Cryoport Inc
For the period ended Dec 31, 2023. Filed Mar 13, 2024.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2023 · Filed Mar 13, 2024
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
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 IntegriCell TM service platform. The IntegriCell TM 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, Cryoshuttle TM 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:
| · · · · · · · | |||
|---|---|---|---|
| · · 2023 · · 2022 · · 2021 | |||
| 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/ft 2, 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 | 447 | 405 |
| Scope 1 | Mobile Sources | 2,016 | 717[1] |
| Scope 1 | Refrigerants | 150 | 230 |
| 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 | 110 | 224 |
| Scope 3 | Employee Business Travel | 32 | 217 |
| 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` | ||
|---|---|---|
| 2021 | 2022 | |
| 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 | 795 | 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 atwww.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 atwww.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 | 13,718additional patients were able to receive therapies over past 24 months | 19,758additional patients were able to receive therapies over past 24 months |
| CryoStork® | Patient Success & Satisfaction | 1,641Intended Parents able to have successful cycles resulting in the birth of a child | 1,952Intended Parents able to have successful cycles resulting in the birth of a child |
| MVE Biological Solutions | Energy Saved | 166,225,209kWh annual energy reduction, equating to 136,733,034 pounds of GHG emissions avoided | 183,225,534kWh annual energy reduction, equating to 51,610,701 pounds of GHG emissions avoided |
| CryoGene | Energy Saved | 1,398,686pounds of GHG emissions avoided due to renewable energy generation | 1,869,763pounds 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 iswww.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.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.