e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
Quarterly report pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
For the quarterly period ended March 31, 2008
Commission file number 0-28288
CARDIOGENESIS CORPORATION
(Exact name of small business issuer as specified in its charter)
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California
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77-0223740 |
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(State of incorporation or organization)
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(I.R.S. Employer |
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Identification Number) |
11 Musick
Irvine, California 92618
(Address of principal executive offices)
(949) 420-1800
(Issuers telephone number)
Check whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of
the Securities Exchange Act during the past 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.
Yes þ No o
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer,
a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in
Rule 12b-2 of the Exchange Act. (Check one):
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o Large accelerated filer
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o Accelerated filer
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o Non-accelerated filer
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þ Smaller reporting company |
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(Do not check if a smaller reporting company) |
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
State the number of shares outstanding of each of the issuers classes of common equity as of
the latest practicable date:
45,274,395 shares of Common Stock, no par value, as of April 30, 2008.
CARDIOGENESIS CORPORATION
TABLE OF CONTENTS
2
Item 1. Financial Statements
CARDIOGENESIS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
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March 31, |
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December 31, |
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2008 |
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2007 |
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(unaudited) |
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(audited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
2,917 |
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$ |
2,824 |
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Accounts receivable, net of allowance for doubtful accounts of $28 |
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1,268 |
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1,763 |
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Inventories |
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1,492 |
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1,602 |
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Prepaids and other current assets |
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389 |
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486 |
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Total current assets |
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6,066 |
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6,675 |
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Long-term investments in marketable securities |
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350 |
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Property and equipment, net |
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403 |
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457 |
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Other assets, net |
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27 |
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27 |
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Total assets |
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$ |
6,846 |
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$ |
7,159 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
257 |
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$ |
169 |
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Accrued liabilities |
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1,040 |
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1,458 |
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Deferred revenue |
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1,240 |
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1,210 |
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Current portion of capital lease obligation |
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10 |
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12 |
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Total current liabilities |
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2,547 |
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2,849 |
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Capital lease obligation, less current portion |
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18 |
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19 |
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Total liabilities |
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2,565 |
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2,868 |
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Commitments and Contingencies |
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Shareholders equity: |
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Preferred stock: |
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no par value; 5,000 shares authorized; none issued and outstanding |
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Common stock: |
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no par value; 75,000 shares authorized; 45,274 shares issued and outstanding |
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173,852 |
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173,826 |
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Accumulated deficit |
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(169,571 |
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(169,535 |
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Total shareholders equity |
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4,281 |
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4,291 |
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Total liabilities and shareholders equity |
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$ |
6,846 |
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$ |
7,159 |
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See accompanying notes.
3
CARDIOGENESIS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(in thousands, except per share amounts)
(unaudited)
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Three months ended |
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March 31, |
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2008 |
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2007 |
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Net revenues |
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$ |
2,982 |
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$ |
3,370 |
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Cost of revenues |
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525 |
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643 |
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Gross profit |
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2,457 |
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2,727 |
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Operating expenses: |
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Research and development |
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216 |
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212 |
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Salaries and employee benefits |
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1,524 |
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1,324 |
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Sales, general and administrative |
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754 |
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726 |
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Total operating expenses |
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2,494 |
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2,262 |
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Operating (loss) income |
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(37 |
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465 |
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Other income (expense): |
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Interest expense |
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(20 |
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(31 |
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Interest income |
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21 |
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28 |
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Non-cash interest expense |
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(46 |
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Change in fair value of derivatives |
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(114 |
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Other non-cash income, net |
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25 |
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Total other income (expense), net |
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1 |
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(138 |
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Net (loss) income |
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(36 |
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$ |
327 |
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Net (loss) earnings per share: |
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Basic |
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$ |
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$ |
0.01 |
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Diluted |
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$ |
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$ |
0.01 |
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Weighted average shares outstanding: |
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Basic |
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45,274 |
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45,274 |
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Diluted |
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45,274 |
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45,290 |
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See accompanying notes.
4
CARDIOGENESIS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
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Three months ended |
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March 31, |
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2008 |
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2007 |
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Cash flows from operating activities: |
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Net (loss) income |
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$ |
(36 |
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$ |
327 |
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Adjustments to reconcile net (loss) income to net cash provided by operating activities: |
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Derivative and warrant fair value adjustments |
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89 |
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Amortization of discount on note payable |
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37 |
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Depreciation and amortization |
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81 |
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130 |
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Bad debt expense |
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62 |
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Amortization of debt issuance costs |
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9 |
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Stock-based compensation expense |
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26 |
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24 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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495 |
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679 |
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Inventories |
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105 |
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(53 |
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Prepaids and other current assets |
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97 |
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33 |
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Accounts payable |
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88 |
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(6 |
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Accrued liabilities |
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(418 |
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(10 |
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Deferred revenue |
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30 |
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(7 |
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Net cash provided by operating activities |
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468 |
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1,314 |
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Cash flows from investing activities: |
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Acquisition of property and equipment |
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(22 |
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Purchase of investments in marketable securities |
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(350 |
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Net cash used in investing activities |
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(372 |
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Cash flows from financing activities: |
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Payments on secured convertible term note |
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(312 |
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Payments on capital lease obligation and short term note payable |
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(3 |
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(92 |
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Net cash used in financing activities |
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(3 |
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(404 |
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Net increase in cash and cash equivalents |
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93 |
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910 |
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Cash and cash equivalents at beginning of period |
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2,824 |
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2,118 |
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Cash and cash equivalents at end of period |
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$ |
2,917 |
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$ |
3,028 |
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Supplemental schedule of cash flow information: |
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Interest paid |
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$ |
1 |
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$ |
27 |
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Taxes paid |
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$ |
5 |
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$ |
1 |
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Supplemental schedule of non-cash financing activities: |
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Reclassification of inventories to fixed assets |
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$ |
5 |
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$ |
50 |
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See accompanying notes.
5
CARDIOGENESIS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. Nature of Operations:
Cardiogenesis Corporation (Cardiogenesis or the Company) was founded in 1989 to design,
develop, and distribute surgical lasers and accessories for the treatment of cardiovascular
disease. Currently, Cardiogenesis emphasis is on the development of products used for
transmyocardial revascularization (TMR) and percutaneous myocardial channeling (PMC), which are
cardiovascular procedures. PMC was formerly referred to as percutaneous myocardial
revascularization (PMR). The new name PMC more literally depicts the immediate physiologic
tissue effect of the Cardiogenesis PMC system to ablate precise, partial thickness channels into
the heart muscle from the inside of the left ventricle.
Cardiogenesis markets its products for sale primarily in the U.S., Europe and Asia.
Cardiogenesis operates in a single segment.
2. Summary of Significant Accounting Policies:
Interim Financial Information:
The accompanying unaudited condensed consolidated financial statements have been prepared by
Cardiogenesis Corporation (the Company) in accordance with accounting principles generally
accepted in the United Sates of America for interim financial information, and pursuant to the
instructions to Form 10-Q and Article 8 of Regulation S-X promulgated by the Securities and
Exchange Commission (SEC). Accordingly, they do not include all of the information and footnotes
required by accounting principles generally accepted in the United States of America for complete
financial statement presentation. In the opinion of management, all adjustments (consisting
primarily of normal recurring accruals) considered necessary for a fair presentation have been
included. These financial statements should be read in conjunction with the Companys audited
consolidated financial statements and notes thereto for the year ended December 31, 2007, contained
in the Companys Annual Report on Form 10-KSB, as filed with the SEC.
These unaudited condensed consolidated financial statements contemplate the realization of
assets and the satisfaction of liabilities in the normal course of business. Although
Cardiogenesis achieved operating income for the year ended December 31, 2007, it does not have a
history of operating income. Management believes its cash balance as of March 31, 2008 and
expected results of operations are sufficient to meet the Companys capital and operating
requirements for the next 12 months.
The Company may require additional financing in the future. There can be no assurance that
the Company will be able to obtain additional debt or equity financing if and when needed or on
terms acceptable to the Company. Any additional debt or equity financing may involve substantial
dilution to the Companys stockholders, restrictive covenants or high interest costs. The failure
to raise needed funds on sufficiently favorable terms could have a material adverse effect on the
Companys business, operating results and financial condition. The Companys long term liquidity
also depends upon its ability to increase revenues from the sale of its products and achieve
consistent profitability. The failure to achieve these goals could have a material adverse effect
on the business, operating results and financial condition.
Net Earnings (Loss) Per Share:
Basic earnings (loss) per share (BEPS) is computed by dividing the net income (loss) by the
weighted average number of common shares outstanding for the period. Diluted earnings (loss) per
share (DEPS) is computed giving effect to all dilutive potential common shares that were
outstanding during the period. Dilutive potential common shares consist of incremental shares
issuable upon the exercise of stock options and warrants using the treasury stock method and
convertible notes payable using the if converted method. The computation of DEPS does not assume
conversion, exercise or contingent exercise of securities that would have an anti-dilutive effect
on earnings.
6
At March 31, 2008 and 2007, there were approximately 63,000 and 1,457,000, respectively,
potentially dilutive shares that were excluded from diluted (loss) income per share as their effect
would be anti-dilutive for the periods then ended.
The following table reconciles BEPS and DEPS and the related weighted average number of shares
outstanding for the three months ended March 31, 2007:
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Numerator |
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Denominator |
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Per Share |
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(Income) |
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(Shares) |
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Amount |
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Basic EPS: |
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Net income |
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$ |
327 |
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$ |
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Income available to common shareholders |
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327 |
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45,274 |
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0.01 |
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Effect of dilutive securities: |
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Options and warrants |
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16 |
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Diluted EPS: |
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Income available to common shareholders
plus assumed conversions |
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$ |
327 |
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45,290 |
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$ |
0.01 |
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Use of Estimates:
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States of America requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. Actual results could differ from those estimates.
Significant estimates made in preparing the unaudited condensed consolidated financial statements
include (but are not limited to) the realizability of accounts receivable and inventories,
recoverability of long-lived assets, and the valuation of warranty obligations, embedded
derivatives, deferred tax assets, stock options and warrants.
Reclassifications:
Certain reclassifications have been made to prior period amounts to conform to the current
period presentation.
Investments in Marketable Securities:
In accordance with Statement of Financial Accounting Standards (SFAS) No. 115, Accounting
for Certain Investments in Debt and Equity Securities (SFAS No. 115), the Company determines the
appropriate classification of its investments in marketable debt securities at the time of purchase
and reevaluates such designation at each balance sheet date. The Companys investments in
marketable securities have been classified and accounted for as available-for-sale based on
managements investment intentions relating to these securities. Available-for-sale securities are
stated at market value based on market quotes. Any significant unrealized gains and losses, net of
deferred taxes, will be recorded as a component of other comprehensive income (loss).
The Company generally invests its excess cash in money market funds and in highly liquid debt
instruments of United States (U.S.) municipalities, corporations, the U.S. government and its
agencies and auction rate securities. All highly liquid investments with stated maturities of three
months or less from the date of purchase are classified as cash equivalents; all investments with
stated maturities of greater than three months are classified as investments in marketable
securities.
Due to disruptions of, and the resulting reduced liquidity in certain financial markets, the
Companys AAA rated auction rate securities with a total purchased cost of approximately $350,000
experienced failed auctions during 2008. Due to the failed auctions, the Company was unable to sell
the securities at their respective costs, resulting in an insignificant temporary decrease in fair
value. These investments
7
have been classified as long-term investments in marketable securities in the Companys
consolidated balance sheet as of March 31, 2008. The Company has concluded that the unrealized
losses on these investments are temporary because (i) the Company believes that the decline in
market value that has occurred is due to general market conditions, (ii) the auction rate
securities continue to be of a high credit quality and interest is paid as due and (iii) the
Company has the intent and ability to hold these investments until a recovery in market value
occurs. The fair value of these securities could change significantly in the future and the Company
may be required to record other-than-temporary impairment charges or additional unrealized losses
in future periods.
Derivative financial instruments:
In October 2004, the Company completed a financing transaction with Laurus Master Fund, Ltd.,
a Cayman Islands corporation (Laurus), pursuant to which the Company issued a Secured convertible
term note (the Note). Prior to the repayment of the Note in October 2007, the Companys
derivative financial instruments consisted of embedded derivatives related to the Note. These
embedded derivatives included certain conversion features and variable interest features. The
accounting treatment of derivatives required that the Company record the derivatives at their fair
values as of the inception date of the agreement, and at fair value as of each subsequent balance
sheet date until the Note was paid off. Any change in fair value was recorded as non-operating,
non-cash income or expense at each reporting date. If the fair value of the derivatives was higher
at the subsequent balance sheet date, the Company recorded a non-operating, non-cash charge. If
the fair value of the derivatives was lower at the subsequent balance sheet date, the Company
recorded non-operating, non-cash income. As a result of the repayment of the Note in October 2007,
the Company does not have any derivative financial instruments as of March 31, 2008.
In connection with the Note, the Company recorded the following items of other income
(expense) during the three months ended March 31, 2007:
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$37,000 of interest expense related to the amortization of the debt discount, |
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$9,000 of interest expense related to the amortization of debt issuance costs, |
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$114,000 of other expense related to the change in fair value of certain derivatives, |
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$25,000 of other income related to the change in fair value of certain warrants. |
Revenue Recognition:
Cardiogenesis recognizes revenue on product sales upon shipment of the products when the price
is fixed or determinable and when collection of sales proceeds is reasonably assured. Where
purchase orders allow customers an acceptance period or other contingencies, revenue is recognized
upon the earlier of acceptance or removal of the contingency.
Revenues from sales to distributors and agents are recognized upon shipment when there is
evidence of an arrangement, delivery has occurred, the sales price is fixed or determinable and
collection of the sales proceeds is reasonably assured. The contracts regarding these sales do not
include any rights of return or price protection clauses.
The Company frequently loans lasers to hospitals in accordance with its loaned laser programs.
Under certain loaned laser programs the Company charges the customer an additional amount (the
Premium) over the stated list price on its handpieces in exchange for the use of the laser or
collects an upfront deposit that can be applied towards the purchase of a laser. These
arrangements meet the definition of a lease and are recorded in accordance with SFAS No. 13
Accounting for Leases (SFAS No. 13) as they convey the right to use the lasers over the period of
time the customers are purchasing handpieces. Based on the provisions of SFAS No. 13, the loaned
lasers are classified as operating leases and are transferred from inventory to fixed assets upon
commencement of the loaned laser program. In addition, the Premium is considered contingent rent
under SFAS No. 29 Determining Contingent Rentals (SFAS No. 29) and therefore, such amounts
allocated to the lease of the laser should be excluded from minimum lease payments and should be
recognized as revenue when the contingency is resolved. In these instances, the contingency is
resolved upon the sale of the handpiece.
8
Cardiogenesis enters into contracts to sell its products and services and, while the majority
of its sales agreements contain standard terms and conditions, there are agreements that contain
multiple elements or non-
standard terms and conditions. As a result, significant contract interpretation is sometimes
required to determine the appropriate accounting, including whether the deliverables specified in a
multiple element arrangement should be treated as separate units of accounting for revenue
recognition purposes and, if so, how the contract value should be allocated among the deliverable
elements and when to recognize revenue for each element. The Company recognizes revenue for such
multiple element arrangements in accordance with Emerging Issues Task Force Issue (EITF) No.
00-21, Revenue Arrangements with Multiple Deliverables.
Segment Disclosures:
The Company operates in one segment. The principal markets for the Companys products are in
the United States, but the Company does have sales to customers in Europe, Canada, Mexico, Asia and
Egypt. For the three months ended March 31, 2008, the Companys international sales were $36,000.
For the three months ended March 31, 2007, the Companys international sales were $63,000.
International sales represent 1% of total sales for the three months ended March 31, 2008 and 2%
for the three months ended March 31, 2007. The majority of international sales are denominated in
U.S. Dollars.
Recent Accounting Pronouncements:
In September 2006 the Financial Accounting Standards Board (the FASB) issued SFAS No. 157,
Fair Value Measurements, which defines fair value, establishes a framework for measuring fair value
in accordance with generally accepted accounting principles, and expands disclosures about fair
value measurements. SFAS No. 157 is effective for financial statements issued for fiscal years
beginning after November 15, 2007. In February 2008 the FASB issued FSP 157-2, Effective Date of
FASB Statement No. 157, which delays the effective date of SFAS No. 157 for non-financial assets
and liabilities to fiscal years beginning after November 15, 2008. The adoption of SFAS No. 157
related to financial assets and liabilities did not have a material impact on the Companys
consolidated financial statements. The Company is currently evaluating the impact, if any, that
SFAS No. 157 may have on our future consolidated financial statements related to non-financial
assets and liabilities.
In December 2007 the FASB issued SFAS No. 141R, Business Combinations, which establishes
principles and requirements for how the acquirer of a business recognizes and measures in its
financial statements the identifiable assets acquired, the liabilities assumed, and any
noncontrolling interest in the acquiree. SFAS No. 141R also provides guidance for recognizing and
measuring the goodwill acquired in the business combination and determines what information to
disclose to enable users of the financial statement to evaluate the nature and financial effects of
the business combination. SFAS No. 141R is effective for financial statements issued for fiscal
years beginning after December 15, 2008. Accordingly, any business combinations we engage in will
be recorded and disclosed according to SFAS No. 141, Business Combinations, until January 1, 2009.
The Company is currently evaluating the impact, if any, that SFAS No. 141R may have on our future
consolidated financial statements.
3. Inventories:
Inventories are stated at the lower of cost (first-in, first-out) or market and consist of the
following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Raw materials |
|
$ |
273 |
|
|
$ |
295 |
|
Work-in-process |
|
|
48 |
|
|
|
96 |
|
Finished goods |
|
|
1,171 |
|
|
|
1,211 |
|
|
|
|
|
|
|
|
Total |
|
$ |
1,492 |
|
|
$ |
1,602 |
|
|
|
|
|
|
|
|
4. Stock-Based Compensation:
On January 1, 2006, the Company adopted SFAS No. 123R, Share-Based Payment, (SFAS No. 123R)
which establishes standards for the accounting of transactions in which an entity exchanges its
equity instruments for goods or services, primarily focusing on accounting for transactions where
an entity obtains employee services in share-
9
based payment transactions. SFAS No. 123R requires a public entity to measure the cost of
employee services received in exchange for an award of equity instruments, including stock options,
based on the grant-date fair value of the award and to recognize it as compensation expense over
the period the employee is required to provide service in exchange for the award, usually the
vesting period. SFAS No. 123R supersedes the Companys previous accounting under Accounting
Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (APB 25) for periods
beginning in fiscal 2006. In March 2005, the SEC issued SAB 107 relating to SFAS No. 123R. The
Company has applied the provisions of SAB 107 in its adoption of SFAS No. 123R.
The Company adopted SFAS No. 123R using the modified prospective transition method, which
requires the application of the accounting standard as of January 1, 2006, the first day of the
Companys fiscal year 2006. The Companys consolidated financial statements for the periods ended
March 31, 2008 and 2007 reflect the impact of SFAS No. 123R.
SFAS No. 123R requires companies to estimate the fair value of share-based payment awards on
the date of grant using an option-pricing model. The value of the portion of the award that is
ultimately expected to vest is recognized as expense over the requisite service periods in the
Companys unaudited consolidated statements of operations. Prior to the adoption of SFAS No. 123R,
the Company accounted for stock-based awards to employees and directors using the intrinsic value
method in accordance with APB 25 as allowed under SFAS No. 123, Accounting for Stock-Based
Compensation (SFAS No. 123). Under the intrinsic value method, stock-based compensation expense
was recognized in the Companys condensed consolidated statements of operations for option grants
to employees and directors below the fair market value of the underlying stock at the date of
grant.
Stock-based compensation expense recognized during the period is based on the value of the
portion of share-based payment awards that is ultimately expected to vest during the period.
Stock-based compensation expense recognized in the Companys unaudited consolidated statements of
operations for the three month periods ended March 31, 2008 and 2007 included compensation expense
for share-based payment awards granted prior to, but not yet vested, as of December 31, 2005 based
on the grant date fair value estimated in accordance with the pro forma provisions of SFAS No. 123
and compensation expense for the share-based payment awards granted subsequent to December 31, 2005
based on the grant date fair value estimated in accordance with the provisions of SFAS No. 123R.
As stock-based compensation expense recognized in the condensed consolidated statements of
operations for the three month periods ended March 31, 2008 and 2007 is based on awards ultimately
expected to vest, it has been reduced for estimated forfeitures. SFAS No. 123R requires
forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods
if actual forfeitures differ from those estimates. The estimated average forfeiture rate for the
three month periods ended March 31, 2008 and 2007 of 0% and 20%, respectively was based on
historical forfeiture experience and expected future employee forfeitures.
SFAS No. 123R requires the cash flows resulting from the tax benefits resulting from tax
deductions in excess of the compensation cost recognized for those options to be classified as
financing cash flows. There were no such tax benefits during the three month periods ended March
31, 2008 and 2007. Prior to the adoption of SFAS No. 123R those benefits would have been reported
as operating cash flows had the Company received any tax benefits related to stock option
exercises.
Description of Plans
The Companys stock option plans provide for grants of options to employees and directors of
the Company to purchase the Companys shares at the fair value of such shares on the grant date
(based on the closing price of the Companys common stock). The options vest immediately or up to
four years beginning on the grant date and have a 10-year term. The terms of the option grants are
determined by the Companys Board of Directors. As of March 31, 2008, the Company is authorized to
issue up to 12,125,000 shares under these plans.
The Companys 1996 Employee Stock Purchase Plan (the ESPP) was adopted in April 1996. As of
March 31, 2008, a total of 1,500,000 common shares are authorized and reserved for issuance under
this plan, as amended and 267,743 shares remain available for issuance. This plan permits
employees to purchase common shares at a price equal to the lower of 85% of the fair market value
of the common stock at the beginning of each offering period or the end of each offering period.
The ESPP has two offering periods, the first one from May 16 through November 15 and the second one
from November 16 through May 15. Employee purchases are nonetheless limited to 15% of
eligible cash compensation, and other restrictions regarding the amount of annual purchases
also apply.
10
The Company has treated the ESPP as a compensatory plan and has recorded compensation expense
of approximately $2,000 and zero during the three month periods ended March 31, 2008 and 2007,
respectively, in accordance with SFAS No. 123R.
From November 15, 2006 to November 15, 2007, the Company suspended the ESPP. As of November
16, 2007, the ESPP has been reinstated. During the three month periods ended March 31, 2008 and
2007, there were no purchases of shares under the ESPP.
Summary of Assumptions and Activity
The fair value of stock-based awards to employees and directors is calculated using the
Black-Scholes option pricing model, even though the model was developed to estimate the fair value
of freely tradable, fully transferable options without vesting restrictions, which differ
significantly from the Companys stock options. The Black-Scholes model also requires subjective
assumptions, including future stock price volatility and expected time to exercise, which greatly
affect the calculated values. The expected term of options granted is derived from historical data
on employee exercises and post-vesting employment termination behavior. The risk-free rate
selected to value any particular grant is based on the U.S. Treasury rate that corresponds to the
term of the grant effective as of the date of the grant. The expected volatility is based on the
historical volatility of the Companys stock price. These factors could change in the future,
affecting the determination of stock-based compensation expense in future periods.
The weighted-average fair value of stock-based compensation is based on the single option
valuation approach. Forfeitures, if any, are estimated and it is assumed no dividends will be
declared. The estimated fair value of stock-based compensation awards to employees is amortized
using the straight-line method over the vesting period of the options.
The Companys fair value calculations for stock-based compensation awards to employees under
its stock option plans for the three months ended March 31, 2008 and 2007 were based on the
following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2008 |
|
|
2007 |
|
Expected term |
|
4 years |
|
4 years |
Expected volatility |
|
|
92.57 |
% |
|
|
106 |
% |
Risk-free interest rate |
|
|
2.24 2.69 |
% |
|
|
4.67 |
% |
Expected dividend yield |
|
|
|
|
|
|
|
|
Compensation expense under the ESPP is measured as the fair value of the employees purchase
rights during the look-back option period as calculated under the Black-Scholes option pricing
model. The weighted average assumptions used in the model are outlined in the following table:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2008 |
|
|
2007 |
|
Expected term |
|
0.50 years |
|
0.50 years |
Expected volatility |
|
|
92.57 |
% |
|
|
106 |
% |
Risk-free interest rate |
|
|
2.24 2.69 |
% |
|
|
4.67 |
% |
Expected dividends |
|
|
|
|
|
|
|
|
11
A summary of option activity as of March 31, 2008 and changes during the three months then
ended, is presented below (shares in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
|
|
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Shares |
|
|
Price |
|
|
Term (Years) |
|
|
Value |
|
Options outstanding at January 1, 2008 |
|
|
3,076 |
|
|
$ |
0.81 |
|
|
|
5.8 |
|
|
$ |
|
|
Options granted |
|
|
445 |
|
|
$ |
0.36 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
(1 |
) |
|
$ |
0.23 |
|
|
|
|
|
|
|
|
|
Options forfeited/canceled |
|
|
(264 |
) |
|
$ |
1.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding and expected to vest at March 31, 2008 |
|
|
3,256 |
|
|
$ |
0.72 |
|
|
|
6.1 |
|
|
$ |
5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at March 31, 2008 |
|
|
2,148 |
|
|
$ |
0.92 |
|
|
|
4.4 |
|
|
$ |
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value is calculated as the difference between the exercise price of
the stock options and the quoted price of the Companys common stock for the 238,000 outstanding
and 30,000 exercisable stock options that were in-the-money at March 31, 2008.
The weighted average grant date fair value of options granted during the three months ended
March 31, 2008 was $0.24 per option, respectively.
As of March 31, 2008, there was approximately $242,000 of total unrecognized compensation cost
related to employee and director stock option compensation arrangements. That cost is expected to
be recognized over the weighted average vesting period of 2.5 years.
The following table summarizes stock-based compensation expense related to stock options and
ESPP purchases under SFAS No. 123R for the three months ended March 31, 2008 and 2007 which was
allocated as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2008 |
|
|
2007 |
|
Stock-based compensation expense included in: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1 |
|
|
$ |
3 |
|
Sales, general and administrative |
|
|
25 |
|
|
|
21 |
|
|
|
|
|
|
|
|
|
|
$ |
26 |
|
|
$ |
24 |
|
|
|
|
|
|
|
|
5. Legal Matters:
Cardiogenesis has been notified that on February 19, 2008, Cardiofocus, Inc. (Cardiofocus)
filed a complaint in the United States District Court for the District of Massachusetts (Case No.
1.08-cv-10285) against the Company and a number of other companies. In the complaint, Cardiofocus
alleges that Cardiogenesis and the other defendants have violated patent rights allegedly held by
Cardiofocus. The complaint does not identify specific alleged monetary damages. Cardiogenesis has
asserted counterclaims for non-infringement and invalidity of the patents and intends to vigorously
defend itself. However, any litigation involves risks and uncertainties and the likely outcome of
the case cannot be determined at this time
Except as described above, the Company is not a party to any material legal proceeding.
6. Related Party Transaction:
In February 2008, the Company provided an unrestricted educational grant of $40,000 to the
University of Arizona Sarver Heart Center to support the research of cardiovascular disease and
stroke. Dr. Marvin Slepian, a member of the Companys board of directors, is also a member of the
Sarver Heart Center. While the Company is
not legally bound to provide any additional funding for such research, the Company may elect
to provide an additional $40,000 grant in the future.
12
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
This Managements Discussion and Analysis contains descriptions of our expectations regarding
future trends affecting our business. These forward-looking statements and other forward-looking
statements made elsewhere in this document are made in reliance upon the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. Please read the section below titled Risk
Factors contained in Part I, Item 1 of our Annual Report on Form 10-KSB for the year ended
December 31, 2007 for a discussion of certain risk factors and other conditions which we believe
could cause actual results to differ materially from those contemplated by the forward-looking
statements. Forward-looking statements are identified by words such as believes, anticipates,
expects, intends, plans, will, may and similar expressions. In addition, any statements
that refer to our plans, expectations, strategies or other characterizations of future events or
circumstances are forward-looking statements. Our business may have changed since the date hereof
and we undertake no obligation to update these forward looking statements.
The following discussion should be read in conjunction with the unaudited condensed
consolidated financial statements and notes thereto included in this Quarterly Report on Form 10-Q.
Overview
Cardiogenesis Corporation, incorporated in California in 1989, designs, develops and
distributes laser-based surgical products and disposable fiber-optic accessories for the treatment
of ischemia associated with advanced cardiovascular disease through laser myocardial
revascularization. This therapeutic procedure is performed surgically as transmyocardial
revascularization (TMR). TMR is a laser-based heart treatment in which transmural channels are
made in the heart muscle. Many scientific experts believe these procedures encourage new vessel
formation, or angiogenesis. TMR is performed by a cardiac surgeon through a surgical incision
while the patient is under general anesthesia. Prospective, randomized, multi-center controlled
clinical trials have demonstrated a significant reduction in angina and increase in exercise
duration in patients treated with the Cardiogenesis TMR system (plus medications), when compared
with patients who received medications alone.
In May 1997, we received CE Mark approval for our TMR laser and fiber optic handpiece delivery
systems. We received CE Mark on our minimally invasive TMR platform PEARL (Port Enabled Angina
Relief with Laser) and on our Phoenix Combination Delivery System in November 2005 and October
2006, respectively. The CE Mark allows us to commercially distribute these products within the
European Community. The CE Marking is an international symbol of adherence to quality assurance
standards and compliance with applicable European medical device directives.
In February 1999, we received approval from the Food and Drug Administration (FDA) for the
marketing of our TMR products for treatment of patients suffering from chronic, severe angina.
Effective July 1999, the Centers for Medicare and Medicaid Services (CMS), formerly known as the
Health Care Financial Administration (HCFA) implemented a national coverage decision for Medicare
coverage for any TMR as a primary and secondary procedure. As a result, hospitals and physicians
are eligible to receive Medicare reimbursement for TMR equipment and procedures on indicated
Medicare patients.
In December 2004, we received FDA approval for the Solargen 2100s, the advanced laser console
for TMR. In addition, in November 2007 we received FDA approval for the PEARL 5.0 Robotic
Handpiece Delivery System designed for delivering TMR therapy with surgical robotic systems. We
are in the process of completing the Investigational Device Exemption (IDE) trial for the PEARL
8.0 Thoracoscopic Handpiece Delivery System, and are supporting the initial clinical application of
the Phoenix Combination Delivery System in Europe and other international locations.
13
As of March 31, 2008, we had an accumulated deficit of $169,571,000. We may continue to incur
operating losses in the future. The timing and amounts of our expenditures will depend upon a
number of factors, including
the efforts required to develop our sales and marketing organization, the timing of market
acceptance of our products and the status and timing of regulatory approvals.
Results of Operations
Net Revenues
We generate our revenues primarily through the sale of our TMR laser systems, fiber optic
handpiece delivery systems, and related services. Net revenues of $2,982,000 for the quarter ended
March 31, 2008 decreased $388,000, or 12%, when compared to net revenues of $3,370,000 for the
quarter ended March 31, 2007. We attribute the decrease in sales for the three months ended March
31, 2008 primarily to turnover of our sales force. A substantial portion of our sales force joined
us during 2007 and we believe that the turnover of our sales force, as well as the learning curve
associated with newly hired sales personnel, negatively impacted revenue for the first three months
of 2008 as compared to the corresponding prior year period.
For the quarter ended March 31, 2008, domestic disposable handpiece revenue decreased by
$208,000, or 9%, and domestic laser revenue decreased by $127,000, or 17%, when compared to the
quarter ended March 31, 2007. In the first quarter of 2008, domestic handpiece revenue included
$195,000 in sales of product to customers operating under our loaned laser program. Sales of
handpieces to customers not operating under the loaned laser program were $1,885,000. In the first
quarter of 2007, domestic handpiece revenue included $222,000 in sales of product to customers
operating under the loaned laser program and sales of handpieces to customers not operating under
the loaned laser program were $2,066,000.
International sales, accounting for approximately 1% of net revenues for the quarter ended
March 31, 2008 decreased $27,000 from the prior year period. In addition, service and other
revenue of $246,000 decreased $24,000 for the quarter ended March 31, 2008, when compared to
$270,000 for the quarter ended March 31, 2007.
Gross Profit
For the quarter ended March 31, 2008, gross margin remained relatively flat at 82% of net
revenues as compared to 81% of net revenues for the quarter ended March 31, 2007.
Research and Development
Research and development expense represents expenses incurred in connection with the
development of technologies and products including the costs of third party studies, salaries and
stock based compensation associated with research and development personnel. For the quarter ended
March 31, 2008, research and development expenditures of $216,000 increased $4,000, or 2%, when
compared to $212,000 for the quarter ended March 31, 2007. As a percentage of revenues, research
and development expenditures were 7% during the quarter ended March 31, 2008 as compared to 6% for
the prior year period.
Salaries and Employee Benefits
Salaries and employee benefit expense represents expenses incurred in connection with the
salaries, stock based compensation, commissions, taxes and benefits for employees, excluding
expenses associated with research and development personnel which are included in research and
development expense. For the quarter ended March 31, 2008, salaries and employee benefits
expenditures of $1,524,000 increased $200,000, or 15%, when compared to $1,324,000 for the quarter
ended March 31, 2007. As a percentage of revenues, salaries and employee benefits expenditures
were 51% during the quarter ended March 31, 2008 as compared to 39% for the prior year period. The
dollar and percentage increase in salaries and employee benefits for the three month period results
primarily from the implementation of a compensation program designed to attract and retain
qualified sales personnel. The compensation program provides income support to certain newly hired
sales personnel during their introductory period of employment.
14
Sales, General and Administrative
Sales, general and administrative expenditures represent all other operating expenses not
included in research and development or salaries and employee benefits expenses. For the quarter
ended March 31, 2008, sales, general and administrative expenditures (SG&A) totaled $754,000, or
25% of net revenues, as compared to $726,000, or 22% of net revenues during the quarter ended March
31, 2007. This represents an increase of $28,000, or 4%. The increase as a percentage of net
revenues is a result of a relatively stable level of SG&A expenditures over a smaller sales base.
Other Income (Expense)
The following table reflects the components of other income (expense):
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2008 |
|
|
2007 |
|
Interest expense Secured Convertible Term Note |
|
$ |
|
|
|
$ |
(24 |
) |
Interest expense other |
|
|
(20 |
) |
|
|
(7 |
) |
Interest income |
|
|
21 |
|
|
|
28 |
|
Non-cash interest expense Accretion of
discount on Note |
|
|
|
|
|
|
(37 |
) |
Non-cash interest expense Amortization of
debt issuance costs relating to the Note |
|
|
|
|
|
|
(9 |
) |
Change in fair value of derivative |
|
|
|
|
|
|
(114 |
) |
Other non-cash income (expense)- Change in fair
value of warrants |
|
|
|
|
|
|
25 |
|
|
|
|
|
|
|
|
Total other income (expense), net |
|
$ |
1 |
|
|
$ |
(138 |
) |
|
|
|
|
|
|
|
Total other income for the three months ended March 31, 2008 was $1,000 as compared to other
expense of $138,000 for the three months ended March 31, 2007. The decrease in expense for the
three month period was primarily due to the fact that at March 31, 2007, the Laurus Note was
outstanding and therefore we incurred expenses associated to the related obligations. However,
since the Note was paid in full in October 2007, for the three months ended March 31, 2008, there
was no associated expense in that period.
Liquidity and Capital Resources
At March 31, 2008, we had cash and cash equivalents of $2,917,000 compared to $2,824,000 at
December 31, 2007, an increase of $93,000. During the three months ended March 31, 2008, we had a
net loss of $36,000 and net cash provided by operating activities of $468,000 primarily from a
decrease in accounts receivable due to a decrease in sales, an increase in accounts payable offset
by a decrease in accrued liabilities.
Cash used in investing activities during the three months ended March 31, 2008 was $372,000
due to property and equipment and marketable securities purchases.
Prior to 2007, we had incurred significant operating losses for several years and at March 31,
2008 we had an accumulated deficit of $169,571,000. Our ability to maintain current operations is
dependent upon maintaining our sales at least at the same levels achieved in the prior year.
Currently, our primary goal is to drive growth in our core products and continue to pursue
regulatory approval for our PEARL 8.0 Thoracoscopic Handpiece Delivery System and Phoenix
Combination Delivery System, while achieving consistent profitability at the operating level. Our
actions have been guided by this initiative, and the resulting cost containment measures have
helped to conserve our cash. Our focus is upon core and critical activities, thus operating
expenses that are nonessential to our core operations have been eliminated.
We believe our cash balance as of March 31, 2008, our projected cash flows from operations and
actions we have taken to reduce sales, general and administrative expenses will be sufficient to
meet our capital, debt and operating requirements through the next 12 months. We believe that if
revenues from sales or new funds from debt or equity instruments are insufficient to maintain the
current expenditure rate, it will be necessary to significantly
reduce our operations until an appropriate solution is implemented.
15
We will have a continuing need for new infusions of cash if we incur losses or are otherwise
unable to generate positive cash flow from operations in the future. We plan to increase our sales
through increased direct sales and marketing efforts on existing products and achieving regulatory
approval for other products. If our direct sales and marketing efforts are unsuccessful or we are
unable to achieve regulatory approval for our products, we will be unable to significantly increase
our revenues. We believe that if we are unable to generate sufficient funds from sales or from
debt or equity issuances to maintain our current expenditure rate, it will be necessary to
significantly reduce our operations. We may be required to seek additional sources of financing,
which could include short-term debt, long-term debt or equity. There is a risk that we may be
unsuccessful in obtaining such financing and that we will not have sufficient cash to fund our
operations.
Related Party Transaction
In February 2008, we provided an unrestricted educational grant of $40,000 to the University
of Arizona Sarver Heart Center to support the research of cardiovascular disease and stroke. Dr.
Marvin Slepian, a member of our board of directors, is also a member of the Sarver Heart Center.
While we are not legally bound to provide any additional funding for such research, we may elect to
provide an additional $40,000 grant in the future. We believe the research will lead to a better
understanding of the pathogenesis of vascular diseases which could ultimately assist us in product
development efforts.
Critical Accounting Policies and Estimates
The preparation of financial statements in conformity with generally accepted accounting
principles requires our management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date
of the financial statements and the reported amounts of revenues and expenses during the reporting
period. Actual results could differ from those estimates.
The following presents a summary of our critical accounting policies and estimates, defined as
those policies and estimates we believe are: (i) the most important to the portrayal of our
financial condition and results of operations, and (ii) that require our most difficult, subjective
or complex judgments, often as a result of the need to make estimates about the effects of matters
that are inherently uncertain. Our most significant estimates relate to the determination of the
allowance for bad debt, inventory reserves, valuation allowance relating to deferred tax assets,
warranty reserve, the assessment of future cash flows in evaluating long-lived assets for
impairment and assumptions used in fair value determination of options.
Revenue Recognition:
We recognize revenue on product sales upon shipment of the products when the price is fixed or
determinable and when collection of sales proceeds is reasonably assured. Where purchase orders
allow customers an acceptance period or other contingencies, revenue is recognized upon the earlier
of acceptance or removal of the contingency.
Revenues from sales to distributors and agents are recognized upon shipment when there is
evidence of an arrangement, delivery has occurred, the sales price is fixed or determinable and
collection of the sales proceeds is reasonably assured. The contracts regarding these sales do not
include any rights of return or price protection clauses.
We frequently loan lasers to hospitals in accordance with our loaned laser programs. Under
certain loaned laser programs we charge the customer an additional amount (the Premium) over the
stated list price on our handpieces in exchange for the use of the laser or we collect an upfront
deposit that can be applied towards the purchase of a laser.
These arrangements meet the definition of a lease and are recorded in accordance with
Statement of Financial Accounting Standards (SFAS) No. 13 Accounting for Leases (SFAS No. 13)
as they convey the right to use the lasers over the period of time the customers are purchasing
handpieces. Based on the provisions of SFAS No. 13, the loaned lasers are classified as operating
leases and are transferred from inventory to fixed assets upon
16
commencement of the loaned laser program. In addition, the Premium is considered contingent
rent under SFAS No. 29 Determining Contingent Rentals (SFAS No. 29) and therefore, such amounts
allocated to the lease of the laser should be excluded from minimum lease payments and should be
recognized as revenue when the contingency is resolved. In these instances, the contingency is
resolved upon the sale of the handpiece.
We enter into contracts to sell our products and services and, while the majority of our sales
agreements contain standard terms and conditions, there are agreements that contain multiple
elements or non-standard terms and conditions. As a result, significant contract interpretation is
sometimes required to determine the appropriate accounting, including whether the deliverables
specified in a multiple element arrangement should be treated as separate units of accounting for
revenue recognition purposes and, if so, how the contract value should be allocated among the
deliverable elements and when to recognize revenue for each element. We recognize revenue for such
multiple element arrangements in accordance with Emerging Issues Task Force Issue (EITF) No.
00-21, Revenue Arrangements with Multiple Deliverables.
Stock Based Compensation:
We account for equity issuances to non-employees in accordance with SFAS No. 123, Accounting
for Stock Based Compensation, and EITF Issue No. 96-18, Accounting for Equity Instruments that are
Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods and Services.
All transactions in which goods or services are the consideration received for the issuance of
equity instruments are accounted for based on the fair value of the consideration received or the
fair value of the equity instrument issued, whichever is more reliably measurable. The measurement
date used to determine the fair value of the equity instrument issued is the earlier of the date on
which the third-party performance is complete or the date on which it is probable that performance
will occur.
On January 1, 2006, we adopted SFAS No. 123R, Share-Based Payment, which requires the
measurement and recognition of compensation expense for all share-based payment awards made to our
employees and directors related to our Amended and Restated 2000 Equity Incentive Plan based on
estimated fair values. We adopted SFAS No. 123R using the modified prospective transition method,
which requires the application of the accounting standard as of January 1, 2006, the first day of
our fiscal year 2006. Our consolidated financial statements for the three months ended March 31,
2008 and 2007 reflect the impact of adopting SFAS No. 123R. The value of the portion of the award
that is ultimately expected to vest is recognized as expense over the requisite service periods in
our consolidated statement of operations. As stock-based compensation expense recognized in the
unaudited condensed consolidated statement of operations for the three months ended March 31, 2008
and 2007 is based on awards ultimately expected to vest, it has been reduced for any estimated
forfeitures if applicable. SFAS No. 123R requires forfeitures to be estimated at the time of grant
and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.
The estimated average forfeiture rate for the three months ended March 31, 2008 and 2007 of zero
and 20%, respectively, was based on historical forfeiture experience and estimated future employee
forfeitures.
Employee stock-based compensation expense recognized under SFAS No. 123R for the three months
ended March 31, 2008 was $26,000, and for the three months ended March 31, 2007 was $24,000 and was
determined by the Black-Scholes valuation model. As of March 31, 2008, total unrecognized
compensation cost, adjusted for estimated forfeitures, related to unvested stock options was
$242,000, which is expected to be recognized as an expense over a weighted-average period of
approximately 2.5 years. See Note 4 to our unaudited condensed consolidated financial statements
for additional information.
Investments in Marketable Securities:
In accordance with SFAS No. 115, Accounting for Certain Investments in Debt and Equity
Securities (SFAS No. 115), we determine the appropriate classification of our investments in
marketable debt securities at the time of purchase and reevaluate such designation at each balance
sheet date. Our investments in marketable securities have been classified and accounted for as
available-for-sale based on managements investment intentions relating to these securities.
Available-for-sale securities are stated at market value based on market quotes. Any significant
unrealized gains and losses, net of deferred taxes, will be recorded as a component of other
comprehensive income (loss).
17
We generally invest excess cash in money market funds and in highly liquid debt instruments of
United States (U.S.) municipalities, corporations, the U.S. government and its agencies and
auction rate securities. All highly liquid investments with stated maturities of three months or
less from the date of purchase are classified as cash equivalents; all investments with stated
maturities of greater than three months are classified as investments in marketable securities.
Due to disruptions of, and the resulting reduced liquidity in certain financial markets, our
AAA rated auction rate securities with a total purchased cost of approximately $350,000 experienced
failed auctions during 2008. Due to the failed auctions, we were unable to sell the securities at
their respective costs, resulting in an insignificant temporary decrease in fair value. These
investments have been classified as long-term investments in marketable securities in our
consolidated balance sheet as of March 31, 2008. We concluded that the unrealized losses on these
investments are temporary because (i) we believe that the decline in market value that has occurred
is due to general market conditions, (ii) the auction rate securities continue to be of a high
credit quality and interest is paid as due and (iii) we have the intent and ability to hold these
investments until a recovery in market value occurs. The fair value of these securities could
change significantly in the future and we may be required to record other-than-temporary impairment
charges or additional unrealized losses in future periods.
Accounts Receivable:
Accounts receivable consist of trade receivables recorded upon recognition of revenue for
product sales, reduced by reserves for the estimated amount deemed uncollectible due to bad debt.
The allowance for doubtful accounts is our best estimate of the amount of probable credit losses in
our existing accounts receivable. We review the allowance for doubtful accounts quarterly with the
corresponding provision included in general and administrative expenses. Past due balances over 90
days and over a specified amount are reviewed individually for collectability. All other balances
are reviewed on a pooled basis by type of receivable. Account balances are charged off against the
allowance when we feel it is probable the receivable will not be recovered. We do not have any
off-balance-sheet credit exposure related to our customers.
Inventories:
Inventories are stated at the lower of cost (principally at actual cost on a first-in,
first-out basis) or market value. We regularly monitor potential excess or obsolete inventory by
analyzing the usage for parts on hand and comparing the market value to cost. When necessary, we
reduce the carrying amount of inventory to its market value.
Accounting for the Impairment or Disposal of Long-Lived Assets:
We assess potential impairment of our long-lived assets when there is evidence that recent
events or changes in circumstances indicate that their carrying value may not be recoverable.
Reviews are performed to determine whether the carrying value of assets is impaired based on
comparison to the undiscounted estimated future cash flows. If the comparison indicates that there
is impairment, the impaired asset is written down to fair value, which is typically calculated
using estimated discounted future cash flows. The amount of impairment would be recognized as the
excess of the assets carrying value over its fair value. Events or changes in circumstances which
may cause impairment include: significant changes in the manner of use of the acquired asset,
negative industry or economic trends, and underperformance relative to historic or projected future
operating results.
18
Income Taxes:
We account for income taxes using the asset and liability method under which deferred tax
assets or liabilities are calculated at the balance sheet date using current tax laws and rates in
effect for the year in which the differences are expected to affect taxable income. Valuation
allowances are established, when necessary, to reduce deferred tax assets to the amounts expected
to be realized.
Item 4(T). Controls and Procedures
Evaluation of Disclosure Controls and Procedures
An evaluation was carried out under the supervision and with the participation of the
Companys management, including our President and our Chief Financial Officer, of the effectiveness
of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e)
and 15d-15(e) under the Securities Exchange Act of 1934) as of March 31, 2008. Based upon that
evaluation, the President and the Chief Financial Officer concluded that the design and operation
of these disclosure controls and procedures at March 31, 2008 were effective in timely alerting
them to the material information relating to the Company (or the Companys consolidated
subsidiaries) required to be included in the Companys periodic filings with the SEC, such that the
information relating to the Company, required to be disclosed in SEC reports (i) is recorded,
processed, summarized and reported within the time periods specified in SEC rules and forms, and
(ii) is accumulated and communicated to the Companys management, including our President and CFO,
as appropriate to allow timely decisions regarding required disclosure.
Inherent Limitations on Effectiveness of Controls
All internal control systems, no matter how well designed, have inherent limitations.
Therefore, even those systems determined to be effective may not prevent or detect misstatements
and can provide only reasonable assurance with respect to financial statement preparation and
presentation. Also, projections of any evaluation of effectiveness to future periods are subject
to the risk that controls may become inadequate because of changes in conditions, or that the
degree of compliance with the policies or procedures may deteriorate.
Changes in internal control over financial reporting
There were no changes in the Companys internal control over financial reporting that occurred
during the quarter ended March 31, 2008 that has materially affected, or are reasonably likely to
materially affect, the Companys internal control over financial reporting.
19
Part II Other Information
Item 1. Legal Proceedings
We have been notified that on February 19, 2008, Cardiofocus, Inc. (Cardiofocus) filed a
complaint in the United States District Court for the District of Massachusetts (Case No.
1.08-cv-10285) against us and a number of other companies. In the complaint, Cardiofocus alleges
that we and the other defendants have violated patent rights allegedly held by Cardiofocus. The
complaint does not identify specific alleged monetary damages. We have asserted counterclaims for
non-infringement and invalidity of the patents and we intend to vigorously defend ourselves.
However, any litigation involves risks and uncertainties and the likely outcome of the case cannot
be determined at this time. In addition, litigation involves significant expenses and distraction
of management resources which may have an adverse effect on our results of operations.
Except as described above, the Company is not a party to any material legal proceeding.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 6. Exhibits
The exhibits below are filed or incorporated herein by reference.
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|
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Exhibit No. |
|
Description |
3.1.1 (1)
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|
Restated Articles of Incorporation, as filed with the California Secretary of State on May 1, 1996 |
|
|
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3.1.2 (2)
|
|
Certificate of Amendment of Restated Articles of Incorporation, as filed with California
Secretary of State on July 18, 2001 |
|
|
|
3.1.3 (3)
|
|
Certificate of Determination of Preferences of Series A Preferred Stock, as filed with the
California Secretary of State on August 23, 2001 |
|
|
|
3.1.4 (4)
|
|
Certificate of Amendment of Restated Articles of Incorporation, as filed with the California
Secretary of State on January 23, 2004 |
|
|
|
3.2 (5)
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Amended and Restated Bylaws |
|
|
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4.1 (6)
|
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Third Amendment to Rights Agreement, dated October 26, 2004, between the Company and EquiServe
Trust Company N.A |
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4.2 (7)
|
|
Second Amendment to Rights Agreement, dated as of January 21, 2004, between Cardiogenesis
Corporation and EquiServe Trust Company, N.A., as Rights Agent |
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|
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4.3 (8)
|
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First Amendment to Rights Agreement, dated as of January 17, 2002, between Cardiogenesis
Corporation and EquiServe Trust Company, N.A., as Rights Agent |
|
|
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4.4 (9)
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Rights Agreement, dated as of August 17, 2001, between Cardiogenesis Corporation and EquiServe
Trust Company, N.A., as Rights Agent |
|
|
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4.5 (10)
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Registration Rights Agreement, dated as of January 21, 2004, by and among Cardiogenesis
Corporation and the investors identified therein |
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|
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4.6 (11)
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Form of Common Stock Purchase Warrant, dated January 21, 2004, having an exercise price of $1.37
per share |
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4.7 (12)
|
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Registration Rights Agreement, dated October 26, 2004, between the Company and Laurus Master
Fund, Ltd. |
20
|
|
|
Exhibit No. |
|
Description |
4.8 (13)
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Common Stock Purchase Warrant, dated October 26, 2004, in favor of Laurus Master Fund, Ltd. |
|
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10.1(14)
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Summary of 2008 Executive Discretionary Bonus Plan |
|
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31.1 (15)
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Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) of Securities Exchange
Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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31.2 (15)
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Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) of Securities Exchange
Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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32.1 (15)
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Certifications of the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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|
|
(1) |
|
Incorporated by reference to Exhibit 3.1 to the Registrants Registration Statement on Form
S-1/A (File No. 33-03770), filed on May 21, 1996 |
|
(2) |
|
Incorporated by reference to Exhibit 3.2 to the Registrants Quarterly Report on Form 10-Q
filed on August 14, 2001 |
|
(3) |
|
Incorporated by reference to Exhibit 4.2 to the Registrants Current Report on Form 8-K filed
on August 20, 2001 |
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(4) |
|
Incorporated by reference to Exhibit 3.1.4 to the Registrants Annual Report on Form 10-K
filed on March 10, 2004 |
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(5) |
|
Incorporated by reference to Exhibit 3.2 to the Registrants Annual Report on Form 10-K
filed on March 10, 2004 |
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(6) |
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Incorporated by reference to Exhibit 4.1 to the Registrants Current Report on Form 8-K filed
October 28, 2004 |
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(7) |
|
Incorporated by reference to Exhibit 4.1 to the Registrants Current Report on Form 8-K filed
January 22, 2004 |
|
(8) |
|
Incorporated by reference to Exhibit 4.1 to the Registrants Current Report on Form 8-K filed
January 18, 2002 |
|
(9) |
|
Incorporated by reference to Exhibit 4.1 to the Registrants Current Report on Form 8-K filed
August 20, 2001 |
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(10) |
|
Incorporated by reference to Exhibit 4.5 to the Registrants Current Report on Form 8-K filed
January 22, 2004 |
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(11) |
|
Incorporated by reference to Exhibit 4.6 to the Registrants Current Report on Form 8-K filed
January 22, 2004 |
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(12) |
|
Incorporated by reference to Exhibit 4.4 to the Registrants Current Report on Form 8-K filed
October 28, 2004 |
|
(13) |
|
Incorporated by reference to Exhibit 4.5 to the Registrants Current Report on Form 8-K filed
October 28, 2004 |
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(14) |
|
Incorporated by reference to Item 5.02 of the Registrants Current Report on Form 8-K filed
March 6, 2008 |
|
(15) |
|
Filed herewith |
21
CARDIOGENESIS CORPORATION
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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CARDIOGENESIS CORPORATION
Registrant
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Date: May 15, 2008 |
/s/ Richard P. Lanigan
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Richard P. Lanigan |
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President
(Principal Executive Officer) |
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Date: May 15, 2008 |
/s/ William R. Abbott
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William R. Abbott |
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Senior Vice President, Chief Financial Officer,
Secretary and Treasurer
(Principal Financial and Accounting Officer) |
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22
Exhibit Index
|
|
|
Exhibit No. |
|
Description |
3.1.1 (1)
|
|
Restated Articles of Incorporation, as filed with the California Secretary of State on May 1, 1996 |
|
|
|
3.1.2 (2)
|
|
Certificate of Amendment of Restated Articles of Incorporation, as filed with California
Secretary of State on July 18, 2001 |
|
|
|
3.1.3 (3)
|
|
Certificate of Determination of Preferences of Series A Preferred Stock, as filed with the
California Secretary of State on August 23, 2001 |
|
|
|
3.1.4 (4)
|
|
Certificate of Amendment of Restated Articles of Incorporation, as filed with the California
Secretary of State on January 23, 2004 |
|
|
|
3.2 (5)
|
|
Amended and Restated Bylaws |
|
|
|
4.1 (6)
|
|
Third Amendment to Rights Agreement, dated October 26, 2004, between the Company and EquiServe
Trust Company N.A |
|
|
|
4.2 (7)
|
|
Second Amendment to Rights Agreement, dated as of January 21, 2004, between Cardiogenesis
Corporation and EquiServe Trust Company, N.A., as Rights Agent |
|
|
|
4.3 (8)
|
|
First Amendment to Rights Agreement, dated as of January 17, 2002, between Cardiogenesis
Corporation and EquiServe Trust Company, N.A., as Rights Agent |
|
|
|
4.4 (9)
|
|
Rights Agreement, dated as of August 17, 2001, between Cardiogenesis Corporation and EquiServe
Trust Company, N.A., as Rights Agent |
|
|
|
4.5 (10)
|
|
Registration Rights Agreement, dated as of January 21, 2004, by and among Cardiogenesis
Corporation and the investors identified therein |
|
|
|
4.6 (11)
|
|
Form of Common Stock Purchase Warrant, dated January 21, 2004, having an exercise price of $1.37
per share |
|
|
|
4.7 (12)
|
|
Registration Rights Agreement, dated October 26, 2004, between the Company and Laurus Master
Fund, Ltd. |
|
|
|
4.8 (13)
|
|
Common Stock Purchase Warrant, dated October 26, 2004, in favor of Laurus Master Fund, Ltd. |
|
|
|
10.1(14)
|
|
Summary of 2008 Executive Discretionary Bonus Plan |
|
|
|
31.1 (15)
|
|
Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) of Securities Exchange
Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
31.2 (15)
|
|
Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) of Securities Exchange
Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
32.1 (15)
|
|
Certifications of the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
(1) |
|
Incorporated by reference to Exhibit 3.1 to the Registrants Registration Statement on Form
S-1/A (File No. 33-03770), filed on May 21, 1996 |
|
(2) |
|
Incorporated by reference to Exhibit 3.2 to the Registrants Quarterly Report on Form 10-Q
filed on August 14, 2001 |
|
(3) |
|
Incorporated by reference to Exhibit 4.2 to the Registrants Current Report on Form 8-K filed
on August 20, 2001 |
|
|
|
(4) |
|
Incorporated by reference to Exhibit 3.1.4 to the Registrants Annual Report on Form 10-K
filed on March 10, 2004 |
|
(5) |
|
Incorporated by reference to Exhibit 3.2 to the Registrants Annual Report on Form 10-K
filed on March 10, 2004 |
|
(6) |
|
Incorporated by reference to Exhibit 4.1 to the Registrants Current Report on Form 8-K filed
October 28, 2004 |
|
(7) |
|
Incorporated by reference to Exhibit 4.1 to the Registrants Current Report on Form 8-K filed
January 22, 2004 |
|
(8) |
|
Incorporated by reference to Exhibit 4.1 to the Registrants Current Report on Form 8-K filed
January 18, 2002 |
|
(9) |
|
Incorporated by reference to Exhibit 4.1 to the Registrants Current Report on Form 8-K filed
August 20, 2001 |
|
(10) |
|
Incorporated by reference to Exhibit 4.5 to the Registrants Current Report on Form 8-K filed
January 22, 2004 |
|
(11) |
|
Incorporated by reference to Exhibit 4.6 to the Registrants Current Report on Form 8-K filed
January 22, 2004 |
|
(12) |
|
Incorporated by reference to Exhibit 4.4 to the Registrants Current Report on Form 8-K filed
October 28, 2004 |
|
(13) |
|
Incorporated by reference to Exhibit 4.5 to the Registrants Current Report on Form 8-K filed
October 28, 2004 |
|
(14) |
|
Incorporated by reference to Item 5.02 of the Registrants Current Report on Form 8-K filed
March 6, 2008 |
|
(15) |
|
Filed herewith |