PRELIMINARY PROSPECTUS |
Subject
to Completion
|
October 6,
2009 |
CRYOPORT,
INC.
Common
Stock and Warrants
This is a
firm commitment public offering of 2,040,816 units, consisting of an aggregate
of 2,040,816 shares of our common stock and warrants to purchase an additional
2,040,816 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 10-to-1. On September 30, 2009, the last reported sale price for
our common stock was $4.90 per share (giving effect to the anticipated 10-to-1
reverse split).
We intend
to apply for listing of our common stock and warrants on the Nasdaq Capital
Market under the symbol “COLD” and “COLDW,” respectively, which we expect to
occur immediately prior to the date of this prospectus. 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 7.
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined whether this
prospectus is truthful or complete. Any representation to the contrary is a
criminal offense.
|
|
Per
share
|
|
|
Total
|
|
Public
offering price
|
|
$ |
|
|
|
$ |
|
|
Underwriting
Discounts and Commissions (1)
|
|
$ |
|
|
|
$ |
|
|
Proceeds,
before expenses, to us (2)
|
|
$ |
|
|
|
$ |
|
|
(1)
|
Does
not include a non-accountable expense allowance equal to 1% of the gross
proceeds of this offering payable to Rodman & Renshaw, LLC, the
representative of the underwriters. Non-accountable expenses are estimated
to be $100,000.
|
(2)
|
We
estimate that the total expenses of this offering will be approximately
$300,000, consisting of $100,000 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.
|
We have
granted a 45-day option to the representative of the underwriters to purchase
306,123 additional shares of common stock and warrants to be offered by us
solely to cover over-allotments, if any. If the underwriters exercise their
right to purchase additional shares of common stock and warrants to cover
over-allotment, we estimate that we will receive gross proceeds of $1,500,000
from the sale of 306,123 shares of common stock and warrants being offered at an
assumed public offering price of $4.90 per share and net proceeds of $1,365,000
after deducting $135,000 for underwriting discounts and commissions. The shares
and warrants 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 underwriter representative, a warrant to purchase up
to 10% (or 204,082) of the shares sold (excluding the over-allotment) for $100.
If the underwriters’ representative exercises this warrant, each share of common
stock may be purchased at $6.125 per share (125% of the price of the units sold
in the 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 to purchasers in the offering on or
about [*], 2009.
Rodman
& Renshaw, LLC
The date
of this prospectus is _____________, 2009.
TABLE
OF CONTENTS
Prospectus
Summary
|
1
|
Risk
Factors
|
7
|
Forward-Looking
Statements
|
19
|
Use
Of Proceeds
|
20
|
Market
For Common Equity And Related Stockholder Matters
|
20
|
Determination
Of Offering Price
|
21
|
Capitalization
|
22
|
Dilution
|
23
|
Management’s
Discussion And Analysis Or Plan Of Operation
|
24
|
Business
|
33
|
Description
Of Property
|
43
|
Legal
Proceedings
|
43
|
Directors
And Executive Officers
|
44
|
Director
Compensation
|
51
|
Compensation
Committee Interlocks And Insider Participation
|
52
|
Security
Ownership Of Certain Beneficial Owners And Management
|
53
|
Certain
Relationships And Related Transactions
|
54
|
Description
Of Securities
|
55
|
Underwriting
And Plan Of Distribution
|
56
|
Legal
Matters
|
64
|
Experts
|
64
|
Where
You Can Find More Information
|
64
|
Disclosure
Of Commission Position On Indemnification For Securities Act
Liabilities
|
65
|
Index
To Financial Statements Cryoport, Inc.
|
66
|
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 7, 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 share amounts and prices assume the consummation of a
reverse stock split, at an anticipated ratio of 10-to-1 to be effected prior to
the effectiveness 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 capable of transporting biological, environmental
and other temperature sensitive materials at temperatures below zero degrees
centigrade. These dry vapor shippers are the first significant
alternative to using dry ice and achieve 10+ day holding times compared to 1–2
day holding times with dry ice.
Our value proposition comes from both
providing a safe, transportation and 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
and allows the customer to track the progress and status of a shipment, and
in-transit temperature monitoring services of the shipper. CryoPort
also provides to its customer at their pick up location, the fully ready charged
shipper containing all freight bills, customs documents and regulatory paperwork
for the entire journey of the shipper.
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°
centigrade. The dry vapor shipper is designed using innovative,
proprietary, and patent pending technology such that there can be no pressure
build up as the liquid nitrogen evaporates, nor any spillage of liquid
nitrogen. 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, “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 (less than -150 ° C).
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 toward globalization. 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 high integrity of maintaining materials at
cryogenic temperatures is considered a priority and where we are 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, capable of
maintaining cryogenic temperatures of minus 150 degrees centigrade or less for
ten 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 had been serving
this market, such as dry ice, are only capable of maintaining such temperature
hold times 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 in connection with longer shipments. Our CryoPort
Express® Shippers are the first significant alternative to using dry ice and
achieve 10+ 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 thirty (30) feet, significantly reduce the risk of damage to the
packaged materials. The durability and long holding times of our
shippers takes on added significance when one considers the increased shipping
time and occurrences of handling in connection with international shipments both
of which amplify the risk of damage during transit.
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 ten or more days, users of our products
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 the package through
our web portal. CryoPort is also able to internally manage its
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 shipping using dry ice, the internal core
of our cryogenic shippers absorbs liquid nitrogen in a gaseous state, which then
maintains the required cryogenic temperatures. Because dry ice is a
hazardous material, as it sublimates, it produces excess CO2 gas which is a
noted greenhouse gas and which may be dangerous in confined spaces where there
is an absence of ventilation or ventilation rates are low. Use of our
shippers does not result in the emission of greenhouse gases or other
potentially toxic materials as is the case with dry ice. In addition,
shipping containers using dry ice are made of corrugated cardboard with
Styrofoam inserts. These shippers are typically not reusable,
resulting in the disposal of cardboard box and Styrofoam, which 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 Courier. We believe that our near term success is best
achieved by establishing a strategic relationship with a global courier which
will enable us to provide a seamless, end-to-end shipping solution to
customers. In addition, we will be able to leverage the courier’s
established express, ground and freight infrastructures and penetrate new
markets with minimal investment. The management team is in advanced discussions
with global freight carriers to establish a strategic partnership in which the
carrier would provide preferred shipping rates, access to logistics, tracking
and custom clearance capabilities. We also expect that the global freight
carrier will utilize their sales force to promote and sell the frozen shipping
services in connection with the carrier. We can not assure you that
we will be able to consummate such an agreement with a global
courier.
Target Large
Clinical Research Organizations and Life Science
Companies. Along with our efforts to establish a strategic
relationship with a global courier, 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 clinical
trials both domestic and international. Management has been in active
dialogue with selected large CRO’s, pharmaceutical and biotechnology companies
to introduce this new frozen shipping solution and to discuss these potential
customers shipping needs. Several of such meetings have included
representatives from a global freight forwarder in joint presentations with
us. We can not assure you that we will be able to consummate an
agreement with one or more large CROs.
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 to 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
and to reduce 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 –but typically
provisioned by manual labor. Certain features of the CryoPort
Express® Portal reduce operating costs and facilitate scaling of CryoPort
but more importantly, they offer 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
it. 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 System. 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 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 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 will become a new standard in
the industry –pioneered by CryoPort and fully integrated into CryoPort Express®
Portal.
Expand to New
Markets. To date we have focused our efforts marketing our
shippers to selected companies in the global CRO, 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 at or below minus
80 or 150 degrees 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 technology may be able to be applied 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 capital stock of CryoPort Systems, Inc., a
California corporation, in exchange for 24,108,105 shares 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 followed by a reorganization into a California corporation on
December 11, 2000, remains the operating company under CryoPort,
Inc. The foregoing does not take
into account the consummation of a reverse stock split, at a ratio of
10-to-1.
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.
Summary
Financial Information
In the
table below we provide you with historical consolidated financial data for the
three month periods ending June 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.
|
|
Three
Months Ended
June
30,
|
|
|
Years
Ended
March
31,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
Net
sales
|
|
$ |
14 |
|
|
$ |
13 |
|
|
$ |
35 |
|
|
$ |
84 |
|
Cost
of sales
|
|
|
149 |
|
|
|
118 |
|
|
|
546 |
|
|
|
386 |
|
Gross
loss
|
|
|
(135 |
) |
|
|
(105 |
) |
|
|
(511 |
) |
|
|
(302 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling,
general and administrative expenses
|
|
|
728 |
|
|
|
560 |
|
|
|
2,387 |
|
|
|
2,551 |
|
Research
and development expenses
|
|
|
88 |
|
|
|
111 |
|
|
|
297 |
|
|
|
166 |
|
Total
operating expenses
|
|
|
816 |
|
|
|
671 |
|
|
|
2,684 |
|
|
|
2,717 |
|
Loss
from operations
|
|
|
(951 |
) |
|
|
(776 |
) |
|
|
(3,195 |
) |
|
|
(3,019 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
1 |
|
|
|
13 |
|
|
|
32 |
|
|
|
50 |
|
Interest
expense
|
|
|
(1,820 |
) |
|
|
(556 |
) |
|
|
(2,693 |
) |
|
|
(1,593 |
) |
Loss
on sale of fixed assets
|
|
|
(1 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
Change
in fair value of derivative liabilities
|
|
|
3,134 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Loss
on extinguishment of debt
|
|
|
|
|
|
|
(6,903 |
) |
|
|
(10,847 |
) |
|
|
|
|
Total
other income (expense), net
|
|
|
1,314 |
|
|
|
(7,446 |
) |
|
|
(13,508 |
) |
|
|
(1,543 |
) |
Income
(loss) before income taxes
|
|
|
363 |
|
|
|
(8,222 |
) |
|
|
(16,703 |
) |
|
|
(4,562 |
) |
Income
taxes
|
|
|
- |
|
|
|
1 |
|
|
|
2 |
|
|
|
2 |
|
Net
income (loss)
|
|
$ |
363 |
|
|
$ |
(8,223 |
) |
|
$ |
(16,705 |
) |
|
$ |
(4,564 |
) |
Earnings
(loss) per share, basic and diluted
(after
giving effect to 10-for-1 reverse
stock split)
|
|
$ |
0.08 |
|
|
$ |
(2.00 |
) |
|
$ |
(4.05 |
) |
|
$ |
(1.16 |
) |
|
|
June
30,
2009
|
|
|
June
30,
2008
|
|
|
March
31,
2009
|
|
|
March
31,
2008
|
|
Assets
|
|
$ |
1,876 |
|
|
$ |
3,240 |
|
|
$ |
1,573 |
|
|
$ |
3,461 |
|
Liabilities
|
|
|
18,475 |
|
|
|
4,653 |
|
|
|
6,348 |
|
|
|
3,461 |
|
Total
Stockholders’ Deficit
|
|
|
(16,599 |
) |
|
|
(1,413 |
) |
|
|
(4,775 |
) |
|
|
- |
|
Liabilities
and Stockholders’ Deficit
|
|
|
1,876 |
|
|
|
3,240 |
|
|
|
1,573 |
|
|
|
3,461 |
|
The
Offering
Securities
offered
|
|
2,040,816
units, each unit consisting of one share of common stock and warrant to
purchase one share of common stock
|
|
|
|
Common
stock to be outstanding immediately prior to offering
|
|
4,733,988
shares (1)
|
|
|
|
Common
stock to be outstanding immediately after this offering
|
|
6,774,804
shares (1)(2)(4)(5)
|
|
|
|
Warrants
to be outstanding immediately
prior to offering
|
|
0(3)
|
|
|
|
Warrants
to be outstanding immediately
after this offering
|
|
2,040,816
warrants.
(2)(3)(6)
|
|
|
|
Use
of Proceeds
|
|
We
expect the net proceeds to us from this offering will be approximately
$8.8 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 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.
|
|
|
|
Over-allotment
option
|
|
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 306,123 units, consisting of 306,123 shares of our common stock
and warrants to purchase 306,123 shares of our common stock, to cover
overallotments.
|
|
|
|
Description
of Warrants
|
|
Each
purchaser will receive a warrant to purchase one share of our common stock
for each share of common stock it purchases in the offering. The warrants
are exercisable at an exercise price of $5.39 per share of common stock.
The warrants are exercisable starting on __________, and expire on
________, 2014. The warrants may be redeemed by us upon ten days prior
notice at any time after the closing bid price of our common stock is at
least $8.09 (representing 165% of the common stock offering price] for a
period of 20 consecutive trading days for $0.01 per
warrant. For additional information regarding the warrants, see
"Description of the Warrants" below.
|
|
|
|
OTC
Bulletin Board symbol for our Common Stock
|
|
CYRX
|
|
|
|
Proposed
Nasdaq Capital Market symbols for our Common Stock and
Warrants
|
|
COLD
and COLDW
|
|
|
|
Risk
Factors
|
|
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
7.
|
(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
outstanding as of September 15, 2009, which was 4,733,988 (after giving effect
to the anticipated 10-to-1 reverse stock split), and does not include (in each
case adjusted for the anticipated 10-to-1 reverse stock split), as of that
date:
|
● |
1,688,846
shares of common stock reserved for issuance upon the conversion of
outstanding convertible debentures and promissory notes with a weighted
average conversion price of $5.54 per share;
|
|
|
|
|
● |
3,911,167 shares
of common stock reserved for issuance upon the exercise of outstanding
warrants with a weighted average exercise price of $5.90 per
share;
|
|
|
|
|
● |
217,992
shares of common stock reserved for issuance upon the exercise of
outstanding stock options with a weighted average exercise price of $5.19
per share; and
|
|
● |
241,139 shares
of common stock available for future grant under our 2002 Stock Incentive
Plan and an additional 1,200,000 shares of common stock that would be
available for future grant under our 2009 Stock Incentive Plan, assuming
such plan is approved by our stockholders at our 2009 Annual Meeting of
Stockholders to be held on October 9,
2009.
|
(2) Assuming the
consummation of the sale of the units offered by this prospectus (but excluding
the units that may be sold upon the exercise of the option granted to the
representative of the underwriters to cover over-allotments), does not include
five year warrants, or the common stock issuable upon the exercise of such
warrants we may be required to issue to our convertible debenture holders to
purchase up to an additional 409,446 shares of our common stock pursuant to
their contractual right, unless they agree to waive such right in connection
with this offering, to maintain a minimum fully diluted ownership equal to 34.5%
of our outstanding capital stock determined on a fully diluted
basis. The exercise price of such warrants will be equal to the
lesser of (i) the offering price of the units offered hereby, and (ii) the
average of the volume weighted average price of our common stock for the five
(5) consecutive trading days ending on the date of the close of the offering
contemplated hereby.
(3) Does not
include outstanding warrants to purchase up to 3,911,167 shares of our
common stock with a weighted average exercise price of $5.90 per
share.
(4) Does not
include 2,040,816 shares of common stock issuable upon the exercise of the
warrants to be issued in connection with this offering.
(5) Does not
include 612,246 shares (including the shares underlying the warrants including
as part of the units) that comprise the units that may be purchased by the
representative of the underwriters upon the exercise of its 45-day option to
cover over-allotments, if any, and 204,082 shares that may be issued to Rodman
& Renshaw, LLC upon exercise of the warrant we will issue to them
(representing 10% of the shares sold by us in the offering, excluding the
over-allotment option).
(6) Does not
include warrants to purchase 306,123 shares of common stock that may be
purchased by the representative of the underwriters upon the exercise of its
45-day option to cover over-allotments, if any, and the warrant that we are
selling to Rodman & Renshaw, LLC for $100 to purchase 204,082 shares
(representing 10% of the warrants sold by us in the offering, excluding the
over-allotment option) that may be issued to Rodman & Renshaw, LLC upon
exercise of the warrant we will sell to them for $100.
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 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:
|
|
Net
Loss
|
|
Fiscal
Year Ended March 31, 2009
|
|
$ |
16,705,151 |
|
Fiscal
Year Ended March 31, 2008
|
|
$ |
4,564,054 |
|
Fiscal
Year Ended March 31, 2007
|
|
$ |
2,326,259 |
|
As of
June 30, 2009 and March 31, 2009, we had accumulated deficits of $39,928,972
(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 and 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
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, 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
June 30, 2009 and March 31, 2009, we had cash and cash equivalents of $556,922
(unaudited) and $249,758, respectively. Additionally, at both points
in time 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 dependant 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 carrier, 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, 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, which could reduce or delay our
future projected revenues and cash-inflows. 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 recent 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 a strategic relationship with a global
courier, 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 a strategic
relationship with a global courier which 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
carrier will utilize their sales force to promote and sell the frozen shipping
services in connection with the carrier. 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 grow with be
substantially delay 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 recent 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
September 15, 2009, there were 4,733,988 shares (assuming the consummation of
the anticipated reverse stock split, at a ratio of 10-to-1) of our common stock
outstanding. Substantially all of these shares are eligible for
trading in the public market. The market price of our common stock
may decline if our common 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 7,259,144 additional shares (assuming the consummation of a
reverse stock split, at a ratio of 10-to-1) of our common stock that are
issuable upon conversion of outstanding convertible debentures and promissory
notes and exercise of outstanding warrants and options or reserved for future
issuance under our stock incentive plans (including our 2009 Stock Incentive
Plan, which is subject to stockholder approval at our 2009 Annual Meeting of
Stockholders to be 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 10-to-1)
|
Common
stock issuable upon conversion of outstanding debentures and convertible
notes payable
|
|
1,688,846
|
Common
shares issuable upon exercise of outstanding warrants
|
|
3,911,167
|
Common
shares reserved for issuance upon exercise of outstanding options
or reserved for future option grants under our stock incentive
plans (including 1,200,000 shares reserved under the 2009 Stock Incentive
Plan)
|
|
1,659,131
|
Total
|
|
7,259,144
|
Of the
total options and warrants outstanding as of September 15, 2009, 4,262,152 would
be considered dilutive to stockholders because we would receive an amount per
share that is less than the market price of our common stock on September 15,
2009.
If
we experience delays, difficulties or unanticipated costs in establishing the
sales, distribution and marketing capabilities necessary to successfully
commercialize our products, we will have difficulty maintaining and increasing
our sales.
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 its third-party collaborators, must also
market our products in compliance with federal, state, local and international
laws relating to the providing of incentives and inducements. Violation of these
laws can result in substantial penalties. 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 maintaining and 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 would also be increasing our competition, as
former employees pose the greatest threat of significant competition to our
business.
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 were unable to
successfully define, develop and introduce competitive new 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 in volume and their
acceptance by customers are important to our future success. A delay in new
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, required regulatory
approvals are not obtained, or any approved 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 the pharmaceutical clinical trial, gene biotechnology, infectious
materials handling, human reproduction markets, and any other market we attempt
to sell our products to and our profitability and growth will depend on a number
of factors, including:
|
● |
Our
shipper’s ability to perform and preserve the integrity of the materials
shipped;
|
|
|
|
|
● |
Relative
convenience and ease of use;
|
|
|
|
|
● |
Availability
of alternative products;
|
|
|
|
|
● |
Pricing
and cost effectiveness;
|
|
● |
Effectiveness
of our or our collaborators’ sales and marketing strategy;
and
|
|
|
|
|
● |
Our
ability to devise a single payer billing scheme with our business
partner.
|
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 U.S. patents and one provisional patent application recently filed all
relating to various aspects of our products. Our patents or patent applications
may be challenged, invalidated or circumvented in the future or the rights
granted may not provide a competitive advantage. We intend to vigorously protect
and defend our intellectual property. Costly and time-consuming litigation
brought by us may be necessary to enforce our patents and to protect our trade
secrets and know-how, or to determine the enforceability, scope and validity of
the proprietary rights of others.
We also
rely upon trade secrets, technical know-how and continuing technological
innovation to develop and maintain our competitive position. We typically
require our employees, consultants, advisors and suppliers to execute
confidentiality agreements and invention assignment and work for hire agreements
in connection with their employment, consulting, or advisory relationships with
us. If any of these agreements are breached, we may not have adequate remedies
available thereunder to protect our intellectual property or we may incur
substantial expenses enforcing our rights. Furthermore, 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 U.S. or internationally. In the
event we were to require licenses to 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 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, which would harm our business.
We are
not aware of any other company that is infringing any of our patents or
trademarks nor do we believe that it is 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, warranty claims and litigation.
Our
products must meet stringent requirements. We warrant to our customers that our
products will be free of defect for various periods of time, depending on the
product. In addition, certain of our contracts include epidemic failure clauses.
If invoked, these clauses may entitle the customer to return or obtain credits
for products and inventory, or to cancel outstanding purchase orders even if the
products themselves are not defective.
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 warranty claims 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 products 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 products 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 products from a number of independent manufacturers in
the United States. We would likely experience significant delays or cessation in
producing our products if a labor strike, natural disaster, local or regional
conflict 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 products. 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 delays to the point that our ability to adequately
service customer needs has been compromised. As the business develops and
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 are 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 to 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
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. In addition, from time to
time, we assume liabilities as a result of entering into indemnification
agreements. 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. 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 Center 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 FDA, FCC
and
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 us from shipping 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 consignee. The failure of these third-parties fail to perform their duties
could result in damage to the contents of the CryoPort shipper resulting in
customer dissatisfaction or liability to CryoPort, even if CryoPort is not at
fault.
If
we cannot compete effectively, we will lose business.
Our
products, services and solutions are positioned to be competitive in the market.
Nevertheless, there are technological and marketing barriers to entry, but 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:
|
● |
Acceptance
of our business model and a per use consolidated
fee structure;
|
|
|
|
|
● |
Ongoing
development of enhanced technical features and
benefits;
|
|
|
|
|
● |
Reductions
in the manufacturing cost of competitors’ products;
|
|
|
|
|
● |
The
ability to maintain and expand distribution channels;
|
|
|
|
|
● |
Brand
name;
|
|
|
|
|
● |
The
ability to deliver our products to our customers when
requested;
|
|
|
|
|
● |
The
timing of introductions of new products and services;
and
|
|
|
|
|
● |
Financial
resources.
|
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, who have greater resources than we do, 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, who have greater resources than we do, 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 we do may be able to bring their product to market faster than we can and
offer their product at a lower price than we can offer our product 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.
In
October 2007 and June 2008, we issued to four institutional investors
convertible debentures which have an outstanding principal balance as of
September 15, 2009, of $7,752,925 (the “Debentures”), and warrants to purchase,
as of September 15, 2009, an aggregate of 16,888,464 shares of our common stock
(without regard to beneficial ownership limitations contained in the transaction
documents, certain anti-dilution provisions, and not taking into account
the consummation of a reverse stock split at a ratio of 10-to-1). 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 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;
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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
(i) preventing us from effecting our contemplated reverse stock split
unless the debenture holders give us 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) impact 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.
The
holders or our outstanding convertible debentures may be entitled to receive
additional warrants as a result of this offering.
Pursuant
to the terms of the Debentures, associated warrants and related transaction
documents, the holders of the Debentures have a contractual right to maintain a
minimum fully diluted ownership equal to 34.5% our outstanding capital stock
determined on a fully diluted basis calculated assuming their full conversion of
the Debentures and full exercise of all warrants (without regard to any
beneficial ownership limitations contained in the Debentures and warrants), and
including the number of shares of common stock previously issued to the
debenture holders pursuant to the conversion of debentures and exercise of
warrants regardless of whether such shares of common stock have been sold by
such holders. Based on our current capitalization determined on a
fully diluted basis, the holders of our convertible debentures currently have a
fully diluted ownership of approximately 44.7%. Unless they agree to
waive their contractual right with respect to the shares of common stock and
warrants to purchase shares of common stock to be issued in this offering, if we
raise gross proceeds of $10 million from this offering at an assumed offering
price of $4.90, we would issue in connection with this offering an aggregate of
4,295,714 shares of common stock and warrants to purchase 4,295,714 shares of
common stock which would reduce the Debenture holders fully diluted ownership to
31.7%. In order to return the Debenture holders to a fully diluted
ownership of 34.5%, we would be required to issue warrants to the debenture
holders to purchase an aggregate of 409,446 shares of our common stock at an
exercise price equal to the lesser of (i) the offering price of the units
offered hereby, and (ii) the average of the volume weighted average price of our
common stock for the five (5) consecutive trading days ending on the date of the
close of this offering.
The
lower the stock price, the greater the number of shares issuable under the
Debentures.
If we
elect to make periodic principal and interest payments in stock in lieu of cash
(or are unable to make cash payments), the number of shares issuable upon
conversion of the Debentures is determined by the market price of our common
stock prevailing at the time of each conversion. The lower the market price, the
greater the number of shares issuable under the Debentures. Upon issuance of the
shares, to the extent that holders of those shares will attempt to sell the
shares into the market, these sales may further reduce the market price of our
common stock. This in turn will increase the number of shares issuable under the
agreement. This may lead to an escalation of lower market prices and ever
greater numbers of shares to be issued. A larger number of shares issuable at a
discount to a continuously declining stock price will expose our stockholders to
greater dilution and a reduction of the value of their investment.
The
issuance of our 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. This is particularly the case if the shares issued
upon conversion and placed into the market exceed the market’s ability to absorb
the increased number of shares of 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.
If there are significant short sales of our stock, the price decline that would
result from this activity will cause the share price to decline more so, which,
in turn, may cause long holders of the stock to sell their shares thereby
contributing to sales of stock in the market. If there is an imbalance on the
sell side of the market for the stock, our stock price will decline. If this
occurs, the number of shares of our common stock that is issuable upon
conversion of the debentures will increase, which will materially dilute
existing stockholders’ equity and voting rights.
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 the particular uses of approximately $8.8 million of the
net proceeds we will receive from this offering. 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 their 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 5,467,567 shares (assuming the consummation of a reverse stock
split, at a ratio of 10-to-1 and without regard to beneficial ownership
limitations contained in certain convertible debentures and warrants) of common
stock, or approximately 35.9% of our outstanding common stock (without giving
effect to the rights of the holders of our October 2007 and May 2008 debentures
to maintain a fully diluted ownership of not less than 34.5%). Of
these shares, 2,187,640 shares, or approximately 14.7% of our outstanding common
stock, will be owned by Enable Growth Partners LP (and affiliated funds), and
Bridge Pointe Master Fund, Ltd. will own 2,493,219 shares or approximately 16.8%
of our outstanding common stock; provided, however, there are provisions in our
debentures and warrant agreements with them that prohibit conversion of
debentures or 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 may not develop or be maintained, which could limit your ability
to sell shares of our common stock or warrants.
Prior to
this offering, there has been a limited public market for our common stock and
no public market for our warrants and the public offering price may bear no
relationship to the price at which the common stock will trade after the
offering. There can be no assurance that an active public market for
our common stock or warrants will develop or be sustained after the 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 prices 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:
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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. Our stock and warrant prices
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, 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 stock and warrants
could decline if one or more equity analysts downgrade our stock or if those
analysts issue other unfavorable commentary or cease publishing reports about us
or our business.
A
significant portion of our total outstanding shares 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 intend to sell shares,
could reduce the market price of our common stock and warrants. After this
offering, we will have 6,774,804 shares of common stock outstanding based
on the number of shares outstanding as of September 15, 2009 and assuming the
consummation of a reverse stock split, at a ratio of 10-to-1. This
includes the 2,040,816 shares that we are selling in this offering, which
may be resold in the public market immediately. The remaining
4,733,988 shares, or 69.88% of our outstanding shares after this offering,
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 and the underwriters. However, the underwriters can
waive the provisions of these lock-up agreements and allow these stockholders to
sell their shares at any time.
In
addition, as of September 15, 2009, there were 241,139 shares (assuming the
consummation of a reverse stock split, at a ratio of 10-to-1) reserved for
future issuance under our stock incentive plans (including our 2009 Stock
Incentive Plan which is subject to stockholder approval at our 2009 Annual
Meeting of Stockholders) that will become eligible for sale in the public market
following the grant of options or issuance of shares to the extent permitted by
any applicable vesting requirements and the lock-up agreements. We
intend to register the resale of all shares of common stock that we may issue
under the forgoing plans. Once we register these shares, they can be
freely sold in the public market upon issuance, subject to the lock-up
agreements.
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 earnings, financial condition and other business and
economic factors affecting it at such time as the board of directors may
consider relevant. In addition, we may not pay any dividends without obtaining
the prior consent of the holders of our October 2007 and May 2008 convertible
debentures. If we do not pay dividends, our common stock may be less
valuable because a return on your investment will only occur if our stock price
appreciates.
If
we effect a reverse stock split, the liquidity of our common stock and market
capitalization could be adversely affected.
On August
31, 2009, the Board voted unanimously, subject to stockholder approval at our
2009 Annual Meeting of Stockholders to be held on October 9, 2009, to approve a
Certificate of Amendment to CryoPort’s Amended and Restated Articles of
Incorporation (the “Reverse Stock Split Articles Amendment”) to give the Board
authorization to effect a reverse stock split of CryoPort’s common stock issued
and outstanding at a ratio to be determined by the Board between one for two and
one for fifteen, without further approval of our stockholders, upon a
determination by the Board that such a reverse stock split is in the best
interests of CryoPort and its stockholders, at any time before June 30, 2010. If
the stockholders approve the Reverse Stock Split Articles Amendment, subject to
our obtaining a waiver from the holders of our October 2007 and May 2008
convertible debentures, the Board intends to effect a reverse stock split to
increase the stock price to a level that will enable it to apply for listing on
the Nasdaq Capital Market or other national 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.
The
implementation of our stock-based incentive plan may dilute your percentage
ownership interest and may also result in downward pressure on the price of our
stock.
On August
31, 2009, our board approved the CryoPort, Inc. 2009 Stock Incentive Plan (“2009
Incentive Plan”), which is designed to replace the CryoPort, Inc. 2002 Stock
Incentive Plan and provides for the grant of stock-based
incentives. If the stockholders approve the 2009 Incentive Plan, we
will be able to grant 1,200,000 shares (assuming the consummation of the
anticipated 10-to-1 reverse stock split) to our officers, directors, employees
and consultants. Stockholders would experience a dilution in
ownership interest of 15%, assuming the maximum issuance of 1,200,000 shares
from stock options or awards of restricted stock under the plan. In
addition, the existence of a significant amount of stock and stock options that
would be issuable upon the adoption and approval of our stock-based incentive
plan may be perceived by the market as having a 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 or other equity
securities could result in additional dilution to our stockholders.
We
believe that our current cash and cash equivalents, anticipated cash flow used
in operations and the net proceeds from this financing 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 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. We cannot assure you
that financing will be available in amounts or on terms acceptable to us, if at
all.
Provisions
in our certificate of incorporation and bylaws or 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 certificate of incorporation and bylaws, as they will be in effect upon
the completion of this offering, 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. These provisions may also
prevent or frustrate attempts by our stockholders to replace or remove our
management. These provisions include:
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Advance
notice requirements for stockholder proposals and
nominations;
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The
ability of our board of directors to make, alter or repeal our
bylaws; and
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Subject
to stockholder approval at our 2009 Annual Stockholders Meeting of a
proposed amendment to our Amended and Restated Articles of Incorporation,
the ability of the board of directors to issue, without further
stockholder approval, up to 2,500,000 shares (assuming the consummation of
a reverse stock split, at a ratio of 10-to-1) of preferred stock with
terms set by the board of directors, which rights could be senior to those
of our common stock.
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The
affirmative vote of the holders of at least a majority of our outstanding shares
of capital stock entitled to vote is necessary to amend or repeal the above
provisions of our certificate of incorporation. In addition, 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 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 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, or Exchange Act. The penny stock rules apply to non-Nasdaq companies
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 control 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 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 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 2009 and on an ongoing basis. It is difficult for us to predict
how long it will take or costly it will be to complete the assessment of the
effectiveness of our internal control over financial reporting to the
satisfaction of our independent registered public accounting firm for each year
and to remediate any deficiencies in our internal control 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 is new 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 determine that our internal control over financial reporting is not
effective as defined under Section 404, we cannot predict how regulators will
react or how the market prices of our shares 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 or warrants will be listed on the Nasdaq Capital
Market.
Simultaneous
with the filing of this registration statement, we will apply for listing of our
common stock and warrants on the Nasdaq Capital Market. After the
consummation of this offering, we believe that we 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, where
our warrants would also trade. 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 after making
a market, 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 the market will
continue.
FORWARD-LOOKING
STATEMENTS
This
prospectus contains forward-looking statements. All statements other
than statements of historical facts 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” or “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:
|
● |
Our
intention to introduce new products or services,
|
|
|
|
|
● |
Our
expectations about the markets for our products or
services,
|
|
|
|
|
● |
Our
expectations about securing a strategic relationship with a global courier
or large clinical research organization,
|
|
|
|
|
● |
Our
future capital needs,
|
|
|
|
|
● |
Results
of our research and development efforts, and
|
|
|
|
|
● |
Success
of our patent applications.
|
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:
|
● |
The
effect of regulation by the FDA and other governmental
agencies,
|
|
|
|
|
● |
Research
and development efforts, including delays in developing, or the failure to
develop, our products,
|
|
|
|
|
● |
The
development of competing or more effective products by other
parties,
|
|
|
|
|
● |
Uncertainty
of market acceptance of our products,
|
|
|
|
|
● |
Errors
in business planning attributable to insufficient market size or
segmentation data,
|
|
|
|
|
● |
Problems
that we may face in manufacturing, marketing, and distributing our
products,
|
|
|
|
|
● |
Problems
that we may encounter in further development of CryoPort Express® Portal
or ability to scale,
|
|
|
|
|
● |
Problems
relating to the development of wireless sensor monitoring devices, or
regulatory approval relating to their use,
|
|
|
|
|
● |
Our
inability to raise additional capital when needed,
|
|
|
|
|
● |
Delays
in the issuance of, or the failure to obtain, patents for certain of our
products and technologies,
|
|
|
|
|
● |
Problems
with important suppliers and strategic business partners,
and
|
|
|
|
|
● |
Difficulties
or delays in establishing marketing relationships with international
parcel couriers.
|
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 other 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 Operation” 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 $8.8 million, based on an assumed public offering
price of $4.90 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 build up inventory, 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.
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 “COLD” and “COLDW,”
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 10-to-1.
Number
of Stockholders
As of
September 15, 2009, there were approximately 125 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
On August
31, 2009, the Board adopted, subject to stockholder approval, the CryoPort, Inc.
2009 Stock Incentive Plan (the “2009 Incentive Plan”), which would authorize and
reserve an additional 1,200,000 shares (assuming the consummation of a reverse
stock split, at a ratio of 10-to-1) of common stock for our incentive
plans.
Reverse
Stock Split
Our Board
has approved a proposal to grant discretionary authority to our Board 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-for-1 reverse stock split and
15-for-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,
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 47,339,884 shares of common stock issued and
outstanding as of September 15, 2009.
Proposed
Reverse
Stock
Split
|
|
Percentage
Reduction in the
Outstanding
Shares of
Common
Stock
|
|
Common
Stock
Outstanding
after the
Reverse
Stock Split
|
|
Common
Stock
Authorized
after the
Reverse
Stock Split (1)
|
|
|
|
|
|
|
|
2
for 1
|
|
50%
|
|
23,669,942
|
|
125,000,000
|
|
|
|
|
|
|
|
5
for 1
|
|
80%
|
|
9,467,977
|
|
125,000,000
|
|
|
|
|
|
|
|
10
for 1
|
|
90%
|
|
4,733,988
|
|
125,000,000
|
|
|
|
|
|
|
|
15
for 1
|
|
93
1/3%
|
|
3,155,992
|
|
125,000,000
|
|
|
|
|
|
|
|
(1)
|
Our
authorized capital currently consists of 125,000,000 shares of common
stock. On August 31, 2009, our Board unanimously approved,
subject to stockholder approval at our annual meeting October 9, 2009, an
amendment to our Amended and Restated Articles of Incorporation to
increase the number of authorized shares of common stock from 125,000,000
to 250,000,000.
|
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
the offering, adjusted for the anticipated reverse stock split on a 10-to-1
basis, prior to the effectiveness of the registration statement of which this
prospectus is a part. We intend to apply for listing of our common stock and
warrants on the Nasdaq Capital Market under the symbols “COLD” and “COLDW,”
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 June 30, 2009 on an actual
(without giving effect to the 10-to-1 reverse stock split) and on a pro forma as
adjusted basis to give effect to the 10-to-1 reverse stock split and the sale of
the units by us in this offering at an assumed public offering price of $4.90
per share (the pro forma adjusted closing share price on September 30, 2009,
giving effect to the 10-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.
|
|
June 30, 2009 |
|
|
|
Actual
|
|
|
As
Adjusted
|
|
Cash
and cash equivalents
|
|
$ |
557,000 |
|
|
$ |
9,357,000 |
|
Current
portion of convertible debentures and other long-term debt, net of debt
discounts of $4,286,593
|
|
$ |
2,586,000 |
|
|
$ |
2,586,000 |
|
Long-term
debt, net of current portion and debt discounts of
$5,968,629
|
|
$ |
1,573,000 |
|
|
$ |
1,573,000 |
|
Stockholders’
equity:
|
|
|
|
|
|
|
|
|
Preferred
stock, $0.001 par value: 25,000,000 shares authorized and
issued, no shares issued and outstanding, actual; and no shares issued
and outstanding, as adjusted (1)
|
|
$ |
- |
|
|
$ |
- |
|
Common
stock, $0.001 par value: 250,000,000 shares authorized;
4,733,988 issued and outstanding, actual; and 6,978,886
shares issued and outstanding, as adjusted(2)(3)
|
|
$ |
44,000 |
|
|
$ |
7,000 |
|
Additional
paid-in capital
|
|
$ |
23,287,000 |
|
|
$ |
32,124,000 |
|
Retained
deficit
|
|
$ |
(39,929,000 |
) |
|
$ |
(39,929,000 |
) |
Total
stockholders’ deficit
|
|
$ |
(16,598,000 |
) |
|
$ |
(7,798,000 |
) |
(1)
|
Assumes
our stockholders approve the proposal at our 2009 Annual Stockholders
Meeting to be held on October 9, 2009, to amend our Amended and Restated
Articles of Incorporation to create a class of blank check preferred stock
consisting of 25,000,000 shares.
|
(2)
|
Assumes
our stockholders approve the proposal at our 2009 Annual Stockholders
Meeting to be held on October 9, 2009, to amend our Amended and Restated
Articles of Incorporation to increase the number of authorized shares of
common stock from 125,000,000 to
250,000,000.
|
(3)
|
The
above table excludes the following:
|
|
● |
1,688,846 shares
of common stock reserved for issuance upon the conversion of outstanding
convertible debentures and promissory notes with a weighted average
conversion price of $5.54 per share;
|
|
|
|
|
● |
3,911,167 shares
of common stock reserved for issuance upon the exercise of outstanding
warrants with a weighted average exercise price of $5.90 per
share;
|
|
|
|
|
● |
217,992
shares of common stock reserved for issuance upon the exercise of
outstanding stock options with a weighted average exercise price of $5.19
per share;
|
|
|
|
|
● |
241,139 shares
of common stock available for future grant under our 2002 Stock Incentive
Plan and an additional 1,200,000 shares of common stock that would be
available for future grant under our 2009 Stock Incentive Plan, assuming
such plan is approved by our stockholders at our 2009 Annual Meeting of
Stockholders to be held on October 9, 2009;
|
|
|
|
|
● |
2,040,816
shares of common stock issuable upon the exercise of the warrants to be
issued in connection with
this offering; and |
|
|
|
|
● |
204,082
shares that may be issued to Rodman & Renshaw, LLC upon exercise of
the warrant we will issue
to them (representing 10% of the shares sold by us in the offering,
excluding the over-allotment option).
|
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 share of common stock 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 June 30, 2009 was
($16,866,565), or ($3.84) per share of common stock (giving effect to the
anticipated 10-to-1 reverse stock split). We calculate net tangible
book value per share by calculating the total assets less goodwill and other
intangible assets and total liabilities, and dividing by the number of shares of
common stock outstanding.
Net
tangible book value dilution per share represents the difference between the
amount per share paid by new investors who purchase shares in this offering and
the pro forma net tangible book value per share of common stock immediately
after completion of this offering. As of June 30, 2009, after giving
effect to:
|
● |
the
sale by us of 2,040,816 units at an assumed public offering price of $4.90
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
$5.39 per share and the application of the estimated net proceeds to us in
this offering as described under “Use of Proceeds”; and
|
|
|
|
|
● |
the
estimated underwriting discounts and commissions and offering expenses
payable by us.
|
|
|
Adjusted
|
|
Public
offering price per share(1)
|
|
$ |
4.90 |
|
Net
tangible book value as of June 30, 2009
|
|
$ |
(3.56 |
) |
Increase
attributable to this offering
|
|
$ |
2.67 |
|
Adjusted
net tangible book value per share after this offering
|
|
$ |
(0.89 |
) |
Dilution
in net tangible book value per share to new investors
|
|
$ |
5.79 |
|
The
following table summarizes as of June 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:
|
● |
The
existing common stockholders; and
|
|
|
|
|
● |
The
new investors in the offering, assuming the sale of 2,040,816 units
offered hereby at a public offering price of $4.90 per
share.
|
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.
|
Shares
Purchased
Number
|
|
Percent
|
|
Total
Consideration
Amount
|
|
Percent
|
|
Average
Price
Per
Share
|
Existing
Stockholders
|
4,733,988
|
|
|
69.88%
|
|
$
|
8,779,000
|
|
|
46.75%
|
|
$
|
1.85
|
New
Investors
|
2,040,816
|
|
|
30.12%
|
|
$
|
10,000,000
|
|
|
53.25%
|
|
$
|
4.90
|
Total
|
6,774,804
|
|
|
100%
|
|
$
|
18,779,000
|
|
|
100%
|
|
$
|
2.77
|
The above
table excludes an aggregate of up to 8,099,960 additional shares of common
stock reserved and available for future issuance (i) upon the conversion of all
outstanding convertible debentures and notes payable, (ii) the exercise of all
outstanding warrants to purchase common stock, (iii) the exercise of all
warrants issued in connection with this public offering, and (iv) under our
employee 2002 Incentive Stock Option Plan as of June 30, 2009. As of
June 30, 2009, 217,992 options have been granted, but have not been exercised
pursuant to the 2002 Incentive Stock Option Plan.
On August
31, 2009, the Board adopted, subject to stockholder approval, the CryoPort, Inc.
2009 Stock Incentive Plan (the “2009 Incentive Plan”), which would authorize and
reserve an additional 1,200,000 shares (assuming the consummation of a reverse
stock split, at a ratio of 10-to-1) of common stock for our incentive
plans. The foregoing number of additional shares that may be issued
does not include the 1,200,000 shares that may be authorized and reserved for
the 2009 Incentive Plan if such plan is approved by the
stockholders.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OR PLAN OF OPERATION
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 capable of transporting biological, environmental
and other temperature sensitive materials at temperatures below zero degrees
centigrade. These dry vapor shippers are the first significant
alternative to using dry ice and achieve 10+ day holding times compared to 1–2
day holding times with dry ice.
Our value proposition comes from both
providing a safe, transportation and environmentally friendly, long lasting
shipper. Through our value added services we 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 and allows the customer to track the progress and status of a
shipment, and
in-transit temperature monitoring services of the
shipper. CryoPort also provides to its customer at their pick
up location, the fully ready charged shipper containing all freight bills,
customs documents and regulatory paperwork for the entire journey of the
shipper.
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°
centigrade. The dry vapor shipper is designed using innovative,
proprietary, and patent pending technology such that there can be no pressure
build up as the liquid nitrogen evaporates, nor any spillage of liquid
nitrogen. 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, “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 (less than -150 ° C).
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 the 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 on 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 concurrently under development to market with our
key customers and, 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 the
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 $13,703, had net income of $363,276, which included
a gain on the change in fair value of our derivative liabilities of $3,134,298
and used cash of $505,960 in our operating activities during the three
months ended June 30, 2009. In addition, we had a working capital
deficit of $15,556,522, and have cash and cash equivalents of $556,922 at June
30, 2009. Our working capital deficit at June 30, 2009 included
$13,664,537 of 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 quarter. Currently
management has projected that cash on hand, including cash borrowed under the
convertible debentures issued in the first and second quarter of fiscal
2010, will be sufficient to allow us to continue its operations into the third
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.
|
|
Fiscal
Year
|
|
|
Fiscal
Three Months
Ended
June 30,
|
|
|
|
2009
(‘000)
|
|
|
2008
|
|
|
2007
|
|
|
2009
|
|
|
2008
|
|
Net
sales
|
|
$ |
35 |
|
|
$ |
84 |
|
|
$ |
67 |
|
|
$ |
14 |
|
|
$ |
13 |
|
Cost
of sales
|
|
|
546 |
|
|
|
386 |
|
|
|
177 |
|
|
|
149 |
|
|
|
118 |
|
Gross
loss
|
|
|
(511 |
) |
|
|
(302 |
) |
|
|
(110 |
) |
|
|
(135 |
) |
|
|
(105 |
) |
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling,
general and administrative
expenses
|
|
|
2,387 |
|
|
|
2,551 |
|
|
|
1,899 |
|
|
|
728 |
|
|
|
560 |
|
Research
and development expenses
|
|
|
297 |
|
|
|
166 |
|
|
|
88 |
|
|
|
88 |
|
|
|
111 |
|
Total
operating expenses
|
|
|
2,684 |
|
|
|
2,717 |
|
|
|
1,987 |
|
|
|
816 |
|
|
|
671 |
|
Loss
from operations
|
|
|
(3,195 |
) |
|
|
(3,019 |
) |
|
|
(2,097 |
) |
|
|
(951 |
) |
|
|
(776 |
) |
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
32 |
|
|
|
50 |
|
|
|
- |
|
|
|
1 |
|
|
|
13 |
|
Interest
expense
|
|
|
(2,693 |
) |
|
|
(1,593 |
) |
|
|
(228 |
) |
|
|
(1,820 |
) |
|
|
(556 |
) |
Loss
on sale of fixed assets
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1 |
) |
|
|
- |
|
Change
in fair value of derivative
liabilities
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
3,134 |
|
|
|
- |
|
Loss
on extinguishment of
debt
|
|
|
(10,847 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(6,903 |
) |
Total
other income (expense), net
|
|
|
(13,508 |
) |
|
|
(1,543 |
) |
|
|
(228 |
) |
|
|
1,314 |
|
|
|
(7,446 |
) |
Income
(loss) before income taxes
|
|
|
(16,703 |
) |
|
|
(4,562 |
) |
|
|
(2,325 |
) |
|
|
363 |
|
|
|
(8,222 |
) |
Income
taxes
|
|
|
2 |
|
|
|
2 |
|
|
|
2 |
|
|
|
- |
|
|
|
1 |
|
Net
income (loss)
|
|
$ |
(16,705 |
) |
|
$ |
4,564 |
|
|
$ |
(2,327 |
) |
|
$ |
363 |
|
|
$ |
(8,223 |
) |
Net
income (loss) available to common stockholders per
common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted loss per
common share
|
|
$ |
(0.41 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.08 |
) |
|
$ |
0.01 |
|
|
$ |
(0.20 |
) |
Weighted
average common shares
outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
41,238,185 |
|
|
|
39,425,118 |
|
|
|
30,943,154 |
|
|
|
42,939,649 |
|
|
|
41,018,074 |
|
Diluted
|
|
|
41,238,185 |
|
|
|
39,425,118 |
|
|
|
30,943,154 |
|
|
|
46,563,395 |
|
|
|
41,018,074 |
|
Three
months ended June 30, 2009 compared to three months ended June 30,
2008:
Net Sales. During the
three months ended June 30, 2009, CryoPort generated $13,703 from reusable
shipper sales compared to revenues of $13,424 for the three month period ended
June 30, 2008, an increase of $279 (2%). 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 also 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 three month period ended June 30, 2009 increased $30,799 (26%) to $149,177
from $118,378 for the three month period ended June 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 three month period ended June 30, 2009 increased by $30,520 (29%)
to $135,474 compared to $104,954 for the three month period ended June 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 $168,269 (30%) to $728,309 for the three month period ended June
30, 2009 as compared to $560,040 for the three month period ended June 30, 2008
due to increased general and administrative costs of $190,556 (44%) and a
decrease in selling expenses of $22,287 (18%). 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 $23,066 (21%) to $87,725 for the three month period ended
June 30, 2009 as compared to $110,791 for the three month period ended June 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 $1,264,429 to $1,820,198 for the three month period ended June 30,
2009 as compared to $555,769 for the three month period ended June 30, 2008.
This increase was due to $1,555,691 of amortized debt discount, $7,904 of
amortized financing fees, and $256,603 of accrued interest, primarily related to
the convertible debentures issued in October 2007, May 2008 and March and May
2009 Private Placement Debentures. 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 $1,481 for the three month period ended June 30, 2009 as
compared to $12,814 for the three month period ended June 30,
2008. Prior year interest income included the impact of increased
cash balances related to the funds received in connection with the convertible
debentures issued in October 2007 and May 2008.
Change in Fair Value of
Derivative Liabilities. CryoPort recognized a
gain on the change in fair market value of derivatives of $3,134,298 during the
three months ended June 30, 2009 compared to $0 in the three months ended June
30, 2008. The gain was due to the adoption of EITF 07-05, which
resulted in a reclassification of the fair value of warrants and debt effective
conversion features from equity to derivative liabilities that are marked to
fair value at each reporting period. The impact of the change in
accounting principle and change in market value of the derivative liabilities
during the first quarter resulted in the recognition of a gain (see Note 2 to
the accompanying unaudited consolidated financial statements).
Loss on Extinguishment of
Debt. CryoPort incurred a loss
on extinguishment of debt of $6,902,941 during the three months ended June 30,
2008 as the result of the April 30, 2008 amendment of the October debentures
which provided for a three month deferral of principal
payments. There was no loss on extinguishment of debt recognized in
the three months ended June 30, 2009. The prior year loss consisted
of a combination of a $5,858,344 increase in the fair market value of warrants
issued in connection with the October debentures as a result of the increase in
the number of shares to be purchased under each of the October warrants and to
the decrease in the exercise price of October warrants from $0.90, $0.92 and
$1.60 to $0.60 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 debentures to reflect the
present value of the debentures as of April 30, 2008.
Net Income
(Loss). As a
result of the factors described above, net income for the three months ended
June 30, 2009 increased by $8,585,757 to $363,276 or $0.08 per share
compared to a net loss of $8,222,481 or ($2.00) per share for the three months
ended June 30, 2008, assuming the consummation of a reverse stock split, at a
ratio of 10-to-1. Loss from operations for the three months ended
June 30, 2009 increased $175,723 to $951,508 compared to $775,785 for the three
months ended June 30, 2008.
Year
Ended March 31, 2009 Compared to Year Ended March 31, 2008:
Net
Sales. 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 convertible debentures issued in October 2007 and May 2008 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 ($4.05) per share compared to $4,564,054 or ($1.16) per share for the year
ended March 31, 2008, assuming the consummation of a reverse stock split, at a
ratio of 10-to-1.
Liquidity
and Capital Resources
As of
June 30, 2009, we had cash and cash equivalents of $556,922 and negative working
capital of $15,556,522. CryoPort’s working capital deficit at June
30, 2009 included $13,664,537 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
quarter. 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 $505,960 for the three months ended June 30,
2009, compared to net cash used in operating activities of $694,914 for the
three months ended June 30, 2008. Net income for the quarter ended
June 30, 2009 of $363,276 included a non-cash gain of $3,134,298 due to the
change in valuation of our derivative liabilities during the quarter and
partially offset by non-cash expenses of $1,975,013 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 $156,406 primarily due to
our Private Placement Debentures and an increase in accounts payable of
$102,893 due primarily to increased general and administrative
expenses. Net cash used in operating activities of $694,914 for the
three months ended June 30, 2008 reflected a net operating loss of $8,222,481,
which included a non-cash loss on extinguishment of debt of $6,902,941 and
non-cash expenses of $532,455 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 $73,084 and were offset
by the positive cash impact of an increase in accrued interest payable related
to our May 2008.
Net cash
used in investing activities for the three months ended June 30, 2009 was
$27,786 compared to net cash used in investing activities of $30,132 for the
comparable period in 2008. Net cash used in investing activities for the three
months ended June 30, 2009 primarily reflected payment of trademark costs. Net
cash used in investing activities for the three months ended June 30, 2008 was
comprised primarily of fixed asset purchases.
Net cash
provided by financing activities for the three months ended June 30, 2009 was
$840,910 and was primarily related to proceeds from our March 2009 Private
Placement Debentures of $926,500, 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 $683,713 for
the three months ended June 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
|
|
|
Less
than
1
Yr
|
|
|
1-3
Years
|
|
|
4-5
Years
|
|
|
After
5
Years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible
Debentures (a)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Lease |
|
|
221,000 |
|
|
|
156,000 |
|
|
|
65,000 |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Private
Placement Convertible Debt
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Contractual Cash Obligations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a)
A portion of the convertible debentures are expected to be paid in equivalent
common stock using a contractual conversion rate of $0.51 per common stock share
(not adjusted for the consummation of a reverse stock split, at a ratio of
10-to-1).
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 sales 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 use-and-return dry 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 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 three months ended June 30, 2009 and 2008, research and development costs
were $87,725 and $110,791, 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 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.
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.
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 in accordance with AICPA Statement of
Position 98-1, Accounting for
Costs of Computer Software Developed or Obtained 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. CryoPort follows the provisions of Staff
Accounting Bulletin (“SAB”) No. 104, Revenue Recognition in Financial
Statements (“SAB 104”), for revenue recognition. Under SAB 104, 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. Products are generally sold
with right of warranty repair for a one year period but with no right of
return. Products shipped to customers for speculation purposes are
not considered sold and no revenue is recorded by CryoPort until sales
acceptance is acknowledged by the customer.
Stock-Based
Compensation. CryoPort accounts for share-based payments to
employees and directors in accordance with Statement of Financial Accounting
Standards (“SFAS”) FAS No. 123(R), Share-Based Payment (“SFAS
123(R)”). SFAS 123(R) requires all share-based payments to employees and
directors, including grants of employee stock options and warrants, to be
recognized 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 under SFAS 123(R). Fair value is
determined at the date of grant. In accordance with SFAS 123(R), 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.
CryoPort
accounts for equity issuances to non-employees in accordance with Emerging
Issues Task Force (“EITF”) Issue No. 96-18, Accounting for Equity Instruments
that are Issued to Other Than Employees for Acquiring, or in Conjunction with
Selling, Goods and Services. All transactions in which goods or services
are the consideration received for the issuance of equity instruments are
accounted for based on the fair value of the consideration received 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.
Employee
stock-based compensation expense recognized under SFAS No. 123(R) for
the three months ended June 30, 2009 was $143,174, determined by the
Black-Scholes valuation model. As of June 30, 2009, total
unrecognized compensation cost, related to unvested stock options and warrants
was approximately $252,055, which is expected to be recognized as an expense
over a weighted-average period of 2 years.
Derivative
Liabilities. Effective April 1,
2009 CryoPort adopted the provisions of Emerging Issues Task Force (“EITF”)
No. 07-5, Determining
Whether an Instrument (or Embedded Feature) is Indexed to an Entity’s Own Stock
(“EITF 07-5”). EITF 07-5 applies to any freestanding financial
instruments or embedded features that have the characteristics of a derivative,
as defined by SFAS No. 133, Accounting for Derivative
Instruments and Hedging Activities, and to any freestanding financial
instruments that are potentially settled in an entity’s own common stock. As a
result of adopting EITF 07-5, 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 pursuant to
EITF Issue No. 98-5, “Accounting for Convertible
Securities with Beneficial Conversion Features or Contingency Adjustable
Conversion Ratio,” and EITF Issue No. 00-27, “Application of EITF Issue No. 98-5
to Certain Convertible Instruments.” 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 SFAS No. 157, Fair Value Measurements
(“SFAS 157”),
which defines fair value, establishes a framework for measuring fair
value in accordance with GAAP, and requires enhanced disclosures about fair
value measurements. SFAS 157 is effective for financial statements issued for
fiscal years beginning after November 15, 2007. In February 2008 the
FASB issued FASB Staff Position (“FSP”) 157-2, Effective Date of FASB Statement
No. 157 , which delayed the effective date of SFAS 157 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 October 2008, the FASB issued FSP FAS 157-3,
Determining the Fair Value of
a Financial Assets When the Market for That Asset is Not Active (“FSP FAS
157-3”) , which
clarifies the application of SFAS 157 in an inactive market and to illustrate
how an entity would determine fair value in an inactive market. In addition, in
April 2009, the FASB issued FSP SFAS 157-4, Determining Fair Value When the
Volume and Level of Activity for the Asset or Liability Have Significantly
Decreased and Identifying Transactions That Are Not Orderly, which
provides additional guidance for estimating fair value in accordance with SFAS
157 when the volume and level of activity for the asset or liability have
significantly decreased. This FSP also includes guidance on identifying
circumstances that indicate a transaction is not orderly. This
pronouncement supersedes FSP SFAS 157-3 and is effective for periods ending
after June 15, 2009. CryoPort has concluded that the adoption of SFAS
157 and related FSPs for non-financial assets and liabilities did not have a
material effect on CryoPort’s consolidated financial statements.
In
November 2007, the EITF issued EITF Issue 07-01, “Accounting for Collaborative
Arrangements” (“EITF 07-01”). EITF 07-01 requires
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.
Further, EITF 07-01 clarified that the determination of whether
transactions within a collaborative arrangement are part of a vendor-customer
(or analogous) relationship subject to Issue 01-9, “Accounting for Consideration Given
by a Vendor to a Customer.” EITF 07-01 is effective for fiscal years
beginning after December 15, 2008. CryoPort has concluded that the adoption
of EITF 07-01 did not have a material effect on CryoPort’s consolidated
financial statements.
In
December 2007, the FASB issued SFAS No. 141 (revised 2007), “Business Combinations” (“SFAS
141(R)”). SFAS 141(R) replaces SFAS No. 141, “Business Combinations,” and
is effective for CryoPort for business combinations for which the acquisition
date is on or after the beginning of the first annual reporting period beginning
on or after December 15, 2008. SFAS 141(R) requires the new acquiring entity to
recognize all assets acquired and liabilities assumed in the transactions,
expense all direct transaction costs and account for the estimated fair value of
contingent consideration. This standard establishes an acquisition-date
fair value for acquired assets and liabilities and fully discloses to investors
the financial effect the acquisition will have. CryoPort is evaluating the
impact this pronouncement will have on any future business
combinations.
In
December 2007, the FASB issued SFAS No. 160, “Noncontrolling Interests in
Consolidated Financial Statements: an Amendment to ARB No. 51” (“SFAS No.
160”). SFAS No. 160 establishes new accounting and reporting standards for the
noncontrolling interest in a subsidiary and for the deconsolidation of a
subsidiary. Specifically, it requires the recognition of a noncontrolling
interest as equity in the consolidated financial statements which will be
separate from the parent’s equity. SFAS No. 160 is effective for fiscal years
and interim periods in those fiscal years beginning on or after December 15,
2008 and early adoption is prohibited. The adoption of SFAS No. 160 did not have
a material effect on CryoPort’s consolidated financial statements.
In March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative
Instruments and Hedging Activities — an amendment of FASB Statement No.
133” (“SFAS 161”). SFAS 161 requires 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 SFAS No. 133, “Accounting for Derivative
Instruments and Hedging Activities”; and (iii) the effect of derivative
instruments and related hedged items on an entity’s financial position,
financial performance and cash flows. SFAS 161 is effective for financial
statements issued for fiscal years and interim periods beginning after November
15, 2008. The adoption of SFAS 161 did not have a material effect on CryoPort’s
consolidated financial statements.
In April
2009, the FASB issued FASB Staff Position (“FSP”) FAS 107-1 and Accounting
Principles Board (“APB”) APB 28-1, Interim Disclosures about Fair Value
of Financial Instruments (“FSP FAS 107-1” and “APB 28-1,” respectively),
which requires disclosures about fair value of financial instruments for interim
reporting periods of publicly traded companies as well as in annual financial
statements. FSP FAS 107-1 and APB 28-1 are effective for interim
reporting periods ending after June 15, 2009. CryoPort has concluded
that the application of FSP FAS 107-1 and APB 23-1 did not have a material
effect on CryoPort’s consolidated financial statements.
In May
2009, the FASB issued Statement (“SFAS”) No. 165, “Subsequent Events” (“SFAS
165”), which establishes standards of accounting and reporting for events
occurring after the balance sheet date but before financial statements are
issued. SFAS 165 requires the disclosure of the date through which an entity has
evaluated subsequent events and the basis for that date, that is, whether the
date represents the date the financial statements were issued or were available
to be issued. The effective date of SFAS 165 is for annual and interim periods
ending after June 15, 2009. CryoPort has evaluated subsequent events for
disclosure and recognition after the balance sheet date of June 30, 2009 through
August 14, 2009, the date the financial statements were issued.
In June
2009, the FASB issued SFAS 167 “Amendments to FASB Interpretation
No. 46” (“SFAS 167”), and SFAS 166 “Accounting for Transfers of
Financial Assets - an Amendment of FASB Statement No. 140” (“SFAS
166”). SFAS 167 amends the existing guidance around FIN 46(R), to
address the elimination of the concept of a qualifying special purpose entity.
Also, it replaces the quantitative-based risks and rewards calculation for
determining which enterprise has a controlling financial interest in a variable
interest entity with an approach focused on identifying which enterprise has the
power to direct the activities of a variable interest entity and the obligation
to absorb losses of the entity or the right to receive benefits from the entity.
Additionally, SFAS 167 provides for additional disclosures about an enterprise’s
involvement with a variable interest entity. SFAS 166 amends SFAS 140 to
eliminate the concept of a qualifying special purpose entity, amends the
derecognition criteria for a transfer to be accounted for as a sale under SFAS
140, and will require additional disclosure over transfers accounted for as a
sale. The effective date for both pronouncements is for the first fiscal year
beginning after November 15, 2009, and will require retrospective application.
CryoPort does not expect the adoption of these two statements to have a material
effect on its consolidated financial statements.
In June
2009, the FASB issued SFAS 168, “The FASB Accounting Standards Codification and
the Hierarchy of Generally Accepted Accounting Principles, a replacement of FASB
Statement No. 162.” SFAS 168 establishes the FASB Accounting Standards
Codification (“Codification”) as the single source of authoritative,
nongovernmental U.S. GAAP, along with rules and interpretive releases of the SEC
as authoritative GAAP for SEC registrants. Although the Codification does not
change GAAP, it substantially reorganizes the literature, and requires
enterprises to revise GAAP references contained in financial statement
disclosures. The effective date of SFAS 168 is for interim and annual periods
ending after September 15, 2009. CryoPort does not expect the adoption of SFAS
168 to have a material effect on its consolidated financial
statements.
Change
in Accounting Principle
In June
2008, the FASB ratified EITF 07-05, “Determining Whether an Instrument is
Indexed to an Entity’s Own Stock” (“EITF No. 07-05”) , to address
concerns regarding the meaning of ”indexed to an entity’s own stock”
as outlined in SFAS No. 133 “Accounting for Derivative Instruments and Hedging
Activities. Equity-linked instruments (or embedded features) that
otherwise meet the definition of a derivative as outlined in SFAS No. 133,
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. EITF 07-05 provides guidance 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. The warrant and
convertible-debt agreements contain adjustment (or ratchet) provisions in the
agreements, and accordingly, we determined that these instruments are not
indexed to CryoPort’ common stock. As a result, CryoPort is required
to account for these instruments as derivatives or liabilities under SFAS No.
133. CryoPort adopted EITF 07-05, beginning April 1, 2009, and
applied its 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 EITF 07-05,
the 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 capable of transporting biological, environmental
and other temperature sensitive materials at temperatures below zero degrees
centigrade. These dry vapor shippers are the first significant
alternative to using dry ice and achieve 10+ day holding times compared to 1–2
day holding times with dry ice.
Our value proposition comes from both
providing a safe, transportation and environmentally friendly, long lasting
shipper. Through our value added services we 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 and allows the customer to track the progress and status of a
shipment, and
in-transit temperature monitoring services of the
shipper. CryoPort also provides to its customer at their pick
up location, the fully ready charged shipper containing all freight bills,
customs documents and regulatory paperwork for the entire journey of the
shipper.
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°
centigrade. The dry vapor shipper is designed using innovative,
proprietary, and patent pending technology such that there can be no pressure
build up as the liquid nitrogen evaporates, nor any spillage of liquid
nitrogen. 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, “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 (less than -150 ° C).
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 capital stock of CryoPort
Systems, Inc., a California corporation, in exchange for 24,108,105 shares 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 followed by a reorganization into
a California corporation on December 11, 2000, remains the operating company
under CryoPort, Inc. The foregoing does not take into account
the consummation of a reverse stock split, at a ratio of 10-to-1.
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. 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 toward globalization. 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 high integrity of maintaining materials at
cryogenic temperatures is considered a priority and where we are 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 degrees
centigrade 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 degrees centigrade. 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
“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 degrees centigrade).
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 vapor phase
liquid nitrogen storage containers that 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 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 pharmaceutical clinical trials, gene
biotechnology, infectious materials handling, and animal and human
reproduction. 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 cryogenic
preserved biological or pharmaceutical materials shipped though overnight
shipping companies.
CryoPort
Express®
Portal
The
CryoPort Express® Portal is used by CryoPort, customers and 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 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 –but
typically provisioned through manual labor. Certain features
of the CryoPort Express® Portal reduce operating costs and facilitate
scaling of CryoPort but more importantly, they offer 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 it. In the future we will add rate and mode optimization and
in-transit monitoring of temperature, location and state-of-health monitoring
(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 dataloggers in the field. Data is converted to pre-designed reports
containing valuable and often actionable information that becomes the quality
control standard or “pedigree” of the shipment. This high value
information will is 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 the customer’s 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 a 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 that the downloading the data is automatic and requires no customer
intervention.
CryoPort
Express®
Analytics
Our
continued development of 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. The analytical results will be utilized by
CryoPort to render consultative customer services. Such things as
on-time deliveries and 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.
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,
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. Alternative phase change materials in place of
liquid nitrogen may be used to increase the potential markets in which these
shippers can be used such as ambient and 2-8°C markets.
Competitive
Strengths
We
believe that our cryogenic shipping solutions 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, capable of
maintaining cryogenic temperatures of minus 150 degrees centigrade or less for
ten 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 had been serving
this market, such as dry ice, are only capable of maintaining such temperature
hold times for a period of one to five days (depending on the size of the
package and amount of dry ice used), thereby potentially jeopardizing the
integrity of the transported materials in connection with longer
shipments. Our CryoPort Express® Shippers are the first significant
alternative to using dry ice and achieve 10+ 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 thirty (30) feet, significantly reduce the risk of damage to the
packaged materials. The durability and long holding times of our
shippers takes on added significance when one considers the increased shipping
time and occurrences of handling in connection with international shipments both
of which amplify the risk of damage during transit.
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 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 ten or more days, users of our products 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 the package through
our web portal. CryoPort is also able to internally manage its
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 shipping using dry ice, the internal core
of our cryogenic shippers absorbs liquid nitrogen in a gaseous state, which then
maintains the required cryogenic temperatures. Because dry ice is a
hazardous material, as it sublimates, it produces excess CO2 gas which is a
noted greenhouse gas and which may be dangerous in confined spaces where there
is an absence of ventilation or ventilation rates are low. Use of our
shippers does not result in the emission of greenhouse gases or other
potentially toxic materials as is the case with dry ice. In addition,
shipping containers using dry ice are made of corrugated cardboard with
Styrofoam inserts. These shippers are typically not reusable,
resulting in the disposal of cardboard box and Styrofoam, which 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 Courier. We believe that our near term success is best
achieved by establishing a strategic relationship with a global courier which
will enable us to provide a seamless, end-to-end shipping solution to
customers. In addition, we will be able to leverage the courier’s
established express, ground and freight infrastructures and penetrate new
markets with minimal investment. The management team is in advanced discussions
with global freight carriers to establish a strategic partnership in which the
carrier would provide preferred shipping rates, access to logistics, tracking
and custom clearance capabilities. We also expect that the global freight
carrier will utilize their sales force to promote and sell the frozen shipping
services in connection with the carrier. We can not assure you that
we will be able to consummate such an agreement with a global
courier.
Target Large
Clinical Research Organizations and Life Science
Companies. Along with our efforts to establish a strategic
relationship with a global courier, 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 clinical
trials both domestic and international. Management has been in active
dialogue with selected large CRO’s, pharmaceutical and biotechnology companies
to introduce this new frozen shipping solution and to discuss these potential
customers shipping needs. Several of such meetings have included
representatives from a global freight forwarder in joint presentations with
us. We can not assure you that we will be able to consummate an
agreement with one or more large CROs.
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, the CryoPort Express® Portal, which
today is used by customers to automate the entry of orders, prepare customs
documentation and to 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
and to reduce 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 –but typically
provisioned by manual labor. Certain features of the CryoPort
Express® Portal reduces operating costs and facilitate scaling of CryoPort
but more importantly, they offer significant value to the customer in terms of
cost avoidance and risk mitigation. Examples include automation of order entry,
development of Key Performance Indicators 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 monitoring (discussed below), via wireless
communications.
Complete
Development of Our Smart Pak Monitoring System. 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 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 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 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 we have focused our efforts marketing our
shippers to selected companies in the global CRO, 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 at or below minus
80 or 150 degrees 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 technology may be able to be applied 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:
USA
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81.4%
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Europe
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17.8%
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Canada
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0.8%
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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
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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 Food and Drug Administration 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 contract research organizations
(“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 up to 36 hours, in the
absence of re-icing (which is quite costly). Because shipments of
packages internationally can take longer than 36 hours 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. According to The Wall Street Journal, January 6,
2000 issue, 30,000 infants are born annually in the United States through
artificial insemination and according to Department of Health statistics, 10
million Americans annually are affected by infertility problems. It
is estimated that this represents at least 50,000 doses of
semen. 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, to stabilize
the cells and to 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. This will require a greater dependence on passively controlled
temperature transport systems (i.e., systems having no external power source).
[References: Cryopak Industries – Investment Package/Annual Report
and US
Department of Commerce - US
Industrial Outlook.]
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., -150°C) 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, -196°C.
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°C, while the
refrigerated compartment at 8°C 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 one and one-half 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 International Air
Transportation Association (“IATA”), the Department of Transportation
(“DOT”), the Center for Disease Control (“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 compromise 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 sell at prices that preclude any
reasonable concept of disposability. 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 three months ended June 30, 2009 and for the fiscal
years ended March 31, 2009 and 2008 were $87,725, $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 an EPA approved
supplier. 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 its intellectual property rights. We currently
own four registered United State trademarks and three issued United States
patents primarily covering various aspects of our products. In
addition, we have filed applications for provisional patents to various aspects
of the shipper and web-portal including one for various aspects of our business
model referred to as the CryoPort Express® System and we intend to file for
additional applications for patents 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 nitrogen retention
systems, systems related to thermal performance, systems related to packaging
integrity, and matters generally relevant to the containment of liquid
nitrogen. Similarly, the trademarks mentioned relate to the cryogenic
temperature shipping activity. Issued patents and trademarks
currently owned by us include:
Type:
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Our
success depends to a significant degree upon our ability to develop proprietary
products and technologies and to obtain patent coverage for these products and
technologies. We intend to file trademark and patent applications
covering any newly developed products, methods and
technologies. However, there can be no guarantee that any of our
pending or future filed applications will be issued as patents. There
can be no guarantee that the U.S. Patent and Trademark Office or some third
party will not initiate an interference proceeding involving any of our pending
applications or issued patents. Finally, there can be no guarantee
that its issued patents or future issued patents, if any, will provide adequate
protection from competition.
Patents
provide some degree of protection for our proprietary
technology. However, the pursuit and assertion of patent rights
involve complex legal and factual determinations and, therefore, are
characterized by significant uncertainty. In addition, the laws
governing patent issuance and the scope of patent coverage continue to
evolve. Moreover, the patent rights we possess or are pursuing
generally cover our technologies to varying degrees. As a result, we
cannot ensure that patents will issue from any of our patent applications, or
that any of its issued patents will offer meaningful protection. In
addition, our issued patents may be successfully challenged, invalidated,
circumvented or rendered unenforceable so that our patent rights may not create
an effective barrier to competition. Moreover, the laws of some
foreign countries may not protect our proprietary rights to the same extent, as
do the laws of the United States. There can be no assurance that any
patents issued to us will provide a legal basis for establishing an exclusive
market for our products or provide us with any competitive advantages, or that
patents of others will not have an adverse effect on our ability to do business
or to continue to use our technologies freely.
We may be
subject to third parties filing claims that our technologies or products
infringe on their intellectual property. We cannot predict whether
third parties will assert such claims against us or whether those claims will
hurt our business. If we are forced to defend against such claims,
regardless of their merit, we may face costly litigation and diversion of
management’s attention and resources. As a result of any such
disputes, we may have to develop, at a substantial cost, non-infringing
technology or enter into licensing agreements. These agreements may
be unavailable on terms acceptable to it, or at all, which could seriously harm
our business or financial condition.
We also
rely on trade secret protection of our intellectual property. We
attempt to protect trade secrets by entering into confidentiality agreements
with third parties, employees and consultants. It is possible that
these agreements may be breached, invalidated or rendered unenforceable, and if
so, our trade secrets could be disclosed to our competitors. Despite
the measures we have taken to protect our intellectual property, parties to its
agreements may breach confidentiality provisions in our contracts or infringe or
misappropriate our patents, copyrights, trademarks, trade secrets and other
proprietary rights. In addition, third parties may independently
discover or invent competitive technologies, or reverse engineer our trade
secrets or other technology. Therefore, the measures we are taking to
protect our proprietary technology may not be adequate.
Government
Regulation
The
shipping of diagnostic specimens, infectious substances and dangerous goods,
whether via air or ground, falls under the jurisdiction of many states, federal
and international agencies. The quality of the containers, packaging
materials and insulation that protect a specimen determine whether or not it
will arrive in a usable condition. Many of the regulations for
transporting dangerous goods in the United States are determined by
international rules formulated under the auspices of the United
Nations. For example, the International Civil Aviation Organization
(“ICAO”) is the United Nations organization that develops regulations (Technical
Instructions) for the safe transport of dangerous goods by air. If
shipment is by air, compliance with the rules established by IATA is required.
IATA is a trade association made up of airlines and air cargo carriers that
publishes annual editions of the IATA Dangerous Goods
Regulations. These regulations interpret and add to the ICAO
Technical Instructions to reflect industry
practices. Additionally, the Center for Disease Control has
regulations (published in the Code of Federal Regulations) for interstate
shipping of specimens, and the Occupational Safety and Health Organization
(“OSHA”) also addresses the safe handling of Class 6.2
Substances. Our CryoPort Express® Shipper meets packing
instruction 602 and 650 and is certified for the shipment of Class 6.2 Dangerous
Goods per the requirements of the International Civil Aviation Organization
(ICAO) Technical Instructions for the Safe Transport of Dangerous Goods by Air
and the International Air Transport Association (IATA). Our
present and planned future versions of the CryoPort Smart Pak datalogger will
likely be subject to regulation
by FAA, FCC, FDA, IATA and possibly other agencies which may be difficult to
determine on a global basis.
We are
also subject to numerous other federal, state and local laws relating to such
matters as safe working conditions, manufacturing practices, environmental
protection, fire hazard control, and disposal of hazardous or potentially
hazardous substances. We may incur significant costs to comply with
such laws and regulations now or in the future.
Employees
As of
September 15, 2009, we had six full-time employees and four consultants,
two of which consultants work for us on a full-time basis.
Insurance
We
currently maintain general liability insurance, with coverage in the amount of
$1 million per occurrence, subject to a $2 million annual
limitation. Claims may be made against us that exceed these
limits. In fiscal year 2009, we did not experience any claims against
our professional liability insurance.
Our
liability policy in 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.
DESCRIPTION
OF PROPERTY
CryoPort’s
corporate, research and development, and warehouse facilities are located in one
leased office and warehouse building with approximately 12,000 square
feet. The facilities are located at 20382 Barents Sea Circle, Lake
Forest, CA 92630. CryoPort currently makes base lease payments of
approximately $13,000 per month, due at the beginning of each month, pursuant to
a two year lease through August 2010 with renewal options for three additional
one year lease terms. The landlord is Viking Investors, Barents Sea,
LLC. The facilities are in good condition and are suitable for
CryoPort’s current requirements. CryoPort currently does not own any
real property.
LEGAL
PROCEEDINGS
In the
ordinary course of business, we are at times subject to various legal
proceedings and disputes, including product liability claims. We
currently are not aware of any such legal proceedings or claim that we believe
will have, individually or in the aggregate, a material adverse effect on our
business, operating results or cash flows. It is our practice to
accrue for open claims based on our historical experience and available
insurance coverage.
DIRECTORS
AND EXECUTIVE OFFICERS
Directors
and Executive Officers
The
following table sets for the name and age of each director and executive
officer, the year first elected as a director and/or executive officer and the
position(s) held with CryoPort:
Name
|
|
Age
|
|
Position
|
|
Date
Elected
|
|
|
|
|
|
|
|
|
|
|
|
Chairman
of the Board, Chief Executive Officer, President and
Director
|
|
|
|
|
|
|
Vice
President of Operations
|
|
|
|
|
|
|
Chief
Financial Officer, Treasurer and Assistant Corporate
Secretary
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Background
of Directors and Officers:
Larry G.
Stambaugh, age 62, was elected as CryoPort’s Chairman of the Board on
December 5, 2008 and became President and Chief Executive Officer on February
20, 2009. Mr. Stambaugh is currently a Principal of Apercu Consulting, a firm
that he established in 2006. From December 1992 to January 2006, Mr. Stambaugh
served as Chairman and Chief Executive Officer of Maxim Pharmaceuticals, a
public company developing cancer and infectious disease drugs which he
co-founded. From December 2007 to February 2008, Mr. Stambaugh reorganized two
biotechnology companies owned by Arrowhead Research Corporation, a public
holding company, Calando Pharmaceuticals and Insert Therapeutics and served as
Chief Executive Officer of each subsidiary. Mr. Stambaugh has more than 30 years
experience building global businesses and setting strategies and has an
extensive background in life sciences and clean tech including relationships
with and knowledge of Contract Research Organizations, biotech and
pharmaceutical companies Mr. Stambaugh serves on several boards including
EcoDog, Ridge Diagnostics, Corporate Directors Forum and BioCom. Mr. Stambaugh
earned his BBA Accounting/Finance from Washburn University in 1969.
Bret
Bollinger, became
Vice president of Operations for CryoPort in February 2008. Prior to
joining CryoPort, Mr. Bollinger was Director of Operations and Engineering for
Triangle Brass Manufacturing from July 2003 to January 2008. Mr.
Bollinger served as a Business Process Consultant for Vistant Corporation, a
division of Cardinal Health from July of 2001 through July 2003 and as
Operations and Order Fulfillment Manager for Ingersoll-Rand’s Safety and
Security Sector, Falcon Lock Company from July of 1999 to July of
2001. Mr. Bollinger has extensive background in manufacturing
environments, including experience with opening both manufacturing and assembly
plants domestically as well as in Mexico. In addition, he has
experience in new product design and implementation. Mr. Bollinger
holds a Bachelor of Science in Mechanical Engineering from Sacramento State
University.
Catherine
Doll, age 49, became Chief Financial Officer, Treasurer and Assistant
Corporate Secretary effective as of August 20, 2009. Ms. Doll is the owner
and chief executive officer of The Gilson Group, LLC, which she founded in 2006.
The Gilson Group, LLC provides financial and accounting consulting services to
public companies, including Sarbanes Oxley Section 404 compliance, SEC and
financial reporting, budgeting and forecasting and finance and accounting
systems implementations and conversions. From 1996 to 2006, Ms. Doll was an
associate with Resources Global Professionals, where she provided management,
financial and accounting services for a variety of clients. Ms. Doll received a
B.A. in Economics, with an emphasis in accounting, from the University of
California, Santa Barbara, in 1983. She has over 25 years of accounting and
financial reporting experience.
Carlton M.
Johnson, Jr.,
age 48, was elected as a director and Secretary to the Board on May 4, 2009 and
serves as Chairman of the Compensation and Governance Committee and is a member
of the Audit Committee. Mr. Johnson has been In-House Legal Counsel for Roswell
Capital Partners, LLC since 1996. Mr. Johnson has been a member of the Alabama
Bar since 1986, the Florida Bar since 1988 and the State Bar of Georgia since
1997. He was a stockholder in the Pensacola, Florida Bar Registered (AV rated)
law firm of Smith, Sauer, DeMaria & Johnson from 1988 to 1996. Mr. Johnson
holds a degree in History/Political Science from Auburn University and Juris
Doctorate from Samford University, Cumberland School of Law. Mr. Johnson also
serves on the boards of Peregrine Pharmaceuticals, Inc. and Patriot Scientific
Corporation. Mr. Johnson’s appointment to the Board fulfills an agreement
between CryoPort and BridgePointe Master Fund Ltd. (“BridgePointe”) to have a
representative of BridgePointe on CryoPort’s Board of Directors pursuant to
CryoPort’s October 2007 and May 2008 Convertible Debentures, as
amended.
Adam M.
Michelin, age 65, became a member of CryoPort’s Board in June 2005 and
serves as Chairman of the Audit Committee and as a member of the Compensation
and Governance Committee. Mr. Michelin is currently the President and Chief
Executive Officer of Redux Holdings, Inc., a position he has held since January
2006. Mr. Michelin has held several executive leadership positions including,
Chief Executive Officer of Enterprise Group from March 2005, Principle of Kibel
Green, Inc., a position he held for 11 years prior to joining Enterprise Group,
and Partner of KPMG LLP for 10 years. Mr. Michelin has over 30 years of practice
in the areas of executive leadership, operations and is very experienced in
evaluating, structuring and implementing solutions for companies in operational
and/or financial crisis. Mr. Michelin received his Juris Doctorate from the
University of West Los Angeles and his Bachelor of Science from Tri State
University.
The
officers of CryoPort hold office until their successors are elected and
qualified, or until their death, resignation or removal.
None of
the directors or officers hold a directorship in any other reporting company
except: Adam Michelin is Director, CEO/President and Treasurer of
Redux Holdings, Inc. (RDXH); CEO/Chairman Naturade Inc.(NRDCQ);
and Carlton Johnson is a member of the Board of Directors of
Peregrine Pharmaceuticals, Inc. (PPHM) and Patriot Scientific Corporation
(PTSC).
None of
the directors or officers listed above has:
|
● |
Had
a bankruptcy petition filed by or against any business of which that
person was a general partner of executive officer either at the time of
the bankruptcy or within two years prior to that time;
|
|
|
|
|
● |
Had
any conviction in a criminal proceeding, or been subject to a pending
criminal proceeding;
|
|
|
|
|
● |
Been
subject to any order, judgment, or decree by any court of competent
jurisdiction, permanently or temporarily enjoining, barring, suspending or
otherwise limiting such person’s involvement in any type of business,
securities or banking activities; and
|
|
|
|
|
● |
Been
found by a court of competent jurisdiction, the Commission, or the
Commodity Futures Trading Commission to have violated a federal or state
securities or commodities law.
|
Committees
of the Board
Our Board
has established an Audit Committee and a Compensation and Governance
Committee. We do not have a formal nominating committee.
Audit
Committee
The
functions of the Audit Committee are to (i) review the qualifications of the
independent auditors, our annual and interim financial statements, the
independent auditor’s report, significant reporting or operating issues and
corporate policies and procedures as they relate to accounting and financial
controls; and (ii) to consider and review other matters relating to our
financial and accounting affairs. The Board has adopted an Audit Committee
charter, which is available on CryoPort’s website at www.cryoport.com under the
tab “Corporate Governance” which is found under the heading “Company.”
Information on our website does not constitute a part of this
prospectus.
The
members of the Audit Committee are Adam Michelin, who is the Audit Committee
Chairman, and Carlton M. Johnson, Jr. Under Nasdaq Marketplace Rule
5605(c)(2)(A) we will be required to have three directors meeting the requisite
Nasdaq audit committee independence requirements. Consequently, there
currently is one vacant seat on the Audit Committee, which we intend to fill
prior to the consummation of this offering. CryoPort has determined
that (i) Adam Michelin qualifies as an “audit committee financial expert” as
defined in Item 401(h) of Regulation S-K of the SEC rules and is “independent”
within the meaning of Nasdaq Rule 5605(a)(2) and the related rules of the SEC,
and (ii) Carlton M. Johnson, Jr. is “independent” within the meaning of Nasdaq
Rule 5605(a)(2) and the related rules of the SEC.
Compensation
and Governance Committee.
The
purpose of the Compensation and Governance Committee is to discharge the Board’s
responsibilities relating to compensation of CryoPort’s directors and
executives, to produce an annual report on executive compensation for inclusion
in CryoPort’s proxy statement, as necessary, and to oversee and advise the Board
on the adoption of policies that govern CryoPort’s compensation programs
including stock and benefit plans. The Compensation and Governance
Committee does not operate under a charter.
The
current members of the Compensation and Governance Committee are Carlton M.
Johnson, Jr., who is the Chairman of the Compensation and Governance Committee,
and Mr. Adam Michelin, each of whom is independent under applicable independence
requirements. Each of the current members of the Compensation and Governance
Committee is a “non-employee director” under Section 16 of the Exchange Act and
an “outside director” for purposes of Section 162(m) of the Internal Revenue
Code of 1986, as amended (the “Code”).
Nominating
Committee
CryoPort
does not have a formal nominating committee. The function of the
nominating committee is handled by CryoPort’s Compensation and Governance
Committee. The Board does not believe that a nominating committee is necessary
because the independent directors participate in the nominating
process.
SUMMARY
COMPENSATION TABLE
Name
and
Principal
Position
|
|
Fiscal
Year
|
|
Salary(1)
($)
|
|
Bonus(7)
($)
|
|
Option
Awards(8)
($)
|
|
All
Other
Compensation(14)
($)
|
|
Total
Compensation
($)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Larry
G. Stambaugh,
President,
Chief Executive Officer
and
Chairman
|
|
2009
2008
|
|
48,000(2)
-
|
|
-
-
|
|
28,695(9)
-
|
|
-
-
|
|
76,695
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Peter
Berry,
Former
President and
Chief
Executive Officer
|
|
2009
2008
|
|
205,000(3)
136,000(3)
|
|
-
30,000
|
|
-
47,395(10)
|
|
7,040
3,300
|
|
259,435
216,695
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dee
S. Kelly, CPA,
Former
Chief Financial Officer and
Vice
President of Finance
|
|
2009
2008
|
|
116,000(4)
100,000(4)
|
|
-
16,000
|
|
-
64,639(11)
|
|
-
-
|
|
120,000
186,639
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bret
Bollinger,
Vice
President of Operations
|
|
2009
2008
|
|
124,000(5)
21,667(5)
|
|
-
-
|
|
119,398(12)
52,983(12)
|
|
6,890
1,196
|
|
188,288
75,846
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Kenneth
Carlson
Vice
President of Sales and Marketing
|
|
2009
2008
|
|
110,000(6)
106,000(6)
|
|
-
14,000
|
|
-
68,877(13)
|
|
5,234
4,540
|
|
115,234
193,417
|
(1)
|
This
column represents salary and consulting compensation as reported as of the
last payroll period prior to or immediately after March 31 of each fiscal
year.
|
(2)
|
This
amount represents the $12,000 paid to Mr. Larry Stambaugh as compensation
for consulting services during fiscal 2009, as well as the $36,000 paid to
Mr. Stambaugh as compensation for services as a Director during fiscal
2009. Mr. Stambaugh was elected as Chairman of the Board on December 10,
2008 and subsequently as President and Chief Executive Officer on February
20, 2009. On August 21, 2009, the Compensation and Governance Committee
approved an employment agreement with Mr. Stambaugh which has an effective
commencement date of August 1, 2009, the details of which are described
below.
|
(3)
|
This
amount represents the $192,000 paid to Mr. Peter Berry during fiscal 2009
as salary for his services as the President and Chief Executive Officer
until February 20, 2009, when he resigned his position. In November and
December 2008, Mr. Berry voluntarily took a reduction in his monthly pay
from $16,000 to $14,500 per month. Mr. Berry resigned from the Board of
Directors effective July 30, 2009 but continues to serve as a consultant
for CryoPort in an advisory role. Effective March 1, 2009, Mr. Berry
entered into a Consulting Agreement to provide advisory services to
CryoPort for the period from March 1, 2009 to January, 1, 2010. The
compensation for Mr. Peter Berry’s consulting services under such
agreement for fiscal 2009 was $16,000 for the month of March 2009 and
$28,890 for each month thereafter until expiration of such
agreement.
|
(4)
|
This
amount represents the $10,000 per month paid to Ms. Dee Kelly as a
part-time consultant for CryoPort during fiscal 2009 and fiscal year ended
March 31, 2008. In fiscal 2009, Ms. Kelly deferred approximately $4,000.
In fiscal 2008, Ms. Kelly deferred approximately $20,000. Ms. Kelly does
not have an employment agreement with CryoPort. Ms. Kelly
resigned all of her officer positions with CryoPort effective August 20,
2009.
|
(5)
|
This
amount represents the $130,000 paid to Mr. Bret Bollinger as salary for
his services as CryoPort’s Vice President of Operations of which $9,000
was deferred as of September 2009 due to Mr. Bollinger’s voluntarily
reduction in his monthly pay from $10,833 to $9,883 in January 2009. Mr.
Bret Bollinger’s became CryoPort’s Vice President of Operations in
February 2008.
|
(6)
|
This
amount represents the $120,000 paid to Mr. Kenneth Carlson as salary for
his services as CryoPort’s Vice President of Sales and Marketing for
fiscal 2009 and fiscal year ended March 31, 2008. In the months of
November 2008 through March 2009, Mr. Carlson voluntarily took a reduction
in his monthly pay from $10,000 to $8,000, resulting in the deferral of
$10,000 in compensation for fiscal
2009.
|
(7)
|
This
amount represents the annual year-end bonus, based on a percentage of
salary, paid to all employees of
CryoPort.
|
(8)
|
This
column represents the expense recorded for the fair value of all stock
options and warrants granted in fiscal 2009 and CryoPort’s fiscal year
ended March 31, 2008, all in accordance with SFAS 123(R). Pursuant to SEC
rules, the amounts shown exclude the impact of estimated forfeitures
related to service-based vesting conditions. For information on the
valuation assumptions with respect to the grants made in 2009 and 2008,
refer to Note 2 “Summary of Significant Accounting Policies – Stock-Based
Compensation” in CryoPort’s Form 10-K for the period ended March 31, 2009,
filed with the SEC on July 1, 2009. For information on the valuation
assumptions with respect to the grants made in 2007, refer to Note 2
“Summary of Significant Accounting Policies – Stock-Based Compensation” in
CryoPort’s Form 10-K for the period ended March 31, 2008, filed with the
SEC on June 30, 2008, and amended on July 14,
2008.
|
(9)
|
This
amount represents the fair value of all options and warrants granted to
Mr. Stambaugh as compensation for services as Director during fiscal 2009.
On December 10, 2008, based on the recommendation of the Compensation and
Governance Committee and approval by the Board, Mr. Stambaugh was granted
500,000 warrants exercisable at $0.84 which vest in three equal
installments on the date of grant and the first and second anniversary of
the date of grant.
|
(10)
|
This
amount represents the fair value of all options and warrants granted to
Mr. Berry as compensation during fiscal 2009. Based on the recommendation
of the Compensation and Governance Committee and approval by the Board,
Mr. Berry was granted incentive awards of 2,620 fully vested warrants
exercisable at $10.70 per share on August 27, 2007 and 2,620 fully vested
warrants exercisable at $10.70 per share on February 28, 2008, assuming
the consummation of a reverse stock split, at a ratio of 10-to-1. The
exercise prices of the warrants are equal to the fair value of CryoPort’s
stock as of the grant dates.
|
(11)
|
This
amount represents the fair value of all options and warrants granted to
Ms. Kelly as compensation for services during fiscal 2009. Based on the
recommendation of the Compensation and Governance Committee and approval
by the Board, Ms. Kelly was granted incentive awards of 6,100 fully vested
warrants exercisable at $10.70 per share on February 28, 2008, assuming
the consummation of a reverse stock split, at a ratio of 10-to-1. The
exercise price of the warrants is equal to the fair value of CryoPort’s
stock as of the grant date.
|
(12)
|
This
amount represents the fair value of all options and warrants granted to
Mr. Bollinger as compensation for services during fiscal 2009. Based on
the recommendation of the Compensation and Governance Committee and
approval by the Board, Mr. Bollinger was granted incentive awards of
15,000 warrants exercisable at $10.70 per share on February 28, 2008 which
vests at a rate of 5,000 upon date of grant, 5,000 on February 28, 2009
and 5,000 on February 28, 2010, assuming the consummation of a reverse
stock split, at a ratio of 10-to-1. The exercise price of the warrants is
equal to the fair value of CryoPort’s stock as of the grant
date. Mr. Bollinger was issued 62,000 warrants in 2009
performance bonus for year 2008.
|
(13)
|
This
amount represents the fair value of all options and warrants granted to
Mr. Carlson as compensation for services during CryoPort’s fiscal year
ended March 31, 2008. Based on the recommendation of the Compensation and
Governance Committee and approval by the Board, Mr. Carlson was granted
incentive awards of 6,500 fully vested warrants exercisable at $10.70 per
share on February 28, 2008, assuming the consummation of a reverse stock
split, at a ratio of 10-to-1. The exercise price of the warrants is equal
to the fair value of CryoPort’s stock as of the grant
date.
|
(14)
|
Amounts
shown in this column reflect the costs of health insurance premiums paid
to each of Messrs. Berry, Carlson and Bollinger. Such items are currently
taxable to such named executive officer. The amount of taxable income for
the individual is determined pursuant to Internal Revenue Service rules
which may differ from the amounts reflected in this
column.
|
Narrative
Disclosure to Summary Compensation Table
Employment
Contracts
Larry G.
Stambaugh
On August
21, 2009, the Compensation and Governance Committee approved an employment
agreement with Mr. Stambaugh, CryoPort’s Chief Executive Officer, President and
Chairman, which commenced effective as of August 1, 2009 and will continue in
effect until Mr. Stambaugh’s employment is terminated under the provisions of
the employment agreement (the “Stambaugh Employment
Agreement”). Pursuant to the terms of the Stambaugh Employment
Agreement, Mr. Stambaugh will be paid an initial annual base salary of $360,000
which may be increased from time to time at the discretion of Compensation and
Governance Committee. Mr. Stambaugh also may be eligible to receive a
discretionary annual bonus of up to sixty percent (60%) of his then effective
annualized base salary pursuant to an incentive plan to be prepared by
CryoPort’s Board with Mr. Stambaugh’s participation and completed at the
earliest practicable time. In addition, in the event that CryoPort
raises an aggregate of $5,000,000 pursuant to equity and/or convertible debt
financings during the period of March 30, 2009 and continuing to the last day of
the term of his employment, then Mr. Stambaugh shall be entitled to receive a
onetime incentive payment in the amount of $125,000. Mr. Stambaugh is
eligible to participate in all employee benefits plans or arrangements which may
be offered by CryoPort during the term of his agreement. CryoPort shall pay the
cost of Mr. Stambaugh’s health insurance coverage in accordance with CryoPort’s
plans and policies during the term of his employment. Mr. Stambaugh shall also
be eligible for twenty-five (25) paid time off days a year, and is entitled to
receive fringe benefits ordinarily and customarily provided by CryoPort to its
senior officers.
In
addition to the previously awarded warrant for 50,000 shares (assuming the
consummation of a reverse stock split, at a ratio of 10-to-1) common stock
issued to Mr. Stambaugh on December 10, 2008, on October 1, 2009, or sooner if
permitted by debt restrictions, Mr. Stambaugh will become entitled to receive an
incentive stock option to acquire 67,000 shares (assuming the consummation of a
reverse stock split, at a ratio of 10-to-1) of common stock of CryoPort at the
greater of the per share fair market value of such common stock or the current
price allowable under CryoPort’s outstanding convertible
debentures. The right to exercise the stock option will vest as to
33⅓% of the underlying shares of common stock upon grant, with the remaining
underlying shares vesting in equal installments on the first and second
anniversary of the grant date.
Mr.
Stambaugh has agreed not to solicit any CryoPort employees during the term of
his employment and the one year period following the termination of his
employment. Payments due to Mr. Stambaugh upon a termination of his
employment agreement are described below.
Catherine
Doll
On July
29, 2009, CryoPort retained the full-time services of Ms. Doll, and she was
appointed by the Board to the offices of Chief Financial Officer, Treasurer
and Assistant Corporate Secretary effective as of August 20,
2009. Pursuant to her agreement with CryoPort, Ms. Doll will be paid
the sum of $10,000 per month in consideration for her services to
CryoPort. In addition, CryoPort has agreed to issue warrants for the
purchase of 2,000 shares (assuming the consummation of a reverse stock split, at
a ratio of 10-to-1) of our common stock. The terms and exercise price
of the warrants will be determined on the date issuance of the warrant is
approved by the Board.
Bret
Bollinger
Bret
Bollinger is subject to an employment agreement which became effective February
1, 2008 (the “Bollinger Employment Agreement”), pursuant to which he is employed
as CryoPort’s Vice President of Operations. Under the terms of the Bollinger
Employment Agreement, as approved by the Compensation and Governance Committee,
Mr. Bollinger’s current annual salary is $130,000 and he is eligible for an
annual cash bonus of up to 30% to 50% of his base salary based on targeted goals
and objectives met, payable in either cash or warrants, as determined by the
President and approved by the Board. In the event that CryoPort terminates Mr.
Bollinger’s employment without “cause,” as defined in the Agreement, then upon
such termination, CryoPort is obligated to pay to Mr. Bollinger as severance an
amount equal to six months of his then current base salary.
Peter
Berry
Prior to
his voluntary resignation on February 20, 2009, Mr. Berry was subject to an
employment agreement with CryoPort dated November 1, 2002, as amended March 17,
2003 (the “Berry Employment Agreement”), pursuant to which he has been employed
as CryoPort’s President and Chief Executive Officer. Based on the
recommendations of the Compensation and Governance Committee, in December 2005,
December 2006, November 2007 and again in December 2008, the Board approved the
extension of Mr. Berry’s employment contract for additional one-year terms with
the same base salary as that provided for in the last year of the original
employment agreement. Under the extended terms of his employment agreement, Mr.
Berry’s annual salary was $192,000 and he was eligible for an annual cash bonus
of up to 40% of his base salary, based on goals and objectives met as
recommended by the Compensation and Governance Committee and approved by the
full Board. On November 1, 2002, pursuant to the Berry Employment Agreement,
CryoPort granted Mr. Berry a stock option to purchase up to 50,000 shares
(assuming the consummation of a reverse stock split, at a ratio of 10-to-1) of
common stock at an exercise price of $5.00 per share, which option vested as to
12,500 shares on the first anniversary of the date of grant, and thereafter
vests in 36 equal monthly installments through November 11, 2006. In the event
that CryoPort terminates Mr. Berry’s employment without “cause,” as defined in
the Berry Employment Agreement, or fails to renew the Agreement except for
“cause,” then upon such termination, CryoPort is obligated to pay to Mr. Berry
as severance an amount equal to his then current base salary, plus any earned
incentive bonus. In March 2003, the Agreement was amended to reflect Mr. Berry’s
agreement to a reduced base salary during the first year of $60,000, and
agreement to forego eligibility for an incentive bonus for such year. In
exchange for the foregoing, CryoPort granted Mr. Berry an additional stock
option to purchase an additional 25,000 shares (assuming the consummation of a
reverse stock split, at a ratio of 10-to-1) of its common stock at a price of
$5.00 per share. The option was vested as to 12,500 shares on the date of grant,
and 6,250 shares on each of September 30, 2003 and March 31, 2004, assuming the
consummation of a reverse stock split, at a ratio of 10-to-1. All other terms of
the Berry Employment Agreement remained unchanged. The Berry Employment
Agreement was further amended by Board consent, due to the financial condition
of CryoPort in 2004 at Mr. Berry’s request, to eliminate the 100% bonus
provision per the contract in year two and defer this bonus into the third year
of the Berry Employment Agreement. This entitled Mr. Berry to earn up to 200% of
his then salary in the third contract year. Mr. Berry’s bonus earned for the
third year of the Berry Employment Agreement was approved for a total of
$100,000 which was included in Mr. Berry’s accrued salaries as of March 31, 2006
and converted into a note payable during fiscal 2007. Mr. Berry’s bonuses earned
for the years ended March 31, 2009 and 2007 based on the terms of the Berry
Employment Agreement were approved by the Board for $30,000 each year. Starting
March 1, 2009, Mr. Berry entered into a Consulting Agreement to provide advisory
services to CryoPort for the period of March 1, 2009 through January 1, 2010.
The compensation for Mr. Berry’s services under this agreement was set for
$16,000 for the month of March 2009 and $28,890 for each month thereafter until
expiration of the contract. On August 26, 2009, Mr. Berry agreed to
accept $20,000 per month through the remainder of the term of the Consulting
Agreement with the deferred portion payable following expiration of the
term.
CryoPort
has no other employment agreements.
Outstanding
Equity Awards At Fiscal Year End 2009(*)
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of
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Unexercised
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Exercisable
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