e10vq
SECURITIES AND EXCHANGE COMMISSION
FORM 10-Q
(Mark One)
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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, 2007
Or
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o |
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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: 0-27598
IRIDEX CORPORATION
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction of
incorporation or organization)
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77-0210467
(I.R.S. Employer
Identification Number) |
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1212 Terra Bella Avenue
Mountain View, California
(Address of principal executive offices)
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94043-1824
(Zip Code) |
Registrants telephone number, including area code: (650) 940-4700
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 o No þ
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a
non-accelerated filer. See definition of accelerated filer and large accelerated filer in Rule 12b-2 of
the Exchange Act.
Large accelerated filer o Accelerated filer o Non-accelerated filer 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
APPLICABLE TO CORPORATE ISSUERS:
The number of shares of common stock, $.01 par value, issued and outstanding as of August 1, 2007 was
8,213,749
PART I FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements (unaudited)
IRIDEX
Corporation
Condensed Consolidated Balance Sheets
(in thousands)
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June 30, |
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December 30, |
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2007 (1) |
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2006 (2) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
3,551 |
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$ |
21,051 |
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Restricted cash |
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3,800 |
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Accounts receivable, net |
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10,208 |
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6,052 |
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Inventories |
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13,973 |
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9,499 |
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Prepaids and other current assets |
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4,152 |
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1,264 |
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Total current assets |
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$ |
35,684 |
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$ |
37,866 |
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Property and equipment, net |
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1,836 |
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1,087 |
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Goodwill |
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9,903 |
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Other intangible assets, net |
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15,250 |
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Other long term assets |
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294 |
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1,224 |
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Total assets |
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$ |
62,967 |
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$ |
40,177 |
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
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$ |
6,075 |
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$ |
1,830 |
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Short term debt |
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3,863 |
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Accrued compensation |
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2,244 |
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1,517 |
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Accrued expenses |
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8,251 |
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2,392 |
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Accrued warranty |
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2,335 |
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866 |
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Deferred revenue |
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4,239 |
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1,415 |
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Current portion of long term debt |
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5,508 |
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Total current liabilities |
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$ |
32,515 |
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$ |
8,020 |
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Commitments and contingencies |
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Stockholders equity: |
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Common stock |
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83 |
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79 |
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Additional paid-in capital |
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33,273 |
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29,697 |
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Accumulated other comprehensive loss |
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(22 |
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Treasury stock |
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(430 |
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(430 |
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(Accumulated deficit) retained earnings |
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(2,452 |
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2,811 |
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Total stockholders equity |
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30,452 |
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32,157 |
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Total liabilities and stockholders equity |
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$ |
62,967 |
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$ |
40,177 |
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(1) |
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Unaudited |
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(2) |
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Derived from the consolidated audited financial statements included in our report filed on
Form 10-K with the SEC for the year ended December 30, 2006. |
The accompanying notes are an integral part of these condensed consolidated financial statements.
-1-
IRIDEX Corporation
Condensed Consolidated Statements of Operations
(Unaudited, in thousands except per share data)
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Three Months Ended |
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Six months ended |
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June 30, |
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July 1, |
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June 30, |
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July 1, |
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2007 |
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2006 |
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2007 |
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2006 |
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Sales |
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$ |
15,249 |
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$ |
8,804 |
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$ |
27,815 |
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$ |
17,647 |
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Cost of sales |
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8,665 |
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4,145 |
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16,023 |
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8,726 |
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Gross profit |
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6,584 |
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4,659 |
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11,792 |
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8,921 |
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Operating expenses: |
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Research and development |
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1,588 |
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1,328 |
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3,317 |
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2,449 |
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Selling, general and administrative |
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7,546 |
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3,864 |
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15,820 |
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7,796 |
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Total operating expenses |
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9,134 |
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5,192 |
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19,137 |
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10,245 |
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Loss from operations |
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(2,550 |
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(533 |
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(7,345 |
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(1,324 |
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Legal settlement |
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2,500 |
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2,500 |
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Interest and other (expense) income, net |
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(293 |
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177 |
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(418 |
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356 |
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Loss before income taxes |
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(343 |
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(356 |
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(5,263 |
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(968 |
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Provision for (benefit from) income taxes |
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(178 |
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131 |
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Net loss |
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$ |
(343 |
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$ |
(534 |
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$ |
(5,263 |
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$ |
(837 |
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Net loss per share basic and diluted |
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$ |
(0.04 |
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$ |
(0.07 |
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$ |
(0.65 |
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$ |
(0.11 |
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Shares used in computing net loss per share basic and diluted |
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8,196 |
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7,694 |
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8,138 |
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7,641 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
-2-
IRIDEX Corporation
Condensed Consolidated Statements of Cash Flows
(Unaudited, in thousands)
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Six months ended |
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June 30, |
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July 1, |
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2007 |
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2006 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(5,263 |
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$ |
(837 |
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Adjustments to reconcile net loss to net cash (used
in) provided by operating activities: |
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Depreciation and amortization |
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1,803 |
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251 |
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Non-cash stock-based compensation |
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740 |
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935 |
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Provision for doubtful accounts |
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42 |
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68 |
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Provision for inventories |
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432 |
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16 |
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Changes in operating assets and liabilities, net
of assets and liabilities acquired: |
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Accounts receivable |
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1,147 |
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486 |
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Inventories |
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(2,169 |
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(299 |
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Prepaids and other current assets |
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224 |
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108 |
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Other long term assets |
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(41 |
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(26 |
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Accounts payable |
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4,243 |
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262 |
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Accrued warranty |
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(302 |
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Accrued expenses |
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(813 |
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(1,115 |
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Deferred revenue |
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938 |
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152 |
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Net cash provided by operating activities |
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$ |
981 |
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$ |
1 |
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Cash flows from investing activities: |
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Purchases of available-for-sale securities |
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$ |
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$ |
(18,519 |
) |
Proceeds from maturity of available-for-sale securities |
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8,778 |
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Purchases of property and equipment |
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(502 |
) |
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(185 |
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Purchases of intangible |
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(170 |
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Restricted cash |
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(3,800 |
) |
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Cash from acquisition owing to seller |
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4,021 |
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Acquisition of business |
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(28,152 |
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Net cash used in investing activities |
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$ |
(28,603 |
) |
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$ |
(9,926 |
) |
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Cash flows from financing activities: |
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Proceeds from issuance of common stock |
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$ |
827 |
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$ |
1,008 |
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Proceeds of credit facility, net of issuance costs |
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11,900 |
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Repayment of credit facility |
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(2,629 |
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Net cash provided by financing activities |
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$ |
10,098 |
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$ |
1,008 |
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Effect of foreign exchange rate changes |
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$ |
24 |
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$ |
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Net decrease in cash and cash equivalents |
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(17,500 |
) |
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(8,917 |
) |
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Cash and cash equivalents at beginning of period |
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$ |
21,051 |
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$ |
12,655 |
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Cash and cash equivalents at end of period |
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$ |
3,551 |
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$ |
3,738 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
-3-
IRIDEX Corporation
Condensed Consolidated Statements of Comprehensive Loss
(Unaudited, in thousands)
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Three months ended |
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Six months ended |
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June 30, |
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July 1, |
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June 30, |
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July 1, |
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2007 |
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2006 |
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2007 |
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2006 |
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Net loss |
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$ |
(343 |
) |
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$ |
(534 |
) |
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$ |
(5,263 |
) |
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$ |
(837 |
) |
Other comprehensive loss: |
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Change in unrealized loss on available for sale securities, net of tax |
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5 |
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14 |
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Foreign currency translation adjustments |
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(13 |
) |
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(22 |
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Comprehensive loss |
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$ |
(356 |
) |
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$ |
(529 |
) |
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$ |
(5,285 |
) |
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$ |
(823 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
-4-
IRIDEX Corporation
Notes to Unaudited Condensed Consolidated Financial Statements
The accompanying unaudited condensed consolidated financial statements of IRIDEX Corporation
(the Company) have been prepared in accordance with generally accepted accounting principles in
the United States for interim financial information and pursuant to the instructions to Form 10-Q
and Article 10-01 of Regulation S-X. Accordingly, they do not include all of the information and
footnotes required by accounting principles generally accepted in the United States for complete
financial statements. In the opinion of management, all adjustments, consisting of normal
recurring adjustments, considered necessary for a fair statement of the financial statements have
been included.
The condensed consolidated financial statements should be read in conjunction with the audited
financial statements and notes thereto, together with managements discussion and analysis of
financial condition and results of operations, contained in our Annual Report on Form 10-K, which
was filed with the Securities and Exchange Commission on March 30, 2007. The results of operations
for the three and six month periods ended June 30, 2007 are not necessarily indicative of the
results for the year ending December 29, 2007 or any future interim period.
The Company expects that its current cash and cash equivalents, cash flow expected to be
generated from operations and available credit facilities, if any, will not be sufficient to meet
the Companys operating requirements, except for the near term and for a period substantially less
than 12 months. Unless the Company is able to modify its planned operating requirements and raise
additional capital, the Companys current cash and cash equivalents, cash flow expected to be
generated from operations and available credit facilities, if any, will not be sufficient to meet
the Companys operating requirements, except for the near term and for a period substantially less
than 12 months.. These planned requirements include amounts owing to American Medical Systems,
Inc. (AMS) due to the acquisition of the assets of the aesthetics business of Laserscope
(Laserscope), a subsidiary of AMS, including the return of cash to AMS obtained through the
acquisition of Laserscopes foreign subsidiaries and payments for inventory under the product
supply agreement (the Product Supply Agreement) the Company entered into with Laserscope in
connection with the asset acquisition (see Note10 below). In addition, for the second fiscal
quarter ending June 30, 2007 the Company was not able to satisfy certain restrictive financial
covenants contained in its credit facilities with Mid-Peninsula Bank and the Export-Import Bank
(the Lenders) as well as an affirmative covenant regarding the preparation and delivery of
quarterly financial statements within 45 days of quarter end (see Note 4). The Company has
received a one-time waiver from Mid-Peninsula Bank with respect to its inability to satisfy the
financial covenants contained in its loan agreements with the Lenders for the period ended June 30,
2007, but can provide no assurance that the Lenders will grant any additional future waivers if
requested. The Company was also not in compliance with its debt covenants at the end of its first
quarter but it was successful in obtaining a waiver of default for that period. In the event of
noncompliance the Lenders would be entitled to exercise their remedies, under these facilities,
which include declaring all obligations immediately due and payable and disposing of the collateral
if obligations were not paid. The Company has modified planned operations in order to increase
cash flows from operations, and intends to raise additional capital through equity or debt
financing in order to enhance liquidity. However, there can be no assurances that the Company will
be successful in these efforts or that any additional capital raised through debt or equity
financings will be available on favorable terms or at all. The accompanying financial statements
do not include any adjustments that might result from the outcome of this uncertainty
-5-
2. |
|
Summary of Significant Accounting Policies |
The Companys significant accounting policies are disclosed in our Annual Report on Form 10-K
for the year ended December 30, 2006 which was filed with the Securities and Exchange Commission on
March 30, 2007. During the six months ended June 30, 2007, the Company has implemented an
accounting policy for the valuation of goodwill and intangible assets.
Revenue Recognition
Our revenues arise from the sale of laser consoles, delivery devices, disposables and service
and support activities. Revenue from product sales is recognized upon receipt of a purchase order
and product shipment provided that no significant obligations remain and collection of the
receivables is reasonably assured. Shipments are generally made with Free-On-Board (FOB) shipping
point terms, whereby title passes upon shipment from our dock. Any shipments with FOB receiving
point terms are recorded as revenue when the shipment arrives at the receiving point. Up-front
fees received in connection with product sales are deferred and recognized upon the associated
product shipments. Revenue relating to extended warranty contracts is recognized on a straight
line basis over the period of the applicable warranty contract. We recognize repair service
revenue upon completion of the work. Cost is recognized as product sales revenue is recognized.
The Companys sales may include post-sales obligations for training or other deliverables. When
these obligations are fulfilled after product shipment, the Company recognizes revenue in
accordance with the multiple element accounting guidance set forth in Emerging Issues Task Force
No. 00-21, Revenue Arrangements with Multiple Deliverables. When the Company has objective and
reliable evidence of fair value of the undelivered elements, it defers revenue attributable to the
post-sale obligations and recognizes such revenue when the obligation is fulfilled. Otherwise, the
Company defers all revenue related to the transaction until all elements are delivered.
In international regions outside of the United Kingdom and France, we utilize distributors to
market and sell our products. We recognize revenues upon shipment for sales through these
independent, third party distributors as we have no continuing obligations subsequent to shipment.
Generally, our distributors are responsible for all marketing, sales, installation, training and
warranty labor coverage for our products. Our standard terms and conditions do not provide price
protection or stock rotation rights to any of our distributors.
Valuation of Goodwill and Intangible Assets
The purchase method of accounting for acquisitions requires estimates and assumptions to
allocate the purchase price to the fair value of net tangible and intangible assets acquired. The
amounts allocated to, and the useful lives estimated for, other intangible assets, affect future
amortization. There are a number of generally accepted valuation methods used to estimate fair
value of intangible assets, and we use primarily a discounted cash flow method, which requires
significant management judgment to forecast the future operating results and to estimate the
discount factors used in the analysis. If assumptions and estimates used to allocate the purchase
price prove to be different based on actual results, future asset impairment charges could be
required.
Goodwill and intangible assets determined to have indefinite lives are not amortized, but are
subject to an annual impairment test. We intend to conduct an annual goodwill impairment test in
the fourth quarter of our fiscal year. To determine any goodwill impairment, a two-step process is
performed on an annual basis, or more frequently if necessary, to determine 1) whether the fair
value of the relevant reporting unit
-6-
exceeds carrying value and 2) to measure the amount of an impairment loss, if any. We have
identified the aesthetics medical device segment as the appropriate reporting unit for this
analysis. We review our intangible assets for impairment whenever events or changes in
circumstances indicate that their carrying value may not be recoverable. An asset is considered
impaired if its carrying amount exceeds the future net cash flow the asset is expected to generate.
If an asset is considered to be impaired, the impairment to be recognized is measured by the
amount by which the carrying amount of the asset exceeds its fair market value. The Company
assesses the recoverability of its long-lived and intangible assets by determining whether the
unamortized balances can be recovered through undiscounted future net cash flows of the related
assets. The amount of impairment, if any, is measured based on projected discounted future net
cash flows.
Goodwill and purchased intangible assets were initially recorded in the first three months of 2007
in conjunction with the acquisition of the aesthetics business of Laserscope (Note 3). We did not
identify any events since the date of acquisition that that would indicate that there has been an
impairment in the carrying value of these assets. However, if there are changes in events or
circumstances, such as an inability to achieve the cash flows originally expected from the
acquisition, which indicate that the recorded value of the intangible assets will not be recovered
through future cash flows, or if the fair value of the aesthetics business unit is determined to be
less than its carrying value, the Company may be required to record an impairment charge for the
intangible assets or goodwill or change the period of expected amortization for the intangible
assets.
Deferred Revenue
Deferred revenue related to warranty contracts is recognized on a straight line basis over the
period of the applicable contract. Cost is recognized as incurred. A reconciliation of changes in
the Companys deferred revenue balances for the six months ending June 30, 2007 and July 1, 2006
follows:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
July 1, |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
Balance, beginning of period |
|
$ |
1,415 |
|
|
$ |
1,072 |
|
Additions to deferral through acquisition |
|
|
1,870 |
|
|
|
|
|
Additions to deferral |
|
|
4,153 |
|
|
|
822 |
|
Revenue recognized |
|
|
(3,199 |
) |
|
|
(670 |
) |
|
|
|
|
|
|
|
Balance, end of period |
|
$ |
4,239 |
|
|
$ |
1,224 |
|
|
|
|
|
|
|
|
Warranty
The Company accrues for an estimated warranty cost upon shipment of products in accordance
with Statement of Financial Accounting Standards (SFAS) No. 5, Accounting for Contingencies.
Actual warranty costs incurred have not materially differed from those accrued. The Companys
warranty policy is effective for shipped products which are considered defective or fail to meet
the product specifications. Warranty costs are reflected in the statement of operations as a cost
of sales. A reconciliation of the changes in the Companys warranty liability for the six months
ending June 30, 2007 and July 1, 2006 follows:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
July 1, |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
Balance, beginning of period |
|
$ |
866 |
|
|
$ |
1,128 |
|
Warranty accrual acquired through acquisition |
|
|
1,771 |
|
|
|
|
|
Accruals for warranties issued during the period |
|
|
497 |
|
|
|
335 |
|
Settlements made in kind during the period |
|
|
(799 |
) |
|
|
(534 |
) |
|
|
|
|
|
|
|
Balance, end of period |
|
$ |
2,335 |
|
|
$ |
929 |
|
|
|
|
|
|
|
|
-7-
Accounting for Uncertainty in Income Taxes
Effective January 1, 2007, the Company adopted Financial Accounting Standards Interpretation,
or FIN, No. 48, Accounting for Uncertainty in Income Taxes an interpretation of FASB Statement
No. 109. FIN No. 48 prescribes a recognition threshold and measurement attribute for the financial
statement recognition and measurement of uncertain tax positions taken or expected to be taken in a
companys income tax return, and also provides guidance on derecognition, classification, interest
and penalties, accounting in interim periods, disclosure, and transition. FIN No. 48 utilizes a
two-step approach for evaluating uncertain tax positions accounted for in accordance with SFAS No.
109, Accounting for Income Taxes (SFAS No. 109). Step one, recognition, requires a company to
determine if the weight of available evidence indicates that a tax position is more likely than not
to be sustained upon audit, including resolution of related appeals or litigation processes, if
any. Step two, measurement, is based on the largest amount of benefit, which is more likely than
not to be realized on ultimate settlement. The cumulative effect of adopting FIN No. 48 on January
1, 2007 is recognized as a change in accounting principle, recorded as an adjustment to the opening
balance of retained earnings on the adoption date. As a result of the implementation of FIN No.
48, the Company recognized no change in the liability for unrecognized tax benefits related to tax
positions taken in prior periods. Upon adoption of FIN No. 48, the Companys policy to include
interest and penalties related to unrecognized tax benefits within the Companys provision for
(benefit from) income taxes did not change. The Companys total amount of unrecognized tax
benefits as of January 1, 2007 (adoption date) was $517,733. Of this amount, none would affect the
Companys effective tax rate if recognized.
On January 16, 2007, the Company completed the acquisition of the aesthetics business from
American Medical Systems, Inc. (AMS) and Laserscope, a wholly owned subsidiary of AMS pursuant to
the terms of the Asset Purchase Agreement dated November 30, 2006 between AMS, Laserscope, and
Iridex Corporation. These financial statements include the results of operations for the acquired
business from the acquisition date.
Iridex purchased the aesthetics business of former Laserscope from AMS due to its
complementary fit with the existing Iridex laser business. Under the terms of the Asset Purchase
Agreement, Iridex Corporation purchased the aesthetics business for the following consideration:
|
|
|
|
|
(in thousands) |
|
|
|
Cash paid on closing |
|
$ |
26,000 |
|
Issuance of common stock |
|
|
2,014 |
|
Post closing adjustment to purchase price |
|
|
(2,766 |
) |
Acquisition costs |
|
|
3,219 |
|
|
|
|
|
Total purchase price |
|
$ |
28,467 |
|
|
|
|
|
Issuance of common stock included 213,435 shares of common stock valued at $9.43 per share.
Acquisition costs include investment banking, legal and accounting fees, and other external
costs directly related to the acquisition.
-8-
The preliminary allocation of the purchase price to tangible and identifiable intangible
assets acquired and liabilities assumed was based on their estimated fair values at the date of
acquisition as determined by management. These estimates are subject to further review by
management upon completion of the audit of the aesthetics business of Laserscope for the year ended
December 31, 2006. Independent valuation experts assisted the Company in determining the valuation
of the intangible assets acquired. Further adjustments to these estimates may be included in the
final allocation of the purchase price, if the adjustment is determined within the purchase
allocation period (up to twelve months of the closing date). The excess of the purchase price over
the tangible and identifiable assets acquired and liabilities assumed has been allocated to
goodwill. The purchase price has been preliminarily allocated as follows:
|
|
|
|
|
(in thousands) |
|
|
|
Accounts Receivable |
|
$ |
5,309 |
|
Finished Goods Inventory |
|
$ |
2,691 |
|
Other current assets |
|
$ |
311 |
|
Property and equipment |
|
$ |
681 |
|
Intangible assets |
|
$ |
16,447 |
|
Deferred Revenue |
|
$ |
(1,870 |
) |
Accrued Warranty |
|
$ |
(1,771 |
) |
Accrued Liabilities |
|
$ |
(3,234 |
) |
Fair value of net assets acquired |
|
$ |
18,564 |
|
|
|
|
|
Goodwill |
|
$ |
9,903 |
|
|
|
|
|
Total purchase price |
|
$ |
28,467 |
|
|
|
|
|
In addition, the Asset Purchase Agreement signed with AMS calls for a post-close adjustment
mechanism which in effect allows for an adjustment to the final purchase price based upon the
parties agreement to the final closing balance sheet and several other items. The Company has
recorded $2.7 million due from AMS as an adjustment to the purchase price as determined under the
terms of the asset purchase agreement and based on an agreement with AMS regarding this post close
adjustment dated August 14, 2007. The total purchase price recorded has been reduced by $1.8
million in the second quarter, based on a $2.0 million decrease in the estimated purchase price
adjustment, less $0.2 million of additional acquisition costs recorded this quarter. As of June 30,
2007 amounts owing to AMS for cash obtained through the acquisition of the foreign
subsidiaries, but not included in the asset purchase agreement was $3.9 million. This cash will be
netted against the payment of $2.7 million owed to the Company under the post close balance sheet
adjustment. Pursuant to the Settlement Agreement reached with AMS, this amount of $1.2 million will
be paid to AMS in weekly installments over the course of the next year.
(See Note 10)
The components of the Companys intangible assets are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Net, |
|
|
|
Useful |
|
|
Annual |
|
|
Carrying |
|
|
Accumulated |
|
|
Carrying |
|
Intangible Asset Acquired |
|
Lives |
|
|
Amortization |
|
|
Value |
|
|
Amortization |
|
|
Value |
|
Gemini Handset Core Technology |
|
10 Years |
|
$ |
299 |
|
|
$ |
2,995 |
|
|
$ |
136 |
|
|
$ |
2,859 |
|
Gemini Current Technology |
|
4 Years |
|
|
1,282 |
|
|
|
5,129 |
|
|
|
581 |
|
|
|
4,548 |
|
Other Products Current
Technology |
|
1 Year |
|
|
341 |
|
|
|
341 |
|
|
|
154 |
|
|
|
187 |
|
Accessories Current Technology |
|
4 Years |
|
|
15 |
|
|
|
62 |
|
|
|
7 |
|
|
|
55 |
|
Services Contractual Customer
Relationships |
|
10 Years |
|
|
532 |
|
|
|
5,318 |
|
|
|
241 |
|
|
|
5,077 |
|
Contractual Distribution
Agreement |
|
5 Years |
|
|
370 |
|
|
|
1,848 |
|
|
|
167 |
|
|
|
1,681 |
|
Trade Name |
|
5 Years |
|
|
151 |
|
|
|
754 |
|
|
|
68 |
|
|
|
686 |
|
Other |
|
3 Years |
|
|
57 |
|
|
|
170 |
|
|
|
13 |
|
|
|
157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,047 |
|
|
$ |
16,617 |
|
|
$ |
1,367 |
|
|
$ |
15,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-9-
Amortization for the technology related intangibles is being recorded in cost of goods sold
and amortization for marketing related intangibles is being recorded in selling, general and
administrative expense.
Through this acquisition, the Company plans to increase its sales into the aesthetic laser
market and augment its core ophthalmic business with enhanced revenue and marketing opportunities.
These factors primarily contributed to a purchase price which resulted in the recording of
goodwill. Goodwill of $9.9 million represents the excess of the purchase price over the fair value
of the net tangible and intangible assets acquired. In accordance with Statement of Financial
Accounting Standards No. 142, Goodwill and Other Intangible Assets, goodwill will not be
amortized but will instead be tested for impairment annually or more frequently if certain
indicators are present.
Estimated future amortization expense for purchased intangible assets from the acquisition is
as follows:
|
|
|
|
|
(in thousands) |
|
|
|
2007 |
|
$ |
2,893 |
|
2008 |
|
$ |
2,723 |
|
2009 |
|
$ |
2,706 |
|
2010 |
|
$ |
2,662 |
|
2011 |
|
$ |
1,413 |
|
Thereafter |
|
$ |
4,221 |
|
|
|
|
|
Total |
|
$ |
16,617 |
|
|
|
|
|
The Company has agreed under a Settlement Agreement dated August 14, 2007 with Laserscope
which amends the Product Supply Agreement which was entered into at the time of acquisition to
purchase at the end of such agreement, quantities of work-in-process, raw and packaging materials,
or spare and replacement parts that have an aggregate book value of $4.1 million. The Company
believes this commitment as defined will result in the acquisition of material useable in its
ordinary course of business through the sale or servicing of aesthetic laser products. (See Note
10)
Supplemental pro forma information that discloses the results of operations for the current
interim period and the prior year comparable period as though the business combination had been
completed as of the beginning of the period being reported on is not available because the
preparation of the financial statements of the acquired business are not complete.
On January 16, 2007, the Company entered into a Business Loan and Security Agreement with
Mid-Peninsula Bank, part of Greater Bay Bank N.A. and Exim Bank. The Credit Agreement provides for
an asset-
-10-
based
revolving line of credit of up to $6.0 million (the Revolving Loans) and a $6.0
million term loan (the Term Loan). Of the Revolving Loans, up to $3.0 million principal amount
will be guaranteed by Exim Bank. The Companys obligations under the Term Loans and the Revolving Loans are secured by a
lien on substantially all of the Companys assets. Interest on the Term Loan and the Revolving
Loans is the prime rate as published in the Wall Street Journal, minus 0.5%. Indebtedness
outstanding under the Term Loan and the Revolving Loan was $5.5 million and $3.9 million
respectively at June 30, 2007. These facilities contain certain financial and other covenants,
including the requirement for Iridex to maintain profitability on a quarterly basis, tangible net
worth of $15.5 million, maintain unrestricted cash/marketable securities of $3 million and maintain
a debt service ratio of 1.75 to 1.00 on an annual basis. At March 31, 2007 and June 30, 2007, the
Company was not in compliance with certain of the financial covenants contained in these
agreements.
On April 19, 2007, the Company and Mid-Peninsula Bank entered into amendments to each of the
loan agreements. Pursuant to the Amendments, the Company agreed to deposit and maintain $3.8
million in cash in a segregated deposit account with Lender as collateral in support of the Term
Loan and to restrict up to $2.2 million of the combined borrowing base from the Line of Credit in
support of the Term Loan. The parties agreed to eliminate the requirement that the Company
maintain a minimum of $3.0 million in aggregate domestic unrestricted cash or marketable
securities. In addition, the Lender increased the credit extended by Lender to the Company under
the Exim Agreement from $3.0 to $5.0 million; however this increase only resulted in a potential
increase in a guarantee by Exim Bank and did not impact the total borrowing availability under the
line. In connection with the Amendments, Lender also agreed to a one-time waiver of certain
financial covenants contained in the loan agreements for the quarter ended March 31, 2007. In
addition, the Company was not in compliance with certain financial covenants contained in the
amended loan agreements at the end of its second fiscal quarter ending June 30, 2007. In addition
the Company was in violation of an affirmative covenant regarding the preparation and delivery of
quarterly financial statements within 45 days of quarter end. In anticipation of this violation
Mid-Peninsula Bank and Export-Import Bank on June 19, 2007 waived the default from the expected
non-compliance at June 30, 2007 of the tangible net worth covenant, the minimum debt service ratio
and the minimum income covenant. This waiver related only to the breach of financial covenants
occurring on June 30, 2007 and did not cover any subsequent breach, should one occur, of the
financial covenants contained within the loan agreements.
In the accompanying balance sheet, all debt under the five year term loan is classified as
current portion of long-term debt due to the fact that a covenant violation has occurred at the
balance sheet date or would have occurred absent a loan modification and it is probable that the
Company will not be able to cure the default (comply with the covenant) at measurement dates that
are within the next 12 months.
In conjunction with the issuance of this debt, the Company incurred $0.1 million of debt
issuance costs which have been capitalized and will be amortized on an effective interest basis
over the term of the debt which is sixty months.
Inventories are stated at the lower of cost or market and include on-hand inventory, sales
evaluation inventory and service loaner inventory. The Company includes evaluation units held for
sales within inventories. The Company carries the evaluation units at cost less amortization over
their estimated economic life of four years. Amortization related to evaluation units is recorded
in cost of sales and reflects the physical deterioration, usage and obsolescence of the products.
Proceeds from the sale of evaluation units are recorded as revenue and all costs incurred to
refurbish a system prior to sale are charged to cost of sales.
-11-
Cost is determined on a standard cost basis which approximates actual cost on a first-in,
first-out (FIFO) method. Lower of cost or market is evaluated by considering obsolescence,
excessive levels of inventory, deterioration and other factors. Adjustments to reduce the cost of
inventory to its net realizable value, if required, are made for estimated excess, obsolescence or impaired inventory and are
charged to cost of goods sold. Factors influencing these adjustments include changes in demand,
product life cycle and development plans, component cost trends, product pricing, physical
deterioration and quality issues. Revisions to these adjustments would be required if these
factors differ from our estimates. The components of inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December |
|
(in thousands) |
|
2007 |
|
|
30, 2006 |
|
Raw materials and work in progress |
|
$ |
6,244 |
|
|
$ |
4,000 |
|
Finished goods |
|
|
7,729 |
|
|
|
5,499 |
|
|
|
|
|
|
|
|
Total inventories |
|
$ |
13,973 |
|
|
$ |
9,499 |
|
|
|
|
|
|
|
|
Patent Litigation On October 19, 2005, the Company filed a suit in the United States
District Court for the Eastern District of Missouri against Synergetics, USA, Inc. for infringement
of a patent. The Company later amended its complaint to assert infringement claims against
Synergetics, Inc.; Synergetics USA, Inc. was dismissed from the suit. The Company alleged that
Synergetics infringed the Companys patent by making and selling infringing products, including its
Quick Disconnect laser probes and its Quick Disconnect Laser Probe Adapter, and sought injunctive
relief, monetary damages, treble damages, costs and attorneys fees. On April 25, 2006,
Synergetics added the Company as a defendant to a then existing lawsuit in the U.S. District Court
for the Eastern District of Pennsylvania. In that litigation, Synergetics alleged that the Company
infringed its patent on a disposable laser probe design.
Trial in the Missouri litigation was scheduled to begin on April 16, 2007, however on April 6,
2007 the parties reached settlement on the claims. Under the terms of the settlement agreement,
the parties agreed to terminate all legal proceedings between the parties and to a fully paid-up,
royalty free, worldwide cross licensing of various patents between the two companies. In
consideration of these licenses Synergetics agreed to pay the Company $6.5 million over a period of
five years. The first payment of $2.5 million by Synergetics was received on April 16, 2007 and
was recorded as other income in the consolidated statement of operations. Additional annual
payments of $0.8 million will be received on each April 16th until 2012.
Management believes that claims which are pending or known to be threatened, will not have a
material adverse effect on the Companys financial position or results of operations and are
adequately covered by the Companys liability insurance. However, it is possible that cash flows
or results of operations could be materially affected in any particular period by the unfavorable
resolution of one or more of these contingencies or because of the diversion of managements
attention and the incurrence of significant expenses.
7. |
|
Computations of Net Loss Per Common Share |
Basic and diluted net loss per share are computed by dividing net loss for the period by the
weighted average number of shares of common stock outstanding during the period. The calculation
of diluted net loss per share includes the dilutive effect of potentially dilutive common stock
provided the inclusion of such potential common stock is not antidilutive. Potentially dilutive
common stock consists of incremental common shares issuable upon the exercise of stock options and
a warrant to purchase common shares.
-12-
During the three months and six months ended July 1, 2006, options to purchase 2,056,448
shares of common stock at a weighted average exercise price of $5.80 as well as a warrant to
purchase 25,000 shares at a weighted average exercise of $6.07 were outstanding but were not
included in the computations of diluted net loss per common share because their effect was
antidilutive. During the three and six months ended June 30, 2007, options to purchase 2,238,142
shares at a weighted average exercise price of $6.49 were available as well as a warrant to
purchase 25,000 shares of common stock at a weighted average exercise price of $6.07 were
outstanding but were not included in the computations of diluted net loss per common share because
their effect was antidilutive. These options and warrant could dilute earnings per share in future
periods.
8. Business Segments
The Company operates in two reportable segments: the ophthalmology medical device segment and
the aesthetics medical device segment. In each segment the Company develops, manufactures, markets
and services medical devices. Our revenues arise from the sale of consoles, delivery devices,
disposables and service and support activities.
Information on reportable segments for the three and six months ended June 30, 2007 and July
1, 2006 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2007 |
|
Three Months Ended July 1, 2006 |
|
|
Ophthalmology |
|
Aesthetics |
|
|
|
|
|
Ophthalmology |
|
Aesthetics |
|
|
|
|
Medical |
|
Medical |
|
|
|
|
|
Medical |
|
Medical |
|
|
(in thousands) |
|
Devices |
|
Devices |
|
Total |
|
Devices |
|
Devices |
|
Total |
Sales |
|
$ |
8,389 |
|
|
$ |
6,860 |
|
|
$ |
15,249 |
|
|
$ |
7,681 |
|
|
$ |
1,123 |
|
|
$ |
8,804 |
|
Direct cost of goods sold |
|
|
2,365 |
|
|
|
3,876 |
|
|
|
6,241 |
|
|
|
2,213 |
|
|
|
475 |
|
|
|
2,688 |
|
|
|
|
Direct gross margin |
|
|
6,024 |
|
|
|
2,984 |
|
|
|
9,008 |
|
|
|
5,468 |
|
|
|
648 |
|
|
|
6,116 |
|
Total unallocated
indirect costs |
|
|
|
|
|
|
|
|
|
|
(9,351 |
) |
|
|
|
|
|
|
|
|
|
|
(6,472 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre-tax income (loss) |
|
|
|
|
|
|
|
|
|
$ |
(343 |
) |
|
|
|
|
|
|
|
|
|
$ |
(356 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2007 |
|
Six Months Ended July 1, 2006 |
|
|
Ophthalmology |
|
Aesthetics |
|
|
|
|
|
Ophthalmology |
|
Aesthetics |
|
|
|
|
Medical |
|
Medical |
|
|
|
|
|
Medical |
|
Medical |
|
|
|
|
Devices |
|
Devices |
|
Total |
|
Devices |
|
Devices |
|
Total |
Sales |
|
$ |
15,578 |
|
|
$ |
12,237 |
|
|
$ |
27,815 |
|
|
$ |
15,221 |
|
|
$ |
2,426 |
|
|
$ |
17,647 |
|
Direct cost of goods sold |
|
|
4,509 |
|
|
|
6,749 |
|
|
|
11,258 |
|
|
|
4,742 |
|
|
|
1,158 |
|
|
|
5,900 |
|
|
|
|
Direct gross margin |
|
|
11,069 |
|
|
|
5,488 |
|
|
|
16,557 |
|
|
|
10,479 |
|
|
|
1,268 |
|
|
|
11,747 |
|
Total unallocated
indirect costs |
|
|
|
|
|
|
|
|
|
|
(21,820 |
) |
|
|
|
|
|
|
|
|
|
|
(12,715 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre-tax income (loss) |
|
|
|
|
|
|
|
|
|
$ |
(5,263 |
) |
|
|
|
|
|
|
|
|
|
$ |
(968 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-13-
Indirect costs of manufacturing, research and development, and selling, general and
administrative costs are not allocated to the segments.
The Companys assets and liabilities are not evaluated on a segment basis. Accordingly, no
disclosure of segment assets and liabilities is provided.
9. |
|
Stock-based Compensation |
Stand-Alone Options
In February 2007, the Compensation Committee of the Companys Board of Directors approved the
grant of 235,000 non-qualified stock options, outside of the Companys existing stock plans, to a
total of 54 new employees, both domestic and international, hired in connection with the Companys
recently completed acquisition of the assets of the aesthetics business of Laserscope. These
options were granted as of February 28, 2007 at an exercise price of $10.06 per share.
The following table shows the pre-tax stock-based compensation expense recognized during the
quarter and included in the Consolidated Statements of Operations for the three and six month
periods ended June 30, 2007 and July 1, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
July 1, |
|
|
June 30, |
|
|
July 1, |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Cost of sales |
|
$ |
44 |
|
|
$ |
31 |
|
|
$ |
70 |
|
|
$ |
67 |
|
Research and development |
|
|
50 |
|
|
|
73 |
|
|
|
112 |
|
|
|
121 |
|
Sales, general and administrative |
|
|
290 |
|
|
|
374 |
|
|
|
558 |
|
|
|
747 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
384 |
|
|
$ |
478 |
|
|
$ |
740 |
|
|
$ |
935 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AMS Settlement
On August 14, 2007, the Company AMS and Laserscope (collectively the Parties), entered into
a Settlement Agreement (the Settlement Agreement). The Parties entered into the Settlement
Agreement to document their full and final agreement as to the amount of the adjustment
contemplated by Section 1.5 of the Asset Purchase Agreement, by and among AMS, Laserscope and the
Company, dated November 30, 2006 (the Purchase Agreement); to amend the Product Supply Agreement,
between Laserscope and the Company, dated January 16, 2007 (the Product Supply Agreement); and to
set forth the Parties mutual understanding as to certain other matters.
The Settlement Agreement provides that, pursuant to Section 1.5 of the Purchase Agreement, the
Company will make an additional payment to AMS of approximately
$1.2 million, which will be the sole and final
adjustment
-14-
to the
purchase price and will be paid in equal weekly installments of
$22,115 beginning August 16, 2007 over the course
of the next year. This $1.2 million amount reflects the net
amount owed by the Company to AMS after taking into account
the $3.9 million in cash obtained through the Companys
acquisition of Laserscopes foreign subsidiaries, which was not
included in the original purchase price, net of $2.7 million
owed to the Company by AMS pursuant to the purchase price adjustment
provisions of the Purchase Agreement.
In addition, the Settlement Agreement modifies and amends certain terms of the Product Supply
Agreement, including among others: (a) agreement upon the current and future products to be built
and delivered by Laserscope to the Company and the payment terms relating thereto; (b) allocation
of and pricing and delivery terms relating to inventory parts to be sold by Laserscope to the
Company and agreement on a payment plan for currently outstanding
invoices, which includes two weekly payments of $100,000 each for the
last two weeks of August, increasing to $150,000 per week for four
weeks in September and (c) agreement upon certain payments to be made by the Company to AMS in the event that
the Company increases its borrowing capacity to more than $12,000,000 under any credit facility
that is senior to the Companys payment obligations under the Settlement Agreement. Under the
terms of the Settlement Agreement, the Company agreed to payments totaling $4,059,557 in respect of
certain inventory and service parts to be purchased from AMS following termination of the Product
Supply Agreement. This sum is to be paid in 39 weekly
installments of $110,185 including an interest charge of 10% per annum beginning on
January 3, 2008. This sum is in settlement of potential payments of up to $9 million for inventory
from AMS following the scheduled termination of the Product Supply Agreement in October 2007.
Under the Settlement Agreement, the Parties also agreed that the Company and AMS will evenly
split AMSs costs associated with the termination of one of Laserscopes French employees who was
originally scheduled to become an employee of the Company.
The parties have also agreed subject to certain limitations, to release each other from any
claims related to indemnification, purchase price and post-closing adjustments in the Purchase
Agreement as well as any amounts due under the Product Supply Agreement. The Company also agreed
to release AMS and Laserscope from any liability from claims related to the sections in the
Purchase Agreement dealing with financial matters, undisclosed liabilities, receivables and
preparation of historical financial statements. The Parties agreed that, other than with respect
to fraud and certain specified representations and warranties, the representations and warranties
contained in the Purchase Agreement terminated contemporaneously with the signing of the Settlement
Agreement and the Parties could no longer make indemnification claims relating thereto.
Upon execution of the Settlement Agreement, the Company also executed a Security Agreement,
dated August 14, 2007 (the Security Agreement), granting AMS and Laserscope a subordinate
security interest in all the Companys assets to secure all of its current and future obligations
to AMS or Laserscope.
Any breach by the Company of any provision of any of its agreements with AMS or Laserscope
shall constitute an immediate default and shall entitle AMS and Laserscope to any and all remedies
available to them under the Security Agreement, the Product Supply Agreement, and the Settlement
Agreement, including, but not limited to, the right to terminate the Product Supply Agreement
immediately upon written notice to the Company with no additional notice period or opportunity to
cure and the right to declare all amounts due from the Company to AMS to be immediately due and
payable in full.
11. |
|
Recent Accounting Pronouncements |
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities Including an Amendment of FASB Statement No. 115 (SFAS No. 159). SFAS
No. 159 permits entities to choose to measure many financial instruments and certain other items at
fair value. Unrealized gains and losses on items for which the fair value option has been elected
will be recognized in earnings at each subsequent reporting date. SFAS No. 159 is effective for
financial statements issued for fiscal years beginning after November 15, 2007. We do not believe
that the adoption of the provisions of SFAS 159 will materially impact our consolidated financial
position and results of operations.
-15-
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
This Quarterly Report on Form 10-Q contains trend analysis and other 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, such as statements relating to levels of
future sales and operating results; broadening our product line through product innovation;: market
acceptance of our products; expectations for future sales growth, generally, including expectations
of additional sales from our new products and new applications of our existing products; our
ability to integrate the newly acquired aesthetics business into our core business successfully and
in a timely manner; the potential for production cost decreases and higher gross margins; our
ability to develop and introduce new products through strategic alliances; our ability to reduce
spending, including a reduction in the use of contractors and consultants ; levels of interest
income and expense; general economic conditions; levels of international sales and our current
liquidity, ability to obtain additional financing and impact of concern regarding our ability to
continue as a going concern; the potential to record an impairment charge to goodwill and
intangible assets and effects of recent accounting pronouncements on our financial position. In
some cases, forward-looking statements can be identified by terminology, such as may, will,
should, expects, plans, anticipates, believes, estimates, predicts, intends,
potential, continue, or the negative of such terms or other comparable terminology. These
statements involve known and unknown risks, uncertainties and other factors which may cause our
actual results, performance or achievements to differ materially from those expressed or implied by
such forward-looking statements, including as a result of the factors set forth under Factors That
May Affect Future Operating Results and other risks detailed in our Annual Report on Form 10-K
filed with the Securities and Exchange Commission on March 30, 2007 and detailed from time to time
in our reports filed with the Securities and Exchange Commission. The reader is cautioned not to
place undue reliance on these forward-looking statements, which reflect managements analysis only
as of the date of this quarterly report on Form 10-Q. We undertake no obligation to update such
forward-looking statements to reflect events or circumstances occurring after the date of this
report.
Overview
IRIDEX Corporation is a leading worldwide provider of therapeutic based laser systems and
delivery devices used to treat eye diseases in ophthalmology and skin conditions in aesthetics.
Our products are sold in the United States predominantly through a direct sales force and
internationally through 95 independent distributors into 107 countries.
Our revenues arise from the sale of our IRIS Medical OcuLight Systems, IQ810 lasers, VariLite,
DioLite 532 systems, delivery devices, disposables and revenues from service and support
activities. Our current family of OcuLight systems includes the IRIS Medical OcuLight Symphony,
OcuLight SL, OcuLight SLx, OcuLight TX, OcuLight GL and OcuLight GLx laser photocoagulation systems
as well as the IQ810 laser. We also produce the Millennium Endolase module which is sold
exclusively to Bausch & Lomb and incorporated into their Millennium Microsurgical System.
In January 2007, the Company acquired Laserscopes aesthetics business including its
subsidiaries in France and the United Kingdom (UK) from American Medical Systems Holdings (AMS).
Laserscope aesthetic treatments encompass minimally invasive surgical treatments for hair removal,
leg vein treatments, wrinkle removal, acne damage, sun damage and skin rejuvenation. These
procedures are usually not performed in an operating room and are therefore paid for by patients
without the assistance of any insurance or Medicare reimbursement. Laserscopes aesthetic products
include the Gemini Laser System, Venus-i Laser Systems, Lyra-i Laser System, Aura-i Laser
System featuring StarPulse and Solis IPL System.
-16-
Lasersopes delivery devices include VersaStat i SmartScan Plus, SmartScan, CoolSpot,
Dermastats and MicronSpot, Dermastats.
We believe that our future growth in revenue will be based upon the successful implementation
of our strategy in these areas: 1) leveraging our core business and increasing recurring revenues,
2) broadening our product lines through product innovation, and 3) successfully integrating the
newly acquired aesthetics business into our core Iridex laser business.
Resignation of CFO
On July 5, 2007, subsequent to the three month period covered by this Quarterly Report on Form
10-Q, Meryl A. Rains, who commenced service as the Companys Chief Financial Officer on February 5,
2007, notified the Company that she was resigning as the Companys Chief Financial Officer,
effective as of July 20, 2007. The Company has hired an interim Chief Financial Officer to serve
while the Company works to identify and hire a permanent Chief Financial Officer.
Results of Operations
The following table sets forth certain operating data as a percentage of sales for the periods
included.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months ended |
|
|
|
June 30, |
|
|
July 1, |
|
|
June 30, |
|
|
July 1, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Sales |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
Cost of sales |
|
|
56.8 |
% |
|
|
47.1 |
% |
|
|
57.6 |
% |
|
|
49.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
43.2 |
% |
|
|
52.9 |
% |
|
|
42.4 |
% |
|
|
50.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
10.4 |
% |
|
|
15.1 |
% |
|
|
11.9 |
% |
|
|
13.9 |
% |
Sales, general and administrative |
|
|
49.5 |
% |
|
|
43.9 |
% |
|
|
56.9 |
% |
|
|
44.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
59.9 |
% |
|
|
59.0 |
% |
|
|
68.8 |
% |
|
|
58.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(16.7 |
)% |
|
|
(6.1 |
)% |
|
|
(26.4 |
)% |
|
|
(7.5 |
)% |
Interest and other expense, net |
|
|
14.4 |
% |
|
|
2.0 |
% |
|
|
7.5 |
% |
|
|
2.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(2.3 |
)% |
|
|
(4.1 |
)% |
|
|
(18.9 |
)% |
|
|
(5.5 |
)% |
Benefit from income taxes |
|
|
0.0 |
% |
|
|
(2.0 |
)% |
|
|
0.0 |
% |
|
|
0.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(2.3 |
)% |
|
|
(6.1 |
)% |
|
|
(18.9 |
)% |
|
|
(4.7 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table sets forth for the periods indicated the amount of sales for our operating
segments and sales as a percentage of total sales of medical devices for the ophthalmology and
aesthetics segments.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, 2007 |
|
|
July 1, 2006 |
|
|
June 30, 2007 |
|
|
July 1, 2006 |
|
|
|
|
|
|
|
Percentage |
|
|
|
|
|
|
Percentage |
|
|
|
|
|
|
Percentage |
|
|
|
|
|
|
Percentage |
|
|
|
|
|
|
|
of total |
|
|
|
|
|
|
of total |
|
|
|
|
|
|
of total |
|
|
|
|
|
|
of total |
|
(dollars in thousands) |
|
Amount |
|
|
sales |
|
|
Amount |
|
|
sales |
|
|
Amount |
|
|
sales |
|
|
Amount |
|
|
sales |
|
Domestic |
|
$ |
8,381 |
|
|
|
55.0 |
% |
|
$ |
5,296 |
|
|
|
60.2 |
% |
|
$ |
15,056 |
|
|
|
54.1 |
% |
|
$ |
10,426 |
|
|
|
59.1 |
% |
International |
|
|
6,868 |
|
|
|
45.0 |
% |
|
|
3,508 |
|
|
|
39.8 |
% |
|
|
12,759 |
|
|
|
45.9 |
% |
|
|
7,221 |
|
|
|
40.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
15,249 |
|
|
|
100.0 |
% |
|
|
8,804 |
|
|
|
100.0 |
% |
|
|
27,815 |
|
|
|
100.0 |
% |
|
|
17,647 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-17-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, 2007 |
|
|
July 1, 2006 |
|
|
June 30, 2007 |
|
|
July 1, 2006 |
|
|
|
|
|
|
|
Percentage |
|
|
|
|
|
|
Percentage |
|
|
|
|
|
|
Percentage |
|
|
|
|
|
|
Percentage |
|
|
|
|
|
|
|
of total |
|
|
|
|
|
|
of total |
|
|
|
|
|
|
of total |
|
|
|
|
|
|
of total |
|
(dollars in thousands) |
|
Amount |
|
|
sales |
|
|
Amount |
|
|
sales |
|
|
Amount |
|
|
sales |
|
|
Amount |
|
|
sales |
|
Ophthalmology: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic |
|
|
4,961 |
|
|
|
32.5 |
% |
|
|
4,544 |
|
|
|
51.6 |
% |
|
|
8,968 |
|
|
|
32.2 |
% |
|
|
8,637 |
|
|
|
49.0 |
% |
International |
|
|
3,428 |
|
|
|
22.5 |
% |
|
|
3,137 |
|
|
|
35.6 |
% |
|
|
6,610 |
|
|
|
23.8 |
% |
|
|
6,584 |
|
|
|
37.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
8,389 |
|
|
|
55.0 |
% |
|
|
7,681 |
|
|
|
87.2 |
% |
|
|
15,578 |
|
|
|
56.0 |
% |
|
|
15,221 |
|
|
|
86.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aesthetics: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic |
|
|
3,420 |
|
|
|
22.4 |
% |
|
|
753 |
|
|
|
8.6 |
% |
|
|
6,088 |
|
|
|
21.9 |
% |
|
|
1,789 |
|
|
|
10.1 |
% |
International |
|
|
3,440 |
|
|
|
22.6 |
% |
|
|
370 |
|
|
|
4.2 |
% |
|
|
6,149 |
|
|
|
22.1 |
% |
|
|
637 |
|
|
|
3.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
6,860 |
|
|
|
45.0 |
% |
|
$ |
1,123 |
|
|
|
12.8 |
% |
|
$ |
12,237 |
|
|
|
44.0 |
% |
|
$ |
2,246 |
|
|
|
13.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ophthalmology and Aesthetics Sales Overview:
We manage and evaluate our business in two segments ophthalmology medical devices and
aesthetic medical devices. We further break down these segments by geographyDomestic (United
States) and International (the rest of the world). In addition, within ophthalmology, we review
trends by laser system sales (laser boxes and delivery devices) and recurring sales (single use
disposable probes, EndoProbes.) The newly acquired Laserscope aesthetics business is included in
the aesthetic segments.
Total sales increased by 73.2% to $15.2 million for the three months ended June 30, 2007 from
$8.8 million for the three months ended July 1, 2006. Domestic sales, which represented 55.0% of
total sales, increased 58.3% to $8.4 million for the three month period ended June 30, 2007 from
$5.3 million for the three months ended July 1, 2006. The increase in domestic sales was the
result of a $1.7 million increase in domestic aesthetic revenue and a $1.0 million increase in
domestic service revenue largely attributable to the newly acquired Laserscope business and a $0.4
million increase in domestic ophthalmology revenue largely related to an increase in disposable
probe revenue. International sales, which represented 45.0% of total sales, increased 95.8% to
$6.9 million for the three month period ended June 30, 2007 from $3.5 million for the three months
ended July 1, 2006. The increase in international sales was the result of a $3.0 million increase
in international aesthetic revenue and a $0.4 million increase in international service revenue
largely attributable to the newly acquired Laserscope aesthetics business and a $0.3 million
increase in international ophthalmology equipment revenue.
Total sales increased by 57.6% to $27.8 million for the six months ended June 30, 2007 from
$17.6 million for the six months ended July 1, 2006. Domestic sales, which accounted for 54.1% of
total sales, increased 44.4% to $15.0 million for the six months ended June 30, 2007 from $10.4
million for the six months ended July 1, 2006. The increase in domestic sales resulted primarily
from an increase of $2.3 million in domestic aesthetics revenue and an increase of $2.2 million in
domestic service revenue both attributable to the Laserscope acquisition and a $0.1 million
increase in domestic ophthalmology revenue. Increased domestic disposable revenue during the
period was offset by decreases in other domestic ophthalmology revenue, primarily OEM revenue.
International sales, which represented 45.9% of total sales increased 76.8% to $12.7 million for
the six month period ended June 30, 2007 from $7.2 million for the six month period ended July 1,
2006. The increase in international sales resulted mainly from an increase of $5.4 million in
international aesthetics revenue largely attributable to the newly acquired Laserscope aesthetics
business and a $0.1 million increase in combined international ophthalmology and international
service revenue.
Ophthalmology Sales
Total ophthalmology sales increased 9.2% to $8.4 million for the three month period ended June
30, 2007 from $7.7 million for the three months ended July 1, 2006. For the three month period
ended June 30, 2007, domestic ophthalmology sales increased 9.2% to $5.0 million from $4.5 million
for the three months ended July 1, 2006. This increase was attributed to a 13% increase in
disposable probe revenue and a 20%
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increase in ophthalmology service revenue. International
ophthalmology equipment sales for the three month period ended June 30, 2007 increased 9.3% to $3.4
million, from $3.1 million for the three months ended July 1, 2006.
For the six months ended June 30, 2007, total ophthalmology sales increased 2.3% to $15.6
million from $15.2 million for the six months ended July 1, 2006. During this period, domestic
ophthalmology sales increased 3.8% to $9.0 million for the six month period ended June 30, 2007
from $8.6 million for the six month period ended July 1, 2006. The total increase in domestic
ophthalmology revenue during this period was primarily due to an increase in domestic disposable
revenue offset by decreased other ophthalmology revenue, primarily OEM sales. International
ophthalmology sales remained constant at $6.6 million for both the six month periods ended June 30,
2007 and July 1, 2006.
Aesthetic Sales
Total aesthetic sales increased $5.7 million from $1.1 million for the three month period
ended July 1, 2006 to $6.9 million for the three month period ended June 30, 2007. Domestic
aesthetic sales increased to $3.4 million for the three month period ended June 30, 2007 from $0.8
million for the three month period ended July 1, 2006. International aesthetic sales increased
$3.0 million from $0.4 million for the three month period ended July 1, 2006 to $3.4 million for
the three month period ended June 30, 2007. The increase in aesthetic revenue was due to the
addition of the newly acquired Laserscope business. Approximately $1.2 million of the
international aesthetics sales were generated from higher than normal expected sales to a single
distributor partially caused by delays in shipment of orders placed in the first quarter of 2007.
For the six months ended June 30, 2007 aesthetics sales increased to $12.2 million from $2.4
million for the six months ended July 1, 2006. Domestic aesthetics sales increased to $6.1 million
for the six months ended June 30, 2007 from $1.8 million for the six months ended July 1, 2006. The
increase in domestic aesthetics sales was driven mainly by the newly acquired Laserscope business.
International aesthetics sales increased to $6.1 million for the six months ended June 30, 2007
from $0.6 million for the comparable period in 2006 largely due to the acquired Laserscope
business.
Gross Margin
Gross profit increased by $1.9 million to $6.6 million for the three months ended June 30,
2007 compared to $4.7 million for the three months ended July 1, 2006. Gross profit as a
percentage of sales for the three months ended June 30, 2007 decreased to 43.2% from 52.9% for the
comparable prior year three month period. The total 9.7% decrease in gross profit as a percentage
of sales during this period resulted from a 78.3% increase in overhead spending combined with a
19.7% increase in direct costs which included $0.5 million of amortization expense of recently acquired intangible assets related to product technology which had a negative impact of 3.0% on
overall gross margin. The overhead spending was primarily the result of increased expenses for the
newly acquired field service organization, and increased spending related to manufacturing
integration activities. Direct cost margin was 71.8% for ophthalmic products and 43.5% for
aesthetics products for the three months ended June 30, 2007.
This compares with 71.8% for ophthalmic products and 57.7% for
aesthetics products for the three months ended July 1, 2006.
Direct cost margins for aesthetics products in 2007 were unfavorably
impacted by the higher mix of international aesthetic sales which typically generate lower average
selling prices. Margins for our ophthalmic Iridex products were flat compared to prior year
levels.
For the six months ended June 30, 2007, gross profit increased by $2.9 million to $11.8
million from $8.9 million for the six months ended July 1, 2006. Gross profit as a percentage of
sales for the six months ended June 30, 2007 decreased to 42.4% from 50.6% for the comparable prior
year six month period. The total 8.2% decrease in gross profit as a percentage of sales during this
period resulted from an 86.9% increase in overhead spending combined with a 15.6% increase in
direct costs which included $0.9 million of
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amortization expense related to the recently acquired
intangible assets. The overhead spending was primarily the result of increased expenses for the
newly acquired field service organization, and increased spending related to manufacturing
integration activities. Direct cost margins were unfavorably impacted by the higher mix of
international aesthetic sales which typically generate lower average selling prices.
Our immediate margin improvement efforts are focused on achieving planned manufacturing cost
efficiencies from integration of the Laserscope products within existing manufacturing capacity.
Integration is expected to be completed by the end of the current fiscal year. In addition we are
working to streamline the structure and efficiency of the newly acquired field service business.
Overall, gross margins as a percentage of sales will continue to fluctuate due to the product mix
of sales, costs associated with future product introductions, changes in the relative proportions
of domestic and international sales, and a variety of other factors. See Factors That May Affect
Future ResultsOur Operating Results May Fluctuate from Quarter to Quarter and Year to Year in
Item 1A of Part II, Section of this report.
Research and Development
Research and development includes the cost of research and product innovation efforts.
Research and product innovation expenses increased by 19.6% to $1.6 million, or 10.4% of net sales,
in the second quarter of 2007 from $1.3 million, or 15.1% of net sales, in the second quarter of
2006. The increase in spending in the second quarter of 2007 in comparison to the second quarter
of 2006 related to $0.2 million in increased salary expense associated with increased headcount and
increased consultant and project spending of $0.1 million associated with increased development
efforts. The decrease in R&D spending as a percentage of sales in the second quarter of 2007 was
due to the increased sales levels in 2007 largely attributable to the Laserscope acquisition. R&D
spending is targeted to approximate 9.0% of net sales in our planned business model.
For the six months ended June 30, 2007 research and development expenses increased 35.4% to
$3.3 million from $2.4 million for the six months ended July 1, 2006. As a percentage of sales,
research and development expense decreased to 11.9% for the six months ended June 30, 2007 from
13.9% for the six months ended July 1, 2006. The increase in research and development expense in
absolute dollars for the six month period ended June 30, 2007 was due primarily to $0.4 million in
increased salaries, benefits and recruiting and relocation expenses and $0.5 million of increased
consultant and project spending associated with development efforts.
Selling, General and Administrative
Selling, general and administrative expense increased in the second quarter of 2007 by $3.7
million to $7.5 million or 49.5% of net sales from $3.9 million or 43.9% of net sales in the second
quarter of 2006. The increase related primarily to higher salary and commission expense due to
increased headcount and associated selling expenses of $1.2 million, $1.1 million for increased
marketing headcount and aesthetics related marketing programs and $0.3 million for amortization of
marketing intangibles. Additionally $1.0 million of selling, general and administrative expense
was incurred in the two acquired Laserscope entities in France and the United Kingdom. General and
administrative expense in the U.S. increased $0.3 million related to increased spending on
consultants and contractors and higher accountant fees. We are planning to reduce the overall
level of selling, general and administrative spending in future quarters through reduced spending
programs and a reduction in the use of consultants and contractors.
For the six months ended June 30, 2007 selling, general and administrative expense increased
102.9% to $15.8 million from $7.8 million for the six months ended July 1, 2006. This increase in
selling, general and administrative expense for the six month period ended June 30, 2007 was due
primarily to $1.9 million in
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increased selling expense associated with increased headcount
including salaries, commissions and employee related expenses, $1.0 million for increased
aesthetics related marketing programs, $0.6 million of increased salary and employee related costs
associated with additional marketing headcount, amortization expense of $0.5 million associated
with marketing intangibles, $0.4 million of increased accounting fees and $0.4 million associated
with increased fees for consultants and contractors. In addition, the acquisition of the two
Laserscope entities in France and the United Kingdom contributed $2.0 million to the 2007
selling, general and administrative spending increase.
Amortization of Purchased Intangibles
In the first quarter of 2007, we completed the acquisition of the aesthetics business from
Laserscope. We recorded in the second quarter of 2007, $0.8 million of amortization expense
related to the acquisition of intangible assets acquired from Laserscope. $0.5 million of this
total was allocated to cost of goods sold since it relates to product technology intangibles. The
remaining $0.3 million of marketing amortization expense is recorded in selling, general and
administrative expenses. We expect to record quarterly amortization expense at these levels for
the remaining two quarters of 2007.
Goodwill and purchased intangible assets were initially recorded in the first three months of 2007
in conjunction with the acquisition of the aesthetics business of Laserscope (Note 3). We did not
identify any events since the date of acquisition that would indicate that there has been an
impairment in the carrying value of these assets. However, if there are changes in events or
circumstances, such as an inability to achieve the cash flows originally expected from the
acquisition, which indicate that the recorded value of the intangible assets will not be recovered
through future cash flows, or if the fair value of the aesthetics business unit is determined to be
less than its carrying value, the Company may be required to record an impairment charge for the
intangible assets or goodwill or change the period of expected amortization for the intangible
assets.
Interest and Other (Expense) Income, Net.
For
the three and six months ended June 30, 2007 net amounts included in Interest and Other Expense,
consisted of $2.5 million of other income associated with a settlement of legal claims related to
patent infringement with Synergetics offset by interest expense on newly acquired
bank debt. For the three and six months ended July 1, 2006 other income was $0.2 million and $0.4
million respectively and consisted of interest income on available for sale securities. We do not
expect to earn interest income in the near future and instead expect to incur interest expense
related to our credit facility.
Income Taxes
Significant components affecting the effective tax rate include pre-tax net income or loss,
changes in valuation allowance, federal and state R&D tax credits, income from tax-exempt
securities, the state composite tax rate and recognition of certain deferred tax assets subject to
valuation allowance. The effective income tax rate for the three and six month period ending July
1, 2006 was 50.0% and 13.5% respectively. The change in the effective tax rate was driven
primarily by the accounting for certain benefits associated with stock compensation expense
commencing in 2006. In 2007 we do not anticipate recording a tax provision until we determine it
is appropriate to revise the valuation allowance.
Liquidity and Capital Resources
The Company expects that its current cash and cash equivalents, cash flow expected to be
generated from operations and available credit facilities, if any, will not be sufficient to meet
the Companys operating
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requirements, except for the near term and for a period substantially less
than 12 months. Unless the Company is able to modify its planned operating requirements and raise
additional capital, the Companys current cash and cash equivalents, cash flow expected to be
generated from operations and available credit facilities, if any, will not be sufficient to meet
the Companys operating requirements, except for the near term and for a period substantially less
than 12 months. In order to address these liquidity issues, the Company plans to, among other things: (i) work
towards integrating the aesthetics business as quickly and efficiently as possible and maximizing
the potential benefits that may be realized from the acquisition, (ii) modify its planned
operations in order to increase our cash flows from operations, (iii) seek to further restructure
or replace its current credit facilities, and (iv) raise additional capital through equity or debt
financing in order to enhance its liquidity.
Generally, the Companys principal sources of liquidity are cash from operations and
borrowings under our credit facility. As of June 30, 2007 we had $3.5 million of cash and cash
equivalents and $3.8 million of restricted cash pursuant to our bank agreements. Under our credit
facility, the restricted cash balances may not be used to fund our operating requirements. Our
cash and cash equivalents decreased by $17.5 million during the six months ended June 30, 2007.
This decrease is primarily due to acquisition related payments, partially offset by financing
activities. In the first six months of 2007, cash provided by
operations was $1.0 million.
Significant changes in working capital accounts were:
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a $2.2 million increase in inventory; |
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a $0.8 million increase in accrued expenses. |
The Company generated positive cash flow from operations despite the $5.3 million loss for the
six months ended June 30, 2007 due to non-cash charges of approximately $2.5 million and increases
in accounts payable and accruals of $5.0 million. In future periods as accounts payable and
accruals are reduced, cash flow from operations will be reduced.
In
the first six months of 2007, cash flow used in investing activities was $28.6 million
primarily related to the acquisition of the aesthetics business of Laserscope. In the first six
months of 2007, cash flows from financing activities included proceeds from the issuance of common
stock under our equity based stock compensation plans of $0.8 million and $9.3 million of cash from
the draw-down of our current credit facility. Included in our cash balance at June 30, 2007 is
$3.9 million of cash owed to Laserscope for cash obtained through the acquisition of the foreign
subsidiaries, but not included in the asset purchase agreement. This cash will be netted against
payments owed to the Company upon settlement of the post close balance sheet adjustment.
On August 14, 2007,
the Company, AMS and Laserscope, (collectively the Parties), entered
into a Settlement Agreement (the Settlement Agreement). The Parties entered into the Settlement
Agreement to document their full and final agreement as to the amount of the adjustment
contemplated by Section 1.5 of the Asset Purchase Agreement, by and among AMS, Laserscope and the
Company, dated November 30, 2006 (the Purchase Agreement); to amend the Product Supply Agreement,
between and between Laserscope and the Company, dated January 16, 2007 (the Product Supply
Agreement); and to set forth the Parties mutual understanding as to certain other matters. The
Settlement Agreement provides that, pursuant to Section 1.5 of the Purchase Agreement, the Company
will make an additional payment to AMS of $1,150,000 which will be the sole and final adjustment to
the purchase price and will be paid in equal weekly installments of
$22,115 beginning August 16, 2007 over the course of the next year. The Settlement Agreement modifies and amends certain terms of
the Product Supply Agreement, including, among others: (a) agreement upon the current and future
products to be built and delivered by Laserscope to the Company and the payment terms relating
thereto; (b) allocation of and pricing and delivery terms relating to inventory parts to be sold by
Laserscope to the Company and agreement on a payment plan for
currently outstanding invoices, which includes two weekly payments of
$100,000 each for the last two weeks of August, increasing to
$150,000 per week for four weeks in September; and (c) agreement upon certain payments to be made by the Company to AMS
in the event that the Company increases its borrowing capacity to more than $12,000,000 under any
credit facility that is senior to the Companys payment obligations under the Settlement Agreement.
Under the terms of the Settlement Agreement, the Company agreed to make payments to AMS totaling
$4,059,557 in respect of
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certain inventory and service parts to be purchased from AMS following termination of the Product Supply Agreement. This sum is to be paid in 39 weekly installments of
$110,185 including an interest charge of 10% per annum beginning on January 3, 2008 and is being paid as a settlement of potential payments
required to be made by the Company to AMS of up to $9 million for inventory to be delivered to the
Company by AMS following the scheduled termination of the Product Supply Agreement in October 2007.
The Company believes that entering into the Settlement Agreement will (a) provide certainty with
respect to its future payment obligations to Laserscope under the
Purchase Agreement and Product Supply Agreement, (b) facilitate the Companys restructuring of
its planned operating requirements, and (c) allow the Company to enhance its liquidity and capital
reserves relative to its future capital needs. (See Note 10 of the Unaudited Condensed
Consolidated Financial Statements in Item 1 of Part I of this report.)
Any breach by the Company of any provision of any of its agreements with AMS or Laserscope
shall constitute an immediate default and shall entitle AMS and Laserscope to any and all remedies
available to them under the Security Agreement, the Product Supply Agreement, and the Settlement
Agreement, including, but not limited to, the right to terminate the Product Supply Agreement
immediately upon written notice to the Company with no additional notice period or opportunity to
cure and the right to declare all amounts due from the Company to AMS to be immediately due and
payable in full.
In April 2007, we received $2.5 million from Synergetics in settlement of a patent
infringement claim and expect to receive subsequent annual payments of $0.8 million per year for
the next five years.
As of June 30, 2007, the Company was not able to satisfy certain restrictive financial
covenants contained in its credit facilities with Mid-Peninsula Bank and the Export-Import Bank
(the Lenders) as well as an affirmative covenant regarding the preparation and delivery of
quarterly financial statements within 45 days of quarter end (see Note 4). The Company has
received a one-time waiver from Mid-Peninsula Bank with respect to its inability to satisfy the
financial covenants contained in its loan agreements with the Lenders for the period ended June 30,
2007, but can provide no assurance that the Lenders will grant any additional future waivers if
requested. The Company was also not in compliance with its debt covenants at the end of its first
quarter but it was successful in obtaining a waiver of default for that period. In the event of
noncompliance the Lenders would be entitled to exercise their remedies, under these facilities,
which include declaring all obligations immediately due and payable and disposing of the collateral
if obligations were not paid. The Company has modified planned operations in order to increase
cash flows from operations, and intends to raise additional capital through equity or debt
financing in order to enhance liquidity. However, there can be no assurances that the Company will
be successful in these efforts or that any additional capital raised through debt or equity
financings will be available on favorable terms or at all. The accompanying financial statements
do not include any adjustments that might result from the outcome of this uncertainty.
Recent
Accounting Pronouncements
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities Including an Amendment of FASB Statement No. 115 (SFAS No. 159). SFAS
No. 159 permits entities to choose to measure many financial instruments and certain other items at
fair value. Unrealized gains and losses on items for which the fair value option has been elected
will be recognized in earnings at each subsequent reporting date. SFAS No. 159 is effective for
financial statements issued for fiscal years beginning after November 15, 2007. We do not believe
that the adoption of the provisions of SFAS 157 will materially impact our consolidated financial
position and results of operations.
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Item 3. Quantitative and Qualitative Disclosure about Market Risk
Quantitative Disclosures
We are exposed to market risks inherent in our operations, primarily related to interest rate
risk and currency risk. These risks arise from transactions and operations entered into in the
normal course of business. We do not use derivatives to alter the interest characteristics of our
marketable securities or our debt instruments. We have no holdings of derivative or commodity
instruments.
Interest Rate Risk.
We are subject to interest rate risks on cash and cash equivalents, our current credit
facility and any future financing requirements.
Qualitative Disclosures
Interest Rate Risk.
Our primary interest rate risk exposures for the periods covered by this report relate to the
impact of interest rate movements on our ability to obtain adequate financing to fund future
operations.
Currency Rate Risk.
Historically, we have denominated our sales both domestically and internationally in US
dollars. With the acquisition of the Laserscope aesthetics business we have acquired two foreign
subsidiaries that make sales and incur the majority of their expenses in their local currencies.
These subsidiaries operate in France and the United Kingston and their currencies are the Euro and
Pounds Sterling respectively. Monthly income and expense from these operations are translated
using average rates and balance sheets are translated using month end rates. Differences are
recorded within stockholders equity as a component of accumulated other comprehensive income
(loss) or to the statement of operations, as applicable. As our revenues denominated in currencies
other than the dollar increase, we have an increased exposure to foreign currency rate risk. Based
on our overall exposure for foreign currency at June 30, 2007, a hypothetical 10% change in foreign
currency rates would not have a material impact on our net sales and operating expenses. We may
elect to mitigate this rate risk, in part or in whole, through the purchase of forward currency
contracts.
Item 4T. Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures
Our management evaluated, with the participation of our Chief Executive Officer (CEO) who is
currently our principal executive officer and principal financial officer, the effectiveness of the
design and operation of our disclosure controls and procedures (as defined in Rule 13A-15(e) and
Rule 15d-15(e) of the Securities Exchange Act of 1934 (the 34 Act), as of the end of the period
covered by this report. Based on that evaluation and as a result of the material weakness in our
internal controls over financial reporting discussed below, the CEO in his capacity as both
principal executive officer and principal financial officer concluded that as of the end of the
period covered by this report, the Companys disclosure controls and procedures were not effective.
Disclosure controls and procedures are designed with the objective of ensuring that (i)
information required to be disclosed in our reports filed under the 34 Act is recorded, processed,
summarized and reported within the time periods specified in the SECs rules and forms and (ii)
information is accumulated
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and communicated to management, including the CEO and CFO, as
appropriate to allow timely decisions regarding required disclosure. Internal control procedures,
which are designed with the objective of providing reasonable assurance that our transactions are
properly authorized, our assets are safeguarded against unauthorized or improper use and its
transactions are properly recorded and reported, are intended to permit the preparation of our
financial statements in conformity with generally accepted accounting principles. To the extent
that elements of our internal control over financial reporting are included within our disclosure
controls and procedures, they are included in the scope of our quarterly controls evaluation.
A material weakness is a control deficiency, or a combination of control deficiencies, that
results in more than a remote likelihood that a material misstatement of the annual or interim
financial statements will not be prevented or detected. Management determined that the following
control deficiencies constitute a material weakness in our internal control over financial
reporting as of June 30, 2007.
In connection with the acquisition of two foreign subsidiaries it has been determined that
these entities lack the necessary internal control and disclosure procedures such that there is
more than a remote likelihood that a material misstatement of our financial statements will not be
prevented or detected.
Also, in connection with the annual audit of our financial statements as of December 30, 2006,
our independent registered public accounting firm communicated to our management and the Audit
Committee of the Board of Directors that they had identified a control deficiency that existed in
the design or operation of our internal controls over financial reporting that they considered to
be a material weakness, because the control deficiency resulted in more than a remote likelihood
that a material misstatement could occur in our annual financial statements and not be prevented or
detected. Specifically, the material weakness identified by our independent accountants relates to
a failure to maintain adequate period-end review procedures to ensure the completeness and accuracy
of certain journal entries impacting general ledger accounts. As a result, an error in a system
generated custom inventory report and errors in two key spreadsheets related to warranty and
deferred revenue resulted in incorrect entries being recorded to the financial statements which
were not identified and corrected by management in a timely manner.
Plan for Remediation of Material Weaknesses
To address the material weaknesses in our internal control over financial reporting identified
above, management has designed a remediation plan which will supplement the existing controls of
the Company.
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The remediation plan addresses the following corrective actions: |
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implementation of additional controls over the preparation and review of key spreadsheets; |
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implementation of automated general ledger reports to replace existing key
spreadsheets where possible; |
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implementation of additional review procedures; |
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enhancement of the current capabilities of the finance function; and |
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implementation of standard control and review procedures over our foreign subsidiaries. |
We continued the process of implementing certain corrective actions relating to our period-end
review procedures during and subsequent to the three month period covered by this quarterly report
on Form 10-Q. We believe that once all of these corrective actions are implemented, including the
enhancement of the capabilities of the finance function, the material weaknesses that were
identified will be mitigated.
Even if we are to successfully remediate each of the material weaknesses described above,
because of inherent limitations, our disclosure controls and procedures may not prevent or detect
misstatements or
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material omissions. 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.
(b) Changes in Internal Controls
There were no changes in our internal controls over financial reporting that occurred during
the period covered by this Quarterly Report on Form 10-Q that have materially affected, or are
reasonably likely to materially affect, our internal control over financial reporting.
Subsequent to the period covered by this Quarterly Report on Form 10-Q, the Companys Chief
Financial Officer who joined the Company in February 2007 resigned.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Patent Litigation On October 19, 2005, the Company filed a suit in the United States
District Court for the Eastern District of Missouri against Synergetics, USA, Inc. for infringement
of a patent. The Company later amended its complaint to assert infringement claims against
Synergetics, Inc.; Synergetics USA, Inc. was dismissed from the suit. The Company alleged that
Synergetics infringed the Companys patent by making and selling infringing products, including its
Quick Disconnect laser probes and its Quick Disconnect Laser Probe Adapter, and sought injunctive
relief, monetary damages, treble damages, costs and attorneys fees. . On April 25, 2006,
Synergetics added the Company as a defendant to a then existing lawsuit in the U.S. District Court
for the Eastern District of Pennsylvania. In that litigation, Synergetics alleged that the Company
infringed its patent on a disposable laser probe design.
Trial in the Missouri litigation was scheduled to begin on April 16, 2007, however on April 6,
2007 the parties reached settlement on the claims. Under the terms of the settlement agreement,
the parties agreed to terminate all legal proceedings between the parties and to a fully paid-up,
royalty free, worldwide cross licensing of various patents between the two companies. In
consideration of these licenses Synergetics agreed to pay the Company $6.5 million over a period of
five years. The first payment of $2.5 million by Synergetics was paid on April 16, 2007, followed
with annual payments of $0.8 million on each April 16th until 2012.
Management believes that claims which are pending or known to be threatened, will not have a
material adverse effect on the Companys financial position or results of operations and are
adequately covered by the Companys liability insurance. However, it is possible that cash flows
or results of operations could be materially affected in any particular period by the unfavorable
resolution of one or more of these contingencies or because of the diversion of managements
attention and the incurrence of significant expenses.
Item 1A. Risk Factors
Factors That May Affect Future Results
In addition to the other information contained in this Quarterly Report Form 10-Q, we have
identified the following risks and uncertainties that may have a material adverse effect on our
business, financial condition or results of operation. You should carefully consider the risks
described below before making an investment decision.
We Do Not Believe
that Our Current Liquidity and Capital Resources Will Be Sufficient to Meet
Our Currently Planned Operating Requirements, Except for the Near Term and for a Period
Substantially Less Than 12 Months, and We May Not Be Able to Comply with the Restrictive Covenants
Contained in Our Loan Agreements with Mid-Peninsula Bank, Part of Greater Bay Bank N.A., and the
Export-Import Bank, Despite Recent Amendments to Such Loan Agreements.
We do not believe
that our current cash and cash equivalents, cash flow expected to be
generated from operations and available credit facilities, if any, will be sufficient to meet the
Companys operating requirements, except for the near term and for a period substantially less than
12 months. Unless we are able to modify our planned operating requirements and raise additional
capital, our current cash and cash equivalents, cash flow expected to be generated from operations
and available credit facilities, if any, will not
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be sufficient to meet our planned operating requirements, except for the near term and for a
period substantially less than 12 months. Our concerns about our ability to satisfy our liquidity
requirements are primarily a result of our current operating performance relative to plan, as well
as our continuing losses, negative cash flows and current liquidity in relation to future
obligations, including our obligations to make payments to certain vendors and to Laserscope under
the Settlement Agreement and Product Supply Agreement and our inability to satisfy certain
covenants under our loan agreement with Mid-Peninsula Bank, part of Greater Bay Bank N.A., and the
Export-Import Bank (the Lenders) as of June 30, 2007 and our potential inability to satisfy the
covenants contained in these agreements, as amended, in the future.
Our recent and current operating performance has not met our expectations, primarily as a
result of our inability to realize the full benefits of the acquisition of the aesthetics business
of Laserscope in our previously anticipated time frame, as well as recent negative cash flows from
operations. In particular, revenues from the aesthetics business have been below our expectations.
Our ability to realize the potential benefits of the acquisition will depend, in part, on our
ability to integrate the aesthetics business. As expected, our efforts towards integrating the
aesthetics business of Laserscope has and will continue to take a significant amount of time and
place a significant strain on our managerial, operational and financial resources, and may continue
to be more difficult and expensive than originally anticipated. This continued diversion of our
managements attention and any additional delays or difficulties encountered in connection with the
integration of the aesthetics business could harm our operating results and increase the difficulty
of our being able to satisfy our liquidity requirements.
In addition, as of March 31, 2007, we were not able to satisfy certain restrictive covenants
contained in our credit facilities with the Lenders. On April 19, 2007, we entered into amendments
with the Lenders pursuant to which, (i) we agreed to deposit and maintain $3.8 million in cash in a
segregated deposit account with the Lenders as collateral in support of our term loan and to
restrict up to $2.2 million of the combined borrowing base from our line of credit in support of
the term loan, and (ii) the parties agreed to eliminate the requirement that we maintain a minimum
of $3.0 million in aggregate domestic unrestricted cash or marketable securities. The Lenders also
agreed to increase the credit extended to the Company under the agreement with the Export-Import
Bank from $3.0 to $5.0 million. In connection with these amendments, Mid-Peninsula Bank agreed to
a one-time waiver of certain financial covenants contained in the loan agreements with the
Mid-Peninsula Bank. As of June 30, 2007, we were again not able to satisfy certain restrictive
covenants contained in our credit facilities with the Lenders, but Mid-Peninsula Bank agreed to a
an additional one-time waiver of certain financial covenants contained in the loan agreements with
the Mid-Peninsula Bank. These one-time waivers do not apply to any other potential future breaches
of any of the financial covenants by the Company contained in the agreements with the Lenders.
Compliance with the financial covenants for which such waiver was obtained is evaluated on a
quarterly basis and the Lenders may not be willing to grant additional waivers if we fail to comply
with restrictive covenants in the future.
If we default on these credit facilities and the Lenders exercise their remedies, this will
further contribute to the difficulties we expect to face in meeting our near- and long-term
liquidity requirements. Our obligations under these credit facilities are secured by a lien on
substantially all of the Companys assets. We currently have drawn down $9.4 million under this
credit facility which is the full amount currently available, and, given our current financial
status, we currently do not expect to be able to satisfy the restrictive covenants relating to
these facilities as of September 30, 2007. In the event of default by the Company with the
covenants under these facilities, the Lenders would be entitled to exercise their remedies, which
include declaring all obligations immediately due and payable and disposing of the collateral if
obligations were not paid. Although we entered into amendments to the loan agreements with the
Lenders in order to enhance our ability to comply with the restrictive covenants contained therein,
we cannot assure you that will be able to comply with these covenants in the future and do not
expect to be in compliance as of the end of the fiscal
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quarter ending September 30, 2007. See Note 4 of Notes to Consolidated Financial Statements
in Item 1 of Part I of this report for more information regarding these credit facilities.
In order to address our liquidity issues, we plan to, among other things: (i) work towards
integrating the aesthetics business as quickly and efficiently as possible and maximizing the
potential benefits that may be realized from the acquisition, (ii) modify our planned operations in
order to increase our cash flows from operations, (iii) seek to further restructure or replace our
current credit facilities, and (iv) raise additional capital through equity or debt financing in
order to enhance our liquidity.
We cannot assure you that we will be successful in these efforts or that any additional
capital raised through debt or equity financings will be available on favorable terms or at all or
that any additional capital raised will be sufficient to address our liquidity or capital resources
needs. If we are unsuccessful in these efforts, we may have to suspend or cease operations or
significantly dilute our stockholders equity holdings.
We Have More Indebtedness and Fewer Liquid Resources After the Acquisition of the Aesthetics
Business of Laserscope, Which Could Adversely Affect Our Cash Flows and Business.
In order to complete the acquisition, we entered into financing arrangements that provide for
a $6 million term loan and a revolving credit line of up to $6 million. We had no debt outstanding
at December 30, 2006. We had $11.9 million outstanding on January 17, 2007 when the acquisition of
the aesthetics business of Laserscope was consummated. We also used the majority of our liquid
resources to finance the acquisition of the aesthetics business of Laserscope. As a result of the
increase in debt, demands on our cash resources have increased following the completion of the
acquisition. The increased levels of debt could, among other things:
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require us to dedicate a substantial portion of our cash flow from operations to
payments on our debt, thereby reducing funds available for working capital, capital
expenditures, acquisitions and other purposes; |
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making it more difficult for us to meet our payment and other obligations under our
outstanding debt; |
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increase our vulnerability to, and limit our flexibility in planning for, adverse
economic and industry conditions; |
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increase our sensitivity to interest rate increases on our indebtedness with variable
interest rates; |
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result in an event of default if we fail to comply with the financial and other
restrictive covenants contained in our debt agreements, which event of default could result
in all of our debt becoming immediately due and payable; |
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affect our credit rating; |
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limit our ability to obtain additional financing to fund future working capital, capital
expenditures, additional acquisitions and other general corporate requirements; |
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create competitive disadvantages compared to other companies with less indebtedness; and |
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limit our ability to apply proceeds from an offering or asset sale to purposes other
than the repayment of debt. |
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As a result of the above, we are currently unable to satisfy certain restrictive financial
covenants contained in our loan agreements and may not be able to do so in the future. In the
event of default by the Company with the covenants under these facilities, the Lenders would be
entitled to exercise their remedies which would include declaring all obligations immediately due
and payable and disposing of the collateral if obligations were not paid.
Our Loan Agreements Contain Covenant Restrictions that May Limit Our Ability to Operate Our
Business and To Service Our Indebtedness, We Will Require a Significant Amount of Cash. Our
Ability to Generate Cash Flow Depends on Many Factors Beyond Our Control.
Our ability to meet our payment and other obligations under our debt depends on our ability to
generate significant cash flows in the future. This, to some extent, is subject to general
economic, financial, competitive, legislative and regulatory factors as well as other factors that
are beyond our control. We cannot assure holders that our business will generate cash flow from
operations, or that future borrowings will be available to us under our credit facilities or
otherwise, in an amount sufficient to enable us to meet our payment obligations under our debt and
to fund other liquidity needs. Our loan agreements contain covenant restrictions that may limit
our ability to operate our business. As discussed above, we are currently unable to satisfy
certain restrictive financial covenants contained in our loan agreements and may not be able to do
so in the future. In the event of default by the Company with the covenants under these
facilities, the Lenders would be entitled to exercise their remedies which would include declaring
all obligations immediately due and payable and disposing of the collateral if obligations were not
paid.
Although We Expect that Our Acquisition of the Aesthetics Business of Laserscope Will Result
in Benefits to the Company, the Company May Not Realize Those Benefits Because of Integration and
Other Challenges.
On January 16, 2007, we completed our acquisition of the aesthetics business of Laserscope
(the Aesthetics Business), a wholly-owned subsidiary of American Medical Systems Holdings, Inc.
To date we have not realized the anticipated benefits of the acquisition and our ability to realize
the anticipated benefits of the acquisition will depend, in part, on our ability to integrate the
Aesthetics Business with our business. Integrating the Aesthetics Business may be expensive and
time-consuming and we may not be able to successfully do so. These integration efforts have taken
a significant amount of time, placed a significant strain on managerial, operational and financial
resources and proven to be more difficult and more expensive than predicted. The diversion of our
managements attention and any delays and difficulties encountered in connection with integrating
the Aesthetics Business could result in the disruption of our on-going business or inconsistencies
in standards, controls, procedures and policies that could negatively affect our ability to
maintain relationships with customers, suppliers, collaborators, employees and others with whom we
have business dealings. These disruptions could harm our operating results. Further, the
following specific factors may adversely affect our ability to integrate the Aesthetics Business:
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coordinating marketing functions; |
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transferring of the manufacturing of the Laserscope products to the Company; |
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unanticipated issues in integrating information, communications and other systems; |
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unanticipated incompatibility of purchasing, logistics, marketing and administration methods; |
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greater than anticipated liabilities; |
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retaining key employees, including members of our aesthetics sales force; |
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consolidating corporate and administrative infrastructures; |
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the diversion of managements attention from ongoing business concerns; |
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coordinating our current product and process development efforts with those of the
Aesthetics Business in a way which permits us to bring future new products to the market in
a timely and cost-effective manner; and |
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coordinating geographically separate organizations. |
We cannot assure you that the combination of the Aesthetics Business with our business will
result in the realization of the full benefits anticipated from the acquisition.
In addition, as part of our acquisition, we entered into agreements with Laserscope to obtain
certain manufacturing support, administrative services and future intellectual property rights. In
the event that Laserscope fails to provide this support and service, or provides such support and
service at a level of quality and timeliness inconsistent with the historical delivery of such
support and service, or fails to grant us the intellectual property rights we expected, our ability
to integrate the Aesthetics Business will be hampered and our operating results may be harmed.
Failure to Remediate the Material Weaknesses in Our Disclosure Controls and Procedures in a
Timely Manner, or at All, Could Harm Our Operating Results or Cause Us to Fail to Meet Our
Regulatory or Reporting Obligations.
We evaluated the effectiveness of our disclosure controls and procedures as of the end of the
period covered by this report and, based on this evaluation, management concluded that our
disclosure controls and procedures were not effective because of the material weaknesses detailed
in Item 4T of Part I of this Quarterly Report on Form 10-Q.
In particular, the material weaknesses identified related to the Companys period-end review
procedures. We are taking a number of remedial actions designed to remedy the material weaknesses
summarized above. However, if despite our remediation efforts, we fail to remediate our material
weaknesses, we could be subject to regulatory scrutiny and a loss of public confidence in our
disclosure controls and procedures. These remediation efforts will likely increase our general and
administrative expenses and could, therefore, have an adverse effect on our reported net income.
Even if we are to successfully remediate such material weaknesses, because of inherent
limitations, our disclosure controls and procedures may not prevent or detect misstatements or
material omissions. 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.
The Requirements of Complying with the Sarbanes-Oxley Act of 2002 Might Strain Our Resources,
Which May Adversely Affect Our Business and Financial Condition.
We are subject to a number of requirements, including the reporting requirements of the
Securities Exchange Act of 1934, as amended, and the Sarbanes-Oxley Act of 2002. Beginning with
our fiscal year ending December 29, 2007 we will be required to comply with the requirements of
Section 404 of the
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Sarbanes-Oxley Act which will require management to perform an assessment of internal control
over financial reporting. We are not currently in a position to comply with the requirements of
Section 404 of the Sarbanes-Oxley Act and have not yet taken the necessary actions to prepare to be
able to do so beginning with our fiscal year ending December 29, 2007. We expect that these
requirements will be difficult to satisfy in a timely manner and that they will place a significant
strain on our systems and resources, especially in light of the recent departure of our Chief
Financial Officer and our need to find a permanent replacement Chief Financial Officer and to
further enhance our finance function. The Sarbanes-Oxley Act requires, among other things, that we
maintain effective disclosure controls and procedures and internal control over financial
reporting. In order to maintain and improve the effectiveness of our disclosure controls and
procedures and internal control over financial reporting, significant resources and management
oversight will be required. As a result, our managements attention might be diverted from other
business concerns, which could have a material adverse effect on our business, financial condition,
and operating results. In addition, we might need to hire additional accounting and financial
staff with appropriate public company experience and technical accounting knowledge, and we might
not be able to do so in a timely fashion.
We Rely on Continued Market Acceptance of Our Existing Products and Any Decline in Sales of
Our Existing Products Would Adversely Affect Our Business and Results of Operations.
We currently market visible and infrared light therapeutic-based photocoagulator medical laser
systems and delivery devices to the ophthalmology and aesthetics markets. We believe that
continued and increased sales, if any, of these medical laser systems is dependent upon a number of
factors including the following:
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acceptance of product performance, features, ease of use, scalability and durability; |
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acceptance of the companys new marketing programs; |
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recommendations and opinions by ophthalmologists, dermatologists, plastic surgeons,
other clinicians and their associated opinion leaders; |
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clinical study outcomes; |
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price of our products and prices of competing products and technologies; |
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availability of competing products, technologies and alternative treatments; and |
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level of reimbursement for treatments administered with our products. |
In addition, we derive a meaningful portion of our sales from recurring revenues including
disposable laser probes, EndoProbes and service. Our ability to increase recurring revenues from
the sale of EndoProbes will depend primarily upon the features of our current products and product
innovation, ease of use and prices of our products, including the relationship to prices of
competing delivery devices. The level of service revenues will depend on our quality of care,
responsiveness and the willingness of our customers to request and utilize our products and
services rather than purchase competing products or services. Any significant decline in market
acceptance of our products or our revenues derived from the sales of laser consoles, delivery
devices or services may have a material adverse effect on our business, results of operations and
financial condition.
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If There is Not Sufficient Demand for the Procedures Performed with Our Products, Practitioner
Demand for Our Products Could be Inhibited, Resulting in Unfavorable Operating Results and Reduced
Growth Potential.
Continued expansion of the global market for laser- and other light-based aesthetic procedures
is a material assumption of our growth strategy. Most procedures performed using our products are
elective procedures not reimbursable through government or private health insurance, and the costs
of such procedures are borne by the patient. The decision to utilize our products may therefore be
influenced by a number of factors, including:
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evolving customer needs; |
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the introduction of new products and technologies; |
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evolving surgical practices; |
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evolving industry standards; |
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the cost of procedures performed using our products; |
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the cost, safety and effectiveness of alternative treatments, including treatments which
are not based upon laser- or other light-based technologies and treatments which use
pharmaceutical products; |
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the success of our sales and marketing efforts; and |
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consumer confidence, which may be impacted by economic and political conditions. |
If, as a result of these factors, there is not sufficient demand for the procedures performed
with our products, practitioner demand for our products could be reduced, resulting in unfavorable
operating results and lower growth potential.
Our Future Success Depends on Our Ability to Develop and Successfully Introduce New Products
and New Applications.
Our future success is dependent upon, among other factors, our ability to develop, obtain
regulatory approval or clearance of, manufacture and market new products. Successful
commercialization of new products and new applications will require that we effectively transfer
production processes from research and development to manufacturing and effectively coordinate with
our suppliers. In addition, we must successfully sell and achieve market acceptance of new
products and applications and enhanced versions of existing products. The extent of, and rate at
which, market acceptance and penetration are achieved by future products is a function of many
variables, which include, among other things, price, safety, efficacy, reliability, marketing and
sales efforts, the development of new applications for these products, the availability of
third-party reimbursement of procedures using our new products, the existence of competing products
and general economic conditions affecting purchasing patterns. Our ability to market and sell new
products may also be subject to government regulation, including approval or clearance by the
United States Food and Drug Administration, or FDA, and foreign government agencies. Any failure
in our ability to successfully develop and introduce new products or enhanced versions of existing
products and achieve market acceptance of new products and new applications could have a material
adverse effect on our operating results and would cause our net revenues to decline.
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While We Devote Significant Resources to Research and Development, Our Research and
Development May Not Lead to New Products that Achieve Commercial Success.
Our research and development process is expensive, prolonged, and entails considerable
uncertainty. Because of the complexities and uncertainties associated with ophthalmic and
aesthetic research and development, products we are currently developing may not complete the
development process or obtain the regulatory approvals required to market such products
successfully. The products currently in our development pipeline may not be approved by regulatory
entities and may not be commercially successful, and our current and planned products could be
surpassed by more effective or advanced products of current or future competitors. Therefore, even
if we are able to successfully develop enhancements or new generations of our products, these
enhancements or new generations of products may not produce revenue in excess of the costs of
development and they may be quickly rendered obsolete by changing customer preferences or the
introduction by our competitors of products embodying new technologies or features.
We Face Strong Competition in Our Markets and Expect the Level of Competition to Grow in the
Foreseeable Future.
Competition in the market for devices used for ophthalmic and aesthetic treatment procedures
is intense and is expected to increase. Our competitive position depends on a number of factors
including product performance, characteristics and functionality, ease of use, scalability,
durability and cost. Our principal competitors in ophthalmology are Lumenis Ltd., Nidek, Carl
Zeiss, Inc., Alcon, and Synergetics, Inc. Most of these companies currently offer a competitive
semiconductor-based laser system in ophthalmology. Also within ophthalmology pharmaceutical
alternative treatments for AMD such as Visudyne (Novartis), Macugen (OSI Pharmaceuticals) and
Lucentis (Genentech) compete rigorously with traditional laser procedures. Our principal
competitors in aesthetic are Palomar Technologies, Candela Corporation, Cutera Inc., Cynosure Inc.
and Lumenis Ltd. Some competitors have substantially greater financial, engineering, product
development, manufacturing, marketing and technical resources than we do. Some companies also have
greater name recognition than we do and long-standing customer relationships. In addition to other
companies that manufacture photocoagulators, we compete with pharmaceuticals, other technologies
and other surgical techniques. Medical companies, academic and research institutions, or others,
may develop new technologies or therapies that are more effective in treating conditions targeted
by us or are less expensive than our current or future products. Any such developments could have
a material adverse effect on our business, financial condition and results of operations.
If We Cannot Increase Our Sales Volumes, Reduce Our Costs or Introduce Higher Margin Products
to Offset Anticipated Reductions in the Average Unit Price of Our Products, Our Operating Results
May Suffer.
We have experienced some declines in the average unit price of our products and expect to
continue to suffer from declines in the future. The average unit price of our products may
decrease in the future in response to changes in product mix, competitive pricing pressures, new
product introductions by our competitors or other factors. If we are unable to offset the
anticipated decrease in our average selling prices by increasing our sales volumes or through new
product introductions, our net revenues will decline. In addition, to maintain our gross margins
we must continue to reduce the manufacturing cost of our products. If we cannot maintain our gross
margins our business could be seriously harmed, particularly if the average selling price of our
products decreases significantly without a corresponding increase in sales.
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We Depend on Sales of Our Ophthalmology Products for a Significant Portion of Our Operating
Results.
We derive, and expect to continue to derive, a large portion of our revenue and profits from
sales of our ophthalmology products. For the fiscal quarter ended
June 30, 2007, our
ophthalmology sales were $8.4 million or 55.0% of total sales. We anticipate that sales of our
ophthalmology products will continue to account for a significant portion of our revenues in the
foreseeable future.
We Depend on International Sales for a Significant Portion of Our Operating Results.
We derive, and expect to continue to derive, a large portion of our revenue from international
sales. For the fiscal quarter ended June 30, 2007, our international sales were $6.9 million. We
anticipate that international sales will continue to account for a significant portion of our
revenues in the foreseeable future. None of our international revenues and costs has been
denominated in foreign currencies. As a result, an increase in the value of the U.S. dollar
relative to foreign currencies makes our products more expensive and thus less competitive in
foreign markets. The factors stated above could have a material adverse effect on our business,
financial condition or results of operations. Our international operations and sales are subject
to a number of other risks and potential costs, including:
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differing local product preferences and product requirements; |
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cultural differences; |
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changes in foreign medical reimbursement and coverage policies and programs; |
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political and economic instability; |
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impact of recessions in economies outside of the United States; |
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difficulty in staffing and managing foreign operations; |
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performance of our international distribution channels; |
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foreign certification requirements, including continued ability to use the CE mark in Europe; |
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reduced or limited protections of intellectual property rights in jurisdictions outside
the United States; |
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longer accounts receivable collection periods; |
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fluctuations in foreign currency exchange rates; |
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potentially adverse tax consequences; and |
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multiple protectionist, adverse and changing foreign governmental laws and regulations. |
Any one or more of these factors stated above could have a material adverse effect on our business,
financial condition or results of operations.
As we expand our existing international operations, especially following our acquisition of
the aesthetics business of Laserscope, we may encounter new risks. For example, as we focus on
building our
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international sales and distribution networks in new geographic regions, we must continue to
develop relationships with qualified local distributors and trading companies. If we are not
successful in developing these relationships, we may not be able to grow sales in these geographic
regions. These or other similar risks could adversely affect our revenue and profitability.
We Are Exposed to Risks Associated With Worldwide Economic Slowdowns and Related
Uncertainties.
Concerns about consumer and investor confidence, volatile corporate profits and reduced
capital spending, international conflicts, terrorist and military activity, civil unrest and
pandemic illness could cause a slowdown in customer orders or cause customer order cancellations.
In addition, political and social turmoil related to international conflicts and terrorist acts may
put further pressure on economic conditions in the United States and abroad. Unstable political,
social and economic conditions make it difficult for our customers, our suppliers and us to
accurately forecast and plan future business activities. In particular, it is difficult to develop
and implement strategy, sustainable business models and efficient operations, as well as
effectively manage supply chain relationships. If such conditions persist, our business, financial
condition and results of operations could suffer.
We Rely on Our Direct Sales Force and Network of International Distributors to Sell Our
Products and any Failure to Maintain Our Direct Sales Force and Distributor Relationships Could
Harm Our Business.
Our ability to sell our products and generate revenue depends upon our direct sales force
within the United States and primarily through relationships with independent distributors outside
the United States. Currently our direct sales force consists of 41 employees and we maintain
relationships with 77 independent distributors internationally selling our products into 107
countries through four direct Area Sales Managers. We generally grant our distributors exclusive
territories for the sale of our products in specified countries. The amount and timing of
resources dedicated by our distributors to the sales of our products is not within our control.
Our international sales are primarily dependent on the efforts of these third parties. If any
distributor breaches terms of its distribution agreement or fails to generate sales of our
products, we may be forced to replace the distributor and our ability to sell our products into
that exclusive sales territory would be adversely affected.
We do not have any long-term employment contracts with the members of our direct sales force.
We may be unable to replace our direct sales force personnel with individuals of equivalent
technical expertise and qualifications, which may limit our revenues and our ability to maintain
market share. The loss of the services of these key personnel would harm our business. Similarly,
our distributor agreements are generally terminable at will by either party and distributors may
terminate their relationships with us, which would affect our international sales and results of
operations.
If We Lose Key Personnel or Fail to Integrate Replacement Personnel Successfully, Our Ability
to Manage Our Business Could Be Impaired.
Our future success depends upon the continued service of our key management, technical, sales,
and other critical personnel. Our officers and other key personnel are employees-at-will, and we
cannot assure you that we will be able to retain them. On July 5, 2007, subsequent to the three
month period covered by this Quarterly Report on Form 10-Q, Meryl A. Rains, who commenced service
as the Companys Chief Financial Officer on February 5, 2007, notified the Company that she was
resigning as the Companys Chief Financial Officer, effective as of July 20, 2007. Although we
have hired an interim Chief Financial Officer, we are continuing to work to identify and hire a new
permanent Chief Financial Officer. Key personnel, including certain members of our aesthetics
sales force who joined the company in connection with the acquisition of
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the aesthetics business of Laserscope, have left our company in the past and there likely will
be additional departures of key personnel from time to time in the future. The loss of any key
employee could result in significant disruptions to our operations, including adversely affecting
the timeliness of product releases, the successful implementation and completion of company
initiatives, and the results of our operations. Competition for these individuals is intense, and
we may not be able to attract, assimilate or retain highly qualified personnel. This competition
for qualified personnel in our industry and the San Francisco Bay Area, as well as other geographic
markets in which we recruit, contributes to increases in the salaries we are required to pay in
order to attract and retain qualified personnel, which may increase our operating expenses and, if
we are unable to pay competitive salaries, hinder our ability to recruit qualified candidates. In
addition, the integration of replacement personnel could be time consuming, may cause additional
disruptions to our operations, and may be unsuccessful.
If We Fail to Accurately Forecast Demand For Our Product and Component Requirements For the
Manufacture of Our Product, We Could Incur Additional Costs or Experience Manufacturing Delays and
May Experience Lost Sales or Significant Inventory Carrying Costs.
We use quarterly and annual forecasts based primarily on our anticipated product orders to
plan our manufacturing efforts and determine our requirements for components and materials. It is
very important that we accurately predict both the demand for our product and the lead times
required to obtain the necessary components and materials. Lead times for components vary
significantly and depend on numerous factors, including the specific supplier, the size of the
order, contract terms and current market demand for such components. If we overestimate the demand
for our product, we may have excess inventory, which would increase our costs. Over the past
several quarters, we have placed a high priority on our asset management efforts to, among other
things, reduce overall inventory levels and increase our cash position. If we underestimate demand
for our product and, consequently, our component and materials requirements, we may have inadequate
inventory, which could interrupt our manufacturing, delay delivery of our product to our customers
and result in the loss of customer sales. We plan to assume responsibility for manufacturing the
aesthetics product line that we acquired from Laserscope when the Product Supply Agreement we
entered into with American Medical Systems Holdings in connection with the acquisition of the
aesthetics business of Laserscope terminates. We expect this transition to occur on or before
October 2007 and we may not have sufficient resources to assume these manufacturing obligations
without increased costs or delays and disruptions in manufacturing. Any of these occurrences would
negatively impact our business and operating results.
We Depend on Sole Source or Limited Source Suppliers.
We rely on third parties to manufacture substantially all of the components used in our
products, including optics, laser diodes and crystals. We have some long term or volume purchase
agreements with our suppliers and currently purchase components on a purchase order basis. Some of
our suppliers and manufacturers are sole or limited sources. In addition, some of these suppliers
are relatively small private companies that may discontinue their operations at any time. There
are risks associated with the use of independent manufacturers, including the following:
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unavailability of, shortages or limitations on the ability to obtain supplies of
components in the quantities that we require; |
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delays in delivery or failure of suppliers to deliver critical components on the dates
we require; |
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failure of suppliers to manufacture components to our specifications, and potentially
reduced quality; and |
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inability to obtain components at acceptable prices. |
Our business and operating results may suffer from the lack of alternative sources of supply
for critical sole and limited source components. The process of qualifying suppliers is complex,
requires extensive testing with our products, and may be lengthy, particularly as new products are
introduced. New suppliers would have to be educated in our production processes. In addition, the
use of alternate components may require design alterations to our products and additional product
testing under FDA and relevant foreign regulatory agency guidelines, which may delay sales and
increase product costs. In order to address our current liquidity issues, we have delayed the time
period in which we have made payments to our vendors that are the sources of our component supply
without the permission of such vendors. These delayed payments, if continued, may adversely affect
these supply relationships and could jeopardize the timely and adequate supply of such components
by such vendors. Until our current liquidity situation is remedied, such delays in payments to our
vendors will persist. Any failures by our vendors to adequately and timely supply limited and sole
source components may impair our ability to offer our existing products, delay the submission of
new products for regulatory approval and market introduction, materially harm our business and
financial condition and cause our stock price to decline. Establishing our own capabilities to
manufacture these components would be expensive and could significantly decrease our profit
margins, and is not practicable at the present time in any case. Our business, results of
operations and financial condition would be adversely affected if we are unable to continue to
timely obtain components in the quantity and quality desired and at the prices we have budgeted.
We Face Risks Associated with our Collaborative and OEM Relationships.
Our collaborators may not pursue further development and commercialization of products
resulting from collaborations with us or may not devote sufficient resources to the marketing and
sale of such products. For example, in 2005 we developed and sold a laser system on an OEM basis
for a third party which positively impacted the revenues and gross margins during the second half
of 2005. We cannot provide assurance that these types of relationships will continue over a longer
period. Our reliance on others for clinical development, manufacturing and distribution of our
products may result in unforeseen problems. Further, our collaborative partners may develop or
pursue alternative technologies either on their own or in collaboration with others. If a
collaborator elects to terminate its agreement with us, our ability to develop, introduce, market
and sell the product may be significantly impaired and we may be forced to discontinue altogether
the product resulting from the collaboration. We may not be able to negotiate alternative
collaboration agreements on acceptable terms, if at all. The failure of any current or future
collaboration efforts could have a material adverse effect on our ability to introduce new products
or applications and therefore could have a material adverse effect on our business, results of
operations and financial condition.
We Face Manufacturing Risks.
The manufacture of our infrared and visible light photocoagulators and the related delivery
devices is a highly complex and precise process. We assemble critical subassemblies and all of our
final products at our facility in Mountain View, California. We may experience manufacturing
difficulties, quality control issues or assembly constraints, particularly with regard to new
products that we may introduce. We may experience increased costs or delays and disruptions in
manufacturing when we transition the production of the aesthetics product line that we acquired
from Laserscope to our facilities upon the termination of the Product Supply Agreement we entered
into with American Medical Systems Holdings in connection with the acquisition of the aesthetics
business of Laserscope. We expect this transition to occur during the fourth quarter of 2007 and
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we may not have sufficient resources to assume these manufacturing obligations without
increased costs or delays and disruptions in manufacturing. We may not be able to manufacture
sufficient quantities of our products, which may require that we qualify other manufacturers for
our products. Furthermore, we may experience delays, disruptions, capacity constraints or quality
control problems in our manufacturing operations and, as a result, product shipments to our
customers could be delayed, which would negatively impact our net revenues.
We Depend on Collaborative Relationships to Produce, Develop, Introduce and Market New
Products, Product Enhancements and New Applications.
We depend on both clinical and commercial collaborative relationships. We entered into a
Product Supply Agreement with American Medical Systems Holdings in connection with the acquisition
of the aesthetics business of Laserscope, pursuant to which American Medical Systems Holdings
currently manufactures a substantial portion of our aesthetics products. We expect to transition
the manufacturing of these products to our facilities on or before October 2007, but we may not
have sufficient resources to assume these manufacturing obligations without increased costs or
delays and disruptions in manufacturing. We have also entered into collaborative relationships
with academic medical centers and physicians in connection with the research and innovation and
clinical testing of our products. Commercially, we currently collaborate with Bausch & Lomb to
design and manufacture a solid-state green wavelength (532nm) laser photocoagulator module, called
the Millennium Endolase module. The Millennium Endolase module is designed to be a component of
Bausch & Lombs ophthalmic surgical suite product offering and is not expected to be sold as a
stand-alone product. Sales of the Millennium Endolase module are dependent upon the actual order
rate from and shipment rate to Bausch & Lomb, which depends on the efforts of our partner and is
beyond our control. We cannot assure you that our relationship with Bausch & Lomb will result in
further sales of our Millennium Endolase module. The failure to obtain any additional future
clinical or commercial collaborations and the resulting failure or success of such arrangements of
any current or future clinical or commercial collaboration relationships could have a material
adverse effect on our ability to introduce new products or applications and therefore could have a
material adverse effect on our business, results of operations and financial condition.
If We Fail to Maintain Our Relationships With Health Care Providers, Customers May Not Buy Our
Products and Our Revenue and Profitability May Decline.
We market our products to numerous health care providers, including eye care professionals,
hospitals, ambulatory surgical centers, corporate optometry chains and group purchasing
organizations. We have developed and strive to maintain close relationships with members of each
of these groups who assist in product research and development and advise us on how to satisfy the
full range of surgeon and patient needs. We rely on these groups to recommend our products to
their patients and to other members of their organizations. The failure of our existing products
and any new products we may introduce to retain the support of these various groups could have a
material adverse effect on our business, financial condition and results of operations.
Our Operating Results May Fluctuate from Quarter to Quarter and Year to Year.
Our sales and operating results may vary significantly from quarter to quarter and from year
to year in the future. Our operating results are affected by a number of factors, many of which
are beyond our control. Factors contributing to these fluctuations include the following:
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general economic uncertainties and political concerns; |
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the timing of the introduction and market acceptance of new products, product
enhancements and new applications; |
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changes in demand for our existing line of aesthetic and ophthalmic products; |
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the cost and availability of components and subassemblies, including the willingness and
ability of our sole or limited source suppliers to timely deliver components at the times
and prices that we have planned; |
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our ability to maintain sales volumes at a level sufficient to cover fixed manufacturing
and operating costs; |
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fluctuations in our product mix between aesthetic and ophthalmic products and foreign
and domestic sales; |
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our ability to address our current liquidity issues; |
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the effect of regulatory approvals and changes in domestic and foreign regulatory requirements; |
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introduction of new products, product enhancements and new applications by our
competitors, entry of new competitors into our markets, pricing pressures and other
competitive factors; |
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our long and highly variable sales cycle; |
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changes in the prices at which we can sell our products; |
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changes in customers or potential customers budgets as a result of, among other
things, reimbursement policies of government programs and private insurers for treatments
that use our products; and |
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increased product innovation costs. |
In addition to these factors, our quarterly results have been, and are expected to continue to
be, affected by seasonal factors.
Our expense levels are based, in part, on expected future sales. If sales levels in a
particular quarter do not meet expectations, we may be unable to adjust operating expenses quickly
enough to compensate for the shortfall of sales, and our results of operations may be adversely
affected. We encountered this adverse effect on our operating results in each of the quarters
ended March 31, 2007 and June 30, 2007. In addition, we have historically made a significant
portion of each quarters product shipments near the end of the quarter. If that pattern
continues, any delays in shipment of products could have a material adverse effect on results of
operations for such quarter. Due to these and other factors, we believe that quarter to quarter
and year to year comparisons of our past operating results may not be meaningful. You should not
rely on our results for any quarter or year as an indication of our future performance. Our
operating results in future quarters and years may be below expectations, which would likely cause
the price of our common stock to fall.
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Our Stock Price Has Been and May Continue to be Volatile and an Investment in Our Common Stock
Could Suffer a Decline in Value.
The trading price of our common stock has been subject to wide fluctuations in response to a
variety of factors, some of which are beyond our control, including quarterly variations in our
operating results, announcements by us or our competitors of new products or of significant
clinical achievements, changes in market valuations of other similar companies in our industry and
general market conditions. In the current calendar year, the trading price of our common stock has
fluctuated from a high of $10.70 per share to a low of $2.32 per share, and there can be no
assurance our common stock trading price will not suffer additional declines, especially in light
of our current liquidity issues. In addition, from time to time, we meet with investors and
potential investors. In addition, we receive attention by securities analysts and present at
analyst meetings when invited. Our common stock may experience an imbalance between supply and
demand resulting from low trading volumes. These broad market fluctuations could have a
significant impact on the market price of our common stock regardless of our performance.
Material Increases in Interest Rates May Harm Our Sales.
We currently sell our products primarily to health care providers in general practice. These
health care providers often purchase our products with funds they secure through various financing
arrangements with third party financial institutions, including credit facilities and short-term
loans. If interest rates continue to increase, these financing arrangements will be more expensive
to our customers, which would effectively increase the overall cost of owning our products for our
customers and, thereby, may decrease demand for our products. Any reduction in the sales of our
products would cause our business to suffer.
We Are Subject To Government Regulation Which May Cause Us to Delay or Withdraw the
Introduction of New Products or New Applications for Our Products.
The medical devices that we market and manufacture are subject to extensive regulation by the
FDA and by foreign and state governments. Under the Federal Food, Drug and Cosmetic Act and the
related regulations, the FDA regulates the design, development, clinical testing, manufacture,
labeling, sale, distribution and promotion of medical devices. Before a new device can be
introduced into the market, the product must undergo rigorous testing and an extensive regulatory
review process implemented by the FDA under federal law. Unless otherwise exempt, a device
manufacturer must obtain market clearance through either the 510(k) pre-market notification process
or the lengthier pre-market approval application (PMA) process. Depending upon the type,
complexity and novelty of the device and the nature of the disease or disorder to be treated, the
FDA process can take several years, require extensive clinical testing and result in significant
expenditures. Even if regulatory approval is obtained, later discovery of previously unknown
safety issues may result in restrictions on the product, including withdrawal of the product from
the market. Other countries also have extensive regulations regarding clinical trials and testing
prior to new product introductions. Our failure to obtain government approvals or any delays in
receipt of such approvals would have a material adverse effect on our business, results of
operations and financial condition.
The FDA imposes additional regulations on manufacturers of approved medical devices. We are
required to comply with the applicable Quality System regulations and our manufacturing facilities
are subject to ongoing periodic inspections by the FDA and corresponding state agencies, including
unannounced inspections, and must be licensed as part of the product approval process before being
utilized for commercial manufacturing. Noncompliance with the applicable requirements can result
in, among other things, fines, injunctions, civil penalties, recall or seizure of products, total
or partial suspension of production, withdrawal of marketing approvals, and criminal prosecution.
The FDA also has the authority to request repair, replacement or refund of the cost of any device
we manufacture or distribute. Any of these actions by the
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FDA would materially and adversely affect our ability to continue operating our business and
the results of our operations.
In addition, we are also subject to varying product standards, packaging requirements,
labeling requirements, tariff regulations, duties and tax requirements. As a result of our sales
in Europe, we are required to have all products CE marked, an international symbol affixed to all
products demonstrating compliance with the European Medical Device Directive and all applicable
standards. While currently all of our released products are CE marked, continued certification is
based on the successful review of our quality system by our European Registrar during their annual
audit. Any loss of certification would have a material adverse effect on our business, results of
operations and financial condition.
If We Fail to Comply With the FDAs Quality System Regulation and Laser Performance Standards,
Our Manufacturing Operations Could Be Halted, and Our Business Would Suffer.
We are currently required to demonstrate and maintain compliance with the FDAs Quality System
Regulation, or QSR. The QSR is a complex regulatory scheme that covers the methods and
documentation of the design, testing, control, manufacturing, labeling, quality assurance,
packaging, storage and shipping of our products. Because our products involve the use of lasers,
our products also are covered by a performance standard for lasers set forth in FDA regulations.
The laser performance standard imposes specific record-keeping, reporting, product testing and
product labeling requirements. These requirements include affixing warning labels to laser
products, as well as incorporating certain safety features in the design of laser products. The
FDA enforces the QSR and laser performance standards through periodic unannounced inspections. We
have been, and anticipate in the future being, subject to such inspections. Our failure to take
satisfactory corrective action in response to an adverse QSR inspection or our failure to comply
with applicable laser performance standards could result in enforcement actions, including a public
warning letter, a shutdown of our manufacturing operations, a recall of our products, civil or
criminal penalties, or other sanctions, such as those described in the preceding paragraph, which
would cause our sales and business to suffer.
If We Modify One of Our FDA Approved Devices, We May Need to Seek Reapproval, Which, if Not
Granted, Would Prevent Us from Selling Our Modified Products or Cause Us to Redesign Our Products.
Any modifications to an FDA-cleared device that would significantly affect its safety or
effectiveness or that would constitute a major change in its intended use would require a new
510(k) clearance or possibly a pre-market approval. We may not be able to obtain additional 510(k)
clearance or pre-market approvals for new products or for modifications to, or additional
indications for, our existing products in a timely fashion, or at all. Delays in obtaining future
clearance would adversely affect our ability to introduce new or enhanced products in a timely
manner, which in turn would harm our revenue and future profitability. We have made modifications
to our devices in the past and may make additional modifications in the future that we believe do
not or will not require additional clearance or approvals. If the FDA disagrees, and requires new
clearances or approvals for the modifications, we may be required to recall and to stop marketing
the modified devices, which could harm our operating results and require us to redesign our
products.
We Rely on Patents and Proprietary Rights to Protect our Intellectual Property and Business.
Our success and ability to compete is dependent in part upon our proprietary information. We
rely on a combination of patents, trade secrets, copyright and trademark laws, nondisclosure and
other contractual agreements and technical measures to protect our intellectual property rights.
We file patent applications to protect technology, inventions and improvements that are significant
to the development of our business. We have been issued fifteen United States patents and five
foreign patents on the technologies related to our
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products and processes. We have approximately five pending patent applications in the United
States and six foreign pending patent applications that have been filed. Our patent applications
may not be approved. Any patents granted now or in the future may offer only limited protection
against potential infringement and development by our competitors of competing products. Moreover,
our competitors, many of which have substantial resources and have made substantial investments in
competing technologies, may seek to apply for and obtain patents that will prevent, limit or
interfere with our ability to make, use or sell our products either in the United States or in
international markets.
In addition to patents, we rely on trade secrets and proprietary know-how which we seek to
protect, in part, through proprietary information agreements with employees, consultants and other
parties. Our proprietary information agreements with our employees and consultants contain
industry standard provisions requiring such individuals to assign to us without additional
consideration any inventions conceived or reduced to practice by them while employed or retained by
us, subject to customary exceptions. Proprietary information agreements with employees,
consultants and others may be breached, and we may not have adequate remedies for any breach.
Also, our trade secrets may become known to or independently developed by competitors.
The laser and medical device industry is characterized by frequent litigation regarding patent
and other intellectual property rights. Companies in the medical device industry have employed
intellectual property litigation to gain a competitive advantage. Numerous patents are held by
others, including academic institutions and our competitors. Until recently patent applications
were maintained in secrecy in the United States until the patents issued. Patent applications
filed in the United States after November 2000 generally will be published eighteen months after
the filing date. However, since patent applications continue to be maintained in secrecy for at
least some period of time, both within the United States and with regards to international patent
applications, we cannot assure you that our technology does not infringe any patents or patent
applications held by third parties. We have, from time to time, been notified of, or have
otherwise been made aware of, claims that we may be infringing upon patents or other proprietary
intellectual property owned by others. If it appears necessary or desirable, we may seek licenses
under such patents or proprietary intellectual property. Although patent holders commonly offer
such licenses, licenses under such patents or intellectual property may not be offered or the terms
of any offered licenses may not be reasonable.
Any claims, with or without merit, and regardless of whether we are successful on the merits,
would be time-consuming, result in costly litigation and diversion of technical and management
personnel, cause shipment delays or require us to develop noninfringing technology or to enter into
royalty or licensing agreements. An adverse determination in a judicial or administrative
proceeding and failure to obtain necessary licenses or develop alternate technologies could prevent
us from manufacturing and selling our products, which would have a material adverse effect on our
business, results of operations and financial condition. Management believes that liabilities
resulting from the matters described in Part II, Item 1, or other claims which are pending or known
to be threatened, will not have a material adverse effect on the Companys financial position or
results of operations. However, it is possible that cash flows or results or operations could be
materially affected in any particular period by the unfavorable resolution of one or more of these
contingencies or because of the diversion of managements attention and the incurrence of
significant expenses.
Because We Do Not Require Training for Users of Our Products, and Sell Our Products to
Non-physicians, There Exists an Increased Potential for Misuse of Our Products, Which Could Harm
Our Reputation and Our Business.
Federal regulations allow us to sell our products to or on the order of licensed
practitioners. The definition of licensed practitioners varies from state to state. As a
result, our products may be purchased or
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operated by physicians with varying levels of training, and in many states by non-physicians,
including nurse practitioners and technicians. Outside the United States, many jurisdictions do
not require specific qualifications or training for purchasers or operators of our products. We do
not supervise the procedures performed with our products, nor do we require that direct medical
supervision occur. We, and our distributors, generally offer but do not require purchasers or
operators of our products to attend training sessions. In addition, we sometimes sell our systems
to companies that rent our systems to third parties and that provide a technician to perform the
procedure. The lack of training and the purchase and use of our products by non-physicians may
result in product misuse and adverse treatment outcomes, which could harm our reputation and expose
us to costly product liability litigation.
Some of Our Laser Systems Are Complex in Design and May Contain Defects That Are Not Detected
Until Deployed By Our Customers, Which Could Increase Our Costs and Reduce Our Revenues.
Laser systems are inherently complex in design and require ongoing regular maintenance. The
manufacture of our lasers, laser products and systems involves a highly complex and precise
process. As a result of the technical complexity of our products, changes in our or our suppliers
manufacturing processes or the inadvertent use of defective materials by us or our suppliers could
result in a material adverse effect on our ability to achieve acceptable manufacturing yields and
product reliability. To the extent that we do not achieve such yields or product reliability, our
business, operating results, financial condition and customer relationships would be adversely
affected. We provide warranties on certain of our product sales, and allowances for estimated
warranty costs are recorded during the period of sale. The determination of such allowances
requires us to make estimates of failure rates and expected costs to repair or replace the products
under warranty. We currently establish warranty reserves based on historical warranty costs for
each product line. If actual return rates and/or repair and replacement costs differ significantly
from our estimates, adjustments to recognize additional cost of sales may be required in future
periods.
Our customers may discover defects in our products after the products have been fully deployed
and operated under peak stress conditions. In addition, some of our products are combined with
products from other vendors, which may contain defects. As a result, should problems occur, it may
be difficult to identify the source of the problem. If we are unable to identify and fix defects
or other problems, we could experience, among other things:
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loss of customers; |
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increased costs of product returns and warranty expenses; |
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damage to our brand reputation; |
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failure to attract new customers or achieve market acceptance; |
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diversion of development and engineering resources; and |
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legal actions by our customers. |
The occurrence of any one or more of the foregoing factors could seriously harm our business,
financial condition and results of operations.
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Our Products Could Be Subject to Recalls Even After Receiving FDA Approval or Clearance. A
Recall Would Harm Our Reputation and Adversely Affect Our Operating Results.
The FDA and similar governmental authorities in other countries in which we market and sell
our products have the authority to require the recall of our products in the event of material
deficiencies or defects in design or manufacture. A government mandated recall, or a voluntary
recall by us, could occur as a result of component failures, manufacturing errors or design
defects, including defects in labeling. A recall could divert managements attention, cause us to
incur significant expenses, harm our reputation with customers and negatively affect our future
sales.
If We Fail to Manage Growth Effectively, Our Business Could Be Disrupted Which Could Harm Our
Operating Results.
We have experienced and may in the future experience growth in our business, both organically
and through the acquisition of business and products. We have made and expect to continue to make
significant investments to enable our future growth through, among other things, new product
innovation and clinical trials for new applications and products. We must also be prepared to
expand our work force and to train, motivate and manage additional employees as the need for
additional personnel arises. Our personnel, systems, procedures and controls may not be adequate
to support our future operations. Any failure to effectively manage future growth could have a
material adverse effect on our business, results of operations and financial condition.
Our Manufacturing Capacity May Not Be Adequate to Meet the Demands of Our Business.
If our sales increase substantially, including increases in the sales of our aesthetic
products, we may need to increase our production capacity and may not be able to do so in a timely,
effective, or cost efficient manner. Any prolonged disruption in the operation of our
manufacturing facilities could materially harm our business. We cannot assure you that if we
choose to scale-up our manufacturing operations, we will have the resources necessary to do so, or
that we will be able to obtain regulatory approvals in a timely fashion, which could affect our
ability to meet product demand or result in additional costs.
If Product Liability Claims are Successfully Asserted Against Us, We may Incur Substantial
Liabilities That May Adversely Affect Our Business or Results of Operations.
We may be subject to product liability claims from time to time. Our products are highly
complex and some are used to treat extremely delicate eye tissue and skin conditions on and near a
patients face. Although we maintain product liability insurance with coverage limits of $10.0
million per occurrence and an annual aggregate maximum of $10.0 million, our coverage from our
insurance policies may not be adequate. Product liability insurance is expensive. We might not be
able to obtain product liability insurance in the future on acceptable terms or in sufficient
amounts to protect us, if at all. A successful claim brought against us in excess of our insurance
coverage could have a material adverse effect on our business, results of operations and financial
condition.
Our Operating Results May be Adversely Affected by Changes in Third Party Coverage and
Reimbursement Policies and any Uncertainty Regarding Healthcare Reform Measures.
Our ophthalmology products are typically purchased by doctors, clinics, hospitals and other
users, which bill various third-party payers, such as governmental programs and private insurance
plans, for the health care services provided to their patients. Third-party payers are
increasingly scrutinizing and challenging the coverage of new products and the level of
reimbursement for covered products. Doctors,
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clinics, hospitals and other users of our products may not obtain adequate reimbursement for
use of our products from third-party payers. While we believe that the laser procedures using our
products have generally been reimbursed, payers may deny coverage and reimbursement for our
products if they determine that the device was not reasonable and necessary for the purpose used,
was investigational or was not cost-effective.
Changes in government legislation or regulation or in private third-party payers policies toward
reimbursement for procedures employing our products may prohibit adequate reimbursement. There
have been a number of legislative and regulatory proposals to change the healthcare system, reduce
the costs of healthcare and change medical reimbursement policies. Doctors, clinics, hospitals and
other users of our products may decline to purchase our products to the extent there is uncertainty
regarding reimbursement of medical procedures using our products and any healthcare reform
measures. Further proposed legislation, regulation and policy changes affecting third party
reimbursement are likely. We are unable to predict what legislation or regulation, if any,
relating to the health care industry or third-party coverage and reimbursement may be enacted in
the future, or what effect such legislation or regulation may have on us. However, denial of
coverage and reimbursement of our products would have a material adverse effect on our business,
results of operations and financial condition.
The Successful Outcome of Clinical Trials and the Development of New Applications Using
Certain of Our Products will Accelerate Future Revenue Growth Rates.
The Companys ability to generate incremental revenue growth will depend, in part, on the
successful outcome of clinical trials that lead to the development of new applications using our
products. Clinical trials are long, expensive and uncertain processes. If the future results of
any of our clinical trials fail to demonstrate improved patient outcomes and/or the development of
new product applications, our ability to generate incremental revenue growth would be adversely
affected.
If Our Facilities Were To Experience Catastrophic Loss, Our Operations Would Be Seriously
Harmed.
Our facilities could be subject to catastrophic loss such as fire, flood or earthquake. All
of our research and product innovation activities, manufacturing, our corporate headquarters and
other critical business operations are located near major earthquake faults in Mountain View,
California. Any such loss at any of our facilities could disrupt our operations, delay production,
shipments and revenue and result in large expense to repair and replace our facilities.
Our Business is Subject to Environmental Regulations.
Our facilities and operations are subject to federal, state and local environmental and
occupational health and safety requirements of the United States and foreign countries, including
those relating to discharges of substances to the air, water and land, the handling, storage and
disposal of hazardous materials and wastes and the cleanup of properties affected by pollutants.
Failure to maintain compliance with these regulations could have a material adverse effect on our
business or financial condition.
In the future, federal, state or local governments in the United States or foreign countries could
enact new or more stringent laws or issue new or more stringent regulations concerning
environmental and worker health and safety matters that could affect our operations. Also, in the
future, contamination may be found to exist at our current or former facilities or off-site locations where we have sent
wastes. We could be held liable for such newly discovered contamination which could have a
material adverse effect on our business or
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financial condition. In addition, changes in environmental and worker health and safety requirements could have a material adverse effect on our
business or financial condition.
Our Export Controls May Not be Adequate to Ensure Compliance With United States Export
Laws, Especially When We Sell Our Products to Distributors Over Which We Have Limited Control.
The United States government has declared an embargo that restricts the export of products and
services to a number of countries, including Iran, Syria, Sudan and Cuba, for a variety of reasons,
including the support by these countries of terrorism. We sell our products through distributors
in Europe, Asia and the Middle East, and in such circumstances, the distributor is responsible for
interacting with the end user of our products, including assisting in the set up of any products
purchased by such end user. In order to comply with United States export laws, we have instituted
export controls including training for our personnel in export restrictions and requirements,
appointing an export control officer to oversee our export procedures, executing agreements with
our distributors that include defining their territory for sale and requirements pertaining to
United States export laws, obtaining end user information from our distributors and screening it to
restricted party lists maintained by the United States government. While we believe that these
procedures are adequate to prevent the export or re-export of our products into countries under
embargo by the United States government, we cannot assure you that our products will not be
exported or re-exported by our distributors into such restricted countries. In particular, our
control over what our distributors do with our products is necessarily limited, and we cannot
assure you that they will not sell our products to an end user in a country in violation of United
States export laws. Any violation of United States export regulations could result in substantial
legal, consulting and accounting costs, and significant fines and/or criminal penalties. In the
event that our products are exported to countries under a United States trade embargo in violation
of applicable United States export laws and regulations, such violations, costs and penalties or
other actions that could be taken against us could adversely affect our reputation and/or have an
adverse effect on our business, financial condition, prospects or results of operations.
We have sold and may continue to sell, with a license, our products into countries that are under
embargo by the United States and as a result have incurred and may continue to incur significant
legal, consulting and accounting fees and may place our Companys reputation at risk.
United States export laws permit the sale of medical products to certain countries under embargo by
the United States government if the seller of such products obtains a license to do so, which
requirements are in place because the United States has designated such countries as state sponsors
of terrorism. Certain of our products have been sold in Sudan and Syria under license through a
distribution agreement with an independent distributor. In addition, certain of our products were
distributed in Iran without United States governmental authorization. The aggregate revenue
generated by sales of our products into Iran, Sudan and Syria have been immaterial to our business
and results of operations
We may continue to supply medical devices to Iran, Sudan and Syria and other countries that are
under embargo by the United States government upon obtaining all necessary licenses. We do not
believe, however, that our sales into such countries will be material to our business or results of
operations. There are risks we face in selling to countries under United States embargo,
including, but not limited to, possible damage to our reputation for sales to countries that are
deemed to support terrorism and failure of our export controls to limit sales strictly to the terms of the relevant
license, which failure may result in civil and criminal penalties. In addition, we may incur
significant legal, consulting and accounting costs in ensuring compliance with our export licenses
to countries under embargo. Any damage to our reputation from such sales, failure to comply with
the terms of our export licenses or the additional costs we incur in making such sales could have a
material adverse impact on our business, financial condition, prospects or results of operations.
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
At our Annual Meeting of Stockholders held on June 7, 2007, with an adjournment until June 19,
2007, 7,267,501 shares of Common Stock, or 88.7% of the total outstanding shares, were voted. The
table below presents the voting results with respect to the proposal to elect seven directors of
the Company to serve for the ensuing year until their successors are elected and qualified, all of
whom were elected.
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FOR |
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WITHHELD |
Theodore Boutacoff |
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6,706,710 |
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560,791 |
|
|
Barry Caldwell |
|
|
5,419,563 |
|
|
|
1,847,938 |
|
|
James Donovan |
|
|
6,490,260 |
|
|
|
777,241 |
|
|
Donald Hammond |
|
|
5,415,284 |
|
|
|
1,852,217 |
|
|
Garrett Garrettson |
|
|
6,154,814 |
|
|
|
1,112,687 |
|
|
Robert Anderson |
|
|
6,624,043 |
|
|
|
643,458 |
|
|
Sanford Fitch |
|
|
6,481,563 |
|
|
|
786,326 |
|
The table below presents the voting results with respect to the proposal to amend our amended
and restated 1998 Stock Plan to increase the number of shares of common stock of the Company
reserved for issuance thereunder, which proposal was adopted by the stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
ABSTAIN |
|
FOR |
|
AGAINST |
|
NO-VOTE |
244,562 |
|
|
3,392,813 |
|
|
|
1,982,482 |
|
|
|
1,647,698 |
|
The table below presents the voting results with respect to the proposal to ratify the
appointment of PricewaterhouseCoopers LLP as independent registered public accountants of the
Company for the fiscal year ending December 29, 2007, which proposal was adopted by the
stockholders:
|
|
|
|
|
|
|
|
|
ABSTAIN |
|
FOR |
|
AGAINST |
4,000 |
|
|
7,210,454 |
|
|
|
53,047 |
|
-48-
Item 5. Other Information
None.
Item 6. Exhibits
|
|
|
10.1
|
|
Settlement Agreement dated as of April 6, 2007 by and between
the Company and Synergetics, Inc. and Synergetics USA, Inc. |
|
|
|
10.2
|
|
First Amendment dated as of April 19, 2007, to the Business Loan
and Security Agreement by and between the Company and
Mid-Peninsula Bank, part of Greater Bay Bank N.A. (which is
incorporated herein by reference to Exhibit 10.1 to the Current
Report on Form 8-K filed with the Commission on April 24, 2007). |
|
|
|
10.3
|
|
Amendment dated as of April 19, 2007, to the Export-Import Bank
Loan and Security Agreement by and between the Company and
Mid-Peninsula Bank, part of Greater Bay Bank N.A. (which is
incorporated herein by reference to Exhibit 10.2 to the Current
Report on Form 8-K filed with the Commission on April 24, 2007). |
|
|
|
10.4
|
|
Business Loan and Security Agreement by and between the Company
and Mid-Peninsula Bank, part of Greater Bay Bank N.A., dated
January 16, 2007 (which is incorporated herein by reference to
Exhibit 99.1 to the Current Report on Form 8-K filed with the
Commission on January 22, 2007). |
|
|
|
10.5
|
|
Export-Import Bank Loan and Security Agreement by and between
the Company and Mid-Peninsula Bank, part of Greater Bay Bank
N.A., dated January 16, 2007 (which is incorporated herein by
reference to Exhibit 99.2 to the Current Report on Form 8-K
filed with the Commission on January 22, 2007). |
|
|
|
10.6
|
|
Letter from Mid-Peninsula Bank, part of Greater Bay Bank N.A.,
to the Company, dated April 23, 2007 (which is incorporated
herein by reference to Exhibit 10.6 to the Current Report on
Form 8-K filed with the Commission on April 24, 2007). |
|
|
|
10.7
|
|
IRIDEX Corporation 1998 Stock Plan, amended and restated as of
June 19, 2007. |
|
|
|
10.8
|
|
Letter Agreement, dated as of June 27, 2007 by and between the
Company and Laserscope, a California corporation and
wholly-owned subsidiary of American Medical Systems, Inc. |
|
|
|
31.1
|
|
Certification of Chief Executive Officer (Principal Executive
and Principal Financial Officer) pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
|
|
32.1
|
|
Certification of Chief Executive Officer (Principal Executive
and Principal Financial Officer) pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002. |
-49-
Trademark Acknowledgments
IRIDEX, the IRIDEX logo, IRIS Medical, OcuLight, SmartKey, EndoProbe and Apex are our
registered trademarks. IRIDERM, G-Probe, DioPexy, DioVet, TruFocus, TrueCW, UltraView, DioLite 532,
Long Pulse, MicroPulse, ScanLite, ColdTip (Handpiece), VariSpot (Handpiece), TruView and EasyFit
product names are our trademarks. All other trademarks or trade names appearing in the Form 10-Q
are the property of their respective owners.
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.
|
|
|
|
|
|
IRIDEX Corporation
(Registrant)
|
|
Date: August 14, 2007 |
By: |
/s/ BARRY G. CALDWELL
|
|
|
|
Name: |
Barry G. Caldwell |
|
|
|
Title: |
President and Chief Executive Officer
(Principal Executive and Principal Financial Officer) |
|
|
-50-
Index
|
|
|
10.1
|
|
Settlement Agreement dated as of April 6, 2007 by and between the
Company and Synergetics, Inc. and Synergetics USA, Inc. |
|
|
|
10.2
|
|
First Amendment dated as of April 19, 2007, to the Business Loan and
Security Agreement by and between the Company and Mid-Peninsula Bank,
part of Greater Bay Bank N.A. (which is incorporated herein by
reference to Exhibit 10.1 to the Current Report on Form 8-K filed
with the Commission on April 24, 2007). |
|
|
|
10.3
|
|
Amendment dated as of April 19, 2007, to the Export-Import Bank Loan
and Security Agreement by and between the Company and Mid-Peninsula
Bank, part of Greater Bay Bank N.A. (which is incorporated herein by
reference to Exhibit 10.2 to the Current Report on Form 8-K filed
with the Commission on April 24, 2007). |
|
|
|
10.4
|
|
Business Loan and Security Agreement by and between the Company and
Mid-Peninsula Bank, part of Greater Bay Bank N.A., dated January 16,
2007 (which is incorporated herein by reference to Exhibit 99.1 to
the Current Report on Form 8-K filed with the Commission on January
22, 2007). |
|
|
|
10.5
|
|
Export-Import Bank Loan and Security Agreement by and between the
Company and Mid-Peninsula Bank, part of Greater Bay Bank N.A., dated
January 16, 2007 (which is incorporated herein by reference to
Exhibit 99.2 to the Current Report on Form 8-K filed with the
Commission on January 22, 2007). |
|
|
|
10.6
|
|
Letter from Mid-Peninsula Bank, part of Greater Bay Bank N.A., to the
Company, dated April 23, 2007 (which is incorporated herein by
reference to Exhibit 10.6 to the Current Report on Form 8-K filed
with the Commission on April 24, 2007). |
|
|
|
10.7
|
|
IRIDEX Corporation 1998 Stock Plan, amended and restated as of June
19, 2007. |
|
|
|
10.8
|
|
Letter Agreement, dated as of June 27, 2007 by and between the
Company and Laserscope, a California corporation and wholly-owned
subsidiary of American Medical Systems, Inc. |
|
|
|
31.1
|
|
Certification of Chief Executive Officer (Principal Executive and
Principal Financial Officer) pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
|
|
32.1
|
|
Certification of Chief Executive Officer (Principal Executive and
Principal Financial Officer) pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |