e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2010.
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 0-28288
CARDIOGENESIS CORPORATION
(Exact name of registrant 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
Identification Number) |
11 Musick
Irvine, California 92618
(Address of principal executive offices)
(949) 420-1800
(Issuers telephone number)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act:
Large accelerated filer o |
Accelerated filer o |
Non-accelerated filer o (Do not check if a smaller reporting company) |
Smaller reporting company þ |
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
As of July 31, 2010, there were 46,732,481 shares of the registrants common stock, no par
value, outstanding.
CARDIOGENESIS CORPORATION
TABLE OF CONTENTS
2
PART I
FINANCIAL INFORMATION
Item 1. Financial Statements
CARDIOGENESIS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
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June 30, |
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December 31, |
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2010 |
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2009 |
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(unaudited) |
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(audited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
2,195 |
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$ |
2,568 |
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Accounts receivable, net of allowance for doubtful accounts of $6 |
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1,054 |
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933 |
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Inventories |
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817 |
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914 |
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Prepaids and other current assets |
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215 |
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253 |
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Total current assets |
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4,281 |
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4,668 |
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Property and equipment, net |
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280 |
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341 |
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Other assets, net |
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9 |
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9 |
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Total assets |
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$ |
4,570 |
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$ |
5,018 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
243 |
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$ |
127 |
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Accrued salaries and related |
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564 |
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604 |
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Accrued liabilities |
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313 |
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299 |
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Deferred revenue |
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787 |
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744 |
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Note payable |
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88 |
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Current portion of capital lease obligations |
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10 |
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9 |
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Total current liabilities |
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1,917 |
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1,871 |
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Capital lease obligations, less current portion |
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9 |
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14 |
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Total liabilities |
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1,926 |
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1,885 |
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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; 45,739 and 45,549 shares
issued and outstanding, respectively |
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174,313 |
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174,217 |
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Accumulated deficit |
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(171,669 |
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(171,084 |
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Total shareholders equity |
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2,644 |
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3,133 |
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Total liabilities and shareholders equity |
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$ |
4,570 |
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$ |
5,018 |
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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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Six months ended |
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June 30, |
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June 30, |
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2010 |
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2009 |
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2010 |
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2009 |
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Net revenues |
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$ |
2,429 |
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$ |
2,236 |
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$ |
5,662 |
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$ |
5,088 |
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Cost of revenues |
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381 |
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391 |
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909 |
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927 |
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Gross profit |
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2,048 |
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1,845 |
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4,753 |
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4,161 |
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Operating expenses: |
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Research and development |
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270 |
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346 |
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558 |
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634 |
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Sales and marketing |
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1,554 |
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1,272 |
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3,285 |
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2,741 |
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General and administrative |
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772 |
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789 |
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1,471 |
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1,645 |
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Total operating expenses |
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2,596 |
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2,407 |
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5,314 |
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5,020 |
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Operating loss |
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(548 |
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(562 |
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(561 |
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(859 |
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Other income (expense): |
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Interest expense |
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(2 |
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(21 |
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(3 |
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(31 |
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Interest income |
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1 |
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1 |
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1 |
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2 |
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Total other expense, net |
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(1 |
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(20 |
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(2 |
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(29 |
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Loss before income taxes |
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(549 |
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(582 |
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(563 |
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(888 |
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Provision for income taxes |
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3 |
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8 |
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7 |
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16 |
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Net loss |
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$ |
(552 |
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$ |
(590 |
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$ |
(570 |
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$ |
(904 |
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Net loss 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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$ |
(0.02 |
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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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$ |
(0.02 |
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Weighted average shares outstanding: |
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Basic |
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45,739 |
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45,519 |
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45,646 |
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45,503 |
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Diluted |
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45,739 |
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45,519 |
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45,646 |
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45,503 |
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See accompanying notes.
4
CARDIOGENESIS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
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Six months ended |
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June 30, |
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2010 |
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2009 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(570 |
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$ |
(904 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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135 |
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152 |
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Provision for doubtful accounts |
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8 |
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Stock-based compensation expense |
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129 |
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100 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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(121 |
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331 |
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Inventories |
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54 |
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(18 |
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Prepaids and other current assets |
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38 |
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106 |
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Accounts payable |
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116 |
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122 |
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Accrued liabilities |
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(26 |
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(167 |
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Deferred revenue |
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43 |
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(1 |
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Net cash used in operating activities |
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(202 |
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(271 |
) |
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Cash flows from investing activities: |
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Acquisition of property and equipment |
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(31 |
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(9 |
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Proceeds from the sale of marketable securities |
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75 |
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Net cash (used in) provided by investing activities |
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(31 |
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66 |
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Cash flows from financing activities: |
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Payments for
repurchase and cancellation of shares |
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(48 |
) |
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Payments on note payable |
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(88 |
) |
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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 capital lease obligations |
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(4 |
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(3 |
) |
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Net cash (used in) provided by in financing activities |
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(140 |
) |
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7 |
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Net decrease in cash and cash equivalents |
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(373 |
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(198 |
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Cash and cash equivalents at beginning of period |
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2,568 |
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2,907 |
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Cash and cash equivalents at end of period |
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$ |
2,195 |
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$ |
2,709 |
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Supplemental schedule of cash flow information: |
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Interest paid |
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$ |
1 |
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$ |
2 |
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Taxes paid |
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$ |
12 |
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$ |
5 |
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Supplemental schedule of non-cash investing and financing activities: |
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Financing of property and equipment |
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$ |
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$ |
12 |
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Reclassification of inventories to property and equipment |
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$ |
43 |
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$ |
146 |
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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 States of
America (GAAP) 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 GAAP 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. The Company has evaluated subsequent events through the filing date of this Form 10-Q,
and determined that no subsequent events have occurred that would require recognition in the
condensed consolidated financial statements or disclosure in the notes thereto other than as
disclosed in the accompanying notes. These unaudited condensed consolidated financial statements
should be read in conjunction with the Companys audited consolidated financial statements and
notes thereto for the year ended December 31, 2009, contained in the Companys Annual Report on
Form 10-K, 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. Cardiogenesis has
incurred significant losses and as of June 30, 2010 it had an accumulated deficit of $171.7
million. Management believes its cash balance as of June 30, 2010 and expected results of
operations are sufficient to meet the Companys capital and operating requirements for the next 12
months.
However, the Company may require additional financing in the future if revenues are not as
expected or the Companys costs exceed its estimates. 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 shareholders, 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. 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 and six months ended June 30, 2010, there were approximately 788,000 and 613,000
potentially dilutive shares, respectively, that were excluded from diluted loss per share as their
effect would have been anti-
6
dilutive for the periods then ended. For the three and six months ended June 30, 2009, there
were approximately 442,000 and 222,000 potentially dilutive shares, respectively.
Use of Estimates:
The preparation of financial statements in conformity with GAAP 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 consolidated financial statements
include (but are not limited 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 stock-based compensation.
Risks and Concentrations:
Cardiogenesis sells its products primarily to hospitals and other healthcare providers in
North America, Europe and Asia. Cardiogenesis performs ongoing credit evaluations of its customers
and generally does not require collateral. Although Cardiogenesis maintains allowances for
potential credit losses that it believes to be adequate, a payment default on a significant sale
could materially and adversely affect its operating results and financial condition. At June 30,
2010 and December 31, 2009, no customer individually accounted for more than 10% of gross accounts
receivable. For the three and six month periods ended June 30, 2010 and June 30, 2009, no customer
individually accounted for more than 10% of net revenues.
As of June 30, 2010, approximately $969,000 of the Companys cash and cash equivalents were
maintained in money market mutual funds, and approximately $1,226,000 of the Companys cash and
cash equivalents were maintained at a major financial institution in the United States. At times,
deposits held with the financial institution may exceed the amount of insurance provided by the
Federal Deposit Insurance Corporation (the FDIC), which provides deposit coverage with limits up
to $250,000 per owner through December 31, 2013. Generally, these deposits may be redeemed upon
demand and, therefore, are believed to bear low risk.
After giving effect to the increased FDIC insurance, at June 30, 2010, the Companys uninsured
cash totaled approximately $1,991,000.
The Company outsources the manufacturing and assembly of its handpieces to a single contract
manufacturer. The Company also outsources the manufacturing of its laser consoles to a different
single contract manufacturer.
Certain components of laser consoles and fiber-optic handpieces are generally acquired from
multiple sources. Other laser and fiber-optic components and subassemblies are purchased from
single sources. Although the Company has identified alternative vendors, the qualification of
additional or replacement vendors for certain components or services is a lengthy process. Any
significant supply interruption would have a material adverse effect on the Companys ability to
manufacture its products and, therefore, would harm its business. The Company intends to continue
to qualify multiple sources for components that are presently single sourced.
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.
7
The Company, at times, will loan laser consoles to hospitals and charge an additional amount
(the Premium) over the stated list price on its handpieces in exchange for the use of the laser
console. In accordance with the accounting standards for leases, these arrangements are recorded as
leases as they convey the right to use the laser console over the period of time the customers are
purchasing handpieces. The loaned laser consoles are classified as operating leases and are
transferred from inventory to property and equipment upon commencement of the loan. In addition,
the Premium is considered contingent rent, and therefore, such amounts allocated to the lease of
the laser console are 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 multiple element arrangements, such as sales of laser consoles and
handpieces, by allocating revenue for each respective element based on its selling price and when
revenue recognition criteria for each element have been met.
In addition to the standard product warranty, the Company periodically offers extended
warranties to its customers in the form of product maintenance services. Service agreements on its
equipment are typically sold separately from the sale of the equipment. In accordance with the
accounting standards for warranties, revenues on these service agreements are recognized ratably
over the life of the agreement, typically one to three years.
Segment Disclosures:
The Company operates in one segment. The principal market for the Companys products is in the
United States. International sales occur primarily in Europe, Mexico and Asia and amounted to
approximately $0 and $40,000 for the three and six months ended June 30, 2010, respectively. For
the three and six months ended June 30, 2009, the Companys international sales were $20,000 and
$92,000, respectively. International sales represented less than 1% of total net revenues for both
the three and six months ended June 30, 2010 and 1% and 2% of total net revenues for the three and
six months ended June 30, 2009, respectively. The majority of international sales are denominated
in U.S. Dollars. All of the Companys long-lived assets are located in the United States.
Recent Accounting Pronouncements:
In September 2009, the Financial Accounting Standards Board (FASB) issued an update to its
accounting guidance regarding multiple-deliverable revenue arrangements. The guidance addresses how
to measure and allocate consideration to one or more units of accounting. Specifically, the
guidance requires that consideration be allocated among multiple deliverables based on relative
selling prices. The guidance establishes a selling price hierarchy of (1) vendor-specific objective
evidence, (2) third-party evidence and (3) estimated selling price. This guidance is effective for
annual periods beginning on or after June 15, 2010 but may be early adopted as of the beginning of
an annual period. The Company adopted this guidance on January 1, 2010 and it did not have a
material impact on its consolidated financial statements.
In January 2010, the FASB issued an update to its accounting guidance regarding fair value
measurement and disclosure. The guidance affects the disclosures made about recurring and
non-recurring fair value measurements. This guidance is effective for annual reporting periods
beginning after December 15, 2009, except for the disclosures about purchases, sales, issuances and
settlements in the roll forward of activity in Level 3 fair value measurements. Those disclosures
are effective for fiscal years beginning after December 15, 2010. Early adoption is permitted. The
Company is currently evaluating the impact that this guidance will have on its consolidated
financial statements.
Other recent accounting pronouncements issued by the FASB (including the Emerging Issues Task
Force (EITF)) and the American Institute of Certified Public Accountants did not, or are not
believed by management to, have a material impact on the Companys present or future consolidated
financial statements.
8
3. Inventories:
Inventories are stated at the lower of cost (first-in, first-out) or market and consist of the
following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
(unaudited) |
|
|
(audited) |
|
Raw materials |
|
$ |
115 |
|
|
$ |
141 |
|
Work-in-process |
|
|
269 |
|
|
|
192 |
|
Finished goods |
|
|
433 |
|
|
|
581 |
|
|
|
|
|
|
|
|
Total |
|
$ |
817 |
|
|
$ |
914 |
|
|
|
|
|
|
|
|
4. Stock-Based Compensation:
In accordance with the accounting standards for stock-based compensation, the Company
recognizes all share-based payments to employees, including grants of employee stock options and
restricted stock grants, based upon their fair values. The Company uses the Black-Scholes option
pricing model to estimate the grant-date fair value of share-based awards with the fair value
determined at the date of grant. The financial statement effect of forfeitures is estimated at the
time of grant and revised, if necessary, if the actual effect differs from those estimates.
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 June 30, 2010, the Company is authorized to
issue up to an aggregate of 12,125,000 shares under these plans.
The Companys 1996 Employee Stock Purchase Plan (the ESPP) was adopted in April 1996 and
amended in July 2005. A total of 1,500,000 common shares are reserved for issuance under the ESPP,
as amended. The ESPP 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 suspended the ESPP effective at the end of the November 16, 2008
offering period.
The Company has treated the ESPP as a compensatory plan.
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 are estimated and it is assumed no dividends will be declared. The
estimated fair value of stock-based
9
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 six months ended June 30, 2010 and 2009 were based on the following
assumptions:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2010 |
|
2009 |
Expected term |
|
5.36 5.54 years |
|
6.30 years |
Expected volatility |
|
|
96.05 97.56 |
% |
|
|
100.86 102.94 |
% |
Risk-free interest rate |
|
|
2.38 2.53 |
% |
|
|
2.11 2.70 |
% |
Expected dividend yield |
|
|
|
|
|
|
|
|
A summary of option activity as of June 30, 2010 and changes during the six 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, 2010 |
|
|
3,223 |
|
|
$ |
0.49 |
|
|
|
|
|
|
|
|
|
Options granted |
|
|
345 |
|
|
$ |
0.37 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
Options forfeited/canceled |
|
|
(193 |
) |
|
$ |
1.34 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding and expected to vest at June 30, 2010 |
|
|
3,375 |
|
|
$ |
0.43 |
|
|
|
6.7 |
|
|
$ |
260 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at June 30, 2010 |
|
|
2,421 |
|
|
$ |
0.50 |
|
|
|
5.8 |
|
|
$ |
148 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 at period end. There were no
stock options exercised during the six months ended June 30, 2010. There were 2,020,634 options
outstanding and 1,371,187 exercisable options as of June 30, 2010, that were in-the-money. At June
30, 2009, there were no exercisable stock options that were in-the-money.
The weighted average grant date fair value of options was $0.29 for both the three and six
months ended June 30, 2010. The weighted average grant date fair value of options granted during
the three and six months ended June 30, 2009 was $0.17 and 0.13 per option, respectively.
As of June 30, 2010, there was approximately $154,000, net of forfeitures, 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 remaining vesting
period of approximately 1.2 years. For the three and six months ended June 30, 2010, the amount of
stock-based compensation expense related to stock options was approximately $39,000 and $73,000,
respectively as compared to $32,000 and $64,000, respectively recognized in the prior year
comparative periods. There was no stock-based compensation expense related to ESPP contributions
during the three and six months ended June 30, 2010. For the three and six months ended June 30,
2009, the amount of stock-based compensation expense related to ESPP contributions was
approximately $0 and $12,000, respectively.
On March 31, 2009, the Company granted awards of restricted stock to each of its employees
totaling approximately 1,208,000 shares with a grant date fair value of approximately $302,000. The
shares vest as to 33% of the shares on the first anniversary of the grant date, 33% of the shares
on the second anniversary of the grant date and 34% of the shares on the third anniversary of the
grant date. In addition, in connection with Paul McCormicks appointment to Executive Chairman, on
July 1, 2009, Mr. McCormick was granted 300,000 shares of restricted stock, with a grant date fair
value of $57,000, under the Companys Stock Option Plan. The restrictions on Mr.
10
McCormicks shares of restricted stock will lapse in equal installments upon the first and
second anniversaries of the date of grant. On May 17, 2010, in connection with his amended
employment agreement, Mr. McCormick was granted an additional 100,000 shares of restricted stock
under the Companys Stock Option Plan. The restrictions of these shares of restricted stock will
lapse on the one year anniversary of the grant date. The grant date fair value of these shares of
restricted stock is $38,000.
During the six month period ended June 30, 2010, the Company repurchased and cancelled 125,983
shares of its common stock in connection with the vesting of 315,324 shares of restricted stock.
The value of the shares repurchased was approximately $48,000, based on the closing market price on
the measurement date. In lieu of remitting the value of the shares to the holders, the Company used
such amount to remit income tax withholdings associated with the vested shares. Accordingly, the
Company recorded the aggregate original issue price of approximately $33,000 to equity and the
difference of the fair value at vesting and the original issue price of approximately $15,000 to
accumulated deficit.
For the three and six months ended June 30, 2010, the stock based compensation related to the
amortization of the related compensation cost of the restricted stock was approximately $29,000 and
$56,000, respectively. For the three and six months ended June 30, 2009, the stock compensation
related to the amortization of the related compensation cost of the restricted stock was
approximately $24,000. Since shares of restricted stock are subject to cliff vesting the unvested
shares as of June 30, 2010, have been excluded from the issued and outstanding shares and basic
loss per share computations. As of June 30, 2010, there was approximately $193,000 of total
unrecognized compensation cost related to restricted stock that is expected to be recognized over
the weighted average remaining vesting period of approximately 1.5 years.
The following table summarizes the restricted stock activity for the six months ended June 30,
2010 (in thousands):
|
|
|
|
|
|
|
June 30, |
|
|
2010 |
Unvested Restricted Stock Outstanding at January 1, 2010 |
|
|
1,256 |
|
Granted |
|
|
100 |
|
Forfeited |
|
|
(47 |
) |
Vested |
|
|
(315 |
) |
|
|
|
|
|
Unvested Restricted Stock Outstanding at June 30, 2010 |
|
|
994 |
|
|
|
|
|
|
The following table summarizes stock-based compensation expense related to stock options,
restricted stock and ESPP purchases for the three and six months ended June 30, 2010 and 2009 which
was allocated as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Stock-based compensation expense included in: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
4 |
|
|
$ |
4 |
|
|
$ |
8 |
|
|
$ |
6 |
|
Sales and marketing |
|
|
26 |
|
|
|
25 |
|
|
|
56 |
|
|
|
48 |
|
General and administrative |
|
|
38 |
|
|
|
27 |
|
|
|
65 |
|
|
|
46 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
68 |
|
|
$ |
56 |
|
|
$ |
129 |
|
|
$ |
100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5. Legal Matters:
As previously reported, 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 had previously violated patent rights allegedly held by CardioFocus. All
of the asserted patents have now expired.
On June 13, 2008, Cardiogenesis filed requests for reexamination of the patents being asserted
against Cardiogenesis with the United States Patent and Trademark Office (USPTO) and asserted
that prior art had been
11
identified that raised substantial new issues of patentability with respect to the inventions
claimed by CardioFocus patents. In August 2008, the USPTO granted Cardiogenesis reexamination
requests. Reexamination requests filed by other named defendants were also granted. The USPTO
finally concluded and CardioFocus is not appealing the following determinations made in
reexamination: (a) all asserted claims of CardioFocus U.S. Patent No. 6,159,203 (the 203
Patent) are unpatentable; (b) 11 of 14 claims of U.S. Patent No. 6,547,780 (the 780 Patent) are
unpatentable; and (c) 8 of 13 claims of U.S. Patent No. 5,843,073 (the 073 Patent) are
unpatentable. Three claims being asserted by CardioFocus against the Company, namely, Claim 2 of
the 780 Patent and Claims 2 and 7 of the 073 Patent have been confirmed by the USPTO.
In view of the reexamination having been completed, the Court, at a status conference held on
April 22, 2010, issued a scheduling order scheduling dates in connection with the litigation
regarding discovery, law and motion practice, a briefing schedule and hearing for patent claim
interpretation proceedings, and other key events. A settlement conference has been scheduled for
October 2010 and trial is set to commence on November 7, 2011.
Since the Courts issuance of the scheduling order, the parties have engaged and continue to
engage in discovery. Cardiogenesis has further filed two (2) further reexamination requests seeking
to invalidate the remaining claims of the 780 Patent and 073 Patent being asserted against
Cardiogenesis. The reexamination requests were filed on June 30, 2010, and are based, in part, on
newly identified prior art not previously considered by the USPTO. A determination as to whether
Cardiogenesis reexamination requests will be granted is expected by September 30, 2010.
The Company intends to defend itself vigorously in this action. At this time, the Company is
unable to predict the outcome of this matter. At this time, the Company believes that the outcome
of this matter will not have a material adverse effect on the Companys financial position, results
of operations, or cash flow. However, as this matter is ongoing, there is no assurance that this
matter will be resolved favorably by the Company or will not result in a material liability.
Except as described above, the Company is not a party to any material legal proceeding.
6. Related Party Transactions:
The Company entered into a consulting agreement with Mr. McCormick, the Companys Chairman of
the Board, effective January 15, 2009. Pursuant to the consulting agreement, Mr. McCormick provided
consulting services relating to corporate strategy development and execution, financing and
investor relations up to 16 hours per week. In consideration for such services, the Company paid
Mr. McCormick $8,000 per month and reimbursed Mr. McCormick for healthcare insurance coverage up to
$15,600 per year. The consulting agreement had a term of 18 months, but was mutually terminated as
of June 30, 2009.
Effective July 1, 2009, the Company entered into an employment agreement with Mr. McCormick
whereby he agreed to serve as the Executive Chairman of the Board of Directors and principal
executive officer of the Company. Under the terms of the employment agreement, Mr. McCormick was
entitled to an annual base salary of $250,000, provided that he devotes at least 75% of his time to
his duties and responsibilities as Executive Chairman under the employment agreement. Mr. McCormick
is entitled to receive certain benefits which will include, at a minimum, medical insurance for Mr.
McCormick and his spouse, as well as no less than three weeks paid vacation per year. In addition,
Mr. McCormick is entitled to be reimbursed for all reasonable expenses incurred by him in respect
of his services to the Company under the employment agreement. The employment agreement had an
initial term of one year, which term is automatically renewed for successive additional one year
periods, unless terminated upon 30 days written notice by either Mr. McCormick or the Company. In
connection with Mr. McCormicks appointment to Executive Chairman, the Board of Directors granted
him 300,000 shares of restricted stock under the Companys Stock Option Plan. The restrictions on
Mr. McCormicks shares of restricted stock lapse in equal instalments upon the first and second
anniversaries of the date of grant.
Effective July 1, 2010, the Company entered into an amendment to the employment agreement
dated as of July 1, 2009 by and between the Company and Mr. McCormick, pursuant to which the
Company and Mr. McCormick agreed to the following changes to his employment agreement: (i) Mr.
McCormick will receive an annual base salary of $200,000, which represents a decrease of $50,000
per year. In conjunction with the amended agreement,
12
on May 17, 2010, the Board of Directors approved a grant of 100,000 shares of restricted stock
under the Corporations Stock Option Plan, with such restrictions lapsing after one year from the
date of grant, and an option to purchase 100,000 shares of common stock, which would vest in full
on the first anniversary of the date of grant.
Effective July 1, 2009, the Company entered into an amendment to the employment agreement
dated as of July 30, 2007 by and between the Company and Richard P. Lanigan, pursuant to which the
Company and Mr. Lanigan agreed to the following changes to his employment agreement: (i) Mr.
Lanigans title will be Executive Vice President, Marketing of the Company, (ii) Mr. Lanigan will
receive an annual base salary of $225,000, which represents a decrease of $22,500 per year, and
(iii) Mr. Lanigan will report directly to the Executive Chairman of the Company.
The Company entered into a consulting agreement with Dr. Marvin Slepian, a member of the
Companys Board of Directors, dated April 1, 2010 and effective March 24, 2010. Pursuant to the
agreement, Dr. Slepian will provide consulting services at the Companys direction relating to
basic and clinical scientific initiatives as well as development of certain scientific and
educational materials. In consideration for such services, the Company will pay Dr. Slepian $400
per hour up to a maximum of $2,500 per day. The agreement may be terminated by either party upon
thirty days written notice. For both the three and six months ended June 30, 2010, the Company paid
Dr. Slepian a total of $2,500 for consulting services half of which is included in research and
development expenses and the other half is included in sales and marketing expenses in the
accompanying consolidated statements of operations.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Managements Discussion and Analysis of Financial Condition and Results of Operations contains
certain statements relating to future results, which are forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities
Exchange Act of 1934, as amended. 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. These
forward-looking statements are based on the beliefs of management, as well as assumptions and
estimates based on information available to us as of the dates such assumptions and estimates are
made, and are subject to certain risks and uncertainties that could cause actual results to differ
materially from historical results or those anticipated, depending on a variety of factors,
including those factors discussed in the section titled Risk Factors contained in Part I, Item 1A
of our Annual Report on Form 10-K for the year ended December 31, 2009. Should one or more of those
risks or uncertainties materialize adversely, or should underlying assumptions or estimates prove
incorrect, actual results may vary materially from those described. Those events and uncertainties
are difficult or impossible to predict accurately and many are beyond our control. Except as may be
required by applicable law, we assume no obligation to publicly release the result of any revisions
that may be made to any forward-looking statements to reflect events or circumstances after the
date of such statements or to reflect the occurrence of anticipated or unanticipated events. 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
We design, develop and distribute laser-based surgical products and disposable fiber-optic
accessories for the treatment of cardiac ischemia associated with advanced cardiovascular disease.
Transmyocardial revascularization or TMR, is a surgical procedure, in which transmural channels are
made in heart muscle that cannot be treated by conventional methods and has been proven to reduce
angina in selected patients. Many experts believe the mechanism of action for the relief of
symptoms is a combination of denervation and angiogenesis.
We have received both FDA approval and a CE mark for our products. Hospitals and physicians
are eligible to receive Medicare reimbursement for TMR equipment and procedures on indicated
Medicare patients.
We generate the majority of our revenue from sales of our laser consoles and our disposable
handpiece units. Due to the current economic slowdown and the reluctance of many customers to make
investments in additional
13
capital equipment, sales of our laser consoles have decreased from historic levels. As a
result of these and other factors, we refocused our sales strategy in 2009 to emphasize sales of
our handpieces, particularly to focus on increasing penetration of accounts with previously
installed laser consoles. In combination with the emphasis on sales of handpieces, we have also
become more active in conducting and sponsoring professional seminars to educate cardiac surgeons,
as well as cardiologists that refer patients to the cardiac surgeon for treatment. Cardiologists
are the gatekeepers for patients with cardiac disease and must be updated on the data and clinical
benefits of TMR. We believe this refocused strategy will be effective in growing our revenue over
the long term.
In addition, we continue our research and development activities in an effort to develop new
technologies for the treatment of cardiac ischemia. We submitted an IDE application in December
2009, to begin a U.S. clinical trial for the PHOENIX handpiece; a product that combines TMR as
tissue stimulation combined with the intramyocardial delivery of biologics or stem cells. We are
currently investing resources to support our domestic strategy. We believe that, if the PHOENIX
handpiece can ultimately obtain FDA marketing approval it will be the core product to enable us to
achieve our desired future growth.
As of June 30, 2010, we had an accumulated deficit of $171.7 million. We may continue to incur
operating losses. 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 laser consoles and handpieces,
which are the components of our TMR System, and related services. In addition, we loan our laser
consoles to hospitals in accordance with our loaned laser programs. Under certain loaned laser
programs we charge the customer an additional amount over the stated list price on our handpieces
in exchange for the use of the laser console or we collect an upfront deposit that can be applied
towards the purchase of a laser console.
Net revenues of $2,429,000 for the three months ended June 30, 2010 increased $193,000, or 9%,
when compared to net revenues of $2,236,000 for the three months ended June 30, 2009. The increase
in sales was primarily attributed to an increase in handpiece revenue for the three month period
ended June 30, 2010, as compared to the prior year. We refocused our sales strategy in 2009 to
emphasize sales of our handpieces, particularly to focus on increasing penetration of accounts with
previously installed laser consoles.
For the three months ended June 30, 2010, domestic handpiece revenue increased by $179,000, or
9%. In the second quarter of 2010, domestic handpiece revenue was $2,081,000, inclusive of $135,000
in sales of product to customers operating under our loaned laser program. In the second quarter of
2009, domestic handpiece revenue was $1,902,000, inclusive of $124,000 in sales of product to
customers operating under our loaned laser program. For the three months ended June 30, 2010 laser
sales were $59,000 as compared to no laser sales in the three months ended June 30, 2009.
There were no international sales during the three months ended June 30, 2010, as compared to
$20,000 of international sales in the three months ended June 30, 2009. In addition, service and
other revenue of $289,000 decreased $25,000 for the three months ended June 30, 2010, when compared
to $314,000 for the quarter ended June 30, 2009.
Net revenues of $5,662,000 for the six months ended June 30, 2010 increased $574,000, or 11%,
when compared to net revenues of $5,088,000 for the six months ended June 30, 2009. This increase
can also be attributed to an increase in domestic handpiece revenue.
For the six months ended June 30, 2010, domestic handpiece revenue increased by $671,000 or
19% and domestic laser revenue increased by $7,000 compared to the six months ended June 30, 2009.
In the first six months of 2010, domestic handpiece revenue was $4,271,000, inclusive of $373,000
in sales of product to customers
14
operating under our loaned laser program. In the first six months of 2009, domestic handpiece
revenue was $3,600,000, inclusive of $235,000 in sales of product to customers operating under our
loaned laser program.
International sales, accounting for less than 1% of net revenues for the six months ended June
30, 2010, decreased $52,000, or 57%, as compared to the prior year period. In addition, service and
other revenue of $578,000 decreased $52,000 for the six months ended June 30, 2010 when compared to
$630,000 for the six months ended June 30, 2009.
Gross Margin
Gross margin, which was of 84% of net revenues for the three months ended June 30, 2010, was
higher than our gross margin of 83% of net revenues for the three months ended June 30, 2009. Gross
profit in absolute dollars increased by $203,000 to $2,048,000 for the current year second quarter
as compared with $1,845,000 for the 2009 second quarter. For the six months ended June 30, 2010,
the gross margin percentage increased to 84% of net revenues as compared to 82% of net revenues for
the six months ended June 30, 2009. Gross profit in absolute dollars increased by $592,000 to
$4,753,000 for the six months ended June 30, 2010, as compared to $4,161,000 for the six months
ended June 30, 2009. The increase in the gross margin percentage for the second quarter was
primarily attributed to a higher average selling price on handpieces.
Research and Development
Research and development expense consists of 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 three months ended June 30, 2010, research and development expenditures of $270,000
decreased $76,000, or 22%, when compared to $346,000 for the three months ended June 30, 2009. As a
percentage of revenues, research and development expenditures were 11% during the three months
ended June 30, 2010 as compared to 15% for the prior year period. For the six months ended June 30,
2010, research and development expenditures of $558,000 decreased $76,000 or 12% when compared to
$634,000 for the six months ended June 30, 2009. As a percentage of revenues, research and
development expenditures were 10% for the six months ended June 30, 2010 as compared to 12% for the
prior year period. The dollar decrease for the three and six months ended June 30, 2010 was
primarily attributed to prior year submissions to the Food and Drug Administration related to the
Premarket Approval Application for the PEARL 8.0 handpiece and the pre-Investigational Device
Exemption to initiate a feasibility trial for the PHOENIX handpiece.
Sales and Marketing
Sales and marketing expense consists of 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 three months ended June 30, 2010, sales and marketing expenditures of $1,554,000
increased $282,000, or 22%, when compared to $1,272,000 for the three months ended June 30, 2009.
As a percentage of revenues, sales and marketing expenditures were 64% during the three months
ended June 30, 2010 as compared to 57% for the prior year period. The increase in sales and
marketing expenditures for the three months ended June 30, 2010 as compared to the prior year
period was primarily due to a $99,000 increase in salary and other employee related expenses as a
result of increased headcount as well as higher commissions expense related to the increase in net
revenues.
For the six months ended June 30, 2010, sales and marketing expenditures of $3,285,000
increased $544,000, or 20%, when compared to $2,741,000 for the six months ended June 30, 2009. As
a percentage of revenues, sales and marketing expenditures were 58% as compared to 54% for the
prior year period. The dollar and percentage increase in sales and marketing expenditures for the
six month periods was also a result of increased headcount which led to higher salaries and wage
expense as well as higher travel and entertainment expense. Salaries and wage expense
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was also higher for the six months ended June 30, 2010, due to higher commission expense as a
result of the increase in net revenues.
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 three months ended June 30, 2010,
general and administrative expenditures totaled $772,000, or 32% of net revenues, as compared to
$789,000, or 35% of net revenues, during the three months ended June 30, 2009. This represents a
decrease of $17,000, or 2%. For the six months ended June 30, 2010, general and administrative
expenditures totaled $1,471,000 or 26% of net revenues as compared to $1,645,000, or 32% of net
revenues, for the six months ended June 30, 2009. The decrease for the three month and six month
periods was primarily a result of a reduced headcount which led to lower salaries and wages
expense.
Liquidity and Capital Resources
At June 30, 2010, we had cash and cash equivalents of $2,195,000 compared to $2,568,000 at
December 31, 2009, a decrease of $373,000. During the six months ended June 30, 2010, cash used in
operating activities totaled $202,000, which primarily resulted from a net loss of $570,000 and an
increase in accounts receivable, partially offset by an increase in accounts payable and a
reduction in inventory levels. During the six months ended June 30, 2009 cash used in operating
activities totaled $271,000, which primarily resulted from a decrease in accrued liabilities offset
by a decrease in accounts receivable, a decrease in prepaids and other current assets, and an
increase in accounts payable.
Cash used in investing activities during the six months ended June 30, 2010 was $31,000 due to
property and equipment purchases. Cash provided by investing activities during the six months ended
June 30, 2009 was $66,000 primarily due to the redemption of investments in marketable securities.
Cash used in financing activities during the six months ended June 30, 2010 was $140,000,
which primarily consisted of repayment of $88,000 related to the short term note payable and
$48,000 related to the purchase and cancellation of 125,983 shares of our common stock for the
payment of income tax withholdings due upon the vesting of restricted stock issued to employees.
Cash provided by investing activities during the six months ended June 30, 2009 was $7,000 which
represented proceeds from purchases of common stock under the Employee Stock Purchase Plan
We have incurred significant operating losses and as of June 30, 2010 we had an accumulated
deficit of $171.7 million. Our ability to maintain current operations is dependent upon increasing
our sales from current levels. Our focus is executing upon our core and critical activities, thus
operating expenses that are nonessential to our core operations have been reduced or eliminated.
We believe our cash balance as of June 30, 2010, cash receipts from sales of our products, and
actions we have taken to manage sales and marketing and general and administrative expenses will be
sufficient to meet our capital, debt and operating requirements through the next twelve months.
However, our actual future capital requirements will depend on many factors, including the
following:
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the success of the commercialization of our products and our refocused sales
strategy; |
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sales and marketing activities, and expansion of our commercial infrastructure,
related to our approved products and product candidates; |
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the results of our clinical trials and requirements to conduct additional
clinical trials; |
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the rate of progress of our research and development programs; |
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the time and expense necessary to obtain regulatory approvals; |
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activities and payments in connection with potential acquisitions of companies,
products or technology; and |
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competitive, technological, market and other developments. |
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In particular, we anticipate that we will have to incur significant expenses to complete the
clinical trials expected to be required to obtain FDA approval of our PHOENIX handpiece. If
revenues from sales of our products are not sufficient to continue our current operations and fund
these clinical trials, we will need to obtain debt or equity financing, significantly reduce our
operations, or abandon clinical trials for the PHOENIX handpiece.
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 successful execution of our refocused sales strategy and achieving regulatory approval for
the PHOENIX handpiece. If these efforts are unsuccessful, we will be unable to significantly
increase our revenues and may have to obtain additional financing to continue our operations or
scale back our operations. Due to the current economic conditions, it has become very difficult for
companies to obtain debt financing on reasonable terms, if at all. In addition, it may be difficult
for us to obtain significant equity financing as a result of our low trading price and trading
volume combined with our stock not being listed on a national securities exchange, such as NYSE
Amex or NASDAQ. As a result, we may not be able to obtain additional financing if required, or even
if we were to obtain any financing, it may contain burdensome restrictions on our business, in the
case of debt financing, or result in significant dilution, in the case of equity financing.
Critical Accounting Policies and Estimates
The preparation of our financial statements requires that we make estimates and assumptions
that affect the reported amounts of assets and liabilities and related disclosure of contingent
assets and liabilities at the date of the financial statements and the reported amounts of revenues
and expenses during the reporting periods. On an ongoing basis, we evaluate these estimates and
assumptions, which are based on historical experience and on other assumptions that we believe to
be reasonable. In the event that any of our estimates and assumptions are inaccurate in any
material respect, it could have a material adverse effect on our reported amounts of assets and
liabilities at the date of the financial statements and the reported amounts of revenues and
expenses during the reporting periods. A summary of our critical accounting policies is included in
Item 7 (Managements Discussion and Analysis of Financial Condition and Results of Operations) of
Part II, of our Annual Report on Form 10-K for the fiscal year ended December 31, 2009. There have
been no material changes to the critical accounting policies disclosed in our Annual Report on Form
10-K for the fiscal year ended December 31, 2009.
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 our
management, including our principal executive officer and our principal 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 June 30, 2010. Based
upon that evaluation, our principal executive officer and our principal financial officer concluded
that the design and operation of these disclosure controls and procedures at June 30, 2010 were
effective in timely alerting them to the material information relating to us required to be
included in our periodic filings with the SEC, such that the information relating to us, 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 our
management, including our principal executive officer and principal financial officer, as
appropriate to allow timely decisions regarding required disclosure.
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 all
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.
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Changes in internal control over financial reporting
There were no changes in our internal control over financial reporting that occurred during
the quarter ended June 30, 2010 that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
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PART II
OTHER INFORMATION
Item 1. Legal Proceedings
As previously reported, 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
had previously violated patent rights allegedly held by CardioFocus. All of the asserted patents
have now expired.
On June 13, 2008, we filed requests for re-examination of the patents being asserted against
us with the United States Patent and Trademark Office, or USPTO, 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 USPTO granted our reexamination requests.
Reexamination requests filed by other named defendants were also granted. The USPTO has now finally
concluded, and CardioFocus is not appealing, the following determinations made in reexamination:
(a) all asserted claims of CardioFocus U.S. Patent No. 6,159,203 are unpatentable; (b) 11 of 14
claims of U.S. Patent No. 6,547,780 are unpatentable; and (c) 8 of 13 claims of U.S. Patent No.
5,843,073 are unpatentable. However, three claims being asserted by CardioFocus against us, namely,
Claim 2 of the 780 patent and Claims 2 and 7 of the 073 patent have been confirmed by the USPTO.
In view of the re-examination having been completed, the Court, at a status conference held on
April 22, 2010, issued a scheduling order scheduling dates in connection with the litigation
regarding discovery, law and motion practice, a briefing schedule and hearing for patent claim
interpretation proceedings, and other key events. A settlement conference has been scheduled for
October 2010 and trial is set to commence on November 7, 2011.
Since the Courts issuance of the scheduling order, the parties have engaged and continue to
engage in discovery. We have further filed two (2) further reexamination requests seeking to
invalidate the remaining claims of the 780 Patent and 073 Patent being asserted against us. The
reexamination requests were filed on June 30, 2010, and are based, in part, on newly identified
prior art not previously considered by the USPTO. A determination as to whether our reexamination
requests will be granted is expected by September 30, 2010.
We intend to defend ourselves vigorously in this action. At this time, we are unable to
predict the outcome of this matter. At this time, we believe that the outcome of this matter will
not have a material adverse effect on our financial position, results of operations, or cash flow.
However, as this matter is ongoing, there is no assurance that this matter will be resolved
favorably by us or will not result in a material liability.
Item 6. Exhibits
The exhibits below are filed or incorporated herein by reference.
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Exhibit No. |
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Description |
10.1
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Amendment to Employment Agreement between Cardiogenesis
Corporation and Paul McCormick, dated as of May 17, 2010
(incorporated by reference to Cardiogenesis Current Report on
Form 8-K filed with the Securities and Exchange Commission on
May 19, 2010). |
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31.1
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Certification of the Principal Executive Officer pursuant to
Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of
1934. |
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31.2
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Certification of the Chief Financial Officer pursuant to Rule
13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934. |
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32.1
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Certification of the Principal Executive Officer pursuant to
Rule 13a-14(b)/15d-14(b) of the Securities Exchange Act of
1934 and 18 U.S.C. Section 1350. |
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32.2
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Certification of the Chief Financial Officer pursuant to Rule
13a-14(b)/15d-14(b) of the Securities Exchange Act of 1934 and
18 U.S.C. Section 1350. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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CARDIOGENESIS CORPORATION
Registrant
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Date: August 09, 2010 |
/s/ Paul J. McCormick
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Paul J. McCormick |
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Executive Chairman
(Principal Executive Officer) |
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Date: August 09, 2010 |
/s/ William R. Abbott
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William R. Abbott |
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Senior Vice President, Chief Financial Officer,
Secretary and Treasurer
(Principal Financial and Accounting Officer) |
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Exhibit Index
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Exhibit No. |
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Description |
10.1
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Amendment to Employment Agreement between Cardiogenesis
Corporation and Paul McCormick, dated as of May 17, 2010
(incorporated by reference to Cardiogenesis Current Report on
Form 8-K filed with the Securities and Exchange Commission on
May 19, 2010). |
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31.1
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Certification of the Principal Executive Officer pursuant to
Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of
1934. |
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31.2
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Certification of the Chief Financial Officer pursuant to Rule
13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934. |
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32.1
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Certification of the Principal Executive Officer pursuant to
Rule 13a-14(b)/15d-14(b) of the Securities Exchange Act of
1934 and 18 U.S.C. Section 1350. |
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32.2
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Certification of the Chief Financial Officer pursuant to Rule
13a-14(b)/15d-14(b) of the Securities Exchange Act of 1934 and
18 U.S.C. Section 1350. |