SEC Comment Letter for CRYOCOR INC (CIK 0001125294) — May 5, 2005
CRYOCOR INC (CIK 0001125294)
Date: May 5, 2005 · CIK: 0001125294 · Accession: 0000000000-05-021925
AI Filing Summary & Sentiment
File numbers found in text: 333-123841
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May 4, 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.
Registration Statement on Form S-1
Filed April 5, 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
supplemental information so we may better understand your
disclosure.
After reviewing this information, we may or may not 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 on 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
General
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
Overview - Page 1
2. We note your stated belief that your trial for AF is the "only
pivotal trial of a minimally invasive, catheter-based system for
treating AF currently underway in the United States." We also
note
the similar statement that appears on page 54. Please provide
supplemental independent support for these statements or remove
them
from the prospectus.
3. Revise the Summary to balance your discussion of your solution
and
strategy with the negative aspects of your business. Disclose
that
the company has incurred operating losses since inception and that
its cryoablation system will need FDA approval before it can be
marketed or used in the United States. In this regard, revise to
briefly clarify the significance to the company of its anticipated
application for premarket approval with the FDA.
4. We note that the cryoablation system has been used at
approximately 40 medical centers worldwide. Please revise to
clarify, if true, that the system is not in use in any medical
center
in the United States.
5. Please provide supplemental support for the statistics cited in
the Summary and Business sections relating to, among other things,
the number of individuals in the United States afflicted by either
AF
or AFL, the number of new cases, and the amount spent annually in
disease-related healthcare costs.
6. Please revise to quantify, if known, how much of the $9 billion
spent on AF-related heathcare costs is attributable to drug
therapy
and how much is attributable to treatment by heat-based ablation
devices. If this information is not known, please disclose that
the
company`s potential market would likely be only a portion of this
amount given that the company`s system for the treatment of AF is
likely to be approved only for the treatment of patients who have
failed drug therapy.
The Offering - Page 3
7. Please revise so that the 17,293,599 shares of common stock
that
will be issuable upon the closing of the offering as dividends on
your Series D redeemable convertible preferred stock and the
4,136,533 shares that will be issuable upon the closing of the
offering as dividends on your Series C convertible preferred stock
are included in the number of shares of common stock to be
outstanding after the offering. Please make corresponding
revisions
to your assumptions on page 4 and revise as necessary throughout
the
prospectus.
Summary Consolidated Financial Data - Page 5
8. Please clarify in footnote (1) and (2) that the non-cash stock-
based compensation expense for research and development, and
selling,
general and administrative relate to expenses in 2004.
Risk Factors - Page 7
We are dependent on the success of our cryoablation system, which
has
not been approved by the FDA . . . - Page 8
9. We note the discussion included in this risk factor regarding
the
allegations of regulatory compliance deficiencies made by your
former
CFO. Please revise to present your discussion of those
allegations
and the related investigation in a separate risk factor under an
appropriate risk factor caption.
10. We note that, in response to allegations made by the company`s
former CFO of irregularities and improprieties in the company`s
clinical trials and FDA compliance process, the company engaged
"outside FDA regulatory counsel" to assist in the investigation.
Please revise to clarify, if true, that the "outside FDA
regulatory
counsel" was independent outside counsel unrelated to the FDA and
not
a representative of the FDA. Please also revise to describe with
greater specificity the nature of the allegations made by the
former
CFO and the time and scope limitations on the outside FDA
regulatory
counsel`s investigation.
11. You disclose that if the company fails to obtain FDA approval
for
at least one indication it will not be permitted to market its
cryoablation system in the United States and may be forced to
cease
operations. It is unclear whether the company may market its
cryoablation system if it only receives FDA approval for one
application, but not the other. Please revise to clarify whether
the
company may market its cryoablation system for an indication
approved
by the FDA, even if the FDA does not approve the other indication.
We may not complete our pivotal trial for AF on schedule . . . -
Page
11
12. Please revise to illustrate this risk by quantifying the
percentage of subjects who have enrolled but failed to continue to
participate in a study as well as the percentage of subjects the
company has been unsuccessful in following for the required 12-
month
period.
If the integrity of the catheter used as part of our cryoablation
system is compromised . . . - Page 12
13. Please revise to address whether the company has encountered
ruptures, leaks or other breaches of the catheter`s integrity
during
the clinical trials or use in any of the medical centers worldwide
that have resulted in serious injury or death.
Even if we obtain regulatory approval, our future growth depends
upon
physician adoption . . . - Page 13
14. We note that your AF trial will study your system only in
patients who have failed drug therapy and the likelihood that the
FDA
will require you to label and advertise your system only for the
treatment of patients who have failed drug therapy. Given your
disclosure that additional clinical trials would be required to
obtain FDA approval for use in a broader population of patients,
please revise to clarify how referring physicians will be
permitted
to refer AF patients to interventional cardiologists or
electrophysiologists for treatment using your cryoablation system
over drug therapy.
Use of Proceeds - Page 30
15. We note that a substantial portion of the expected net
proceeds
will be used for working capital and general corporate purposes.
Please revise to provide more specific disclosure regarding the
anticipated use of these proceeds.
Capitalization - Page 31
16. Please respond to the following comments regarding your
capitalization table and notes:
a. Revise to remove the caption relating to cash and cash
equivalents
from your presentation of capitalization.
b. Please tell us why you believe that it is appropriate to
exclude
the current portion of your long-term debt of $1,000,000 as of
December 31, 2004 from your capitalization table.
c. Please reconcile the amount of debt, both short-term and long-
term, on an actual basis as of December 31, 2004, the addition of
$7
million of long-term debt in March 2005, the repayment of $1.8
million in debt with those proceeds, and the balance of long-term
debt of $7 million as of December 31, 2004, pro forma.
d. Please revise to reflect the effects of the conversion of your
convertible preferred stock separately from the sale of your
common
stock in the offering.
e. Please disclose the aggregate exercise price of the warrants to
purchase an aggregate of 4,684,431 shares of your common stock
that
will terminate if and to the extent not exercised prior to the
completion of the offering.
f. Please tell us why you do not reflect the shares of your common
stock that will be issued as dividends upon conversion of your
Series
D and C convertible preferred stock as one of the adjustments
related
to the conversion of that stock as shown in the table on page 31.
Similarly, please tell us why you do not reflect those shares in
the
dilution table on page 33.
g. Please tell us and disclose why you calculated the shares to
issue
as dividends upon the conversion of the Series D redeemable
convertible preferred stock as of June 4, 2005 and the Series C
convertible preferred stock as of March 18, 2005. Provide similar
information to us and in your disclosure for the dilution
information
beginning on page 33 and throughout the filing where you refer to
this same information.
Dilution - Page 33
17. Please quantify the further dilution to be experienced by your
new investors to extent your outstanding options and warrants are
exercised. Please also expand your disclosures in this section to
explain how the table that discloses "shares purchased" and "total
consideration" would change if you assume the exercise of all
outstanding options and warrants.
Selected Consolidated Financial Data - Page 35
18. Please tell us and disclose how you determined the pro forma
number of shares used to compute basic and diluted net loss per
share
attributable to common stockholders.
19. Please revise to include your total long-term obligations in
the
table. See Item 301 of Regulation S-K. Please also briefly
describe,
or cross-reference to where you discuss, the increase of $7
million
in your long-term debt in March 2005.
Management`s Discussion and Analysis of Financial Condition and
Results of Operations - Page 37
Results of Operations - Page 38
20. We note on page F-15 that you increased your inventory reserve
by
approximately $500,000. Please revise your discussion of changes
in
cost of sales to disclose the nature, timing, measurement and
amount
of the reserve. Quantify the remaining balance of inventory items
previously written-down or written-off and the significant
components
of that balance as long as a significant balance of such items
remain
on hand. Disclose in MD&A (if true) that no significant sales of
such
items have occurred to date. Alternatively, disclose the impact
of
these sales on gross profit margin for the period. Finally,
disclose
when and how you will dispose of the remaining items and/or the
fact
that you have no set timeline for the sale of scrapping of these
items.
21. In cases where you cite more than one factor in explaining a
change in a financial statement item, please quantify each factor
to
the extent practicable. Also, please revise to disclose the number
of
finance and administrative employees added during 2005, similar to
your discussion for research and development expenses, or tell us
why
you believe the disclosure is not required.
22. We note your disclosure under Legal Proceedings beginning on
page
79. Please tell us why you did not discuss the impact of not being
successful in the proceedings within MD&A. Tell us and disclose,
if
significant, whether or not the underlying patents claims are
material to your business.
23. Please tell us and revise to explain why sales outside the
United
States have not been significant to date given that you were
approved
for these sales in 2002.
Liquidity and Capital Resources - Page 39
24. Please reconcile the disclosures on page 40 with your
discussion
and quantification of use of proceeds on page 30.
Contractual Obligations - Page 41
25. With respect to your discussion of the agreements with
clinical
sites and contract research organizations, please tell us why you
have not included this information within the table as a purchase
obligation. Explain to us why the agreements are not agreements to
purchase services that are enforceable and legally binding on you
and
that specify all significant terms, including fixed or minimum
quantities to be purchased, fixed, minimum or variable price
provisions, and the approximate timing of the transaction. Include
a
discussion of the significant terms of these agreements.
Critical Accounting Policies and Significant Judgments and
Estimates
- Page 41
26. Since 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 MD&A:
a. The aggregate intrinsic value of all outstanding options based
on
the midpoint of the estimated IPO price range.
b. 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.
c. 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.
d. Disclose the valuation method used and the reasons why you
choose
that method.
27. Due to the significance of the grants made in 2005, please
also
discuss the amount of deferred stock compensation you will record
associated with those options and the timing of the related
amortization.
Business - Page 45
Market Overview - Page 49
28. Please supplementally provide us with copies of the articles
and
periodicals cited throughout this section.
29. Supplementally advise whether the Atrial Fibrillation
Foundation
and the National Institute of Neurological Disorders and Stroke
have
consented to being named and the inclusion of their data in the
prospectus.
CryoCor`s Clinical Development Program and Status - Page 57
30. Please supplementally provide us with copies of the articles
cited in the table on page 59 and throughout the Business section.
We may have further comments.
Sales and Marketing - Page 65
31. Please file your distribution agreements as exhibits or tell
us
why they are not required to be filed.
Intellectual Property - Page 71
32. Please describe the material terms of your license and other
agreements with Cryogen.
Management - Page 81
33. Please revise where appropriate to clarify whether Mr.
Wheeler,
as Chairman of the Board, is serving as such in an executive or
non-
executive capacity.
Executive Officers and Directors- Page 81
34. Please revise the biographical summaries for each of your
directors who is an officer, director, employee and/or affiliate
of
one or more of your principal stockholders and/or their affiliates
to
clarify with greater specificity the nature of the relationship
between each such director and the principal stockholder and/or
its
affiliates during the past five years.
Audit Committee - Page 85
35. We note that Mr. Minocherhomjee beneficially owns
approximately
24% of your outstanding shares. We also note your statement that
your board has determined that Mr. Minocherhomjee is independent
for
purposes of Rule 10A-3 of the Exchange Act, despite the fact that
he
falls outside the safe harbor provisions of Rule 10A-3(e)(1)(ii).
Please revise to explain the basis for the board`s determination,