Endocare, Inc.
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
|
|
|
þ |
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2007
OR
|
|
|
o |
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE TRANSITION PERIOD FROM TO
COMMISSION FILE NUMBER: 001-15063
Endocare, Inc.
(Exact name of Registrant as Specified in Its Charter)
|
|
|
DELAWARE
|
|
33-0618093 |
(State of Incorporation)
|
|
(I.R.S. Employer I.D. No.) |
201 TECHNOLOGY DRIVE, IRVINE, CALIFORNIA 92618
(Address of Principal Executive Office, Including Zip Code)
(949) 450-5400
(Registrants Telephone Number, Including Area Code)
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the Registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. (1) Yes þ No o; (2) Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, or a non-accelerated filer. See definitions of accelerated filer and large accelerated
filer in Rule 12b-2 of the Exchange Act. (Check one):
Large Accelerated Filer o Accelerated Filer þ Non-Accelerated Filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
The number of shares of the Registrants common stock, par value $.001 per share, outstanding
at June 30, 2007 was 34,784,939.
PART I FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
ENDOCARE, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
(Unaudited) |
|
|
|
(In thousands, except per share data) |
|
Total revenues |
|
$ |
7,901 |
|
|
$ |
6,908 |
|
|
$ |
15,447 |
|
|
$ |
14,170 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues |
|
|
2,713 |
|
|
|
3,256 |
|
|
|
5,335 |
|
|
|
7,021 |
|
Research and development |
|
|
621 |
|
|
|
475 |
|
|
|
1,236 |
|
|
|
1,486 |
|
Selling and marketing |
|
|
4,099 |
|
|
|
3,904 |
|
|
|
7,862 |
|
|
|
7,673 |
|
General and administrative |
|
|
2,845 |
|
|
|
2,072 |
|
|
|
6,674 |
|
|
|
6,067 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses |
|
|
10,278 |
|
|
|
9,707 |
|
|
|
21,107 |
|
|
|
22,247 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(2,377 |
) |
|
|
(2,799 |
) |
|
|
(5,660 |
) |
|
|
(8,077 |
) |
Interest expense related to common stock
warrants |
|
|
|
|
|
|
1,908 |
|
|
|
|
|
|
|
1,696 |
|
Interest income, net |
|
|
113 |
|
|
|
183 |
|
|
|
139 |
|
|
|
349 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations before taxes |
|
|
(2,264 |
) |
|
|
(708 |
) |
|
|
(5,521 |
) |
|
|
(6,032 |
) |
Tax benefit on continuing operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
151 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations |
|
|
(2,264 |
) |
|
|
(708 |
) |
|
|
(5,521 |
) |
|
|
(5,881 |
) |
Income from discontinued operations
(including gain on disposal of $0.5 million in
2006), net of taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
245 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(2,264 |
) |
|
$ |
(708 |
) |
|
$ |
(5,521 |
) |
|
$ |
(5,636 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per share basic and diluted: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations |
|
$ |
(0.07 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.17 |
) |
|
$ |
(0.20 |
) |
Discontinued operations |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares of common stock
outstanding |
|
|
32,748 |
|
|
|
30,166 |
|
|
|
31,854 |
|
|
|
30,155 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
ENDOCARE, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
|
(Unaudited) |
|
|
|
(In thousands, except |
|
|
|
per share data) |
|
ASSETS
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
7,245 |
|
|
$ |
1,811 |
|
Accounts receivable, net |
|
|
5,079 |
|
|
|
4,161 |
|
Inventories, net |
|
|
2,597 |
|
|
|
2,260 |
|
Prepaid expenses and other current assets |
|
|
1,862 |
|
|
|
1,284 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
16,783 |
|
|
|
9,516 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
786 |
|
|
|
1,040 |
|
Intangibles, net |
|
|
3,328 |
|
|
|
3,613 |
|
Investments and other assets |
|
|
982 |
|
|
|
2,077 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
21,879 |
|
|
$ |
16,246 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,384 |
|
|
$ |
3,393 |
|
Accrued compensation |
|
|
2,911 |
|
|
|
3,000 |
|
Line of credit |
|
|
1,123 |
|
|
|
|
|
Other accrued liabilities |
|
|
3,379 |
|
|
|
3,594 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
10,797 |
|
|
|
9,987 |
|
|
|
|
|
|
|
|
|
|
Other long term liabilities |
|
|
194 |
|
|
|
74 |
|
Common stock warrants |
|
|
|
|
|
|
1,307 |
|
|
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 1,000
shares authorized; none issued and
outstanding |
|
|
|
|
|
|
|
|
Common stock, $0.001 par value; 50,000
shares authorized; 34,785 and 30,679
issued and outstanding as of June 30,
2007 and December 31, 2006, respectively |
|
|
35 |
|
|
|
31 |
|
Additional paid-in capital |
|
|
197,190 |
|
|
|
181,289 |
|
Accumulated deficit |
|
|
(186,337 |
) |
|
|
(176,442 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
10,888 |
|
|
|
4,878 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
21,879 |
|
|
$ |
16,246 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
ENDOCARE, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
|
(Unaudited) |
|
|
|
(In thousands) |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(5,521 |
) |
|
$ |
(5,636 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Gain on divestiture |
|
|
|
|
|
|
(418 |
) |
Depreciation and amortization |
|
|
613 |
|
|
|
857 |
|
Loss on sale of placement units and other fixed assets |
|
|
52 |
|
|
|
|
|
Extinguishment of payroll tax liabilities |
|
|
(121 |
) |
|
|
(869 |
) |
Stock-based compensation |
|
|
1,576 |
|
|
|
1,858 |
|
Net interest expense related to common stock warrants |
|
|
|
|
|
|
(1,696 |
) |
|
|
|
|
|
|
|
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(918 |
) |
|
|
540 |
|
Inventories |
|
|
(407 |
) |
|
|
305 |
|
Prepaid expenses and other assets |
|
|
516 |
|
|
|
531 |
|
Accounts payable |
|
|
(7 |
) |
|
|
(279 |
) |
Accrued compensation |
|
|
79 |
|
|
|
(1,045 |
) |
Other liabilities |
|
|
(95 |
) |
|
|
(1,561 |
) |
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(4,233 |
) |
|
|
(7,413 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(56 |
) |
|
|
(86 |
) |
Proceeds from divestitures |
|
|
|
|
|
|
7,277 |
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
(56 |
) |
|
|
7,191 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Stock options exercised |
|
|
|
|
|
|
108 |
|
Net borrowings on line of credit |
|
|
1,123 |
|
|
|
|
|
Proceeds from sale of common stock |
|
|
8,600 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
9,723 |
|
|
|
108 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
5,434 |
|
|
|
(114 |
) |
Cash and cash equivalents, beginning of period |
|
|
1,811 |
|
|
|
8,108 |
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
7,245 |
|
|
$ |
7,994 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash activities: |
|
|
|
|
|
|
|
|
Transfer of inventory to property and equipment for placement at customer sites |
|
$ |
174 |
|
|
$ |
361 |
|
Transfer of Cryocare Surgical Systems from property and equipment to inventory
for sale |
|
$ |
105 |
|
|
$ |
376 |
|
Note receivable received in divestiture |
|
$ |
|
|
|
$ |
1,425 |
|
Adoption of FSP 00-19-2: |
|
|
|
|
|
|
|
|
Reduction of retained earnings |
|
$ |
4,373 |
|
|
$ |
|
|
Increase in additional paid-in capital |
|
$ |
5,680 |
|
|
$ |
|
|
Reduction of common stock warrant liability |
|
$ |
1,307 |
|
|
$ |
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
Endocare, Inc. and Subsidiary
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Tabular numbers in thousands, except per share data)
(Unaudited)
1. Organization and Operations
We are a medical device company focused on developing, manufacturing and selling cryoablation
products which have the potential to assist physicians in improving and extending life by use in
the treatment of cancer and other tumors. We were formed in 1990 as a research and development
division of Medstone International, Inc. (Medstone), a manufacturer of shockwave lithotripsy
equipment for the treatment of kidney stones. Following our incorporation under the laws of the
state of Delaware in 1994, we became an independent, publicly-owned corporation upon Medstones
distribution of our stock to the existing stockholders on January 1, 1996.
Through February 10, 2006, we also offered vacuum therapy systems for non-pharmaceutical
treatment of erectile dysfunction through our wholly-owned subsidiary Timm Medical Technologies,
Inc. (Timm Medical), which was sold to a third party effective February 10, 2006 (see Note 4 -
Sale of Timm Medical). The operating results of Timm Medical through the date of sale are
included in discontinued operations.
2. Basis of Presentation
Following the rules and regulations of the Securities and Exchange Commission (SEC), we have
omitted footnote disclosures in this report that would substantially duplicate the disclosures
contained in our annual audited financial statements. The accompanying condensed consolidated
financial statements should be read together with the consolidated financial statements and the
notes thereto included in our Annual Report on Form 10-K, filed with the SEC on March 16, 2007.
The accompanying condensed consolidated financial statements reflect all adjustments,
consisting solely of normal recurring accruals, needed to present fairly the financial results for
these interim periods. The condensed consolidated results of operations presented for the interim
periods are not necessarily indicative of the results for a full year. All intercompany
transactions and accounts have been eliminated in consolidation.
3. Recent Operating Results and Liquidity
Since inception, we have incurred losses from operations and have reported negative cash
flows. As of June 30, 2007, we had an accumulated deficit of $186.3 million and cash and cash
equivalents of $7.2 million. Of the cash balance, $1.1 million is borrowed on our line of credit,
which is payable on a current basis. As of June 30, 2007, we have sold $1.6 million in stock under
our agreement with Fusion Capital Fund II, LLC (Fusion Capital) and $7.0 million in stock to
Frazier Healthcare V, L.P. (Frazier) as more fully described below.
We do not expect to reach cash flow positive operations in 2007, and we expect to continue to
generate losses from operations for the foreseeable future. These losses have resulted in part from
our continued investment to gain acceptance of our technology and investment in initiatives that we
believe should ultimately result in cost reductions. Although in July 2006 we resolved the
investigations by the SEC and DOJ of our historical accounting and financial reporting (see Note 10
Commitments and Contingencies), we still have obligations to indemnify and advance the legal
fees of our former officers and former directors in connection with the ongoing investigations and
legal proceedings related to those individuals. The amount of those legal fees may exceed the
reimbursement due to us from our directors and officers liability insurance, and the excess may
have a material adverse effect on our business, financial condition, results of operations and
liquidity. For the six months ended June 30, 2007, we incurred expenses of $1.0 million relating
to legal fees of former officers and former directors and recorded insurance recoveries of $0.7
million. As of June 30, 2007, there remained an aggregate of $0.3 million in coverage. For a
description of this insurance coverage, please refer to the Form 8-K that we filed on February 25,
2005 and Note 10 Commitments and Contingencies.
6
We also face large cash expenditures in the future related to past due state and local tax
obligations, primarily sales and use taxes, which we estimate to be approximately $2.5 million.
The amount was fully accrued as of June 30, 2007. We are in the process of negotiating resolutions
of the past due state and local tax obligations with the applicable tax authorities. However,
there is no assurance that these obligations will be reduced as a result of the negotiations or
that we will be allowed to pay the amounts due over an extended period of time.
We also intend to continue investing in our sales and marketing efforts to physicians in order
to raise awareness and gain further acceptance of our technology. This investment is required in
order to increase physicians usage of our technology in the treatment of prostate and renal
cancers, lung and liver cancers and palliative intervention (treatment of pain associated with
metastases). Such costs will be reported as current period charges under generally accepted
accounting principles.
We received $7.0 million from the sale of our common stock to Frazier in May 2007. Our other
funding sources include a $16.0 million common stock purchase agreement with Fusion Capital and a
$4.0 million credit agreement with Silicon Valley Bank discussed below. The funding availability
under both agreements is subject to many conditions, some of which are predicated on events that
are not within our control. Under the Fusion Capital agreement, we are limited as to the amount of
stock we can sell each time. It also contains default provisions and is automatically suspended if
the trading prices of our shares fall below $1.00. In addition, the extent to which we rely on
Fusion Capital as a source of funding will depend on a number of factors including the prevailing
market price per share of our common stock. The bank credit facility contains restrictive covenants
and subjective acceleration clauses that permit the lender to accelerate payment of all outstanding
balances or cease to make further advances to us in the event of default or if the lender
determines in its judgment that a material adverse change has occurred or will occur. Although we
are in compliance with these conditions and covenants as of June 30, 2007, there is no assurance
that we will be able to comply with all requirements in future periods, that we can obtain a waiver
if an event of default occurs or that the lender will not exercise the subjective acceleration
clause. Accordingly, we cannot guarantee that these capital resources will be available when needed
or will be sufficient.
As of June 30, 2007, we had sold 880,191 shares of stock to Fusion Capital for total gross
proceeds of $1.6 million. Since we have authorized 8,000,000 shares for sale under the stock
purchase agreement, the selling price of our common stock to Fusion Capital would have to average
at least $2.00 per share for us to receive the maximum proceeds of $16.0 million. As of June 30,
2007, we had $1.1 million outstanding under the line of credit facility, which expires on February
27, 2008. The terms of these agreements are described in Note 5 Private Placement of Common
Stock and Warrants, and Note 6 Bank Line of Credit.
Our continuing losses, cash flow deficits, and our obligations, along with the contingencies
in our funding sources, together raise substantial doubt about our ability to continue as a going
concern. The accompanying financial statements have been prepared assuming that we will continue as
a going concern and do not include any adjustments to reflect the possible future effects on the
recoverability and classification of assets or the amounts and classification of liabilities that
may result from the outcome of this uncertainty.
We expect to use existing cash reserves, working capital through the sale of our products, as
well as future proceeds from sales, if any, of common stock to Fusion Capital and borrowings under
our credit facility, to finance our projected operating and cash flow needs, along with continued
expense management efforts. We have reduced operating cash use over the past five years by
streamlining our corporate structure, focusing resources on our core products and strategic
initiatives, re-engineering our products to lower manufacturing costs, reducing use of consultants
and professional services and delaying or eliminating non-essential spending. We have also
instituted additional equity incentive programs to reduce cash compensation outlays.
We may borrow funds under our line of credit with our bank for short-term needs as long as we
remain in compliance with the representations, warranties, covenants and borrowing conditions. We
believe that the financing with Fusion Capital and our line of credit with our bank should provide
us with the capital resources that we need to reach the point where our operations will generate
positive cash flows. However, our cash needs are not entirely predictable. Even if we are able to
access the full $16.0 million under the common stock purchase agreement with Fusion Capital, we may
still need additional capital to fully implement our business, operating and development plans. In
addition, if financing from Fusion Capital were to prove unavailable or prohibitively dilutive and
if we are unable to sell enough of our products, we would need to secure another source of funding
in order to satisfy our
7
working capital needs. Accordingly, we cannot guarantee the availability of these capital
resources or that they will be sufficient to fund our ongoing operations to the point where our
operations will generate positive cash flows.
Because of the subjective acceleration clauses and other contingencies referred to above, the
audit report of our independent auditors contained in our Annual Report on Form 10-K filed on March
16, 2007 contains an unqualified opinion with an explanatory paragraph, to the effect that there is
substantial doubt about our ability to continue as a going concern. This opinion could itself have
a material adverse effect on our business, financial condition, results of operations and cash
flows.
4. Sale of Timm Medical
On January 13, 2006, we entered into a stock purchase agreement with Plethora Solutions
Holdings plc (Plethora), a company listed on the London Stock Exchange. Under this agreement
Plethora agreed to acquire Timm Medical, a wholly owned subsidiary of Endocare, for $9.5 million.
The transaction closed on February 10, 2006. After the sale, we did not receive significant direct
cash flows from Timm Medical and had no significant continuing involvement in its operations. In
accordance with Statement of Financial Accounting Standard (SFAS) No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets, the assets and liabilities of Timm Medical were
classified as discontinued operations in the condensed consolidated financial statements from the
date we decided to sell Timm Medical. Sale proceeds (net of $0.6 million in transaction costs)
totaled $8.9 million and resulted in a gain on sale of $0.5 million in the first quarter of 2006.
Gross proceeds of $9.5 million include cash of $8.1 million and a two-year, five percent promissory
note for $1.4 million which is secured by the assets of Timm Medical. The note is convertible into
Plethoras ordinary shares at any time at our option. If Plethoras shares trade above a specified
price for 20 consecutive days, Plethora has the option to require conversion. We are
currently in discussions with Plethora to potentially accelerate the payment of the note for a lump
sum discounted amount. Based on these discussions we have reserved $0.3 million of the note
balance in the fourth quarter of 2006. Net cash proceeds from the divestiture were $7.3 million
after $0.6 million in transaction costs and $40,000 in cash of Timm Medical as of the date of
disposition.
We agreed to retain certain assets and liabilities of Timm Medical, including all tax
liabilities totaling $1.1 million, obligations and rights to a $2.7 million note receivable from
SRS Medical Corporation, relating to the sale of Timm Medicals urinary incontinence product line
in 2003, certain litigation to which Timm Medical was a party and ownership of Urohealth BV (Timm
Medicals wholly-owned subsidiary with insignificant operations). Assets and liabilities we
retained and their related revenues and expenses are excluded from discontinued operations. The
stock purchase agreement requires that payments under the promissory note described above be placed
in an indemnification escrow in certain circumstances to indemnify Plethora against certain claims
and liabilities.
Assets and liabilities sold to Plethora as of February 10, 2006 included the following:
|
|
|
|
|
Assets: |
|
|
|
|
Cash, inventories and other current assets |
|
$ |
1,041 |
|
Property and equipment, net |
|
|
71 |
|
Goodwill, net |
|
|
4,552 |
|
Intangibles, net |
|
|
3,680 |
|
Other assets |
|
|
65 |
|
|
|
|
|
Total assets |
|
|
9,409 |
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
Accounts payable and other current liabilities |
|
|
502 |
|
Other accrued liabilities |
|
|
486 |
|
|
|
|
|
Total liabilities |
|
|
988 |
|
|
|
|
|
|
|
|
|
|
Net assets |
|
$ |
8,421 |
|
|
|
|
|
Revenues for Timm Medical were $1.0 million (for the period from January 1, 2006 through date
of sale, February 10, 2006). Income from discontinued operations for the six months ended June 30,
2006 included a $0.5 million gain on disposal and is net of $0.2 million in taxes.
8
5. Private Placement of Common Stock and Warrants
May 2007 Private Placement
On May 24, 2007 we entered into a common stock subscription agreement with Frazier and on May
25, 2007 we entered into a registration rights agreement with Frazier. Under the subscription
agreement, Frazier agreed to purchase 3,255,814 shares of our common stock at a price per share of
$2.15, for aggregate proceeds to us of $7.0 million.
In the subscription agreement, Frazier agreed to lock-up provisions restricting the
transferability of the shares, for a period of one year for 75 percent of the shares and a period
of 18 months for 25 percent of the shares. The lock-up provisions expire early if we undergo a
change in control or if we issue significant additional amounts of securities in certain
circumstances after May 25, 2007, as described in the subscription agreement.
In the registration rights agreement, we agreed to file a registration statement with the SEC
on or before February 25, 2008 to register the shares for resale. We also agreed to use
commercially reasonable efforts to cause the registration statement to become effective as promptly
as possible thereafter, with the intention that the registration statement will be available for
resale by Frazier once the lock-up restrictions expire. In addition, we agreed to use commercially
reasonable efforts to keep the registration statement effective until May 25, 2010.
Fusion Capital Equity Purchase Agreement
On October 25, 2006, we entered into a common stock purchase agreement with Fusion Capital as
described above under Note 3 Recent Operating Results and Liquidity. Under this agreement we
have the right to sell to Fusion Capital up to $16.0 million worth of common stock, at our
election, over a two year period at prices determined based upon the market price of our common
stock at the time of each sale, without any fixed discount. Common stock may be sold in $100,000
increments every fourth business day, with additional $150,000 increments available every third
business day if the market price per share of our common stock is $1.50 or higher, subject to our
ability to comply with certain ongoing requirements discussed below. This $150,000 increment can be
further increased at graduated levels up to $1.0 million if the market price per share increases
from $1.50 to $6.00. If the price of the stock is below $1.00 per share, the obligation for Fusion
Capital to buy any shares of stock is automatically suspended. Under the terms of the agreement, we
issued 473,957 shares of common stock to Fusion Capital for no consideration as a commitment fee.
Under a related registration rights agreement, before Fusion Capital was obligated to purchase
shares, we were required to file a registration statement covering the sale of up to 8,473,957
common shares within 20 days of signing the agreement. The registration statement was filed in
November 2006 and declared effective by the SEC on December 1, 2006. We subsequently filed a
post-effective amendment to the registration statement, which was declared effective March 30,
2007. We are required to maintain effectiveness of the registration statement until the earlier of
the date that Fusion Capital may sell the shares without restriction pursuant to Rule 144(k) or the
date that Fusion Capital has sold all purchased shares and no available unpurchased shares remain
under the agreement. Upon occurrence of certain events of default as defined in the stock purchase
agreement, including lapse of effectiveness of the registration statement for 10 or more
consecutive business days or for 30 or more business days within a 365-day period, suspension of
trading for 3 business days, delisting of the shares from the principal market on which they are
traded, failure by our stock transfer agent to issue shares within 5 business days, or other
material breaches, Fusion Capital may terminate the stock purchase agreement. We have the right to
terminate the agreement at any time.
Through June 30, 2007, we had sold 880,191 shares for gross proceeds of $1.6 million. We are
obligated to pay a transaction fee equal to 6.0 percent of the stock proceeds to an investment
advisory firm under a pre-existing capital advisory agreement. In relation to this agreement we
have prepaid $100,000 in fees to the investment advisory firm in 2006. Through June 30, 2007 we
incurred $99,000 of these fees. As of June 30, 2007, we have approximately $14.4 million in
remaining funding available with Fusion based on our closing stock price on that date.
9
March 2005 Private Placement
On March 11, 2005, we completed a private placement of 5,635,378 shares of our common stock
and detachable warrants to purchase 3,944,748 common shares at an offering price of $2.77 per
share, for aggregate gross proceeds of $15.6 million. Transaction costs were $1.0 million,
resulting in net proceeds of $14.6 million. Of the total warrants, 1,972,374 had an initial
exercise price of $3.50 (Series A warrants) per share and 1,972,374 had an initial exercise price
of $4.00 (Series B warrants) per share. The expiration date of the warrants is May 1, 2010. One
current member and one former member of our management team made personal investments totaling $0.7
million in the aggregate, and a member of our Board of Directors invested $0.3 million.
The warrants have an anti-dilution clause that is triggered upon issuance of a certain number
of shares of our common stock that reduces the effective exercise price of the warrants to preserve
the ownership of the warrant holders. As a result of our May 2007 private placement and the
issuance of shares to Fusion Capital through June 30, 2007, the exercise price of the Series A
Warrants decreased to $3.34 to effectively provide holders an additional 95,019 shares and the
Series B Warrant exercise price decreased to $3.79 effectively providing the Series B Warrant
holders an additional 111,592 shares.
The warrants initially are exercisable at any time during their term for cash only. The
warrants may be exercised on a cashless exercise basis in limited circumstances after the first
anniversary of the closing date if there is not an effective registration statement covering the
resale of the shares underlying the warrants. Each warrant is callable by us at a price of $0.01
per share underlying such warrant if our stock trades above certain dollar per share thresholds
($6.50 for the Series A warrants and $7.50 for Series B warrants) for 20 consecutive days
commencing on any date after the effectiveness of the registration statement, provided that (a) we
provide 30-day advanced written notice (Notice Period), (b) we simultaneously call all warrants on
the same terms and (c) all common shares issuable are registered. Holders may exercise their
warrants during the Notice Period and warrants which remain unexercised will be redeemed at $0.01
per share.
Upon exercise, we will pay transaction fees equal to 6.0 percent of the warrant proceeds under
a pre-existing capital advisory agreement.
Pursuant to the terms of the registration rights agreement relating to the March 2005
financing, we filed with the SEC a registration statement on Form S-2 under the Securities Act of
1933, as amended, covering the resale of all of the common stock purchased and the common stock originally
underlying the issued warrants. The S-2 registration statement was declared effective September 28,
2005. We subsequently filed a post-effective amendment on Form S-3, which was declared effective
March 28, 2006 and a post-effective amendment on Form S-1, which was declared effective March 30,
2007.
The registration rights agreement provides that if a registration statement is not filed
within 30 days of closing or does not become effective within 90 days thereafter, then in addition
to any other rights the holders may have, we will be required to pay each holder an amount in cash,
as liquidated damages, equal to one percent of the aggregate purchase price paid by such holder per
month. We incurred $0.6 million of liquidated damages through September 28, 2005, when the S-2
registration statement was declared effective.
Under the registration rights agreement, we could incur similar liquidated damages in the
future (equal to one percent of the aggregate purchase price paid by each affected holder per
month) if holders are unable to make sales under the registration statement (for example, if we
fail to keep the registration statement current as required by SEC rules or if future amendments to
the registration statement are not declared effective in a timely manner). The registration
obligation remains outstanding until the earlier of the date on which all shares issuable upon
exercise of the warrants have been issued and resold by the holders of the warrants or the date on
which all such shares can be resold by the holders without registration.
Since the liquidated damages under the registration rights agreement could in some cases
exceed a reasonable discount for delivering unregistered shares, we accounted for the registration
payment arrangement and warrants as one instrument classified as a derivative (a non-current
liability) under EITF No. 00-19, Accounting for Derivative Financial Instruments Indexed to, and
Potentially Settled in, a Companys Own Stock. We allocated a portion of the March 2005 offering
proceeds to the warrants based on their fair value at issuance. Through December 31, 2006, we
revalued the warrants as a derivative instrument quarterly in connection with changes in the
underlying stock price and other assumptions, with the change in value recorded as interest
expense. In December 2006, the Financial
10
Accounting Standards Board issued FASB Staff Position (FSP) No. 00-19-2, Accounting for
Registration Payment Arrangements, which changed the way we account for the outstanding warrants.
FSP No. 00-19-2 specifies that the contingent obligation to make future payments or otherwise
transfer consideration under a registration payment arrangement should be separately recognized and
measured in accordance with SFAS No. 5, Accounting for Contingencies. For registration payment
arrangements and financial instruments subject to those arrangements that were entered into prior
to the issuance of this FSP and that continue to be outstanding at the adoption date, this guidance
is effective for fiscal years beginning after December 15, 2006 and interim periods within those
fiscal years. Upon adoption of FSP No. 00-19-2 on January 1, 2007, the value of the warrants as of
the original issue date ($5.7 million) was reclassified to equity without regard to the contingent
obligation to transfer consideration under the registration payment arrangement. The difference
between the $5.7 million and the carrying value of the warrant liability as of December 31, 2006
($1.3 million) was recorded as a cumulative-effect adjustment to reduce opening retained earnings
on January 1, 2007. Hereafter, accruals for liquidated damages, if any, will be recorded when they
are probable and reasonably estimable.
6. Bank Line of Credit
As described above in Note 3 Recent Operating Results and Liquidity, on October
26, 2005, we entered into a one-year credit facility with Silicon Valley Bank (the lender), which
provided up to $4.0 million in borrowings for working capital purposes in the form of a revolving
line of credit and term loans (not to exceed $500,000). The agreement was amended in February,
April and December 2006 and was extended to February 28, 2007. In February 2007 the agreement was
further extended to February 27, 2008, as described below.
The credit facility permits the borrowings up to the lesser of $4.0 million or amounts
available under a borrowing base formula based on eligible accounts receivable and inventory. As
amended, the borrowing base is (i) 85 percent of eligible accounts receivable, plus (ii) the lesser
of 30 percent of the value of eligible inventory or $500,000. Borrowings are secured by all of our
assets, including all receivable collections which are held in trust for the Bank. Interest is
payable monthly at prime rate plus 1.5 percent. The agreement requires a one-time commitment fee of
$40,000 paid on the effective date and an annual facility fee equal to 0.5 percent of the unused
portion of the facility. A termination fee will also be assessed if the credit facility is
terminated prior to expiration. We had no outstanding borrowings at December 31, 2006. As of June
30, 2007 there was $1.1 million outstanding on the line of credit.
As a condition to each advance under the credit facility, all representations and warranties
by us must be materially true and no event of default must have occurred or be continuing. In
addition, the lender, in its good faith business judgment, must determine that no material adverse
change has occurred. A material adverse change occurs when there is a material impairment in the
priority of the lenders lien in the collateral or its value, a material adverse change in our
business, operations or condition, a material impairment of the prospect of repayment or if the
lender determines, in its good faith reasonable judgment, that there is a reasonable likelihood
that we will fail to comply with one or more financial covenant in the next financial reporting
period.
The agreement governing the credit facility contains various financial and operating covenants
that impose limitations on our ability, among other things, to incur additional indebtedness, merge
or consolidate, sell assets except in the ordinary course of business, make certain investments,
enter into leases and pay dividends without the consent of the lender. The credit facility also
includes a subjective acceleration clause and a requirement to maintain a lock box with the lender
to which all collections are deposited. Under the subjective acceleration clause, the lender may
declare default and terminate the credit facility if it determines that a material adverse charge
has occurred. If the aggregate outstanding advances plus reserves placed by the lender against the
loan availability exceeds 50 percent of the receivable borrowing base component as defined, or if a
default occurs, all current and future lock box proceeds will be applied against the outstanding
borrowings. The credit facility also contains cross-default provisions and a minimum tangible net
worth requirement measured on a monthly basis. Tangible net worth must be equal to or greater than
the sum of a base amount ($1,000 as of June 30, 2007) plus 25 percent of all consideration received
from issuing equity securities and subordinated debt and 25 percent of positive consolidated net
income in each quarter.
We were not in compliance with the minimum tangible net worth covenant for the months
September 2006 to November 2006. On December 22, 2006, we signed an amendment to the agreement
governing the credit facility. Among other things, the amendment (i) modified the borrowing base to
increase the eligible accounts receivable
11
from 80 percent to 85 percent and modified the definition of accounts that are ineligible
under the borrowing base calculation; (ii) modified the loan margin as defined to 1.50 percent, and
(iii) waived non-compliance with the minimum tangible net worth requirement at September 30, 2006,
October 31, 2006 and November 30, 2006, and modified the terms of the covenant. As of December 31,
2006 and June 30, 2007, we were in compliance with all covenants. During February through May
2007, the outstanding advances exceeded 50 percent of the receivable borrowing base referred to
above. As required by the agreement our lock-box proceeds were applied daily to reduce the
outstanding advances and we re-borrowed the amount subject to the lenders approval through June
30, 2007. The daily borrowings and repayments have been presented on a net basis in the condensed
consolidated statements of cash flows. As of July 13, 2007, we were no longer required to repay
and re-borrow funds on a daily basis.
On February 23, 2007, the credit agreement was amended to further modify the minimum tangible
net worth provision and to extend the maturity date to February 27, 2008.
7. Capital Stock and Net Loss Per Share
Basic net loss per share is computed by dividing net loss by the weighted average number of
common shares outstanding for the respective periods. Diluted loss per share, calculated using the
treasury stock method, gives effect to the potential dilution that could occur upon the exercise of
certain stock options and warrants that were outstanding during the respective periods presented.
For periods when we reported a net loss, these potentially dilutive common shares were excluded
from the diluted loss per share calculation because they were anti-dilutive.
On August 6, 2007, our Board of Directors authorized us to proceed with a one-for-three reverse
stock split of our outstanding common stock in order to satisfy the minimum bid price requirement
for initial listing on The NASDAQ Capital Market. The record date established for the reverse
stock split is August 20, 2007. As described in the proxy statement that we filed with the SEC on
April 9, 2007, stock and stock equivalents including shares available for issuance under equity
compensation plans will be automatically adjusted to reflect the stock split. However, the stock
split will not affect our authorized capital stock, which will remain at 50,000,000 shares of
common stock and 1,000,000 shares of preferred stock. Our Board reserves the right, exercisable at
any time prior to the effectiveness of the stock split, to modify the ratio or record date of the
stock split or to not proceed with the stock split.
8. Stock-Based Compensation
Our equity incentive programs include stock options, restricted stock units and deferred stock
units. Some awards vest based on continuous service while others vest or accelerate-vest based on
performance conditions, such as profitability goals. On January 1, 2006, we adopted SFAS No. 123
(revised), Share-Based Payment (SFAS No. 123R), which requires measurement and recognition of
compensation expense for all share-based awards made to employees and directors.
Under SFAS No. 123R, the fair value of share-based awards is estimated at grant date using an
option pricing model, and the portion that is ultimately expected to vest is recognized as
compensation cost over the requisite service period. For awards that vest based on service, we
record compensation expense ratably over the service period from the date of grant. For
performance-based awards, we begin recording compensation expense over the remaining service period
when we determine that achievement is probable. Change in estimates as to the probability of
vesting is recorded through cumulative catch-up adjustments when the assessment is made. Since
share-based compensation under SFAS No. 123R is recognized only for those awards that are
ultimately expected to vest, we have applied an estimated forfeiture rate to unvested awards for
the purpose of calculating compensation cost. These estimates will be revised, if necessary, in
future periods if actual forfeitures differ from the estimates. Changes in forfeiture estimates
impact compensation cost in the period in which the change in estimate occurs. We use the
Black-Scholes option-pricing model to estimate the fair value of share-based awards. The
determination of fair value using the Black-Scholes option-pricing model is affected by our stock
price as well as assumptions regarding a number of complex and subjective variables, including
expected stock price volatility, risk-free interest rate, expected dividends and projected employee
stock option exercise behaviors.
9. Inventories
Inventories, consisting of raw materials, work-in-process and finished goods, are stated at
the lower of cost or market, with cost determined by the first-in, first-out method. Reserves for
slow-moving and obsolete inventories are provided based on historical experience and product
demand. We evaluate the adequacy of these reserves periodically.
12
The following is a summary of inventories (excluding assets of discontinued operations):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Raw materials |
|
$ |
1,865 |
|
|
$ |
1,750 |
|
Work in process |
|
|
614 |
|
|
|
300 |
|
Finished goods |
|
|
723 |
|
|
|
778 |
|
|
|
|
|
|
|
|
Total inventories |
|
|
3,202 |
|
|
|
2,828 |
|
Less: inventory reserve |
|
|
(605 |
) |
|
|
(568 |
) |
|
|
|
|
|
|
|
Inventories, net |
|
$ |
2,597 |
|
|
$ |
2,260 |
|
|
|
|
|
|
|
|
10. Commitments and Contingencies
Legal Proceedings
Governmental Investigations and Legal Proceedings
As reported in the Form 8-K that we filed on July 20, 2006, we executed a consent to entry of
judgment in favor of the SEC on July 14, 2006 and entered into a non-prosecution agreement with the
DOJ on July 18, 2006. These two agreements effectively resolve with respect to us the
investigations begun by the SEC and by the DOJ in January 2003, regarding allegations that we and
certain of our former officers and former directors and one current employee issued, or caused to
be issued, false and misleading statements regarding our financial results for 2001 and 2002 and
related matters. Under the terms of the consent judgment with the SEC: (i) we paid $750,000 in
civil penalties and disgorgement; and (2) we agreed to a stipulated judgment enjoining future
violations of securities laws. On April 7, 2006, we entered into an escrow agreement with Morrison
& Foerster LLP, our outside counsel, pursuant to which we placed the $750,000 anticipated
settlement in escrow with Morrison & Foerster at the request of the SEC staff. The funds were
released from the escrow to the SEC in August 2006. A liability for the monetary penalty was
accrued in 2004.
The investigations and legal proceedings related to certain former officers and former
directors remain ongoing and are not affected by our settlements with the SEC and DOJ. We remain
contractually obligated to pay legal fees for and otherwise indemnify these former officers and
former directors. On August 9, 2006 the SEC filed civil fraud charges in federal district court
against two former officers. On April 9, 2007, these two former officers were indicted by a
federal grand jury in Orange County, California. Our directors and officers liability insurance
may fund certain losses, including defense costs, related to these matters. As of June 30, 2007,
we had $0.3 million in remaining available coverage under the applicable excess directors and
officers liability policy. This policy reimburses 75 percent of the first $2.25 million in
eligible costs to a maximum of approximately $1.7 million, zero percent of the next $500,000 and
57.5 percent of the next $1 million to a maximum of $0.6 million. For further information regarding
this coverage, please refer to the Form 8-K that we filed on February 25, 2005.
Lawsuit with KPMG LLP
On October 26, 2006, we filed a lawsuit with the Superior Court of the State of California for
the County of Orange against our former independent auditor, KPMG LLP, for professional negligence
and breach of contract, seeking damages in an amount to be determined at trial. Previously, we had
entered into a Mediation and Tolling Agreement with KPMG pursuant to which KPMG agreed that the
statute of limitations would be tolled to provide an opportunity for mediation between the parties.
We engaged in mediation with KPMG on September 27, 2006 but the parties were unable to reach
settlement. Accordingly, we proceeded with the filing of the lawsuit. In response to our claims
against KPMG, KPMG filed a cross-complaint against us and certain former officers. Under the
cross-complaint, KPMG makes claims against us for breach of contract, violations of the federal
racketeering statute and conspiracy to violate the federal racketeering statute, seeking damages in
an amount to be determined at trial. We are not able to predict the outcome of this lawsuit.
Other Litigation
In January 2006, we entered into a settlement and release agreement with certain parties
against whom we had a claim from a judgment awarded to us in prior years. We received $162,500 in
the settlement of this claim, which was recorded as a reduction of general and administrative
expenses in the first quarter of 2006.
13
In addition, in the normal course of business, we are subject to various other legal matters,
which we believe will not individually or collectively have a material adverse effect on our
consolidated financial condition, results of operations or cash flows. However, the results of
litigation and claims cannot be predicted with certainty, and we cannot provide assurance that the
outcome of various legal matters will not have a material adverse effect on our consolidated
financial condition, results of operations or cash flows. As of June 30, 2007, we have not
established a liability for contingencies in the consolidated balance sheets since the likelihood
of loss and potential liability cannot be reliably estimated at this time. However, our evaluation
of the likelihood of an unfavorable outcome with respect to these actions could change in the
future.
From time to time, we have received correspondence alleging infringement of proprietary rights
of third parties. No assurance can be given that any relevant claims of third parties would not be
upheld as valid and enforceable, and therefore we could be prevented from practicing the subject
matter claimed or would be required to obtain licenses from the owners of any such proprietary
rights to avoid infringement. We do not expect any material adverse effect on our consolidated
financial condition, results of operations or cash flows because of such claims.
11. Income Taxes
On January 1, 2007, we adopted Financial Accounting Standards Board (FASB) Interpretation No.
48, Accounting for Uncertainty in Income Taxes, an interpretation of SFAS No. 109, Accounting for
Income Taxes (FIN 48). FIN 48 creates a single model to address accounting for uncertainty in tax
positions. It clarifies the accounting for income taxes, by prescribing a minimum recognition
threshold a tax position is required to meet before being recognized in the financial statements.
FIN 48 also provides guidance on derecognition, measurement, classification, interest and
penalties, accounting in interim periods, disclosure and transition.
As of the adoption date, we had $240,000 of unrecognized tax benefits, all of which would
affect our effective tax rate if recognized. A reconciliation of the beginning and ending amount of
unrecognized tax benefit is as follows:
|
|
|
|
|
Balance as of January 1, 2007 |
|
$ |
240,000 |
|
Additions based on tax positions related to the current year |
|
|
|
|
Additions for tax positions of prior years |
|
|
|
|
Reductions for tax positions of prior years |
|
|
|
|
Settlements |
|
|
|
|
|
|
|
|
Balance as of June 30, 2007 |
|
$ |
240,000 |
|
|
|
|
|
Because of our historical losses, FIN 48 did not have an effect on our accounting and disclosure
for income taxes. We do not anticipate that there will be a material change in the balance of the
unrecognized tax benefits within the next twelve months. We recognize interest and penalties
related to uncertain tax positions in income tax expense. We have approximately $40,000 of accrued
interest related to uncertain tax positions as of January 1, 2007 and June 30, 2007. The tax years
2003 through 2006 remain open to examination by the major taxing jurisdictions to which we are
subject.
We reported no net income tax expense from continuing and discontinued operations during the
three and six months ended June 30, 2007 and 2006 due to our operating losses. The 2006 tax benefit
on continuing operations of $0.2 million is the result of the 2006 first quarter pre-tax book
losses being utilized against pre-tax book income from discontinued operations. There is an
offsetting tax provision within discontinued operations. Due to our history of operating losses,
management has determined that it is more likely than not that our deferred tax assets will not be
realized through future earnings. Accordingly, valuation allowances were recorded to fully reserve
the deferred tax assets as of June 30, 2007 and December 31, 2006.
14
12. Results of Operations
Revenues and cost of revenues from continuing operations related to the following products and
services for the periods ended June 30, 2007 and 2006 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cryoablation disposable products |
|
$ |
5,417 |
|
|
$ |
3,397 |
|
|
$ |
10,620 |
|
|
$ |
5,808 |
|
Cryocare Surgical Systems |
|
|
521 |
|
|
|
225 |
|
|
|
998 |
|
|
|
445 |
|
Other |
|
|
115 |
|
|
|
12 |
|
|
|
149 |
|
|
|
22 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,053 |
|
|
|
3,634 |
|
|
|
11,767 |
|
|
|
6,275 |
|
Cryoablation procedure fees |
|
|
1,746 |
|
|
|
3,135 |
|
|
|
3,488 |
|
|
|
7,598 |
|
Cardiac royalties (CryoCath) |
|
|
102 |
|
|
|
139 |
|
|
|
192 |
|
|
|
297 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
7,901 |
|
|
$ |
6,908 |
|
|
$ |
15,447 |
|
|
$ |
14,170 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs of Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cryoablation disposable products and procedure fees |
|
$ |
2,353 |
|
|
$ |
3,028 |
|
|
$ |
4,746 |
|
|
$ |
6,424 |
|
Cryocare Surgical Systems |
|
|
360 |
|
|
|
228 |
|
|
|
589 |
|
|
|
597 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,713 |
|
|
$ |
3,256 |
|
|
$ |
5,335 |
|
|
$ |
7,021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues for cryoablation disposable product sales and procedure fees are combined for
reporting purposes. Sales of cryoablation disposable products and procedure fees both incorporate
similar inventory when sold and we do not separately track the cost of disposals sold directly to
customers and those consumed in cryoablation procedures. Cryoablation procedure services are
provided to medical facilities upon request to facilitate the overall delivery of our technology
into the marketplace.
13. Recent Accounting Pronouncements
Other recent accounting pronouncements issued by the FASB (including its Emerging Issues Task
Force), the American Institute of Certified Public Accountants, and the SEC did not, or are not
believed by management to, have a material impact on our present or future consolidated financial
statements.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis should be read in conjunction with the unaudited
condensed consolidated financial statements and notes thereto included in Part I Item 1 of this
report, and the audited consolidated financial statements and notes thereto, and Managements
Discussion and Analysis of Financial Condition and Results of Operations contained in the Annual
Report on Form 10-K for the fiscal year ended December 31, 2006.
This discussion contains forward-looking statements based on our current expectations. There
are various factors many beyond our control that could cause our actual results or the
occurrence or timing of expected events to differ materially from those anticipated in these
forward-looking statements. Some of these factors are described below and other factors are
described elsewhere in this Quarterly Report on Form 10-Q or under Risk Factors in our Annual
Report on Form 10-K referred to above. In addition, there are factors not described in this
Quarterly Report on Form 10-Q or in our Annual Report on Form 10-K that could cause our actual
results or the occurrence or timing of expected events to differ materially from those anticipated
in these forward-looking statements. All forward-looking statements included in this Quarterly
Report on Form 10-Q are based on information available to us as of the date hereof, and we assume
no obligation to update any such forward-looking statements.
Overview
We are an innovative medical device company focused on the development of minimally invasive
technologies for tissue and tumor ablation through cryoablation, which is the use of lethal ice to
destroy tissue, such as tumors, for therapeutic purposes. We develop and manufacture devices for
the treatment of prostate and renal cancers and we believe that our proprietary technologies have
broad applications across a number of markets, including the ablation of tumors in the lung and
liver and palliative intervention (treatment of pain associated with metastases).
Today, our FDA-cleared Cryocare Surgical System occupies a growing position in the urological
market for treatment of prostate and renal cancers. Because of our initial concentration on
prostate and renal cancers, the majority of our sales and marketing resources are directed toward
the promotion of our technology to urologists. In addition to selling our cryosurgical disposable
products to hospitals and mobile service companies, we contract
15
directly with hospitals for the use of our Cryocare Surgical System and disposable products on
a fee-for-service basis. Since 2003, we also maintain a dedicated sales team focused on selling
percutaneous cryoablation procedures related to liver, kidney and lung cancer and palliative
intervention to interventional radiology physicians throughout the United States. We intend to
continue to identify and develop new markets for our cryosurgical products and technologies,
particularly in the area of tumor ablation.
We previously owned Timm Medical Technologies, Inc. (Timm Medical), a company focused on
erectile dysfunction products. We sold Timm Medical to United Kingdom-based Plethora Solutions
Holdings plc effective on February 10, 2006.
Strategy, Key Metrics and Developments
Our primary objective is to grow market share, currently measured in terms of the estimated
number of procedures performed with our Cryocare Surgical System, which we calculate using two
primary components. The first component is the actual number of cryoablation cases for which we
provide the cryoablation products for a treatment and are also responsible for performing the
service element on behalf of the healthcare facility. Cryoablation services generally consist of
rental and transport of a Cryocare Surgical System as well as the service of a technician to assist
the physician with the setup and monitoring of the equipment. In the second, we compute an
estimated cryoablation case equivalent based on direct sales of our cryoablation disposable
products (without the service component) by using the expected disposable product usage for those
sales. Estimated procedure growth has been an important metric to which we have referred during
the past several years in order to measure the success of our strategy.
In addition to being a key business metric, procedure growth has been an important driver of
revenue growth, because a significant percentage of our revenue consists of sales of the disposable
products used in procedures performed with the Cryocare Surgical System, as shown below under
Results of Operations. In 2003 we redirected our strategy for our cryoablation business away from
emphasizing sales of Cryocare Surgical Systems and instead toward seeking to increase sales of
cryoablation disposable products. Historically, we were responsible for performing the service
element of the procedure on behalf of the healthcare facility for the majority of our reported
procedures. Beginning in 2004, we changed our business model to emphasize our strength as a medical
device manufacturer and strategically reduced the amount of revenues attributable to the service
model where we are responsible for performing the service element of the procedures on behalf of
the healthcare facility for a procedure fee. By the fourth quarter of 2006, we had achieved our
goal of having the substantial majority of our procedures comprised of sales of cryoablation
disposable products without the service element. During 2006, we succeeded in causing the
percentage of total estimated domestic cryoablation procedures for which we perform the service
element to decline from 50 percent of total reported procedures for the three months ended March
31, 2006 to 20 percent of total reported procedures for the three months ended December 31, 2006.
During the three months ended June 30, 2007, the percentage for which we performed the service
element of the procedure declined further to 15 percent of total reported procedures.
Given that we have accomplished the business model transition mentioned above, the majority of
our revenues are from sales of cryoablation disposable products and we will again be able to view
revenue growth as an important business metric going forward. One result of our new model is that
our customers hospitals and third-party service providers are now carrying inventories of our
probes and other equipment for use in performing cryoablation procedures. Because of the
variability of probe use across patients and applications, determining precisely how many
procedures are performed based on sales of cryoablation disposable products is becoming more
difficult. Because we are less involved in providing the service element of the procedure, we also
will have less ability to ensure that we receive accurate case information in order to validate the
assumptions we use about how many cryoprobes are used in an average procedure. Accordingly, we
have decided that beginning in the fourth quarter of 2007 and going forward, in addition to revenues, we will begin to
provide alternative business metrics such as the number of cryoprobes sold during the period. We
believe that these measurements can provide more useful data to the investment community and other
users of our financial statements and will allow us to be more precise with the data we provide.
For periods through the end of 2007, we will continue to report estimated procedure numbers
and the estimated growth rates of those procedures over prior periods.
16
The change in our business model and revenue mix discussed above also has impacted our gross
margin due to the disparity in per-procedure revenue between cases for which we are responsible for
providing the service element and cases for which we merely sell disposable products. This
disparity results from the fact that the revenue from a case for which we merely sell disposable
products is less than the revenue from a case for which we are also responsible for providing the
service element (referred to as procedure fees below). As the percentage of cases for which we
merely sell disposable products increases relative to cases for which we are responsible for
providing the service element, our incremental revenues grow at a slower rate than our overall
procedure growth. However, the gross profit realized is generally equivalent since we do not incur
fees to third party subcontractors for cases for which we merely sell disposable products. In
contrast, in cases for which we are responsible for providing the service element, we typically
subcontract with a third party service provider to provide the service element on our behalf and
thereby incur service fees. As a result, our gross margin (gross profit as a percent of revenues)
increases as we shift from procedure fees to sale of disposable products. As a result of this
shift, over time, we expect the number of procedures performed to become a less important measure
of our business and our revenues to become a more important metric.
In the past several years, we have been successful in increasing the estimated number of
domestic cryoablation procedures on a year-over-year basis. In 2005 total estimated procedures
increased 36 percent to 6,407 from 4,713 in 2004. In 2006 total estimated procedures increased 22
percent to 7,802. During the three months ended June 30, 2007, total estimated procedures
increased 26 percent to 2,435 from 1,938 in the three months ended June 30, 2006. During the six
months ended June 30, 2007, total estimated procedures increased 28 percent to 4,750 from 3,699 in
the prior year period.
The factors driving interest in and utilization of cryoablation by urologists include
increased awareness and acceptance of cryoablation by physicians and industry thought leaders,
continued publication of clinical follow up data on the effectiveness of cryoablation, including
10-year data presented in 2005, increased awareness among patients of cryoablation and its
preferred outcomes as compared to other modalities, the efforts of our dedicated cryoablation sales
force and our continued expenditure of funds on physician training as well as patient education
and advocacy.
We believe that one of the factors that adversely impacts procedure growth and revenues is
that certain urologists decide from time to time to try new techniques for the treatment of
prostate cancer. We cannot predict the extent to which this factor may continue to affect us.
However, the prostate cancer treatment market is very competitive and there are many different
treatment options that have been developed and that are continuing to be developed.
Results of Operations
Revenues and costs of revenues from continuing operations related to the following products
and services for the three and six months ended June 30, 2007 and 2006 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cryoablation disposable products |
|
$ |
5,417 |
|
|
$ |
3,397 |
|
|
$ |
10,620 |
|
|
$ |
5,808 |
|
Cryocare Surgical Systems |
|
|
521 |
|
|
|
225 |
|
|
|
998 |
|
|
|
445 |
|
Other |
|
|
115 |
|
|
|
12 |
|
|
|
149 |
|
|
|
22 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,053 |
|
|
|
3,634 |
|
|
|
11,767 |
|
|
|
6,275 |
|
Cryoablation procedure fees |
|
|
1,746 |
|
|
|
3,135 |
|
|
|
3,488 |
|
|
|
7,598 |
|
Cardiac royalties (CryoCath) |
|
|
102 |
|
|
|
139 |
|
|
|
192 |
|
|
|
297 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
7,901 |
|
|
$ |
6,908 |
|
|
$ |
15,447 |
|
|
$ |
14,170 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs of Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cryoablation disposable products and procedure fees |
|
$ |
2,353 |
|
|
$ |
3,028 |
|
|
$ |
4,746 |
|
|
$ |
6,424 |
|
Cryocare Surgical Systems |
|
|
360 |
|
|
|
228 |
|
|
|
589 |
|
|
|
597 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,713 |
|
|
$ |
3,256 |
|
|
$ |
5,335 |
|
|
$ |
7,021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17
Costs of revenues for cryoablation disposable products and procedure fees are combined for
reporting purposes. Sales of cryoablation disposable products and procedure fees incorporate
similar inventory when sold and we do not separately track the cost of disposable products sold
directly to customers and those consumed in cryoablation procedures.
We recognize revenues from sales of Cryocare Surgical Systems and disposable cryoprobes when
persuasive evidence of an arrangement exists, delivery has occurred, the fee is fixed and
determinable, and collectibility is reasonably assured. Per-procedure fees are recorded when the
service has been rendered.
Costs of revenues consist of fixed and variable costs incurred in the manufacture of our
products in addition to depreciation of Cryocare Surgical Systems placed in the field with
customers under our placement program or with our sales and service personnel. We incur an
additional cost of revenues in the form of a fee for equipment usage and other services when a
procedure is performed on a system owned by an unrelated service provider. The fee paid to the
third-party service provider is charged to costs of revenues when the procedure is performed and
billed.
Research and development expenses include expenses associated with the design and development
of new products as well as enhancements to existing products. We expense research and development
costs when incurred. Our research and development efforts are occasionally subject to significant
non-recurring expenses and fees that can cause some variability in our quarterly research and
development expenses.
Selling and marketing expenses primarily consist of salaries, commissions and related benefits
and overhead costs for employees and activities in the areas of selling, marketing and customer
service. Expenses associated with advertising, trade shows, promotional and physician training
costs related to marketing our products are also classified as selling and marketing expenses.
General and administrative expenses primarily consist of salaries and related benefits and
overhead costs for employees and activities in the areas of legal affairs, finance, information
technology, human resources and administration. Fees for attorneys, independent auditors and
certain other outside consultants are also included where their services are related to general and
administrative activities. This category also includes reserves for bad debt and litigation losses
less amounts recoverable under our insurance policies. Litigation reserves and insurance recoveries
are recorded when such amounts are probable and can be reasonably estimated.
Effective January 1, 2006, we adopted Statement of Financial Accounting Standards No. 123
(revised 2004), Share Based Payment (SFAS No. 123R) using the modified-prospective transition
method. Under that transition method, compensation cost recognized in the six months ended June 30,
2007 and 2006 included (a) compensation cost for all share-based payments granted prior to, but not
yet vested as of January 1, 2006 based on the grant date fair value estimated in accordance with
the original provisions of SFAS 123 and (b) compensation cost for all share-based payments granted
subsequent to January 1, 2006, based on the grant date fair value estimate in accordance with the
provisions of SFAS 123R. As of June 30, 2007, there was $2.6 million of total unrecognized
compensation costs related to stock options and $2.8 million related to restricted stock units. The
stock-option compensation cost is expected to be amortized on a straight-line basis over a weighted
average period of 1.08 years less any stock options forfeited prior to vesting. Compensation costs
related to restricted stock units will be recorded over the remaining service period (2007 through
2009) if it is probable the performance conditions (Profitability Goals) will be satisfied. No
expense related to these performance based awards has been recorded as of June 30, 2007.
Three Months Ended June 30, 2007 Compared to Three Months Ended June 30, 2006
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
|
(dollars in thousands) |
|
2007 |
|
|
2006 |
|
|
$ Change |
|
|
% Change |
|
Cryoablation disposable products |
|
$ |
5,417 |
|
|
$ |
3,397 |
|
|
$ |
2,020 |
|
|
|
59.5 |
% |
Cryocare Surgical Systems |
|
|
521 |
|
|
|
225 |
|
|
|
296 |
|
|
|
131.6 |
% |
Other |
|
|
115 |
|
|
|
12 |
|
|
|
103 |
|
|
|
858.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,053 |
|
|
|
3,634 |
|
|
|
2,419 |
|
|
|
66.6 |
% |
Cryoablation procedure fees |
|
|
1,746 |
|
|
|
3,135 |
|
|
|
(1,389 |
) |
|
|
(44.3 |
)% |
Cardiac royalties (CryoCath) |
|
|
102 |
|
|
|
139 |
|
|
|
(37 |
) |
|
|
(26.6 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
7,901 |
|
|
$ |
6,908 |
|
|
$ |
993 |
|
|
|
14.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18
Although our total number of estimated procedures increased approximately 26 percent to 2,435
from 1,938 for the three months ended June 30, 2007 compared to June 30, 2006, our increase in
revenue is not reflective of this increase because of our change in revenue mix. Generally, we earn
less revenue per estimated case for sales of cryoablation disposable products than for procedure
fees; however the related gross margin as a percent of revenues for sales of cryoablation
disposable products is greater. Of the total estimated procedures performed during the three
months ended June 30, 2007, 15 percent were those for which we provided cryoablation services and
85 percent were from the sale of cryoablation disposable products. This compares to 33 percent for
cryoablation services and 67 percent for sales of cryoablation disposable products during the three
months ended June 30, 2006.
Also contributing to growth in sales of cryoablation products was an increase in sales to a
market served by interventional radiologists, treating tumors in the kidney, lung and liver and
palliative intervention. Direct sales of disposable products and interventional radiology
procedures generally have a lower average selling price than procedures performed by urologists on
prostate and renal treatments although costs of revenues are also lower.
Cardiac royalty revenues decreased for the three months ended June 30, 2007 over the same
period in 2006. The contractual rate of royalties CryoCath is obligated to pay us as a percentage
of related revenues decreased from 5.0 percent in 2006 to 3.0 percent in 2007.
Revenues from sales of Cryocare Surgical Systems increased primarily due to increased
international sales of our systems.
Cost of Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
June 30, |
|
|
(dollars in thousands) |
|
2007 |
|
2006 |
|
$ Change |
Three months ended |
|
$ |
2,713 |
|
|
$ |
3,256 |
|
|
$ |
(543 |
) |
Percent of revenues |
|
|
34.3 |
% |
|
|
47.1 |
% |
|
|
|
|
The decrease in cost of revenues resulted primarily from the change in the mix of our revenues
from those where we are responsible for providing cryoablation procedure services to solely selling
cryoablation disposable products. This mix shift led to a decrease in the number of cases for which
we paid fees to third party service providers. In addition, costs of revenues declined due to
decreases in materials, labor and overhead costs. During the three months ended June 30, 2007 and
2006, substantially all of our cryoablation procedures for which we were responsible for the
service element were performed by third party service providers at an additional cost to us.
Gross Profit and Gross Margin
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2007 |
|
|
2006 |
|
|
$ Change |
|
Cryoablation disposable products and procedure fees |
|
$ |
4,810 |
|
|
$ |
3,504 |
|
|
$ |
1,306 |
|
Cryocare surgical systems |
|
|
161 |
|
|
|
(3 |
) |
|
|
164 |
|
Cardiac royalties (CryoCath) and other |
|
|
217 |
|
|
|
151 |
|
|
|
66 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
5,188 |
|
|
$ |
3,652 |
|
|
$ |
1,536 |
|
|
|
|
|
|
|
|
|
|
|
19
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Percentage |
|
|
|
June 30, |
|
|
Point |
|
(percent of revenues) |
|
2007 |
|
|
2006 |
|
|
Change |
|
Cryoablation disposable products and procedure fees |
|
|
60.9 |
% |
|
|
50.7 |
% |
|
|
10.2 |
% |
Cryocare Surgical Systems |
|
|
2.0 |
% |
|
|
|
|
|
|
2.0 |
% |
Cardiac royalties (CryoCath) |
|
|
2.8 |
% |
|
|
2.2 |
% |
|
|
0.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
65.7 |
% |
|
|
52.9 |
% |
|
|
12.8 |
% |
|
|
|
|
|
|
|
|
|
|
The positive trend in gross margins (gross profit as a percentage of revenues) was primarily related to our shift from procedures where
we bear responsibility for the service element of the procedure to those where we solely sell our
cryoablation disposable products. Sales of cryoablation disposable products yield a higher gross
margin than procedures performed by third party subcontractors. We also
have continued to reduce manufacturing costs for our cryoablation disposable products, while
increasing efficiencies in production.
Research and Development Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
Research and development expenses |
|
$ |
621 |
|
|
$ |
475 |
|
|
$ |
146 |
|
|
|
30.7 |
% |
Percent of total revenues |
|
|
7.9 |
% |
|
|
6.9 |
% |
|
|
|
|
|
|
|
|
This increase is primarily attributable to expenses related to clinical studies, which are
generally recognized in conjunction with milestones inherent in the studies and enrollment of
patients, and as such are not always predictable in amount and timing. In 2007, we are focusing
our research dollars on those areas in which cryoablation research is required to substantiate
reimbursement codes and coverage. The 2007 increase in clinical studies expense was partially
offset by a reduction in consulting, engineering supplies and stock-based compensation.
Selling and Marketing Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
Selling and marketing expenses |
|
$ |
4,099 |
|
|
$ |
3,904 |
|
|
$ |
195 |
|
|
|
5.0 |
% |
Percent of total revenues |
|
|
51.9 |
% |
|
|
56.5 |
% |
|
|
|
|
|
|
|
|
Our efforts to reduce costs have been effective resulting in reductions in travel and
entertainment costs, consulting costs and advertising, trade shows and related expenses totaling
$0.2 million for the three months ended June 30, 2007. However, due mainly to the increased
revenues in the current quarter over the same period last year, our cash compensation related costs
increased $0.5 million. Included in selling and marketing expenses for the three months ended June
30, 2007 and 2006 were $0.1 million and $0.2 million in non-cash stock-based compensation expense,
respectively.
General and Administrative Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
General and administrative expenses |
|
$ |
2,845 |
|
|
$ |
2,072 |
|
|
$ |
773 |
|
|
|
37.3 |
% |
Percent of total revenues |
|
|
36.0 |
% |
|
|
30.0 |
% |
|
|
|
|
|
|
|
|
20
The 2007 and 2006 periods included a $0.1 million and $0.9 million reduction in accrued
payroll taxes pertaining to employee loans forgiven and stock option exercises that occurred in
2002 and prior, which was no longer statutorily due. Also included in general and administrative
expenses for each of the quarters ended June 30, 2007 and June 30, 2006 was $0.7 million of
non-cash stock-based compensation expense.
Interest Expense Related to Common Stock Warrants.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
Interest expense
related to common stock
warrants |
|
$ |
|
|
|
$ |
(1,908 |
) |
|
$ |
(1,908 |
) |
|
|
(100.0 |
%) |
Percent of total revenues |
|
|
|
|
|
|
(27.6 |
)% |
|
|
|
|
|
|
|
|
Interest expense related to common stock warrants resulted from the decrease in the fair value
of common stock warrants in connection with our March 2005 private placement. As a result of a
provision for liquidated damages under a related registration rights agreement, these warrants were
accounted for as derivatives through December 31, 2006 and were carried at fair value with changes
in fair value recorded through interest expense. Effective January 1, 2007, we adopted FASB Staff
Position (FSP) No. 00-19-02, Accounting for Registration Payment Arrangements, which no longer
requires the warrants to be recorded as derivatives and no interest expense was recorded for these
warrants during the three months ended June 30, 2007. See Note 5 Private Placement of Common
Stock and Warrants for further discussion.
Interest Income, Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
Interest income, net |
|
$ |
113 |
|
|
$ |
183 |
|
|
$ |
(70 |
) |
|
|
(38.3 |
)% |
Percent of total revenues |
|
|
1.4 |
% |
|
|
2.6 |
% |
|
|
|
|
|
|
|
|
Interest income, net in the 2007 and 2006 periods includes interest income on a note
receivable for the 2003 sale of our urinary incontinence product line and interest income earned
from the investment of our cash balances.
Net Loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
Net loss |
|
$ |
(2,264 |
) |
|
$ |
(708 |
) |
|
$ |
1,556 |
|
|
|
219.8 |
% |
Percent of total revenues |
|
|
(28.7 |
)% |
|
|
(10.2 |
)% |
|
|
|
|
|
|
|
|
Net loss for the three months ended June 30, 2007 was $0.07 per basic and diluted share on
32.7 million weighted average shares outstanding, compared to a net loss of $0.02 per basic and
diluted share on 30.2 million weighted average shares outstanding during the same period in 2006.
21
Six Months Ended June 30, 2007 Compared to Six Months Ended June 30, 2006
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
|
(dollars in thousands) |
|
2007 |
|
|
2006 |
|
|
$ Change |
|
|
% Change |
|
Cryoablation disposable products |
|
$ |
10,620 |
|
|
$ |
5,808 |
|
|
$ |
4,812 |
|
|
|
82.9 |
% |
Cryocare Surgical Systems |
|
|
998 |
|
|
|
445 |
|
|
|
553 |
|
|
|
124.3 |
% |
Other |
|
|
149 |
|
|
|
22 |
|
|
|
127 |
|
|
|
577.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,767 |
|
|
|
6,275 |
|
|
|
5,492 |
|
|
|
87.5 |
% |
Cryoablation procedure fees |
|
|
3,488 |
|
|
|
7,598 |
|
|
|
(4,110 |
) |
|
|
(54.1 |
)% |
Cardiac royalties (CryoCath) |
|
|
192 |
|
|
|
297 |
|
|
|
(105 |
) |
|
|
(35.4 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
15,447 |
|
|
$ |
14,170 |
|
|
$ |
1,277 |
|
|
|
9.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Although our total number of estimated procedures increased approximately 28 percent to 4,750
from 3,699 for the six months ended June 30, 2007 compared to June 30, 2006, our increase in
revenue is not reflective of this increase because of our change in revenue mix. Generally, we earn
less revenue per estimated case for sales of cryoablation disposable products than for procedure
fees; however the related gross margin as a percent of revenues for sales of cryoablation
disposable products is greater. Of the total estimated procedures performed during the six months
ended June 30, 2007, 15 percent were those for which we provided cryoablation services and 85
percent were from the sale of cryoablation disposable products. This compares to 41 percent for
cryoablation services and 59 percent for sales of cryoablation disposable products during the six
months ended June 30, 2006.
Also contributing to growth in sales of cryoablation products was an increase in sales to a
market served by interventional radiologists, treating tumors in the kidney, lung and liver and
palliative intervention. Direct sales of disposable products and interventional radiology
procedures generally have a lower average selling price than procedures performed by urologists on
prostate and renal treatments although costs of revenues are also lower.
Cardiac royalty revenues decreased for the six months ended June 30, 2007 over the same period
in 2006. The contractual rate of royalties CryoCath is obligated to pay us as a percentage of
related revenues decreased from 5.0 percent in 2006 to 3.0 percent in 2007.
Revenues from sales of Cryocare Surgical Systems increased primarily due to increased
international sales of our systems.
Cost of Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
June 30, |
|
|
(dollars in thousands) |
|
2007 |
|
2006 |
|
$ Change |
Six months ended |
|
$ |
5,335 |
|
|
$ |
7,021 |
|
|
$ |
(1,686 |
) |
Percent of revenues |
|
|
34.5 |
% |
|
|
49.5 |
% |
|
|
|
|
The decrease in cost of revenues resulted primarily from the change in the mix of our revenues
from those where we are responsible for providing cryoablation procedure services to solely selling
cryoablation disposable products. This mix shift led to a decrease in the number of cases for which
we paid fees to third party service providers. In addition, costs of revenues declined due to
decreases in materials, labor and overhead costs. During the six months ended June 30, 2007 and
2006, substantially all of our cryoablation procedures for which we were responsible for the
service element were performed by third party service providers at an additional cost to us.
Gross Profit and Gross Margin
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2007 |
|
|
2006 |
|
|
$ Change |
|
Cryoablation disposable products and procedure fees |
|
$ |
9,362 |
|
|
$ |
6,982 |
|
|
$ |
2,380 |
|
Cryocare surgical systems |
|
|
409 |
|
|
|
(152 |
) |
|
|
561 |
|
Cardiac royalties (CryoCath) and other |
|
|
341 |
|
|
|
319 |
|
|
|
22 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
10,112 |
|
|
$ |
7,149 |
|
|
$ |
2,963 |
|
|
|
|
|
|
|
|
|
|
|
22
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
Percentage |
|
|
|
June 30, |
|
|
Point |
|
(percent of revenues) |
|
2007 |
|
|
2006 |
|
|
Change |
|
Cryoablation disposable products and procedure fees |
|
|
60.6 |
% |
|
|
49.3 |
% |
|
|
11.3 |
% |
Cryocare surgical systems |
|
|
2.7 |
% |
|
|
(1.1 |
%) |
|
|
3.8 |
% |
Cardiac royalties (CryoCath) and other |
|
|
2.2 |
% |
|
|
2.3 |
% |
|
|
(0.1 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
65.5 |
% |
|
|
50.5 |
% |
|
|
15.0 |
% |
|
|
|
|
|
|
|
|
|
|
The positive trend in gross margins (gross profit as a percentage of revenues) was primarily related to our shift from procedures where
we bear responsibility for the service element of the procedure to those where we solely sell our
cryoablation disposable products. Sales of cryoablation disposable products yield a higher gross
margin than procedures performed by third party subcontractors. We also
have continued to reduce manufacturing costs for our cryoablation disposable products, while
increasing efficiencies in production.
Research and Development Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
Research and development expenses |
|
$ |
1,236 |
|
|
$ |
1,486 |
|
|
$ |
(250 |
) |
|
|
(16.8 |
)% |
Percent of total revenues |
|
|
8.0 |
% |
|
|
10.5 |
% |
|
|
|
|
|
|
|
|
This decrease is primarily attributable to a $0.2 million reduction in educational grants and
clinical studies expenses. In 2007, we are focusing our research dollars on those areas in which
cryoablation research is required to substantiate reimbursement codes and coverage. In addition,
these expenses are generally recognized in conjunction with milestones inherent in the studies and
as such are not always predictable in amount and timing. Also contributing to the decrease is a
reduction in consulting, engineering supplies and stock-based compensation.
Selling and Marketing Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
Selling and marketing expenses |
|
$ |
7,862 |
|
|
$ |
7,673 |
|
|
$ |
189 |
|
|
|
2.5 |
% |
Percent of total revenues |
|
|
50.9 |
% |
|
|
54.1 |
% |
|
|
|
|
|
|
|
|
Our efforts to reduce costs have been effective resulting in reductions in travel and
entertainment costs, consulting costs and advertising, trade shows and related expenses totaling
$0.5 million for the six months ended June 30, 2007. However, due mainly to the increased revenues
in the current six month period over the same period last year, our cash compensation related costs
increased $0.9 million. Included in selling and marketing expenses for the six months ended June
30, 2007 and 2006 were $0.2 million and $0.4 million in non-cash stock-based compensation expense,
respectively.
General and Administrative Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
General and administrative expenses |
|
$ |
6,674 |
|
|
$ |
6,067 |
|
|
$ |
607 |
|
|
|
10.0 |
% |
Percent of total revenues |
|
|
43.2 |
% |
|
|
42.8 |
% |
|
|
|
|
|
|
|
|
23
This increase is primarily due to increased legal fees generated by the law firms representing
the former officers and former directors in connection with the ongoing SEC and DOJ matters, as
well as legal action taken against KPMG as described in Note 10 Commitments and Contingencies.
The legal fees, net of insurance reimbursement, incurred during the six months ended June 30, 2007
were $0.4 million greater than those incurred during the six months ended June 30, 2006. In
addition, legal fees related to legal action against KPMG were $0.3 million during 2007. Included
in general and administrative expenses during the 2007 and 2006 period was a $0.1 million and $0.9
million reduction in accrued payroll taxes pertaining to employee loans forgiven and stock option
exercises that occurred in 2002 and prior, which was no longer statutorily due. As a result of our
concerted effort to reduce costs, our audit, accounting and consulting fees decreased by over $0.6
million for the six months ended June 30, 2007 as compared to the same period in 2006. Also
offsetting the increased legal and payroll tax expense is the recovery of previously unbilled sales and
use taxes from liable customers of $0.2 million. Also included in general and administrative
expenses for each of the six months ended June 30, 2007 and June 30, 2006 was $1.3 million of
non-cash stock-based compensation expense.
Interest Expense Related to Common Stock Warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
Interest expense related to common stock warrants |
|
$ |
|
|
|
$ |
(1,696 |
) |
|
$ |
(1,696 |
) |
|
|
(100.0 |
%) |
Percent of total revenues |
|
|
|
|
|
|
(12.0 |
%) |
|
|
|
|
|
|
|
|
Interest expense related to common stock warrants resulted from the decrease in the fair value
of common stock warrants related to our March 2005 private placement. As a result of a provision
for liquidated damages under a related registration rights agreement, these warrants were accounted
for as derivatives through December 31, 2006 and were carried at fair value with changes in fair
value recorded through interest expense. Effective January 1, 2007, we adopted FASB Staff Position
(FSP) No. 00-19-02, Accounting for Registration Payment Arrangements, which no longer requires the
warrants to be recorded as derivatives and no interest expense was recorded for these warrants
during the six months ended June 30, 2007. See Note 5 Private Placement of Common Stock and
Warrants for further discussion.
Interest Income, Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
Interest income, net |
|
$ |
139 |
|
|
$ |
349 |
|
|
$ |
(210 |
) |
|
|
(60.2 |
)% |
Percent of total revenues |
|
|
0.9 |
% |
|
|
2.5 |
% |
|
|
|
|
|
|
|
|
Interest income, net in the 2007 and 2006 periods includes interest income on a note
receivable for the 2003 sale of our urinary incontinence product line and interest income earned
from the investment of our cash balances.
Net Loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, |
|
|
|
|
(dollars in thousands) |
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
Net loss |
|
$ |
(5,521 |
) |
|
$ |
(5,636 |
) |
|
$ |
(115 |
) |
|
|
(2.0 |
)% |
Percent of total revenues |
|
|
(35.7 |
)% |
|
|
(39.8 |
)% |
|
|
|
|
|
|
|
|
Net
loss for the six ended June 30, 2007 was $0.17 per basic and diluted share on 31.9 million
weighted average shares outstanding, compared to a net loss of $0.19 per basic and diluted share on
30.2 million weighted average shares outstanding during the same period in 2006.
24
Liquidity and Capital Resources
Since inception, we have incurred losses from operations and have reported negative cash
flows. As of June 30, 2007, we had an accumulated deficit of $186.3 million and cash and cash
equivalents of $7.2 million.
We do not expect to reach cash flow positive operations in 2007, and we expect to continue to
generate losses from operations for the foreseeable future. These losses have resulted in part from
our continued investment to gain acceptance of our technology and investments in initiatives that
we believe should ultimately result in cost reductions. Although in July 2006 we resolved the
investigations by the SEC and DOJ of our historical accounting and financial reporting (see Note 10
Commitments and Contingencies), we still have obligations to indemnify and advance the legal
fees of our former officers and former directors in connection with the ongoing investigations and
legal proceedings related to those individuals. The amount of those legal fees may exceed the
reimbursement due to us from our directors and officers liability insurance, and the excess may
have a material adverse effect on our business, financial condition, results of operations and
liquidity. For the six months ended June 30, 2007, we incurred expenses of $1.0 million relating to
legal fees of former officers and former directors, and recorded insurance recoveries of $0.7
million. As of June 30, 2007, there remained an aggregate of $0.3 million available under this
insurance coverage. For a description of this insurance coverage, please refer to the Form 8-K
that we filed on February 25, 2005 and Note 10 Commitments and Contingencies.
We also face large cash expenditures in the future related to past due state and local taxes,
primarily sales and use tax obligations, which we estimate to be approximately $2.5 million and
which was accrued as of June 30, 2007. We are in the process of negotiating resolutions of the past
due state and local tax obligations with the applicable tax authorities.
As discussed in Note 5 Private Placement of Common Stock and Warrants, on October 25, 2006,
we entered into an agreement with Fusion Capital which gives us the right to sell to Fusion Capital
up to $16.0 million of common stock over a two year period at prices determined based upon the
market price of our common stock at the time of each sale without any fixed discount (in $100,000
increments every fourth business day, with additional $150,000 increments available every third
business day if the market price per share of our common stock is $1.50 or higher), subject to our
ability to comply with certain ongoing requirements. These requirements include, among others,
maintaining effectiveness of the registration statement covering the sale of the shares purchased
by Fusion Capital, and maintenance of per share trading prices at or above $1.00. The $150,000
increment can be increased if the market price of our common stock increases. The SEC declared the
registration statement effective on December 1, 2006.
Through June 30, 2007 we have sold 880,191 shares of stock to Fusion Capital for total gross
proceeds of $1.6 million. Since we have authorized 8,000,000 shares for sale under the stock
purchase agreement, the selling price of our common stock to Fusion Capital would have had to
average at least $2.00 per share for us to receive the maximum proceeds of $16.0 million.
On May 24, 2007 we sold 3,255,814 shares of our common stock to Frazier Healthcare V, L.P. at
a price per share of $2.15, for aggregate proceeds of $7.0 million.
We will use existing cash reserves, as well as future proceeds from sales, if any, of common
stock to Fusion Capital, to finance our projected operating and cash flow needs, along with
continued expense management efforts. In addition, we may borrow funds under our line of credit
with our bank as long as we remain in compliance with the representations, warranties, covenants
and borrowing conditions set forth in the agreements governing the line of credit. The funds we can
borrow are based on eligible trade receivables and inventory as defined. The credit facility
includes a subjective acceleration clause and a requirement to maintain a lock box with the lender,
the proceeds from which will be applied to reduce the outstanding borrowings upon our default or if
other conditions are met. We were not in compliance with the minimum tangible net worth covenant
under our bank line of credit for the months of September to November 2006. On December 22, 2006,
we signed an amendment to the Loan and Security
Agreement. Among other things, the amendment (i) modifies the borrowing base to increase the
eligible accounts receivable from 80 percent to 85 percent and modifies the definition of accounts
that are ineligible under the borrowing base calculation; (ii) modifies the loan margin as defined
to 1.50 percent, and (iii) waives non-
25
compliance with the minimum tangible net worth requirement as
of September 30, 2006, October 31, 2006 and November 30, 2006, as well as modifies the terms of the
covenant. As of December 31, 2006 and June 30, 2007, we were in compliance with all covenants. On
February 23, 2007, the credit agreement was amended to further modify the minimum tangible net
worth provision and to extend the maturity date to February 27, 2008. As of June 30, 2007 we had
$1.1 million outstanding on the line of credit. During February through May 2007, outstanding
advances exceeded 50 percent of the accounts receivable borrowing base referred to above. As
required by the agreement, our lock-box proceeds were applied daily to reduce the outstanding
advances and we re-borrow the amount subject to the lenders approval through June 30, 2007. As of
July 13, 2007, we were no longer required to repay and re-borrow funds on a daily basis.
Our cash needs are not entirely predictable and the future availability of funds from Fusion
Capital and our bank is subject to many conditions, including certain subjective acceleration
clauses and other provisions, some of which are predicated on events that are not within our
control. Accordingly, we cannot guarantee the availability of these capital resources or that they
will be sufficient to fund our ongoing operations to the point where our operations will generate
positive cash flows.
However, we believe that the Fusion Capital financing and bank line of credit, together with
the $7.0 million that we received from Frazier Healthcare V, L.P., should provide us with the
capital resources that we need to reach the point where our operations will generate positive cash
flows.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
The primary objective of our investment activities is to preserve principal while at the same
time maximizing the income we receive from our invested cash without significantly increasing risk
of loss. Our financial instruments include cash, cash equivalents, accounts and notes receivable,
minority investments, accounts payable, accrued liabilities and bank debt. As of June 30, 2007, the
carrying values of our financial instruments approximated their fair values. Our policy is not to
enter into derivative financial instruments. In addition, we do not enter into any futures or
forward contracts and therefore we do not have significant market risk exposure with respect to
commodity prices.
Although we transact our business in U.S. dollars, future fluctuations in the value of the
U.S. dollar may affect the price competitiveness of our products. However, we do not believe that
we currently have any significant direct foreign currency exchange rate risk and have not hedged
exposures denominated in foreign currencies or any other derivative financial instruments.
Item 4. Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures. We maintain disclosure controls and
procedures that are designed to ensure that information required to be disclosed in our reports
pursuant to the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and
reported within the time periods specified in the SECs rules and forms and that such information
is accumulated and communicated to our management, including our chief executive officer and chief
financial officer, as appropriate, to allow for timely decisions regarding required disclosure. In
designing and evaluating the disclosure controls and procedures, management recognizes that any
controls and procedures, no matter how well designed and operated, can provide only reasonable
assurance of achieving the desired control objectives, and management is required to apply its
judgment in evaluating the cost-benefit relationship of possible controls and procedures.
As required by Rule 13a-15(b) of the Securities Exchange Act of 1934, as amended, we carried
out an evaluation, under the supervision and with the participation of our management, including
our chief executive officer and chief financial officer, of the effectiveness of the design and
operation of our disclosure controls and procedures as of the end of the quarter covered by this
report. Based on the foregoing, our chief executive officer and chief financial officer concluded
that our disclosure controls and procedures were effective at the reasonable assurance level.
(b) Changes in Internal Controls. There was no change in our internal control over financial
reporting during our second fiscal quarter for 2007 that has materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
26
PART II OTHER INFORMATION
Item 1. Legal Proceedings
Please refer to the legal proceedings described in Part I, Item 3, Legal Proceedings in the
Form 10-K that we filed on March 16, 2007 and in Part II, Item 1, Legal Proceedings in the Form
10-Q that we filed on May 9, 2007. There have been no new reportable legal proceedings or material
developments since the prior quarter.
Item 1A. Risk Factors
Please see our 2006 Annual Report on Form 10-K filed with the SEC on March 16, 2007, which
includes a detailed discussion of our risk factors. There have been no material changes in our risk
factors from those disclosed in the Form 10-K, except for updating the following risk factor:
In order to qualify our stock for relisting, our Board has approved a one-for-three
reverse stock split to be become effective on August 20, 2007; this reverse stock split could
adversely affect our stockholders.
In order to qualify our stock for relisting, we may effectuate a reverse stock split. AMEX
requires a minimum bid price of $2.00, The NASDAQ Capital Market requires a minimum bid price of
$4.00 and The NASDAQ Global Market requires a minimum bid price of $5.00. As of July 31, 2007, the
closing price for our common stock as reported on the OTC Bulletin Board was $2.48 per share. Our
stockholders have authorized us to effectuate a reverse stock split at any time until May 10, 2009.
The authorization allows for an exchange ratio ranging from one-to-two to one-to-five, including
any fraction within that range. On August 6, 2007, our Board of Directors approved a one-for-three
reverse stock split to become effective after the close of the market on August 20, 2007 in order
to enable us to satisfy the $4.00 minimum bid price requirement of The NASDAQ Capital Market. In
many instances historically the markets have reacted negatively to the effectuation of a reverse
stock split. The trading price of our stock may be negatively affected by the reverse stock split.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None, except as previously reported.
Item 3. Defaults Upon Senior Securities
Not applicable.
Item 4. Submission of Matters to a Vote of Security Holders
We held our Annual Meeting of Stockholders on Thursday, May 10, 2007. Our stockholders
approved the following matters at the Annual Meeting by the votes indicated:
1. The stockholders elected the following six directors to our Board of Directors to serve
until the 2008 Annual Meeting of Stockholders or until their respective successors are duly elected
and qualified:
|
|
|
|
|
|
|
|
|
|
|
Number of Shares |
|
|
|
For |
|
|
Abstain |
|
|
|
|
John R. Daniels, M.D. |
|
|
22,758,048 |
|
|
|
165,667 |
|
Craig T. Davenport |
|
|
22,651,648 |
|
|
|
272,067 |
|
David L. Goldsmith |
|
|
22,707,348 |
|
|
|
216,367 |
|
Eric S. Kentor |
|
|
22,758,048 |
|
|
|
165,667 |
|
Terrence A. Noonan |
|
|
22,707,848 |
|
|
|
215,867 |
|
Thomas R. Testman |
|
|
22,757,348 |
|
|
|
166,367 |
|
2. The stockholders voted to authorize our Board of Directors, in its discretion, to amend our
Restated Certificate of Incorporation to effectuate a reverse stock split of our common stock, at
an exchange ratio ranging from one-to-two to one-to-five, including any fraction within that range,
at any time before May 10, 2009:
|
|
|
|
|
|
|
Number of Shares |
For |
|
|
21,747,512 |
|
Against |
|
|
748,600 |
|
Abstain |
|
|
427,603 |
|
3. The stockholders ratified the selection of Ernst & Young LLP as our independent auditor for
the fiscal year ending December 31, 2007:
|
|
|
|
|
|
|
Number of Shares |
For |
|
|
22,751,715 |
|
Against |
|
|
140,925 |
|
Abstain |
|
|
31,075 |
|
27
Item 5. Other Information
None.
Item 6. Exhibits
A list of exhibits to this Form 10-Q is found in the Exhibit Index immediately following the
Signature Page of this Form 10-Q, which is hereby incorporated by reference herein.
28
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this Form 10-Q to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
|
|
|
|
ENDOCARE, INC.
|
|
|
By: |
/s/ CRAIG T. DAVENPORT
|
|
|
|
Craig T. Davenport |
|
|
|
Chief Executive Officer, President and
Chairman of the Board
(Duly Authorized Officer) |
|
|
|
|
|
|
|
|
|
|
|
By: |
/s/ MICHAEL R. RODRIGUEZ
|
|
|
|
Michael R. Rodriguez |
|
|
|
Senior Vice President, Finance and
Chief Financial Officer
(Principal Financial and
Accounting Officer) |
|
|
Date: August 6, 2007
29
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
No. |
|
Description |
|
|
|
2.1(1)
|
|
Stock Purchase Agreement, dated as of January 13, 2006, by and among the Company, Plethora
Solutions Holdings plc and Timm Medical Technologies, Inc. The schedules and other
attachments to this exhibit were omitted. The Company agrees to furnish a copy of any
omitted schedules or attachments to the Securities and Exchange Commission upon request. |
|
|
|
2.2(2)
|
|
$1,425,000 Secured Convertible Promissory Note, dated as of February 10, 2006, from
Plethora Solutions Holdings plc to the Company. |
|
|
|
3.1(3)
|
|
Certificate of Amendment of Restated Certificate of Incorporation of the Company. |
|
|
|
3.2(3)
|
|
Certificate of Designation of Series A Junior Participating Preferred Stock of the Company. |
|
|
|
3.3(3)
|
|
Restated Certificate of Incorporation. |
|
|
|
3.4(4)
|
|
Amended and Restated Bylaws of the Company. |
|
|
|
4.1(5)
|
|
Form of Stock Certificate. |
|
|
|
4.2(6)
|
|
Form of Series A Warrant. |
|
|
|
4.3(6)
|
|
Form of Series B Warrant. |
|
|
|
4.4(7)
|
|
Rights Agreement, dated as of March 31, 1999, between the Company and U.S. Stock Transfer
Corporation, which includes the form of Certificate of Designation for the Series A Junior
Participating Preferred Stock as Exhibit A, the form of Rights Certificate as Exhibit B
and the Summary of Rights to Purchase Series A Preferred Shares as Exhibit C. |
|
|
|
4.5(8)
|
|
Amendment No. 1 to Rights Agreement, dated as of September 24, 2005, between the Company
and U.S. Stock Transfer Corporation. |
|
|
|
10.1(9)
|
|
Common Stock Subscription Agreement, dated as of May 24, 2007, by and between Endocare,
Inc. and Frazier Healthcare V, L.P. |
|
|
|
10.2(9)
|
|
Registration Rights Agreement, dated as of May 25, 2007, by and between Endocare, Inc. and
Frazier Healthcare V, L.P. |
|
|
|
31.1
|
|
Certification under Section 302 of the Sarbanes-Oxley Act of 2002 for Craig T. Davenport. |
|
|
|
31.2
|
|
Certification under Section 302 of the Sarbanes-Oxley Act of 2002 for Michael R. Rodriguez. |
|
|
|
32.1
|
|
Certification under Section 906 of the Sarbanes-Oxley Act of 2002 for Craig T. Davenport. |
|
|
|
32.2
|
|
Certification under Section 906 of the Sarbanes-Oxley Act of 2002 for Michael R. Rodriguez. |
|
|
|
(1) |
|
Previously filed as an exhibit to our Form 8-K filed on January 18, 2006. |
|
(2) |
|
Previously filed as an exhibit to our Form 10-K filed on March 16, 2006. |
30
|
|
|
(3) |
|
Previously filed as an exhibit to our Registration Statement on Form S-3 filed on September 20, 2001. |
|
(4) |
|
Previously filed as an exhibit to our Form 10-K filed on March 15, 2004. |
|
(5) |
|
Previously filed as an exhibit to our Form 10-K for the year ended December 31, 1995. |
|
(6) |
|
Previously filed as an exhibit to our Form 8-K filed on March 16, 2005. |
|
(7) |
|
Previously filed as an exhibit to our Form 8-K filed on June 3, 1999. |
|
(8) |
|
Previously filed as an exhibit to our Form 8-K filed on June 28, 2005. |
|
(9) |
|
Previously filed as an exhibit to our Form 8-K filed on May 29, 2007 |
31