cryoport_s1a1.htm
As filed with the Securities
and Exchange Commission on January 12, 2010 |
Registration Number
333-162350 |
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
AMENDMENT
NO. 1
TO
FORM
S-1/A
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
CRYOPORT,
INC.
(Exact
Name of Registrant as Specified in its Charter)
Nevada
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3086
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88-0313393
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(State
or Other Jurisdiction of
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(Primary
Standard Industrial
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(I.R.S.
Employer
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Incorporation
or Organization)
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Classification
Code Number)
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Identification
No.)
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20382
Barents Sea Circle
Lake
Forest, California 92630
(Address,
Including Zip Code, and Telephone Number, Including Area Code, of Principal
Executive Offices)
Larry
G. Stambaugh
Chief
Executive Officer
20382
Barents Sea Circle
Lake
Forest, California 92630
(949)
470-2300
(Name,
Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent
For Service)
Copies
to:
Mark
R. Ziebell, Esq.
Anthony
Ippolito, Esq.
Snell
& Wilmer L.L.P.
600
Anton Boulevard., Suite 1400
Costa
Mesa, California 92626
Tel:
(714) 427-7400
Fax:
(714) 427-7799
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Gregory
Sichenzia, Esq.
Thomas
Rose, Esq.
Sichenzia
Ross Friedman Ference LLP
61
Broadway
New
York, New York 10006
Tel:
(212) 930-9700
Fax:
(212) 930-9725
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Approximate
date of commencement of proposed sale to the public: As soon as practicable after this
registration statement becomes effective.
If
any of the securities being registered on this form are to be offered on a
delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, as amended, check the following box. ý
If
this form is filed to register additional securities for an offering pursuant to
Rule 462(b) under the Securities Act, please check the following box and list
the Securities Act registration statement number of the earlier effective
registration statement for the same offering. o
If
this form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, please check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. o
If
this form is a post-effective amendment filed pursuant to Rule 462(d) under the
Securities Act, check the following box and list the Securities Act registration
number of the earlier effective registration statement for the same offering.
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See definition of “accelerated filer”, “large accelerated
filer”, “non-accelerated filer” and “smaller reporting company” in Rule 12b-2 of
the Exchange Act.
Large
accelerated filer o
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Accelerated
filer o
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Non-accelerated
filer o
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Smaller
reporting company ý
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(Do
not check if smaller reporting company)
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CALCULATION
OF REGISTRATION FEE
Title
of Each Class of Securities to be Registered
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Amount
To Be
Registered
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Proposed
Maximum
Aggregate
Offering
Price(2)
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Amount
of
Registration
Fee(1)
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Units,
each consisting of one share of common stock, $0.001 par value, and one
warrant(2)
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Shares
of common stock included as part of the units(2)
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(3) |
Warrants
included as part of the units(2)
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(3) |
Shares
of common stock underlying the warrants included in the units(2)(4)
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(5) |
Unless
otherwise indicated, all share amounts and prices assume the consummation of a
reverse stock split, at a ratio of 12-to-1, to be effected prior to the
effectiveness of the registration statement, with the exact timing of the
reverse stock split to be determined by the registrant’s Board of
Directors.
(1)
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Estimated
solely for purposes of calculating the registration fee pursuant to Rule
457(o) under the Securities Act.
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(2)
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Includes
468,750 units that the representative of the underwriters has the option
to purchase to cover over-allotments, if any.
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(3)
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No
fee required pursuant to Rule 457(g) under the Securities
Act.
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(4)
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Pursuant
to Rule 416, the registrant is also registering an indeterminate number of
additional shares of common stock that are issuable by reason of the
anti-dilution provisions of the warrants.
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(5)
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The
registrant previously paid
$1,347.57.
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The
registrant hereby amends this registration statement on such date or date(s) as
may be necessary to delay its effective date until the registrant shall file a
further amendment which specifically states that this registration statement
shall thereafter become effective in accordance with Section 8(a) of the
Securities Act, or until the registration statement shall become effective on
such date as the commission acting pursuant to said Section 8(a) may
determine.
The information in this prospectus is not complete and may be changed.
The securities may not be sold until the registration statement filed with the
Securities and Exchange Commission is effective. This prospectus is not an offer
to sell these securities and it is not soliciting an offer to buy these
securities in any state where the offer or sale is not permitted.
PRELIMINARY
PROSPECTUS
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Subject to Completion
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January
12, 2010
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3,125,000
Units
CRYOPORT,
INC.
Common
Stock and Warrants
This is a
firm commitment public offering of 3,125,000 units, consisting of an aggregate
of 3,125,000 shares of our common stock and warrants to purchase an
additional 3,125,000 shares of our common stock. Each unit
consists of one share of common stock and a warrant to purchase one share of
common stock at an exercise price of 110% of the public offering price of
the units in this offering. The common stock and warrants are
immediately separable and will be issued separately.
Our
common stock is currently traded on the OTC Bulletin Board under the symbol
CYRX. Prior to the effectiveness of the registration statement of
which this prospectus is a part, we will effect a reverse stock split
anticipated to be on a 12-to-1 basis. On December 30, 2009, the last
reported sale price for our common stock was $4.80 per share (giving effect to
the anticipated 12-to-1 reverse split). We have applied for
listing of our common stock and warrants on the NASDAQ Capital Market under the
symbols “CYPT” and “CYPTW,” respectively. No assurance can be given
that our application will be approved. If the application is not
approved, we will not complete this offering and the shares of our common stock
will continue to be traded on the OTC Bulletin Board.
Investing
in our common stock and warrants involves a high degree of
risk. Please read “Risk Factors” beginning on page 9.
Neither
the Securities and Exchange Commission (the “SEC”) nor any state securities
commission has approved or disapproved these securities or determined whether
this prospectus is truthful or complete. Any representation to the
contrary is a criminal offense.
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Per
unit
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Total
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$ |
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$ |
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Underwriting
discounts and commissions (1)
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$ |
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$ |
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Proceeds,
before expenses, to us (2)
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$ |
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$ |
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(1)
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Does
not include a non-accountable expense allowance equal to 1% of the gross
proceeds of this offering payable to Rodman & Renshaw, LLC, the
underwriters’ representative. Non-accountable expenses are estimated to be
$150,000.
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(2)
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We
estimate that the total expenses of this offering will be approximately
$350,000, consisting of $150,000 for the underwriter’s non-accountable
expense allowance (equal to 1% of the gross proceeds) and $200,000 for
legal, accounting, printing costs and various fees associated with the
registration and listing of our shares of common stock and
warrants.
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We have
granted a 45-day option to the representative of the underwriters to purchase
468,750 units to be offered by us solely to cover over-allotments, if
any. If the underwriters exercise their right to purchase additional
units to cover over-allotments, we estimate that we will receive gross proceeds
of $2,250,000 from the sale of 468,750 units being offered at an assumed public
offering price of $4.80 per unit and net proceeds of $2,047,500 after
deducting $202,500 for underwriting discounts and commissions. The
units issuable upon exercise of the underwriter option are identical to those
offered by this prospectus and have been registered under the registration
statement of which this prospectus forms a part.
In
connection with this offering, we have also agreed to sell to Rodman &
Renshaw, LLC, the underwriters’ representative, a warrant to purchase
up to 5% (or 156,250) of the shares of common stock sold (excluding the
over-allotment) for $100. If the underwriters’ representative
exercises this warrant, each share of common stock may be purchased at $6.00 per
share (125% of the price of the units sold in this offering), commencing on a
date which is one year from the effective date of the registration statement and
expiring five years from the effective date of the registration
statement. The warrant may be exercised on a cashless
basis.
The
underwriters expect to deliver our shares of common stock and warrants to
purchasers in this offering on or about [*], 2010.
Rodman
& Renshaw, LLC
The date
of this prospectus is _____________, 2010.
TABLE
OF CONTENTS
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Forward-Looking
Statements
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Market
For Common Equity And Related Stockholder Matters
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Determination
Of Offering Price
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Management’s
Discussion And Analysis Of Financial Condition and Results of
Operations
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Directors
And Executive Officers
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Compensation
Committee Interlocks And Insider Participation
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Security
Ownership Of Certain Beneficial Owners And
Management
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Certain
Relationships And Related Transactions
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Description
Of Securities
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Underwriting
And Plan Of Distribution
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Where
You Can Find More Information
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Disclosure
Of Commission Position On Indemnification For Securities Act
Liabilities
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Index
To Consolidated Financial Statements
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You may
only rely on the information contained in this prospectus or that we have
referred you to. We have not authorized anyone to provide you with
different information. This prospectus does not constitute an offer
to sell or a solicitation of an offer to buy any securities other than the
common stock and warrants offered by this prospectus. This prospectus
does not constitute an offer to sell or a solicitation of an offer to buy any
common stock or warrants in any circumstances in which such offer or
solicitation is unlawful. Neither the delivery of this prospectus nor
any sale made in connection with this prospectus shall, under any circumstances,
create any implication that there has been no change in our affairs since the
date of this prospectus or that the information incorporated by reference to
this prospectus is correct as of any time after its date.
PROSPECTUS
SUMMARY
This
summary highlights information contained elsewhere in this prospectus and does
not contain all of the information you should consider before investing in our
common stock and warrants. You should read this entire prospectus
carefully, especially the risks of investing in our common stock and warrants
discussed under “Risk Factors” beginning on page 9, and the consolidated
financial statements and notes to those consolidated financial statements,
before making an investment decision. CryoPort, Inc. is referred to throughout
this prospectus as “CryoPort,” “we” or “us.”
Unless
otherwise indicated, all common stock and prices in this
prospectus assume the consummation of a reverse stock split, at an
anticipated ratio of 12-to-1 to be effected prior to the effective date of the
registration statement of which this prospectus is a part, with the exact timing
of the reverse stock split and the ratio to be determined by our Board of
Directors.
Overview
We are a
provider of an innovative cold chain frozen shipping system dedicated to
providing superior, affordable cryogenic shipping solutions that ensure the
safety, status and temperature of high value, temperature sensitive
materials. We have developed a line of cost effective reusable
cryogenic transport containers (referred to as a "shipper") capable of
transporting biological, environmental and other temperature sensitive materials
at temperatures below 0° Celsius. These dry vapor shippers are one of
the first significant alternatives to dry ice shipping and achieve 10-plus day
holding times compared to one to two day holding times with dry ice (assuming no
re-icing during transit).
Our value
proposition comes from both providing safe transportation and
an environmentally friendly, long lasting shipper, and through our value
added services that offer a simple hassle-free solution for our
customers. These value-added services include an internet-based web
portal that enables the customer to initiate shipping service, track the
progress and status of a shipment, and provides in-transit temperature
monitoring of the shipper. CryoPort also provides a fully ready
charged shipper containing all freight bills, customs documents, and regulatory
paperwork for the entire journey of the shipper to our customers at their
pick up location.
Our
principal focus has been the further development and commercial launch of
CryoPort Express® Portal, an innovative IT solution for shipping and tracking
high-value specimens through overnight shipping companies, and our CryoPort
Express® Shipper, a line of dry vapor
cryogenic shippers for the transport of biological and pharmaceutical
materials. A dry vapor cryogenic shipper is a container that uses
liquid nitrogen in dry vapor form, which is suspended inside a vacuum insulated
bottle as a refrigerant, to provide storage temperatures below minus 150°
Celsius. The dry vapor shipper is designed using innovative,
proprietary, and patented technology which prevents spillage of liquid nitrogen
and pressure build up as the liquid nitrogen evaporates. A
proprietary foam retention system is employed to ensure that liquid nitrogen
stays inside the vacuum container, even when placed upside-down or on its side,
as is often the case when in the custody of a shipping
company. Biological specimens are stored in a specimen chamber,
referred to as a “well,” inside the container. Refrigeration is
provided by harmless
cold nitrogen gas evolving from the liquid nitrogen entrapped within the foam
retention system surrounding the well. Biological specimens
transported using our cryogenic shipper can include clinical samples,
diagnostics, live cell pharmaceutical products (such as cancer vaccines, semen
and embryos, infectious substances) and other items that require and/or are
protected through continuous exposure to frozen or cryogenic temperatures (below
minus 150° Celsius).
Market
Opportunity
As a
result of growing globalization, including with respect to such areas as life
science clinical trials and distribution of pharmaceutical products, the
requirement for effective solutions for keeping certain clinical samples and
pharmaceutical products at frozen temperatures takes on added significance due
to extended shipping times, customs delays and logistics
challenges. Today, such goods are traditionally shipped in cardboard
insulated containers packed with dry ice, gel/freezer packs or a combination
thereof. The current dry ice solutions have limitations that severely
limit their effective and efficient use for both short and long-distances (e.g.,
international). Conventional dry ice shipments often require labor
intensive “re-icing” operations resulting in higher labor and shipping
costs.
We
believe that our patented cryogenic shippers make us well positioned to take
advantage of the growing demand for effective and efficient international
transport of temperature sensitive materials resulting from continued
globalization. Of particular significance is the trend within the
pharmaceutical and biotechnology industries toward
globalization. We believe this presents a new and unique opportunity
for pharmaceutical companies, particularly early or developmental stage
companies, to conduct some of their clinical trials in foreign countries where
the cost may be cheaper and/or because the foreign countries significantly
larger population provides a larger pool of potential patients suffering from
the indication that the drug candidate is being developed to
treat. We also plan to provide domestic shipping solutions in
situations and regions where there is a high priority placed on maintaining the
integrity of materials shipped at cryogenic temperatures and where we can be
cost effective.
Competitive
Strengths
We
believe that our cryogenic shipping systems provide us with the following
competitive strengths:
Maintaining the
Integrity of Materials Shipped. We have developed our CryoPort
Express® Shippers, a line of cryogenic dry vapor shippers, to be capable of
maintaining cryogenic temperatures of minus 150° Celsius or less for 10-plus
days. Our CryoPort Express® Shippers were developed with a view
towards meeting the needs of the global biotechnology and pharmaceutical
industries which require the ability to transport live cell pharmaceutical
products, such as cancer vaccines, diagnostic materials, reproductive tissues,
infectious and other biological substances, and other items at constant frozen
or cryogenic temperatures. Traditional methods that have been serving
this market, such as dry ice, are only capable of maintaining such temperatures
for a period of one to two days (depending on the size of the package and amount
of dry ice used), thereby potentially jeopardizing the integrity of the
transported materials during longer shipments. We believe our
CryoPort Express® Shippers are the first significant alternative to using dry
ice that achieves 10-plus day holding times.
Durability of
Shipping Devices. Because the outer shell of our CryoPort
Express® Shippers are made from durable materials, as compared to corrugated
cardboard boxes with Styrofoam inserts or similar materials, the risk of damage
to the container and its contents is significantly reduced. Where
corrugated cardboard boxes are susceptible to being crushed or damaged during
shipment, our shippers, which have been tested and are capable of withstanding
drops of up to 30 feet, significantly reduce the risk of damage to the packaged
materials. The durability and long holding times of our shippers has
greater significance for international (or other long distance) shipments due to
the increased shipping times and amplified risk of damage during transit and
mishandling during shipment.
Cost. We
believe we have developed a solution for the shipment of temperature sensitive
materials which is not only more effective, but also more cost efficient,
especially in international shipping. Shipping temperature sensitive
materials using the traditional method of dry ice requires multiple steps,
manual intervention/monitoring, and the coordination of re-icing tasks at
several locations to provide a solution lasting for more than several
days. The cost of developing and maintaining the infrastructure
necessary to support these operations frequently depend on off-shore third party
contractors which adds significant cost. Because our cryogenic
shippers are capable of hold times of 10-plus days, customers will not require
the same extensive infrastructure needed for dry ice
shipments. Furthermore, because our shippers do not rely on dry ice
(which is a hazardous material that produces CO2 gas as it sublimates), there
are more freight carrier alternatives available for our shippers and generally
lower freight charges.
Tracking and
Monitoring. We have developed a sophisticated web portal with
user friendly features that will be used for capturing customer orders and
tracking shipments. Our portal enables CryoPort employees to manage
multi-route shipments with minimal amount of human resources by using programmed
analogs and exception monitoring. In addition, our customers are able
to place orders, track shipments, and monitor the status of their packages
through our web portal. CryoPort is also able to internally manage
its shipper inventory, track incoming and outgoing assets, report on shipping
performance metrics, and invoice for shipping services through the technology
employed through its web portal.
The Green
Alternative. Unlike shippers using dry ice, the internal core
of our cryogenic shippers absorbs liquid nitrogen in a gaseous state to
maintain the required cryogenic temperatures. Dry ice is a hazardous
material because it produces excess CO2 gas as it sublimates which is a noted
greenhouse gas and which may be dangerous in confined spaces where there is an
absence or low rates of ventilation. Use of our shippers does not
result in the emission of greenhouse gases or other potentially toxic
materials. In addition, shippers using dry ice are made of corrugated
cardboard with Styrofoam inserts. These shippers are typically not
reusable, resulting in the disposal of the cardboard box. Further,
Styrofoam should not be disposed of in landfills because it is not
biodegradable. Our shippers do not contain Styrofoam, nor do they
present similar landfill disposal issues or other environmental
challenges.
Technology. Once our CryoPort
Express® System
is fully operational, it will represent the most complete and comprehensive
shipping solution available in the market for high-value temperature sensitive
materials. It will reduce operating costs for CryoPort and its
customers and it will provide customized analytics to monitor shipping
efficiency and the health and status of the materials entrusted to our
care.
Key
Business Strategies
Relationship with
Global Couriers. We believe that our near term success is best
achieved by establishing strategic relationships with global couriers which will
enable us to provide a seamless, end-to-end shipping solution to our
customers. In addition, we will be able to leverage the couriers’
established express, ground and freight infrastructures and penetrate new
markets with minimal investment. The management team is in advanced
discussions with one global freight courier and commencing discussions with
others to establish partnerships in which the couriers would provide preferred
shipping rates, access to logistics, tracking, and custom clearance
capabilities. We also expect that the global freight couriers will utilize
their sales forces to promote and sell the frozen shipping
services. We can not assure you that we will be able to consummate
such an agreement with any global couriers.
Target Large
Clinical Research Organizations and Life Science
Companies. Along with our efforts to establish a strategic
relationship with global couriers, we intend to increase our marketing efforts
to the large clinical research organizations (“CRO”) and pharmaceutical and
biotechnology companies engaged in the management and/or conduct of both
domestic and international clinical trials. Management has been in
active dialogue with selected large CROs, and pharmaceutical and biotechnology
companies to introduce this new frozen shipping solution and to discuss these
potential customers’ shipping needs. Several of these meetings have been
joint presentations including representatives from a global
courier. We can not assure you that we will be able to consummate an
agreement with one or more large CROs, or pharmaceutical or biotechnology
companies.
Position CryoPort
Express® Portal as a New
Customer Tool for Cost Optimization and Risk Mitigation. In 2008, we
began development of an internal IT system, CryoPort Express® Portal, which
today is used by customers to automate the entry of orders, prepare customs
documentation, and facilitate status and location monitoring of shipped orders
while in transit. The CryoPort Express® Portal is fully
integrated with IT systems at FedEx and runs in a browser requiring no software
installation. It is used by CryoPort to manage shipping operations
typically provisioned by manual labor thereby reducing administrative costs
relating to order-entry, order processing, preparation of shipping documents,
back-office accounting, and to support the high level of customer service
expected by the industry. In addition to reducing operating
costs and facilitating scaling of CryoPort’s operations, more importantly we
believe the CryoPort Express® Portal offers significant value to the
customer in terms of cost avoidance and risk mitigation. Examples
include automation of order entry, development of Key Performance Indicators
(“KPI”) to support our efforts for continuous process improvements in our
business, and programmatic exception monitoring to detect and sometimes
anticipate delays in the shipping process, often before the customer or the
shipping company becomes aware of the delays. In the future we intend
to add rate and mode optimization and in-transit monitoring of temperature,
location and state-of-health monitoring (discussed below) via wireless
communications.
Complete
Development of Our Smart Pak Monitoring Device. In July 2008,
we launched Phase I of our CryoPort Express® Portal which enabled our customers
to enter orders and track their packages during transit. We recently
completed successful testing of Phase II of our Smart Pak Monitoring Device
which is an automated data logger capable of tracking the internal and external
temperatures of samples shipped in our CryoPort Express® Shipper. We
anticipate commercial launch of this new feature in 2010. Phase III
of our Smart Pak Monitoring Device development plan, which we expect to launch
by the end of fiscal year 2010, consists of adding a wireless communications
capability to each shipper to enable monitoring of a shipper’s location,
specimen temperature, and overall state of health of the contents during
transit, which will be fully integrated into the CryoPort Express®
Portal. We anticipate that, due to the high value and importance
placed on the contents of the shipper by the customer, location and
state-of-health monitoring of the contents will become a new standard in
the industry pioneered by CryoPort.
Expand to New
Markets. To date our marketing efforts have focused
on global CROs, and on select companies in the biotechnology and
pharmaceutical industries. Once we have expanded our market presence
in these industries and established the strategic relationships referenced
above, we intend to explore opportunities in other markets where there is a
need to ship temperature sensitive materials such as the food, environmental,
semiconductor and petroleum industries.
Re-Purpose
Product Capability. Presently,
CryoPort products address the needs of biotechnology and pharmaceutical
customers who require sustainable frozen shipping temperatures generally
between the range of minus 80° to minus 150° Celsius. While the
frozen market represents a large opportunity for CryoPort, an adjacent market
exists for the shipment of materials at chilled temperatures. Based
on a report prepared by DHL Worldwide Express, Inc. in April 2001, the market
for pharmaceutical shipments at chilled temperatures is more than double the
market for cryogenic and frozen shipments. CryoPort’s technology may
be applicable to these markets as well since the design concepts of CryoPort
products can be applied to stabilize materials at any desired
temperature. CryoPort is exploring these expansions of its current
business model.
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, on
March 15, 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, in exchange for 2,009,009 shares (after giving effect to
the anticipated 12-to-1 reverse stock split) of our common stock (which
represented approximately 81% of the total issued and outstanding shares of
common stock following the close of the transaction). CryoPort
Systems, Inc, which was originally formed in 1999 as a California limited
liability company, and subsequently reorganized into a California corporation on
December 11, 2000, remains the operating company under CryoPort,
Inc.
Our
Corporate Information
Our
principal executive offices are located at 20382 Barents Sea Circle, Lake
Forest, California 92630. The telephone number of our principal
executive offices is (949) 470-2300, and our main corporate website is
www.cryoport.com. The information on, or that can be accessed
through, our website is not part of this prospectus.
We own,
have rights to, or have applied for the service marks and trade names that we
use in conjunction with our business, including CryoPort (both alone and with a
design logo) and CryoPort Express (both alone and with a design
logo). All other trademarks and trade names appearing in this
prospectus are the property of their respective holders.
Recent
Developments
On
January 12, 2010, we entered into an Amendment to Debentures and Warrants,
Agreement and Waiver with the holders of our Debentures
(as defined below) (the “2010 Amendment”). Pursuant to the 2010
Amendment, the debenture holders agreed to defer until March 1, 2010 our
obligation to make the January 1, 2010 and February 1, 2010 debenture
amortization payments (each in the aggregate amount of $200,000). In
addition, subject to our consummating this offering for gross proceeds of not
less than $10,000,000 at a per unit price of not less than $4.80 per unit (after
giving effect to the anticipated 12-to-1 reverse stock split) and obtaining
the listing of our common stock and warrants offered hereby on the NASDAQ
Capital Market by no later than March 1, 2010, the debenture holders have
consented and agreed, among other items, to the following:
● our
effecting a reverse stock split of our outstanding common stock at a ratio not
to exceed 15-to-1 (the maximum ratio previously approved by our
stockholders at our 2009 Annual Stockholders Meeting);
● each
will convert $1,357,215 in principal amount of the outstanding principal balance
of such holder's debenture in exchange for a number of shares of our common
stock which, when added to the shares of common stock then owned by such
holder, will represent 9.9% of the outstanding shares of our common stock
after giving effect the consummation of this offering;
● our
payment in full, from the net proceeds of this offering and within five days
following the consummation thereof, of the remaining outstanding principal
balance of the holders’ debentures following the foregoing conversion (estimated
to be $3,266,995 in the aggregate);
● release
their security interest in our and our subsidiary's assets, including all
intellectual property; and
● the
termination of certain anti-dilution provisions contained in the warrants
held by the debenture holders and their right to maintain a fully-diluted
ownership of our common stock equal to 34.5%.
Subject
to the occurrence of the foregoing, we have agreed to reduce the exercise price
of the warrants held by the debenture holders from $5.40 per share to $4.80
per share (after giving effect to the anticipated 12-to-1 reverse stock
split).
Summary
Financial Information
In the
table below we provide you with historical consolidated financial data for the
six month periods ending September 30, 2009 and 2008 and the fiscal years ended
March 31, 2009 and 2008, derived from our audited and unaudited consolidated
financial statements included elsewhere in this
prospectus. Historical results are not necessarily indicative of the
results that may be expected for any future period. When you read
this historical selected financial data, it is important that you read along
with it the appropriate historical consolidated financial statements and related
notes and “Management’s Discussion and Analysis of Financial Condition and
Results of Operations” included elsewhere in this prospectus.
|
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Six
Months Ended
September
30,
(unaudited)
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Years
Ended
March
31,
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2009
(‘000)
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2008
(‘000)
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|
2009
(‘000)
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2008
(‘000)
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Selling,
general and administrative expenses
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Research
and development expenses
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Loss
on sale of fixed assets
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Change
in fair value of derivative liabilities
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Loss
on extinguishment of debt
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Loss
per share, basic and diluted (after
giving effect to the anticipated 12-to-1 reverse stock
split)
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September
30,
2009
(unaudited)
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September
30,
2008
(unaudited)
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March
31,
2009
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March
31,
2008
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Total
Stockholders’ Deficit
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Liabilities
and Stockholders’ Deficit
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The
Offering
Securities
offered
|
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3,125,000
units, each unit consisting of one share of common stock and warrant to
purchase one share of common stock.
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Common
stock to be outstanding immediately prior to offering
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4,167,943
shares of common stock (1)
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Common
stock to be outstanding immediately after this offering
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7,292,943 shares
of common stock (1)(3)(4)
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Warrants
to be outstanding immediately prior to offering
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0(2)
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Warrants
to be outstanding immediately after this offering
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3,125,000 warrants (2)(5)
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Use
of Proceeds
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We
expect the net proceeds to us from this offering will be approximately
$13.3 million after deducting the underwriting discount and estimated
offering expenses (assuming the representative of the underwriters does
not exercise its option to cover over-allotments). We intend to
use those net proceeds primarily to repay a portion of our outstanding
debt, build up inventory, for capital expenditures, including establishing
selected global staging and refurbishing sites, and for working capital
and general corporate purposes. See “Use of Proceeds” for more
information.
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Over-allotment
option
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We
have granted the underwriters an option for a period of 45 days to
purchase, on the same terms and conditions set forth above, up to an
additional 468,750 units, consisting of 468,750 shares of our common stock
and warrants to purchase 468,750 shares of our common stock, to cover
over-allotments.
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Description
of Warrants
|
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Each
purchaser will receive a warrant to purchase one share of our common stock
for each share of common stock it purchases in this
offering. The warrants are exercisable at an exercise price of
$5.28 per share of common stock. The warrants are exercisable
starting on __________, and expire on ________, 2015. The
warrants may be redeemed by us upon 10 days prior notice at any time after
the closing bid price of our common stock is at least $7.92 (representing
165% of the unit offering price) for a period of 20 consecutive trading
days for $0.01 per warrant. See “Description of the Warrants”
below for more information.
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OTC
Bulletin Board symbol for our Common Stock
|
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CYRX
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Proposed
NASDAQ Capital Market symbols for our Common Stock and
Warrants
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CYPT
and CYPTW
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Risk
Factors
|
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The
purchase of our common stock and warrants involves a high degree of
risk. You should carefully review and consider “Risk Factors”
beginning on page 9.
|
(1) The
number of shares of common stock to be outstanding immediately prior to and
after this offering as reflected in the table above is based on the actual
number of shares of common stock outstanding as of November 30, 2009, which was
4,167,943 (after giving effect to the anticipated 12-to-1 reverse stock split),
and does not include (in each case adjusted for the anticipated 12-to-1 reverse
stock split), as of that date:
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●
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1,800,502 shares
of common stock reserved for issuance upon the conversion of outstanding
convertible debentures after giving effect to the 2010 Amendment,
which will be effective upon the consummation of this offering, pursuant
to which we will repay approximately fifty-five percent (55%) of the
outstanding principal balance of such debentures with proceeds from this
offering with the holders converting the remaining outstanding principal
balance into the foregoing number of shares of common
stock;
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●
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225,736 shares
of common stock reserved for issuance upon the conversion of outstanding
convertible promissory notes with a conversion price of $6.12 per
share;
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●
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3,042,406
shares of common stock reserved for issuance upon the exercise of
outstanding warrants with a weighted average exercise price of $5.52 per
share, after giving effect to the 2010 Amendment pursuant to which the
exercise price of the warrants held by the holders of our convertible
debentures will be reduced from $5.40 per share to $4.80 per
share (assuming the consummation of the anticipated reverse stock
split, at a ratio of 12-to-1);
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●
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74,292
shares of common stock reserved for issuance upon the exercise of
outstanding stock options with a weighted average exercise price of $7.05
per share; and
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●
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254,483 shares
of common stock available for future grant under our 2002 Stock Incentive
Plan and an additional 942,500 shares of common stock available for future
grant under our 2009 Stock Incentive
Plan.
|
(2) Does
not include outstanding warrants to purchase up to 3,042,406 shares of our
common stock with a weighted average exercise price of $5.52 per share, after
giving effect to the 2010 Amendment pursuant to which the exercise price of
the warrants held by the holders of our convertible debentures will be
reduced from $5.40 per share to $4.80 per share (assuming the consummation
of the anticipated reverse stock split, at a ratio of 12-to-1).
(3) Does
not include 3,125,000 shares of common stock issuable upon the exercise of the
warrants to be issued in connection with this offering.
(4) Does
not include 937,500 shares of common stock (including the shares of common
stock underlying the warrants included as part of the units) that comprise the
units that may be purchased by the underwriters' representative upon the
exercise of its 45-day option to cover over-allotments, if any, and 156,250
shares of common stock that may be issued to Rodman & Renshaw, LLC upon
exercise of the warrant we will sell to them (representing 5% of the shares
of common stock sold by us in this offering, excluding the over-allotment
option).
(5) Does
not include warrants to purchase 468,750 shares of common stock that may be
purchased by the underwriters' representative upon the exercise of its
45-day option to cover over-allotments, if any, and the warrant that we
will sell to Rodman & Renshaw, LLC for $100 to purchase 156,250 shares of
common stock (representing 5% of the shares of common stock sold by us
in this offering, excluding the over-allotment option) that may be issued to
Rodman & Renshaw, LLC upon exercise of such warrant.
Except as
otherwise indicated, all information in the prospectus supplement assumes no
exercise by the underwriters of their over-allotment option.
RISK
FACTORS
An investment in our shares of common
stock and warrants involves a high degree of risk. Before making an
investment decision, you should carefully consider all of the risks described in
this prospectus. If any of the risks discussed in this prospectus
actually occur, our business, financial condition and results of operations
could be materially and adversely affected. If this were to happen,
the price of our shares of common stock could decline significantly and you may
lose all or a part of your investment. Our forward-looking statements in
this prospectus are subject to the following risks and
uncertainties. Our actual results could differ materially from those
anticipated by our forward-looking statements as a result of the risk factors
below. See “Forward-Looking Statements.”
Risks Related to Our
Business
We
have incurred significant losses to date and may continue to incur
losses.
We have
incurred net losses in each fiscal year since we commenced
operations. The following table represents net losses incurred in
each of our last three fiscal years:
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|
Net
Loss
|
|
Fiscal
Year Ended March 31, 2009
|
|
|
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Fiscal
Year Ended March 31, 2008
|
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Fiscal
Year Ended March 31, 2007
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As of
September 30, 2009 and March 31, 2009, we had accumulated deficits of
$47,828,293 (unaudited) and $30,634,355, respectively. While we
expect to continue to derive revenues from our current products and services, in
order to achieve and sustain profitable operations, we must successfully
commercialize our CryoPort Express® System, significantly expand our market
presence and increase revenues. We may continue to incur losses in
the future and may never generate revenues sufficient to become profitable or to
sustain profitability. Continuing losses may impair our ability to
raise the additional capital required to continue and expand our
operations.
Our
auditors have expressed doubt about our ability to continue as a going
concern.
The
Report of Independent Registered Public Accounting Firm to our March 31, 2009
consolidated financial statements includes an explanatory paragraph stating that
the recurring losses and negative cash flows from operations since inception
and our working deficit and cash and cash equivalent balance at March 31,
2009 raise substantial doubt about our ability to continue as a going
concern. The consolidated financial statements do not include any
adjustments that might result from the outcome of this
uncertainty. If we are unable to establish to the satisfaction of our
independent registered public accounting firm that the net proceeds from this
offering will be sufficient, based on our projected cashflows, to allow for the
removal of this “going concern” qualification, we will not be able to obtain
approval of our NASDAQ listing application.
If
we are unable to obtain additional funding, we may have to reduce or discontinue
our business operations.
As of
September 30, 2009 and March 31, 2009, we had cash and cash equivalents of
$1,120,758 (unaudited) and $249,758, respectively. Additionally, at
each of the foregoing dates our current liabilities significantly exceeded our
current assets. We have expended substantial funds on the research
and development of our products and IT systems. As a result, we have
historically experienced negative cash flows from operations and we expect to
continue to experience negative cash flows from operations in the
future. Therefore, our ability to continue and expand our operations
is highly dependent on the amount of cash and cash equivalents on hand combined
with our ability to raise additional capital to fund our future
operations.
We
anticipate based on currently proposed plans and assumptions relating to our
ability to market and sell our products (but not including any strategic
relationship with a global courier), that our cash on hand and the proceeds from
this offering, together with projected cash flows, will satisfy our operational
and capital requirements for the next 18 to 30 months. There are a
number of uncertainties associated with our financial projections that could
reduce or delay our future projected revenues and cash-inflows, including, but
not limited to, our ability to complete the commercialization of our CryoPort
Express® System, increase our customer base and revenues and enter into a
strategic relationship with a global courier. If our projected
revenues and cash-inflows are reduced or delayed, we may not have sufficient
capital to operate through the next 18 to 30 months unless we raise more
capital. Additionally, if we are unable to realize satisfactory
revenue in the near future, we will be required to seek additional financing to
continue our operations beyond that period. We will also require
additional financing to expand into other markets and further develop and market
our products. Except for the units to be offered in this offering, we
have no current arrangements with respect to any additional
financing. Consequently, there can be no assurance that any
additional financing on commercially reasonable terms, or at all, will be
available when needed. The inability to obtain additional capital may
reduce our ability to continue to conduct business operations. Any
additional equity financing may involve substantial dilution to our then
existing stockholders. In addition, raising additional funding may be
complicated by certain provisions in the securities purchase agreements and
related transaction documents, as amended, entered into in connection with our
prior convertible debenture financings. The uncertainties surrounding
our future cash inflows have raised substantial doubt regarding our ability to
continue as a going concern.
If
we are not successful in establishing strategic relationships with one or more
global couriers, we may not be able to successfully increase revenues and
cashflow which could adversely affect our operations.
We
believe that our near term success is best achieved by establishing strategic
relationships with one or more global couriers. Such a relationship
will enable us to provide a seamless, end-to-end shipping solution to customers
and allow us to leverage the courier’s established express, ground and freight
infrastructures and penetrate new markets with minimal
investment. Further, we expect that the global freight courier will
utilize its sales force to promote and sell our frozen shipping
services. If we are not successful in establishing such a
relationship with a global courier, sales and marketing efforts will be
significantly impacted and anticipated revenue growth will be substantially
delayed which could have an adverse affect on our operations.
Current
economic conditions and capital markets are in a period of disruption and
instability which could adversely affect our ability to access the capital
markets, and thus adversely affect our business and liquidity.
The
current economic conditions and financial crisis have had, and will continue to
have, a negative impact on our ability to access the capital markets, and thus
have a negative impact on our business and liquidity. The shortage of
liquidity and credit combined with substantial losses in worldwide equity
markets could lead to an extended worldwide recession. We may face
significant challenges if conditions in the capital markets do not
improve. Our ability to access the capital markets has been and
continues to be severely restricted at a time when we need to access such
markets, which could have a negative impact on our business plans, including the
commercialization of our CryoPort Express® System and other research and
development activities. Even if we are able to raise capital, it may
not be at a price or on terms that are favorable to us. We cannot
predict the occurrence of future financial disruptions or how long the current
market conditions may continue.
The
sale of substantial shares of our common stock may depress our stock
price.
As of
November 30, 2009, there were 4,167,943 shares (assuming the consummation
of the anticipated reverse stock split, at a ratio of 12-to-1) of our common
stock outstanding. Substantially all of these shares of common stock
are eligible for trading in the public market. The market price of
our common stock may decline if our stockholders sell a large number of shares
of our common stock in the public market, or the market perceives that such
sales may occur.
We could
also issue up to 6,339,919 additional shares (assuming the consummation of the
anticipated reverse stock split, at a ratio of 12-to-1 and the issuance of
1,800,502 shares pursuant to the 2010 Amendment) of our common stock that are
issuable upon the conversion of outstanding convertible debentures and
promissory notes and the exercise of outstanding warrants and options or
reserved for future issuance under our stock incentive plans (including our 2009
Stock Incentive Plan, which was approved by our stockholders at our 2009 Annual
Meeting of Stockholders held on October 9, 2009), as further described in the
following table:
|
|
Number
of Shares of Common
Stock
Issuable or Reserved For
Issuance
(assuming the consummation of the anticipated reverse stock split, at a
ratio of 12-to-1)
|
Common
stock issuable upon conversion of outstanding debentures and convertible
promissory notes (after giving effect to the 2010
Amendment)
|
|
|
|
Common
stock issuable upon exercise of outstanding warrants
|
|
|
|
Common
stock reserved for issuance upon exercise of outstanding options
or reserved for future incentive awards under our stock incentive
plans
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|
Of the
total options and warrants outstanding as of November 30, 2009, options and
warrants exercisable for an aggregate of 2,650,794 shares of common stock (after
giving effect to the anticipated 12-to-1 reverse stock split) would be
considered dilutive to the value of our stockholders’ interest in CryoPort
because we would receive an amount per share that is less than the market price
of our common stock on November 30, 2009.
We
will have difficulty increasing our sales if we experience delays, difficulties
or unanticipated costs in establishing the sales, distribution and marketing
capabilities necessary to successfully commercialize our products.
We are
continuing to develop sales, distribution and marketing capabilities in the
Americas, Europe and Asia. It will be expensive and time-consuming
for us to develop a global marketing and sales network. Moreover, we
may choose, or find it necessary, to enter into additional strategic
collaborations to sell, market and distribute our products. We may
not be able to provide adequate incentive to our sales force or to establish and
maintain favorable distribution and marketing collaborations with other
companies to promote our products. In addition, any third party with
whom we have established a marketing and distribution relationship may not
devote sufficient time to the marketing and sales of our products thereby
exposing us to potential expenses in exiting such distribution
agreements. We, and any of our third party collaborators, must also
market our products in compliance with federal, state, local and international
laws relating to the provision of incentives and
inducements. Violation of these laws can result in substantial
penalties. Therefore, if we are unable to successfully motivate and
expand our marketing and sales force and further develop our sales and marketing
capabilities, or if our distributors fail to promote our products, we will have
difficulty increasing our sales.
Our
ability to grow and compete in our industry will be hampered if we are unable to
retain the continued service of our key professionals or to identify, hire and
retain additional qualified professionals.
A
critical factor to our business is our ability to attract and retain qualified
professionals including key employees and consultants. We are
continually at risk of losing current professionals or being unable to hire
additional professionals as needed. If we are unable to attract new
qualified employees, our ability to grow will be adversely
affected. If we are unable to retain current employees or strategic
consultants, our financial condition and ability to maintain operations may be
adversely affected.
We
are dependent on new products and services, the lack of which would harm our
competitive position.
Our
future revenue stream depends to a large degree on our ability to bring new
products and services to market on a timely basis. We must continue
to make significant investments in research and development in order to continue
to develop new products and services, enhance existing products and services,
and achieve market acceptance of such products and services. We may
incur problems in the future in innovating and introducing new products and
services. Our development stage products and services may not be
successfully completed or, if developed, may not achieve significant customer
acceptance. If we are unable to successfully define, develop and
introduce new, competitive products and services and enhance existing products
and services, our future results of operations would be adversely
affected. Development and manufacturing schedules for technology
products and services are difficult to predict, and we might not achieve timely
initial customer shipments of new products and services. The timely
availability of these products and services and their acceptance by customers
are important to our future success. A delay in new product or
enhanced product introductions could have a significant impact on our results of
operations.
Because
of these risks, our research and development efforts may not result in any
commercially viable products. If significant portions of these
development efforts are not successfully completed, or any new or enhanced
products are not commercially successful, our business, financial condition and
results of operations may be materially harmed.
If
we successfully develop products, but those products do not achieve and maintain
market acceptance, our business will not be profitable.
The
degree of acceptance of our CryoPort Express® Shipper, or any future product or
services, by our current target markets, and any other markets to which we
attempt to sell our products and services, and our profitability and growth will
depend on a number of factors including, among others:
|
●
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our
shipper’s ability to
perform and preserve the integrity of the materials
shipped;
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●
|
relative
convenience and ease of use of our shipper and/or web
portal;
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●
|
availability
of alternative products;
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●
|
pricing
and cost effectiveness; and
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|
●
|
effectiveness
of our or our collaborators’ sales and marketing
strategy.
|
If any
products we may develop do not achieve market acceptance, then we may not
generate sufficient revenue to achieve or maintain profitability.
In
addition, even if our products achieve market acceptance, we may not be able to
maintain that market acceptance over time if new products or technologies are
introduced that are more favorably received than our products, are more cost
effective, or render our products obsolete.
Our
success depends, in part, on our ability to obtain patent protection for our
products, preserve our trade secrets, and operate without infringing the
proprietary rights of others.
Our
policy is to seek to protect our proprietary position by, among other methods,
filing United States patent applications related to our technology, inventions
and improvements that are important to the development of our
business. We have three issued U.S. patents and one recently
filed provisional patent application, all relating to various aspects of our
products and services. Our patents or provisional patent application
may be challenged, invalidated or circumvented in the future or the rights
granted may not provide a competitive advantage. We intend to
vigorously protect and defend our intellectual property. Costly and
time-consuming litigation brought by us may be necessary to enforce our patents
and to protect our trade secrets and know-how, or to determine the
enforceability, scope and validity of the proprietary rights of
others.
We also
rely upon trade secrets, technical know-how and continuing technological
innovation to develop and maintain our competitive position. In the
past our employees, consultants, advisors and suppliers have not always executed
confidentiality agreements and invention assignment and work for hire agreements
in connection with their employment, consulting, or advisory
relationships. Consequently, we may not have adequate remedies
available to us to protect our intellectual property should one of these parties
attempt to use our trade secrets or refuse to assign any rights he or she may
have in any intellectual property he or she developed for
us. Additionally, our competitors may independently develop
substantially equivalent proprietary information and techniques or otherwise
gain access to our proprietary technology, or we may not be able to meaningfully
protect our rights in unpatented proprietary technology.
We cannot
assure you that our current and potential competitors and other third parties
have not filed (or in the future will not file) patent applications for (or have
not received or in the future will not receive) patents or obtain additional
proprietary rights that will prevent, limit or interfere with our ability to
make, use or sell our products either in the United States or
internationally. In the event we are required to license patents
issued to third parties, such licenses may not be available or, if available,
may not be available on terms acceptable to us. In addition, we
cannot assure you that we would be successful in any attempt to redesign our
products or processes to avoid infringement or that any such redesign could be
accomplished in a cost-effective manner. Accordingly, an adverse
determination in a judicial or administrative proceeding or failure to obtain
necessary licenses could prevent us from manufacturing and selling our products
or offering our services, which would harm our business.
We are
not aware of any third party that is infringing any of our patents or trademarks
nor do we believe that we are infringing on the patents or trademarks of any
other person or organization.
Our
products may contain errors or defects, which could result in damage to our
reputation, lost revenues, diverted development resources and increased service
costs and litigation.
Our
products must meet stringent requirements and we must
develop our products quickly to keep pace with the rapidly changing
market. Products and services as sophisticated as ours could contain
undetected errors or defects, especially when first introduced or when new
models or versions are released. In general, our products may not be
free from errors or defects after commercial shipments have begun, which could
result in damage to our reputation, lost revenues, diverted development
resources, increased customer service and support costs, and
litigation. The costs incurred in correcting any product errors or
defects may be substantial and could adversely affect our business, results of
operations and financial condition.
If
we experience manufacturing delays or interruptions in production, then we may
experience customer dissatisfaction and our reputation could
suffer.
If we
fail to produce enough shippers at our own manufacturing facility or at a third
party manufacturing facility, or if we fail to complete our shipper recycling
processes as planned, we may be unable to deliver shippers to our customers on a
timely basis, which could lead to customer dissatisfaction and could harm our
reputation and ability to compete. We currently acquire various
component parts for our shippers from various independent manufacturers in the
United States. We would likely experience significant delays or
cessation in producing our shippers if a labor strike, natural disaster or other
supply disruption were to occur at any of our main suppliers. If we
are unable to procure a component from one of our manufacturers, we may be
required to enter into arrangements with one or more alternative manufacturing
companies which may cause delays in producing our shippers. In
addition, because we depend on third party manufacturers, our profit margins may
be lower, which will make it more difficult for us to achieve
profitability. To date, we have not experienced any material delay
that has adversely impacted our operations. As our business develops
and the quantity of production increases, it becomes more likely that such
problems could arise.
Because
we rely on a limited number of suppliers, we may experience difficulty in
meeting our customers’ demands for our products in a timely manner or within
budget.
We
currently purchase key components of our products from a variety of outside
sources. Some of these components may only be available to us through
a few sources, however, management has identified alternative materials and
suppliers should the need arise. We generally do not have long-term
agreements with any of our suppliers.
Consequently,
in the event that our suppliers delay or interrupt the supply of components for
any reason, we could potentially experience higher product costs and longer lead
times in order fulfillment. Suppliers that we materially rely upon
include Spaulding Composites Company and Lydall Thermal Acoustical
Sales.
Our
CryoPort Express® Portal may be subject to intentional disruption that could
adversely impact our reputation and future sales.
We have
implemented our CryoPort Express® Portal which is used by our customers and
business partners to automate the entry of orders, prepare customs documentation
and facilitate status and location monitoring of shipped orders while in
transit. Although we believe we have sufficient controls in place to
prevent intentional disruptions, we could be a target of attacks specifically
designed to impede the performance of the CryoPort Express®
Portal. Similarly, experienced computer programmers may attempt to
penetrate our CryoPort Express® Portal in an effort to search for and
misappropriate proprietary or confidential information or cause interruptions of
our services. Because the techniques used by such computer
programmers to access or sabotage networks change frequently and may not be
recognized until launched against a target, we may be unable to anticipate these
techniques. Our activities could be adversely affected and our
reputation, brand and future sales harmed if these intentionally disruptive
efforts are successful.
Our
services may expose us to liability in excess of our current insurance
coverage.
Our
products involve significant risks of liability, which may substantially exceed
the revenues we derive from our services. We cannot predict the
magnitude of these potential liabilities.
We
currently maintain general liability insurance, with coverage in the amount of
$1 million per occurrence, subject to a $2 million annual limitation, and
product liability insurance with a $1 million annual coverage
limitation. Claims may be made against us that exceed these
limits.
Our
liability policy is an “occurrence” based policy. Thus, our policy is
complete when we purchased it and following cancellation of the policy it
continues to provide coverage for future claims based on conduct that took place
during the policy term. However, our insurance may not protect us
against liability because our policies typically have various exceptions to the
claims covered and also require us to assume some costs of the claim even though
a portion of the claim may be covered. In addition, if we expand into
new markets, we may not be aware of the need for, or be able to obtain insurance
coverage for such activities or, if insurance is obtained, the dollar amount of
any liabilities incurred could exceed our insurance coverage. A
partially or completely uninsured claim, if successful and of significant
magnitude, could have a material adverse effect on our business, financial
condition and results of operations.
Complying
with certain regulations that apply to shipments using our products can limit
our activities and increase our cost of operations.
Shipments
using our products and services are subject to various regulations in the
countries in which we operate. For example, shipments using our
products may be required to comply with the shipping requirements promulgated by
the Centers for Disease Control (“CDC”), the Occupational Safety and Health
Organization (“OSHA”), the Department of Transportation (“DOT”) as well as rules
established by the International Air Transportation Association (“IATA”) and the
International Civil Aviation Organization (“ICAO”). Additionally, our
datalogger may be subject to regulation and certification by the Food and Drug
Administration (“FDA”), Federal Communications Commission (“FCC”), and Federal
Aviation Administration (“FAA”). We will need to ensure that our
products and services comply with relevant rules and regulations to make
our products and services marketable, and in some cases compliance is
difficult to determine. Significant changes in such regulations could
require costly changes to our products and services or prevent use of our
shippers for an extended period of time while we seek to comply with changed
regulations. If we are unable to comply with any of these rule or
regulations or fail to obtain any required approvals, our ability to market our
products and services may be adversely affected. In addition, even if
we are able to comply with these rules and regulations, compliance can result in
increased costs. In either event, our financial results and condition
may be adversely affected. We depend on our business partners and
unrelated and frequently unknown third party agents in foreign countries to act
on our behalf to complete the importation process and to make delivery of our
shippers to the final user. The failure of these third parties to
perform their duties could result in damage to the contents of the shipper
resulting in customer dissatisfaction or liability to us, even if we are not at
fault.
If
we cannot compete effectively, we will lose business.
Our
products, services and solutions are positioned to be competitive in the
cold-chain shipping market. While there are technological and
marketing barriers to entry, we cannot guarantee that the barriers we are
capable of producing will be sufficient to defend the market share we wish to
gain against future competitors. The principal competitive factors in
this market include:
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acceptance
of our business model and a per use consolidated
fee structure;
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ongoing
development of enhanced technical features and
benefits;
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reductions
in the manufacturing cost of competitors’ products;
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the
ability to maintain and expand distribution channels;
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brand
name;
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the
ability to deliver our products to our customers when
requested;
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the
timing of introductions of new products and services;
and
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financial
resources.
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Current
and prospective competitors have substantially greater resources, more
customers, longer operating histories, greater name recognition and more
established relationships in the industry. As a result, these
competitors may be able to develop and expand their networks and product
offerings more quickly, devote greater resources to the marketing and sale of
their products and adopt more aggressive pricing policies. In
addition, these competitors have entered and will likely continue to enter into
business relationships to provide additional products competitive to those we
provide or plan to provide.
We
may not be able to compete with our competitors in the industry because many of
them have greater resources than we do.
We expect
to continue to experience significant and increasing levels of competition in
the future. In addition, there may be other companies which are
currently developing competitive products and services or which may in the
future develop technologies and products that are comparable, superior or less
costly than our own. For example, some cryogenic equipment
manufacturers with greater resources currently have solutions for storing and
transporting cryogenic liquid and gasses and may develop storage solutions that
compete with our products. Additionally, some specialty couriers with
greater resources currently provide dry ice transportation and may develop other
products in the future, both of which compete with our products. A
competitor that has greater resources than us may be able to bring its product
to market faster than we can and offer its product at a lower price than us to
establish market share. We may not be able to successfully compete
with a competitor that has greater resources and such competition may adversely
affect our business.
Risks
Relating to Our Current Financing Arrangements
Our
outstanding convertible debentures impose certain restrictions on how we conduct
our business. In addition, all of our assets, including our
intellectual property, are pledged to secure this indebtedness. If we
fail to meet our obligations to the debenture holders, our payment obligations
may be accelerated and the collateral securing the indebtedness may be sold to
satisfy these obligations.
We issued
convertible debentures in October 2007 (the "October 2007 Debentures") and in
May 2008 (the "May 2008 Debentures," and together with the October 2007
Debentures, the "Debentures"). The Debentures were issued to four
institutional investors and have an outstanding principal balance of $5,981,425
as of November 30, 2009. In addition, in October 2007 and May 2008, we
issued to these institutional investors warrants to purchase, as of
November 30, 2009, an aggregate of 1,107,671 shares of our common stock
(without regard to beneficial ownership limitations contained in the transaction
documents and certain anti-dilution provisions, but after giving effect to the
anticipated 12-to-1 reverse stock split). As collateral to secure our
repayment obligations to the holders of the Debentures we have granted such
holders a first priority security interest in generally all of our assets,
including our intellectual property.
The
Debentures, warrant agreements and related transactional documents contain
various covenants that presently restrict our operating
flexibility. Pursuant to the foregoing documents, we may not, among
other things:
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effect
a reverse stock split of our outstanding common stock;
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incur
additional indebtedness, except for certain permitted
indebtedness. Permitted indebtedness is defined to include
lease obligations and purchase money indebtedness of up to an aggregate of
$200,000 and indebtedness that is expressly subordinated to the Debentures
and matures following the maturity date of the
Debentures;
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incur
additional liens on any of our assets except for certain permitted liens
including but not limited liens for taxes, assessments and government
charges not yet due and liens incurred in connection with permitted
indebtedness;
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pay
cash dividends;
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redeem
any outstanding shares of our common stock or any outstanding options or
warrants to purchase shares of our common stock except in connection with
a the repurchase of stock from former directors and officers provided such
repurchases do not exceed $100,000 during the term of the
Debentures;
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enter
into transactions with affiliates other than on arms-length terms;
and
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make
any revisions to the terms of existing contractual agreements for the
Notes Payable to Former Officer, Related Party Notes Payable and the Line
of Credit (as each is referred to in our Form 10-Q for the period ended
June 30, 2009).
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In
addition, so long as the Debentures are outstanding;
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we
must maintain a total cash balance of no less than $100,000 at all
times;
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we
must maintain an average monthly operating cash burn of no more than
$500,000 with operating cash burn is defined by taking net income (or
loss) and adding back all non-cash items and excludes changes in assets,
liabilities and financing activities;
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we
must maintain minimum current ratio of 0.5 to 1 with the calculation made
by excluding the current portion of the convertible notes payable and
accrued interest, and liability from derivative instruments from current
liability for the current ratio;
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our
accounts payable shall not exceed $750,000; and
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our
accrued salaries shall not exceed
$350,000.
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These
provisions could have important consequences for us, including, but not limited
to, (i) preventing us from effecting our contemplated reverse stock split
unless the debenture holders provide a waiver, (ii) making it more difficult for
us to obtain additional debt financing, or obtain new debt financing on terms
favorable to us, because a new lender will have to be willing to be subordinate
to the debenture holders, (iii) causing us to use a portion of our
available cash for debt repayment and service rather than other perceived needs,
and/or (iv) impacting our ability to take advantage of significant,
perceived business opportunities. Our failure to timely repay our
obligations under the Debentures, which mature on July 1, 2010, or meet the
covenants set forth in the Debentures and related transaction documents could
give rise to a default under the Debentures or such transaction
documents. In the event of an uncured default, all amounts owed to
the holders may be declared immediately due and payable and the debenture
holders will have the right to enforce their security interest in the assets
securing the Debentures. In such event, the Debenture holders could
take possession of any or all of our assets in which they hold a security
interest, and dispose of those assets to the extent necessary to pay off our
debts, which would materially harm our business.
In the event that we consummate this offering for a minimum gross
proceeds of $10,000,000 and comply with certain other provisions of the 2010
Amendment, then the foregoing limitations and covenants will terminate following
consummation of this offering.
The
issuance of our common stock upon conversion of the Debentures could encourage
short sales by third parties, which could contribute to the future decline of
our stock price and materially dilute existing stockholders’ equity and voting
rights.
The
Debentures have the potential to cause significant downward pressure on the
price of our common stock if they are converted, as is contemplated in the 2010
Amendment (at least with respect to approximately half of the outstanding
balance). This is particularly the case if the shares of common
stock are placed into the market and exceed the market’s ability to
absorb such shares of common stock. Such an event could place
further downward pressure on the price of our common stock. The
opportunity exists for short sellers and others to contribute to the future
decline of our stock price. Significant short sales of our
stock would place downward pressure on the market price of our common
stock, which could cause the price to further decline. If the
foregoing factors cause a continual decline in our stock price, long-term
holders of our common stock might be encouraged to start selling their shares of
our common stock, creating a further imbalance on the sell side of the market
for the stock, which could cause our stock price to further
decline.
Risks
Relating Principally to This Offering and Our Capital Structure
We
have broad discretion in the use of the net proceeds from this offering and may
not use them effectively.
We cannot
specify with certainty all of the particular uses of approximately $13.3
million of the net proceeds we will receive from this offering. Other
than our obligation to repay $3,266,995 of the Debentures pursuant to the 2010
Amendment, our management will have broad discretion in the application of
the net proceeds. Accordingly, you will have to rely upon the
judgment of our management with respect to the use of the proceeds, with only
limited information concerning management’s specific intentions. Our
management may spend a portion or all of the net proceeds from this offering in
ways that our stockholders may not desire or that may not yield a favorable
return. The failure by our management to apply these funds
effectively could harm our business. Pending its use, we may invest
the net proceeds from this offering in a manner that does not produce income or
that loses value.
Our
existing stockholders will retain significant control over us following the
completion of this offering.
The
concentration of ownership of our stock may have the effect of delaying or
preventing a change in control of CryoPort and may adversely affect the voting
or other rights of other holders of our common stock. Upon completion
of this offering, our directors, executive officers and debenture holders will
beneficially own 5,105,661 shares (assuming the consummation of a reverse stock
split, at a ratio of 12-to-1 and without regard to beneficial ownership
limitations contained in certain warrants) of common stock assuming the exercise
of all outstanding warrants, options and conversion of all convertible debt, and
the effectiveness of the 2010 Amendment; or approximately 32.2%
of our outstanding common stock. Of these shares of common stock,
2,219,539 shares, or approximately 14.0%
of our outstanding common stock, will be owned by Enable Growth Partners LP (and
affiliated funds), and 2,126,876 shares, or approximately 13.4%
of our outstanding common stock, will be owned by BridgePointe Master Fund,
Ltd.; provided, however, there are provisions in their warrant agreements that
prohibit exercise of warrants to the extent that their respective beneficial
ownership would exceed 4.99% as a result of such conversion or exercise (which
limitation may be waived and increased to 9.99% upon not less than 61 days prior
notice).
An
active market for our common stock and warrants may not develop or be
maintained, which could limit your ability to sell your common stock and/or
warrants.
Prior to
this offering, there has been a limited public market for our common stock and
no market for our warrants and the public offering price may bear no
relationship to the price at which our common stock and warrants will trade
after this offering. There can be no assurance that an active public
market for our common stock or warrants will develop or be sustained after this
offering or how liquid that market might become. As a result,
investors may not be able to sell their common stock or warrants at or above the
public offering price or at the time that they would like to sell.
Our
stock and warrant price may be volatile.
The
market price of our common stock and warrants is likely to be highly volatile
and could fluctuate widely in price in response to various factors, many of
which are beyond our control, including, but not limited to:
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technological
innovations or new products and services by us or our
competitors;
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additions
or departures of key personnel;
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sales
of our common stock;
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our
ability to integrate operations, technology, products and
services;
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our
ability to execute our business plan;
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operating
results below expectations;
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loss
of any strategic relationship;
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industry
developments;
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economic
and other external factors; and
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period-to-period
fluctuations in our financial
results.
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You may
consider any one of these factors to be material. The price of common
stock and warrants may fluctuate widely as a result of any of the above listed
factors. In addition, the securities markets have from time to time
experienced significant price and volume fluctuations that are unrelated to the
operating performance of particular companies. These market
fluctuations may also materially and adversely affect the market price of our
common stock and warrants.
If
equity research analysts do not publish research or reports about our business
or if they issue unfavorable commentary or downgrade our common stock and
warrants, the price of our common stock and warrants could decline.
The
trading market for our common stock and warrants will rely in part on the
research and reports that equity research analysts publish about us and our
business. We do not control these analysts. The price of
our common stock and warrants could decline if one or more equity analyst
downgrades our stock or if analysts issue other unfavorable commentary or cease
publishing reports about us or our business.
A
significant portion of our total outstanding shares of common stock may be sold
into the public market in the near future, which could cause the market price of
our common stock and warrants to drop significantly, even if our business is
doing well.
Sales of
a substantial number of shares of our common stock in the public market could
occur at any time after the expiration of the lock-up agreements described in
“Underwriting and Plan of Distribution.” These sales, or the market
perception that the holders of a large number of shares of common stock intend
to sell shares of common stock, could reduce the market price of our common
stock and warrants. After this offering, we will have
9,093,445 shares of common stock outstanding based on the number of shares
of common stock outstanding as of November 30, 2009 and the debenture
holders conversion of a portion of the outstanding principal balance of their
debentures pursuant to the 2010 Amendment, and assuming the consummation of a
reverse stock split, at a ratio of 12-to-1. This includes the
3,125,000 shares of common stock that we are selling in this offering, which may
be resold in the public market immediately. The remaining
5,968,445 shares of common stock, or 66% of our outstanding shares of
common stock after this offering, including 1,800,502 shares of common stock we
will issue to our debenture holders in connection with their conversion of a
portion of the outstanding principal balance of the debentures pursuant to the
2010 Amendment, will be able to be sold, subject to any applicable volume
limitations under federal securities laws, 180 days after the date of this
prospectus, subject to extension in specified instances, due to lock-up
agreements between the holders of these shares of common stock and the
underwriters. However, the underwriters can waive the provisions of
these lock-up agreements and allow these stockholders to sell their shares of
common stock at any time.
We
have not paid dividends on our common stock in the past and do not expect to pay
dividends in the foreseeable future. Any return on investment may be
limited to the value of our common stock.
We have
never paid cash dividends on our common stock and do not anticipate paying cash
dividends in the foreseeable future. The payment of dividends on our
common stock will depend on our earnings, financial condition and other business
and economic factors affecting us at such time as the Board of Directors may
consider the payment of any such dividends. In addition, we may not
pay any dividends without obtaining the prior consent of the holders of
our Debentures (provided, however, that this restriction will terminate
upon the consummation of this offering pursuant to the 2010 Amendment). If
we do not pay dividends, our common stock may be less valuable because a return
on your investment will only occur if the price of our common stock
appreciates.
When
we effect a reverse stock split, the liquidity of our common stock and market
capitalization could be adversely affected.
At our
2009 Annual Meeting of Stockholders held on October 9, 2009, our stockholders
approved a Certificate of Amendment to our Amended and Restated Articles of
Incorporation to give our Board of Directors the authority to effect a reverse
stock split of our issued and outstanding common stock at a ratio to be
determined by the Board of Directors between 2-to-1 and 15-to-1, without further
approval of our stockholders, upon a determination by the Board of Directors
that such a reverse stock split is in the best interests of CryoPort and its
stockholders, at any time before June 30, 2010. Subject to our
compliance with the 2010 Amendment, the Board of Directors intends to effect a
reverse stock split in order to increase the stock price to a level that will
enable it to apply for listing on the NASDAQ Capital Market or other national
stock exchange.
A reverse
stock split is often viewed negatively by the market and, consequently, can lead
to a decrease in our overall market capitalization. If the per share
market price does not increase proportionately as a result of the reverse split,
then the value of our company as measured by our market capitalization will be
reduced, perhaps significantly. In addition, because the reverse
split will significantly reduce the number of shares of our common stock that
are outstanding, the liquidity of our common stock could be adversely affected
and you may find it more difficult to purchase or sell shares of our common
stock.
Our
stock-based incentive plan may dilute your percentage ownership interest and may
also result in downward pressure on the price of our stock.
At our
2009 Annual Meeting of Stockholders held on October 9, 2009, our stockholders
approved the CryoPort, Inc. 2009 Stock Incentive Plan (“2009 Plan”), which is
designed to replace the CryoPort, Inc. 2002 Stock Incentive Plan (the "2002
Plan") and provides for the grant of stock-based incentives. A total
of 1,000,000 shares of our common stock (after giving effect to the anticipated
12-to-1 reverse stock split) are reserved under the 2009 Plan for awards to
our officers, directors, employees and consultants as determined by our Board of
Directors. Stockholders would experience a dilution in ownership
interest of approximately 15%, assuming the maximum issuance of 1,000,000 shares
of common stock (after giving effect to the anticipated 12-to-1 reverse stock
split) upon the exercise of stock options granted or other awards issued under
the 2009 Plan. In addition, the existence of a significant number of
shares of common stock reserved under the 2009 Plan may be perceived by the
market as having a potential dilutive effect, which could lead to a decrease in
the price of our common stock.
We
may need additional capital, and the sale of additional shares of common stock
or other equity securities could result in additional dilution to our
stockholders.
We
believe that our current cash and cash equivalents, anticipated cash flow from
operations and the net proceeds from this offering will be sufficient to meet
our anticipated cash needs for a period of 18 to 30 months. We may,
however, require additional cash resources due to changed business conditions or
other future developments, including any investments or acquisitions we may
decide to pursue. If our resources are insufficient to satisfy our
cash requirements, we may seek to sell additional equity or debt securities or
obtain a credit facility. The sale of additional equity securities,
or debt securities convertible into equity securities, could result in
additional dilution to our stockholders. The incurrence of
indebtedness would result in increased debt service obligations and could result
in operating and financing covenants that would restrict our
operations.
Provisions
in our bylaws and Nevada law might discourage, delay or prevent a change of
control of our company or changes in our management and, as a result, may
depress the trading price of our common stock.
Provisions
of our bylaws and Nevada law may discourage, delay or prevent a merger,
acquisition or other change in control that stockholders may consider favorable,
including transactions in which you might otherwise receive a premium for your
shares of our common stock. The relevant bylaw provisions may also
prevent or frustrate attempts by our stockholders to replace or remove our
management. These provisions include advance notice requirements
for stockholder proposals and nominations, and the ability of our Board of
Directors to make, alter or repeal our bylaws.
Absent
approval of our Board of Directors, our bylaws may only be amended or repealed
by the affirmative vote of the holders of at least a majority of our outstanding
shares of capital stock entitled to vote.
In
addition, Section 78.438 of the Nevada Revised Statutes prohibits a
publicly-held Nevada corporation from engaging in a business combination with an
interested stockholder (generally defined as a person which together with its
affiliates owns, or within the last three years has owned, 10% of our voting
stock, for a period of three years after the date of the transaction in which
the person became an interested stockholder) unless the business combination is
approved in a prescribed manner.
The
existence of the foregoing provisions and other potential anti-takeover measures
could limit the price that investors might be willing to pay in the future for
shares of our common stock. They could also deter potential acquirers
of our company, thereby reducing the likelihood that you could receive a premium
for your common stock in an acquisition.
Our
stock is deemed to be penny stock.
Our stock
is currently traded on the OTC Bulletin Board and is subject to the “penny stock
rules” adopted pursuant to Section 15(g) of the Securities Exchange Act of
1934, as amended (the “Exchange Act”). The penny stock rules apply to
companies not listed on a national exchange whose common stock trades at less
than $5.00 per share or which have tangible net worth of less than $5,000,000
($2,000,000 if the company has been operating for three or more
years). Such rules require, among other things, that brokers who
trade “penny stock” to persons other than “established customers” complete
certain documentation, make suitability inquiries of investors and provide
investors with certain information concerning trading in the security, including
a risk disclosure document and quote information under certain
circumstances. Penny stocks sold in violation of the applicable rules
may entitle the buyer of the stock to rescind the sale and receive a full refund
from the broker.
Many
brokers have decided not to trade “penny stock” because of the requirements of
the penny stock rules and, as a result, the number of broker-dealers willing to
act as market makers in such securities is limited. In the event that
we remain subject to the “penny stock rules” for any significant period, there
may develop an adverse impact on the market, if any, for our
securities. Because our securities are subject to the “penny stock
rules,” investors will find it more difficult to dispose of our
securities. Further, for companies whose securities are traded in the
OTC Bulletin Board, it is more difficult: (i) to obtain accurate
quotations, (ii) to obtain coverage for significant news events because major
wire services, such as the Dow Jones News Service, generally do not publish
press releases about such companies, and (iii) to obtain needed
capital.
If
we fail to maintain effective internal controls over financial reporting, the
price of our common stock may be adversely affected.
Our
internal controls over financial reporting may have weaknesses and conditions
that could require correction or remediation, the disclosure of which may have
an adverse impact on the price of our common stock. We are required to
establish and maintain appropriate internal controls over financial
reporting. Failure to establish those controls (or any failure of those
controls once established) could adversely impact our public disclosures
regarding our business, financial condition or results of operations. In
addition, management’s assessment of internal controls over financial reporting
may identify weaknesses and conditions that need to be addressed in our internal
controls over financial reporting or other matters that may raise concerns for
investors. Any actual or perceived weaknesses and conditions that need to
be addressed in our internal control over financial reporting, disclosure of
management’s assessment of our internal controls over financial reporting, or
disclosure of our independent registered public accounting firm’s attestation to
the effectiveness of our internal controls over financial reporting, when
required, may have an adverse impact on the price of our common
stock.
Standards
for compliance with Section 404 of the Sarbanes-Oxley Act of 2002 are uncertain,
and if we fail to comply in a timely manner, our business could be harmed and
our stock price could decline.
Rules
adopted by the SEC pursuant to Section 404 of the Sarbanes-Oxley Act of 2002
require an annual assessment of our internal controls over financial reporting,
and attestation of our assessment by our independent registered public
accounting firm. The standards that must be met for management to assess
the internal controls over financial reporting as effective are evolving and
complex, and require significant documentation, testing, and possible
remediation to meet the detailed standards. We expect to continue to incur
significant expenses and to devote resources to continued Section 404 compliance
during the remainder of fiscal 2010 and on an ongoing basis. It is
difficult for us to predict how long it will take or how costly it will be to
complete the assessment of the effectiveness of our internal controls over
financial reporting to the satisfaction of our independent registered public
accounting firm for each year, and to remediate any deficiencies in our internal
controls over financial reporting. As a result, we may not be able to
complete the assessment and remediation process on a timely basis. In
addition, the attestation process by our independent registered public
accounting firm will be new for fiscal 2011 and we may encounter problems or
delays in completing the implementation of any requested improvements and
receiving an attestation of our assessment by our independent registered public
accounting firm. In the event that our Chief Executive Officer, Chief
Financial Officer or independent registered public accounting firm determines
that our internal controls over financial reporting are not effective as defined
under Section 404, we cannot predict how regulators will react or how the market
price of our common stock will be affected; however, we believe that there is a
risk that investor confidence and share value may be negatively
impacted.
If
we fail to remain current in our reporting requirements, our securities could be
removed from the OTC Bulletin Board, which would limit the ability of
broker-dealers to sell our securities and the ability of stockholders to sell
their securities in the secondary market.
Companies
trading on the OTC Bulletin Board must be reporting issuers under Section 12 of
the Exchange Act, and must be current in their reports under Section 13, in
order to maintain price quotation privileges on the OTC Bulletin
Board. If we fail to remain current on our reporting requirements, we
could be removed from the OTC Bulletin Board. As a result, the market
liquidity for our securities could be severely adversely affected by limiting
the ability of broker-dealers to sell our securities and the ability of
stockholders to sell their securities in the secondary market.
There
is no guarantee that our shares of common stock or warrants will be listed on
the NASDAQ Capital Market.
In
connection with the filing of this registration statement, we applied for
listing of our common stock and warrants on the NASDAQ Capital
Market. After the consummation of this offering, we believe that we
will satisfy the listing requirements and expect that our common stock and
warrants will be listed on the NASDAQ Capital Market. Such listing,
however, is not guaranteed. If the application is not approved, we
will not complete this offering and the shares of our common stock will continue
to be traded on the OTC Bulletin Board, and our warrants will not be traded on
any quotation system. Even if such listing is approved, there can be
no assurance any broker will be interested in trading our
stock. Therefore, it may be difficult to sell your shares of common
stock if you desire or need to sell them. Our lead underwriter,
Rodman & Renshaw, LLC, is not obligated to make a market in our securities,
and even if they make a market, they can discontinue market making at any time
without notice. Neither we nor the underwriters can provide any
assurance that an active and liquid trading market in our securities will
develop or, if developed, that such market will continue.
Even if our common stock and warrants are approved for listing on the
NASDAQ Capital Market, there is no guarantee that we will be able to maintain
such listing for any period of time by perpetually satisfying NASDAQ's continued
listing requirements.
FORWARD-LOOKING
STATEMENTS
This
prospectus contains forward-looking statements. All statements other
than statements of historical fact contained in this prospectus, including
statements regarding our future results of operations and financial position,
business strategy and plans and objectives of management for future operations,
are forward-looking statements. These statements involve known and
unknown risks, uncertainties and other factors that may cause our actual
results, performance or achievements to be materially different from any future
results, performance or achievements expressed or implied by the forward-looking
statements.
In some
cases, you can identify forward-looking statements by terms such as “may,”
“will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,”
“target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,”
“potential,” “continue,” or the negative of these terms or other similar
words. These statements are only predictions. We have
based these forward-looking statements largely on our current expectations and
projections about future events and financial trends that we believe may affect
our business, financial condition and results of operations. We
discuss many of the risks in greater detail under the heading “Risk
Factors.” Also, these forward-looking statements represent our
estimates and assumptions only as of the date of this
prospectus. Forward-looking statements in this prospectus include,
but are not necessarily limited to, those relating to:
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our
intention to introduce new products or services,
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our
expectations about the markets for our products or
services,
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our
expectations about securing a strategic relationship with a global courier
or large clinical research organization,
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our
future capital needs,
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results
of our research and development efforts, and
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success
of our patent applications.
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Forward-looking
statements are subject to risks and uncertainties, certain of which are beyond
our control. Actual results could differ materially from those
anticipated as a result of the factors described in “Risk Factors” in this
prospectus and detailed in our other SEC filings, including among
others:
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the
effect of regulation by United States and foreign governmental
agencies,
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research
and development efforts, including delays in developing, or the failure to
develop, our products,
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the
development of competing or more effective products by other
parties,
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uncertainty
of market acceptance of our products,
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errors
in business planning attributable to insufficient market size or
segmentation data,
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problems
that we may face in manufacturing, marketing, and distributing our
products,
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problems
that we may encounter in further development of CryoPort Express® Portal
or its ability to scale to meet customer demand and
needs,
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problems
relating to the development of wireless sensor monitoring devices, or
regulatory approval relating to their use,
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our
inability to raise additional capital when needed,
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delays
in the issuance of, or the failure to obtain, patents for certain of our
products and technologies,
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problems
with important suppliers and strategic business partners,
and
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difficulties
or delays in establishing marketing relationships with international
couriers.
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Because
of these risks and uncertainties, the forward-looking events and circumstances
discussed in this prospectus might not transpire. Except for our
ongoing obligations to disclose material information as required by the federal
securities laws, we undertake no obligation to release publicly any revisions to
any forward-looking statements to reflect events or circumstances after the date
hereof or to reflect the occurrence of unanticipated events. All of
the above factors are difficult to predict, contain uncertainties that may
materially affect our actual results and may be beyond our
control. New factors emerge from time to time, and it is not possible
for our management to predict all of such factors or to assess the effect of
each factor on our business.
This
prospectus also contains estimates and other industry and statistical data
developed by independent parties and by us relating to market size, growth and
segmentation of markets. This data involves a number of assumptions
and limitations, and you are cautioned not to give undue weight to such
estimates. We have not independently verified these estimates
generated by independent parties and contained in this prospectus and,
accordingly, we cannot guarantee their accuracy or completeness. In
addition, projections, assumptions and estimates of our future performance and
the future performance of the industries in which we operate are necessarily
subject to a high degree of uncertainty and risk due to a variety of factors,
including those described in “Risk Factors,” “Management’s Discussion and
Analysis of Financial Condition and Results of Operations,” and elsewhere in
this prospectus. These and other factors could cause results to
differ materially from those expressed in the estimates made by the independent
parties and by us.
USE
OF PROCEEDS
We
estimate that the net proceeds to us from the sale of the units that we are
offering will be approximately $13.3 million, based on an assumed public
offering price of $4.80 per unit, after deducting underwriting discounts and
commissions and estimated offering expenses that we must pay. We
intend to use those net proceeds primarily to repay a portion of the outstanding
principal balance of the Debentures, build up our inventory of shippers, for
capital expenditures, including establishing selected global staging and
refurbishing sites, and for working capital and general corporate
purposes. We may also use these proceeds to finance the acquisition
of complimentary businesses or services. We currently have no
agreements or commitments for any specific acquisitions at this
time.
As
of November 30, 2009, the outstanding principal balance of the Debentures was
$5,981,425. The Debentures mature on July 1, 2010 and, as of November
30, 2009, had an interest rate of 8%. Pursuant to the 2010 Amendment,
upon the consummation of this offering, we must repay $3,266,995
of the principal balance of the Debentures with some of the net proceeds
from this offering. We increased the principal balance of the
Debentures by $628,826
during the prior twelve (12) months which reflects the conversion of accrued
interest payable into principal and the conversion of both accrued interest
payable and future interest payable into principal pursuant to the terms of the
September 2009 Amendment to the Debentures.
Pending
any use, as described above, we plan to invest the net proceeds in
investment-grade, short-term, interest-bearing securities.
MARKET
FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Market Information
Presently,
our common stock is traded through the OTC Bulletin Board under the symbol
CYRX. We intend to list our common stock and warrants on the NASDAQ
Capital Market under the symbols “CYPT” and “CYPTW,”
respectively. There can be no assurances that an active public market
for our common stock will develop or be sustained. The following
table sets forth, for the periods indicated, the high and low sales prices for
our common stock assuming the consummation of a reverse stock split, at a ratio
of 12-to-1.
Number
of Stockholders
As of
November 30, 2009, there were approximately 136 holders of record of our
common stock.
Dividend
Policy
Historically,
we have not paid any dividends to the holders of our common stock and we do not
expect to pay any such dividends in the foreseeable future as we expect to
retain our future earnings for use in the operation and expansion of our
business.
Securities
Authorized For Issuance Under Equity Compensation Plans
CryoPort
currently maintains two equity compensation plans, the 2002 Plan and the 2009
Plan. Our Compensation and Governance Committee is responsible for
making reviewing and recommending grants of options under these plans which are
approved by the Board of Directors. The 2002 Plan, which was approved
by CryoPort’s stockholders in October 2002, allows for the grant of options to
purchase up to 416,666 shares (assuming the consummation of a reverse stock
split, at a ratio of 12-to-1) of CryoPort’s common stock. The 2002
Plan provides for the granting of options to purchase shares of CryoPort’s
common stock at prices not less than the fair market value of the stock at the
date of grant and generally expire 10 years after the date of
grant. The stock options are subject to vesting requirements,
generally three or four years. The 2002 Plan also provides for the
granting of restricted shares of common stock subject to vesting
requirements. As of November 30, 2009, a total of 254,983 shares
(after giving effect to the anticipated 12-to-1 reverse stock split) of common
stock remained available for future option grants under the 2002
Plan.
The 2009
Plan provides for the grant of stock-based incentives. The 2009 Plan
allows for the grant of up to 1,000,000 shares (after giving effect to the
anticipated 12-to-1 reverse stock split) of our common stock for awards to
our officers, directors, employees and consultants. The 2009 Plan
provides for the grant of incentive stock options, nonqualified stock options,
restricted stock rights, restricted stock, performance share units, performance
shares, performance cash awards, stock appreciation rights, and stock grant
awards. The 2009 Plan also permits the grant of awards that qualify
for the “performance-based compensation” exception to the $1,000,000 limitation
on the deduction of compensation imposed by Section 162(m) of the
Code. As
of November 30, 2009, a total of 942,500 shares (after giving effect to the
anticipated 12-to-1 reverse stock split) of our common stock remained available
for future grants under the 2009 Plan.
Reverse
Stock Split
Our stockholders
have approved a proposal to grant discretionary authority to our Board of
Directors to amend our Amended and Restated Articles of Incorporation to effect
a reverse stock split of our issued and outstanding common stock at any time
before June 30, 2010 at any whole number ratio between a 2-to-1 reverse
stock split and a 15-to-1 reverse stock split, with the exact exchange ratio and
timing of the reverse stock split (if at all) to be determined at the discretion
of the Board of Directors, without decreasing the number of our shares of
authorized capital stock.
The
reverse stock split will be effected simultaneously for all our then existing
common stock and the exchange ratio will be the same for all of our shares of
issued and outstanding common stock. The reverse stock split will
affect all of our stockholders uniformly and will not affect any stockholder’s
percentage ownership interests in us, except to the extent that the reverse
stock split results in any of our stockholders owning a fractional
share. If this occurs, we will pay a cash payment in lieu of issuing
fractional shares. Shares of common stock issued pursuant to the
reverse stock split will remain fully paid and nonassessable. The
information in the following table is based on 50,015,318 shares of common stock
(not adjusted for the anticipated 12-to-1 reverse stock split) issued and
outstanding as of November 30, 2009.
Proposed
Reverse
Stock
Split
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Percentage
Reduction in the Outstanding Shares
of
Common Stock
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Common
Stock Outstanding After the Reverse Stock Split
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Common
Stock Authorized After the Reverse Stock Split
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2-to-1
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50%
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25,007,659
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250,000,000
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5-to-1
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80%
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10,003,063
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250,000,000
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12-to-1
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912/3%
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4,167,943
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250,000,000
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15-to-1
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931/3%
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3,334,355
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250,000,000
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DETERMINATION
OF OFFERING PRICE
The
public offering price of the units offered by this prospectus will be based on
the closing market price of the stock immediately prior to the closing date of
this offering, adjusted for the anticipated reverse stock split on a 12-to-1
basis, prior to the effectiveness of the registration statement of which this
prospectus is a part. We have applied for listing of our common stock
and warrants on the NASDAQ Capital Market under the symbols “CYPT” and “CYPTW,”
respectively. No assurance can be given that our application will be
approved. If the application is not approved, we will not complete
this offering and the shares of our common stock will continue to be traded on
the OTC Bulletin Board.
CAPITALIZATION
The
following table sets forth our cash and cash equivalents, convertible
debentures, notes payable and capitalization as of September 30, 2009 on an
actual (after giving effect to the anticipated 12-to-1 reverse stock split) and
on a pro forma as adjusted basis to give effect to the sale of the units by us
in this offering at an assumed public offering price of $4.80 per share (the pro
forma adjusted closing share price on December 30, 2009, after giving effect to
the anticipated 12-to-1 reverse stock split), after deducting estimated
underwriting discounts and commissions and estimated offering expenses payable
by us and the application of the estimated net proceeds of this offering as
described under “Use of Proceeds.”
This
table should be read in conjunction with our consolidated financial statements
and related notes and the sections entitled “Management’s Discussion and
Analysis of Financial Condition and Results of Operations,” “Use of Proceeds,”
and “Description of Capital Stock” appearing elsewhere in this
prospectus.
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September
30, 2009
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Actual
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As
Adjusted
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Cash
and cash equivalents
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Derivative
liabilities |
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18,404,578 |
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1,119,595 |
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Convertible
notes payable and accrued interest, net of discount of
$775,960
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Current
portion of convertible debentures and other long-term debt, net of debt
discounts of $2,468,355
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Convertible
notes payable, net of current portion and discount of
$6,351,425
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Common
stock, $0.001 par value: 250,000,000 shares authorized; 3,965,470 issued
and outstanding, actual; and 9,093,445 shares issued and outstanding,
as adjusted(1)
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Additional
paid-in capital
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)
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Total
stockholders’ equity (deficit)
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(1) The
above table assumes the issuance of 1,800,502 shares of our common stock to the
holders of our convertible debentures upon their conversion of a portion of the
outstanding principal amount of such debentures upon the consummation of this
offering pursuant to the 2010 Amendment, issuance of 68,519 shares of our common
stock to the holders of our convertible debentures upon their conversion of a
portion of the outstanding principal amount of such debentures with a conversion
price of $5.40 prior to this offering, the issuance of 133,955 shares of
our common stock for services and the exercise of warrants prior to this
offering and excludes the following:
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225,736 shares
of common stock reserved for issuance upon the conversion of outstanding
convertible promissory notes with a conversion price of $6.12 per
share;
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3,042,406
shares of common stock reserved for issuance upon the exercise of
outstanding warrants with a weighted average exercise price of $5.52 per
share;
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74,292
shares of common stock reserved for issuance upon the exercise of
outstanding stock options with a weighted average exercise price of $7.05
per share;
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254,453 shares
of common stock available for future grant under our 2002 Stock Incentive
Plan and an additional 942,500 shares of common stock available for future
grant under our 2009 Stock Incentive Plan;
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3,125,000 shares
of common stock issuable upon the exercise of the warrants to be issued in
connection with this offering; and
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156,250 shares
of common stock that may be issued to Rodman & Renshaw, LLC upon
exercise of the warrant we will sell to them (representing 5% of the
shares of common stock sold by us in this offering, excluding the
over-allotment option).
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DILUTION
If you
invest in our common stock, your interest will be diluted to the extent of the
difference between the public offering price per unit you pay and the as
adjusted net tangible book value per share of our common stock after this
offering. Our net tangible book value as of September 30, 2009 was
($23,637,942), or ($5.96) per share of common stock (after giving effect to the
anticipated 12-to-1 reverse stock split). We calculate net tangible
book value per share by calculating the difference between the total assets less
goodwill and other intangible assets and total liabilities, and dividing the
result by the number of shares of common stock outstanding.
Net
tangible book value dilution per share represents the difference between the
amount per unit paid by new investors who purchase units in this offering and
the pro forma net tangible book value per share of common stock immediately
after completion of this offering as of September 30, 2009, after giving
effect to:
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the
sale by us of 3,125,000 units at an assumed public offering price of
$4.80 per share, each unit consisting of one share of common stock and one
warrant to purchase one share of common stock at an exercise price of
$5.28 per share and the application of the estimated net proceeds to us in
this offering as described under “Use of Proceeds”;
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the
issuance of 1,800,502 shares of common stock to the holders of our
convertible debentures upon their conversion of a portion of the
outstanding principal amount of such debentures upon the consummation of
this offering pursuant to the 2010 Amendment;
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the
issuance of 68,519 shares of common stock to the holders of our
convertible debentures upon their conversion of a portion of the
outstanding principal amount of such debentures prior to this offering;
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the
issuance of 133,955 shares of common stock for services and the exercise
of warrants prior to this offering; and
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the
estimated underwriting discounts and commissions and offering expenses
payable by us.
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Adjusted
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Public
offering price per share
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Net
tangible book value as of September 30, 2009
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Increase
attributable to this offering
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Adjusted
net tangible book value per share after this
offering
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Dilution
in net tangible book value per share to new
investors
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The
following table summarizes as of November 30, 2009, on a pro forma basis to
reflect the same adjustments described above, the number of shares of common
stock purchased from us, the total consideration paid and the average price per
share paid by:
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The
existing common stockholders (including the holders of
our Debentures who are converting a portion of the
outstanding principal amount of the Debentures upon the consummation of
this offering pursuant to the 2010 Amendment); and
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●
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The
new investors in this offering, assuming the sale of 3,125,000 units
offered hereby at a public offering price of $4.80 per
share.
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The
calculations are based upon total consideration given by new and existing
stockholders, before any deduction of estimated underwriting discounts and
commissions and offering expenses.
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Shares
of common stock Purchased
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Total
Consideration
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Average
Price
Per
Share
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Number
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Percent
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Amount
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Percent
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25,683,494 |
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The above
table excludes an aggregate of up to 6,779,933 additional shares of common
stock reserved and available for future issuance (i) upon the conversion of all
outstanding convertible promissory notes, (ii) the exercise of all
outstanding stock options and warrants to purchase common stock, (iii) the
exercise of all warrants issued in connection with this public offering, and
(iv) under our employee 2002 Plan and our 2009 Plan as of September 30,
2009. As of September 30, 2009, options to purchase 74,292 shares of
common stock have been granted, but have not been exercised pursuant to the 2002
Plan and the 2009 Plan.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
Forward-Looking
Statements
The
following discussion and analysis of our financial condition and results of
operations should be read in conjunction with our consolidated financial
statements and related notes that appear elsewhere in this
prospectus. In addition to historical consolidated financial
information, the following discussion contains forward-looking statements that
reflect our plans, estimates and beliefs. Our actual results could
differ materially from those discussed in the forward-looking
statements. Factors that could cause or contribute to these
differences include those discussed below and elsewhere in this prospectus,
particularly in “Risk Factors.”
General
Overview
We are a
provider of an innovative cold chain frozen shipping system dedicated to
providing superior, affordable cryogenic shipping solutions that ensure the
safety, status and temperature, of high value, temperature sensitive
materials. We have developed a line of cost effective reusable
cryogenic transport containers (referred to as "shippers") capable of
transporting biological, environmental and other temperature sensitive materials
at temperatures below 0° Celsius. These dry vapor shippers are one of
the first significant alternatives to dry ice shipping and achieve 10-plus day
holding times compared to one to two day holding times with dry
ice.
Our value
proposition comes from both providing safe transportation and an
environmentally friendly, long lasting shipper, and through our value added
services that offer a simple hassle-free solution for our
customers. These value-added services include an internet-based web
portal that enables the customer to initiate shipping service, track the
progress and status of a shipment, and provides in-transit temperature
monitoring services of the shipper. CryoPort also provides a fully
ready charged shipper containing all freight bills, customs documents and
regulatory paperwork for the entire journey of the shipper to our customers
at their pick up location.
Our
principal focus has been the further development and commercial launch of
CryoPort Express® Portal, an innovative IT solution for shipping and tracking
high-value specimens through overnight shipping companies, and our CryoPort
Express® Shipper, a line of dry vapor cryogenic shippers for the transport of
biological and pharmaceutical materials. A dry vapor cryogenic
shipper is a container that uses liquid nitrogen in dry vapor form, which is
suspended inside a vacuum insulated bottle as a refrigerant, to provide storage
temperatures below minus 150° Celsius. The dry vapor shipper is
designed using innovative, proprietary, and patented technology which prevents
spillage of liquid nitrogen and pressure build up as the liquid nitrogen
evaporates. A proprietary foam retention system is employed to ensure
that liquid nitrogen stays inside the vacuum container, even when placed
upside-down or on its side, as is often the case when in the custody of a
shipping company. Biological specimens are stored in a specimen
chamber, referred to as a “well,” inside the container and refrigeration is
provided by harmless
cold nitrogen gas evolving from the liquid nitrogen entrapped within the foam
retention system surrounding the well. Biological specimens
transported using our cryogenic shipper can include clinical samples,
diagnostics, live cell pharmaceutical products (such as cancer vaccines, semen
and embryos, infectious substances) and other items that require and/or are
protected through continuous exposure to frozen or cryogenic temperatures (below
minus 150° Celsius).
During
our early years, our limited revenue was derived from the sale of our reusable
product line. Our current business plan focuses on per-use leasing of the
shipping container and added-value services that will be used by us to provide
an end-to-end and cost-optimized shipping solution to life science companies
moving pharmaceutical and biological samples in clinical trials and
pharmaceutical distribution.
Going
Concern
As
reported in the Report of Independent Registered Public Accounting Firm to our
March 31, 2009 and 2008 consolidated financial statements, we have incurred
recurring losses and negative cash flows from operations since
inception. These factors, among others, raise substantial doubt about
our ability to continue as a going concern.
There are
significant uncertainties which negatively affect our
operations. These are principally related to (i) the expected ramp up
of sales of the new CryoPort Express® System, (ii) the absence of any commitment
or firm orders from key customers in our target markets, (iii) the success in
bringing additional products currently under development to market with our key
customers, and (iv) risks associated with scaling company operations to
meet demand. Moreover, there is no assurance as to when, if ever, we
will be able to conduct our operations on a profitable basis. Our
limited historical sales for our reusable product, limited introductory sales to
date of the CryoPort Express® System and the lack of any purchase requirements
in our existing distribution agreements, make it impossible to identify any
trends in our business prospects.
We have
not generated significant revenues from operations and have no assurance of any
future revenues. We generated revenues from operations of $35,124,
incurred a net loss of $16,705,151 and used cash of $2,586,470 in our operating
activities during the year ended March 31, 2009. We generated
revenues from operations of $22,181, had a net loss of $7,536,045, which
included a loss on the change in fair value of our derivative liabilities of
$1,401,550 and used cash of $1,145,497 in our operating activities during
the six months ended September 30, 2009. In addition, we had a
working capital deficit of $22,902,096, and have cash and cash equivalents of
$1,120,758 at September 30, 2009. Our working capital deficit at
September 30, 2009 included $18,404,758 relating to derivative liabilities, the
balance of which represented the fair value of warrants and embedded conversion
features related to our convertible debentures and were reclassified from equity
during the six months ended September 30, 2009 (see Note 9 in the
accompanying unaudited consolidated financial statements). Currently
management has projected that cash on hand, including cash borrowed under the
convertible promissory notes issued in the first, second, and third
quarters of fiscal 2010, will be sufficient to allow us to continue our
operations into the fourth quarter of fiscal 2010 until more significant funding
can be secured. These matters raise substantial doubt about our
ability to continue as a going concern.
Results
of Operations
The
following table sets forth, for the periods indicated, certain information
derived from our consolidated statements of operations.
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Fiscal
Year
|
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|
For
the Six Months
Ended
September 30,
(unaudited)
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2009
(‘000)
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2008
(‘000)
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2007
(‘000)
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2009
(‘000)
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2008
(‘000)
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Selling,
general and administrative expenses
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Research
and development expenses
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Loss
on sale of fixed assets
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Change
in fair value of derivative liabilities
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)
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Loss
on extinguishment of debt
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)
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Net
loss available to common stockholders per common
share:
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Basic
and diluted loss per common share
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Weighted
average common shares outstanding:
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Basic
and diluted (after giving effect to the anticipated 12-to-1 reverse stock
split)
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Six
months ended September 30, 2009 compared to six months ended September 30,
2008:
Revenues. During the
six months ended September 30, 2009, CryoPort generated $22,181 from shipper
sales compared to revenues of $19,406 in the same period of the prior year, an
increase of $2,775 (14%). The low revenues in both years was
primarily due to CryoPort’s shift initiated in mid-2006 in its sales and
marketing focus from the reusable shipper product line. CryoPort
discontinued sales of the reusable shippers to allow resources to focus on
further development and launch of the CryoPort Express® System and its
introduction into the biopharmaceutical industry sector during fiscal 2009,
which resulted in the slight increase in sales year over year. The
slow increase in product sales was the result of delays in CryoPort securing
adequate funding for the manufacturing and full commercialization of the
CryoPort Express®.
Cost of
Sales. Cost of sales for the six month period ended September
30, 2009 increased $73,113 (29%) to $326,444 from $253,331 for the six month
period ended September 30, 2008 primarily as the result of increased fixed
overhead manufacturing costs which resulted from CryoPort’s discontinuation of
the reusable shippers and refocus of manufacturing operation for the CryoPort
Express® System. During both periods, cost of sales exceeded sales
due to fixed manufacturing costs and plant
underutilization.
Gross Loss. Gross
loss for the six month period ended September 30, 2009 increased by $70,338
(30%) to $304,263 compared to $233,925 for the six month period ended September
30, 2008. The increase in gross loss is due to low revenues and
increased fixed overhead manufacturing costs which resulted from the refocus of
CryoPort’s manufacturing operations as discussed above and plant under
utilization.
Selling, General and
Administrative Expenses. Selling, general and administrative expenses
increased by $167,771 (13%) to $1,507,502 for the six month period ended
September 30, 2009 as compared to $1,339,731 for the six month period ended
September 30, 2008 due primarily to a $189,136 (17%) increase in general and
administrative expenses from $1,124,148 for the six month period ended September
30, 2008 to $1,313,284 for the six month period ended September 30, 2009 and by
a $21,365 (10%) decrease in sales and marketing expenses from $215,583 for the
six month period ended September 30, 2008 to $194,218 for the six month period
ended September 30, 2009. The increase in general and administrative
expenses was due to increases in legal and accounting fees, consulting fees and
travel expenses. The increase in legal fees was associated with
CryoPort’s strategic partnering activities and debt
restructuring. The decrease in selling expenses was primarily related
to a decrease in advertising and promotional costs, consulting and travel costs
due to a reduction over prior year costs for additional market research, product
development and the development of customer relationships for the
commercialization of the CryoPort Express® System. These increases in
general and administrative expenses were partially offset by CryoPort’s efforts
to minimize overall costs and diversion of resources to the focus on
market development and sales ramp up of the CryoPort Express®
System.
Research and Development
Expenses. Research and development expenses decreased by
$35,453 (16%) to $180,791 for the six month period ended September 30, 2009 as
compared to $216,244 for the six month period ended September 30,
2008. Prior year expenses included consulting costs associated with
software development for the web based system to be used with the CryoPort
Express® One-Way Shipper, and to other research and development activity related
to the CryoPort Express® One-Way Shipper System, as CryoPort strove to develop
improvements in both the manufacturing processes and product materials for the
purpose of achieving additional product cost
efficiencies.
Interest Expense.
Interest expense increased $2,929,388 to $4,143,256 for the six month period
ended September 30, 2009 as compared to $1,213,868 for the six month period
ended September 30, 2008. This increase was due to $3,737,569 of
amortized debt discount, $25,579 of amortized financing fees, and $380,108 of
accrued interest, primarily related to the Debentures and the Private
Placement Debentures that were issued during the six month period ended
September 30, 2009. These increases were partially offset by a
reduction in interest expense for related party notes payable and notes payable
to officers as the result of the payments made against the principal note
balances.
Interest
Income. CryoPort recorded interest income of $3,714 for the
six month period ended September 30, 2009 as compared to $24,008 for the six
month period ended September 30, 2008. Prior year interest income
included the impact of increased cash balances related to the funds received in
connection with the Debentures.
Gain (Loss) on
Extinguishment of Debt. CryoPort incurred a loss on
extinguishment of debt of $6,902,941 during the six months ended September 30,
2008 as the result of the April 30, 2008 Amendment of the October Debentures
which provided for a six month deferral of principal payments. The
loss consists of a combination of the $5,858,344 increase in the fair market
value of warrants issued in connection with the October 2007 Debentures as a
result of the increase in the number of shares of common stock to be purchased
under each of the October Warrants and to the decrease in the exercise price of
October 2007 Warrants from $10.80, $11.04 and $19.20 to $7.20 each, the
elimination of the April 30, 2008 unamortized balance of deferred financing
costs of $312,197 and the $732,400 reduction in the unamortized discount balance
related to the October 2007 Debentures to reflect the present value of the
debentures as of April 30, 2008 (see Note 8 of the accompanying unaudited
consolidated financial statements). There was no loss on
extinguishment of debt during the six months ended September 30,
2009.
CryoPort
incurred a gain on extinguishment of debt of $91,727 during the six months ended
September 30, 2008 as the result of the August 29, 2008 Amendment of the October
Debentures which provided for an increase of $866,202 in the principal balance
of the October Debentures for the interest that would have been paid September
30, 2008 and December 31, 2008 and for 15% of the aforementioned interest and
the outstanding principal as of the date of the amendment. The gain
consists of a combination of the $866,202 increase in principal offset by the
$899,004 increase in the unamortized discount balance and the previously accrued
interest of $58,925 related to the October Debentures to reflect the present
value of the debentures as of August 29, 2008 (see Note 8 of the accompanying
unaudited consolidated financial statements). There was no gain on
extinguishment of debt in the six months ended September 30,
2009.
Net
Loss. As a result of the factors described above, the net loss
for the six months ended September 30, 2009 decreased by $2,255,729 to
$7,536,045 or ($2.02) per share compared to $9,791,774 or ($2.85) per share for
the six months ended September 30, 2008, assuming the consummation of a reverse
stock split, at a ratio of 12-to-1. Loss from operations for the six
months ended September 30, 2009 increased $202,656 to $1,992,556 compared to
$1,789,900 for the six months ended September 30, 2008.
Year
Ended March 31, 2009 Compared to Year Ended March 31, 2008:
Revenues. During
the year ended March 31, 2009, CryoPort generated revenues of $35,124 compared
to revenues of $83,564 during the year ended March 31, 2008, a decrease of
$48,440 (58.0%). These low revenues in both years is primarily due to
CryoPort’s shift initiated in mid-2006 in its sales and marketing focus from the
reusable shipper product line. Further, the decrease in revenues was
caused by the discontinuation of the sales of the reusable shippers early fiscal
2009 to allow resources to focus on the further development and launch of the
CryoPort Express® System and its introduction into the biopharmaceutical
industry sector during fiscal 2009 and to the delays in CryoPort’s securing
adequate funding for the manufacturing and full commercialization of the
CryoPort Express®.
Cost of
Sales. Cost of sales for the year ended March 31, 2009
increased $159,781 (41.4%) to $546,152 from $386,371 for the year ended March
31, 2008 as the result of increased fixed overhead manufacturing costs resulting
from CryoPort’s discontinuation of the reusable shippers and preparation of
manufacturing operation for the launch of the new CryoPort Express® System
during fiscal 2009. During both periods, cost of sales exceeded sales
due to fixed manufacturing costs and plant underutilization.
Gross
Loss. Gross loss for the year ended March 31, 2009 increased
by $208,221 (68.8%) to $511,028 compared to $302,807 for the year ended March
31, 2008. The increase in the gross loss is due to decreased revenues
and increased fixed overhead manufacturing costs resulting from CryoPort’s
discontinuation of the reusable shippers and preparation of manufacturing
operation for the launch of the new CryoPort Express® System during fiscal
2009.
Selling, General and
Administrative Expenses. Selling, general and administrative
expenses decreased by $163,491 (6.4%) to $2,387,287 for the year ended March 31,
2009 compared to $2,550,778 for the year ended March 31, 2008 due mainly to
a decrease in general and administrative costs of $213,453 (9.6%) which was
partially offset by an increase in selling expenses of $49,962
(15.4%). The decrease in general and administrative expenses was
primarily due to CryoPort’s efforts to minimize overall costs and diversion
of resources to the focus on market development and sales ramp up of
the CryoPort Express® System. These general and administrative cost
reductions were partially offset by increases in legal and accounting fees,
insurance premiums and travel expenses. The increased selling
expenses were primarily related to increased advertising and promotional costs,
consulting and travel costs as the result of additional market research,
product development and the development of customer relationships for the
commercialization of the CryoPort Express® System.
Research and Development
Expenses. Research and development expenses increased by
$131,151 (78.9%) to $297,378 for the year ended March 31, 2009 as compared to
$166,227 for the year ended March 31, 2008 in relation to the progression of the
research and development activity, related to the initial development of the web
based customer service portal utilized by the CryoPort Express®
System. Further these efforts are expected to lead to the
introduction of shippers of varying sizes based on market requirements,
constructed of lower cost materials and utilizing high volume manufacturing
methods that will make it practical to provide the cryogenic packages offered by
the CryoPort Express® System. Other research and development effort
has been directed toward third party certification testing and improvements to
the liquid nitrogen retention system to render it more reliable in the general
shipping environment and to the design of the outer packaging.
Interest
Expense. Interest expense increased $1,100,665 to $2,693,383
for the year ended March 31, 2009 as compared to $1,592,718 for the year ended
March 31, 2008. This increase is primarily due to the interest costs
related to the Debentures including primarily increases of $1,008,130
resulting from the amortization of additional debt discounts and $150,913 of
interest expense on the face value of the debentures which were partially offset
by reductions in amortization of deferred financing fees and interest expense
for related party notes payable as the result of the payments made against the
principal note balances.
Interest Income. CryoPort recorded
interest income of $32,098 for the year ended March 31, 2009 as compared to
$50,076 for the year ended March 31, 2008 as the result of decreased cash
balances related to the use of funds for operations during the
year.
Loss on Extinguishment of
Debt.
CryoPort incurred a total combined loss on extinguishment of debt of
$10,846,573 during the year ended March 31, 2009 as the result of the resulting
change in valuation of the debt and related warrants associated with the
Amendments to the October 2008 Debentures in April 2008, August 2008 and January
2009 and the change in valuation of the debt and related warrants associated
with the January 2009 Amendment to the May 2008 Debentures. The loss
consists of a combined total loss on extinguishment of debt on the October 2007
Debentures of $9,449,498 and $1,397,075 on the May 2008 Debentures. There was no
loss on extinguishment of debt during the year ended March 31,
2008.
Net
Loss. As a result of the factors described above, the net loss
for the year ended March 31, 2009 increased by $12,141,097 (266%) to $16,705,151
or ($4.86) per share compared to $4,564,054 or ($1.38) per share for the year
ended March 31, 2008, assuming the consummation of a reverse stock split, at a
ratio of 12-to-1.
Liquidity
and Capital Resources
As of
September 30, 2009, we had cash and cash equivalents of $1,120,758 and negative
working capital of $22,902,096. CryoPort’s working capital deficit at
September 30, 2009 included $18,404,578 of derivative liabilities, the balance
of which represented the fair value of warrants and embedded conversion features
related to CryoPort’s convertible debentures and were reclassed from equity
during the six months ended September 30, 2009. As of March 31, 2009,
CryoPort had cash and cash equivalents of $249,758 and negative working capital
of $3,693,015.
Net cash
used in operating activities was $1,145,497 for the six months ended September
30, 2009, compared to net cash used in operating activities of $1,584,022 for
the six months ended September 30, 2008. Net loss for the six months
ended September 30, 2009 of $ 7,536,045 included a non-cash loss of
$1,401,550 due to the change in valuation of our derivative liabilities and
non-cash expenses of $3,737,569 due primarily to discount amortization related
to our convertible debt instruments. Offsetting the cash impact of
our net operating loss (excluding non-cash items) was an increase in accrued
interest payable of $278,325 primarily due to our Private Placement Debentures
and an increase in accounts payable of $175,268 due primarily to increased
general and administrative expenses. Net cash used in operating
activities of $1,584,022 for the six months ended September 30, 2008 reflected a
net operating loss of $9,791,774, which included a non-cash loss on
extinguishment of debt of $6,811,214 and non-cash expenses of $958,856 due
primarily to discount amortization related to our convertible debt
instruments. In addition to our net operating loss and related cash
impact, inventories increased by $299,393 and were offset by the positive cash
impact of an increase in accrued interest payable related to our May 2008
debenture.
Net cash
used in investing activities for the six months ended September 30, 2009 was
$34,139 compared to net cash used in investing activities of $53,676 for the
comparable period in 2008. Net cash used in investing activities for
the six months ended September 30, 2009 primarily reflected payment of trademark
costs. Net cash used in investing activities for the six months ended
September 30, 2008 was comprised primarily of fixed asset
purchases.
Net cash
provided by financing activities for the six months ended September 30, 2009 was
$2,050,636 and was primarily related to proceeds from our Private Placement
Debentures of $1,321,500, which were partially offset by payment of deferred
financing costs and payments on our related party notes payable. Net
cash provided by financing activities of $625,713 for the six months ended
September 30, 2008 reflected proceeds from our May 2008 Debentures of
$1,062,500, which were partially offset by payments for financing costs,
repayments on convertible and related party notes payable.
Contractual
Obligations and Commitments
The
following summarizes CryoPort’s contractual obligations at March 31, 2009, and
the effects such obligations are expected to have on liquidity and cash flow in
future periods:
|
|
Payments
Due by Period
|
|
Contractual
Obligations
|
|
Total
|
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|
Less
than
1
Yr
|
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|
1-3
Years
|
|
|
4-5
Years
|
|
|
After
5
Years
|
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Convertible
Debentures (a)
|
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Private
Placement Convertible Debt
|
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Total
Contractual Cash Obligations
|
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(a)
Pursuant to the 2010 Amendment, a portion of the outstanding principal balance
of the Debentures will be converted into shares of common stock upon
completion of this offering.
Impact of
Inflation. From time to
time, CryoPort experiences price increases from third party manufacturers and
these increases cannot always be passed on to CryoPort’s
customers. While these price increases have not had a material impact
on CryoPort’s historical operations or profitability in the past, they could
affect revenues in the future.
Research
and Development
We have
completed the research and development efforts associated with initial
phases of the web-based order entry and tracking system and the CryoPort
Express® Shippers, a line of dry vapor cryogenic shippers, the essential
components of our CryoPort Express® System, which has been developed to provide
a one-call total solution for the transport of temperature sensitive, biological
and pharmaceutical materials. We continue to provide ongoing
research associated with the CryoPort Express® System, as we develop
improvements in both the manufacturing processes and product materials and in
the web-based customer service portal for the purpose of achieving additional
cost efficiencies and customer functionality. As with any research
effort, there is uncertainty and risk associated with whether these efforts will
produce results in a timely manner so as to enhance our market
position. For the six months ended September 30, 2009 and 2008,
research and development costs were $180,791 and $216,244,
respectively. CryoPort’s sponsored research and development costs
related to future products and redesign of present products are expensed as
incurred and include such costs as salaries, employee benefits, costs determined
utilizing the Black-Scholes option-pricing model for options issued to the
Scientific Advisory Board and prototype design and materials costs.
Our
research and development efforts are focused on continually improving the
features of the CryoPort Express® System including the web-based customer
service portal and the CryoPort Express® Shippers. Further, these
efforts are expected to lead to the introduction of shippers of varying sizes
based on market requirements, constructed of lower cost materials and utilizing
high volume manufacturing methods that will make it practical to provide the
cryogenic shippers offered by the CryoPort Express® System. Other
research and development effort has been directed toward improvements to the
liquid nitrogen retention system to render it more reliable in the general
shipping environment and to the design of the outer packaging.
Critical
Accounting Policies
CryoPort’s
consolidated financial statements have been prepared in accordance with
accounting principles generally accepted in the United States
(“GAAP”). The preparation of these financial statements requires us
to make estimates and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses, and related disclosure of contingent assets
and liabilities. CryoPort bases its estimates on historical
experience and on various other assumptions that are believed to be reasonable
under the circumstances, the results of which form the basis of making judgments
about the carrying values of assets and liabilities that are not readily
apparent from other sources. Actual results may differ from these
estimates under different assumptions or conditions, however, in the past the
estimates and assumptions have been materially accurate and have not required
any significant changes. Specific sensitivity of each of the
estimates and assumptions to change based on other outcomes that are reasonably
likely to occur and would have a material effect is identified individually in
each of the discussions of the critical accounting policies described
below. Should we experience significant changes in the estimates or
assumptions which would cause a material change to the amounts used in the
preparation of our financial statements, material quantitative information will
be made available to investors as soon as it is reasonably
available.
CryoPort
believes the following critical accounting policies, among others, affect our
more significant judgments and estimates used in the preparation of our
unaudited consolidated financial statements:
Allowance for
Doubtful Accounts. CryoPort maintains allowances for doubtful
accounts for estimated losses resulting from the inability of CryoPort’s
customers to make required payments. The allowance for doubtful
accounts is based on specific identification of customer accounts and CryoPort’s
best estimate of the likelihood of potential loss, taking into account such
factors as the financial condition and payment history of major
customers. CryoPort evaluates the collectability of CryoPort’s
receivables at least quarterly. Such costs of allowance for doubtful
accounts is subject to estimates based on the historical actual costs of bad
debt experienced, total accounts receivable amounts, age of accounts receivable
and any knowledge of the customers’ ability or inability to pay outstanding
balances. If the financial condition of CryoPort’s customers were to
deteriorate, resulting in impairment of their ability to make payments,
additional allowances may be required. The differences could be
material and could significantly impact cash flows from operating
activities.
Inventory. CryoPort writes
down its inventories for estimated obsolescence or unmarketable inventory equal
to the difference between the cost of inventory and the estimated market value
based upon assumptions about future demand, future pricing and market
conditions. Inventory reserve costs are subject to estimates made by
CryoPort based on historical experience, inventory quantities, age of inventory
and any known expectations for product changes. If actual future
demands, future pricing or market conditions are less favorable than those
projected by management, additional inventory write-downs may be required and
the differences could be material. Such differences might
significantly impact cash flows from operating activities. Once
established, write-downs are considered permanent adjustments to the cost basis
of the obsolete or unmarketable inventories.
During
our early years, our limited revenue was derived from the sale of our reusable
product line. Our current business plan focuses on per-use leasing of
the shipping container and added-value services that will be used by us to
provide an end-to-end and cost-optimized shipping solution.
We
provide shipping containers to our customers and charge a fee in exchange for
the use of the containers. CryoPort's arrangements are similar to the
accounting standard for leases since they convey the right to use the containers
over a period of time. We retain title to the containers and provide
our customers the use of the containers for a specified shipping
cycle. At the culmination of a customer’s shipping cycle, the
container is returned to us. As a result, during the quarter ended
September 30, 2009, we reclassified the containers from inventory to fixed
assets upon commencement of the loaned-container program.
Intangible
Assets. Intangible assets
are comprised of patents and trademarks and software development
costs. CryoPort capitalizes costs of obtaining patents and trademarks
which are amortized, using the straight-line method over their estimated useful
life of five years. CryoPort capitalizes certain costs related to
software developed for internal use. Software
development costs incurred during the preliminary or maintenance project stages
are expensed as incurred, while costs incurred during the application
development stage are capitalized and amortized using the straight-line method
over the estimated useful life of the software which is five
years. Capitalized costs include purchased materials and costs of
services including the valuation of warrants issued to consultants using the
Black-Scholes option pricing model.
Impairment of
Long-Lived Assets. CryoPort assesses the recoverability of its
long-lived assets by determining whether the depreciation and amortization of
long-lived assets over their remaining lives can be recovered through projected
undiscounted cash flows. The amount of long-lived asset impairment is
measured based on fair value and is charged to operations in the period in which
long-lived asset impairment is determined by
management. Manufacturing fixed assets are subject to obsolescence
potential as result of changes in customer demands, manufacturing process
changes and changes in materials used. CryoPort is not currently
aware of any such changes that would cause impairment to the value of its
manufacturing fixed assets.
Deferred
Financing Costs. Deferred financing costs represent costs
incurred in connection with the issuance of the convertible notes
payable. Deferred financing costs are being amortized over the term
of the financing instrument on a straight-line basis, which approximates the
effective interest method.
Accrued Warranty
Costs. CryoPort estimates the costs of the standard warranty,
which is included with the reusable shippers at no additional cost to the
customer for a period up to one year. These estimated costs are
recorded as accrued warranty costs at the time of product sale. These
estimated costs are subject to estimates made by CryoPort based on the
historical actual warranty costs, number of products returned for warranty
repair, and length of warranty coverage.
Revenue
Recognition. Four conditions must be met before revenue can be
recognized: (i) there is persuasive evidence that an arrangement exists; (ii)
delivery has occurred or service has been rendered; (iii) the price is fixed or
determinable; and (iv) collection is reasonably assured. CryoPort records a
provision for sales returns and claims based upon historical experience. Actual
returns and claims in any future period may differ from CryoPort’s
estimates.
During
our early years, our limited revenue was derived from the sale of our reusable
product line. Our current business plan focuses on per-use leasing of
the shipping container and added-value services that will be used by us to
provide an end-to-end and cost-optimized shipping solution.
We
provide shipping containers to our customers and charge a fee in exchange for
the use of the containers. CryoPort’s arrangements are similar to the
accounting standard for leases since they convey the right to use the containers
over a period of time. We retain title to the containers and provide
our customers the use of the containers for a specified shipping
cycle. At the culmination of a customer’s shipping cycle, the
container is returned to us. As a result, during the quarter ended
September 30, 2009, we reclassified the containers from inventory to fixed
assets upon commencement of the loaned-container program.
Stock-Based
Compensation. CryoPort accounts for share-based payments to
employees and directors in the consolidated financial statements based upon
their fair values. CryoPort uses the Black-Scholes option pricing
model to estimate the grant-date fair value of share-based
awards. Fair value is determined at the date of grant. The
consolidated financial statement effect of forfeitures is estimated at the time
of grant and revised, if necessary, if the actual effect differs from those
estimates. The estimated average forfeiture rate for the periods
ended June 30, 2009 and 2008 was zero as CryoPort has not had a significant
history of forfeitures and does not expect forfeitures in the
future.
All
transactions in which goods or services are the consideration received by
non-employees for the issuance of equity instruments are accounted for based on
the fair value of the consideration received by non-employees or the fair value
of the equity instrument issued, whichever is more reliably
measurable. The measurement date used to determine the fair value of
the equity instrument issued is the earlier of the date on which the third party
performance is complete or the date on which it is probable that performance
will occur.
Derivative
Liabilities. Our issued and
outstanding common stock purchase warrants and embedded conversion features
previously treated as equity pursuant to the derivative treatment exemption were
no longer afforded equity treatment, and the fair value of these common stock
purchase warrants and embedded conversion features, some of which have exercise
price reset features and some that were issued with convertible debt, from
equity to liability status as if these warrants were treated as a derivative
liability since their date of issue. The common stock purchase
warrants were not issued with the intent of effectively hedging any future cash
flow, fair value of any asset, liability or any net investment in a foreign
operation. The warrants do not qualify for hedge accounting, and as
such, all future changes in the fair value of these warrants will be recognized
currently in earnings until such time as the warrants are exercised or
expire. These common stock purchase warrants do not trade in an
active securities market, and as such, we estimate the fair value of these
warrants using the Black-Scholes option pricing model.
Convertible
Debentures. If the conversion feature of conventional
convertible debt provides for a rate of conversion that is below market value,
this feature is characterized as a beneficial conversion feature
(“BCF”). A BCF is recorded by CryoPort as a debt
discount. In those circumstances, the convertible debt will be
recorded net of the discount related to the BCF. CryoPort amortizes
the discount to interest expense over the life of the debt using the effective
interest method.
Recent
Accounting Pronouncements
In
September 2006, the FASB issued new standards that defined fair value,
established a framework for measuring fair value in accordance with GAAP, and
required enhanced disclosures about fair value measurements. This framework
became effective for financial statements issued for fiscal years beginning
after November 15, 2007. In February 2008 the FASB delayed the
effective date of the fair value framework for non-financial assets and
liabilities, other than those that are recognized or disclosed at fair value on
a recurring basis, to fiscal years beginning after November 15, 2008. In
addition, in October 2008, the FASB clarified the application of the
framework in an inactive market and to illustrate how an entity would determine
fair value in an inactive market. Our adoption of the fair value framework and
for non-financial assets and liabilities did not have a material impact on our
consolidated financial statements.
In
November 2007, the Emerging Issues Task Force (EITF) issued guidance that
required collaborators to present the results of activities for which they act
as the principal on a gross basis and report any payments received from (made
to) other collaborators based on other applicable GAAP or, in the absence of
other applicable GAAP, based on analogy to authoritative accounting literature
or a reasonable, rational, and consistently applied accounting policy election.
The guidance clarified that the determination of whether transactions within a
collaborative arrangement are part of a vendor-customer (or analogous)
relationship. The guidance was effective for fiscal years beginning
after December 15, 2008 and did not have a material impact on our consolidated
financial statements.
In
December 2007, the FASB revised the requirements for accounting for
business combinations, which requires companies to record most identifiable
assets, liabilities, noncontrolling interests, and goodwill acquired in a
business combination at “full fair value.” The revised guidelines
require companies to record fair value estimates of contingent consideration and
certain other potential liabilities during the original purchase price
allocation and to expense acquisition costs as incurred. These revised standards
apply to all business combinations, including combinations by contract alone.
Further, all business combinations are to be accounted for by applying the
acquisition method. The revised business combination accounting standards were
effective for fiscal years beginning on or after December 15, 2008. Our
adoption of the business combination accounting standards did not have a
material impact on our consolidated financial statements and any future business
combinations will be evaluated under this accounting standard.
In
December 2007, the FASB issued new standards that required noncontrolling
interests (previously referred to as minority interests) be treated as a
separate component of equity, not as a liability or other item outside of
permanent equity. These guidelines apply to the accounting for noncontrolling
interests and transactions with non-controlling interest holders in consolidated
financial statements and will be applied prospectively to all noncontrolling
interests, including any that arose before the effective date except that
comparative period information must be recast to classify noncontrolling
interests in equity, attribute net income and other comprehensive income to
noncontrolling interests, and provide other required disclosures. Our adoption
of accounting for noncontrolling interests at the beginning of fiscal year 2009
had no impact on our consolidated financial statements.
In March
2008, the FASB issued new standards that required enhanced disclosures regarding
derivatives and hedging activities, including: (i) the manner in which an entity
uses derivative instruments; (ii) the manner in which derivative instruments and
related hedged items are accounted for under existing guidance; and (iii) the
effect of derivative instruments and related hedged items on an entity’s
financial position, financial performance and cash flows. The standards are
effective for financial statements issued for fiscal years and interim periods
beginning after November 15, 2008. Our adoption of the enhanced derivative and
hedging activity disclosures did not have a material impact on our consolidated
financial statements.
In
April 2009, the FASB expanded fair value disclosures required for all
financial instruments to interim periods for publicly traded entities. Entities
are required to disclose the method(s) and significant assumptions used to
estimate the fair value of financial instruments in financial statements on an
interim basis and to highlight any changes of the methods and significant
assumptions from prior periods. It does not require interim disclosures of
credit or market risks. The revised disclosure requirements did not have a
material impact on our consolidated financial statements.
In May
2009, the FASB issued established general standards of accounting for and
disclosures of events that occur after the balance sheet date, but before
financial statements are issued or are available to be issued (subsequent
events). These standards are effective prospectively for interim or annual
financial periods ending after June 15, 2009. The Company’s adoption of these
standards did not have a material impact on our consolidated financial
statements. We have evaluated subsequent events through the date of our issuance
of the consolidated financial statements.
In
June 2009, the FASB issued The FASB Accounting Standard Codification and
the Hierarchy of Generally Accepted Accounting Principles (the Codification) as
a single source of authoritative nongovernmental GAAP to be launched
July 1, 2009. The Codification does not change current GAAP, but is
intended to simplify user access to all authoritative GAAP by providing all the
authoritative literature related to a particular topic in one place. The
Codification became effective for us in the interim period ending
September 30, 2009, and as a result all references made to GAAP use the new
Codification numbering system prescribed by the FASB. However, as the
Codification is not intended to change existing GAAP, it is not expected to have
any impact on our financial position, operating results or cash
flows.
Change
in Accounting Principle
In June
2008, the EITF issued guidance to address concerns regarding the meaning of
"indexed to an entity’s own stock" as outlined in the accounting guidance for
derivative instruments and hedging activities. Equity-linked instruments (or
embedded features) that otherwise meet the definition of a derivative are not
accounted for as derivatives if certain criteria are met, one of which is that
the instrument (or embedded feature) must be indexed to the entity’s own
stock. Guidance is provided on how to determine if equity linked
instruments (or embedded features) such as warrants to purchase our stock and
convertible notes are considered indexed to our stock. Our warrant
and convertible-debt agreements contained adjustment (or ratchet) provisions in
the agreements, and accordingly, we determined that these instruments were not
indexed to our common stock. As a result, we were required to account for these
instruments as derivatives or liabilities. We adopted the guidance
beginning April 1, 2009, and applied the provisions to outstanding instruments
as of that date. The cumulative effect at April 1, 2009 to record, at fair
value, a liability for the warrants and embedded conversion feature, including
the effects on the discounts on the convertible notes of $2,595,059, resulted in
an aggregate reduction to equity of $13,875,623, consisting of a reduction to
additional paid-in capital of $4,217,730 and an increase in the accumulated
deficit of $9,657,893 to reflect the change in the accounting. Under the new
guidance our warrants and embedded conversion features will be carried at fair
value and adjusted quarterly through earnings.
BUSINESS
Overview
We are a
provider of an innovative cold chain frozen shipping system dedicated to
providing superior, affordable cryogenic shipping solutions that ensure the
safety, status and temperature of high value, temperature sensitive
materials. We have developed a line of cost effective reusable
cryogenic transport containers (referred to as "shippers") capable of
transporting biological, environmental and other temperature sensitive materials
at temperatures below 0° Celsius. These dry vapor shippers are one of
the first significant alternatives to dry ice shipping and achieve 10-plus day
holding times compared to one to two day holding times with dry
ice.
Our value
proposition comes from both providing safe transportation and an
environmentally friendly, long lasting shipper, and through our value added
services that offer a simple hassle-free solution for our
customers. These value-added services include an internet-based web
portal that enables the customer to initiate shipping service, track the
progress and status of a shipment, and provides in-transit temperature
monitoring services of the shipper. CryoPort also provides a fully
ready charged shipper containing all freight bills, customs documents and
regulatory paperwork for the entire journey of the shipper to its customers at
their pick up location.
Our
principal focus has been the further development and commercial launch of
CryoPort Express® Portal, an innovative IT solution for shipping and tracking
high-value specimens through overnight shipping companies, and our CryoPort
Express® Shipper, a line of dry vapor
cryogenic shippers for the transport of biological and pharmaceutical
materials. A dry vapor cryogenic shipper is a container that uses
liquid nitrogen in dry vapor form, which is suspended inside a vacuum insulated
bottle as a refrigerant, to provide storage temperatures below minus 150°
Celsius. The dry vapor shipper is designed using innovative,
proprietary, and patented technology which prevents spillage of liquid nitrogen
and pressure build up as the liquid nitrogen evaporates. A
proprietary foam retention system is employed to ensure that liquid nitrogen
stays inside the vacuum container, even when placed upside-down or on its side,
as is often the case when in the custody of a shipping
company. Biological specimens are stored in a specimen chamber,
referred to as a “well,” inside the container and refrigeration is provided by
harmless cold nitrogen
gas evolving from the liquid nitrogen entrapped within the foam retention system
surrounding the well. Biological specimens transported using our
cryogenic shipper can include clinical samples, diagnostics, live cell
pharmaceutical products (such as cancer vaccines, semen and embryos, infectious
substances) and other items that require and/or are protected through continuous
exposure to frozen or cryogenic temperatures (below minus 150 °
Celsius).
Corporate
History and Structure
CryoPort,
Inc. is a Nevada corporation originally incorporated under the name
G.T.5-Limited (“GT5”) on May 25, 1990. In connection with a Share
Exchange Agreement, on March 15, 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, in exchange for 2,009,009 shares (after
giving effect to the anticipated 12-to-1 reverse stock split) of our common
stock (which represented approximately 81% of the total issued and outstanding
shares of common stock following the close of the
transaction). CryoPort Systems, Inc, which was originally formed in
1999 as a California limited liability company, and subsequently reorganized
into a California corporation on December 11, 2000, remains the operating
company under CryoPort, Inc.
Market
Opportunity
As a
result of growing globalization, including with respect to such areas as life
science clinical trials and distribution of pharmaceutical products, the
requirement for effective solutions for keeping certain clinical samples and
pharmaceutical products at frozen temperatures takes on added significance due
to extended shipping times, custom delays and logistics
challenges. Today, such goods are traditionally shipped in cardboard
insulated containers packed with dry ice, gel/freezer packs or a combination
thereof. The current dry ice solutions have limitations that severely
limit their effective and efficient use for both short and long-distances (e.g.,
international). Conventional dry ice shipments often require labor
intensive “re-icing” operations resulting in higher labor and shipping
costs.
We
believe that our patented cryogenic shippers make us well positioned to take
advantage of the growing demand for effective and efficient international
transport of temperature sensitive materials resulting from continued
globalization. Of particular significance is the trend within the
pharmaceutical and biotechnology industries toward
globalization. We believe this presents a new and unique opportunity
for pharmaceutical companies, particularly early or developmental stage
companies, to conduct some of their clinical trials in foreign countries where
the cost may be cheaper and/or because the foreign countries significantly
larger population provides a larger pool of potential patients suffering from
the indication that the drug candidate is being designed to treat. We
also plan to provide domestic shipping solutions in situations and regions where
there is a high priority placed on maintaining the integrity of materials
shipped at cryogenic temperatures and where we can be cost
effective.
Our
product offering and service offering consists of our CryoPort Express®
Shippers, a line of reusable dry vapor shippers, our Smart Pak datalogger, a
temperature monitoring system (which, together with our CryoPort Express®
Shippers, comprise our new business model referred to as the CryoPort Express®
System) and a containment bag which is used in connection with the shipment of
infectious or dangerous goods using the CryoPort Express® Shipper.
The
CryoPort Express® Shippers
Our
CryoPort Express® Shippers are a line of multiple size, cryogenic dry vapor
shippers capable of maintaining cryogenic temperatures of minus 150° Celsius or
below for a period of 10 or more days. A dry cryogenic shipper is a
device that uses liquid nitrogen contained inside a vacuum insulated bottle
which serves as a refrigerant to provide storage temperatures below minus 150°
Celsius. Our CryoPort Express® shipper is designed to ensure that
there is no pressure build up as the liquid nitrogen evaporates or spillage of
liquid nitrogen. We have developed a proprietary foam retention
system to ensure that liquid nitrogen stays inside the vacuum container, which
allows the shipper to be designated as a dry shipper meeting International Air
Transport Association (“IATA”) requirements. Biological or
pharmaceutical specimens are stored in a specimen chamber, referred to as a
“well”, inside the container and refrigeration is provided by cold nitrogen gas
evolving from the liquid nitrogen entrapped within the foam retention
system. Specimens that may be transported using our cryogenic shipper
include live cell pharmaceutical products such as cancer vaccines, diagnostic
materials, semen and embryos, infectious substances and other items that require
continuous exposure to frozen or cryogenic temperatures (e.g., temperatures
below minus 150° Celsius).
The
technology underlying the CryoPort Express® Shipper was developed by modifying
and advancing technology from our first generation of reusable cryogenic dry
shippers. While our CryoPort Express® Shippers share many of the
characteristics and basic design details of our earlier shippers, we are
manufacturing our CryoPort Express® Shippers from alternative, lower cost
materials, which will reduce overall operating costs. We maintain
ongoing development efforts related to our shippers which are principally
focused on material properties, particularly those properties related to the low
temperature requirement, the vacuum retention characteristics, such as the
permeability of the materials, and lower cost materials in an effort to meet the
market needs for achieving a lower cost frozen and cryogenic shipping
solution. Other advances additional to the development work on the
cryogenic container include both an improved liquid nitrogen retention system
and a secondary protective, spill proof packaging system. This
secondary system, outer packaging has a low cost that lends itself to
disposability, and it is made of recyclable materials. Further, it
adds an additional liquid nitrogen retention capability to further assure
compliance with IATA and ICAO regulations that prohibit egress of liquid
nitrogen from the shipping package. IACO stands for the International
Civil Aviation Organization, which is a United Nations organization that
develops regulations for the safe transport of dangerous goods by
air.
Our
CryoPort Express® Shippers are lightweight, low-cost, re-usable dry vapor liquid
nitrogen storage containers that we believe combine the best features of
packaging, cryogenics and high vacuum technology. A CryoPort Express®
Shipper is composed of an aluminum metallic dewar flask, with a well for holding
the biological material in the inner chamber. The dewar flask, or
“thermos bottle,” is an example of a practical device in which the conduction,
convection and radiation of heat are reduced as much as possible. The
inner chamber of the shipper is surrounded by a high surface, low density open
cell plastic foam material which retains the liquid nitrogen in-situ by
absorption, adsorption and surface tension. Absorption is defined as
the taking up of matter in bulk by other matter, as in the dissolving of a gas
by a liquid, whereas adsorption is the surface retention of solid, liquid or gas
molecules, atoms or ions by a solid or liquid. This material absorbs
liquid nitrogen several times faster than currently used materials, while
providing the shipper with a hold time and capacity to transport biological
materials safely and conveniently. The annular space between the
inner and outer dewar chambers is evacuated to a very high vacuum (10-6
Torr). The specimen-holding chamber has a primary cap to enclose the
specimens, and a removable and replaceable secondary cap to further enclose the
specimen holding container and to contain the liquid nitrogen. The
entire dewar vessel is then wrapped in a plurality of insulating and cushioning
materials and placed in a disposable outer packaging made of recyclable
material.
We
believe the above product configuration satisfies the needs of the markets that
require the temperature-critical, frozen and refrigerated transport of
biological materials, such as the pharmaceutical clinical trials, gene
biotechnology, infectious materials handling, and animal and human reproduction
markets. Due to our proprietary technology and innovative design, our
shippers are less prone to losing functional hold time when not kept in an
upright position than the competing products because such proprietary technology
and innovative design prevent the spilling or leakage of the liquid nitrogen
when the container is tipped or on its side which would adversely affect the
functional hold time of the container.
An
important feature of the CryoPort Express® Shippers is their compliance with the
stringent packaging requirements of IATA Packing Instructions 602 and 650,
respectively. These instructions include the internal pressure
(hydraulic) and drop performance requirements.
The CryoPort
Express®
System
The
CryoPort Express® System is comprised of the CryoPort Express® Shipper, the CryoPort Express® Smart Pak data logger, CryoPort Express® Portal, which manages order
entry and all aspects of shipping operations, and CryoPort Express® Analytics, which monitors
shipment performance metrics and evaluates temperature monitoring data collected
by the data logger during shipment. The CryoPort Express® System is
focused on improving the reliability of frozen shipping while reducing the
customers’ overall operating costs. This is accomplished by providing
a complete end-to-end solution for the transport and monitoring of frozen or
cryogenically preserved biological or pharmaceutical materials shipped though
overnight shipping companies.
CryoPort
Express®
Portal
The
CryoPort Express® Portal is used by CryoPort, our customers and our
business partners to automate the entry of orders, prepare customs documentation
and to facilitate status and location monitoring of shipped orders while in
transit. As an example, the CryoPort Express® Portal is
fully integrated with IT systems at FedEx and runs in a browser requiring no
software installation. It is used by CryoPort to manage shipping
operations and to reduce administrative costs typically provisioned through
manual labor relating to order-entry, order processing, preparation of shipping
documents and back-office accounting. It is also used to support the high level
of customer service expected by the industry. Certain features of the
CryoPort Express® Portal reduce operating costs and facilitate the scaling
of CryoPort’s business, but more importantly they offer significant value to the
customer in terms of cost avoidance and risk mitigation. Examples
these features include automation of order entry, development of Key Performance
Indicators (“KPI”) to support our efforts for continuous process improvements in
our business, and programmatic exception monitoring to detect and sometimes
anticipate delays in the shipping process, often before the customer or the
shipping company becomes aware of it. In the future we will add rate
and mode optimization and in-transit monitoring of temperature, location and
state of health (discussed below), via wireless communications.
The
CryoPort Express® Portal also serves as the communications nerve center for
the management, collection and analysis of Smart Pak data harvested from Smart
Pak data loggers in the field. Data is converted into pre-designed reports
containing valuable and often actionable information that becomes the quality
control standard or “pedigree” of the shipment. This high value
information can be utilized by CryoPort to provide consultative services to the
customer relating to cryogenics.
The
CryoPort Express® Smart
Pak
Temperature
monitoring is a high value feature from our customers' perspective as it is
an effective and reliable method to determine that the shipment materials were
not damaged or degraded during shipment due to temperature
fluctuations. We recently completed successful testing of Phase II of
our Smart Pak System which is a self-contained automated data logger capable of
recording the internal and external temperatures of samples shipped in our
CryoPort Express® Shipper, and we anticipate commercial launch of this added
feature in 2010.
Phase III
of our Smart Pak System is anticipated to launch by the end of fiscal year 2010,
and consists of adding a smart chip to each shipper with wireless
connectivity to enable our customers to monitor a shipper’s location, specimen
temperature and overall state of health via our web portal. A key
feature of the Phase III product is automatic downloading of data which requires
no customer intervention.
CryoPort
Express®
Analytics
Our
continued development of the CryoPort Express® Portal is a strategic element of
our business strategy and the CryoPort Express® Portal system has been
designed to support planned future features with this thought in
mind. Analytics is a term used by IT professionals to refer to
performance benchmarks or Key Performance Indicators (KPI’s) that management
utilizes to measure performance against desired standards. Examples include
time-based metrics for order processing time and on-time deliveries by our
shipping partners, as well as profiling shipping lanes to determine average
transit times and predicting an exception if a
shipment is taking longer than it should based on historical
metrics. The analytical results will be utilized by CryoPort to
render consultative customer services.
Biological
Material Holders
We have
also developed a patented containment bag which is used in connection with the
shipment of infectious or dangerous goods using the CryoPort Express® Shipper.
Up to five vials, watertight primary receptacles, are placed onto aluminum
holders and up to fifteen holders (75 vials) are placed into an absorbent pouch
which is designed to absorb the entire contents of all the vials in the event of
leakage. This pouch containing up to 75 vials is then placed in a
watertight secondary packaging Tyvek bag capable of withstanding cryogenic
temperatures, and then sealed. This bag is then placed into the well
of the cryogenic shipper.
Future
Products
We are
continuing our research and development efforts which are expected to lead to
the introduction of additional dry vapor shippers, including larger and smaller
size units constructed of lower cost materials and utilizing high volume
manufacturing methods. We are also exploring the use of alternative
phase change materials in place of liquid nitrogen in order to seek entry into
the ambient temperature and chilled (2° to 8° Celsius) shipping
markets.
Competitive
Strengths
We
believe that our cryogenic shipping systems provide us with the following
competitive strengths:
Maintaining the
Integrity of Materials Shipped. We have developed our CryoPort
Express® Shippers, a line of cryogenic dry vapor shippers, to be capable of
maintaining cryogenic temperatures of minus 150° Celsius or less for 10-plus
days. Our CryoPort Express® Shippers were developed with a view
towards meeting the needs of the global biotechnology and pharmaceutical
industries which require the ability to transport live cell pharmaceutical
products, such as cancer vaccines, diagnostic materials, reproductive tissues,
infectious and other biological substances, and other items at constant frozen
or cryogenic temperatures. Traditional methods that have been serving
this market, such as dry ice, are only capable of maintaining such temperatures
for a period of one to two days (depending on the size of the package and amount
of dry ice used), thereby potentially jeopardizing the integrity of the
transported materials during longer shipments. We believe our
CryoPort Express® Shippers are the first significant alternative to using dry
ice that achieves 10-plus day holding times.
Durability of
Shipping Devices. Because the outer shell of our CryoPort
Express® Shippers are made from durable materials, as compared to corrugated
cardboard boxes with Styrofoam inserts or similar materials, the risk of damage
to the container and its contents is significantly reduced. Where
corrugated cardboard boxes are susceptible to being crushed or damaged during
shipment, our shippers, which have been tested and are capable of withstanding
drops of up to 30 feet, significantly reduce the risk of damage to the packaged
materials. The durability and long holding times of our shippers has
greater significance for international (or other long distance) shipments due to
the increased shipping times and amplified risk of damage during transit and
mishandling during shipment.
Cost. We
believe we have developed a solution for the shipment of temperature sensitive
materials which is not only more effective, but also more cost efficient,
especially in international shipping. Shipping temperature sensitive
materials using the traditional method of dry ice requires multiple steps,
manual intervention/monitoring, and the coordination of re-icing tasks at
several locations to provide a solution lasting for more than several
days. The cost of developing and maintaining the infrastructure
necessary to support these operations frequently depend on off-shore third party
contractors which adds significant cost. Because our cryogenic
shippers are capable of hold times of 10 plus days, customers will not require
the same extensive infrastructure needed for dry ice
shipments. Furthermore, because our shippers do not rely on dry ice
(which is a hazardous material that produces CO2 gas as it sublimates), there
are more freight carrier alternatives available for our shippers and generally
lower freight charges.
Tracking and
Monitoring. We have developed a sophisticated web portal with
user friendly features that will be used for capturing customer orders and
tracking shipments. Our portal enables CryoPort employees to manage
multi-route shipments with minimal amount of human resources by using programmed
analogs and exception monitoring. In addition, our customers are able
to place orders, track shipments, and monitor the status of their package
through our web portal. CryoPort is also able to internally manage
its shipper inventory, track incoming and outgoing assets, report on shipping
performance metrics, and invoice for shipping services through the technology
employed through its web portal.
The Green
Alternative. Unlike shippers using dry ice, the internal core
of our cryogenic shippers absorbs liquid nitrogen in a gaseous state which then
maintains the required cryogenic temperatures. Dry ice is a hazardous
material because it produces excess CO2 gas as it sublimates which is a noted
greenhouse gas and which may be dangerous in confined spaces where there is an
absence or low rates of ventilation. Use of our shippers does not
result in the emission of greenhouse gases or other potentially toxic
materials. In addition, shippers using dry ice are made of corrugated
cardboard with Styrofoam inserts. These shippers are typically not
reusable, resulting in the disposal of the cardboard box. Further,
Styrofoam should not be disposed of in landfills because it is not
biodegradable. Our shippers do not contain Styrofoam, nor do they
present similar landfill disposal issues or other environmental
challenges.
Technology. Once our CryoPort
Express® System
is fully operational, it will represent the most complete and comprehensive
shipping solution available in the market for high-value temperature sensitive
materials. It will reduce operating costs for CryoPort and its
customers and it will provide customized analytics to monitor shipping
efficiency and the health and status of the materials entrusted to our
care.
Key
Business Strategies
Relationship with
Global Couriers. We believe that our near term success is best
achieved by establishing strategic relationships with global couriers which will
enable us to provide a seamless, end-to-end shipping solution to our
customers. In addition, we will be able to leverage the couriers’
established express, ground and freight infrastructures and penetrate new
markets with minimal investment. The management team is in advanced
discussions with one global freight courier and commencing discussions with
others to establish partnerships in which the couriers would provide preferred
shipping rates, access to logistics, tracking and custom clearance
capabilities. We also expect that the global freight couriers will utilize
their sales forces to promote and sell the frozen shipping
services. We can not assure you that we will be able to consummate
such an agreement with any global couriers.
Target Large
Clinical Research Organizations and Life Science
Companies. Along with our efforts to establish a strategic
relationship with global couriers, we intend to increase our marketing efforts
to the large CROs and pharmaceutical and biotechnology companies engaged in
the management and/or conduct of both domestic and international clinical
trials. Management has been in active dialogue with selected large
CROs, and pharmaceutical and biotechnology companies to introduce this new
frozen shipping solution and to discuss these potential customers’ shipping
needs. Several of these meetings have been joint presentations including
representatives from a global courier. We can not assure you that we
will be able to consummate an agreement with one or more large CROs, or
pharmaceutical or biotechnology companies.
Position CryoPort
Express® Portal as a New
Customer Tool for Cost Optimization and Risk Mitigation. In 2008, we
began development of an internal IT system, CryoPort Express® Portal, which
today is used by customers to automate the entry of orders, prepare customs
documentation, and facilitate status and location monitoring of shipped orders
while in transit. The CryoPort Express® Portal is fully
integrated with IT systems at FedEx and runs in a browser requiring no software
installation. It is used by CryoPort to manage shipping operations
typically provisioned by manual labor thereby reducing administrative costs
relating to order-entry, order processing, preparation of shipping documents,
back-office accounting and to support the high level of customer service
expected by the industry. In addition to reducing operating
costs and facilitate scaling of CryoPort’s operations, more importantly we
believe the CryoPort Express® Portal offers significant value to the
customer in terms of cost avoidance and risk mitigation. Examples
include automation of order entry, development of Key Performance Indicators
(“KPI”) to support our efforts for continuous process improvements in our
business, and programmatic exception monitoring to detect and sometimes
anticipate delays in the shipping process, often before the customer or the
shipping company becomes aware of the delays. In the future we intend
to add rate and mode optimization and in-transit monitoring of temperature,
location and state-of-health monitoring via wireless
communications.
Complete
Development of Our Smart Pak Monitoring Device. In July 2008,
we launched Phase I of our CryoPort Express® Portal which enabled our customers
to enter orders and track their packages during transit. We recently
completed successful testing of Phase II of our Smart Pak Monitoring Device
which is an automated data logger capable of tracking the internal and external
temperatures of samples shipped in our CryoPort Express® Shipper. We
anticipate commercial launch of this new feature in 2010. Phase III
of our Smart Pak Monitoring Device development plan, which we expect to launch
by the end of fiscal year 2010, consists of adding a wireless communications
capability to each shipper to enable monitoring of a shipper’s location,
specimen temperature, and overall state of health of the contents during
transit. We anticipate that, due to the high value and importance
placed on the contents of the shipper by the customer, location and
state-of-health monitoring the contents will become a new standard in the
industry pioneered by CryoPort and fully integrated into CryoPort Express®
Portal.
Completing
the development of our Smart Pak Wireless Monitoring Device is a key component
of our CryoPort Express® System which, once fully implemented, will provide
customers with a one-stop solution, via our web portal, to manage the scheduling
and shipping of temperature sensitive biological or pharmaceutical samples and
drug materials, as well as any other materials requiring cryogenic
transport.
Expand to New
Markets. To date our marketing efforts have focused on select
companies in the global CRO, and biotechnology and pharmaceutical
industries. Once we have expanded our market presence in these
industries and established the strategic relationships referenced above, we
intend to explore opportunities in other markets following the first year of
commercialization where there is a need to ship temperature sensitive materials
such as the food, environmental, semiconductor and petroleum
industries.
Re-Purpose
Product Capability. Presently,
CryoPort products address the needs of biotechnology and pharmaceutical
customers who require sustainable frozen shipping temperatures generally
between the range of minus 80° to minus 150° Celsius. While the
frozen market represents a large opportunity for CryoPort, an adjacent market
exists for the shipment of materials at chilled temperatures. Based
on a report prepared by DHL Worldwide Express, Inc. in April 2001, the market
for pharmaceutical shipments at chilled temperatures is more than double the
market for cryogenic and frozen shipments. CryoPort’s technology may
be applicable to these markets as well since the design concepts of CryoPort
products can be applied to stabilize materials at any desired
temperature. CryoPort is exploring these expansions of its current
business model.
Sales
and Marketing
We
currently have one internal sales person who manages both our direct sales
efforts and our limited third party resellers, which include Miller Supply, Air
Liquide and Tegrant. Our current distribution channels cover the
Americas, Europe and Asia. During the fiscal year ended March 31,
2009, Miller Supply accounted for 18% of our overall sales
volumes. These sales comprised our shipping accessories and our first
generation reusable dry vapor shippers which we discontinued during the past
fiscal year.
Our
geographical sales for the year ended March 31, 2009 were as
follows:
We plan
to further expand our sales and marketing efforts through the establishment of a
strategic relationship with a global courier and, subject to available financial
resources, the hiring of additional sales and marketing personnel.
Customers
To date,
most of our customers have been in the pharmaceutical or medical
industries. As we initially focus or efforts to increase revenues, we
believe that the primary target customers for our CryoPort Express® System are
concentrated in the following markets, for the following reasons:
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Pharmaceutical
clinical trials / Contract Research Organizations;
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Gene
biotechnology;
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Transport
of infectious materials and dangerous goods;
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Pharmaceutical
distribution; and
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Human
assisted reproduction/artificial
insemination.
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Pharmaceutical
Clinical Trials. Every pharmaceutical company developing a new
drug must be approved by the FDA who conducts clinical trials to, among other
things, test the safety and efficacy of the potential new drug. Presently,
a significant amount of clinical trial activity is managed by a number of large
CROs. Due to the growing downsizing trend in the pharmaceutical
industry, CROs are going to obtain an increasing share of the clinical trial
market.
In
connection with the clinical trials, due to globalization the companies may
enroll patients from all over the world who regularly submit a blood or other
specimen at the local hospital, doctor’s office or laboratory. These
samples are then sent to specified testing laboratories, which may be local or
in another country. The testing laboratories will typically set the
requirements for the storage and shipment of blood specimens. In
addition, several of the drugs used by the patients require frozen shipping to
the sites of the clinical trials. While both domestic and
international shipping of these specimens is accomplished using dry ice today,
international shipments especially present several problems, as dry ice, under
the best of circumstances, can only provide freezing for one to two days,
in the absence of re-icing (which is quite costly). Because shipments
of packages internationally can take longer than one to two days or be
delayed due to flight cancellations, incorrect destinations, labor problems,
ground logistics, customs and safety reasons, dry ice is not always a reliable
and cost effective option. 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 years. Sample integrity during the shipping process is
vital to retaining the maximum number of patients in each trial. Our
shippers are ideally suited for this market, as our longer hold time ensures
that specimens can be sent over long distances with minimal concern that they
will arrive in a condition that will cause their exclusion from the
trial. There are also many instances in domestic shipments where the
CryoPort Express® Shipper will provide higher reliability and be cost
effective.
Furthermore,
the IATA requires that all airborne shipments of laboratory specimens be
transmitted in either IATA 650 or 602 certified packaging. We have
developed and obtained IATA certification of the CryoPort Express® System, which
is ideally suited for this market, in particular due to the elimination of the
cost to return the reusable shipper.
Gene
Biotechnology. The gene biotechnology market includes basic
and applied research and development in diverse areas such as stem cells,
cloning, gene therapy, DNA tumor vaccines, tissue engineering, genomics, and
blood products. Company’s participating in the foregoing fields rely on the
frozen transport of specimens in connection with their research and development
efforts, for which our CryoPort Express® Shippers are ideally
suited.
Transport of
Infectious Materials and Dangerous Goods. The transport of
infectious materials must be classified as such and must maintain strict
adherence to regulations that protect public safety while maintaining the
viability of the material being shipped. Some blood products are
considered infective and must be treated as such. Pharmaceutical
companies, private research laboratories and hospitals ship tissue cultures and
microbiology specimens, which are also potentially infectious materials, between
a variety of entities, including private and public health reference
laboratories. Almost all specimens in this infectious materials
category require either a refrigerated or frozen environment. We
believe our CryoPort Express® Shipper is ideally suited to meet the shipping
requirements of this market.
Partly in
response to the attack on the World Trade Center and the anthrax scare,
government officials and health care professionals are focusing renewed
attention on the possibility of attacks involving biological and chemical
weapons such as anthrax, smallpox and sarin gas. Efforts expended on
research and development to counteract biowarfare agents requires the frozen
transport of these agents to and from facilities conducting the research and
development. Vaccine research, including methods of vaccine delivery,
also requires frozen transport. We believe our CryoPort Express®
Shipper is ideally suited to this type of research and development.
Pharmaceutical
Distribution. The current focus for the CryoPort Express®
System also includes the area of pharmaceutical distribution. There
are a significant number of therapeutic drugs and vaccines currently or soon to
be, undergoing clinical trials. After the FDA approves them for
commercial marketing, it will be necessary for the manufacturers to have a
reliable and economical method of distribution to the physician who will
administer the product to the patient. Although there are not now a
large number of drugs requiring cryogenic transport, there are a number in the
development pipeline. It is likely that the most efficient and
reliable method of distribution will be to ship a single dosage to the
administering physician. These drugs are typically identified to
individual patients and therefore will require a complete tracking history from
the manufacturer to the patient. The most reliable method of doing
this is to ship a unit dosage specifically for each patient. Because
the drugs require maintenance at frozen or cryogenic temperatures, each such
shipment will require a frozen or cryogenic shipping
package. CryoPort anticipates being in a position to service that
need.
Assisted Human
Reproduction. We estimate that artificial insemination
procedures in the United States account for at least 50,000 doses of semen
annually. Since relatively few sperm banks provide donor semen,
frozen shipping
is almost always involved. As with animal semen, human semen must be
stored and shipped at cryogenic temperatures to retain viability, stabilize
the cells, and ensure reproducible results. This can only be
accomplished with the use of liquid nitrogen or LN2 dry vapor
shippers. CryoPort anticipates that this market will continue to
increase as this practice gains acceptance in new areas of the
world.
In
addition to the above markets, our longer-term plans include expanding into new
markets including, the diagnostics, food, environmental, semiconductor and
petroleum industries.
Industry
Overview
Our
products and services are sold into a rapidly growing niche of the packaging
industry focused on the temperature sensitive packaging and shipping of
biological materials. Expenditures for “value added” packaging for
frozen transport have been increasing for the past several years and, due in
part to continued globalization, are expected to continue to increase even more
in the future as more domestic and international biotechnology firms introduce
pharmaceutical products that require continuous refrigeration at cryogenic
temperatures. We believe this will require a greater dependence on
passively controlled temperature transport systems (i.e., systems having no
external power source).
We
believe that growth in the following markets has resulted in the need for
increased efficiencies and greater flexibility in the temperature sensitive
packaging market:
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Pharmaceutical
clinical trials, including transport of tissue culture
samples;
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Pharmaceutical
commercial product distribution;
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Transportation
of diagnostic specimens;
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Transportation
of infectious materials;
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Intra
laboratory diagnostic testing;
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Transport
of temperature-sensitive specimens by courier;
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Analysis
of biological samples;
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Environmental
sampling;
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Gene
and stem cell biotechnology and vaccine production; and
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Food
engineering.
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Many of
the biological products in these above markets require transport in a frozen
state as well as the need for shipping containers which have the ability to
maintain a frozen, cryogenic environment (e.g., minus 150° Celsius) for a period
ranging from two to ten days (depending on the distance and mode of
shipment). These products include semen, embryo, tissue, tissue
cultures, cultures of viruses and bacteria, enzymes, DNA materials, vaccines and
certain pharmaceutical products. In some instances, transport of
these products requires temperatures at, or approaching, minus 196°
Celsius.
One
problem faced by many companies operating in these specialized markets is the
limited number of cryogenic shipping systems serving their needs, particularly
in the areas of pharmaceutical companies conducting clinical
trials. The currently adopted protocol and the most common method for
packaging frozen transport in these industries is the use of solid carbon
dioxide (dry ice). Dry ice is used in shipping extensively to
maintain a frozen state for a period of one to four days. Dry ice is
used in the transport of many biological products, such as pharmaceuticals,
laboratory specimens and certain infectious materials that do not require true
cryogenic temperatures. The common approach to shipping these items
via ground freight is to pack the product in a container, such as an expanded
polystyrene (Styrofoam) box or a molded polyurethane box, with a variable
quantity of dry ice. The box is taped or strapped shut and shipped to
its destination with freight charges based on its initial shipping
weight.
With
respect to shipments via specialized courier services, there is no standardized
method or device currently in use for the purpose of transporting
temperature-sensitive frozen biological specimens. One common method
for courier transport of biologicals is to place frozen specimens, refrigerated
specimens, and ambient specimens into a compartmentalized container, similar in
size to a 55 quart Coleman or Igloo cooler. The freezer compartment
in the container is loaded with a quantity of dry ice at minus 78° Celsius,
while the refrigerated compartment at 8° Celsius utilizes ice
substitutes.
Two
manufacturers of the polystyrene and polyurethane containers frequently used in
the shipping and courier transport of dry ice frozen specimens are Insulated
Shipping Containers, Inc. and Tegrant (formerly SCA Thermosafe). When
these containers are used with dry ice, the average sublimation rate (e.g., the
rate at which dry ice turns from a solid to a gaseous state) in a container with
a 1½ inch wall thickness is slightly less than three pounds per 24
hours. Other existing refrigerant systems employ the use of gel packs
and ice substitutes for temperature maintenance. Gels and eutectic
solutions (phase changing materials) with a wide range of phasing temperatures
have been developed in recent years to meet the needs of products with varying
specific temperature control requirements.
The use
of dry ice and ice substitutes, however, regardless of external packaging used,
are frequently inadequate because they do not provide low enough storage
temperatures and, in the case of dry ice, last for only a few days without
re-icing. As a result, companies run the risk of increased costs due
to lost specimens and additional shipping charges due to the need to
re-ice.
Some of
the other disadvantages to using dry ice for shipping or transporting
temperature sensitive products are as follows:
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Availability
of a dry ice source;
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Handling
and storage of the dry ice;
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Cost
of the dry ice;
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Weight
of containers when packed with dry ice;
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Securing
a shipping container with a high enough R-value (which is a measure of
thermal resistance) to hold the dry ice and product for the required time
period;
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Securing
a shipping container that meets the requirements of IATA, the DOT,
the CDC, and other regulatory agencies; and
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The
emission of green house gases into the
environment.
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Due to
the limitations of dry ice, shipment of specimens at true cryogenic temperatures
can only be accomplished using liquid nitrogen dry vapor shippers, or by
shipping over actual liquid nitrogen. While such shippers provide
solutions to the issues encountered when shipping with dry ice, they too are
experiencing some criticisms by users or potential users. For
example, the cost for these products typically can range from $650 to $3,000 per
unit, which can substantially limit their use for the transport of many common
biologics, particularly with respect to small quantities such as is the case
with direct to the physician drug delivery. Because of the initial
cost and limited production of these containers, they are designed to be
reusable. However, the cost of returning these heavy containers can
be significant, particularly in international markets, because most applications
require only one-way shipping. We expect to provide a cost effective
solution compared to dry ice. We believe we will provide an overall
cost savings of 10% to 20% for international and specialty shipments compared to
dry ice.
Another
problem with these existing systems relates to the hold time of the unit in a
normal, upright position versus the hold time when the unit is placed on its
side or inverted. If a container is laying on its side or is inverted the
liquid nitrogen is prone to leaking out of the container due to a combination of
factors, including a shift in the equilibrium height of the liquid nitrogen
in the absorbent material and the relocation of the point of
gravity, which affects the hold time and compromises the dependability of
the dry shipper, particularly when used in circumstances requiring lengthy
shipping times. Due to the use of our proprietary technology, our
CryoPort Express® Shippers are not prone to leakage when on their side or
inverted, thereby protecting the integrity of our shipper's hold
time.
Competition
Within
our intended markets for our CryoPort Express® Shippers, there is limited known
competition. We intend to become competitive by reason of our
improved technology in our products and through the use of our service enabled
business model. The CryoPort Express® System provides a simple,
effective solution for the frozen or cryogenic transport of biological or
pharmaceutical materials using CryoPort Express® Portal, our web-based
order-entry system, which manages the scheduling and shipping of the CryoPort
Express® Shippers. In addition to the traditional dry ice shipping,
suppliers, such as MVE/Chart Industries, Taylor Wharton, and Air Liquide, have
various models of dry shippers available that are prohibitive for multi-use
and multi-shipment purposes due to their significantly greater unit costs
and unit weight (which may substantially increase the shipping
cost). On the other hand, they are more established and have larger
organizations and have greater financial, operational, sales and marketing
resources and experience in research and development than we
do. Factors that we believe give us a competitive advantage are
attributable to our shipping container which allows our shipper to retain liquid
nitrogen when placed in non-upright positions, the overall “leak-proofness” of
the our package which determines compliance with shipping regulations and the
overall weight and volume of the package which determines shipping costs, and
our business model represented by the merged integration of our shipper with
CryoPort Express Portal and Smart Pak datalogger into a seamless shipping,
tracking and monitoring solution. Other companies that offer
potentially competitive products include Industrial Insulation Systems, which
offers cryogenic transport units and has partnered with Marathon Products Inc.,
a manufacturer and global supplier of wireless temperature data collecting
devices used for documenting environmentally sensitive products through the cold
chain and Kodiak Thermal Technologies, Inc. which offers, among other
containers, a repeat use active-cool container that uses free piston stirling
cycle technology. While not having their own shipping devices,
BioStorage Technologies is potentially a competitive company through their
management services offered for cold-chain logistics and long term biomaterial
storage. In addition, BioMatrica, Inc. is developing and offering
technology that stabilizes biological samples and research materials at room
temperature. They presently offer these technologies primarily to
research and academic institutions, however, their technology may eventually
enter the broader cold-chain market.
Research
and Development
Our
research and development efforts are focused on continually improving the
features of the CryoPort Express® System including the web based customer
service portal and the CryoPort Express® Shippers. Further these
efforts are expected to lead to the introduction of shippers of varying sizes
based on market requirements, constructed of lower cost materials and utilizing
high volume manufacturing methods that will make it practical to provide the
cryogenic packages offered by the CryoPort Express® System. Other
research and development effort has been directed toward improvements to the
liquid nitrogen retention system to render it more reliable in the general
shipping environment and to the design of the outer
packaging. Alternative phase change materials in place of liquid
nitrogen may be used to increase the potential markets these shippers can serve
such as ambient and 2-8°C markets. Our research and development
expenditures during the six months ended September 30, 2009 and for the
fiscal years ended March 31, 2009 and 2008 were $180,791, $297,378 and
$166,227, respectively.
Manufacturing
The
component parts for our products are primarily manufactured at third party
manufacturing facilities. We also have a warehouse at our corporate
offices in Lake Forest, California, where we are capable of manufacturing
certain parts and fully assemble our products. Most of the
components that we use in the manufacture of our products are available from
more than one qualified supplier. For some components, however, there
are relatively few alternate sources of supply and the establishment of
additional or replacement suppliers may not be accomplished immediately,
however, we have identified alternate qualified suppliers which we believe could
replace existing suppliers. Should this occur, we believe the maximum
disruption of production could be a short period of time, on the order of
approximately four to six weeks.
Primary
manufacturers used by us include Spaulding Composites Company, Peterson Spinning
and Stamping, Lydall Industrial Thermal Solutions, and Ludwig,
Inc. There are no specific agreements with any manufacturer nor are
there any long term commitments to any manufacturer. We believe that
any of the manufactures currently used by us could be replaced within a short
period of time as none have a proprietary component or a substantial capital
investment specific to our products.
Our
production and manufacturing process incorporates innovative technologies
developed for aerospace and other industries which are cost effective, easier to
use and more functional than the traditional dry ice devices and other methods
currently used for the shipment of temperature-sensitive
materials. Our manufacturing process uses non-hazardous cleaning
solutions which are provided and disposed of by a supplier approved by the
Environmental Protection Agency (the “EPA”). EPA compliance costs for
us are therefore negligible.
Intellectual
Property
In order
to remain competitive, we must develop and maintain protection on the
proprietary aspects of its technologies. We rely on a combination of
patents, copyrights, trademarks, trade secret laws and confidentiality
agreements to protect our intellectual property rights. We
currently own four registered United States trademarks and three issued United
States patents primarily covering various aspects of our products. In
addition, we have filed a patent application for various aspects of our
shipper and web-portal, which includes, in part, various aspects of our business
model referred to as the CryoPort Express® System, and we intend to file
additional patent applications to strengthen our intellectual property
rights. The technology covered by the above indicated issued patents
relates to matters specific to the use of liquid nitrogen dewars in connection
with the shipment of biological materials. The concepts include those
of disposability, package configuration details, liquid