He was appointed Chairman of the Board in October 2015.  He served on the Board of Directors and standing committees of Solera Holdings, Inc. from April 2007 through November 2011.  From June 2004 to May 2006, Mr. Shelton was the Chairman and CEO of Wellness, Inc., a provider of advanced, integrated hospital and clinical environments.  Prior to that, he served as Visiting Executive to IBM Research and Head of IBM’s WebFountain.  From October 1998 to October 1999, Mr. Shelton was Chairman, President and CEO of NDC Holdings II, Inc.  Between October 1996 and July 1998, he was President and CEO of Continental Graphics Holdings, Inc. From October 1991 to July 1996, Mr. Shelton served as President and CEO of Thomson Business Information Group.  Mr. Shelton has a B.S. in Business Administration from the University of Tennessee and an M.B.A. from Harvard University.   Mr. Shelton’s extensive leadership, management, strategic planning and financial expertise through his various leadership and directorship roles in public, private and global companies, makes him well-qualified to serve as a member of the board of directors.

Robert S. Stefanovich. Mr. Stefanovich, age 61, became Chief Financial Officer and Treasurer for the Company in June 2011. In 2019, he was also given the title Senior Vice President. From 2011 to 2019, Mr. Stefanovich served as the Secretary of the Company. From June 15, 2012 to November 4, 2012, Mr. Stefanovich served as the Principal Executive Officer of the Company. From November 2007 through March 2011, Mr. Stefanovich served as Chief Financial Officer of Novalar Pharmaceuticals, Inc., a venture-backed specialty pharmaceutical company. Prior to that, he held several senior leadership positions, including interim Chief Financial Officer of Xcorporeal, Inc., a publicly traded medical device company, Executive Vice President and Chief Financial Officer of Artemis International Solutions Corporation, a publicly traded software company, Chief Financial Officer and Secretary of Aethlon Medical Inc., a publicly traded medical device company and Vice President of Administration at SAIC, a Fortune 500 company. Mr. Stefanovich also served as a member of the Software Advisory Group and an Audit Manager with Price Waterhouse LLP’s (now

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PricewaterhouseCoopers) hi-tech practice in San Jose, California and Frankfurt, Germany. He received his Master of Business Administration and Engineering from University of Darmstadt, Germany.

Mark Sawicki, Ph.D. Dr. Sawicki, age 53, became President and Chief Executive Officer of Cryoport Systems, LLC, a wholly-owned subsidiary of the Company, and the Senior Vice President and Chief Scientific Officer of the Company in September 2020 and served as the Chief Commercial Officer of Cryoport Systems from January 2015 to August 2020. Dr. Sawicki brings over 20 years of business development and sales management experience, having consistently delivered on corporate revenue and market share goals in the pharmaceutical and biotechnology industries. Dr. Sawicki previously served as the Chief Business Officer at AAIPharma Services Corporation/Cambridge Major Laboratories Inc. (now Alcami Corporation), a contract development, testing, and manufacturing organization for pharma and biotech companies. Additionally, he has served in senior business development roles at CMC Biologics, a provider of biopharmaceutical contract manufacturing services, and Albany Molecular Research Inc. (AMRI), a contract research and manufacturing organization. Dr. Sawicki holds a bachelor’s in biochemistry from the State University of New York at Buffalo and a Ph.D. in biochemistry from the State University of New York at Buffalo, School of Medicine and Biomedical Sciences. He also received graduate training at the Hauptman Woodard Medical Research Institute. Dr. Sawicki has authored a dozen scientific publications in drug discovery with a focus on oncology and immunology.

Edward J. Zecchini. Mr. Zecchini, age 65, became Chief Digital and Technology Officer (CDTO) for the Company in February 2024.  Prior to joining the Company as the CDTO, Mr. Zecchini was a member of the Cryoport, Inc. Board of Directors from September 2013 through February 2024. Mr. Zecchini currently serves on the Board of TribeHealth, Inc. From 2018 to 2022, Mr. Zecchini also served as a director of the publicly traded behavioral healthcare company, Ontrak, Inc. Mr. Zecchini served as Chief Information Officer at Remedy Partners, Inc., from April 2014 to October 2019 and served as Executive Vice President and Chief Technology Officer at Sandata Technologies, LLC, from May 2010 to March 2014. Prior to that, Mr. Zecchini held senior executive positions at Touchstone Healthcare Partnership, HealthMarkets, Inc., Thomson Healthcare and SportsTicker, Inc. Mr. Zecchini has over thirty years of experience in the healthcare and information technology industries. Mr. Zecchini holds a Bachelor of Arts degree from the State University of New York at Oswego.

Available Information

Our main corporate website address is www.cryoportinc.com. The information on or that can be accessed through our website is not part of this Form 10-K. We electronically file with the SEC our Annual Report on Form 10‑K, Quarterly Reports on Form 10‑Q, Current Reports on Form 8‑K and amendments to the reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, proxy statements and the reports filed pursuant to Section 16(a) of the Exchange Act.. We make available free of charge on or through our website copies of these reports and proxy statements as soon as reasonably practicable after we electronically file these reports and proxy statements with, or furnish them to, the SEC. The SEC also maintains an internet site that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov.

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