CRYOPORT, INC. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. (form 10-Q) – Marketscreener.com




In this Quarterly Report on Form 10-Q (this “Quarterly Report”), the terms “Cryoport,” “Company” and similar terms refer to Cryoport, Inc. and its consolidated subsidiaries, unless the context suggest otherwise.
SAFE HARBOR FOR FORWARD LOOKING STATEMENTS:
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? Industry leading temperature-controlled packaging and data management at all
temperatures via MVE Biological Solutions, Cryoport Systems and CRYOPDP
? Logistics planning, management, and transportation of critical materials
globally via Cryoport Systems and CRYOPDP
? cGMP storage and distribution (equipment and services) of life science
materials via CRYOGENE, MVE Biological Solutions and Cryoport Systems
? Kitting, labelling, drug return and return therapy destruction via Cryoport
Systems
? Consulting services in support of custom primary and secondary packaging, as
These service platforms have been designed to effectively support, for example, the following use cases:
Cell-based Autologous Immunotherapy (Personalized Medicine) Solutions, designed
for therapies in which our Cryoport ELITE™, Cryoport Express®, and CRYOPDP
Solutions serve as an enabling technology for the safe and efficient storage
and transportation of leukapheresis or apheresis blood products as well as
manufactured autologous cellular-based immunotherapies. This is accomplished by
providing a comprehensive logistics solution for the verified
chain-of-condition, chain-of-custody, chain-of-identity, and Chain of
Compliance® transport from, (a) the collection of the patient’s blood or cells
? at a point-of-care setting, to (b) a central processing facility where they are
manufactured into a personalized medicine, to (c) the safe, cryogenically
preserved delivery of these often irreplaceable cells to a point-of-care
treatment facility for infusion into the patient. The Advanced Therapy
Shippers™ and Cryoport ELITE™ Shippers are designed specifically for this
market. If required, Cryoport Express® Shippers can also serve as a temporary
freezer/repository supporting the efficient distribution of the personalized
medicine to the patient when and where the medical provider needs it, without
the expense and inconvenience of on-sight, cryopreservation storage freezers.
Allogeneic Therapy Solutions, designed for allogeneic therapies in which our
Cryoport ELITE™, Cryoport Express®, and CRYOPDP Solutions serve as enabling
technologies for the safe and efficient storage and transportation of healthy
donor blood products as well as the manufactured allogeneic therapies by
providing a comprehensive logistic solutions for the verified
? chain-of-condition, chain-of-custody, chain-of-identity, and Chain of
Compliance® transport from, (a) the blood collection center, to (b) the
manufacturing facility for the allogeneic therapy, to (c) a storage and
fulfillment facility, or (d) to a point-of-care treatment facility for infusion
into the patient. This is another market where the Cryoport Systems’ Advanced
Gene Therapy Solutions, designed for gene therapies in which our Cryoport
ELITE™ solution has been purpose designed to be a best-in-class platform for
the safe and efficient transportation of gene therapy products at -80°C by
? providing comprehensive packaging, logistics, and storage solutions for the
verified chain-of-condition, chain-of-custody, chain-of-identity, and Chain of
Compliance® transport from (a) the manufacturing facility for the gene therapy,
to (b) a storage and fulfillment facility, or (c) to a point-of-care treatment
require distribution to a residential or community care setting. Our CRYOPDP
? unit has developed specific processes and services in support of
Direct-to-Patient requirements that include regulatory, security,
accessibility, good distribution practices (GDP), and confidentiality
considerations.
Consulting Services, provides our clients an opportunity to leverage our
in-house talent and knowledge to design custom logistics plans, perform lane
assessment, lane and carrier validation; design custom packaging and
? validation, permitting clinical trial logistics design; commercial launch
planning; systems integration; and end user training. Additionally, our
Consulting Services team has developed a “Packaging Center of Excellence” in
support of the advanced therapies space.
Cell Therapies. As per the Alliance for Regenerative Medicine, cell therapy is
“the administration of viable, often purified cells into a patient’s body to
grow, replace, or repair damaged tissue for the treatment of a disease. A
variety of different types of cells can be used in cell therapy, including
hematopoietic (blood-forming) stem cells, skeletal muscle stem cells, neural
stem cells, mesenchymal stem cells (adult stem cells that differentiate into
? structures as connective tissues, blood, lymphatics, bone, and cartilage),
lymphocytes, dendritic cells, and pancreatic islet cells. Cell therapies may be
autologous, meaning that the patient receives cells from their own body, or
they may be allogeneic, meaning the patient receives cells from a donor.
Allogeneic cell therapies are often referred to as “off-the-shelf” therapies,
as they are derived from a donor who is not the patient, enabling advance
preparation and available to the patient immediately at the time of need.”
Gene Therapies. As per the Alliance for Regenerative Medicine, “Gene therapy
seeks to modify or introduce genes into a patient’s body with the goal of
durably treating, preventing, or potentially even curing disease, including
several types of cancer, viral diseases, and inherited disorders.” These
? therapies often cost more than $1,000,000 per patient and are irreplaceable.
Significant funding has been committed to this space with more than $10.2
billion in funding in 2021 as reported by the Alliance for Regenerative
Medicine in their 2021 report. Cryoport has developed its ELITE™ -80°C shipper
line to support this space as a best-in-class product.
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Russian Invasion of Ukraine
Three months ended September 30, 2022 compared to three months ended September 30, 2021:
The following table summarizes certain information derived from our condensed consolidated statements of operations (in thousands):
(1,024) 967 (94.4) %
(8,526) $ 1,210 (14.2) %
Total revenues by market (in thousands):
(1) Foreign exchange impacts were derived by applying the average currency rates
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Revenues by market
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.
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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.
Nine months ended September 30, 2022 compared to nine months ended September 30, 2021:
The following table summarizes certain information derived from our condensed consolidated statements of operations (in thousands):
Net loss attributable to common stockholders $ (33,897) $
(21,638) $ (12,259) 56.7 %
Total revenues by market (in thousands):
(1) Foreign exchange impacts were derived by applying the average currency rates
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Revenues by market
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.
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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
Adjusted EBITDA
Liquidity and Capital Resources
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