EDGAR 10-K Filing

Company CIK: 1124524
Filing Year: 2024
Filename: 1124524_10-K_2024_0001558370-24-003128.json

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ITEM 1. BUSINESS
Item 1. Business
Overview
Cryoport is a global leader in supply chain solutions for cell & gene therapies that enable manufacturers, contract manufacturers (CDMO’s), contract research organizations (CRO’s), developers, and researchers to carry out their respective business. We provide a broad array of supply chain solutions for the life sciences industry. Through our platform of critical products and solutions including advanced temperature-controlled packaging, informatics, specialized bio-logistics services, bio-storage, bio-services, and cryogenic systems, we are “Enabling the Future of MedicineTM”, worldwide, through our innovative systems, compliant procedures, and agile approach to superior supply chain management.
With over 50 strategic international locations in 17 countries, Cryoport’s global platform provides mission-critical solutions to over 3,000 customers working with biopharma/pharma, animal health, and reproductive medicine companies, universities, research institutions, and government agencies. Our platform of solutions and services together with our global team of over 1,100 dedicated colleagues delivers a unique combination of innovative supply chain technologies and services through our industry-leading brands, including Cryoport Systems, MVE Biological Solutions, CRYOPDP, and CRYOGENE.
Cryoport’s advanced temperature-controlled supply chain platform is designed to support the global distribution of high-value commercial biologic and cell-based products and therapies regulated by the United States Food and Drug Administration (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.
Over the last several years, we have grown to become a leader in supporting the clinical trials and commercial launches of cell & gene therapies globally. As of December 31, 2023, we supported 675 clinical trials, of which 82 were in Phase 3, and 12 commercial therapies. We believe regenerative medicine advanced therapies that successfully advance through the clinical trial process and receive commercial approval from the respective regulatory agencies will represent opportunities to become significant revenue drivers for us as the majority of them will require comprehensive temperature-controlled supply chain support and other services at commercial scale. Additionally, we expect that most will select us as their critical supply chain solutions partner as a result of our work in connection with their respective clinical trials and our long track record of innovation and market responsiveness.
In addition, Cryoport also supports the animal health market and the human reproductive market on a global basis with its advanced supply chain platform. The animal health market is composed of supporting animal husbandry and companion and recreation animal health. The human reproductive market is largely composed of In-Vitro Fertilization (IVF) support for patients and fertility clinics.
The Markets We Serve
Cryoport serves the life sciences industry as a provider of integrated temperature-controlled supply chain solutions supporting the biopharma/pharma, animal health, and reproductive medicine markets.
Acquisitions
Over the last five years we have extended our supply chain solutions for the life sciences through the following acquisitions:
● In May 2019, we acquired Cryogene Labs (CRYOGENE), which is today a state-of-the-art temperature-controlled biostorage solutions business strategically located in Houston, Texas. CRYOGENE is an industry leader in the management of pre-clinical and clinical biostorage services, including critical biological commodities supporting clinical research, the advancement of cell and gene therapy, and public health research. It provides customized, end-to-end chain of custody/chain of condition solutions for its clients. CRYOGENE’s GMP (good manufacturing practices) operation is an FDA audited operation serving all temperature categories of the temperature-controlled supply chain for the life sciences.
● In October 2020, we acquired CRYOPDP, a leading global provider of innovative temperature-controlled logistics solutions for high value, time critical and temperature-sensitive biopharmaceutical/pharmaceuticals. CRYOPDP provides the biopharma market with temperature-controlled logistics, including packaging, pick-pack kit preparation, premium services, and specialty biopharma/pharma courier support. At the time of acquisition, CRYOPDP added a network of 22 global logistics centers located in 12 countries to our global network. These additions expanded our logistics network to provide “last mile” services and to better serve our global multi-national clients. They also added redundancies and backup that reduced supply chain risk for our clients.
● In October 2020, we also acquired MVE Biological Solutions (MVE), the global leader providing cryobiological storage and transportation systems for the life sciences industry through its advanced line of cryogenic systems including stainless-steel freezers, aluminum dewars and related ancillary equipment used in the storage and/or transport of life sciences commodities. MVE’s three primary manufacturing facilities are located in Ball Ground, GA, New Prague, MN and Chengdu, China. The acquisition was a vertical integration that, in addition to expanding our footprint to handle the growing demand driven by the growth in the cell and gene therapy market, was intended to further secure our supply of cryogenic systems. MVE’s clients include cell and gene therapy, medical laboratories, biotech/pharmaceutical research facilities, blood and tissue banks, animal breeders, academic institutions, veterinary laboratories, large-scale biorepositories, fertility clinics, government agencies, and other institutions.
● In April 2021 and May 2021, we acquired Critical Transport Solutions Australia (CTSA) in Australia and F-airGate in Belgium, respectively, to further enhance CRYOPDP’s existing global temperature-controlled logistics capabilities in the APAC (Asia Pacific) and EMEA (Europe, the Middle East and Africa) regions.
● In April 2022, we acquired Cell&Co BioServices in Clermont-Ferrand, France with additional operations in Pont-du-Château, France to further enhance our existing global temperature-controlled supply chain capabilities. Cell&Co BioServices is a bioservices business providing biorepository, kitting, and logistics services to the life sciences industry and now a part of Cryoport Systems’ Global Supply Chain Center Network.
● In July 2022, we acquired Polar Expres based in Madrid, Spain, which provides temperature-controlled logistics solutions dedicated to the life sciences industry. Polar Expres operates logistics centers in Madrid and Barcelona supporting the rapidly growing life sciences market. This acquisition further expanded CRYOPDP’s footprint in the EMEA region.
● In July 2022, we also acquired Cell Matters based in Liège, Belgium, a company with cryobiology expertise, providing cryoprocess optimization, cryoprocessing, and cryopreservation solutions to the life sciences industry. This acquisition is tied to Cryoport Systems’ initiative to establish standardized, integrated apheresis processing, biostorage, and distribution solutions for cellular therapies. The new platform will leverage the cryo-processing expertise of Cell Matters (rebranded IntegriCell™) to provide consistent, high-quality cellular starting material for use in the manufacture of life-saving cellular therapies.
● In November 2023, we acquired TEC4MED LifeScience GmbH (Tec4med) based in Darmstadt, Germany. Tec4med provides next generation pharmaceutical supply chain visibility by integrating condition monitoring, cloud and artificial intelligence (AI) solutions. ISO 9001-certified, Tec4med works with pharmaceutical-compliant, ready-to-use devices and software, offering customer-specific integrations. Tec4med broadens our portfolio of condition monitoring solutions and provides additional resources and capabilities to drive new product development and accelerate our European market expansion, particularly in the DACH region (Germany, Austria, Switzerland).
● In November 2023, we also acquired Bluebird Express, LLC ("Bluebird Express"), a provider of time-sensitive domestic and international transportation services with key operations centers in Los Angeles (LAX) and New York (JFK), Bluebird Express has over 20 years of experience in providing these services, is a fully accredited cargo agent certified by the International Air Transport Association (IATA) and an indirect air carrier (IAC) authorized and regulated by the Transportation Security Administration (TSA).
Cryoport Products and Services
We continuously expand our products and services across the supply chain with innovative, technology-centric solutions to support the development and distribution of life sciences products and therapies.
Our suite of market leading products and services include, but are not limited to the following:
Cryoport Express® Shippers - Cryoport Express® Shippers range from liquid nitrogen dry vapor shippers (-150℃) to our C3™ Shippers (2-8℃), which are powered by phase-change materials. The Cryoport Express® Shippers are precision-engineered assemblies that are reliable, cost-effective, and reusable or recyclable. Our liquid nitrogen dry vapor Cryoport Express® Shippers utilize an innovative application of ‘dry vapor’ liquid nitrogen technology and, most often, include a SmartPak™ Condition Monitoring System. Cryoport Express® Shippers meet IATA (International Air Transport Association) requirements for transport, including Class 6.2 infectious substances, are also ISTA (International Safe Transit Association) “Transit Tested” certified and carry the CE (“Conformité Européenne”) mark demonstrating conformance with European Union (“EU”) health, safety, and environmental protection standards.
Cryoport ELITE™ Shipper Systems
● Cryoport ELITE™ -80°C Gene Therapy Shipper - As the first product in a high-performance line of Cryoport ELITE™ Shippers, the company has designed a best-in-class family of -80°C shippers that have superior temperature management properties as well as incorporate next generation protection, handling, and data collection and management systems including our SmartPak™ Condition Monitoring System. The Cryoport ELITE™ shipper line has been developed in conjunction with one of the leaders in the gene therapy space for clinical and commercial gene therapy distribution. The ELITE™ shipper platform was launched during the second quarter of 2023.
● Cryoport ELITE™ Cryosphere™ Shipper - The second product in the new high-performance line of Cryoport ELITE™ Shippers is the Cryosphere™, which is a gravitationally stabilized shipper to support the cell and gene therapy and other life sciences markets. This shipper is designed to passively stabilize the payload through an internal gravitational sphere, thereby keeping the payload in an upright orientation regardless of the external shipper orientation. This innovative technology further mitigates one of the key risks during storage, handling, and transport, which is maintaining constant cryogenic temperatures. In addition, the Cryosphere™ has advanced shock and vibration absorption properties to further protect its payload and it will be outfitted with Cryoport’s state-of-the-art condition monitoring systems.
Cryoport Consulting Services - Cryoport Consulting Services functions in an expert advisory capacity to offer solutions to address risk factors present in temperature-controlled supply chain and logistics. To develop tailored scalable solutions, our cross-functional team collaborates with our clients to understand supply chain, logistics, time, shipper, and packaging concerns. Cryoport Consulting Services employs a structured approach to managing, executing, and developing risk mitigation plans. Our clients benefit from our quality driven processes and solutions delivered by our high integrity team leveraging industry-standard best practices and years of experience partnering with leading regenerative medicine companies from early clinical through post-commercialization. Service solutions range from comprehensive physical, thermal and shipping qualifications of shipping systems and/or packaging to developing user-friendly custom packaging solutions focused on the challenges unique to our regenerative medicine customers. Through our Packaging Center of Excellence, we serve our clients in biopharma/pharma, animal health, and reproductive medicine markets by providing state-of-the-art customized packaging, testing, qualification capabilities and a host of other services.
Cryoport Bioservices - In June 2022, Cryoport Systems launched its first two Global Supply Chain Centers in Houston, Texas and Morris Plains, New Jersey. These state-of-the-art facilities combine our existing logistics processes and capabilities with our new, cutting edge Bioservices infrastructure - all under one roof, as Cryoport Systems’ Global Supply Chain Center Network. These new Global Supply Chain Centers offer a new and fully integrated approach designed to support cell and gene therapies including comprehensive controlled temperature storage, fulfilment, kit production, secondary packaging, labelling of therapeutic products and GMP raw materials storage along with advanced world class logistics. In April 2022, we acquired Cell&Co BioServices in Clermont-Ferrand, France with additional bioservices operations in Pont-du-Château, France to accelerate the setup of our bioservices capabilities in the EMEA region. Further expansion of the Global Supply Chain Center network is expected to include additional sites in the Americas, EMEA and APAC regions. The addition of these facilities and services are expected to address our clients’ increasing need for comprehensive and integrated solutions offerings and the expected growth in the global biostorage and bioservices markets, which are driven by the acceleration of clinical trials and the commercialization of regenerative medicine therapies on a global basis.
CRYOGENE - provides unparalleled solutions for the provision of pre-clinical temperature-controlled biological materials management services to the life sciences industry. These services include comprehensive specimen storage, processing, collection, and retrieval at our CRYOGENE operations in Houston, Texas, which is a cGMP-compliant operation. CRYOGENE is currently in the process of completing the setup of a biostorage facility in San Antonio, Texas and is evaluating other locations for geographic expansion.
CRYOPDP Temperature-controlled Logistics - CRYOPDP is a specialist providing global and innovative temperature-controlled logistics solutions to the biopharmaceutical/pharmaceuticals industry. CRYOPDP operates with expertise an exhaustive range of temperature-controlled logistics services including temperature-controlled packaging and premium transport solutions from cryogenic (-196°C to -150°C) to controlled ambient (+15°C to +25°C) temperatures.
Cryoport CryoshuttleTM - provides our clients with dedicated local transportation support using Cryoport trained drivers and vehicles. The Cryoshuttle is dedicated to the management of Cryoport owned and managed equipment on behalf of our clients providing a better user experience.
IntegriCellTM Services - in conjunction with our acquisition of Cell Matters in July 2022, Cryoport launched its IntegriCellTM service platform. The IntegriCellTM platform is designed as a fully standardized apheresis cryo-processing platform that is expected to be built out on a global basis. The platform services include apheresis/leukapheresis collection via partners, CryoshuttleTM transportation services, cryo-process optimization, cryo-processing services, and bioservices support to provide a more consistent starting product and increased patient accessibility into the community care setting for regenerative medicine therapies.
Tec4Med - our most recent acquisition in November 2023 is a next generation pharmaceutical supply chain visibility platform. The Tec4Med solutions provide cold-chain packaging temperature and location monitoring, warehouse monitoring as well as bench top monitoring for laboratories and research facilities. The Tec4Med technology is expected to be incorporated into many of Cryoport’s products and services in the coming years.
MVE Biological Solutions
● MVE Biological Solutions’ Fusion® Cryogenic System - is the world’s first and only self-sustaining cryogenic freezer. The MVE Fusion® can operate as a stand-alone unit, requiring no on-going liquid nitrogen supply or connection to an external liquid nitrogen source. Fusion® cryogenic freezers are a perfect solution for remote geographic locations, isolated laboratories, high elevation facilities, or facilities without existing liquid nitrogen infrastructure.
● MVE Biological Solutions’ Vario® Cryogenic System - is an innovative cryogenic freezer system that can support temperatures anywhere between -20°C and -150°C. In addition to providing greater flexibility, the Vario® series of cryogenic freezer systems provide effective and consistent temperature profiles with less than 1% of the power consumption and a 70% reduction in overall operating cost savings compared to traditional mechanical freezers.
Competitive Advantages
With our first-to-market integrated platform of technology-driven supply chain solutions serving the life sciences industry, we have established a substantial lead over potential competitors by focusing on de-risking critical processes central to the manufacture of cell and gene therapies. Working with our in-depth knowledge of information technology, cryopreservation, packaging, temperature-controlled logistics, bioservices, and cryogenic systems, our management, technical, business development and service support teams approach our growing markets with valued insights, adaptability, innovation, creative thinking and a mindset of problem resolution which will provide clients with certainty of performance.
The most common alternatives to Cryoport’s platform of solutions are “older technologies” and/or systems as well as partial, non-integrated and/or non-regulated, non-validated solutions. In fact, a portion of the biopharma market and much of the animal health and reproductive medicine markets still use liquid nitrogen and/or dry ice with no monitoring or ongoing validation processes for equipment and/or procedures. Non-integrated systems with assets and technologies managed by multiple entities introduce gaps in policies, procedures, information, and validation of the supply chain solutions which in turn create inherent and material risks during the biostorage, packaging, fulfillment, information gathering, transport processes and other related activities required to securely deliver biopharma products and services in the life sciences.
Through our experience, we know that supply chain processes can have a large impact on temperature sensitive product/commodity conditions. This is especially important for high value, and, at times, irreplaceable commodities for which we
provide products and services, whether in support of research, clinical trials or commercial distribution. We therefore seek to exceed the most demanding standards in the industry, such as, among others, ISO 13485, ISO 21973, ISO 9001, ISTA, and IATA.
Throughout our company, we have implemented Quality-by-Design processes that allow us to assess internal and in-field events including the impact of packaging and supply chain processes and procedures on the commodity being shipped, and the equipment being used for each individual shipment. With the acquisition of CRYOPDP, Cryoport has increasing control and accountability around distribution which in turn provides better performance and risk management for our clients and their critical therapies. We have been qualified as a temperature-controlled solutions provider for hundreds of life sciences companies, institutions, and governments. During 2023, we have logged over 500,000 shipments to over 130 countries with hundreds of different types of life sciences materials in the last 12 months.
Cryoport Systems’ Cryoportal® Logistics Management System (Cryoportal®) is an important backbone technology that is integrated with our partners, such as FedEx, UPS, DHL, nmdp Biotherapies (formerly known as Be The Match Biotherapies), Lonza, and others. The Cryoportal® Logistics Management System handles order entry, keeps track of our global inventory, and provides algorithms for predictive analysis on every shipment while in transit, globally. Cryoport Systems’ customer service team monitors every in-transit shipment 24/7/365 and, by leveraging the Cryoportal®, they have the unique ability to see issues that arise and take corrective measures up to and including intervention to potentially save a shipment in trouble.
Embedded within the Cryoportal® is our Chain of Compliance®, which is important for regulatory reasons and risk mitigation to our processes. Each of our reusable products, including every Cryoport Express® and ELITE™ shipper and every SmartPak® Condition Monitoring System, has a unique ID attached for its entire life. Thereby, Cryoport personnel can pull any Cryoport shipper out of our fleet and provide customers and/or regulatory agencies with its (and all its components) entire history including every journey it has taken, for whom it was shipped, the contents shipped, the Cryoport shipper’s performance during transit, and the time of its return to a Cryoport Systems’ Global Logistics facility. It also provides technician log information on the validated cleaning process, recertification process of the unit and its components, and recalibration of the SmartPak® Condition Monitoring System as being acceptable for its next use. All this traceability information is securely stored in our Cryoportal® Logistics Management System for our clients to access at any time. We believe that this represents a significant differentiator for Cryoport in the markets it serves.
The acquisition of CRYOPDP in 2020 significantly expanded Cryoport’s global logistics network. CRYOPDP has more than 25 years of experience serving the global life sciences industry as a specialty courier with innovative and dependable temperature-controlled logistics solutions focused on the pharma/biopharma market. Over the last three years, CRYOPDP further expanded organically as well as through further development of locations in India and the acquisitions in Ireland, Belgium, Spain and Australia. Most recently, in November 2023, CRYOPDP acquired Bluebird Express, a provider of time-sensitive domestic and international transportation services with key operations centers in Los Angeles and New York, to further strengthen its U.S. logistics capabilities. CRYOPDP currently has over 30 offices/logistics centers in 16 countries.
The acquisition of MVE Biological Solutions in 2020 enabled Cryoport to become the leading global provider of cryogenic systems and solutions. MVE Biological Solutions’ is a leader in the supply of cryogenic systems globally and it is an important part of our global supply chain platform. With its long history of producing the highest quality, most dependable products in the industry, it has set the standard for the manufacture of cryogenic systems including vacuum insulated products, freezer, and shipper solutions used for storage and/or distribution of critical biological material for almost 60 years. MVE Biological Solutions’ equipment is used extensively throughout the life sciences industry and is known for providing the trusted cryogenic storage and/or transportation solutions within the pharma/biopharma, animal health and reproductive medicine markets.
Segment Reporting
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. The chief operating decision maker is our Chief Executive Officer. The Company and its chief operating decision maker view the Company’s operations and manage its business in one operating segment.
Customers and Distribution
As a result of growing globalization in cell and gene therapy (regenerative medicine), biologics, biopharma, biotechnology, clinical trials, distribution of biopharmaceutical products, animal health and reproductive medicine, the requirement for effective and reliable solutions for keeping clinical samples, pharmaceutical products and other specimens at controlled temperatures requires more
sophisticated supply chain solutions in areas such as distribution, complex shipping routes, extended shipping times, potential custom delays, general logistics challenges, biostorage, etc. We believe that our platform of 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 the new therapies being developed in the regenerative medicine market, such as autologous and allogeneic cell therapies and gene therapies, that require tightly controlled temperatures through the development, biostorage, transportation, and delivery processes to maintain efficacy and safety.
During the year ended December 31, 2023, one customer accounted for 10.5% of our total revenues. During the years ended December 31, 2022 and 2021, no single customer accounted for over 10% of our total revenues.
Our geographical revenues, by origin, for the years ended December 31, 2023, 2022 and 2021, were as follows:
Americas
54.5
%
54.0
%
54.0
%
Europe, the Middle East and Africa (EMEA)
26.1
%
28.2
%
26.7
%
Asia Pacific (APAC)
19.4
%
17.8
%
19.3
%
Customer types
Our major customer types include:
Clinical Trials - Every pharmaceutical or biopharma company developing a new drug or therapy must seek development protocol approval by regulatory bodies, e.g., the FDA or EMA. Usually, these agencies require clinical trials to be designed to test the safety and efficacy of the potential new drug or therapy among other things. Importantly, clinical trial specimens are often irreplaceable because each one represents clinical data at a prescribed point in time, in a series of specimens on a given patient, who may be participating in a trial for up to several years. Sample integrity and information gathering during the transportation and biostorage process is vital to retaining patients in each trial and staying on schedule.
Biotechnology and Diagnostic Companies - The biotechnology market includes basic and applied research and development in diverse areas such as stem cells, gene therapy, DNA tumor vaccines, tissue engineering, genomics, blood products, etc. Companies participating in the foregoing fields rely on temperature-controlled storage and transport of specimens in connection with their research and development efforts, for which our suite of global temperature-controlled supply chain solutions are ideally suited.
Cell & Gene Therapy Companies - Rapid advancements are underway in the research and development of cell-based therapies, which involve cellular material being infused into a patient. In allogeneic cell therapies, the donor is a different person than the recipient of the cells. Autologous cell therapy is a personalized therapeutic intervention that uses an individual’s cells, which are cultured and expanded outside the body, and reintroduced into the individual. Once cells are manufactured into a cellular therapy, in either case, they must be stored and shipped cryogenically for which our Cryoport Express® and Cryoport ELITE™ Shipper solutions, CRYOPDP logistics solutions, CRYOGENE’s biostorage capabilities, and MVE Biological Solutions’ cryogenic systems are ideally suited.
Contract Research, Development & Manufacturing Companies - Increasingly, as evidenced by our strategic partnership with Lonza, CROs and Contract Development and Manufacturing Organizations (“CDMOs”) are engaging our services exclusively in conjunction with their contract services platform to provide a higher level of service to our mutual client base. We anticipate that these relationships, which are mutually beneficial to both parties as well as our client base, will accelerate and expand to include our entire portfolio of services as cell and gene therapy clinical trials advance and as commercial therapies ramp on a global basis.
Central Laboratories - With the increase and globalization of clinical studies and trials, supply chain support has become more complex and ensuring sample integrity has become more challenging. Reliable, specialty courier costs are now consuming an increasing portion of global protocol budgets. Thus, we believe laboratories performing the testing of samples collected during the conduct of these global multi-site studies are looking for cost effective, state-of-the-art temperature-controlled supply chain solutions. CRYOPDP’s services and its global network of logistic centers have successfully supported central laboratories throughout the world for many years.
Fertility Clinics and IVF - Maintaining cryogenic temperatures during shipping and transfer of In Vitro Fertilization (IVF) specimens like eggs, sperm, or embryos is critical for cell integrity to retain viability, stabilize the cells, and ensure reproducible results and successful IVF treatment. We believe that Cryoport Systems solutions for reproductive medicine are very compelling and well
received. Additionally, MVE Biological Solutions supplies cryogenic systems to fertility clinics that wish to store and/or ship reproductive materials in their possession.
Animal Health Companies - Our primary focus in the animal health market is supporting protein production. We provide cryogenic storage dewars to bovine breeders for the support of beef and milk production through artificial insemination, on a global basis. We also provide temperature-controlled supply chain services for advanced vaccines, primarily for aviary. MVE Biological Solutions and Cryoport Systems are our primary participants in this market. We also support therapies for companion and recreational animals which include canine and equine, in addition to veterinary laboratories and other animal related reproductive and health areas.
University and Health Center Research Facilities - Research is conducted globally at major universities and health centers and is often done in collaboration with others which requires using Cryoport Express® Shippers, CRYOPDP, and/or CRYOGENE services. Our broad line of products and services provide solutions tailored to these institutions and individual researchers.
Sales and Marketing
We serve clients throughout the life sciences industry and our sales and marketing initiatives are global in nature, focusing on addressing each customer’s “pain points” and anticipated needs through our temperature-controlled supply chain solutions. Our marketing teams design and implement targeted digital campaigns to support our commercial strategy and promote our innovative portfolio of solutions and capabilities. Our marketing initiatives are designed to drive our business development, program management, consulting, other related activities and increase awareness of our advanced temperature-controlled supply chain solutions.
Competition
We believe Cryoport is unique in its offering, and we have not identified any competition that offers solutions that are as comprehensive or as widely proven in the global market as our platform of temperature-controlled supply chain solutions for the life sciences. However, we do have competition from companies that offer products and/or services that could be considered competitive to certain components or elements of our platform of temperature-controlled supply chain solutions, including specialty couriers, such as World Courier Group, Inc., Marken, Biocair and Quick Life Science Group, along with companies that offer products such as Biolife Solutions, Azenta Life Sciences, and IC Biomedical. In addition, life science companies may develop their own in-house temperature-controlled supply chain solutions, systems and procedures to cover their specific needs.
Engineering and Development
Our research, development, and engineering efforts are focused on continually investigating new technologies that can improve our services, and the features of our products and solutions in order to address market needs.
Cryoport Data Management Systems
Tec4Med and SkyTrax™ Condition Monitoring Systems - Cryoport’s Tec4Med and SkyTrax™ Condition Monitoring Systems are connected data platforms for the temperature sensitive supply chain. Tec4med provides an integrated suite of hardware and user-friendly software delivering intelligent supply chain data and predictive analytics. The Tec4med eco-system enables end-to-end supply chain visibility and optimization, unifying a digitization of the supply chain. The Tec4Cloud FDA 21 CFR Part 11 compliant web platform delivers actionable supply chain data (including multi-channel alerts) and can be white label customized with client branding. SkyTrax™ is a next generation proprietary-designed Condition Monitoring System, custom-built for the cell and gene industry. In addition to being 4G/LTE compliant, cellular network agnostic, with a full sensor array to track location, temperature, humidity, light, shock, orientation, and geofencing, with Bluetooth and Wi-Fi capabilities. The Cryoport team is currently developing a product roadmap for a unified approach to the suite of condition monitoring solutions.
Cryoportal® 2.0 and UnITy™ - Cryoport Systems’ Cryoportal® 2.0. Logistics Management Platforms was launched during the second quarter of 2023 and is ISO 21973 compliant as a supply chain management platform. In addition to managing all aspects of a given client shipment, it also manages all elements of the Chain of Compliance™ based aspects of the packaging as well including shipper management, requalification, and processing. Cryoportal® 2.0 is complemented by CRYOPDP’s UnITy™ Transportation Management System. UnITy™ provides functionalities in addition to transport management that include warehousing management, quality management, customer experience portal, mobile apps for track and trace during transport and storage as well as integration with
transportation agents and business partners. The combination of these two powerful informatics platforms provides Cryoport clients with a comprehensive status of their clinical or commercial distribution activities, while supporting regulatory requirements and further sets Cryoport apart from competition.
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 know-how 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 are working with the existing supplier to overcome its deficiency.
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, 2023, we owned approximately 65 issued patents and have more than 120 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.
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.
Cryoport’s Quality Assurance and Regulatory Affairs Programs
Cryoport is committed to quality, and this is reflected in all aspects of our global organization. From our innovative design of products and services to our continuous improvement initiatives, Cryoport has implemented comprehensive quality standards that match or exceed the stringent requirements within the markets we serve. Cryoport’s Quality Management Systems have been designed, implemented, and certified to meet ISO 9001:2015 and ISO 13485 standards in key global locations, demonstrating the discipline necessary to maintain a positive compliance profile. With our strong foundation in ISO 9001:2015 and ISO 13485, we leverage industry-specific experience with applicable regulatory requirements, and industry expectations, to create processes and procedures that incorporate strong operational practices of checks with verification. Our Quality Management Systems are designed to ensure proper controls in manufacturing, temperature-controlled supply chain services, logistics, bioprocessing, customer/client education, contracting, processing, shipping and biostorage, accumulation, and communication.
Our Quality Management Systems incorporate notable good practice quality guidelines and regulations (GxP) elements, beyond those stipulated in ISO 9001:2015 and ISO 13485, to ensure our customers are supported in the manner necessary to maintain standards and to secure a positive compliance profile for Cryoport as a supplier and partner. Notable elements include, but are not limited to, Good Documentation Practices, Good Manufacturing Practices, Good Distribution Practices, archival processes and procedures, Supplier Controls, and Corrective Action and Preventive Action (CAPA) procedures, to highlight a few examples.
Through procedural requirements, Cryoport provides substantial risk-mitigation strategies throughout its full offering of products, systems, and services to support and maintain customer confidence. Metrics and key performance indicators are accumulated regularly, and are trended to predict, and mitigate, potential risks to operations. Operating and senior management utilized this information to enact decisions regarding procedures, processes, resource allocation, and corrective actions. Quality-driven initiatives are supported throughout our global organization. We are also subject to GMED, which is an international reference body in the certification of health care and medical devices quality management systems under ISO 9001, NF EN, and ISO 13485. As such, we are subject to audits by a Medical Device Single Audit Program (MDSAP) auditing organization. Cryoport’s cryogenic biostorage facilities are routinely inspected by the FDA and The Foundation for the Accreditation of Cellular Therapy (FACT) to confirm regulatory compliance to industry requirements related to drug applications, filings, and maintenance of various cryogenically stored materials.
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 will likely be 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 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. Additionally, registrations for import are in place for various countries with these requirements.
For additional information, see “Part I, Item 1A - Risk Factors-Risks Related to Regulatory and Legal Matters” in this Form 10-K.
Environmental, Social and Governance (“ESG”) Program
Beginning in 2020 we initiated a formal internal review of our ESG policies, procedures, and performance. Subsequently in February 2021, we publicly disclosed ESG information based on the framework and standards set by the Sustainability Accounting Standards Board (SASB) and the Taskforce on Climate-related Financial Disclosures (TCFD). Building upon our first report, we began with the goal of developing a formal, thoughtful, comprehensive, and right-sized sustainability program that would be used as a foundation for effectively organizing, reporting, and measuring our performance to set ESG goals in the future.
In June 2021, we began a materiality assessment to guide our overall sustainability strategy. The intent of the materiality assessment was to understand what ESG topics were important to our key stakeholders, to take into consideration Cryoport’s business strategy development, and to understand Cryoport’s global internal priorities. There were three key activities for this phase of the process: Benchmarking against peer companies, ratings received from Ecovadis, ISS, MSCI, and Sustainalytics, and interviews with key stakeholders.
The information and feedback received from the materiality assessment was aggregated into a customized and weighted materiality matrix. The following Materiality Matrix follows GRI Standards recommendations and plots topics based on their relative priority resulting from the materiality assessment.
Once the Materiality Matrix was developed, several meetings were conducted internally with our ESG committee and our Board of Directors’ Nomination and Governance Committee to evaluate the findings.
In 2022, our initial key focus was on Greenhouse Gas (GHG) Emissions. GHG emissions were the foremost priority identified in our Materiality Matrix and represent a clear global significance for companies, consumers, and other stakeholders. In 2022, Cryoport engaged an ESG advisor to assist in creating a report of our estimated global GHG emissions during 2021.
In 2023, Cryoport again engaged an ESG advisor to assist in creating a report of our estimated global GHG emissions during 2022. The following summarizes that report.
Summary of our 2022 GHG Emissions Report
Methodology
We used the World Resource Institute’s Greenhouse Gas Protocol - Corporate Accounting and Reporting Standard (Revised Edition) to calculate the company’s GHG emissions. The standard provides accounting tools to measure, manage, and report on GHG emissions. This protocol classifies emissions into three “scopes.” Scope 1 emissions includes direct GHG emissions, which occur from sources that are owned or controlled by a company. Scope 2 emissions include indirect GHG emission from purchased electricity. Scope 3 emissions include all other indirect GHG emissions.
Organizational Boundary
The reporting boundary for the purposes of the report is Cryoport, Inc. and its consolidated subsidiaries, which includes five business units (MVE, Cryoport Systems, CRYOPDP, Cryogene and Cell & Co.) and 56 facility locations across 16 countries (United States, China, Netherlands, Portugal, France, Belgium, United Kingdom, Poland, Germany, Singapore, India, South Korea, Australia, Spain, Ireland, and Japan) in 2022.
Scope
The scope of the report includes our Scope 1 emissions (Direct) and Scope 2 emissions (Indirect emissions from purchased electricity), but generally excludes Scope 3 emissions (Other indirect emissions). However, we did quantify Scope 3 emissions from business travel for one business unit, downstream transportation from one business unit, and waste for two business units because the data was readily available to quantify such emissions. The following sources of emissions were included in the scope of the report for the identified business units:
Emission Source
Business Units
Source of Information
Scope 1
Stationary Combustion
All
Actual natural gas consumption from utility invoices for majority of locations; spend data or pro rata for approximately three locations
Scope 1
Mobile Sources
All
Actual fuel consumption data from fuel vendor invoices or mileage data
Scope 1
Fugitive Emissions
All
Actual refrigerant recharge amounts
Scope 2
Purchased Electricity (Location-Based)
CRYOPDP
Actual electricity usage from utility invoices for majority of locations; spend data or pro rata for approximately five locations
Scope 2
Purchased Electricity (Market-Based)
All (used location-based data for CRYOPDP)
Actual electricity usage from utility invoices for majority of locations; spend data or pro rata for approximately five locations. EFECs purchased for the CRYOGENE locations.
Scope 3
Employee Business Travel
CRYOPDP
Actual airline mileage for CRYOPDP PT location; travel agency carbon emission estimates
Scope 3
Downstream Product Transport
CRYOPDP
Shipment weights and mileage for CRYOPDP
Scope 3
Waste
MVE, one Cryoport Systems location
Actual facility waste disposal amounts for four locations
Some of the Scope 3 emissions that contribute to our global carbon footprint, but for which we determined that data was not reasonably available for us to quantify in this report include, but are not limited to, transportation and distribution provided by third parties in the performance of our services; use and end-of-life treatment of sold products; and purchased goods and services.
Assumptions
We used various assumptions to quantify GHG emissions in the report. As with any projections or estimates, actual results or numbers may vary based upon factors such as variations in processes and operations, availability and quality of data, and methodologies used for measurement and estimation. Changes to emission estimates may occur if updated data or emission methodologies become available. The following are some primary assumptions or estimates that we made in the 2022 report:
Stationary Combustion - Natural Gas. Natural gas usage for heating was estimated for several company locations based on spend data and regional utility rates.
Mobile Sources - Vehicle Fuel Consumption. For fleet vehicles where actual fuel usage was not available, vehicle fuel consumption was estimated based on the miles driven and average fuel economy of the vehicle type.
Purchased Electricity (Location-Based). Electricity usage was estimated for several company locations based on either (i) square footage using a US average intensity for offices of 13.6 kWh/ft2, or (ii) spend data and regional utility rates, depending on what information was available.
Utility Estimations. When there were gaps in electricity or natural gas data, the average of the prior and following months data was used to estimate the missing information.
Results
Our 2021 and 2022 Total Emissions, as calculated in the 2021 and 2022 reports, are as follows:
Emission Source
2021 Total Emissions
(MT CO2-e)
2022 Total Emissions (MT CO2-e)
Scope 1
Stationary Combustion
Scope 1
Mobile Sources
2,016
717[1]
Scope 1
Refrigerants
Scope 2
Purchased Electricity (Location-Based)
6,988
4,879[2]
Total Scope 1 and 2 (location-based)
9,602 MT CO2-e
6,231 MT CO2-e
Scope 3
Waste
Scope 3
Employee Business Travel
Scope 3
Downstream Product Transport
--
9,581
Total Scope 1, 2 (location-based), and 3
9,744 MT CO2-e
16,253 MT CO2-e
[1] The reduction of Total Emissions from Mobile Sources is primarily due to a change in emission factors used to determine CRYOPDP mobile sources in 2022 compared to 2021.
[2] The reduction of Total Emissions from Purchased Electricity (Location-Based) is primarily a result of the emission factor used for our electricity purchased in China in 2022 being significantly lower than it was in 2021.
The following charts show the percent of total emissions in 2021 and 2022 that was contributed by each type of emission quantified in the 2021 and 2022 reports:
Carbon Footprint Intensities
The following table shows our 2021 and 2022 carbon footprint intensities in relation to square feet of our facilities, revenue, and employees as calculated in our 2021 and 2022 reports.
02`
Total Scope 1 + 2 (location-based) Emissions
9,602 MT CO2-e
6,231 MT CO2-e
Intensity by Square Footage
Total Facility Square Footage
555,732 ft2
628,629 ft2
Emissions per Square Foot
0.01728 MT CO2-e / ft2
0.009912 MT CO2-e / ft2
Intensity by Employee
Number of Employees
1,024
Emissions per Employee
12.08 MT CO2-e / employee
6.08 MT CO2-e / employee
Intensity by Revenue
Total Revenue
$223 million
$237.28 million
Emissions per $ million Revenue
43.13 MT CO2-e / $ million
26.26 MT CO2-e / $ million
Next Steps
Cryoport plans to continue to calculate an annual carbon footprint. Conducting an annual carbon footprint not only allows Cryoport to track changes (i.e., increases or reductions in emissions, fuel usage, or energy usage by facility) and refine our processes and procedures used to estimate our carbon footprint, but will also be helpful in ultimately setting emission reduction targets.
We are also considering focusing on other topics within our materiality matrix (e.g., resource efficiency) to further the company’s ESG journey.
Supporting Our People (December 31, 2023)
● Total Headcount: 1,170 (Full-Time 1,019, Part-Time 11, Contingent 140)
● Languages Spoken: 20
● Countries: 17
● Average Years of Service: 5.33 Years
Cryoport’s global team of employees are our most valuable resource, from our teams on the front line in our global supply chain and logistics centers, to our manufacturing operations, to our business development personnel, to the engineers who design our products and services, to our quality assurance and regulatory teams that assure the safety, quality, compliance, and integrity of our products.
Our success depends on the health, talent, and dedication of our global team. As we grow our team, we strive to retain, develop, and provide advancement opportunities for our employees. We endeavor to make Cryoport a superior growth workplace with a diverse, inclusive, and equitable environment where all team members have the opportunity to flourish.
Diversity, Equity & Inclusion (DEI)
We are committed to inclusion, equity, and diverse representation for our employees across our Company. Cryoport is an Equal Employment Opportunity employer and currently tracks gender distribution across its operations and management. We maintain clear policies related to anti-harassment, discrimination, and retaliation, and provide an anonymous, third party-managed reporting hotline for employees to report incidents of harassment, discrimination, and policy violations. We provide annual online corporate training programs on harassment, diversity and inclusion, business ethics and code of conduct. In addition, Cryoport’s recruiting programs include targeted outreach to a variety of under-represented constituents, including minorities, women, veterans, and disabled populations to help improve recruiting efforts while gaining valuable insights from a diverse set of recruits. Cryoport has partnered with or targeted organizations like Hire Heroes, Career OneStop, recruiting at Historical Black Colleges, Accounting and Financial Women’s Alliance, and Women in Technology.
Human Resources (“HR”) departments in each Cryoport business unit manage HR priorities, including team member career development, engagement, and health and wellness. Our Corporate HR department promotes consistency of policies across operating companies and manages executive development and team member benefits.
Cryoport understands that some of the industries in which we operate, including manufacturing, are typically male dominated. As of December 2023, women represented a total of approximately 33% of all employees, 29% of all managers, 36% of all directors, and 20% of all senior leadership positions (Vice President and above). Cryoport understands that there is work to be done to create a more equitable and representative senior leadership team and continue to push gender diversity throughout its operations.
We are committed to offering competitive compensation that accounts for geography, industry, experience, and performance. Our compensation programs and practices are designed to attract new employees, motivate, and reward performance, drive growth and support retention. Compensation at Cryoport includes base wages and generally includes incentive opportunities such as restricted stock units, equity stock options, and/or cash bonuses.
Employee Health & Safety
Safety is a priority in every aspect of our business. Across our companies, we are committed to making our workplaces and communities safer for our employees, customers, and the public. Our corporate philosophy is embedded in our day-to-day work through rigorous policies and continual education.
Cryoport’s Employee Health & Safety (EHS) programs have resulted in strong safety performance, as demonstrated by our total injury rate (TIR) and lost time injury rate (LTIR) being significantly lower than the global industry averages. Facilitated by our culture of continuous improvement, we are committed to continue to work toward reducing our TIR and LTIR numbers even further.
To understand and improve our safety performance, we evaluate our operational performance across a variety of indicators-including lost-time-injury rate (LTIR)-on a daily basis. In 2023, our LTIR was 1.79, compared to 1.23 in 2022. In addition to looking at lagging indicators of safety performance, we frequently evaluate the effectiveness of new metrics, including leading indicators, as we strive to improve our safety performance. Cryoport’s operating companies are responsible for implementing policies and procedures aligned with international standards that account for their business and the associated health and safety risks.
Innovating Responsibility
Cryoport recognizes the role we play in protecting the health and safety of current and future generations through services and solutions that promote sustainability, resilience, and respect for the environment. We strive for a product base that is of the highest quality and with long use phases to minimize impact associated with production of new product, and Cryoport reviews opportunities to eliminate materials of concern and related managed waste streams on a regular cadence.
Product & Service Quality
As a temperature-controlled supply chain provider to the life sciences industry, Cryoport must comply with the safe transportation of regulated hazardous materials. As a result, we have designed and developed several features in its various products to
comply with US DOT, IATA, ICAO, and other regulatory and guidance bodies. Additionally, safety warnings are included in our product labeling as well as our manuals. Our products are designed to conform to the following standards (where applicable):
● ISO 13485 (Section 7.3 Design and Development, ISO, QMS)
● ISO 14971 Application of Risk Management, ISO
● Medical Device Directive Medical Devices Directive 93/42/EEC, and Directive 2007/47/EC amending Council Directive 93/42/EEC concerning medical devices
● Low Voltage Directive (LVD) (2014/35/EU)
● Electromagnetic Compatibility Directive (2014/30/EU)
● RoHS 2 (2011/65/EU) (we are actively working on RoHS 3 and REACH)
● Safety Requirements For Electrical Equipment For Measurement, Control, And Laboratory Use - Part 1:
● General Requirements [UL 61010-1:2012 Ed.3+R:29Apr2016]
● Safety Requirements For Electrical Equipment For Measurement, Control, And Laboratory Use - Part 1:
● General Requirements (R2017) [CSA C22.2#61010-1-12:2012 Ed.3+U1; U2]
● IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
● IEC 61326-1:2012 - Electrical Equipment For Measurement, Control And Laboratory Use - EMC Requirements - Part 1: General Requirements
● ASME SEC. VIII Pressure Vessel Code (Fusion Only)
● EU Pressure Equipment Directive (EU97/23/EC) (Fusion Only)
● FCC 47 CFR Class B Verification (Fusion Only)
● IEC 62304 Medical device software - Software life cycle processes
These standards are woven into our development methodology used to design all new products within the organization. This development process includes a risk management assessment done in accordance with ISO 14971 that identifies hazards and mitigates risks via design improvements, process improvement, and warnings (including labels and safety information shipped with the product).
We pride ourselves on our exceptional operational quality. In 2023, we estimate that our temperature-controlled supply chain solutions focused on cell and gene therapies had a 99.95% delivery success rate and due to this performance we estimate that 19,665 additional patients were able to receive therapies over the past 24 months. In 2023, we estimate that our CryoStork® solution had a 99.99% delivery success rate and due to this performance we estimate that 1,952 intended parents are potentially able to have successful cycles resulting in the birth of a child on an annual basis because of our CryoStork® solution.
While rare, recalls of product may become necessary. The primary responsibility for recall management lies with our Vice President of Quality Assurance and Regulatory Affairs for manufacturing. The executive staff is involved in decision and implementation processes depending upon the specifics of any recall required. Customer service personnel, sales staff and other resources would then be utilized in reaching all distributors and direct end users. Results of recalls are evaluated daily until the recall is closed. There were no product recalls during 2023.
Product Lifecycle Management
Cryoport creates unique products with long-term use in mind. Cryoport products are primarily constructed of recyclable aluminum or stainless steel, and we approach the extension of product lifecycles through the following four areas:
● Longevity
● Reparability
● Reusability
● Recyclability
We strive for a product base with long use phases to minimize impact associated with production of new product. At our MVE Biological Solutions production facility, in 2023, we manufactured cryogenic freezer units that we estimate utilize approximately 1/1865 of the energy used by conventional mechanical freezers used for similar applications. For example, our freezer production displaced annual electricity consumption by 183,225,534 kWh from what would otherwise be consumed from alternative products. This amount of electricity could power 16,132 homes annually. This reduction in energy consumption from our freezer lines alone equates to 151,610,701 pounds of GHG emissions avoided or the emissions equivalent to 15,303 passenger vehicles driven for one year.
Cryoport regularly reviews opportunities to eliminate the use of materials considered hazardous and related managed waste streams on a regular cadence. Cryoport does not utilize any substances of concern in our products; We do currently utilize minimal quantities of hazardous materials that are not listed substances of concern in our operations, primarily in the form of isopropanol, epoxies, butyl cellosolve, lacquer thinner, paint, hyamine and isopropyl alcohol. These materials and the insignificant quantities of hazardous wastes generated in our production facilities are managed in compliance with all state and federal regulations. Any hazardous waste that is generated is tracked and managed with an overall goal of eliminating hazardous materials where possible. Cryoport strives to have a conflict-free supply chain and is committed to working with its suppliers to increase transparency regarding the origin of minerals contained in its products, including minerals identified as conflict minerals (tin, tungsten, tantalum, and gold), and has adopted a Conflict Minerals Policy, which is available on our website at www.cryoportinc.com on the “Investor Relations: Governance” page under the heading “Governance Documents.”
Governing Ethically
Cryoport recognizes constructive supplier relationships as essential to our ability to meet customer requirements for quality solutions. We expect our business partners to share our commitment to ethics, integrity, compliance, safety, human rights, data security, and environmental protection. By the same token, as a provider accountable to thousands of companies worldwide, we pledge, through our ESG performance, to meet or exceed our clients’ requirements for the same.
Business Ethics
We are committed to operating with honesty, truthfulness and transparency in accordance with the highest ethical and corporate governance standards - mutual respect, integrity and trust are our foundation. As an ethical operator, we have developed a robust Code of Conduct and hold ourselves accountable to it in all we do. All employees across our operations are provided with training and reference materials to reinforce this commitment to integrity and ethics in our business. Our policies are clearly defined, published in local languages where applicable, and include guidance on topics including, but not limited to:
● Corruption
● Anti-Trust and Anti-Competitive Behavior
● Insider Dealings
● Gifts
● Bribes (e.g., explicit prohibition of facilitation payments)
● Conflicts of Interest
● Intellectual Property
● Compliance
● Truthful and accurate reporting
● Interactions with Healthcare professionals
● Whistleblower protections (including non-retaliation)
● Political Activity and Contributions (e.g., explicit prohibition of contribution of any kind to any candidate or political party without express prior approval of the Board of Directors - this covers both direct contributions and indirection support; no political contributions have been made in recent years)
In addition to our Code of Conduct, our senior leadership team actively oversees the governance of our ethics programs to help ensure that commitment is driven from the top down, and that program owners are accountable for successful program compliance.
Cryoport does not conduct clinical trials, animal testing or use human tissue of any kind in the manufacture or design of our products, and our Code of Conduct governs the ethical behavior of our employees across Cryoport operations. Further, the Company does not conduct lobbying activities.
Supplier Management
Temperature-controlled supply chain support to the life sciences industry is critical to all that Cryoport does; therefore, we take an active approach to managing suppliers and partners to ensure that appropriate compliance, health, safety, labor practices, and ethical standards are employed. Our internal diligence process for third-party vendors including a supplier questionnaire that is required for vendor approval and a regular auditing scheme thereafter for existing suppliers. The questionnaire is intended to verify that programs exist to manage material risk areas associated with the given supplier’s operations and particular consideration is paid to bribery or other
forms of corrupt activity. No suppliers are approved until this mandatory due diligence is complete and a completed assessment form is on file.
As an example of verification that programs exist to manage material risks for any given supplier, if our transportation suppliers employ or work with a Dangerous Goods Safety Advisor, we confirm the presence of a credentialed role responsible for overseeing activities associated with dangerous goods, including but not limited to, employee training and coaching, reporting, and monitoring of activities associated with the transportation of dangerous goods. The purpose of this inquiry is to gauge the degree of oversight over dangerous goods management by our suppliers to help ensure product and employee welfare.
Our Code of Conduct extends through our suppliers and thus sets an expectation for our suppliers to commit to operating with honesty, truthfulness and transparency in accordance to the highest ethical and corporate governance standards, as Cryoport personifies through our operations. Per our Code of Conduct, Cryoport will not tolerate the use by suppliers of forced labor in any form.
Data Privacy & Security
Cryoport uses an outside Center for Internet Security (CIS) assessment firm to evaluate its data security controls in an effort protect our businesses and secure the information of our employees and customers. The evaluation process utilizes the CIS Critical Security Controls Capability Maturity Model Integration (CMMI) methodology, and is an ongoing initiative used to continuously improve the CMMI rating for the Company.
Our customers rely on Cryoport to securely and reliably deliver temperature-controlled supply chain solutions globally, including providing a secure online portal for order entry, tracking, condition monitoring, and for the retrieval of historic information. Protecting the privacy of our customers and vendors is essential to maintaining their trust, and we take a proactive approach to safeguard all data and ensure a secure environment. With the increasing presence and sophistication of online threats, we must ensure continuous improvement to protect our business and our customers. We regularly review our technology, policies, and practices to maintain compliance with all relevant regulations. We do not sell customers’ data to third parties. Additionally, Cryoport employees with a computer are required to complete an annual online training course on information security and data privacy. The course addresses a range of topics related to information security and data privacy, including awareness regarding social engineering and cybercrimes, protecting the workplace, and protecting data.
Code of Ethics
Our Code of Ethical Business Conduct (the “Code of Ethics”) applies to our directors and all employees, including our Chief Executive Officer and Chief Financial Officer and is available on our website at www.cryoportinc.com on the “Investor Relations: Governance” page under the heading “Governance Documents.”
The Code of Ethics serves as the foundation of our corporate integrity and compliance program. Our officers, directors, and managers are responsible for promoting the principles within the Code of Ethics and fostering a culture of ethical conduct. We regularly review and update the Code of Ethics to ensure it remains relevant and available to our global employees. The Code of Ethics covers a breadth of topics, including conflicts of interest, equal employment opportunity and anti-harassment, environmental compliance and sustainability, insider trading rules, and how to report violations of Company policies. Our commitment to doing the right thing depends on our employees’ being comfortable in reporting any suspected violations of law or unethical conduct, and our leaders’ abilities to address suspected violations promptly, with respect. Our global policy against retaliation encourages employees to come forward to report concerns in good faith. When a matter is reported to a manager or our HR department, the concern is reviewed to determine whether it should be escalated to the legal department. The legal department also has criteria for further escalation, if necessary, to legal department management. Every new hire is introduced to the Code of Ethics through training and orientation.
We develop and update these policies when we identify a need for employee clarification, the emergence of new laws or regulations, or other external factors. We routinely update the language in our policies, and how we present information, to ensure our employees understand the risks they face in their jobs, and steps they can take to mitigate those risks and report potential problems.
Our commitment to human rights is an important part of the Code of Ethics. We are committed to protecting and advancing human rights in our operations around the world. We pay fair wages and comply with wage laws in all the countries where we operate. We prohibit the use of child, compulsory, or forced labor, and we share the zero-tolerance policies adopted by the United States and other governments against slavery and human trafficking. We prohibit the trafficking of persons for any purpose and trafficking-related activities, and we expect the same from our suppliers and vendors.
Cryoport Societal and Environmental Impact Statements
Examples of some of our positive societal and environmental impacts for 2022 and 2023 include the following:
Pathway
Impacts
2022 Outcomes
2023 Outcomes
Cryoport Systems / CRYOPDP
Access for Patients
13,718
additional patients were able to receive therapies over past 24 months
19,758
additional patients were able to receive therapies over past 24 months
CryoStork®
Patient Success & Satisfaction
1,641
Intended Parents able to have successful cycles resulting in the birth of a child
1,952
Intended Parents able to have successful cycles resulting in the birth of a child
MVE Biological Solutions
Energy Saved
166,225,209
kWh annual energy reduction, equating to
136,733,034 pounds of GHG emissions avoided
183,225,534
kWh annual energy reduction, equating to
51,610,701 pounds of GHG emissions avoided
CryoGene
Energy Saved
1,398,686
pounds of GHG emissions avoided due to renewable energy generation
1,869,763
pounds of GHG emissions avoided due to renewable energy generation
Our positive impacts for 2022 and 2023 were based on the following:
Access to Patients. Our calculation of the number of additional patients that were able to receive therapies was based our success rate for shipments, which is higher than the average success rate in the cold chain markets of 80%, pursuant to Rodrigue, J-P (2020), The Geography of Transport Systems, Fifth Edition, New York: Routledge.
Patient Success & Satisfaction. Our calculation of the number of intended parents able to have successful cycles resulting the birth of a child is based on the weighted average chance of a live singleton birth per intended egg retrieval across women of all ages of 27.23% as reported in the 2020 Society for Assisted Reproductive Technology (SART) Clinic Summary Report (CSR).
Energy Saved - MVE Biological Solutions. Our calculation of energy reduction is based on the reduced energy consumption from MVE freezer use compared to the average energy consumed by operation of mechanical freezers, which we assumed to be 31.7 kWh/day based on product specifications from a mechanical freezer manufacturer.
Energy Saved - CRYOGENE. CRYOGENE consumed 1,835,88 kWh of energy from renewable resources in 2022. Our calculation of GHG emissions avoided is based on the output mission rates for GHG emissions from the EPA eGRID data (2021) for the Electric Reliability Council of Texas (ERCOT).
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, 2023, we had 1,170 employees: 1,019 full-time, 11 part-time, and 140 temporary, of which 527 are located in the Americas, 324 in EMEA and 319 in APAC. This increase of over 146 employees compared to December 31, 2022 is, primarily as a result of the further build out of our global organization, both organically and through acquisitions, to support our expanded solutions offering and the expected growth in the markets we serve. 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 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 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 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 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.
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. We make available free of charge on or through our website copies of these reports as soon as reasonably practicable after we electronically file these reports 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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ITEM 1A. RISK FACTORS
ITEM 1A. RISK FACTORS
The following risk factors could materially and adversely affect our business, financial condition and results of operations. These risk factors do not identify all of the risks that we face.
Risks Related to Our Business
As an increasingly global business, we are exposed to economic, political, and other risks in different countries which could materially reduce our sales, profitability or cash flows, or materially increase our liabilities.
Since we manufacture and sell our products worldwide, our business is subject to risks associated with doing business internationally. Our future results could be harmed by a variety of factors, including:
● changes in foreign currency exchange rates, exchange controls and currency restrictions;
● changes in a specific country’s or region’s political, social or economic conditions;
● political, economic and social instability, including acts of war;
● outbreak of disease or illness in any of the countries in which we sell our products or in which we or our suppliers operate;
● tariffs, other trade protection measures, and import or export licensing requirements;
● potentially negative consequences from changes in U.S. and international tax laws;
● difficulty in staffing and managing geographically widespread operations;
● changes in customer spending due to the increased economic uncertainties and the disruption in the capital markets;
● requirements relating to withholding taxes on remittances and other payments by subsidiaries;
● restrictions on our ability to own or operate subsidiaries, make investments or acquire new businesses in these jurisdictions;
● restrictions on our ability to repatriate dividends from our foreign subsidiaries;
● difficulty in collecting international accounts receivable;
● difficulty in enforcement of contractual obligations under non-U.S. law;
● transportation delays or interruptions; and
● changes in regulatory requirements including as it relates to protection of our intellectual property.
The functional currency for most of our foreign operations is the applicable local currency. As a result, fluctuations in foreign currency exchange rates affect the results of our operations and the value of our foreign assets and liabilities, which in turn may adversely affect results of operations and cash flows and the comparability of period-to-period results of operations. Changes in foreign currency exchange rates may also affect the relative prices at which we and foreign competitors sell products in the same market. Foreign governmental policies and actions regarding currency valuation could result in actions by the United States and other countries to offset the effects of such fluctuations. Given the unpredictability and volatility of foreign currency exchange rates, ongoing or unusual volatility may adversely impact our business and financial conditions.
We depend on the availability of certain component products used in our solutions; delays or increased costs in the procurement of components manufactured by third parties could adversely affect our business operations, financial performance and results of operations, and we may experience customer dissatisfaction and harm to our reputation.
If we fail to procure sufficient components used in our products from our third-party manufacturers, we may be unable to deliver our solutions to our customers on a timely basis, which could lead to customer dissatisfaction and could harm our reputation and ability to compete. We currently acquire various component parts for our solutions from various independent manufacturers, some of which are sole sourced. We would likely experience significant delays or cessation in producing some of these components if a labor
strike, natural disaster, public health crisis, act of war or other supply disruption were to occur. If we are unable to procure a component from one of our manufacturers, we may be required to enter into arrangements with one or more alternative manufacturing companies, which may cause delays in producing components or result in significant increase in costs. To date, we have not experienced any material delay that has adversely impacted our operations, but this does not mean that we will continue to have timely access to adequate supplies of essential materials and components in the future or that supplies of these materials and components will be available on satisfactory terms when needed. If our vendors for these materials and components are unable to meet our requirements, fail to make shipments in a timely manner, or ship defective materials or components, we could experience a shortage or delay in supply or fail to meet our contractual requirements, which would adversely affect our results of operations and negatively impact our cash flow and profitability. Continued delay in our ability to produce and deliver our products and services could also cause our customers to purchase alternative products and services from our competitors and/or harm our reputation.
Our products and services may contain errors or defects, which could result in damage to our reputation, lost revenues, diverted development resources and increased service costs, litigation and product recalls. These risks may be heightened when our products or services are used in connection with human reproductive medicine.
Our products and services must meet stringent requirements and we must develop our products and services solutions quickly to keep pace with the rapidly changing market. Products and services as sophisticated as ours could contain undetected errors or defects, especially when first introduced or when new equipment or versions of our software are released. If our products and services are not free from errors or defects, we may incur an injury to our reputation, lost revenues, diverted development resources, increased customer service and support costs, product recalls and litigation. The costs incurred in correcting any product errors or defects may be substantial and could adversely affect our business, results of operations and financial condition.
Due to the low temperatures at which some of our products are used and the fact that some of our products are relied upon by our customers or end users in their facilities or operations or are manufactured for relatively broad medical, transportation, or consumer use, we face an inherent risk of exposure to claims in the event that the failure, use, or misuse of our products results, or is alleged to result, in death, bodily injury, property or sample damage, or economic loss. The amount of damages for which we are potentially held liable for may be higher when our products or services are used in connection with human reproductive medicine than when they are used for other purposes. For example, in some states, damage to an embryo may be deemed wrongful death for which punitive or other damages may be awarded, which would not otherwise be available. In addition, we specialize in the secure storage of biological specimens, materials and samples covering the full range of temperatures from cryogenic through controlled room temperature. Any damage to these specimens, materials and samples may be attributed to a failure of our storage systems or services, which could lead to claims for damages made by customers and could also harm our relationship with customers and damage our reputation in the life sciences industry, resulting in material harm to our business.
Although we currently maintain product liability coverage, which we believe is adequate for product liability claims and for the continued operation of our business, it includes customary exclusions and conditions, may not cover certain specialized applications and generally does not cover warranty claims. Additionally, such insurance may become difficult to obtain or be unobtainable in the future on terms acceptable to us. A successful product liability claim or series of claims against us, including one or more consumer claims purporting to constitute class actions or claims resulting from extraordinary loss events, in excess of or outside our insurance coverage, or a significant warranty claim or series of claims against us, could materially decrease our liquidity, impair our financial condition, and adversely affect our results of operations. See “-Risks Related to Our Business-Our products and services may expose us to liability in excess of our current insurance coverage” for additional information.
In addition, regardless of merit or eventual outcome, product liability claims may result in, among other things, costs of litigation, distraction of management’s attention from our primary business, the inability to commercialize our existing or new products, decreased demand for our products or, if cleared or approved, products in development, damage to our business reputation, product recalls or withdrawals from the market, withdrawal of clinical trial participants, substantial monetary awards to patients or other claimants, or loss of revenue.
While we may attempt to manage our product liability exposure by proactively recalling or withdrawing from the market any defective products, any recall or market withdrawal of our products may delay the supply of those products to our customers and may impact our reputation. We can provide no assurance that we will be successful in initiating appropriate market recall or market withdrawal efforts that may be required in the future or that these efforts will have the intended effect of preventing product malfunctions and the accompanying product liability that may result. Additionally, any recall could result in significant costs to us and significant adverse publicity, which could harm our ability to market our products in the future. Such recalls and withdrawals may also be used by
our competitors to harm our reputation for safety or be perceived by customers as a safety risk when considering the use of our products. Though it may not be possible to quantify the economic impact of a recall, it could have a material adverse effect on our business, financial condition and results of operations.
Additionally, for some of our products we offer a limited warranty for product returns which are due to defects in quality and workmanship. We estimate our potential liability for future product returns and establish reserves on our financial statements in amounts that we believe will be sufficient to address our warranty obligations; however, our actual liability for product returns may significantly exceed the amount of our reserves. If we underestimate our potential liability for future product returns, or if unanticipated events result in returns that exceed our historical experience, our financial condition and operating results could be materially and adversely affected.
Our business operations, financial performance and results of operations have been adversely affected and could in the future be materially adversely affected by the pandemics, epidemics or other public health crises, such as COVID-19.
The occurrence of pandemics, epidemics or other public health crises could materially affect our business, financial condition, results of operations and cash flows, including due to negative impacts to the global economy, disruptions to global supply chains and workforce participation, and volatility and disruption of financial markets. For example, since COVID-19’s initial outbreak, governments and businesses took unprecedented measures in response, including restrictions on travel and business operations, temporary closures of businesses, and quarantine and shelter-in-place orders. Such response significantly curtailed global economic activity and caused significant volatility and disruption in global financial markets. The COVID-19 pandemic and the measures taken by many countries in response have adversely affected and could in the future materially adversely impact our business operations, financial performance and results of operations. During the course of the pandemic, certain of our facilities have experienced disruptions, such as our MVE Biological Solutions manufacturing facility in Chengdu, China that was temporarily impacted by COVID-19 lockdowns in China during the third quarter of 2022, and similar disruptions could occur in the future.
The extent to which COVID-19 or other public health crises may impact our business operations, financial performance and results of operations remains uncertain and will depend on many factors outside our control, including the timing, extent, trajectory and duration of the public health crisis, the emergence of new variants, the development, availability, distribution and effectiveness of vaccines and treatments, and the imposition of protective public safety measures. Additional future impacts on us may include material adverse effects on our manufacturing, supply chain and distribution channels, our ability to execute our strategic plans, and our profitability. The potential effects of public health crises may also impact and potentially heighten many of our other risk factors discussed in this “Risk Factors” section.
We will have difficulty increasing our revenues if we experience delays, difficulties or unanticipated costs in establishing the sales, marketing and distribution capabilities necessary to successfully commercialize our solutions.
We plan to further enhance our sales, marketing and distribution capabilities in the Americas, EMEA, and APAC. It will be expensive and time-consuming for us to develop and integrate our global marketing and sales network and thus we intend to further broaden our strategic alliances with domestic and international providers of shipping services and other solutions providers to the life sciences industry to incorporate use of our platform of solutions in their service offerings. We may not be able to provide adequate incentive to our sales force or to establish and maintain favorable distribution and marketing collaborations with others to promote our solutions. In addition, any third party with whom we have established a marketing and distribution relationship may not devote sufficient time to the marketing and sales of our solutions, thereby exposing us to potential expenses in exiting such distribution agreements. We, and any of our alliance partners, must also market our services in compliance with federal, state, local and international laws relating to the provision of incentives and inducements. Violation of these laws can result in substantial penalties. Therefore, if we are unable to successfully motivate and expand our marketing and sales force and further develop our sales and marketing capabilities, or if our alliance partners fail to promote our solutions, we will have difficulty increasing our revenues and the revenue may not offset the additional expense of expansion.
We expect to base our equipment and inventory purchasing decisions on our forecasts of customers’ demand, and if our forecasts are inaccurate, our operating results could be materially harmed.
As our customer base increases, we expect the need to purchase additional equipment and inventory. Our forecasts will be based on multiple assumptions, each of which may cause our estimates to be inaccurate, affecting our ability to provide products to our customers. When demand for our products increases significantly, we may not be able to meet demand on a timely basis, and we may need to expend a significant amount of time working with our customers to allocate limited supply and maintain positive customer
relations, or we may incur additional costs in order to rush the manufacture and delivery of additional products. If we underestimate customers’ demand, we may forego revenue opportunities, lose market share and damage our customer relationships. Conversely, if we overestimate customer demand, we may purchase more equipment and inventory than we are able to use or sell at any given time or at all. As a result of our failure to properly estimate demand for our products, we could have excess or obsolete equipment and/or inventory, resulting in a decline in the value of our equipment and/or inventory, which would increase our costs of revenues and reduce our liquidity. Our failure to accurately manage our equipment purchases and inventory relative to demand would adversely affect our operating results.
If we suffer a disruption or loss to our factories, facilities or distribution system due to factors outside of our control, our operations could be seriously harmed.
We rely on our distribution system including third-party shipment and carrier services to transport our shippers containing biological material. These third-party operations could be subject to natural disasters, adverse weather conditions, other business disruptions, and carrier error, which could cause delays in the delivery of our shippers, which in turn could cause serious harm to the biological material being shipped. As a result, any prolonged delay in shipment, whether due to technical difficulties, power failures, break-ins, destruction or damage to carrier facilities as a result of a natural disaster, fire, or any other reason, could result in damage to the contents of the shipper.
Additionally, our factories and facilities may be subject to catastrophic loss due to fire, flood, terrorism, increasing severity or frequency of extreme weather events, or other natural or man-made disasters, as well as disruptions due to a widespread outbreak of an illness or any other public health crisis, such as the COVID-19 pandemic. In particular, certain components of our key products are manufactured in China, which may be more likely than other locations to have disruptions caused by the response to a public health crisis, such as COVID-19. For example, our MVE Biological Solutions manufacturing facility in Chengdu, China was temporarily impacted by COVID-19 lockdowns in China during the third quarter of 2022, and similar disruptions could occur in the future.
Further, we operate facilities that specialize in the secure storage of biological specimens, materials and samples. If natural disasters or similar events, like hurricanes, fires or explosions or large-scale accidents or power outages, were to occur that prevented us from using all or a significant portion of these facilities, damaged critical infrastructure or our customers’ biological samples, or otherwise disrupted operations at such facilities, this could affect our ability to maintain ongoing operations and cause us to incur significant expenses. Insurance coverage may not be adequate to fully cover losses in any particular case.
For example, in January 2022, a fire occurred at the MVE Biological Solutions manufacturing facility located in New Prague, Minnesota, which manufactures aluminum dewars and is one of MVE Biological Solutions’ three global manufacturing facilities. As a consequence of the fire damage, the New Prague manufacturing operations were curtailed on an interim basis until the necessary repairs were completed, which adversely impacted our revenue in the first quarter of 2022. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations-MVE Biological Solutions Fire” for additional information.
Our products and services may expose us to liability in excess of our current insurance coverage.
Our platform of products and services involve significant risks of liability, which may substantially exceed the revenues we derive from them. We cannot predict the magnitude of these potential liabilities. We currently maintain general liability insurance and product liability insurance. Claims may be made against us that exceed the limits of these policies.
Our liability policy is an “occurrence” based policy. Thus, our policy is complete when we purchased it and following cancellation of the policy it continues to provide coverage for future claims based on conduct that took place during the policy term. Our insurance coverage, however, may not protect us against all liability because our policies typically have various exceptions to the claims covered and also require us to assume some costs of the claim even though a portion of the claim may be covered. In addition, if we expand into new markets, we may not be aware of the need for, or be able to obtain insurance coverage for such activities or, if insurance is obtained, the dollar amount of any liabilities incurred could exceed our insurance coverage. A partially or completely uninsured claim, if successful and of significant magnitude, could have a material adverse effect on our business, financial condition and results of operations.
If we use biological and hazardous materials in a manner that causes injury, we could be liable for damages.
Our customers may ship potentially harmful biological materials in our dewars. We cannot eliminate the risk of accidental contamination or injury to employees or third parties from the use, storage, handling or disposal of these materials. In the event of
contamination or injury, we could be held liable for any resulting damages, and any liability could exceed our resources or any applicable insurance coverage we may have. Additionally, we are subject to, on an ongoing basis, federal, state and local laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. In the event of an accident, we could be held liable for damages.
We operate in a competitive industry and if we cannot compete effectively, we will lose business.
We expect to continue to experience significant and increasing levels of competition in the future. While there are technological and marketing barriers to entry, we cannot guarantee that these barriers will be sufficient to defend our market share against current and future competitors. Our principal competitive considerations in our market include:
● financial resources to allocate to proper marketing and an appropriate sales effort;
● acceptance of our solutions model;
● acceptance of our solutions including per use fee structures and other charges for services;
● keeping up technologically with ongoing development of enhanced features and benefits;
● the ability to develop and maintain and expand strategic alliances;
● establishing our brand name;
● our ability to deliver our solutions to our customers when requested; and
● our timing of introductions of new solutions and services.
Our future revenue stream depends to a large degree on our ability to bring new solutions and services to market on a timely basis. We generally sell our products in industries that are characterized by increased competition through frequent innovation, rapid technological changes and changing industry standards. Without the timely introduction of new products, services and enhancements, our products and services may become obsolete over time, in which case our revenue and operating results could suffer.
There may also be other companies which are currently developing competitive products and services or which may in the future develop technologies and products that are comparable, superior or less costly than our own. For example, some specialty couriers and packaging manufacturers with greater resources currently provide temperature-controlled packaging solutions and may develop other products or solutions in the future, both of which compete with our products. A competitor that has greater resources than us may be able to develop and expand their networks and product offerings more quickly, devote greater resources to the marketing and sale of their solutions and adopt more aggressive pricing policies. We may not be able to successfully compete with a competitor that has greater resources, which may adversely affect our business.
If we successfully develop products and/or services, but those products and/or services do not achieve and maintain market acceptance, our business will not be profitable.
The degree of acceptance of our platform of existing products and services or any future products or services by our current target markets, and any other markets to which we attempt to sell our products and services, as well as our profitability and growth, will depend on a number of factors including, among others, our shippers’ ability to perform and preserve the integrity of the materials shipped, relative convenience and ease of use of our shippers and/or Cryoportal®, reliability and effectiveness of our biostorage services, availability of alternative products or new technologies that make our solutions and services less desirable or competitive, pricing and cost effectiveness, effectiveness of our or our collaborators’ sales and marketing strategy and the adoption cycles of our targeted customers.
In addition, even if our products and services achieve market acceptance, we may not be able to maintain that market acceptance over time if new products or services are introduced that are more favorably received than our products and services, are more cost effective, or render our products obsolete. Further, there can be no assurance that future developments in technology will not make our technology non-competitive or obsolete, or significantly reduce our operating margins or the demand for our offerings, or otherwise negatively impact our ability to be profitable.
The integration and operation of acquired businesses may disrupt our business and create additional expenses, and we may not achieve the anticipated benefits of the acquisitions.
Integration of an acquired business involves numerous risks, including assimilation of operations of the acquired business and difficulties in the convergence of systems and processes, the diversion of management’s attention from other business concerns, risks of entering markets in which we have had no or only limited direct experience, assumption of unknown or unquantifiable liabilities, difficulties in completing strategic initiatives already underway in the acquired company, and unfamiliarity with partners of the acquired company, each of which could have a material adverse effect on our business, results of operations and financial condition. We cannot assure that these risks or other unforeseen factors will not offset the intended benefits of the acquisitions, in whole or in part.
Additionally, potential acquisition opportunities become available to us from time to time, and we periodically engage in discussions or negotiations relating to potential acquisitions, including acquisitions that may be material in size or scope to our business. Any acquisition may or may not occur and, if an acquisition does occur, it may not be successful in enhancing our business for one or more of the following reasons:
● any business acquired may not be integrated successfully and may not prove profitable;
● the price we pay for any business acquired may overstate the value of that business or otherwise be too high;
● liabilities we take on through the acquisition may prove to be higher than we expected;
● we may fail to achieve acquisition synergies; or
● the focus on the integration of operations of acquired entities may divert management’s attention from the day-to-day operation of our businesses.
Acquisitions and strategic investments and alliances may also require us to integrate and collaborate with a different company culture, management team, business model, business infrastructure and sales and distribution methodology, and assimilate and retain geographically dispersed, decentralized operations and personnel. Depending on the size and complexity of an acquisition, our successful integration of the entity depends on a variety of factors, including introducing new products and meeting revenue targets as expected, the retention of key employees and key customers, increased exposure to certain governmental regulations and compliance requirements and increased costs and use of resources. Further, the integration of acquired businesses is likely to result in our systems and internal controls becoming increasingly complex and more difficult to manage. Any difficulties in the assimilation of acquired businesses into our control system could harm our operating results or cause us to fail to meet our financial reporting obligations.
Even if we are able to successfully integrate acquired businesses, we may not be able to realize the revenue and other synergies and growth that we anticipated from the acquisition in the time frame that we expected, and the costs of achieving these benefits may be higher than what we expected. As a result, the acquisition and integration of acquired businesses may not contribute to our earnings as expected and we may not achieve the other anticipated strategic and financial benefits of such transactions.
Further impairment of our goodwill or intangible assets could have a material non-cash adverse impact on our results of operations.
We assess goodwill for impairment on an annual basis in the fourth quarter or more frequently if we believe indicators of impairment exist. In addition, intangible assets and their related useful lives are reviewed at least annually to determine whether there are any adverse conditions that would indicate the carrying value of these assets may not be recoverable. Our valuation methodology for assessing impairment requires management to make judgments and assumptions based on experience and to rely heavily on projections of future operating performance. Because we operate in highly competitive environments, projections of our future operating results and cash flows may vary significantly from our actual results. If in future periods we determine that our goodwill or intangible assets are further impaired, we will recognize a non-cash impairment charge with respect to these assets, which would adversely affect our results of operations.
Risks Related to Our Technology and Intellectual Property
We rely upon certain critical information systems, including our Cryoportal® software platform, for the operation of our business; the failure of any critical information system could adversely impact our reputation and future revenues, and we may be required to increase our spending on data and system security.
We rely upon certain critical information systems, including our Cryoportal® software platform which is used by our customers and business partners to automate the entry of orders, prepare customs documentation and facilitate status and location monitoring of shipped orders while in transit. In addition, the provision of services to our customers and the operation of our networks and systems involve the storage and transmission of significant amounts of proprietary information and sensitive or confidential data, including personal information of customers, employees and others. Our technology infrastructure and critical information systems are subject to damage or interruption from a number of potential sources, including unauthorized intrusions, cyberattacks, software viruses or other malware, natural disasters, power failures, employee error or malfeasances and other events. Despite our best efforts, no cybersecurity or emergency recovery process is failsafe, and if our safeguards fail or our technology infrastructure or critical information systems are compromised, the safety and efficiency of our operations could be materially harmed, our reputation could suffer, and we could face additional costs, liabilities, costly legal challenges.
Cyberattacks, data incidents and breaches in the security of our information systems and networks and of the electronic and confidential information in our possession could materially adversely impact our business, financial condition and results of operations, in addition to our reputation and relationships with our employees, customers, suppliers and business partners.
As part of our normal business activities, we collect and store or have access to certain proprietary confidential, and personal information, including information about our employees, customers, suppliers and business partners, which may be entitled to protection under a number of regulatory regimes. The protection and security of our network systems and our own information, as well as information relating to our employees, customers, suppliers, business partners and others, is vitally important to us. Any failure of us to maintain the security of our network systems and the proprietary, confidential, and personal data in our possession, including via the penetration of our network security and the misappropriation of proprietary, confidential and personal information, could result in costly investigations and remediation, business disruption, damage to our reputation, financial obligations to third parties, fines, penalties, regulatory proceedings and private litigation with potentially large costs, and also result in deterioration in our employees’, customers’, suppliers’ and business partners’ confidence in us and other competitive disadvantages, and thus could have a material adverse effect on our business, financial condition and results of operations.
The frequency, intensity, and sophistication of cyberattacks and data security incidents has significantly increased in recent years and is constant. As with many other businesses, we are continually subject to cyberattacks and the risk of data security incidents. Due to the increased risk of these types of attacks and incidents, we have implemented information technology and data security tools, measures, and processes designed to protect our networks systems, services, and the personal, confidential or proprietary information in our possession, and to ensure an effective response to any cyberattack or data security incident. We also have privacy and data security policies in place that are designed to detect, prevent, and/or mitigate cyberattacks and data security incidents. Whether or not these policies, tools, and measures are ultimately successful, the expenditures could have an adverse impact on our financial condition and results of operations, and divert management’s attention from pursuing our strategic objectives. As newer technologies evolve, we could be exposed to increased risks from cyberattacks, data security events, and data breaches, including those from human error, negligence or mismanagement or from illegal or fraudulent acts.
Although we take the security of our network systems and information seriously, there can be no assurance that the security measures we employ will effectively prevent unauthorized persons from obtaining unauthorized access to our systems and information due to the evolving nature and intensity of cyberattacks and threats to data security, in light of new and sophisticated tools and methods used by criminals and cyberterrorists to penetrate and compromise systems, including computer viruses, malware, ransomware, phishing, misrepresentation, social engineering and forgery, which make it increasingly challenging to anticipate, harder to detect, and more difficult to adequately mitigate these risks. While we have cyber security insurance, we may incur significant costs in the event of a successful cyber incident against us or in responding to and recovering from a cyber incident that are not covered by, or exceed the limits of, such insurance. Additionally, the cost and operational consequences of implementing, maintaining and enhancing further data or system protection measures could increase significantly to overcome increasingly intense, complex and sophisticated global cyber threats.
Our success depends, in part, on our ability to obtain patent protection for our solutions, preserve our trade secrets, and operate without infringing the proprietary rights of others.
Our policy is to seek to protect our proprietary position by, among other methods, filing United States patent applications related to our technology, inventions and improvements that are important to the development of our business. Our patents or patent applications may be challenged, invalidated or circumvented in the future or the rights granted may not provide a competitive advantage. We intend to vigorously protect and defend our intellectual property. Costly and time-consuming litigation brought by us may be necessary to enforce our patents and to protect our trade secrets and know-how, or to determine the enforceability, scope and validity of the proprietary rights of others.
We also rely upon trade secrets, technical know-how and continuing technological innovation to develop and maintain our competitive position. We seek to protect these trade secrets, in part, by entering into confidentiality agreements and inventions assignment and work for hire agreements in connection with employment, consulting, or advisory relationships. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Additionally, our competitors may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our proprietary technology, or we may not be able to meaningfully protect our rights in unpatented proprietary technology.
Our current and potential competitors and other third parties may have or obtain patents or additional proprietary rights that would prevent, limit or interfere with our ability to make, use or sell our solutions either in the United States or internationally. Additionally, we may face assertions of claims by holders of patents alleging that we are infringing upon their patent rights, which claims may be without merit, but may nonetheless result in our incurring substantial costs of defense.
Risks Related to Regulatory and Legal Matters
Complying with certain regulations that apply to shipments using our solutions can limit our activities and increase our cost of operations.
Shipments using our solutions and services are subject to various regulations in the various countries in which we operate. For example, shipments using our solutions may be required to comply with the shipping requirements promulgated by the CDC, the Occupational Safety and Health Organization (“OSHA”), the DOT as well as rules established by the IATA and the ICAO. Additionally, our data logger may be subject to regulation and certification by the FDA, the FCC, and the FAA. We will need to ensure that our solutions and services comply with relevant rules and regulations to make our solutions and services marketable, and in some cases, compliance is difficult to determine. Significant changes in such regulations could require costly changes to our solutions and services or prevent use of our shippers for an extended period of time while we seek to comply with changed regulations. If we are unable to comply with any of these rules or regulations or fail to obtain any required approvals, our ability to market our solutions and services may be adversely affected. In addition, even if we are able to comply with these rules and regulations, compliance can result in increased costs. In either event, our financial results and condition may be adversely affected. We depend on our business partners and unrelated and frequently unknown third-party agents in foreign countries to act on our behalf to complete the importation process and to make delivery of our shippers to the final user. The failure of these third parties to perform their duties could result in damage to the contents of the shipper resulting in customer dissatisfaction or liability to us, even if we are not at fault.
Changes in trade policy, tariff and import/export regulations may have a material adverse effect on our business, financial condition and results of operations.
Our international operations and transactions depend upon favorable trade relations between the United States and the foreign countries in which our customers and suppliers have operations. It may be time consuming and expensive for us to adapt to any changes in U.S. or international social, political, regulatory and economic conditions or in laws and policies governing foreign trade, manufacturing, development and investment in the territories or countries where we currently sell our products or conduct our business. If such changes occur, it could adversely affect our business.
We, along with our customers, are subject to various international governmental regulations. Compliance with or changes in such regulations may cause us to incur significant expenses, and if we fail to maintain satisfactory compliance with certain regulations, we may be forced to recall products and cease their manufacture and distribution, and we could be subject to civil or criminal penalties.
We, along with our customers, are subject to various significant international, federal, state and local regulations, including but not limited to regulations in the areas of health and safety, packaging, product content, employment, labor and immigration, import/export controls, trade restrictions and anti-competition. In addition, as a global organization, we are subject to data privacy and security laws, regulations, and customer-imposed controls in numerous jurisdictions as a result of having access to and processing confidential, personal, sensitive and/or patient health data in the course of our business. The EU’s General Data Protection Regulation (“GDPR”), which became effective in May 2018, applies to our activities related to products and services that we offer to EU customers and workers. The GDPR established new requirements regarding the handling of personal data and includes significant penalties for non-compliance (including possible fines of up to 4 percent of total company revenue). Other governmental authorities around the world have passed or are considering similar types of legislative and regulatory proposals concerning data protection. Each of these privacy, security and data protection laws and regulations could impose significant limitations and increase our cost of providing our products and services where we process end user personal data and could harm our results of operations and expose us to significant fines, penalties and other damages.
We must also comply with complex foreign and U.S. laws and regulations, such as the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act, and other local laws prohibiting corrupt payments to governmental officials, anti-competition regulations and sanctions imposed by the U.S. Office of Foreign Assets Control and other similar laws and regulations. Violations of these laws and regulations could result in fines and penalties, criminal sanctions, restrictions on our business conduct and on our ability to offer our products in one or more countries, and could also materially affect our brand, our ability to attract and retain employees, our international operations, our business and our operating results. Although we have implemented policies and procedures designed to ensure compliance with these laws and regulations, there can be no assurance that our employees, contractors, or agents will not violate our policies.
These regulations are complex, change frequently and have tended to become more stringent over time. We may be required to incur significant expenses to comply with these regulations or to remedy any violations of these regulations. Any failure by us to comply with applicable government regulations could also result in the cessation of our operations or portions of our operations, product recalls or impositions of fines and restrictions on our ability to carry on or expand our operations. In addition, because many of our products are regulated or sold into regulated industries, we must comply with additional regulations in marketing our products. Any significant change in these regulations could reduce demand for our products, force us to modify our products to comply with new regulations or increase our costs of producing these products. If demand for our products is adversely affected or our costs increase, our operating results and business would suffer.
We are subject to regulation by the FDA or certain similar foreign regulatory agencies, and failure to comply with such regulations could harm our reputation, business, financial condition and results of operations.
Certain of our operations are subject to regulation by the FDA or similar foreign regulatory agencies. In addition, we may in the future develop products that are subject to regulation as medical devices by the FDA and similar foreign regulatory agencies. For example, we are aware that China’s National Medical Products Administration has had discussions that may require certain of our products to be registered as Class II medical devices. The regulations enforced by the FDA and similar foreign regulatory agencies govern a wide variety of product-related activities, including the research, development, testing, manufacture, quality control, approval, clearance, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, marketing, post-approval monitoring and reporting, pricing, and export and import of pharmaceutical products. If we or any of our customers, suppliers or distributors fail to comply with FDA and other applicable foreign regulatory requirements or are perceived to potentially have failed to comply, we may face, among other things, warning letters; adverse publicity affecting both us and our customers; investigations or notices of non-compliance, fines, injunctions, and civil penalties; import or export restrictions; partial suspensions or total shutdown of production facilities or the imposition of operating restrictions; increased difficulty in obtaining required FDA clearances or approvals or foreign equivalents; seizures or recalls of our products or those of our customers; or the inability to sell our products and services. Any such FDA or other foreign regulatory agency actions could disrupt our business and operations, lead to significant remedial costs and have a material adverse impact on our financial position and results of operations.
Risks Related to Our Financial Condition
Historically, we have incurred significant losses and we may continue to incur losses in the future.
As of December 31, 2023, we had an accumulated deficit of $642.4 million. In order to achieve and sustain revenue growth in the future, we must expand our market presence and revenues from existing and new customers. We may continue to incur losses in the future and may never generate revenues sufficient to become profitable or to sustain profitability. Continuing losses may impair our ability to raise the additional capital required to continue and expand our operations.
Our indebtedness and liabilities could limit the cash flow available for our operations and expose us to risks that could adversely affect our business, financial condition and results of operations.
We have a substantial amount of indebtedness. As of December 31, 2023, we had approximately $468.7 million of indebtedness and other liabilities, including trade payables, on a consolidated basis. We may also incur additional indebtedness to meet future financing needs. Our indebtedness could have significant negative consequences for our security holders and our business, results of operations and financial condition by, among other things:
● increasing our vulnerability to adverse economic and industry conditions;
● limiting our ability to obtain additional financing;
● requiring the dedication of a substantial portion of our cash flow from operations to service our indebtedness, which will reduce the amount of cash available for other purposes;
● limiting our flexibility to plan for, or react to, changes in our business;
● diluting the interests of our existing stockholders as a result of issuing shares of our common stock upon conversion of any convertible indebtedness; and
● placing us at a possible competitive disadvantage with competitors that are less leveraged than us or have better access to capital.
Our business may not generate sufficient funds, and we may otherwise be unable to maintain sufficient cash reserves, to pay amounts due under our indebtedness, including our outstanding convertible senior notes (collectively, the “Convertible Senior Notes”) consisting of our 3.00% convertible senior notes due 2025 (the “2025 Convertible Senior Notes”) and our 0.75% convertible senior notes due 2026 (the “2026 Convertible Senior Notes”), and our cash needs may increase in the future. In addition, any future indebtedness that we may incur may contain financial and other restrictive covenants that limit our ability to operate our business, raise capital or make payments under our other indebtedness. If we fail to comply with these covenants or to make payments under our indebtedness when due, then we would be in default under that indebtedness, which could, in turn, result in that and our other indebtedness becoming immediately payable in full.
Risks Related to Our Preferred Stock
The issuance of shares of our Series C Preferred Stock reduces the relative voting power of holders of our common stock, dilutes the ownership of such holders, and may adversely affect the market price of our common stock.
In connection with financing our acquisition of MVE Biological Solutions, on October 1, 2020, we completed the sale of 250,000 shares of a newly designated Series C Convertible Preferred Stock, par value $0.001 (“Series C Preferred Stock”), at a price of $1,000 per share, the original purchase price, to funds affiliated with The Blackstone Group Inc., or Blackstone. The holders of our Series C Preferred Stock are entitled to dividends at a rate of 4.0% per annum, paid-in-kind, accruing daily and paid quarterly in arrears and are also entitled to participate in dividends declared or paid on the common stock on an as-converted basis.
Each holder of our Series C Preferred Stock (collectively, the “Series C Preferred Stockholders”) has the right, at its option, to convert its Series C Preferred Stock, in whole or in part, into common stock at a conversion price equal to $38.6152 per share subject to certain customary adjustments. Subject to certain conditions, we may, at our option, require conversion of all of the outstanding shares of Class C Preferred Stock to common stock if, for at least 20 trading days during the 30 consecutive trading days immediately preceding the date we notify the Class C Preferred Stockholders of the election to convert, the closing price of our Common Stock is at least 150% of the conversion price. On February 5, 2021, the Company received a waiver and conversion notice from Blackstone Freeze Parent L.P. and Blackstone Tactical Opportunities Fund - FD L.P. and converted an aggregate of 50,000 shares of the Series C Preferred Stock, resulting in the issuance of an aggregate of 1,312,860 shares of common stock.
Any subsequent conversion of shares of the Series C Preferred Stock to shares of our common stock would further dilute the ownership interest of existing holders of our common stock, and any sale in the public market of shares of our common stock issuable upon conversion of the Series C Preferred Stock could adversely affect prevailing market prices of our common stock. Additionally, we granted the Series C Preferred Stockholders customary registration rights in respect of their securities. These registration rights facilitate the resale of our common stock issuable upon conversion of such securities into the public market, and any such resale would increase the number of shares of our common stock available for public trading.
The Series C Preferred Stockholders may exercise influence over us, including through their right to nominate for election one member to our board of directors.
The Series C Preferred Stockholders are generally entitled to vote with the holders of the shares of common stock on all matters submitted for a vote of holders of shares of Common Stock (voting together with the holders of shares of common stock as one class) on an as-converted basis, subject to certain NASDAQ voting limitations, if applicable. Additionally, the consent of the holders of a majority of the outstanding shares of Series C Preferred Stock is required for so long as any shares of the Series C Preferred Stock remain outstanding for (i) amendments to the Company’s organizational documents that have an adverse effect on the holders of Series C Preferred Stock and (ii) issuances by the Company of securities that are senior to, or equal in priority with, the Series C Preferred Stock, including any shares of the Company’s Series A Preferred Stock or Series B Preferred Stock. In addition, for so long as 75% of the Series C Preferred Stock issued in connection with the related securities purchase agreement remains outstanding, the consent of the holders of a majority of the outstanding shares of Series C Preferred Stock will be required for (i) any voluntary dissolution, liquidation, bankruptcy, winding up or deregistration or delisting and (ii) incurrence by Cryoport of any indebtedness unless our ratio of debt to LTM EBITDA (as defined in the Certificate of Designation of the Series C Preferred Stock) would be less than a ratio of 5-to-1 on a pro forma basis giving effect to such incurrence and the use of proceeds therefrom.
Additionally, an affiliate of Blackstone has the right to nominate for election one member to our board of directors for so long as certain parties hold 66.67% of the Series C Preferred Stock issued in the Blackstone financing transaction. If elected, the director designated by Blackstone is entitled to serve on committees of our board of directors, subject to applicable law and NASDAQ rules. Notwithstanding the fact that all directors will be subject to fiduciary duties to us and to applicable law, the interests of the director designated by Blackstone may differ from the interests of our security holders as a whole or of our other directors.
As a result, the Series C Preferred Stockholders have the ability to influence the outcome of certain matters affecting our governance and capitalization. The sponsors of the Series C Preferred Stockholders are in the business of making or advising on investments in companies, including businesses that may directly or indirectly compete with certain portions of our business, and they may have interests that diverge from, or even conflict with, those of our other shareholders. They may also pursue acquisition opportunities that may be complementary to our business, and, as a result, those acquisition opportunities may not be available to us. Our obligations to the Series C Preferred Stockholders could also limit our ability to obtain additional financing or increase our borrowing costs, which could have an adverse effect on our financial condition.
Our Series C Preferred Stock has rights, preferences, and privileges that are not held by, and are preferential to, the rights of holders of our common stock, which could adversely affect our liquidity and financial condition.
The Series C Preferred Stockholders have the right under the Certificate of Designation of the Series C Preferred Stock to receive a liquidation preference entitling them to be paid an amount per share equal to the greater of (i) the original purchase price, plus all accrued and unpaid dividends and (ii) the amount that the holder would have been entitled to receive at such time if the Series C Preferred Stock were converted into common stock. In addition, the Series C Preferred Stockholders are entitled to dividends at a rate of 4.0% per annum, paid-in-kind, accruing daily and paid quarterly in arrears. The Series C Preferred Stockholders are also entitled to participate in dividends declared or paid on the common stock on an as-converted basis.
Risks Related to Ownership of Our Common Stock
Certain of our existing stockholders own and have the right to acquire a substantial number of shares of common stock.
As of February 23, 2024, our directors, executive officers and beneficial owners of 5% or more of our outstanding common stock beneficially owned 33,447,953 shares of common stock assuming their conversion of all outstanding Series C Preferred Stock and their exercise of all outstanding options held by them that are exercisable within 60 days of February 23, 2024, which represented approximately 62.7% % of our outstanding common stock. As such, the concentration of beneficial ownership of our common stock may have the effect of delaying or preventing a change in control of Cryoport and may adversely affect the voting or other rights of other holders of our common stock.
Future sales of shares of our common stock may depress the price of our shares and be dilutive to our existing stockholders.
Future issuances of shares of our common stock or the availability of shares for resale in the open market may decrease the market price per share of our common stock. As of February 23, 2024, there were 48,977,476 shares of our common stock outstanding. Substantially all of these shares of common stock are eligible for trading in the public market. The market price of our common stock may decline if our stockholders sell a large number of shares of our common stock in the public market, or the market perceives that such sales may occur.
As of December 31, 2023, we could also issue up to an additional 8,301,449 shares of our common stock upon exercise of outstanding options and vesting of restricted stock units and 873,468 shares of our common stock reserved for future issuance under our stock incentive plans. In addition, we reserved 599,954 shares of our common stock issuable upon conversion of the 2025 Convertible Senior Notes, 3,156,483 shares of our common stock issuable upon conversion of the 2026 Convertible Senior Notes, and 5,894,535 shares of our common stock issuable upon conversion of our Series C Convertible Preferred Stock. The exercise of any options or vesting of restricted stock units, as well as the issuance of our common stock upon conversion of the Convertible Senior Notes, the Series C Convertible Preferred Stock, or in connection with acquisitions and other issuances of our common stock, could have an adverse effect on the market price of the shares of our common stock and dilute our existing stockholders.
To the extent that we raise additional funds through the sale of equity or convertible debt securities, the issuance of such securities will result in dilution to our stockholders. Further, investors purchasing shares or other securities in the future could have rights superior to existing stockholders.
Our stock price has been and will likely continue to be volatile.
The market price of our common stock has been highly volatile and could fluctuate widely in price in response to various factors, many of which are beyond our control, including, but not limited to technological innovations or new solutions and services by us or our competitors, additions or departures of key personnel, sales of our common stock, our ability to execute our business plan, our operating results being below expectations, loss of any strategic relationship, industry developments, economic and other external factors and period-to-period fluctuations in our financial results.
In addition, the securities markets have from time-to-time experienced significant price and volume fluctuations that are unrelated to the operating performance of companies. These market fluctuations may also materially and adversely affect the market price of our common stock.
We have not paid dividends on our common stock in the past and do not expect to pay dividends in the foreseeable future. Any return on investment may be limited to the value of our common stock.
We have never paid cash dividends on our common stock and do not anticipate paying cash dividends in the foreseeable future. Any future determination to pay dividends will be at the discretion of our board of directors, subject to compliance with covenants in current and future agreements governing our indebtedness, and will depend on our results of operations, financial condition, capital requirements, contractual arrangements and other factors that our board of directors deems relevant. If we do not pay dividends, our common stock may be less valuable because a return on your investment will only occur if the price of our common stock appreciates.
Our Articles of Incorporation allows our Board of Directors to issue up to 2,500,000 shares of “blank check” preferred stock.
Our Articles of Incorporation allows our board of directors to issue up to 2,500,000 shares of “blank check” preferred stock, without action by our stockholders. We have designated 800,000 shares as Class A Preferred Stock, 585,000 shares as Class B Preferred Stock and 250,000 shares of Series C Preferred Stock, of which 200,000 shares of Series C Preferred Stock are issued and outstanding at February 23, 2024. See “-Risks Related to Our Preferred Stock” for additional information regarding our outstanding Series C Preferred Stock. Without limiting the foregoing, (i) such shares of preferred stock could have liquidation rights that are senior to the liquidation preference applicable to our common stock and Preferred Stock, (ii) such shares of preferred stock could have voting or conversion rights, which could adversely affect the voting power of the holders of our common stock and preferred stock and (iii) the ownership interest of holders of our common stock will be diluted following the issuance of any such shares of preferred stock. In addition, the issuance of such shares of blank check preferred stock could have the effect of discouraging, delaying or preventing a change of control of our Company.
Provisions in our bylaws and Nevada law might discourage, delay or prevent a change of control of our Company or changes in our management and, as a result, may depress the trading price of our common stock.
Provisions of our bylaws and Nevada law may discourage, delay or prevent a merger, acquisition or other change in control that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares of our common stock. The relevant bylaw provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management. These provisions include advance notice requirements for stockholder proposals and nominations, and the ability of our board of directors to make, alter or repeal our bylaws.
In addition, Section 78.411, et seq. of the Nevada Revised Statutes prohibits a publicly-held Nevada corporation from engaging in a business combination with an interested stockholder (generally defined as a person which together with its affiliates owns, or within the last two years has owned, 10% of our voting stock) for a period of two years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner.
The existence of the foregoing provisions and other potential anti-takeover measures could limit the price that investors might be willing to pay in the future for shares of our common stock. They could also deter potential acquirers of our Company, thereby reducing the likelihood that you could receive a premium for your common stock in an acquisition.
General Risk Factors
Our ability to grow and compete in our industry will be hampered if we are unable to retain the continued service of our key professionals or to identify, hire and retain additional qualified professionals.
Our success in implementing our business strategy depends largely on the skills, experience and performance of key members of our executive management team and others in key management positions. The collective efforts of each of these persons working as a team will be critical to us as we continue to develop our technologies, tests and engineering and development and sales programs. As a result of the difficulty in locating qualified new management, the loss or incapacity of existing members of our executive management team could adversely affect our operations. If we were to lose one or more of these key employees, we could experience difficulties in finding qualified successors, competing effectively, developing our technologies and implementing our business strategy. We do not maintain “key person” insurance on any of our employees.
In addition, a critical factor to our business is our ability to attract and retain qualified professionals including key employees and consultants. We are continually at risk of losing current professionals or being unable to hire additional professionals as needed. If we are unable to attract new qualified employees, our ability to grow will be adversely affected. If we are unable to retain current employees or strategic consultants, our financial condition and ability to maintain operations may be adversely affected.
If equity research analysts do not publish research or reports about our business or if they issue unfavorable commentary or downgrade our common stock, the price of our common stock could decline.
The trading market for our common stock relies in part on the research and reports that equity research analysts publish about us and our business. We do not control these analysts. The price of our common stock could decline if one or more equity analyst downgrades our stock or if analysts downgrade our stock or issue other unfavorable commentary or cease publishing reports about us or our business.

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ITEM 1B. UNRESOLVED STAFF COMMENTS
ITEM 1B. Unresolved Staff Comments
Not applicable.

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ITEM 2. PROPERTIES
ITEM 2. Properties
Our principal executive office is located in Brentwood, Tennessee. We lease or own various corporate, global logistics and supply chain centers, biostorage, manufacturing, and research and development facilities at over 50 sites across the Americas, EMEA and APAC regions.
The following table summarizes our principal facilities and other materially important physical properties as of December 31, 2023:
Location
Ownership
Use
Brentwood, Tennessee
Leased
Principle Executive Office
Irvine, California
Leased
Administrative, Global Supply Chain Center, and Research and Development Center
Morris Plains, New Jersey
Leased
Global Supply Chain Center, Administrative, and Logistics Center
Houston, Texas
Leased
Administrative, Global Supply Chain Center and Biostorage Center
Hoofddorp, the Netherlands
Leased
Global Supply Chain Center
Ball Ground, Georgia
Leased
Administrative, Manufacturing, and Research and Development Center
New Prague, Minnesota
Owned
Manufacturing
Chengdu, China
Owned
Administrative and Manufacturing
Clermont-Ferrand, France
Owned
Administrative and Global Supply Chain Center
Lisbon, Portugal
Leased
Administrative
Tremblay en France, France
Leased
Administrative and Global Logistics Center
We believe that these facilities are adequate, suitable and of sufficient capacity to support our immediate needs.

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ITEM 3. LEGAL PROCEEDINGS
ITEM 3. Legal Proceedings
In the ordinary course of business, we are at times subject to various legal proceedings and disputes, including product liability claims. We currently are not aware of any such legal proceedings or claim that we believe will have, individually or in the aggregate, a material adverse effect on our business, operating results or cash flows. It is our practice to accrue for open claims based on our historical experience and available insurance coverage.

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ITEM 4. MINE SAFETY DISCLOSURE
ITEM 4. Mine Safety Disclosures
Not applicable
PART II

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ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY
ITEM 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Common Stock
As of February 23, 2024, there were 48,977,476 shares of common stock outstanding and 158 stockholders of record. Because many shares of our common stock are held by brokers and other institutions on behalf of stockholders, we are unable to estimate the total number of stockholders represented by these stockholders of record.
Market Information
The Company’s common stock is currently listed on the NASDAQ Capital Market and is traded under the symbol “CYRX.”
Stock Performance Graph (1)
The graph below compares Cryoport’s cumulative 5-year total shareholder return on common stock with the cumulative total returns of the Russell 3000 Index and S&P 1500 Life Sciences Tools & Services Industry Index. The graph tracks the performance of a $100 investment in our common stock and in each index from December 31, 2018 to December 31, 2023 and assumes that, as to such indices, dividends were reinvested. We have never paid cash dividends on our common stock. The stock price performance on the following graph is not necessarily indicative of future stock price performance.
COMPARISON OF 5 YEAR CUMULATIVE TOTAL RETURN*
Among Cryoport, Inc., the Russell 3000 Index and the S&P 1500 Life Sciences Tools & Services Industry Index
*$100 invested on 12/31/18 in Cryoport common stock or applicable index. Fiscal year ending December 31.
(1)
The information contained in the performance graph shall not be deemed to be “soliciting material” or to be “filed” with the SEC, and such information shall not be incorporated by reference into any future filing under the Securities Act or the Exchange Act, except to the extent that Cryoport specifically incorporates it by reference into such filing.
Dividends
No dividends on common stock have been declared or paid by the Company. The Company intends to employ all available funds for the development of its business and, accordingly, does not intend to pay any cash dividends in the foreseeable future. Any future determination to pay dividends will be at the discretion of our board of directors, subject to compliance with covenants in current and future agreements governing our indebtedness, and will depend on our results of operations, financial condition, capital requirements, contractual arrangements and other factors that our board of directors deems relevant.
Recent Sale of Unregistered Securities
On April 14, 2022, in connection with the Company’s acquisition of Cell&Co, SAS, the Company issued 15,152 shares of the Company’s common stock with a fair value of $0.4 million to certain sellers as partial consideration for such seller’s interest in the business pursuant to the exemptions for registration provided by Rule 903 under Regulation S of the Securities Act, on the basis that each recipient was not a U.S. person as defined in Rule 902 of Regulation S.
Issuer Purchases of Equity Securities
None.

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ITEM 6. SELECTED FINANCIAL DATA
ITEM 6. [Reserved]

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ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS
ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of our operations should be read in conjunction with our consolidated financial statements and related notes included elsewhere in this Form 10-K. Our actual results could differ materially from those contained in forward-looking statements due to a number of factors. See “Forward-Looking Statements” in this Form 10-K.
For further discussion and analysis regarding our financial condition and results of operations for the year ended December 31, 2022 as compared to the year ended December 31, 2021, refer to “Part II, Item 7 - Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed with the SEC on February 28, 2023.
General Overview
Cryoport is a leading global provider of innovative products and services supporting the life sciences in the biopharma/pharma, animal health, and reproductive medicine markets. Our mission is to enable the future of medicine for a new era of life sciences. With over 50 strategic locations covering the Americas, EMEA (Europe, the Middle East and Africa) and APAC (Asia Pacific), Cryoport's global platform provides mission-critical bio-logistics, bio-storage, bio-processing, and cryogenic systems to over 3,000 customers worldwide. Our platform of solutions and services, together with our global team of over 1,100 dedicated colleagues, delivers a unique combination of innovative supply chain technologies and services through our industry-leading brands, including Cryoport Systems, MVE Biological Solutions, CRYOPDP, and CRYOGENE.
See the “Business” section in Part I, Item 1 of this Form 10-K for additional information.
MVE Biological Solutions Fire
On January 25, 2022, a fire occurred at the MVE Biological Solutions manufacturing facility located in New Prague, Minnesota (“New Prague fire”). The New Prague facility manufactures aluminum dewars and is one of MVE Biological Solutions’ three global manufacturing facilities. There were no injuries reported and damage was limited to a portion of the facility. As a consequence of the fire damage, the New Prague manufacturing operations were curtailed on an interim basis until the necessary repairs were completed. Production was resumed at the facility during the week of February 14, 2022 and ramped up production toward the end of the first quarter of 2022. The Company estimated a revenue impact of approximately $9.4 million, primarily limited to the first quarter of 2022.
The New Prague fire resulted in a loss of inventory, fixed assets, and other contents at the site. We have adequate property damage and business interruption insurance under which we filed a claim with the insurance carrier. As of December 31, 2023, the Company received a total of $15.1 million in insurance proceeds, of which the final payment of $2.2 million was received in the first quarter of 2023.
For the years ended December 31, 2023 and 2022, the Company recognized a gain of $2.6 million and $4.8 million, respectively, related to business interruption insurance under which we filed a claim with the insurance carrier. Proceeds from insurance settlements, except for those directly related to investing activities, were recognized as cash inflows from operating activities. The losses related to such an event are recognized as incurred. Insurance proceeds are recorded to the extent of the losses and then, only if recovery is realized or probable. Any gains in excess of losses are recognized only when the contingencies regarding the recovery are resolved, and the amount is fixed or determinable.
Impact of Inflation
Inflation generally impacts us by increasing our costs of labor, material, transportation and pricing from third party manufacturers. While the rates of inflation have not had a material impact on our financial statements in the past, we have seen some impact on gross margins in 2023 and 2022. Based on the current economic outlook, inflationary pressures could affect our financial performance in the future if cost increases cannot be offset by net realized annual price increases and productivity gains.
Critical Accounting Policies and Estimates
Our discussion and analysis of our consolidated financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in conformity with accounting principles generally accepted in the U.S., or U.S. GAAP. While our significant accounting policies are more fully described in the notes to our consolidated financial statements, we have identified the policies and estimates below as being critical to our business operations and the understanding of our results of operations. These policies require management’s most difficult, subjective or complex judgements, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. The impact of and any associated risks related to these policies on our business operations are discussed throughout “Management’s Discussion and Analysis of Financial Condition,” including in the “Results of Operations” section, where such policies affect our reported and expected financial results. Although we believe that our estimates, assumptions, and judgements are reasonable, they are based upon information presently available. Actual results may differ significantly from these estimates under different assumptions, judgments, or conditions.
The SEC defines critical accounting policies as those that are, in management’s view, most important to the portrayal of our financial condition and results of operations and most demanding of our judgment. We consider the following policies and estimates to be critical to an understanding of our consolidated financial statements and the uncertainties associated with the complex judgments made by us that could impact our results of operations, financial position and cash flows: Revenue Recognition, Business Combinations, Intangible Assets and Goodwill, Convertible Senior Notes, Stock-based Compensation, and Income Taxes. See Note 2: “Summary of Significant Accounting Policies” of our accompanying consolidated financial statements for a description of our critical accounting policies and estimates.
Revenue Recognition
Revenues are recognized when control is transferred to customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods and services. Revenue recognition is evaluated through the following five steps: (i) identification of the contract, or contracts, with a customer; (ii) identification of the performance obligations in the contract; (iii) determination of the transaction price; (iv) allocation of the transaction price to the performance obligations in the contract; and (v) recognition of revenue when or as a performance obligation is satisfied.
Performance Obligations
At contract inception, an assessment of the goods and services promised in the contracts with customers is performed and a performance obligation is identified for each distinct promise to transfer to the customer a good or service (or bundle of goods or services). To identify the performance obligations, the Company considers all of the goods or services promised in the contract regardless of whether they are explicitly stated or are implied by customary business practices. Revenue is recognized when our performance obligation has been met. The Company considers control to have transferred upon delivery because the Company has a present right to
payment at that time since the Company has satisfied its performance obligations related to the successful delivery. In instances where the customer has elected to use their own freight, revenue is recognized upon delivery of the shipper to the customer.
For arrangements under which the Company provides biological specimen storage services and logistics support and management to the customer, the Company satisfies its performance obligations as those services are performed whereby the customer simultaneously receives and consumes the benefits of such services under the agreement.
Revenue generated from short-term logistics and engineering consulting services provided to customers is recognized when the Company satisfies the contractually defined performance obligations. When a contract includes multiple performance obligations, the contract price is allocated among the performance obligations based upon the stand-alone selling prices. Approved contract modifications are accounted for as either a separate contract or as part of the existing contract depending on the nature of the modification.
Our performance obligations on our orders and under the terms of agreements with customers are generally satisfied within one year from a given reporting date and, therefore, we omit disclosure of the transaction price allocated to remaining performance obligations on open orders.
Shipping and handling activities related to contracts with customers are accounted for as costs to fulfill our promise to transfer the associated products pursuant to the accounting policy election allowed under Topic 606 and are not considered a separate performance obligation to our customers. Accordingly, the Company records amounts billed for shipping and handling as a component of revenue. Shipping and handling fees and costs are included in cost of revenues in the accompanying condensed consolidated statements of operations.
Revenues are recognized net of any taxes collected from customers, which are subsequently remitted to governmental agencies.
Business Combinations
Amounts paid for acquisitions are allocated to the tangible and intangible assets acquired and liabilities assumed, if any, based on their fair values at the dates of acquisition. This purchase price allocation process requires management to make significant estimates and assumptions with respect to intangible assets. The fair value of identifiable intangible assets is based on detailed valuations that use information and assumptions determined by management. Any excess of purchase price over the fair value of the net tangible and intangible assets acquired is allocated to goodwill. While we use our best estimates and assumptions to accurately value assets acquired and liabilities assumed at the acquisition date as well as any contingent consideration, where applicable, our estimates are inherently uncertain and subject to refinement. As a result, during the measurement period, which may be up to one year from the acquisition date, we record adjustments to the assets acquired and liabilities assumed with the corresponding offset to goodwill. Upon conclusion of the measurement period or final determination of the values of assets acquired or liabilities assumed, whichever comes first, any subsequent adjustments are recorded to our consolidated statements of operations.
We use the income approach to determine the fair value of certain identifiable intangible assets such as customer relationships. This approach determines fair value by estimating after-tax cash flows attributable to these assets over their respective useful lives and then discounting these after-tax cash flows back to a present value. We base our assumptions on estimates of future cash flows, expected growth rates, expected trends in technology, etc. We base the discount rates used to arrive at a present value as of the date of acquisition on the time value of money and certain industry-specific risk factors. We believe the estimated purchased customer relationships, agent networks, software, developed technologies, and trademarks/tradenames so determined represent the fair value at the date of acquisition and do not exceed the amount a third party would pay for the assets.
Intangible Assets and Goodwill
Intangible assets
Intangible assets with a definite life are amortized over their useful lives using the straight-line method, which is the best estimate of the value we are receiving over the useful life of the intangible asset and another systematic method was not deemed more appropriate. The amortization expense is recorded within selling, general and administrative expense in the consolidated statements of operations. Intangible assets and their related useful lives are reviewed at least annually to determine if any adverse conditions exist that would indicate the carrying value of these assets may not be recoverable. More frequent impairment assessments are conducted if certain conditions exist, including a change in the competitive landscape, any internal decisions to pursue new or different technology strategies, a loss of a significant customer, or a significant change in the marketplace, including changes in the prices paid for the Company’s products or changes in the size of the market for the Company’s products. If impairment indicators are present, the Company determines whether the underlying intangible asset is recoverable through estimated future undiscounted cash flows. If the asset is not found to be recoverable, it is written down to the estimated fair value of the asset based on the sum of the future discounted cash flows expected to result from the use and disposition of the asset. If the estimate of an intangible asset’s remaining useful life is changed, the remaining carrying amount of the intangible asset is amortized prospectively over the revised remaining useful life. The Company continues to believe that its definite-lived intangible assets are recoverable at December 31, 2023. The Company has performed a quantitative impairment assessment in the fourth quarter of 2023 and concluded that there has been no impairment of our intangible assets for the periods presented.
Goodwill
We test goodwill for impairment on an annual basis in the fourth quarter or more frequently if management believes indicators of impairment exist. Events that would indicate impairment and trigger an interim impairment assessment include, but are not limited to, current economic and market conditions, including a decline in market capitalization, a significant adverse change in legal factors, business climate or operational performance of the business, and an adverse action or assessment by a regulator. Accounting guidance also permits an optional qualitative assessment for goodwill to determine whether it is more likely than not that the carrying value of a reporting unit exceeds its fair value. If, after this qualitative assessment, we determine that it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, then no further quantitative testing would be necessary. A quantitative assessment is performed if the qualitative assessment results in a more likely than not determination or if a qualitative assessment is not performed. The quantitative assessment considers whether the carrying amount of a reporting unit exceeds its fair value, in which case an impairment charge is recorded to the extent the reporting unit’s carrying value exceeds its fair value. As a result of our 2023 quantitative assessment, we concluded that goodwill related to the MVE reporting unit is impaired as of December 31, 2023, and recorded an impairment charge of $49.6 million in the consolidated statement of operations for the year ended December 31, 2023 (see Note 8).
Convertible Senior Notes
The Convertible Senior Notes are accounted for in accordance with ASC 470-20, Debt with Conversion and Other Options (“ASC 470-20”) and ASC 815-40, Contracts in Entity’s Own Equity (“ASC 815-40”). Under ASC 815-40, to qualify for equity classification (or nonbifurcation, if embedded) the instrument (or embedded feature) must be both (1) indexed to the issuer’s stock and (2) meet the requirements of the equity classification guidance. Based upon the Company’s analysis, it was determined the Convertible Senior Notes do contain embedded features indexed to its own stock, but do not meet the requirements for bifurcation and recognition as derivatives, and therefore do not need to be separately recognized. Accordingly, the proceeds received from the issuance of the Convertible Senior Notes were recorded as a single liability on the consolidated balance sheets.
Stock-based Compensation
We use the Black-Scholes option pricing model to calculate the fair value of stock option awards on the grant date. The expected option life assumption is estimated based on the simplified method. Accordingly, the Company has utilized the average of the contractual term of the options and the weighted average vesting period for all options to calculate the expected option term. The risk-free interest rate assumption is based upon observed interest rates appropriate for the expected term of our employee stock options. The expected volatility is based on the average of the historical volatility and the implied volatility of our stock commensurate with the expected life of the stock-based award. We do not anticipate paying dividends on our common stock in the foreseeable future.
We recognize stock-based compensation cost on a straight-line basis over the vesting period. Stock-based compensation expense is recognized only for those awards that ultimately vest.
Income Taxes
Deferred taxes are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse. Valuation allowances are provided, if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. We account for uncertain tax positions using a “more-likely-than-not” threshold for recognizing and resolving uncertain tax positions. The evaluation of uncertain tax positions is based on factors including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity and changes in facts or circumstances related to a tax position. We evaluate our tax position on a quarterly basis. We also accrue for potential interest and penalties related to unrecognized tax benefits in income tax expense.
Results of Operations
Results of Operations for Year Ended December 31, 2023 Compared to the Year Ended December 31, 2022
The following table summarizes certain information derived from our consolidated statements of operations (in thousands):
Year Ended
December 31,
$ Change
% Change
($ in 000’s)
Service revenues
$
144,087
$
133,879
$
10,208
7.6%
Product revenues
89,168
103,398
(14,230)
(13.8)%
Total revenues
233,255
237,277
(4,022)
(1.7)%
Cost of service revenues
(81,820)
(75,187)
(6,633)
8.8%
Cost of product revenues
(52,103)
(58,217)
6,114
(10.5)%
Total cost of revenues
(133,923)
(133,404)
(519)
0.4%
Gross margin
99,332
103,873
(4,541)
(4.4)%
Selling, general and administrative
(146,880)
(120,055)
(26,825)
22.3%
Engineering and development
(18,040)
(15,722)
(2,318)
14.7%
Goodwill impairment
(49,569)
-
(49,569)
Investment income
10,577
8,474
2,103
24.8%
Interest expense
(5,503)
(6,142)
(10.4)%
Gain on extinguishment of debt, net
5,679
-
5,679
100.0%
Other income (expense), net
5,056
(5,522)
10,578
(191.6)%
Benefit from (provision for) income taxes
(239)
(2,239)
2,000
(89.3)%
Net loss
$
(99,587)
$
(37,333)
$
(62,254)
166.7%
Paid-in-kind dividend on Series C convertible preferred stock
(8,000)
(8,000)
-
0.0%
Net loss attributable to common stockholders
$
(107,587)
$
(45,333)
$
(62,254)
137.3%
Total revenues by market
Year Ended December 31,
$ Change
% Change
($ in 000’s)
Pharma/Biopharmaceutical
$
192,583
$
193,879
$
(1,296)
(0.7)
%
Animal Health
30,379
33,465
(3,086)
(9.2)
%
Human Reproductive Medicine
10,293
9,933
3.6
%
Total revenues
$
233,255
$
237,277
$
(4,022)
(1.7)
%
Revenues. Revenues decreased $4.0 million, or 1.7%, to $233.3 million for the year ended December 31, 2023, as compared to $237.3 million for the year ended December 31, 2022.
Revenues by type
Service revenues increased by $10.2 million, or 7.6%, from $133.9 million to $144.1 million for the year ended December 31, 2023, as compared to the same period in 2022. Services revenue was driven by year-over-year growth in BioStorage/BioServices and Commercial Cell & Gene therapy revenue of 44.7% and 32.5%, respectively, demonstrating strong demand for our services offerings. We also continued to gain clinical trial market share with Cryoport supporting a total of 675 clinical trials globally at year end 2023, of which 82 of these clinical trials were in phase 3, representing an overall increase of 21 clinical trials from 654 clinical trials at year end 2022. Our company continues to lead the way in providing advanced temperature-controlled supply chain solutions designed to support the development of cell & gene therapies and our future growth.
Product revenues decreased by $14.2 million, or 13.8%, from $103.4 million to $89.2 million for the year ended December 31, 2023, as compared to the same period in 2022. This was primarily a result of decreased demand for cryogenic freezer systems that commenced during the second quarter of 2023, particularly in China. This decrease was partially offset by the recovery from the fire at our manufacturing facility in New Prague, Minnesota that negatively impacted the first quarter of 2022 by $9.4 million. Product revenues consist primarily of revenue from our portfolio of cryogenic stainless-steel freezers, aluminum dewars and related ancillary equipment used in the storage and transport of life sciences commodities, which includes the rapidly growing Cell and Gene Therapy market through a global network of distributors and direct client relationships.
Revenues by market
Revenues from the biopharma/pharma market decreased by $1.3 million, or 0.7%, from $193.9 million to $192.6 million for the year ended December 31, 2023, as compared to the same period in 2022. Revenue was impacted by decreased demand for cryogenic systems, particularly in China, where product revenues through direct and indirect channels decreased by $7.2 million, or 51%, clinical trial start delays; and slower than expected ramps of products from certain clients. This was partially offset by the support of commercially launched therapies and an increase in our BioStorage/BioServices revenue. As of December 31, 2023, we support 675 global clinical trials, of which 519 trials are in the Americas, 112 are in EMEA and 44 are in APAC, compared to 654 clinical trials supported as of December 31, 2022 (502 trials are in the Americas, 110 in EMEA and 42 are in APAC). As of December 31, 2023, we supported 82 Phase 3 clinical trials, of which 58 are in the Americas, 22 are in EMEA, and 2 are in APAC. This compares to 79 Phase 3 clinical trials (55 in the Americas, 22 in EMEA and 2 in APAC) supported as of December 31, 2022. The activity in the clinical trial space, particularly in the Cell and Gene Therapy market is expected to drive future revenue growth as these clinical trials advance and the resulting therapies are commercialized on a global basis.
Our revenues from the animal health market decreased by $3.1 million, or 9.2%, from $33.5 million to $30.4 million for the year ended December 31, 2023, as compared to the same period in 2022. This decrease was result of lower than expected demand for cryogenic systems from breeders.
Revenues in the reproductive medicine market increased by $0.4 million, or 3.6%, from $9.9 million to $10.3 million for the year ended December 31, 2023, as compared to the same period in 2022. This increase was driven by demand for our cryogenic logistics solution and partially offset by a decrease in product revenue as a result of lower demand for cryogenic systems.
Gross margin and cost of revenues. Gross margin for the year ended December 31, 2023 was 42.6% of total revenues, as compared to 43.8% of total revenues for the year ended December 31, 2022. Cost of total revenues increased $0.5 million to $133.9 million for the year ended December 31, 2023, as compared to $133.4 million in the same period in 2022.
Gross margin for our service revenues was 43.2% of service revenues, as compared to 43.8% of service revenues for the year ended December 31, 2022. Our cost of revenues is primarily comprised of freight charges, payroll and associated expenses related to our global logistics and supply chain centers, depreciation expenses of our Cryoport Express® Shippers and supplies and consumables used for our solutions.
Gross margin for our product revenues was 41.6% of product revenues, as compared to 43.7% of product revenues for the year ended December 31, 2022. The decrease was driven by unfavorable manufacturing variances during the first quarter of 2023, primarily as a result of inflationary pressures related to certain manufacturing costs and the buildup of safety stock during the second half of 2022, partially offset by favorable product mix. Product revenues, related cost of revenues and resulting gross margins were primarily driven by our MVE Biological Solutions business. Our cost of product revenues was primarily comprised of materials, direct and indirect labor, inbound freight charges, purchasing and receiving, inspection, and distribution and warehousing of inventory. In addition, shop supplies, facility maintenance costs and depreciation expense for assets used in the manufacturing process were included in cost of product revenues.
Selling, general and administrative expenses. Selling, general and administrative (“SG&A”) expenses include the costs associated with selling our products and services and costs required to support our marketing efforts including legal, accounting, patent, shareholder services, amortization of intangible assets and other administrative functions.
For the year ended December 31, 2023, SG&A expenses increased by $26.8 million, or 22.3% as compared to the same period in 2022. This increase is driven by the further build out of our competencies and infrastructure to support the continuing scaling of our business and demand for Cryoport’s systems and solutions and buildout of new competencies, such as IntegriCellTM platform, a standardized integrated apheresis cryopreservation and distribution solution for cell therapies for which Cryoport is currently building out two centers of excellence located in the Houston, Texas, U.S. and Liège, Belgium which are expected to be fully operational and ready for validation during the first quarter of 2024. Wages and associated employee costs increased $14.2 million from $52.8 million in 2022 to $67.3 million in 2023. Integration and acquisition costs increased $4.8 million, primarily as a result of exploring a strategic business opportunity and acquisitions, stock compensation expense increased $2.4 million, depreciation and amortization increased $2.4 million, primarily due to additional fixed assets purchased or acquired in our recent business acquisitions and the launch of Cryoportal® 2 Logistics Management Platform in May 2023 and facility and other overhead allocations increased $2.1 million, primarily driven by our facility expansions in Houston, Texas and Morris Plains, New Jersey.
Engineering and development expenses. Engineering and development expenses increased by $2.3 million, or 14.7%, for the year ended December 31, 2023, as compared to the same period in 2022. The increase was primarily due to an increase of $1.6 million in wages and associated employee costs to add software development and engineering resources. We continually strive to improve and expand the features of our Cryoport Express®, Cryoport ELITE™ Solutions and portfolio of temperature-controlled services and products. Our primary developments are directed towards facilitating the safe, reliable and efficient transport and storage of life science commodities through innovative and technology-based solutions. This includes significantly enhancing our Cryoportal® Logistics Management Platform and related technology solutions as well as developments to expand our Cryoport Express® and shipper fleet. In addition, engineering and development efforts are also focused on MVE Biological Solutions’ portfolio of advanced cryogenic stainless-steel freezers, aluminum dewars and related ancillary equipment used in the storage and transport of life sciences commodities. We supplement our internal engineering and development resources with subject matter experts and consultants to enhance our capabilities and shorten development cycles.
Goodwill Impairment. Goodwill impairment was $49.6 million for the year ended December 31, 2023, as a result of our 2023 quantitative impairment assessment.
Investment Income. Investment income increased by $2.1 million, for the year ended December 31, 2023, as compared to the prior year as a result of higher average invested cash balances offset by lower interest rates on such invested cash balances.
Interest expense. Interest expense decreased by $0.6 million, from $6.1 million to $5.5 million for the year ended December 31, 2023, as compared to the prior year due to interest on the convertible senior notes and amortization of the related debt discount.
Gain on extinguishment of debt. In September 2023, the Company repurchased $31.3 million in aggregate principal amount of the 2026 Senior Notes for a repurchase price of $25.0 million in cash resulting in a net gain of $5.7 million, which includes the write off of $0.6 million of unamortized debt issuance costs.
Other income (expense), net. The increase in other income (expense), net for the year ended December 31, 2023, as compared to the prior year is primarily due to an increase of $12.7 million in short-term investment net unrealized gains which was partially offset by a decrease in the gain on insurance claim of $2.2 million related to the New Prague fire as compared to prior year.
Provision for income taxes. The provision for income taxes decreased by $2.0 million for the year ended December 31, 2023, as compared to the same period in the prior year, resulting in effective tax rates of negative 0.2% and negative 6.4%, respectively. The decrease in tax expense and the increase in the effective tax rate for the year ended December 31, 2023, as compared to the prior year is due to higher taxable foreign earnings subject to tax at differing rates and an increase in our domestic losses which resulted in no additional tax benefit. The effective tax rate of negative 0.2% for the year ended December 31, 2023, differed from the U.S. federal statutory rate of 21% primarily due to changes in the valuation allowance that we maintain against our deferred tax assets, the impairment of goodwill and the relative mix of income earned by certain foreign subsidiaries being taxed at different rates than the U.S. federal statuary rate.
Paid-in-kind dividend on Series C convertible preferred stock. The paid-in-kind dividend relates to the private placement of Series C Preferred Stock with Blackstone.
Non-GAAP Financial Measures
We provide adjusted EBITDA and revenue at constant currency, both non-GAAP financial measures, as supplemental measures to U.S. GAAP measures regarding our operating performance. Non-GAAP financial measures are not calculated in accordance with U.S. GAAP, are not based on any comprehensive set of accounting rules or principles and may be different from non-GAAP financial measures presented by other companies. Non-GAAP financial measures, including adjusted EBITDA and revenue at constant currency, should not be considered as a substitute for, or superior to, measures of financial performance prepared in accordance with U.S. GAAP.
Adjusted EBITDA
Adjusted EBITDA is defined as net loss adjusted for interest expense, income taxes, depreciation and amortization expense, stock-based compensation expense, acquisition and integration costs, investment income, unrealized gain or loss on investments, foreign currency gain or loss, gain on insurance claim, gain on extinguishment of debt, goodwill impairment charge and charges or gains resulting from non-recurring events.
Management believes adjusted EBITDA provides a useful measure of our operating results, a meaningful comparison with historical results and with the results of other companies, and insight into our ongoing operating performance. Further, management and our board of directors utilize adjusted EBITDA to gain a better understanding of our comparative operating performance from period-to-period and as a basis for planning and forecasting future periods. Adjusted EBITDA is also a significant performance measure used by us in connection with our incentive compensation programs. Management believes adjusted EBITDA, when read in conjunction with our U.S. GAAP financials, is useful to investors because it provides a basis for meaningful period-to-period comparisons of our ongoing operating results, including results of operations, against investor and analyst financial models, identifying trends in our underlying business and performing related trend analyses, and it provides a better understanding of how management plans and measures our underlying business.
A reconciliation of adjusted EBITDA to net loss, the most directly comparable U.S. GAAP financial measure, is presented below.
Cryoport, Inc. and Subsidiaries
Adjusted EBITDA Reconciliation
(Unaudited, in thousands)
Three Months Ended
Year Ended
December 31,
December 31,
GAAP net loss
$
(62,389)
$
(9,436)
$
(99,587)
$
(37,333)
Non-GAAP adjustments to net loss:
Depreciation and amortization expense
7,449
6,134
27,487
22,765
Acquisition and integration costs
6,945
2,165
Investment income
(2,615)
(2,677)
(10,577)
(8,474)
Unrealized (gain)/loss on investments
(3,542)
(1,042)
(1,242)
11,508
Gain on insurance claim
-
-
(2,642)
(4,815)
Foreign currency gain
(1,078)
(1,212)
(964)
(584)
Interest expense, net
1,306
1,456
5,503
6,142
Stock-based compensation expense
5,848
5,333
22,808
20,082
Gain on extinguishment of debt, net
-
-
(5,679)
-
Goodwill impairment
49,569
-
49,569
-
Change in fair value of contingent consideration
(665)
(601)
Other non-recurring costs
-
-
Income taxes
(1,359)
1,477
2,239
Adjusted EBITDA
(6,648)
(8,304)
13,908
Revenue at Constant Currency
We believe that revenue growth is a key indicator of how our Company is progressing from period to period and we believe that the non-GAAP financial measure “revenue at constant currency” is useful to investors in analyzing the underlying trends in revenue. Under U.S. GAAP, revenues received in local (non-U.S. dollar) currency are translated into U.S. dollars at the average exchange rate for the period presented. As a result, fluctuations in foreign currency exchange rates affect the results of our operations and the value of our foreign assets and liabilities, which in turn may adversely affect results of operations and cash flows and the comparability of period-to-period results of operations. When we use the term “constant currency,” it means that we have translated local currency revenues for the current reporting period into U.S. dollars using the same average foreign currency exchange rates for the conversion of revenues into U.S. dollars that we used to translate local currency revenues for the comparable reporting period of the prior year.
Recent fluctuations in foreign currency exchange rates, including the increased strength of the U.S. dollar against the Euro, British Pound, Chinese Yuan, and Indian Rupee has adversely impacted our results of operations and cash flow from our operations in EMEA and APAC. For the year ended December 31, 2023, our revenues would have been approximately $0.5 million higher in constant currency.
However, we also believe that data on constant currency period-over-period changes have limitations, particularly as the currency effects that are eliminated could constitute a significant element of our revenue and could significantly impact our performance. We therefore limit our use of constant currency period-over-period changes to a measure for the impact of currency fluctuations on the translation of local currency revenue into U.S. dollars. We do not evaluate our results and performance without considering both period-over-period changes in non-GAAP constant currency revenue on the one hand and changes in revenue prepared in accordance with U.S. GAAP on the other. We caution the readers of this report to follow a similar approach by considering revenue on constant currency period-over-period changes only in addition to, and not as a substitute for, or superior to, changes in revenue prepared in accordance with U.S. GAAP.
Cryoport, Inc. and Subsidiaries
Revenues by Market at Constant Currency
(Unaudited, in thousands)
Year Ended December 31, 2023
Biopharma/
Animal
Reproductive
Pharma
Health
Medicine
Total
As Reported
$
192,583
$
30,379
$
10,293
$
233,255
Non-GAAP Constant Currency
192,781
30,654
10,288
233,723
FX Impact [$]
$
(198)
$
(275)
$
$
(468)
FX Impact [%]
(0.1)
%
(0.9)
%
0.0
%
(0.2)
%
Liquidity and Capital Resources
As of December 31, 2023, the Company had cash and cash equivalents of $46.3 million, short-term investments of $410.4 million and working capital of $489.5 million. We expect to continue to incur significant expenses for the foreseeable future and to incur operating losses in the near term while we make investments in new supply chain initiatives, geographic expansion and technology to support our anticipated growth. Historically, we have financed our operations primarily through sales of equity securities and debt instruments.
The Company’s management recognizes that the Company may need to obtain additional capital to fund its operations and potential acquisitions until sustained profitable operations are achieved. Additional funding plans may include obtaining additional capital through equity and/or debt funding sources. No assurance can be given that additional capital, if needed, will be available when required or upon terms acceptable to the Company. The Company’s management believes that, based on its current plans and assumptions, the current cash and cash equivalents on hand, short-term investments, together with projected cash flows, will satisfy our operational and capital requirements for at least the next twelve months.
Cash flows Summary
For the Year Ended December 31,
$ Change
(in thousands)
Operating activities
$
(757)
$
(1,851)
$
1,094
Investing activities
36,045
(59,681)
95,726
Financing activities
(23,798)
(39,174)
15,376
Effect of exchange rate changes on cash and cash equivalents
(1,739)
(1,800)
Net increase (decrease) in cash and cash equivalents
$
9,751
$
(102,506)
$
112,257
Operating activities
For the year ended December 31, 2023, our operating activities used $0.8 million of cash, reflecting the net loss of $99.6 million offset by non-cash expenses of $100.0 million primarily comprised of $49.6 million of goodwill impairment, $27.5 million of depreciation and amortization, $22.8 million of stock-based compensation, $5.1 million of non-cash operating lease expense, which was partially offset by a gain on the extinguishment of debt of $5.7 million and the gain on the insurance settlement of $2.6 million related to the fire at our New Prague, Minnesota manufacturing plant in January 2022. Also contributing to the cash impact of our net operating loss, excluding non-cash items, was a decrease in operating lease liabilities of $4.6 million, a decrease in accounts payable and other accrued expenses of $2.8 million, and a decrease in net deferred tax liability of $2.0 million, which were partially offset by a decrease
in accounts receivable of $3.7 million, an increase in accrued compensation and related expenses of $2.9 million, and a decrease in inventories of $1.5 million.
Investing activities
Net cash provided by investing activities of $36.0 million during the year ended December 31, 2023 was primarily due to the $130.0 million maturity of short-term investments. These proceeds were partially offset by the purchase of short-term investments of $42.7 million, facility expansions (including leasehold improvements, furniture and equipment) and additional purchases of Cryoport Express® Shippers, Smart Pak IITM Condition Monitoring Systems, freezers and computer equipment for $38.8 million, the acquisitions of Bluebird Express, Tec4med and SCI JA8 for $7.3 million, and software development costs for our Cryoportal® Logistics Management System of $5.2 million.
Financing Activity
Net cash used in financing activities totaled $23.8 million during the year ended December 31, 2023, was primarily as a result of $25.0 million paid for the repurchase 2026 Senior Notes, partially offset by proceeds of $1.5 million from the exercise of stock options.
Convertible Senior Notes
2026 Convertible Senior Notes
In November 2021, the Company issued $402.5 million aggregate principal amount of its 0.75% Convertible Senior Notes due 2026. The Company received $390.4 million in net proceeds from the offering, after deducting underwriting discounts and commission of $12.1 million and incurred approximately $0.6 million of third-party offering related costs. The 2026 Convertible Senior Notes bear cash interest at a rate of 0.75% per annum, are payable semi-annually in arrears on June 1 and December 1 of each year, beginning on June 1, 2022, and will mature on December 1, 2026, unless earlier repurchased, redeemed, or converted in accordance with the terms of the 2026 Convertible Senior Notes.
2025 Convertible Senior Notes
In May 2020, the Company issued $115.0 million aggregate principal amount of its 3.00% Convertible Senior Notes due 2025. The Company received $111.3 million in net proceeds from the offering, after deducting underwriting discounts and commission of $12.1 million and incurred approximately $0.3 million in third-party offering related costs. The 2025 Convertible Senior Notes bear cash interest at a rate of 3.00% per annum, are payable semi-annually on June 1 and December 1 of each year, beginning on December 1, 2020, and will mature on June 1, 2025, unless earlier repurchased, redeemed, or converted in accordance with the terms of the 2025 Convertible Senior Notes. On November 9, 2021, the Company entered into separate, privately negotiated note purchase agreements with a limited number of holders of the 2025 Convertible Senior Notes pursuant to which the Company repurchased approximately $100.7 million principal amount of 2025 Convertible Senior Notes for an aggregate cash repurchase price of approximately $351.1 million, which includes accrued and unpaid interest on the repurchased 2025 Convertible Senior Notes.
The Convertible Senior Notes comprise the Company’s senior, unsecured obligations and are (i) equal in right of payment with the Company’s existing and future senior, unsecured indebtedness; (ii) senior in right of payment to the Company’s existing and future indebtedness that is expressly subordinated to the Convertible Senior Notes; (iii) effectively subordinated to the Company’s existing and future secured indebtedness, to the extent of the value of the collateral securing that indebtedness; and (iv) structurally subordinated to all existing and future indebtedness and other liabilities, including trade payables, and (to the extent the Company is not a holder thereof) preferred equity, if any, of the Company’s subsidiaries. As of December 31, 2023, approximately $14.3 million aggregate principal amount of the 2025 Convertible Senior Notes remain outstanding and approximately $371.2 million aggregate principal amount of the 2026 Convertible Senior Notes remain outstanding. See Note 10: “Convertible Senior Notes” of our accompanying consolidated financial statements for additional information.
November 2021 Registered Direct Placement and Stock Purchase Agreements
Concurrent with the issuance of the 2026 Convertible Senior Notes in November 2021, the Company conducted a registered direct placement of 3,072,038 shares of its common stock at a price of $81.10 per share (“Concurrent Placement”). The Company used the net proceeds from the Concurrent Placement, together with a portion of the net proceeds from the issuance of the 2026 Convertible Senior Notes, to repurchase approximately $100.7 million principal amount of the 2025 Convertible Senior Notes as discussed above. The remainder of the net proceeds of approximately $288.4 million, after deducting banker fees, are used for general corporate purposes. See Note 10: “Convertible Senior Notes” of our accompanying consolidated financial statements for additional information.
January 2021 Public Offering
On January 25, 2021, the Company completed an underwritten public offering of 4,356,059 shares of its common stock. The shares were issued and sold pursuant to an underwriting agreement dated January 20, 2021, by and among the Company, on the one hand, and Morgan Stanley & Co. LLC, Jefferies LLC, SVB Leerink LLC and UBS Securities LLC, as representatives of certain underwriters, on the other hand, at a public offering price per share of $66.00, before deducting underwriting discounts and commissions. The shares include 568,181 shares issued and sold pursuant to the underwriters’ exercise in full of their option to purchase additional shares of common stock pursuant to the underwriting agreement. The Company received net proceeds of approximately $269.8 million from the offering after deducting underwriting discounts and commissions and offering expenses paid by the Company.
Repurchase Program
In March 2022, the Company announced that its board of directors authorized a repurchase program (the “Repurchase Program”) through December 31, 2025, authorizing the repurchase of common stock and/or convertible senior notes in the amount of up to $100.0 million from time to time on the open market or otherwise, in such quantities, at such prices, and in such manner as determined by the Company’s management at its discretion. The size and timing of any repurchase will depend on a number of factors, including the market price of the Company’s common stock, general market and economic conditions, and applicable legal requirements. The Company purchased 1,604,994 shares of its common stock under the Repurchase Program during the year ended December 31, 2022, at an average price of $23.63 per share, for an aggregate purchase price of $37.9 million. These shares were returned to the status of authorized but unissued shares of common stock. All share repurchases were made using cash resources and are reported in the period based on the settlement date of the applicable repurchase. There were no shares repurchased during the year ended December 31, 2023.
In September 2023, the Company repurchased $31.3 million in aggregate principal amount of the 2026 Convertible Senior Notes for a repurchase price of $25.0 million in cash. The Company recorded $5.7 million as a gain on extinguishment of debt on its condensed consolidated statement of operations for the year ended December 31, 2023, which includes the write off of $0.6 million of unamortized debt issuance costs.
As of December 31, 2023, the Company had $37.1 million remaining under the Repurchase Program.

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ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
We are exposed to market risk for the effect of interest rate changes, foreign currency fluctuations, and changes in the market values of our investments.
Interest Rate Risk
Our exposure to market risk for changes in interest rates relates primarily to our investment portfolio and our long-term debt. Our long-term debt is carried at amortized cost and fluctuations in interest rates do not impact our consolidated financial statements. However, the fair value of our debt, which pays interest at a fixed rate, will generally fluctuate with movements of interest rates, increasing when interest rates are declining and declining when interest rates are increasing. We invest our excess cash in high investment grade money market funds and investment grade short to intermediate-term fixed income securities. Fixed income securities may have their fair market value adversely affected due to a rise in interest rates, and we may suffer losses if forced to sell securities that have declined in market value due to changes in interest rates. As of December 31, 2023, the estimated fair value of the Convertible Senior Notes was $319.8 million. For additional information about the Convertible Senior Notes, see Note 10 in our accompanying consolidated financial statements.
Foreign Exchange Risk
We operate in the United States and other foreign countries, which creates exposure to foreign currency exchange fluctuations. Net sales and related expenses generated from our international business are primarily denominated in the functional currencies of the corresponding subsidiaries and primarily include Euros, British Pounds, Chinese Yuan, and Indian Rupee. The results of operations of, and certain of our intercompany balances associated with, our internationally focused business are exposed to foreign exchange rate fluctuations. Upon consolidation, as foreign exchange rates vary, revenues and other operating results may differ materially from expectations and we may record material gain or losses on the remeasurement of intercompany balances. For example, for the year ended December 31, 2023, revenues from our international business, which accounted for 38.0% of our consolidated revenues, decreased by $0.7 million in comparison with the same period in the prior year as a result of fluctuations in foreign exchange rates. The impact of fluctuations in foreign exchange rates is derived by applying the average currency rates for the same period of the prior year to the current period revenues.
We have foreign exchange risk related to foreign-denominated cash and cash equivalents. Based on the foreign-dominated cash balance as of December 31, 2023, of $28.6 million, an assumed 5%, 10%, and 20% adverse change to foreign exchange would result in declines of $1.4 million, $2.9 million and $5.7 million, respectively, reported as accumulated other comprehensive income (loss) and included as a separate component of stockholders’ equity.
We have foreign exchange risk related to our long and short-term foreign-denominated intercompany loan balances. Based on the long-term intercompany loan balances as of December 31, 2023, an assumed 5%, 10%, and 20% adverse change to foreign exchange would result in losses of $4.3 million, $8.6 million, and $17.1 million, respectively, recorded to “Accumulated other comprehensive income (loss)”. Based on the short-term intercompany loan balances as of December 31, 2023, an assumed 5%, 10%, and 20% adverse change to foreign exchange would result in losses of $2.7 million, $5.3 million, and $10.7 million, respectively, reported as “Other income (expense), net”.

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ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Item 8. Financial Statements and Supplementary Data
Our annual consolidated financial statements are included in Part IV, Item 15 of this Form 10-K and are incorporated into this Item 8 by reference.

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ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
None.

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ITEM 9A. CONTROLS AND PROCEDURES
Item 9A. Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures
The term “disclosure controls and procedures” (as defined in Rule 13a-15(e) and 15d-15(e) under the Exchange Act) refers to the controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we have conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of December 31, 2023. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, 2023.
(b) Management’s Report on Internal Control Over Financial Reporting.
Management’s Report on Internal Control Over Financial Reporting which appears on the following page is incorporated herein by reference.
Deloitte & Touche LLP, an independent registered public accounting firm, has audited the effectiveness of our internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act) as of December 31, 2023, as stated in its attestation report included in Part II, Item 8. “Financial Statements and Supplementary Data” included elsewhere in this Form 10-K.
(c) Changes In Internal Control Over Financial Reporting
During the quarter ended December 31, 2023, there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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ITEM 9B. OTHER INFORMATION
Item 9B. Other Information
Insider Trading Arrangements and Policies
During the three months ended December 31, 2023, none of our directors or officers (as defined in Exchange Act Rule 16a-1(f)) adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” each as defined in Item 408 of Regulation S-K of the Securities Act.

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ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Item 10. Directors, Executive Officers and Corporate Governance
A list of our executive officers and their respective biographical information appears in Part I, Item 1 of this Form 10-K.
We have adopted a corporate code of conduct that applies to our directors and all employees, including our Chief Executive Officer and Chief Financial Officer. We have posted the text of our corporate code of conduct on our website at www.cryoportinc.com on the “Investor Relations: Governance” page under the heading “Governance Documents.” We intend to satisfy the requirement under Item 5.05 of Form 8-K regarding disclosure of amendments to, or waivers from, provisions of our corporate code of conduct by posting such information on our website.
The other information required under this item is incorporated by reference from our definitive proxy statement related to our 2024 Annual Meeting of Stockholders, or the Proxy Statement, to be filed with the SEC within 120 days of our fiscal year ended December 31, 2023.

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ITEM 11. EXECUTIVE COMPENSATION
Item 11. Executive Compensation
The information required by this item can be found in our Proxy Statement and is incorporated herein by reference.

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ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this item can be found in our Proxy Statement and is incorporated herein by reference.

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ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this item can be found in our Proxy Statement and is incorporated herein by reference.

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ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
Item 14. Principal Accountant Fees and Services
The information required by this item can be found in our Proxy Statement and is incorporated herein by reference.
PART IV

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ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
Item 15. Exhibits and Financial Statement Schedules
(a)(1) Consolidated Financial Statements:
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 34)
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 42)
Consolidated Balance Sheets as of December 31, 2023 and 2022
Consolidated Statements of Operations for the years ended December 31, 2023, 2022 and 2021
Consolidated Statements of Comprehensive Loss for the years ended December 31, 2023, 2022 and 2021
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2023, 2022 and 2021
Consolidated Statements of Cash Flows for the years ended December 31, 2023, 2022 and 2021
Notes to Consolidated Financial Statements
(a)(2) Financial Statement Schedules: All financial statement schedules are omitted because they are not applicable or the required information is included in the Consolidated Financial Statements or notes thereto.
(a)(3) Exhibits.
Index to Exhibits
Exhibit No.
Description
2.1˄
Asset Purchase Agreement, dated May 14, 2019, by and between Cryogene, Inc. and CryoGene Partners. Incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K dated May 14, 2019.
2.2˄
Purchase Agreement, dated as of August 24, 2020, by and between Cryoport, Inc. and Chart Industries, Inc. Incorporated by reference to Exhibit 2.1 of the Company’s Current Report on Form 8-K dated August 25, 2020.
3.1
Amended and Restated Articles of Incorporation of the Company, as amended. Incorporated by reference to Exhibit 3.1 to the Company’s Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2012.
3.2
Amended and Restated Bylaws of the Company. Incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K dated November 15, 2023.
3.3
Amended and Restated Certificate of Designation of Class A Preferred Stock. Incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K dated March 30, 2015.
3.4
Certificate of Designation of Class B Preferred Stock. Incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K dated February 20, 2015.
3.5
Amendment to Certificate of Designation of Class B Preferred Stock. Incorporated by reference to the Company’s Amendment No. 1 to Registration Statement on Form S-1 dated April 17, 2015 and referred to as Exhibit 3.6.
3.6
Certificate of Change filed with the Nevada Secretary of State on May 12, 2015. Incorporated by reference to Exhibit 3.7 of the Company’s Annual Report on Form 10-K filed with the SEC on May 19, 2015.
3.7
Amendment to Certificate of Designation of Class A Preferred Stock. Incorporated by reference to the Company’s Amendment No. 4 to Registration Statement on Form S-1 dated June 22, 2015 and referred to as Exhibit 3.8.
3.8
Amendment to Certificate of Designation of Class B Preferred Stock. Incorporated by reference to the Company’s Amendment No. 4 to Registration Statement on Form S-1 dated June 22, 2015 and referred to as Exhibit 3.9.
3.9
Amendment to Certificate of Designation of Class A Preferred Stock. Incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K dated September 1, 2015.
3.10
Amendment to Certificate of Designation of Class B Preferred Stock. Incorporated by reference to Exhibit 3.2 of the Company’s Current Report on Form 8-K dated September 1, 2015.
3.11
Certificate of Amendment filed with the Nevada Secretary of State on November 23, 2015. Incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K dated November 23, 2015.
3.12
Certificate of Amendment filed with the Nevada Secretary of State on May 30, 2018. Incorporated by reference to Exhibit 3.12 of the Company’s Annual Report on Form 10-K filed with the SEC on March 13, 2019.
3.13
Certificate of Designation of 4.0% Series C Convertible Preferred Stock of the Company. Incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K dated October 1, 2020.
4.1
Description of the Company’s securities. Incorporated by reference to Exhibit 4.1 of the Company’s Annual Report on Form 10-K filed with the SEC on March 1, 2021.
4.2
Indenture, dated May 26, 2020, between Cryoport, Inc. and U.S. Bank National Association, as trustee. Incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K dated May 27, 2020.
Exhibit No.
Description
4.3
Form of certificate representing the 3.00% Convertible Senior Notes due 2025. Incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K dated May 27, 2020.
4.4
Indenture, dated as of November 12, 2021, between Cryoport, Inc. and U.S. Bank National Association, as trustee. Incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K dated November 12, 2021.
4.5
Form of certificate representing the 0.75% Convertible Senior Notes due 2026. Incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K dated November 12, 2021.
10.1*
2011 Stock Incentive Plan (as amended and restated). Incorporated by reference to Exhibit A of the Company’s Definitive Proxy Statement on Schedule 14A filed with the SEC on July 30, 2012.
10.2*
Stock Option Agreement dated December 18, 2014 between the Company and Jerrell Shelton. Incorporated by reference to Exhibit 10.42 of the Company’s Annual Report on Form 10-K filed with the SEC on May 19, 2015.
10.3*
2015 Omnibus Equity Incentive Plan. Incorporated by reference to Appendix A of the Company’s Definitive Proxy Statement on Schedule 14A filed with the SEC on October 1, 2015.
10.4*
Cryoport, Inc. 2018 Omnibus Equity Incentive Plan (as amended by the First Amendment and the Second Amendment, effective April 30, 2021). Incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K dated May 5, 2021.
10.5*
Form of Stock Option Award Agreement under the 2018 Omnibus Equity Incentive Plan. Incorporated by reference to Exhibit 10.6 of the Company’s Annual Report on Form 10-K filed with the SEC on March 1, 2021.
10.6*
Form of Non-Qualified Stock Option Award Agreement under the 2018 Omnibus Equity Incentive Plan. Incorporated by reference to Exhibit 10.7 of the Company’s Annual Report on Form 10-K filed with the SEC on March 1, 2021.
10.7*
Form of Restrictive Stock Right Award Agreement under the 2018 Omnibus Equity Incentive Plan. Incorporated by reference to Exhibit 10.8 of the Company’s Annual Report on Form 10-K filed with the SEC on March 1, 2021.
10.8*
Amended and Restated Employment Agreement dated February 15, 2024 between the Company and Jerrell W. Shelton. Incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K dated February 15, 2024.
10.9*
Amended and Restated Employment Agreement dated February 15, 2024 between the Company and Robert S. Stefanovich. Incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K dated February 15, 2024.
10.10*
Amended and Restated Employment Agreement dated February 15, 2024 between the Company and Mark Sawicki. Incorporated by reference to Exhibit 10.3 of the Company’s Current Report on Form 8-K dated February 15, 2024.
10.11*+
Employment Agreement dated February 19, 2024 between the Company and Edward Zecchini.
10.12
Registration Rights Agreement, dated May 26, 2020, among Cryoport, Inc., Jefferies LLC and SVB Leerink LLC. Incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K dated May 27, 2020.
10.13
Securities Purchase Agreement, dated August 21, 2020, between Cryoport, Inc. and each of the Sellers identified therein. Incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K dated August 21, 2020.
10.14˄
Securities Purchase Agreement, dated as of August 24, 2020, by and between Cryoport, Inc. and BTO Freeze Parent L.P. Incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K dated August 25, 2020.
Exhibit No.
Description
10.15
Registration Rights Agreement, dated as of October 1, 2020, by and among Cryoport, Inc., BTO Freeze Parent L.P. and Blackstone Tactical Opportunities Fund - FD L.P. Incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K dated October 1, 2020.
10.16
Amendment No. 1 to Securities Purchase Agreement, dated October 1, 2020, by and among Cryoport Inc., Cryoport Netherlands B.V. and the other parties thereto. Incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K dated October 1, 2020.
16.1
Letter to Securities and Exchange Commission from Ernst & Young LLP dated March 15, 2023. Incorporated by reference to Exhibit 16.1 of the Company’s Current Report on Form 8-K dated March 15, 2023.
21+
Subsidiaries of Registrant.
23.1+
Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm.
23.2+
Consent of Deloitte & Touche LLP, Independent Registered Public Accounting Firm.
31.1+
Certification of Principal Executive Officer, pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934.
31.2+
Certification of Principal Financial Officer, pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934.
32.1+
Certification of Principal Executive Officer, pursuant to Rule 13a-14(b)/15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350.
32.2+
Certification of Principal Financial Officer, pursuant to Rule 13a-14(b)/15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350.
97+
Cryoport, Inc. Clawback Policy
101.INS+
Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
101.SCH+
Inline XBRL Taxonomy Extension Schema Document.
101.CAL+
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF+
Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB+
Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE+
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
˄ Certain exhibits and schedules have been omitted pursuant to Item 601(b)(2) or Item 601(a)(5) of Regulation S-K. The Company hereby undertakes to furnish copies of such omitted materials supplementally upon request by the SEC.
*
Indicates a management contract or compensatory plan or arrangement.
+
Filed or furnished herewith.