SEC Company Response from CARDIOGENESIS — Aug 30, 2005
CARDIOGENESIS CORP /CA (CIK 0000863680)
Date: Aug. 30, 2005 · CIK: 0000863680 · Accession: 0000950137-05-010885
AI Filing Summary & Sentiment
File numbers found in text: 000-28288
Referenced dates: June 14, 2005
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August 26, 2005
SEC FILE NO. 000-28288
VIA FACSIMILE AND FIRST CLASS MAIL
Mr. Gary Todd
Securities and Exchange Commission
Division of Corporate Finance
450 Fifth Street, N.W.
Washington, D.C. 20549
Re: Securities and Exchange Commission letter dated June 14, 2005 (the “Comment
Letter”), Cardiogenesis Corporation’s Form 10-K for the fiscal year ended December 31,
2004 and Form 10-Q for the quarter ended March 31, 2005 (File No. 000-28288)
Dear Mr. Todd:
The Staff provided comments, by letter dated June 14, 2005 (the “Comment Letter”), to the
Company’s Registration Statement on Form 10-K for the year ended December 31, 2004 and Form 10-Q
for the quarter ended March 31, 2005.
Each comment contained in the Comment Letter has been set forth below immediately prior to our
response and each response has been numbered to correspond to the sequential numbering of the
Comment Letter.
Mr. Gary Todd
August 26, 2005
Page 2
FORM 10K RESPONSES
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations,
pg 27
1) Results of Operations, page 28
COMMENT: We see that research and development expenses in both 2004 and 2003 were reduced by
reversals of “amounts recorded in prior years for estimated clinical trial obligations subsequently
determined not to be needed.” In a supplemental response, tell us more about how you account for
clinical trial obligations. Provide a full explanation of your underlying policies and practices
and clarify the bases in GAAP. Tell us when the accruals were originally provided and explain why
they were appropriate when recorded. Also describe the factors leading you to conclude that the
provisions were no longer necessary and explain why the timing of the reversals in appropriate. In
future filings please make accounting policy disclosure for this matter, including disclosure about
the nature and extent of estimates and uncertainties underlying the accounting.
RESPONSE: From 1996-2000, Cardiogenesis operated several clinical trials on the TMR and PMC
cardiovascular procedures. Under the trial agreements, the various hospital institutions were to
be paid by Cardiogenesis when the initial procedure and subsequent follow-up examinations were
performed. The trial agreement indicated a specific reimbursement amount per procedure or
follow-up.
When each procedure or follow-up was performed, Cardiogenesis accrued the amount owed for the
procedure. This is consistent with GAAP since Cardiogenesis recognized the expense when the
triggering event, the procedure, occurred. Pursuant to the investigational agreement, the hospital
institutions were to invoice Cardiogenesis for the procedure and submit the Case Report Form
(“CRF”) which documents the physician or nurse’s evaluation of the patient. Once the invoice and
CRF were submitted, Cardiogenesis remitted payment to the institution.
In a number of cases, the institutions submitted the CRF but did not invoice us for the procedures.
In cases where the institution did not invoice us, the clinical accrual remained on our books for
a number of years and did not change. We contacted our legal counsel to determine what contractual
obligations we had to satisfy payments if an invoice or other demand for payment were to be
presented to us. Outside legal counsel informed us that the contracts with the institutions fell
under contract law and that the State of California’s statute of limitations for a contract is 4
years.
Mr. Gary Todd
August 26, 2005
Page 3
To determine which specific clinical trial accrual to reduce, we used our clinical trial worksheet
which reflects the date of procedure, the institution and the amount accrued. Using the statute of
limitations under State of California contract law as our basis for reversal, we reversed the
accrual 4 years following the date the procedure was performed and the related accrual was made.
As of the date of this letter, there are no remaining such accruals on our balance sheet.
2) Liquidity and Capital Resources, page 31
COMMENT: We refer to the contractual obligations table on page 33. In future filings please
present the convertible note obligation in its gross amount. As appropriate, the disclosure should
also present explanation about the restricted cash to the extent important to an understanding of
the arrangement and your obligations thereunder. Also apply this comment to the table of future
principal obligations presented in Note 7.
RESPONSE: We have noted your comment and will incorporate the changes into our future filings.
Consolidated Financial Statements
3) Consolidated Balance Sheet, pg 44:
COMMENT: Please expand the footnotes to future filings to clarify the nature of and basis for the
item titled “other long-term liability”. Alternatively, provide a more specific caption title.
Also tell us about this item supplementally.
RESPONSE: The $496,000 on the Consolidated Balance Sheets with the heading “Other long-term
liability” represents the fair value of the warrant the Company issued in January 2004 to purchase
3,100,000 shares of the Company’s common stock at a price of $1.37 per share. Please refer to page
32 of the Company’s Form 10-K which describes the warrant issuance under liquidity. The description
that the $496,000 represents the fair value of the warrant will be disclosed in the future in our
notes to our consolidated financial statements.
4) Consolidated Statements of Operations and Comprehensive Loss, pg 45:
COMMENT: In future filings provide a more specific description of the item labeled “other non-cash
expense” totaling $290,000 for 2004. Also tell us about this item in your response.
RESPONSE: Please refer to the table on page 30 of the Company’s Form 10-K with respect to the
discussion on Non-Operating Expense (Income). The purpose of this table was to provide detail to
the reader for each non-operating expense line item on the income statement. The line
Mr. Gary Todd
August 26, 2005
Page 4
item on the income statement titled “Other non-cash expense” for $290,000 corresponds to the line
item on the table on page 30 titled “Other non-cash expense- Change in fair value of warrants”.
As of December 31, 2004, we had 2 warrants outstanding. The sum of the changes in fair value total
$290,000 as follows:
1.
In January 2004, we issued a warrant to a private investor to purchase
3,100,000 shares of our common stock (please see pg. 32 paragraph 1). This warrant
was recorded on our balance sheet in October 2004, as explained in Response #5
below, at $341,000. At 12/31/04 the fair value of this warrant increased to
$496,000, as shown on the balance sheet line item “Other long-term liability”, and
therefore, the $155,000 income statement impact was a component of the $290,000
shown on the line item “other non-cash expense.
2.
In October 2004, we issued another warrant to a different investor to
purchase an aggregate of 2,640,000 shares of our common stock (please see pg. 32
paragraph 2). In October, we recorded the fair value of the warrant, which was
$631,000. At 12/31/04 the fair value of this warrant increased to $766,000 and was
included on the line titled “Secured Convertible Term Note and related
obligations”. The difference of $135,000 was the remaining component of the income
statement line item titled “other non-cash expense” totaling $290,000.
This information will be clarified in future filings.
5) Consolidated Statements of Shareholders’ Equity, page 46:
COMMENT: In future filings please present footnote disclosure describing the nature of and reason
for the $341,000 reclassification of stock purchase warrants from equity to long-term liabilities.
Also address this matter in your response.
RESPONSE: With the signing of the Laurus agreement in October 2004, we no longer had enough
authorized shares to cover potential conversion of every equity instrument currently outstanding.
Under EITF 00-19, it is assumed that there may be a circumstance that cash payment may have to be
made by the Company to compensate the holder of these instruments, if authorized shares are not
available. Therefore, in October 2004, we recognized a liability for the value of the warrants at
the date of the signing of the agreement with Laurus (a debit to equity and a credit to long-term
liabilities for $341,000). At 12/31/04 the value of the warrant had increased to $496,000 (shown
in the line item “Other long-term liability” on the balance sheet) and therefore, we recognized an
expense of $155,000 included in “Other non-cash expense” on the income statement for $155,000 to
“mark to market” the value of the warrant (debit expense $155,000 and credit the liability for
$155,000). This information will be clarified in future filings.
Mr. Gary Todd
August 26, 2005
Page 5
Note 2: Summary of Significant Accounting Policies, page 48
6) Revenue Recognition, page 50:
COMMENT: We see that you loan laser devices to hospitals in transactions where hospitals agree to
purchase a minimum number of handpieces at a premium over the list price. We note that you normally
amortize the premium over the twenty-four month useful life assigned to the lasers. Tell us more
about this accounting and support that your methods are appropriate in GAAP. In connection with
that response, clarify the following:
a) With respect to the lasers, tell us whether lease accounting is applicable. In substance,
are these leasing arrangements? If so, how does your accounting to conform to the requirements
of leasing GAAP, including SFAS No. 13?
•
We believe that EITF 01-8, “Determining Whether an Arrangement Contains a Lease,” is
relevant with respect to this issue. The EITF indicates that inventory should be excluded
from SFAS No. 13, “Accounting for Leases.” We believe our laser inventory does qualify as
inventory as contemplated by the EITF 01-8 and SFAS No. 13. More importantly, however, we
want to emphasize that substantially all of our evaluation contracts signed by our
customers have no explicit contractual term as to the length of such arrangements. These
evaluation contracts are set up to allow customers to use the lasers over a trial period,
which is not defined in the contract and ultimately varies from customer to customer, with
the intention of negotiating a subsequent sale of such lasers within a relatively short
time period. The evaluation period begins when the laser is installed at the customer
location and remains our property until such time that the customer purchases the laser at
a mutually agreed to price. Following the completion of the trial period, which in
substantially all instances is 90 days to 2 years, we evaluate the prospects for future
sales in handpieces and/or the sale of the actual laser unit with this customer and will
either allow the laser to remain at the customer location for an additional limited period,
negotiate the sale of the laser to the customer, or arrange for the return of the laser to
our warehouse. Accordingly, since there is no definitive contractual period in connection
with these evaluation contracts, we have concluded that such contracts are excluded from
SFAS No. 13 consideration.
b) Describe the basis for concluding that the lasers have a twenty-four month useful life. Do
customers who purchase laser devices need to replace those units every two years?
•
As noted above, because these evaluation contracts do not have explicitly stated
contractual lengths of time, and because our intent, using the evaluation contracts as a
promotional vehicle, is to allow for the demonstration of the effectiveness of the laser to
effect a subsequent sale of said laser over a relatively short time period, we have
determined that it would be unusual for the actual terms of the evaluation contract to
exceed 24 months. As a result, we believe that revenue is properly deferred over the
Mr. Gary Todd
August 26, 2005
Page 6
period of usage of the evaluation contract (i.e., revenue recognition is not front-loaded)
and that in the event of subsequent laser sales resulting from successful customer
evaluations, that such sales transactions are recorded according to our standard commercial
terms.
c) Further clarify how you record and relieve deferred revenues, including timing. Are the
minimum handpieces shipped at the inception of the arrangement? If not, how do you apply the
twenty-four month useful life assumption? For instance, if a handpiece is shipped six months
after inception of an arrangement, is the premium amortized over twenty-four months or over the
remaining eighteen month useful life of the laser?
•
Handpieces are typically ordered and shipped ratably over the various evaluation
periods, as noted above. When we sell a handpiece above the list price in accordance with
evaluation contracts, the portion of the premiums that we recognize in one month must be
equal to or less than 1/24th of the laser’s fair value (i.e., our average commercial
selling price). Therefore, if the laser has been loaned to (i.e., under evaluation with) a
specific customer for less than 24 months, any handpiece premiums during a month that are
in excess of 1/24th of the laser’s fair value must be recognized in a subsequent
month. In the next month, the portion of the previous month’s deferred premiums and the
current month’s premiums if any can be recognized up to 1/24th of the laser
value. If a specific laser has been at a facility for greater than 24 months, which is
uncommon, any remaining deferred premiums are recognized in full.
d) Tell us how you determined the amount of consideration to be assigned to the handpieces and
the loaned lasers. Why is it appropriate to assign only the premium over the list price to
revenue from the loaned laser?
•
The methodology was based on the fact that when a customer is not paying an outright fee
to buy or use the laser, customers are willing to pay a premium over the list price for
handpieces since there is inherent value to the customer in using the laser. This inherent
value is easily determined because substantially all customers not under evaluation
contracts pay the actual list price for such handpieces.
e) Tell us and disclose in future filings how you account for loaned lasers that are converted to
outright sales during the loan period.
•
When a laser is converted to an outright sale during the loan period, the laser is
removed from our books as follows:
1.
The accumulated amortized cost recorded to date is debited.
2.
The gross book value of this inventory is credited.
3.
The net debit (i.e., “2” less “1”) is then expensed as cost of goods
sold.
Mr. Gary Todd
August 26, 2005
Page 7
4.
The actual sales price of the laser is recognized as revenue and the
related amount due from the customer in connection with the sale is debited to
accounts receivable.
5.
Any remaining deferred revenue from premiums associated with handpieces
on this specific evaluation contract is recognized.
7) Warranties, page 51
COMMENT: Unless insignificant, expand future filings to present the quantitative disclosures about
warranties required by paragraph 14 of FIN 45.
RESPONSE: We have noted your comment and will incorporate the change into our future filings.
Note 7. Long-term liabilities, pg 55
8) COMMENT: In future filings please present a numerical reconciliation between the principal
amount of the note and the carrying amount of the indebtedness on your balance sheet. Here, or in
MD&A, please also present some disclosure about the nature of an embedded derivative, including
reasonably specific disclosure about why you believe each of the identified items is a derivative
defined in SFAS 133.
RESPONSE: We have noted your comments and will incorporate the changes into our future filings.
9) COMMENT: We see the significant impact of the