SEC Comment Letter for CRYOCOR INC (CIK 0001125294) — May 25, 2005
CRYOCOR INC (CIK 0001125294)
Date: May 25, 2005 · CIK: 0001125294 · Accession: 0000000000-05-025968
AI Filing Summary & Sentiment
File numbers found in text: 333-123841
Show Raw Text
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
May 25, 2005
Mail Stop 03-06
Gregory M. Ayers, M.D., Ph.D.
Chief Executive Officer
CryoCor, Inc.
9717 Pacific Heights Blvd.
San Diego, California 92121
Re: CryoCor, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed May 10, 2005
File No. 333-123841
Dear Mr. Ayers:
We have reviewed your filing and have the following
comments.
Where indicated, we think you should revise your document in
response
to these comments. If you disagree, we will consider your
explanation as to why our comment is inapplicable or a revision is
unnecessary. Please be as detailed as necessary in your
explanation.
In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure. After
reviewing this information, we may raise additional comments.
We welcome any questions you may have about our comments or
any
other aspect of our review. Feel free to call us at the telephone
numbers listed at the end of this letter.
Amendment No. 1 to Form S-1
1. We note your response and the supplemental material provided in
response to comment 5. The source provided in Tab 7 appears to
indicate that the cost of certain drugs is actually excluded from
the
$9 billion disclosed to be spent annually on "drug-based therapy
and
other disease-related healthcare costs." For this reason, and
because the company`s system is likely to be approved for use in
patients for whom drug therapy has failed, rather than as an
alternative to drug therapy, it appears that the amount spent on
drug-based therapy is not necessarily an appropriate indicator of
the
size of the company`s potential market. If you elect to retain
the
reference to the $9 billion figure in your prospectus, please
revise
to clarify, if true, that the company is unable to estimate the
size
of the potential market for its products and that the $9 billion
spent on "drug-based therapy and other disease-related healthcare
costs" is not necessarily a relevant indicator of the size of the
company`s potential market.
Use of Proceeds, page 31
2. We note your response to comment 15. It appears that most of
the
anticipated proceeds to be used for working capital and general
corporate purposes will be used before FDA approval is obtained.
Please provide more specific disclosure regarding the anticipated
use
of these proceeds.
Management`s Discussion and Analysis of Financial Condition and
Results of Operations, page 38
3. Please refer to prior comment 22. Please tell us and disclose
why
you are pursuing the interference proceedings which may result in
substantial costs if the underlying patents are not material to
your
business. Explain to what the patents relate.
4. Please refer to prior comment 23. We note your revised
disclosure. It is not clear why you would not invest funds into
selling and marketing activities outside the United States if this
investment would result in significant sales. It is also not
clear
whether sales outside the United States will be negatively
impacted
unless and until you receive U.S. FDA approval. Please clarify.
Audit Committee, page 87
5. We note your response to comment 35. However, particularly in
light of Mr. Minocherhomjee`s status as a member of the board of
managers of the limited liability company that controls the
entities
affiliated with William Blair & Company, L.L.C. that currently
beneficially own approximately 24% of the company`s outstanding
shares, we are unable to concur with your conclusion that Mr.
Minocherhomjee is not an affiliated person within the meaning of
Rule
10A-3 of the Exchange Act. Please revise accordingly.
Certain Relationships and Related Party Transactions, page 104
Participation in this Offering, page 107
6. We note your added disclosure that certain of your existing
investors have indicated an interest in purchasing $12 million
worth
of the shares offered. Please revise to disclose the portion of
the
$12 million and the corresponding number of shares that are
proposed
to be purchased by each investor.
Description of Capital Stock, page 111
7. Please discuss the purpose and effect of the provisions
contained
in Section 5(b) of the Bylaws that will be effective upon the
closing
of your offering.
Underwriting, page 121
8. We note your response to comment 42, including your statement
that
the lead underwriter will seek a representation from members of
the
syndicate or selling group that they will comply with Section 5 in
connection with any offer, sale or distribution of securities in
the
offering. Please additionally confirm, if true, that the lead
underwriter will also obtain a representation from each member of
the
syndicate or selling group that the member will follow procedures
for
electronic distributions previously cleared with the staff if the
member engages in the electronic offer, sale or distribution of
securities in connection with this offering.
Consolidated Financial Statements, page F-1
Note 1. Summary of Significant Accounting Policies, page F-8
Revenue Recognition, page F-9
9. Please refer to prior comment 46. In your response you state
that
sales related to the disposable catheters account for 95% of your
revenues. We also note from your website that the disposable
catheter must be used in conjunction with the cryoablation console
which incorporates the CryoArm. Please tell us and disclose if
you
loan the console equipment to your customers or if they must
purchase
the console equipment from other sources. If the disposable
catheters you are selling are not being used with your console and
CryoArm, then please revise the filing to clarify the nature of
these
sales. If you do loan the console equipment to your customers
please
tell us and disclose how this affects the pricing of the
disposable
catheters and how you account for the loaned equipment and why.
In
addition, please tell us why you do not currently sell the console
system.
Clinical Trial Expenses, page F-10
10. Please refer to prior comment 47. In your response you state
that
you accrue the costs associated with your clinical patients when
such
costs become estimable and probable, in accordance with SFAS 5,
however you disclose on page 45 and F-10 that these costs are
accrued
as the services to the patient are provided. Please reconcile and
clarify how you account for costs associated with your clinical
patients. Additionally, please tell us why the costs associated
with
your clinical patients should be accounted for as a loss
contingency
under SFAS 5 and not expensed as incurred under SFAS 2. Please
explain in more detail your selection and application of U.S.
GAAP.
Discuss when you believe that the liability is incurred under your
agreements and why. Discuss the significant terms, rights and
obligations under these agreements and how your accounting
considered
these significant terms, rights and obligations.
Note 5. Preferred Stock and Stockholders` Equity (Deficit), page
F-
18
Preferred Stock, page F-18
11. In your disclosure you state that the Series A, B, C and D
preferred stock will automatically convert into common shares
concurrent with the closing of an underwritten pubic offering with
a
minimum per common share purchase price of $18.45 with gross
proceeds
of at least $40 million. However, we note that $18.45 is not
within
the offering range disclosed in the prospectus of $10.00 to $14.00
and that the minimum gross proceeds of $40 million will not be met
in
this offering of 2,850,000 shares of common stock. Therefore,
please
revise the document, specifically the Capitalization table, the
Dilution table and the Consolidated Balance Sheets, to remove all
disclosure of the automatic conversion of the preferred stock
shares
into the common stock shares at the completion of the initial
public
offering, or please tell us and revise to disclose if you reflect
the
conversion as a result of a vote that has occurred in which the
Series A, B, C and D stockholders have agreed to the conversion.
12. Please refer to prior comment 50. In your response you state
that
the conversion rate for the Series B preferred stock is .2825,
however you disclose that the conversion rate is .2751. We also
note
that your response states that the total amount of converted
shares
is 5,910,024. However, on page 5 we note that you disclose the
total
amount of converted shares is 5,920,024. Please reconcile these
amounts and revise, if necessary.
13. Please refer to prior comment 49. In your response you state
that
you state that the additional common shares issuable related to
the
Series B and C convertible preferred stock as a result of the
antidilution provisions do not result in a beneficial conversion
feature. Please provide us with the following:
* Please tell us and revise to disclose the original conversion
rates
of each of the Series A, B, C and D convertible preferred stock.
* Please tell us the reason for the changes from the original
conversion rates to the revised conversion rates and how you
accounted for these changes.
* Please tell us and revise to disclose all of the significant
features related to the Series A, B, C and D convertible preferred
stock including the anti-dilution terms. Additionally, we note in
your response to comment 49 that you provide us with only the
anti-
dilution provisions related to Series B and C, please verify that
there were no anti-dilution terms related to the Series A
convertible
preferred stock.
* Please tell us why you believe that there is no incremental
intrinsic value resulting from the resolution of the contingency
under EITF 00-27.
Stock Warrants, page F-21
14. Please refer to prior comment 51. Please disclose the
significant assumptions used to determine the fair value of the
warrant issued in conjunction with the subordinated bridge notes.
Tell us how you determined the amount of the beneficial conversion
feature.
2000 Stock Option Plan, page F-22
15. Please refer to prior comment 53. We continue to note that a
material amount of equity instruments were granted during the 12
months prior to the date of the most recent balance sheet included
in
your Form S-1. Additionally, we note that your valuation is
retrospective and the valuation determination was completed by
your
management and board of directors. That is, the valuation was not
a
contemporaneous valuation performed by an unrelated valuation
specialist. Based on the facts provided, we continue to believe
that
you should disclose the following information for equity
instruments
granted during the 12 months prior to the most recent balance
sheet
included in the registration statement:
* For each grant date, the number of options or shares granted,
the
exercise price, the fair value of the common stock, and the
intrinsic
value, if any, per option.
* Since the valuation specialist was a related party (i.e.,
management) please include a statement disclosing that fact.
Stock Options Granted to Nonemployees, page F-24
16. Please refer to prior comment 56. We note from your response
and
this note that you use a Black-Scholes valuation model to
determine
the fair value of the options granted to consultants. Please
provide
us with the fair value of the underlying common stock based upon
the
Company`s reassessed value at the time of vesting used in the
Black
Scholes model. Additionally, please reconcile your response where
you state that a 7-year estimated life is used in the Black
Scholes
calculation with your disclosure on page F-24 where you state a
10-
year estimated life is used in the calculation.
Item 15. Recent Sales of Unregistered Securities, page II-2
17. We note your response to comment 63. Please file the March
24,
2005 commitment agreement as an exhibit, or tell us why you
believe
it is not required to be filed.
* * *
As appropriate, please amend your registration statement in
response to these comments. You may wish to provide us with
marked
copies of the amendment to expedite our review. Please furnish a
cover letter with your amendment that keys your responses to our
comments and provides any requested information. Detailed cover
letters greatly facilitate our review. Please understand that we
may
have additional comments after reviewing your amendment and
responses
to our comments.
You may contact Traci Hornfeck at (202) 551-3642 or Kaitlan
Tillan, Assistant Chief Accountant, at (202) 551-3604 if you have
questions regarding comments on the financial statements and
related
matters. Please contact Eduardo Aleman at (202) 551-3646 or me at
(202) 551-3607 with any other questions.
Sincerely,
David Ritenour
Special Counsel
cc (via fax): Frederick T. Muto, Esq.
Matthew T. Browne, Esq.
??
??
??
??
Gregory M. Ayers, M.D., Ph.D.
CryoCor, Inc.
May 25, 2005
Page 1
</TEXT>
</DOCUMENT>