November 30, 2005
Mail Stop 6010
Bernard Hausen, M.D., Ph.D.
Chief Executive Officer
Cardica, Inc.
900 Saginaw Drive
Redwood City, California 94063
Re: Cardica, Inc.
Registration Statement on Form S-1
Filed November 4, 2005
File No. 333-129497
Dear Mr. Hausen:
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.
Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
We look forward to working with you in these respects. 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.
Form S-1
1. Please confirm that any preliminary prospectus you circulate
will
include all non-Rule 430A information. This includes the price
range
and related information based on a bona fide estimate of the
public
offering price within that range, and other information that was
left
blank throughout the document. Also, note that we may have
additional comments after you file this information.
Prospectus Summary, page 1
2. Please provide supplemental support for the industry data
attributed to the American Heart Association. Please tell us
whether
the AHA has consented to the use of its name in the registration
statement.
3. Disclose your relationship with Guidant Corporation, including
the
amount and percentage of your total net revenues attributable to
Guidant in prior fiscal years, the termination of the agreements
upon
which those revenues were based, and the effect on future
revenues.
Our Solutions, page 6
4. Please balance your disclosure relating to the potential for
reducing operating room associated expenses with the fact that the
automated anastomotic systems you offer are far more expensive
than
the current method of sutures.
Risk Factors, page 6
Our products may never gain any significant degree of market
acceptance..., page 8
5. Please expand this risk factor to highlight any significant
limitations and technical difficulties you have encountered that
have
affected patency rates.
We currently lack a significant source of product revenue..., page
16
6. Revise this caption to clarify that your agreements with
Guidant,
which accounted for a majority of your past revenues, have been
terminated. In the risk factor, explain why the agreements were
terminated, quantify the total amount of revenues generated in the
past from those agreements, and explain the effect termination
will
have on your future revenues.
Dilution, page 25
7. Expand the disclosure to explain how the amounts would change
if
you assume all outstanding warrants and options were exercised.
Management`s Discussion and Analysis, page 29
8. Expand the fourth paragraph to explain in more detail why
Guidant
terminated the distribution and development and supply agreements.
Disclose your intent with regard to future distribution of your
products in Europe.
Results of Operations, page 32
Research and Development, pages 32 and 33
9. We note your disclosure that the increase in research and
development due to stock compensation and product development
expenses for C-PortxA and X-Port programs was offset by decreases
in
expenses for the PAS-Port program. Please revise to disclose the
underlying reasons for fluctuations in product development
expenses
for each of your programs.
10. Please further explain the significant decrease in research
and
development expenses in fiscal 2004 compared to 2003, including
the
reason for the decreases in depreciation and other expenses.
Business, page 37
11. Tell us the standard you used in characterizing your automated
system as "highly reliable and consistent."
12. Please provide us with the independent study cited on page 39.
Our Solutions, page 40
13. Please balance your disclosure to address any disadvantages of
using staples made of stainless steel as opposed to competitors`
products made of different materials, such as nitinol.
Our Products, page 42
14. Please expand your disclosure to address the frequency of use
of
arterial grafts compared to vein grafts. Address any
disadvantages
to being designed for use only with vein grants, and not arterial
grafts.
15. Please revise your disclosure to address any risks and/or
difficulties associated with removal of staples inserted with your
system, as opposed to hand-sewn sutures.
16. Please tell us the sources of, and provide support for, the
industry data cited on page 44.
17. Revise your disclosure to expand on the reasons why it was
necessary to convert anastomoses in 16 of the patients enrolled in
the C-Port system pivotal trial to hand-sewn anastomoses.
18. Please tell us the MACE rates for patients with hand-sewn
grafts.
Future Product Programs, page 43
19. Please disclose any significant experiences where you have
encountered leaks in the seals of the anastomosis performed with
your
C-Port system and any material consequences to patients of such
leaks.
International Clinical Studies, page 46
20. Please expand your Worldwide Market Survey disclosure to
describe
how your data during the follow up period compares favorably to
the
reoccurrence rate of angina in patients with hand-sewn
anastomoses.
Sales and Marketing, page 49
21. Discuss the loss of Guidant as a distributor of your products
in
Europe and the extent to which your agreements with Guidant, which
have been terminated, contributed to your revenues in the past.
Management, page 60
Scientific Advisors, page 61
22. If the board serves a management role, please provide complete
disclosure as required for other directors, such as the disclosure
by
Regulation S-K Item 401. Otherwise, relocate the disclosure about
the board to an appropriate section of your prospectus other than
the
"Management" section. Also ensure that the extent of the board`s
role is clear. For example, clarify:
* How often they meet,
* The extent of their obligations to you,
* Your obligations to them,
* Whether they have an equity interest, and
* Whether they are the source of performance data regarding your
product.
Certain Relationships..., page 70
Loans to Executive Officers and Directors, page 71
23. In the last paragraph on page 71, you refer to "the table
above."
Revise to clarify what table you are referencing. The current
disclosure is confusing.
24. Explain what you mean when you say that "the shares purchased
upon exercise secured the various loans and were valued in excess
of
the principal balances of the applicable loans," and quantify the
difference.
25. When you fill in the table with the "deemed compensation,"
include a footnote stating what interest rates you apply.
Agreements with Allen & Company LLC, page 73
26. Reconcile the amount of shares stated in the first paragraph
with
the amount beneficially owned by Allen & Company Incorporated in
the
table on page 74.
Transactions with a Relative..., page 73
27. Expand to describe the services provided by Timothy Knodel,
and
clarify whether he continues to be paid as an independent
contractor.
Principal Stockholders, page 74
28. The number of shares beneficially owned by Mr. Powers should
be
reflected in the table, not just the footnotes. Please revise
accordingly.
29. It appears that notes (12) and (13) are misnumbered. Please
revise or advise.
Financial Statements
Index to Financial Statements, page F-1
30. Consideration should be given to the updating requirements of
Rule 3-12 of Regulation S-X.
Revenue Recognition, page F-12
31. Please revise to clarify why shipment is the appropriate point
to
recognize product sales revenue and clarify whether there are any
post shipment obligations, sales incentives or customer acceptance
provisions and how these impact your revenue recognition
practices.
In addition, disclose your policy and tell us the basis for
recognition of the development revenues discussed on page 18.
Note 7. Subordinated Convertible Note, page F-18
32. We note your disclosure on page 33 that you recognized a $1.1
million charge in fiscal year 2004 for the early extinguishment of
debt. Please revise to include disclosures in your audited
financial
statements of the underlying debt, your accounting for the
extinguishment and the components of the expense recorded on your
income statement.
Note 8. Stockholders` (Deficit), page F-18
Convertible Preferred Stock, page F-18
33. We see that certain stock options contain provisions whereby
the
holder can early exercise their options and that these shares are
subject to repurchase by the company. Tell us how you considered
Issue 23 of EITF 00-23 in determining your accounting for this
provision. Clarify whether the repurchase price is at fair value.
Discuss the factors you considered in determining whether you
"expect" to repurchase the shares within six months after exercise
or
share issuance. Additionally, disclose whether the repurchase
provision is at the option of the company or the employee and how
this feature impacts your accounting.
34. Refer to your disclosure that the weighted-average estimated
fair
value of options granted to employees at fair value during the
year
ended June 30, 2005 was $0.11 and that the weighted-average
estimated
fair value of options granted to employees at below fair value
during
the year ended June 30, 2005 was $0.84. We also note your
disclosure
that you determined that the fair value of your common stock
increased from $0.95 to $2.50 during the year ended June 30, 2005.
Please revise your disclosure to reconcile these statements.
Deferred stock-based compensation, page F-21
35. Please note that we are deferring any evaluation of stock
compensation recognized until the estimated offering price is
specified, and we may have further comments in that regard when
you
file the amendment containing that information.
36. Please revise to clarify how you determined the $2 million
compensation charge related to the loans you made to three
directors
discussed on page 32.
37. Please provide us with a schedule showing in chronological
order,
the date of grant, optionee, number of options granted, exercise
price and the deemed fair value of the underlying shares of common
stock for the options issued within the year preceding the
contemplated IPO. Also, provide a similar schedule for issuances
of
common stock and warrants. Please indicate the compensation
recorded
for each of these issuances and reconcile to the amounts recorded
in
the financial statements. Tell us the objective evidence and
analysis
which supports your determination of the fair value at each grant
and
stock issuance date. Discuss the nature of any events which
occurred
between the dates of grant or issuance and the date the
registration
statement was filed. In addition, provide the estimated pricing
information and date this was discussed with underwriters and
indicate whether this was considered in determining estimated fair
value of the stock, options and warrants issued.
38. From your disclosure on page F-14, we see that your valuation
was
retrospective. We believe that the following disclosures would be
helpful to an investor since changes in your methodologies and
assumptions could have a material impact upon your financial
statements. Please revise to provide the following disclosures in
Management`s Discussion and Analysis:
* The aggregate intrinsic value of all outstanding options based
on
the midpoint of the estimated IPO price range.
* Discuss the significant factors, assumptions and methodologies
used
in determining fair value for those options granted during the
twelve
months prior to the date of the most recent balance sheet.
* Discuss each significant factor contributing to the difference
between the fair value as of the date of grant and the estimated
IPO
price for options granted during the twelve months prior to the
date
of the most recent balance sheet.
* Disclose the valuation method used and the reasons why you
selected
that method.
Note 12. Settlement of Stockholder Loans, page F-24
39. Disclose the accounting treatment for the full payment of the
promissory notes discussed in Note 12. In addition, clarify how
the
$3 value per share for the stock tendered was determined.
Exhibit 23.1
40. Please include an updated and signed consent from your
independent auditors with any amendment filed.
Exhibits
41. We may have further comments after our review of the
confidential
treatment request that you intend to file regarding several
agreements.
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.
We urge all persons who are responsible for the accuracy and
adequacy of the disclosure in the filing to be certain that the
filing includes all information required under the Securities Act
of
1933 and that they have provided all information investors require
for an informed investment decision. Since the company and its
management are in possession of all facts relating to a company`s
disclosure, they are responsible for the accuracy and adequacy of
the
disclosures they have made.
Notwithstanding our comments, in the event the company
requests
acceleration of the effective date of the pending registration
statement, it should furnish a letter, at the time of such
request,
acknowledging that:
? should the Commission or the staff, acting pursuant to
delegated
authority, declare the filing effective, it does not foreclose the
Commission from taking any action with respect to the filing;
? the action of the Commission or the staff, acting pursuant to
delegated authority, in declaring the filing effective, does not
relieve the company from its full responsibility for the adequacy
and
accuracy of the disclosure in the filing; and
? the company may not assert staff comments and the declaration
of
effectiveness as a defense in any proceeding initiated by the
Commission or any person under the federal securities laws of the
United States.
In addition, please be advised that the Division of
Enforcement
has access to all information you provide to the staff of the
Division of Corporation Finance in connection with our review of
your
filing or in response to our comments on your filing.
We will consider a written request for acceleration of the
effective date of the registration statement as confirmation of
the
fact that those requesting acceleration are aware of their
respective
responsibilities under the Securities Act of 1933 and the
Securities
Exchange Act of 1934 as they relate to the proposed public
offering
of the securities specified in the above registration statement.
We
will act on the request and, pursuant to delegated authority,
grant
acceleration of the effective date.
We direct your attention to Rules 460 and 461 regarding
requesting acceleration of a registration statement. Please allow
adequate time after the filing of any amendment for further review
before submitting a request for acceleration. Please provide this
request at least two business days in advance of the requested
effective date.
You may contact Kristin Lochhead at (202) 551-3664 or Brian
Cascio, Accounting Branch Chief, at (202) 551-3676 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) 551-3800 with any other questions.
Sincerely,
Peggy Fisher
Assistant Director
cc(via facsimile): Nancy Wotjas, Esq.
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Bernard Hausen
Cardica, Inc.
November 30, 2005
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