SEC Comment Letter for ENDOCARE INC (CIK 0001003464) — Jun 1, 2005
ENDOCARE INC (CIK 0001003464)
Date: June 1, 2005 · CIK: 0001003464 · Accession: 0000000000-05-026689
AI Filing Summary & Sentiment
File numbers found in text: 333-123866
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Mail Stop 0306
May 4, 2005
Michael R. Rodriguez
Endocare, Inc.
Chief Financial Officer
201 Technology Drive
Irvine, California 92618
Re: Endocare, Inc.
Registration Statement on Form S-2 filed April 5, 2005
File No. 333-123866
Dear Mr. Rodriquez:
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.
Registration Statement on Form S-2
Fee Table
1. Please clarify whether the investors in this offering will also
be
sold the rights mentioned in the second risk factor on page 8.
Prospectus Summary - Page 4
2. Please explain the terms "cryoablation procedures" and
"cyrosurgical technologies."
3.
Clearly distinguish between the medical indications for which your
product has received FDA clearance and those which would
constitute
"off-label" use. Likewise clearly distinguish between the markets
from which you currently generate revenue and those which are
solely
potential markets.
We face risks related to investigations - Page 5
4. Briefly highlight the subject of the statements mentioned in
the
first sentence.
Our common stock was delisted - Page 6
5. Briefly highlight why your stock was delisted. Also, with a
view
toward clarifying the last sentence of the first paragraph, tell
us:
* Whether you satisfy the objective criteria for listing on a
national stock exchange,
* What steps you have taken to relist your stock, and
* When you intend to complete the listing application process.
There is uncertainty relating to third party reimbursement, which
is
critical ... products - Page 7
6. Please expand the appropriate section to discuss in greater
detail
"certain of our business practices do not fit or will not fit ...
anti-kickback law" such as which business practices do not fit
within
the safe harbor, which certain practices will not fit within the
safe
harbor, what changes have occurred that they won`t fall within the
safe harbor, etc.
We face risks relating to compliance with new federal requirements
... information - Page 9
7. Please explain the term "HIPAA."
We could be negatively impacted - Page 10
8. Briefly highlight the nature of your financial relationships
that
present the risk cited.
Our intangible assets and goodwill could become impaired - Page 12
9. Please briefly highlight the operational circumstances that led
you to conclude that the impairment charge and write-off was
necessary.
Selling Securityholders - Page 15
10. Please supplementally advise whether any of the selling
security
holders are broker-dealers.
11. Revise the language of the third paragraph to mare closely
track
the language of Rule 416(a).
Stockholder Rights Plan - Page 22
12. Please balance the disclosure in the second sentence with
equally
prominent disclosure regarding how the plan could deter or prevent
transactions that shareholders deem to be in their interests.
Also
add appropriate risk factors.
13. Explain clearly how the plan operates to achieve the goals
mentioned in the second sentence.
Where you can find more information - Page 25
14. Please revise the paragraph numbered "4" to clarify that you
are
not "forward incorporating" your filings by reference.
Annual Report on Form 10-K for the year ended December 31, 2004
The History of Cyrosurgery - Page 3
15. Please expand the disclosure to clarify, if true, that "Newly
published ten-year data" is based on your study.
Key Clinical Advantages of our Cyrocare CS System - Page 4
16. Please tell us about any adverse effects from your products
and
where you have disclosed those effects to balance your disclosure
of
the advantages of your system.
Raw Materials - Page 7
17. Please describe the material terms of your material supply
agreements, including duration and termination provisions. Also
file
the agreements as exhibits.
Government Contracts - Page 10
18. Please supplementally advise whether your bid has been
accepted.
Health Care Regulatory Issues - Page 12
19. Provide more specific disclosure about how your operations fit
within these laws. For example, we note your disclosure on page
regarding your relationships with relationshipswith third parties
owned or controlled by urologists.
HIPAA and Other Privacy Laws - Page 13
20. Please supplementally advise of the status of your efforts
discussed in the last sentence of the second paragraph of this
section.
Competition - Page 14
21. Please clarify whether competitors currently provide
cryoablation
products that compete with yours. Clarify your competitive
position
relative to those products.
Item 3. Legal Proceedings - Page 23
22. The disclosure concerning "insurance carriers agreed to fund
...
total of $8.95 million in cash" appears to conflict with the
disclosure in your Form 8-Ks filed December 28, 2004 and February
25,
2005. Please advise. Also, supplementally advise whether the
"reservations and rights by the carriers" have had or may have a
material effect on the amount to be paid by the carriers.
23. With a view toward disclosure, supplementally identify the
"corporate governance measures" mentioned in the third paragraph.
Holders - Page 25
24. Supplementally analyze whether you are eligible to terminate
the
Exchange Act registration of your securities. If so, add a risk
factor to your Form S-2 to explain the associated risks, including
your ability to elect to terminate the registration and the
associated public disclosure requirements at any time.
Results of Operations - Page 28
25. With a view toward clarified disclosure, please reconcile the
paragraph following the table which mentions your receipt of a fee
for the kit and technical services with your disclosure on page 34
that you can retain the entire procedure fee. When you retain the
entire procedure fee, how do the doctors and medical facilities
receive compensation? When you retain the entire fee or provide
services, must you have a medical license?
26.
Please tell us and disclose in future filings the amount of
revenue
recognized in 2004 resulting from payments received in 2004 for
systems which had been excluded from revenues in prior years and
the
amount of amortization of deferred systems revenues. Tell us and
disclose in future filings the associated cost of revenues from
these
prior year sales that were recorded at the time of sale. Tell us
the
amount of sales and cost of sales related to Cryocare Surgical
Systems that were formerly placement units. Explain to us in more
detail the accounting policy related to the sales and cost of
sales
for these transactions and cite the accounting literature upon
which
you relied.
27. With a view toward clarified disclosure, tell us what you mean
by
the disclosure on page 29 "costs on royalty revenue from
CryoCath."
Also tell us how those costs were eliminated.
Liquidity and Capital Resources - Page 33
28. Please supplementally advise of the status of the negotiations
concerning your tax obligations.
Contractual Obligations - Page 33
29. Please revise future filings to ensure that you disclose all
of
your purchase obligations, or tell us why the current presentation
excluding purchase orders less than $100,000 is appropriate.
Item 9A. Controls and Procedures
30. In future filings, please describe in greater detail the
changes
to your internal control over financial reporting as required by
Item
308(c) of Regulation S-K.
Part III - Page 36
31. We will provide any comments on your recently filed Part III
disclosure separately.
Consolidated Statements of Operations - Page F-2
32. We note that you derive revenues from the provision of
services.
If you derive income from more than one of the subcaptions of Rule
5-
03.1 of Regulation S-X, then you should separately reflect both
the
revenues and related cost of sales for each subcaption where the
total revenues from that subcaption represent more than 10% of
your
total revenues. See Item 5-03(b) of Regulation S-X.
33. Please tell us why you classified the gain and loss on
divestitures in 2003 and 2004 within non-operating income and
expenses and not within your loss from operations. See paragraph
45
of SFAS 144.
Revenue Recognition - Page F-9
34. We note your disclosure on page 34 that you reduce revenues
for
customer concessions, and defer revenue recognition for minimum
procedure guarantees and contingent payment arrangements. Please
tell
us and disclose in future filings the nature of the concessions
and
contingent payment arrangements and how you account for each and
why.
Cite the accounting literature upon which you relied. Please
supplementally quantify the amounts of each program for the
periods
presented.
35. We note that the majority of your ongoing revenues are derived
from "cryoprobes, disposables and bundled procedure fees." Please
tell us the amount of revenues derived from bundled procedure fees
in
each period presented, including the latest interim period. Also
tell
us the amount of revenues and cost of revenues related to bundled
procedure fees where you do not own the equipment and provide the
service, if available. You state on page 34 that in many
instances,
the equipment used in these procedures is owned by a third-party
who
contracts with you to perform the services. You state that these
third-party service providers are usually entities owned or
controlled by the urologists who perform the cryosurgical
procedure.
Please tell us in more detail about the significant terms of these
agreements. Discuss the parties to the transaction and any
relationship between the parties. In your response, tell us why
you
record these revenues gross and not net by addressing the
indicators
in EITF 99-19.
36. Please tell us the difference between a loan of a mobile
Cryocare
Surgical System and the consignment of a system. See disclosure on
page 34. Tell us the significant terms of your agreements related
to
each and how and why you account for those agreements. Cite the
accounting literature upon which you relied. Also tell us why the
total cost of units placed has decreased from 2003 to 2004 if your
operational strategy relies upon increasing the placement of units
to
drive sales of disposables.
37. We note that the "timing of payments received and the
recognition
of such payments as revenue under collaborative arrangements and
strategic alliances" have caused your operating results to
fluctuate
in the past and can be expected to cause those operations to
"fluctuate from time to time in the future." See page 11 of your
Form
S-2. Please tell us in more detail about how the timing of
payments
caused your operating results to fluctuate. Explain the parties,
significant terms, rights, and obligations of your collaborative
arrangements and strategic alliances. Discuss how these
collaborative
arrangements and strategic alliances have caused your operating
results to fluctuate in the past. Quantify the impact for each of
the
periods presented and tell us where you discuss the accounting for
this revenue in the notes to your financial statements and the
fluctuations on your operations in your MD&A.
Stock-Based Compensation - Page F-14
38. Please tell us why you reflect volatility factors of 1.14 and
1.57 in fiscal 2002 and 2003, respectively. These amounts appear
low,
especially in relation to your volatility factor of 88.6 in fiscal
2004.
Note 5. Asset Impairment - Page F-16
39. We note your reference to an "independent third-party
appraiser"
in this note, on page 30 in MD&A, and on page 12 of your Form S-2.
Please note that if you elect to continue to make such a reference
and intend to incorporate your Form 10-K by reference in any
registration statement you will be required to identify the
appraisal
firm under "Experts" and include their consent in the registration
statement. Alternatively, we encourage you to instead clearly
disclose that management is primarily responsible for estimating
fair
value for impairment purposes. We will not object if you wish to
state, in revised disclosure, that management considered a number
of
factors, including valuations or appraisals, when estimating fair
value. Regardless of your decision, your disclosure should
clearly
indicate that management is responsible for the valuation.
Additionally, you should disclose the method and significant
assumptions used in determining the fair value.
Cryosurgical Products of Cardiac Applications - Page F-19
40. Please tell us the significant terms and your rights and
obligations under the agreement with CryoCath. Tell us why none of
the proceeds from the sale of your Cryosurgical products were
allocated to the 12-year non-compete agreement. Additionally, we
note
that you are required to attend quarterly and annual technical
update
meetings through 2014. Tell us more about the nature and purpose
of
these meetings. Discuss your considerations of this and other
continuing obligations under the agreement in determining that
100%
of the gain on the sale should be recorded in 2003. In addition,
explain why you recorded revenues and cost of revenues from
product
lines divested in 2003 during 2004.
Note 14. Subsequent Events - Page F-33
41. Please tell us how you plan to account for the warrants and
the
related registration rights agreement and why. See EITF 00-19,
SFAS
133 and 150.
Item 15. Exhibits, Financial Statements and Schedules
42. Please clarify which exhibits are the subject of a
confidential
treatment request.
* * *
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 supplemental 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 filings reviewed by the staff to
be
certain that they have provided all information investors require
for
an informed 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
e