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 September 30, 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 definition of accelerated
filer, large accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange
Act. (Check one):
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company þ |
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(Do not check if a smaller reporting company) |
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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:
45,314,389 shares of Common Stock, no par value, as of October 31, 2008.
CARDIOGENESIS CORPORATION
TABLE OF CONTENTS
PART I
FINANCIAL INFORMATION
2
Item 1. Financial Statements
CARDIOGENESIS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
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September 30, |
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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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$ |
3,439 |
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$ |
2,824 |
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Accounts receivable, net of allowance for doubtful accounts of $49 and $28, respectively |
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1,319 |
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1,763 |
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Inventories |
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1,380 |
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1,602 |
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Prepaids and other current assets |
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466 |
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486 |
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Total current assets |
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6,604 |
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6,675 |
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Long-term investments in marketable securities |
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75 |
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Property and equipment, net |
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341 |
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457 |
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Other assets, net |
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27 |
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27 |
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Total assets |
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$ |
7,047 |
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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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$ |
338 |
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$ |
169 |
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Accrued liabilities |
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1,124 |
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1,458 |
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Deferred revenue |
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902 |
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1,210 |
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Current portion of capital lease obligation |
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8 |
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12 |
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Total current liabilities |
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2,372 |
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2,849 |
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Capital lease obligation, less current portion |
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14 |
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19 |
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Total liabilities |
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2,386 |
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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; 45,314 and 45,274 shares issued and outstanding, respectively |
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173,938 |
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173,826 |
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Accumulated deficit |
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(169,277 |
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(169,535 |
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Total shareholders equity |
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4,661 |
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4,291 |
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Total liabilities and shareholders equity |
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$ |
7,047 |
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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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Nine months ended |
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September 30, |
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September 30, |
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2008 |
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2007 |
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2008 |
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2007 |
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Net revenues |
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$ |
2,618 |
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$ |
3,486 |
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$ |
9,719 |
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$ |
9,292 |
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Cost of revenues |
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474 |
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739 |
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1,589 |
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1,913 |
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Gross profit |
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2,144 |
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2,747 |
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8,130 |
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7,379 |
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Operating expenses: |
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Research and development |
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165 |
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103 |
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633 |
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612 |
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Sales and marketing |
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1,536 |
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1,246 |
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4,858 |
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3,268 |
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General and administrative |
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753 |
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719 |
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2,404 |
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2,611 |
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Total operating expenses |
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2,454 |
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2,068 |
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7,895 |
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6,491 |
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Operating (loss) income |
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(310 |
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679 |
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235 |
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888 |
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Other income (expense): |
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Interest expense |
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(1 |
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(10 |
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(22 |
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(59 |
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Interest income |
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13 |
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29 |
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55 |
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94 |
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Non-cash interest expense |
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(13 |
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(89 |
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Change in fair value of derivatives |
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(133 |
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(323 |
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Other non-cash income, net |
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38 |
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151 |
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Total other income (expense), net |
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12 |
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(89 |
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33 |
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(226 |
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(Loss) income before income taxes |
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(298 |
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590 |
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268 |
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662 |
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Tax provision |
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10 |
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10 |
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Net (loss) income |
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$ |
(308 |
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$ |
590 |
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$ |
258 |
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$ |
662 |
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Net (loss) earnings per share: |
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Basic |
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$ |
(0.01 |
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$ |
0.01 |
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$ |
0.01 |
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$ |
0.01 |
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Diluted |
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$ |
(0.01 |
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$ |
0.01 |
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$ |
0.01 |
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$ |
0.01 |
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Weighted average shares outstanding: |
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Basic |
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45,292 |
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45,274 |
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45,292 |
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45,274 |
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Diluted |
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45,292 |
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45,274 |
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45,328 |
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45,274 |
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See accompanying notes.
4
CARDIOGENESIS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
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Nine months ended |
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September 30, |
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2008 |
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2007 |
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Cash flows from operating activities: |
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Net income |
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$ |
258 |
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$ |
662 |
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Adjustments to reconcile net income to net cash provided by operating activities: |
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Derivative and warrant fair value adjustments |
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172 |
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Amortization of discount on note payable |
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72 |
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Depreciation and amortization |
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219 |
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366 |
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Bad debt expense |
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21 |
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62 |
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Amortization of debt issuance costs |
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17 |
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Stock-based compensation expense |
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102 |
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62 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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423 |
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240 |
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Inventories |
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237 |
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(329 |
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Prepaids and other current assets |
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20 |
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79 |
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Other assets |
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10 |
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Accounts payable |
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169 |
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187 |
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Accrued liabilities |
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(334 |
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(156 |
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Deferred revenue |
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(308 |
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(65 |
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Net cash provided by operating activities |
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807 |
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1,379 |
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Cash flows from investing activities: |
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Acquisition of property and equipment |
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(118 |
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(45 |
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Purchase of investments in marketable securities |
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(150 |
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Proceeds from the sale of marketable securities |
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75 |
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Net cash used in investing activities |
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(193 |
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(45 |
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Cash flows from financing activities: |
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Net proceeds from issuance of common stock from exercise of options and from
stock purchased under the Employee Stock Purchase Plan |
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10 |
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Payments on secured convertible term note |
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(937 |
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Payments on capital lease obligation and short term note payable |
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(9 |
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(98 |
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Net cash provided by (used in) financing activities |
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1 |
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(1,035 |
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Net increase in cash and cash equivalents |
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615 |
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299 |
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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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$ |
3,439 |
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$ |
2,417 |
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Supplemental schedule of cash flow information: |
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Interest paid |
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$ |
3 |
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$ |
55 |
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Taxes paid |
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$ |
14 |
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$ |
67 |
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Supplemental schedule of non-cash investing activities: |
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Reclassification of fixed assets to inventories |
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$ |
15 |
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$ |
296 |
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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 single-use fiber optic laser delivery systems
(handpieces) for the treatment of cardiovascular disease. Currently, Cardiogenesis emphasis is
on the development of products for transmyocardial revascularization (TMR), a treatment for
cardiac ischemia in patients with severe angina.
Cardiogenesis markets its products for sale primarily in the United States and 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
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 and for the nine
months ended September 30, 2008, it does not have a history of operating income. Management
believes its cash balance as of September 30, 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.
For the three months ended September 30, 2008, there were approximately 23,000 potentially
dilutive shares that were related to stock options. For the three and nine months ended September
30, 2007, there were approximately 208,000 potentially dilutive shares related to the potential
conversion of convertible debt. For the three and nine
6
months ended September 30, 2007 and the three months ended September 30, 2008, the potentially
diluted shares were excluded from the diluted income (loss) per share as their effect would be
anti-dilutive.
The following table reconciles BEPS and DEPS and the related weighted average number of shares
outstanding for the nine months ended September 30, 2008 (in thousands, except per share amounts):
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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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$ |
258 |
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$ |
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Income available to common shareholders |
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258 |
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45,292 |
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0.01 |
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Effect of dilutive securities: |
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Options |
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36 |
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Diluted EPS: |
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Income available to common shareholders
plus assumed exercises |
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$ |
258 |
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45,328 |
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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:
Effective January 1, 2008, the Company adopted Statement of Financial Accounting Standards
(SFAS) No. 157, Fair Value Measurements (SFAS No. 157), except as it applies to the
nonfinancial assets and nonfinancial liabilities subject to FSP SFAS No. 157-2, Effective Date of
FASB Statement No. 157. SFAS No. 157 clarifies that fair value is an exit price, representing the
amount that would be received to sell an asset or paid to transfer a liability in an orderly
transaction between market participants. As such, fair value is a market-based measurement that
should be determined based on assumptions that market participants would use in pricing an asset or
liability. As a basis for considering such assumptions, SFAS No. 157 establishes a three-tier
value hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair
value:
Level 1 Observable inputs that reflect quoted prices (unadjusted) for identical assets
or liabilities in active markets.
Level 2 Include other inputs that are directly or indirectly observable in the
marketplace.
Level 3 Unobservable inputs which are supported by little or no market activity.
The fair value hierarchy also requires an entity to maximize the use of observable inputs and
minimize the use of unobservable inputs when measuring fair value.
7
In accordance with SFAS No. 157, the Company measures its cash and cash equivalents and
marketable securities at fair value. The Companys investments in auction rate securities are
classified within level 3 due to a lack of a liquid market for such securities. The Company has
formed its own opinion on the condition of the securities based on information regarding the
quality of the security and the quality of the collateral, among other things.
In accordance with the fair value hierarchy described above, the following table shows the
fair value of the Companys financial assets that are required to be measured at fair value on a
recurring basis at September 30, 2008 (in thousands):
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|
|
|
|
|
|
|
|
|
|
|
|
Quoted |
|
|
|
|
|
|
|
|
|
|
|
|
|
Market Prices |
|
|
|
|
|
|
|
|
|
|
|
|
|
in Active |
|
|
Significant |
|
|
|
|
|
|
|
|
|
|
Markets for |
|
|
Other |
|
|
Significant |
|
|
|
Fair Value at |
|
|
Identical |
|
|
Observable |
|
|
Unobservable |
|
|
|
September 30, |
|
|
Assets |
|
|
Inputs |
|
|
Inputs |
|
Description |
|
2008 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
Marketable Securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction Rate Securities |
|
$ |
75 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
75 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table provides a reconciliation of the beginning and ending balances for the
Companys assets measured at fair value using significant unobservable inputs (Level 3) as defined
in SFAS No. 157 at September 30, 2008 (in thousands):
|
|
|
|
|
Description |
|
|
|
|
Balance at December 31, 2007 |
|
$ |
|
|
Transfers into Level 3 |
|
|
750 |
|
Transfers out of Level 3 |
|
|
(675 |
) |
Total unrealized losses |
|
|
|
|
Total realized gains/(losses) |
|
|
|
|
|
|
|
|
Balance at September 30, 2008 |
|
$ |
75 |
|
|
|
|
|
Marketable securities measured at fair value using Level 3 inputs are comprised entirely of
auction rate securities. Although auction rate securities would typically be measured using Level
2 inputs, the recent failure of auctions (beginning in February 2008) and the lack of market
activity and liquidity required that these securities be measured using Level 3 inputs. The
underlying assets of the Companys auction rate securities are collateralized primarily by the
underlying assets of certain AAA rated funds.
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 September 30, 2008.
8
In connection with the Note, the Company recorded the following items of other income
(expense) during the three and nine months ended September 30, 2007, respectively:
|
|
|
$11,000 and $72,000 of interest expense related to the accretion of the debt discount, |
|
|
|
|
$2,000 and $17,000 of interest expense related to the amortization of debt issuance
costs, |
|
|
|
|
$133,000 and $323,000 of other expense related to the change in fair value of certain
derivatives, |
|
|
|
|
$38,000 and $151,000 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.
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. For arrangements
that involve multiple elements, such as sales of lasers and handpieces, revenue is allocated to
each respective element based on its relative fair value and recognized when revenue recognition
criteria for each element have been met.
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 and nine months ended September 30, 2008, the Companys international sales
were $4,000 and $96,000, respectively. For the three and nine months ended September 30, 2007, the
Companys international sales were $163,000 and $243,000, respectively. International sales
represent approximately 1% of total sales for the three and nine months ended September 30, 2008,
respectively, and 5% and 3% of total sales for the three and nine months ended September 30, 2007,
respectively. 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, (SFAS No. 157), which defines fair value, establishes a framework for
measuring fair value in
9
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 its future consolidated financial statements related to non-financial
assets and liabilities.
In October 2008, the FASB issued FASB Staff Position No. 157-3, Determining the Fair Value of
a Financial Asset When the Market for That Asset is Not Active (FSP 157-3). FSP 157-3 clarifies
the application of SFAS 157 in a market that is not active, and provides an illustrative example
intended to address certain key application issues. FSP 157-3 is effective immediately, and
applies to the Companys September 30, 2008 financial statements. The Company has concluded that
the application of FSP 157-3 did not have a material impact on its consolidated financial position
and results of operations as of and for the periods ended September 30, 2008.
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 the Company
engages 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 its 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):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
|
(unaudited) |
|
|
(audited) |
|
Raw materials |
|
$ |
253 |
|
|
$ |
295 |
|
Work-in-process |
|
|
72 |
|
|
|
96 |
|
Finished goods |
|
|
1,055 |
|
|
|
1,211 |
|
|
|
|
|
|
|
|
Total |
|
$ |
1,380 |
|
|
$ |
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-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 Staff
Accounting Bulletin No. 107 (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 three and nine
month periods ended September 30, 2008 and
10
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 and nine month periods ended September 30, 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 unaudited
condensed consolidated statements of operations for the three and nine month periods ended
September 30, 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 and nine month periods ended September 30, 2008
and 2007 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 and nine month periods
ended September 30, 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 September 30, 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
September 30, 2008, a total of 1,500,000 common shares are authorized and reserved for issuance
under this plan, as amended and 230,804 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.
The Company has treated the ESPP as a compensatory plan and has recorded compensation expense
of approximately $7,000 and $13,000 during the three and nine month periods ended September 30,
2008, respectively, and zero during the three and nine month periods ended September 30, 2007 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 and nine month periods ended September
30, 2008, there were zero and 36,939 shares purchased under the ESPP, respectively. During the
three and nine month periods ended September 30, 2007, there were no shares purchased under the
ESPP.
11
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 nine months ended September 30, 2008 and 2007 were based on the
following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2008 |
|
2007 |
Expected term |
|
4 years |
|
4 years |
Expected volatility |
|
|
91.5 92.9% |
|
|
|
96.19% |
|
Risk-free interest rate |
|
|
2.29 3.53% |
|
|
|
4.75% |
|
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:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2008 |
|
2007 |
Expected term |
|
0.50 years |
|
0.50 years |
Expected volatility |
|
|
91.5 92.9% |
|
|
|
96.19% |
|
Risk-free interest rate |
|
|
2.29 3.53% |
|
|
|
4.75% |
|
Expected dividends |
|
|
|
|
|
|
|
|
A summary of option activity as of September 30, 2008 and changes during the nine months then
ended, is presented below (in thousands except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
760 |
|
|
$ |
0.34 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
(3 |
) |
|
$ |
0.27 |
|
|
|
|
|
|
|
|
|
Options forfeited/canceled |
|
|
(391 |
) |
|
$ |
1.17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding and expected to vest at September 30, 2008 |
|
|
3,442 |
|
|
$ |
0.67 |
|
|
|
5.9 |
|
|
$ |
11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at September 30, 2008 |
|
|
2,300 |
|
|
$ |
0.83 |
|
|
|
4.3 |
|
|
$ |
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12
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 362,000 outstanding
and 121,000 exercisable stock options that were in-the-money at September 30, 2008.
The weighted average grant date fair value of options granted during the three and nine months
ended September 30, 2008 was $0.25 and $0.23 per option, respectively. The weighted average grant
date fair value of options granted during the nine months ended September 30, 2007 was $0.22 per
option. There were no options granted or exercised during the three months ended September 30,
2007.
As of September 30, 2008, there was approximately $219,000 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 2.2 years.
The following table summarizes stock-based compensation expense related to stock options and
ESPP purchases under SFAS No. 123R for the three and nine months ended September 30, 2008 and 2007
which was allocated as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
September 30, |
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Stock-based compensation expense included in: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1 |
|
|
$ |
2 |
|
|
$ |
3 |
|
|
$ |
8 |
|
Sales and marketing |
|
|
24 |
|
|
|
5 |
|
|
|
59 |
|
|
|
25 |
|
General and administrative |
|
|
15 |
|
|
|
10 |
|
|
|
40 |
|
|
|
29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
40 |
|
|
$ |
17 |
|
|
$ |
102 |
|
|
$ |
62 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5. Legal Matters:
Previously, 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.
On June 13, 2008, Cardiogenesis filed requests for reexamination of the patents being asserted
against Cardiogenesis with the United States Patent and Trademark Office and asserted that prior
art had been identified that raised substantial new issues of patentability with respect to the
inventions claimed by Cardiofocus patents. In August 2008, the United States Patent and Trademark
Office granted Cardiogenesis reexamination requests. Reexamination requests filed by other named
defendants were also granted.
Because the reexamination requests were granted and substantial new issues of patentability
raised, Cardiogenesis, along with other named defendants, moved to stay the litigation until the
reexamination of Cardiofocus asserted patents is completed. On October 14, 2008, an Order was
issued by the Court staying the present litigation for one (1) year or until the reexamination is
completed, which ever occurs sooner. After one year, if the reexamination continues, the Court
will consider further extensions of the stay, for a period not to exceed one additional year, upon
good cause shown by the defendants.
Cardiogenesis intends to continue 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 Transactions:
The Company provided unrestricted educational grants of $40,000 in February 2008 and $40,000
in June 2008 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 Director of Interventional Cardiology at Sarver
13
Heart Center. The Company is not legally bound to provide any additional funding for such
research but may choose to do so in the future.
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. 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. Please
read the section 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. Such factors include, among others, (i) the effects of any
inability of us to obtain financing if and when needed to fund operations and the effect on recent
uncertainty in global credit markets and the economy in general, (ii) the effect of any failure of
our technology or products to be accepted in the marketplace, (iii) the effect of Medicare and
other insurance reimbursement policies and rates, (iv) the effect of FDA and other regulations on
our business and product development, as well as other factors, many of which are outside of our
control. 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 surgical lasers and single-use fiber optic laser delivery systems (handpieces) for
the treatment of cardiac ischemia in patients with severe angina. This therapy is a surgical
laser-based heart treatment in which transmural channels are made in the heart muscle to improve
cardiac perfusion and is referred to as Transmyocardial Revascularization or TMR. It is performed
by a cardiac surgeon through a surgical incision while the patient is under general anesthesia.
The procedure can be performed adjunctively with coronary bypass or as a sole therapy. 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 technology,
when compared with patients who received medications alone. Many scientific experts believe these
procedures encourage new vessel formation, or angiogenesis.
In May 1997, we received CE Mark approval for our TMR 2000 laser system and Sologrip®
handpieces. We received CE Mark for our minimally invasive PEARL® (Port Enabled Angina Relief with
Laser) handpieces (PEARL 5.0 Robotic delivery system (PEARL 5.0) and PEARL 8.0 Thoracoscopic
delivery system (PEARL 8.0)) and our PHOENIX Combination delivery system (PHOENIX) in November
2005 and October 2006, respectively. The less-invasive PEARL 5.0 handpiece is compatible for use
with surgical robotic systems, including Intuitive Surgical, Inc.s da Vinci Surgical System®,
while the PHOENIX handpiece combines the delivery of laser energy and precise injection of a
biologic substance through the same handpiece. 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 2000 Laser and Sologrip handpieces for treatment of 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 TMR as a primary and secondary procedure.
In December 2004, we received FDA approval for the Solargen® 2100s Laser Console, our second
generation TMR laser system. In addition, in November 2007 we received FDA approval for the PEARL
5.0 handpiece 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
handpiece, and we are developing our FDA
14
regulatory strategy for the PHOENIX handpiece.
As of September 30, 2008, we had an accumulated deficit of $169,277,000. We may 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, handpieces, and
related services. Net revenues of $2,618,000 for the quarter ended September 30, 2008 decreased
$868,000, or 25%, when compared to net revenues of $3,486,000 for the quarter ended September 30,
2007. We attribute the decrease in sales for the three months ended September 30, 2008 primarily
to the decrease in the number of lasers and disposable handpieces sold.
For the quarter ended September 30, 2008, domestic handpiece revenue decreased by $238,000, or
11%, and domestic laser revenue decreased by $464,000, or 55%, when compared to the quarter ended
September 30, 2007. In the third quarter of 2008, domestic handpiece revenue included $154,000 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 $1,824,000. In the third quarter of
2007, domestic handpiece revenue included $150,000 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 less than 1% of net revenues for the quarter ended
September 30, 2008 decreased $158,000 from the prior year period. We define international sales as
sales to customers located outside of the United States. In addition, service and other revenue of
$263,000 decreased $8,000 for the quarter ended September 30, 2008, when compared to $271,000 for
the quarter ended September 30, 2007.
Net revenues of $9,719,000 for the nine months ended September 30, 2008 increased $427,000, or
5%, when compared to net revenues of $9,292,000 for the nine months ended September 30, 2007. We
attribute the increase in sales for the nine months ended September 30, 2008 primarily to the
increase in the number of laser units sold.
For the nine months ended September 30, 2008, domestic disposable handpiece revenue decreased
by $153,000, or 2%, and domestic laser revenue increased by $759,000, or 42%, compared to the nine
months ended September 30, 2007. Included in the domestic disposable handpiece revenue, was
$234,000 related to revenue which had been previously deferred and became recognizable during the
second quarter of 2008. For the nine months ended September 30, 2008, domestic handpiece revenue
included $625,000 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 $5,614,000. For the
nine months ended September 30, 2007, domestic handpiece revenue included $648,000 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 $5,745,000.
International sales, accounting for approximately 1% of net revenues for the nine months ended
September 30, 2008, decreased $147,000 from the prior year period. In addition, service and other
revenue of $812,000 decreased $30,000 for the nine months ended September 30, 2008, when compared
to $842,000 for the nine months ended September 30, 2007.
Gross Profit
For the quarter ended September 30, 2008, gross margin increased to 82% of net revenues as
compared to 79% of net revenues for the quarter ended September 30, 2007. The increase in gross
margin for the three month period is primarily attributable to an increase in the average selling
price of disposable handpieces.
For
the nine months ended September 30, 2008, gross margin increased to 84% of net revenues as
compared to
15
79% of net
revenues for the nine months ended September 30, 2007. The increase in gross margin for the nine month period is primarily attributed to higher average selling prices for both
laser and disposable handpiece units. In addition, during the second
quarter of 2008, we recognized $234,000 of deferred revenue for which
there is no associated cost of goods sold.
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 September 30, 2008, research and development expenditures of $165,000
increased $62,000, or 60%, when compared to $103,000 for the quarter ended September 30, 2007. As
a percentage of revenues, research and development expenditures were 6% during the quarter ended
September 30, 2008 as compared to 3% for the prior year period. For the nine months ended
September 30, 2008, research and development expenditures of $633,000 increased $21,000, or 3%,
when compared to $612,000 for the nine months ended September 30, 2007. As a percentage of
revenues, research and development expenditures were 7% for the nine months ended September 30,
2008 and 2007, respectively. The dollar increase for both the three months and nine months ended
September 30, 2008 was attributed primarily to an increase in the use of outside services. The
increase of research and development expenditures as a percentage of revenues in the quarter ended
September 30, 2008 was primarily due to an increase in the use of outside services combined with
decreased revenues in the most recent quarter as compared to the prior year period.
Sales and Marketing
Sales and marketing expense represents expenses incurred in connection with the salaries,
stock-based compensation, commissions, taxes and benefits for sales, marketing and service
employees and other sales, general and administrative expenses directly associated with the sales,
marketing and service departments.
For the quarter ended September 30, 2008, sales and marketing expenditures of $1,536,000
increased $290,000, or 23%, when compared to $1,246,000 for the quarter ended September 30, 2007.
As a percentage of revenues, sales and marketing expenditures were 59% during the quarter ended
September 30, 2008 as compared to 36% for the prior year period. The dollar and percentage
increase in sales and marketing expenditures for the three month
period was primarily due to higher compensation expenses related to
investments made to strengthen the sales and marketing organization. The percentage increase in sales and
marketing expenditures for the three month period was also a result of a lower revenue base in the
current period.
For the nine months ended September 30, 2008, sales and marketing expenditures of $4,858,000
increased $1,590,000, or 49%, when compared to $3,268,000 for the nine months ended September 30,
2007. As a percentage of revenues, sales and marketing expenditures were 50% during the quarter
ended September 30, 2008 as compared to 35% for the prior year period. The dollar and percentage
increase in sales and marketing expenditures for the nine month
period was primarily due to higher compensation expenses related to
investments made to strengthen the sales and marketing organization.
General and Administrative
General and administrative expenditures represent all other operating expenses not included in
research and development or sales and marketing expenses. For the quarter ended September 30,
2008, general and administrative expenditures (G&A) totaled $753,000, or 29% of net revenues, as
compared to $719,000, or 21% of net revenues during the quarter ended September 30, 2007. This
represents an increase of $34,000, or 5%. The increase as a percentage of revenues was due to
expenditures being incurred over a smaller revenue base. For the nine months ended September 30,
2008, G&A totaled $2,404,000, or 25% of net revenues, as compared to $2,611,000, or 28% of net
revenues, for the nine months ended September 30, 2007. This
reduction of $207,000, or
8%, was primarily attributable to lower insurance expense in the current
year.
16
Other Income (Expense)
The following table reflects the components of other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
|
Nine months ended September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
($ In thousands) |
|
|
|
|
|
Interest expense Secured
Convertible Term Note |
|
$ |
|
|
|
$ |
(9 |
) |
|
$ |
|
|
|
$ |
(50 |
) |
Interest expense other |
|
|
(1 |
) |
|
|
(1 |
) |
|
|
(22 |
) |
|
|
(9 |
) |
Interest income |
|
|
13 |
|
|
|
29 |
|
|
|
55 |
|
|
|
94 |
|
Non-cash interest expense
Accretion of discount on Note |
|
|
|
|
|
|
(11 |
) |
|
|
|
|
|
|
(72 |
) |
Non-cash interest expense
Amortization of debt issuance
costs relating to the Note |
|
|
|
|
|
|
(2 |
) |
|
|
|
|
|
|
(17 |
) |
Change in fair value of derivative |
|
|
|
|
|
|
(133 |
) |
|
|
|
|
|
|
(323 |
) |
Other
non-cash income (expense)
Change in fair value of warrants |
|
|
|
|
|
|
38 |
|
|
|
|
|
|
|
151 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense), net. |
|
$ |
12 |
|
|
$ |
(89 |
) |
|
$ |
33 |
|
|
$ |
(226 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net other income for the three months ended September 30, 2008 was $12,000 as compared to net
other expense for the three months ended September 30, 2007 of $89,000. For the nine months ended
September 30, 2008 net other income was $33,000 as compared to net other expense of $226,000 for
the nine months ended September 30, 2007. For both the three and nine month periods, the changes
in the components of other income and expense were primarily due to the fact that at September 30,
2007 we incurred expenses and income associated with certain outstanding debt obligations.
However, since such debt was paid in full in October 2007, for the three and nine months ended
September 30, 2008, there was no associated expense or income in those periods.
Liquidity and Capital Resources
At September 30, 2008, we had cash and cash equivalents of $3,439,000 compared to $2,824,000
at December 31, 2007, an increase of $615,000. During the nine months ended September 30, 2008, we
had net income of $258,000 and net cash provided by operating activities of $807,000 primarily from
a decrease in accounts receivable, inventories, and prepaid expenses in addition to an increase in
accounts payable. These changes were offset by a decrease in accrued liabilities and deferred
revenue. The decrease in deferred revenue primarily relates to the recognition of $234,000 of
previously deferred revenue in accordance with EITF No. 00-21 which became recognizable during the
second quarter of 2008.
Cash used in investing activities during the nine months ended September 30, 2008 was $193,000
due to property and equipment and net marketable securities purchases.
Prior to 2007, we had incurred significant operating losses for several years and at September
30, 2008 we had an accumulated deficit of $169,277,000. 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 and PHOENIX handpieces, 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 September 30, 2008, our projected cash flows from operations
and actions we have taken to reduce 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
17
instruments are insufficient to maintain the
current expenditure rate, it will be necessary to significantly reduce our operations until an
appropriate solution is implemented.
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. As a result, we may be required to seek additional sources of financing, which could
include short-term debt, long-term debt or equity. 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 as we would not have sufficient
cash to fund our operations.
Related Party Transactions
We provided unrestricted educational grants of $40,000 in February 2008 and $40,000 in June
2008 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 Director of
Interventional Cardiology of the Sarver Heart Center. While we are not legally bound to provide
any additional funding for such research, we may elect to do so in the future. We believe the
research will lead to a better understanding of the mechanisms of action for TMR 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 commencement of the loaned laser
program. In addition, the Premium is considered contingent rent under SFAS
18
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. For arrangements that involve multiple
elements, such as sales of lasers and handpieces, revenue is allocated to each respective element
based on its relative fair value and recognized when revenue recognition criteria for each element
have been met.
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 unaudited condensed consolidated financial statements for the three and
nine months ended September 30, 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 condensed consolidated statement of operations. As
stock-based compensation expense recognized in the unaudited condensed consolidated statement of
operations for the three and nine months ended September 30, 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 forfeiture
rate was based on historical forfeiture experience and estimated future employee forfeitures.
Employee stock-based compensation expense recognized under SFAS No. 123R for the three and
nine months ended September 30, 2008 was $40,000 and $102,000, respectively, and for the three and
nine months ended September 30, 2007 was $17,000 and $62,000, respectively, and was determined by
the Black-Scholes valuation model. As of September 30, 2008, total unrecognized compensation cost,
adjusted for estimated forfeitures, related to unvested stock options was $219,000, which is
expected to be recognized as an expense over a weighted-average period of approximately 2.2 years.
See Note 4 to our unaudited condensed consolidated financial statements for additional information.
Investments in Marketable Securities:
Effective January 1, 2008, we adopted SFAS No. 157, except as it applies to the nonfinancial
assets and nonfinancial liabilities subject to FSP SFAS No. 157-2. SFAS No. 157 clarifies that
fair value is an exit price, representing the amount that would be received to sell an asset or
paid to transfer a liability in an orderly transaction between market participants. As such, fair
value is a market-based measurement that should be determined based on assumptions that market
participants would use in pricing an asset or liability. As a basis for considering such
19
assumptions, SFAS No. 157 establishes a three-tier value hierarchy, which prioritizes the
inputs used in the valuation methodologies in measuring fair value:
Level 1 Observable inputs that reflect quoted prices (unadjusted) for identical assets
or liabilities in active markets.
Level 2 Include other inputs that are directly or indirectly observable in the
marketplace.
Level 3 Unobservable inputs which are supported by little or no market activity.
The fair value hierarchy also requires an entity to maximize the use of observable inputs and
minimize the use of unobservable inputs when measuring fair value.
In accordance with SFAS No. 157, we measure our cash and cash equivalents and marketable
securities at fair value. Our investments in auction rate securities are classified within level 3
due to a lack of a liquid market for such securities. We have formed our own opinion on the
condition of the securities based on information regarding the quality of the security and the
quality of the collateral, among other things.
In accordance with the fair value hierarchy described above, the following table shows the
fair value of our financial assets that are required to be measured at fair value on a recurring
basis at September 30, 2008 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted |
|
|
|
|
|
|
|
|
|
|
|
|
|
Market Prices |
|
|
|
|
|
|
|
|
|
|
|
|
|
in Active |
|
|
Significant |
|
|
|
|
|
|
|
|
|
|
Markets for |
|
|
Other |
|
|
Significant |
|
|
|
Fair Value at |
|
|
Identical |
|
|
Observable |
|
|
Unobservable |
|
|
|
September 30, |
|
|
Assets |
|
|
Inputs |
|
|
Inputs |
|
Description |
|
2008 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
Marketable Securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction Rate Securities |
|
$ |
75 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
75 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table provides a reconciliation of the beginning and ending balances for our
assets measured at fair value using significant unobservable inputs (Level 3) as defined in SFAS
No. 157 at September 30, 2008 (in thousands):
|
|
|
|
|
Description |
|
|
|
|
Balance at December 31, 2007 |
|
$ |
|
|
Transfers into Level 3 |
|
|
750 |
|
Transfers out of Level 3 |
|
|
(675 |
) |
Total unrealized losses |
|
|
|
|
Total realized gains/(losses) |
|
|
|
|
|
|
|
|
Balance at September 30, 2008 |
|
$ |
75 |
|
|
|
|
|
Marketable securities measured at fair value using Level 3 inputs are comprised entirely of
auction rate securities. Although auction rate securities would typically be measured using Level
2 inputs, the recent failure of auctions (beginning in February 2008) and the lack of market
activity and liquidity required that these securities be measured using Level 3 inputs. The
underlying assets of our auction rate securities are collateralized primarily by the underlying
assets of certain AAA rated funds.
Accounts Receivable:
Accounts receivable consist of trade receivables recorded upon recognition of revenue for
product sales, reduced
20
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.
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 September 30, 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 September 30, 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.
21
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 September 30, 2008 that has materially affected, or are reasonably likely
to materially affect, the Companys internal control over financial reporting.
22
Part II Other Information
Item 1. Legal Proceedings
Previously, 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.
On June 13, 2008, we filed requests for reexamination of the patents being asserted against us
with the United States Patent and Trademark Office and asserted that prior art had been identified
that raised substantial new issues of patentability with respect to the inventions claimed by
Cardiofocus patents. In August 2008, the United States Patent and Trademark Office granted our
reexamination requests. Reexamination requests filed by other named defendants were also granted.
Because the reexamination requests were granted and substantial new issues of patentability
raised, we, along with other named defendants, moved to stay the litigation until the reexamination
of Cardiofocus asserted patents is completed. On October 14, 2008, an Order was issued by the
Court staying the present litigation for one (1) year or until the reexamination is completed,
which ever occurs sooner. After one year, if the reexamination continues, the Court will consider
further extensions of the stay, for a period not to exceed one additional year, upon good cause
shown by the defendants.
We intend to continue 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, we are not a party to any material legal proceeding.
Item 6. Exhibits
The exhibits below are filed or incorporated herein by reference.
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Exhibit No. |
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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)
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Certificate of Amendment of Restated Articles of Incorporation, as filed with California
Secretary of State on July 18, 2001 |
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3.1.3 (3)
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Certificate of Determination of Preferences of Series A Preferred Stock, as filed with the
California Secretary of State on August 23, 2001 |
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3.1.4 (4)
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Certificate of Amendment of Restated Articles of Incorporation, as filed with the California
Secretary of State on January 23, 2004 |
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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)
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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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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 |
23
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Exhibit No. |
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Description |
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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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. |
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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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31.1 (14)
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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 (14)
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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 (14)
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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) |
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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 |
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(2) |
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Incorporated by reference to Exhibit 3.2 to the Registrants Quarterly Report on Form 10-Q
filed on August 14, 2001 |
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(3) |
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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) |
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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) |
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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) |
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Incorporated by reference to Exhibit 4.1 to the Registrants Current Report on Form 8-K filed
January 22, 2004 |
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(8) |
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Incorporated by reference to Exhibit 4.1 to the Registrants Current Report on Form 8-K filed
January 18, 2002 |
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(9) |
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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) |
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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) |
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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) |
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Incorporated by reference to Exhibit 4.4 to the Registrants Current Report on Form 8-K filed
October 28, 2004 |
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(13) |
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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) |
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Filed herewith |
24
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 |
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Registrant |
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Date: November 13, 2008
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/s/ Richard P. Lanigan
Richard P. Lanigan
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President |
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(Principal Executive Officer) |
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Date: November 13, 2008
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/s/ William R. Abbott
William R. Abbott
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Senior Vice President, Chief Financial Officer, Secretary and |
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Treasurer |
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(Principal Financial and Accounting Officer) |
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25
Exhibit Index
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|
|
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)
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|
Certificate of Determination of Preferences of Series A Preferred Stock, as filed with the
California Secretary of State on August 23, 2001 |
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|
|
3.1.4 (4)
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|
Certificate of Amendment of Restated Articles of Incorporation, as filed with the California
Secretary of State on January 23, 2004 |
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|
|
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 |
|
|
|
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)
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|
Form of Common Stock Purchase Warrant, dated January 21, 2004, having an exercise price of $1.37
per share |
|
|
|
4.7 (12)
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|
Registration Rights Agreement, dated October 26, 2004, between the Company and Laurus Master
Fund, Ltd. |
|
|
|
4.8 (13)
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|
Common Stock Purchase Warrant, dated October 26, 2004, in favor of Laurus Master Fund, Ltd. |
|
|
|
31.1 (14)
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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 (14)
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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 |
|
|
|
32.1 (14)
|
|
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) |
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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) |
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Incorporated by reference to Exhibit 3.2 to the Registrants Quarterly Report on Form 10-Q
filed on August 14, 2001 |
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(3) |
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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) |
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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) |
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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) |
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Incorporated by reference to Exhibit 4.1 to the Registrants Current Report on Form 8-K filed
January 22, 2004 |
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(8) |
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Incorporated by reference to Exhibit 4.1 to the Registrants Current Report on Form 8-K filed
January 18, 2002 |
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(9) |
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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) |
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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) |
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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 |
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(13) |
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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) |
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Filed herewith |