SEC Company Response from Cryoport, Inc. (CYRX) (CIK 0001124524) (CYRX) — Jan 26, 2006
Cryoport, Inc. (CYRX) (CIK 0001124524)
Date: Jan. 26, 2006 · CIK: 0001124524 · Accession: 0001144204-06-002835
AI Filing Summary & Sentiment
Referenced dates: January 9, 2006
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GARY
CURTIS CANNON
ATTORNEY
AT LAW
12341
Briardale Way
San
Diego, CA 92128-5212
____________________
Telephone
(858) 391-9083 Facsimile (858) 391-9084
email:
garycurtiscannon@lawyer.com
January
24, 2006
Jeffrey
Riedler
Assistant
Director
Division
of Corporate Finance
United
States Securities and Exchange Commission
Washington,
D.C. 20549
Re:
CryoPort,
Inc.
Form
10-SB, Amendment 1
Filed
December 19, 2005
File
No.
0-51578
Dear
Mr.
Riedler,
In
response to your comment letter dated January 9, 2006, I have been requested
by
Peter Berry, Chief Executive Officer and President of Cryoport, Inc. (the
“Company”), to respond on behalf of the Company to the SEC comments regarding
the Company’s Form 10-SB/A1 filing. It is CryoPort’s intent to file an Amended
Form 10-SB/A2 concurrently with the submission of this letter. To that end,
I
have provided individual responses to the comments below. Concurrently the
Company will make the electronic filing of Form 10-SB/A2. The Company responses
are in bold type following the restatements of the SEC comments/questions as
follows:
FORM
10-SB
Overview,
page 4
1.
We
note the revisions pursuant to comment 4, and we reissue the comment
in
part. Please discuss the development status of your disposable shippers.
Discuss the steps you have taken toward developing these products,
and
discuss the steps you will need to take to bring the products to
market.
The
Company has inserted the following additional discussion to the
Overview
section on Pages 4 & 5:
“The
proposed disposable products are planned to share many of the characteristics
and basic design details of the currently available reusable products. The
expected shared characteristics include general geometry and shape, similar
liquid capacities and similar thermal performance characteristics. As a result,
much of the market experience gained from the sale of these products is directly
relevant to the usage characteristics of the proposed disposable products.
There
are two general sizes planned. A larger size of approximately 5 liters capacity,
based on a product that has been produced for 4 years, is planned for shipping
larger quantities of material and / or for use when longer holding times are
required. A smaller size of approximately 1 liter capacity is planned for unit
dose shipments, or small quantity shipments, that are direct to the end user
and
thus require shorter holding times. Because the shipment quantity is fairly
small, a shorter holding time capability does not admit an unacceptable
financial risk of product loss. The basis of the migration from reusable status
to disposable status is primarily one of cost; disposability requires a
generally lower cost product. Lower cost is achieved from higher production
quantities, from lower cost materials and from automated manufacturing methods.
The currently ongoing development related to these items is principally focused
on material properties, particularly those properties related to the low
temperature requirement and the vacuum retention characteristics; i.e.,
permeability of the materials. Several different metallic and polymeric
materials have been subjected to testing to this point. One non-traditional
material has been qualified and is available for production subject to the
demand for higher production quantities that will justify the capital
investment. Other materials are currently being evaluated for long term vacuum
retention characteristics by analyzing permeation properties. These are long
term tests that are being conducted by a commercial, well known laboratory.
Further on steps that are required to successfully market the products to a
broad spectrum of potential customers are largely related to a perceived need
to
customize the product characteristics to specific customer’s requirements. This
can only be accomplished once the potential customer is identified and
preliminary discussions are begun relative to the specific needs of that
customer. Items potentially involved at this stage include the required holding
time, the required product capacity, and the impacts of the distribution
environment from in plant packing to end use unpacking. We believe that each
potential customer may have a specific set of needs that can be satisfied from
a
catalog like listing of the generic characteristics of the planned products.
Other advances additional to the development work on the cryogenic container
include both an improved liquid nitrogen retention system and a secondary
protective packaging system. This secondary system has a low cost that lends
itself to disposal. 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.”
Development
of International Programs and Markets, Page 10
2.
We
reissue comment 10 in part. Please disclose whether the 10-day hold
time
referenced in this section is a static hold time or a functional hold
time.
In
order to further clarify the specification of static hold time in comparison
to
the functional hold time of the Company’s shippers the following has been
inserted in the section Development
of International Programs and Markets
now located on page 11:
“The
maximum guaranteed temperature hold time of our 5 liter shipper is 16 days
which
is quoted under perfect and ideal conditions when in a "static” (i.e.
stationary) condition only. The functional (in shipping use) hold time of this
same 5 liter shipper is 10 days. Functional hold times are intended to be an
indication only of how many days a shipper can be expected
to hold its temperature when subjected to normal shipping
usage.”
-2-
Sales
and Marketing, Page 14
3.
We
note your response to comment 11, and we reissue the comment. Please
identify in your filing your South American sales agent, and state
the
amount of revenues this agent accounted for. We note filing as an exhibit
the agreement with this agent would “create difficulties.” Please note
that if the agreement falls under Item 601(b)(10) of Regulation S-B,
it
must be filed regardless of your preference to keep it confidential.
Therefore, please either file the agreement as an exhibit or provide
us
with an analysis as to why this agreement is not required to be filed
under Item 601(b)(10) of Regulation S-B. Please note that if you file
it,
you may request confidential treatment for the immaterial sensitive
terms
by following the procedure outlined in Rule 24b-2 of the Exchange Act
and
Staff Legal Bulletin 1, which can be found at .
The
Company has inserted the following sentence in the Sales
and Marketing
section now found on page 15:
“The
Company’s South American agent is CryoPort Systems Ltda. in Sao Paulo, Brazil
and all South American revenues reported have been generated by this agent
in
the Brazilian market.”
Management
would prefer not to file the agreement as an exhibit for the following
reasons:
§
It
is a straightforward sales agent agreement that has been in existence
for
more than 3 years and pre-dates current management.
§
The
agreement is “too generous” as negotiated by previous management with
respect to the following:
-
The term of the agreement is 10 years.
-
The agreement is exclusive.
-
The territory is too vast and unrealistic - (all of South
America).
-
The agreement offers a 17% commission to the agent.
-
The agreement has no performance metrics in place.
§
Management
does not intend to duplicate these terms in any future agreements and
intends to renegotiate this agreement at the earliest
opportunity.
Current
management has and is only establishing and negotiating shorter term,
non-exclusive agreements with performance metrics and lower levels of agent
commissions in more limited territories. Management believes that filing this
agreement could create difficulties with other current and future selling agent
agreements.
-3-
Manufacturing,
page 18
4.
We
note that in response to comment 15, you state, “It is believed that any
of the currently used manufacturers could be replaced within a short
period of time…” This statement appears to contradict a sentence in the
previous paragraph that reads, “For some components, however, there are
relatively few alternative sources of supply and the establishment
of
additional or replacement suppliers may not be accomplished quickly.”
Please reconcile. It appears you should identify the suppliers that
would
be difficult to replace.
In
order to clarify its position for replacement of supply sources, the Company
has
modified the discussion in the Manufacturing
section now located on page 19 as follows:
“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, the Company has identified alternate
qualified suppliers which the Company believes could replace existing suppliers.
Should this occur, the Company believes the maximum disruption of production
could be a short period of time, on the order of approximately four to six
weeks. The Company anticipates that this will initially be the case with the
outer shell the Company is developing for its disposable
shipper.”
Item
2. Management’s Discussion and Analysis or Plan of Operations, page
28
Liquidity
of Capital Resources, page 28
5.
We
note your response to comment 26 and reissue the comment. Please be
aware
that you are required to disclose all information that is material
to
investors, regardless of any commercial harm disclosure might
cause.
·
Please
identify the vaccine manufacturers that are using your product in clinical
trials, and identify the “two large, and well established manufacturing
companies” with whom you are currently
negotiating.
·
Please
file all agreements you have entered into with the above parties and
discuss the agreements’ material terms in your filing. If you do not
believe the agreements and their terms are not material to investors,
please explain to us why not.
·
We
note that in a May 11, 2005 press release, you stated Cell Genesys
purchased over 100 of your “reusable lightweight shippers with a projected
need over the coming months for several hundred more.” Subsequently, in a
July 27, 2005 press release, you refer to a customer that purchased
100
reusable shippers and was scheduled to purchase an additional 400 units
through April 2006. This press release described this relationship
as
“exciting… as we believe this customer has a number of products in their
pipeline that will be able to benefit by using CryoPort shippers in
the
future.” Please disclose this relationship in your filing. It would appear
to affect your disclosure under items 101, 303, and 601 of Regulation
S-B.
Also, tell us whether Cell Genesys is one of the parties referenced
in the
first bullet point above.
-4-
The
vaccine manufacturers that have purchased the Company’s products are Cancervax,
Cell Genesys and Argos Therapeutics. All sales are made on purchase order basis
only and the Company has no pending purchase orders with these vaccine
manufacturers at this time.
Since
negotiations are still underway with two large potential manufacturing partners
management believes that nothing will be served by disclosing the names of
these
companies to any potential investor since nothing has yet been agreed and since
both companies are well known disclosing their names could in fact have a
“misleading” effect on any potential investors evaluation of the
Company.
No
agreements have been entered into with any of the above referenced companies
other than confidentiality and non-disclosure agreements.
Cell
Genesys is one of the parties referred to in bullet point one and is the party
referred to in the July 2005 press release. Subsequent to the May 11, 2005
press
release, Cell Genesys requested that the Company refrain from using their name
in any future press release without their explicit permission in order to
protect their confidentiality. In compliance with the customer’s request, the
Company is not using the customer’s name in the Form
10-SB/A2.
At the time of the July 2005 release, the Company did not have permission from
Cell Genesys to use their name in the release and therefore did not specify
the
customer’s name.
Critical
Accounting Policies, page 32
6.
Regarding
prior comment thirty on Section V. of Financial Reporting Release
72,
please tell us how, for each of your critical accounting estimates
or
assumptions, you have discussed the following or revise your disclosure
to
discuss the following:
·
how
accurate the estimate/assumption has been in the
past;
·
how
much the estimate/assumption has changed in the
past;
·
specific
sensitivity of the estimate/assumption to change, based on other outcomes
that are reasonably likely to occur and would have a material effect;
and
·
quantitative
information about the estimate/assumption, when it is reasonably available
and will provide material