e10vq
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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 March 31, 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 þ No o
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, $.01 par value, issued and outstanding as of June 26, 2007 was 8,211,562
PART I FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements (unaudted)
IRIDEX Corporation
Condensed Consolidated Balance Sheets
(in thousands)
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March 31, |
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December 30, |
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2007 (1) |
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2006(2) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
9,568 |
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$ |
21,051 |
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Accounts receivable, net |
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9,688 |
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6,052 |
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Inventories |
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13,244 |
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9,499 |
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Prepaids and other current assets |
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2,218 |
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1,264 |
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Total current assets |
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$ |
34,718 |
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$ |
37,866 |
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Property and equipment, net |
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1,789 |
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1,087 |
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Goodwill |
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11,751 |
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Other intangible assets, net |
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15,841 |
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Other long term assets |
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324 |
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1,224 |
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Total assets |
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$ |
64,423 |
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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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$ |
5,460 |
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$ |
1,830 |
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Short term debt |
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5,236 |
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Accrued compensation |
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1,849 |
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1,517 |
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Accrued expenses |
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9,686 |
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2,392 |
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Accrued warranty |
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2,336 |
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866 |
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Deferred revenue |
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3,685 |
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1,415 |
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Current portion of long term debt |
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5,901 |
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Total liabilities |
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$ |
34,153 |
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$ |
8,020 |
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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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32,735 |
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29,697 |
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Accumulated other comprehensive loss |
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(9 |
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Treasury stock |
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(430 |
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(430 |
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Retained earnings (accumulated deficit) |
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(2,109 |
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2,811 |
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Total stockholders equity |
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30,270 |
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32,157 |
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Total liabilities and stockholders equity |
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$ |
64,423 |
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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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March 31, 2007 |
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April 1, 2006 |
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Sales |
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$ |
12,566 |
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$ |
8,843 |
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Cost of sales |
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7,357 |
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4,581 |
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Gross profit |
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5,209 |
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4,262 |
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Operating expenses: |
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Research and development |
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1,729 |
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1,121 |
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Selling, general and administrative |
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8,274 |
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3,932 |
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Total operating expenses |
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10,003 |
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5,053 |
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Loss from operations |
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(4,794 |
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(791 |
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Interest and other income (expense), net |
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(126 |
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179 |
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Loss before income taxes |
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(4,920 |
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(612 |
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Benefit from income taxes |
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309 |
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Net loss |
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$ |
(4,920 |
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$ |
(303 |
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Net loss per share basic and diluted |
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$ |
(0.61 |
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$ |
(0.04 |
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Shares used in computing net loss per share basic and diluted |
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8,080 |
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7,587 |
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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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Three Months Ended |
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March 31, |
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April 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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$ |
(4,920 |
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$ |
(303 |
) |
Adjustments to reconcile net loss to net cash provided by (used in) operating
activities: |
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Depreciation and amortization |
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802 |
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133 |
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Non-cash stock-based compensation |
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356 |
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457 |
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Tax benefit from stock option exercises |
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249 |
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Excess tax benefit related to stock-based compensation expense |
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(124 |
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Provision for (recoveries of) doubtful accounts |
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(4 |
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Provision for inventories |
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285 |
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67 |
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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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1,687 |
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495 |
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Inventories |
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(1,327 |
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(257 |
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Prepaids and other current assets |
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36 |
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(205 |
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Other long term assets |
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(71 |
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Accounts payable |
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3,602 |
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15 |
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Accrued warranty |
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(543 |
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Accrued expenses |
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880 |
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(1,153 |
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Deferred revenue |
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393 |
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(59 |
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Net cash provided by (used in) operating activities |
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$ |
1,180 |
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$ |
(689 |
) |
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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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$ |
(15,512 |
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Proceeds from maturity of available-for-sale securities |
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6,142 |
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Purchases of property and equipment |
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(217 |
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(69 |
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Cash
received from acquisition |
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5,246 |
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Cash
acquired in acquisition paid to seller |
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(1,261 |
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Acquisition of business |
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(28,151 |
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Net cash used in investing activities |
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$ |
(24,383 |
) |
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$ |
(9,439 |
) |
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Cash flows from financing activities: |
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Proceeds from issuance of common stock |
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$ |
672 |
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$ |
605 |
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Excess tax benefit related to stock-based compensation expense |
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124 |
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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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(863 |
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Net cash provided by financing activities |
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$ |
11,709 |
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$ |
729 |
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Effect of foreign exchange rate changes |
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$ |
11 |
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$ |
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Net decrease in cash and cash equivalents |
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(11,483 |
) |
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(9,399 |
) |
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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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$ |
9,568 |
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$ |
3,256 |
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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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March 31, |
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April 1, |
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2007 |
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2006 |
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Net loss |
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$ |
(4,920 |
) |
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$ |
(303 |
) |
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Other comprehensive loss: |
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Change in unrealized loss on available for sale securities, net of tax |
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9 |
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Foreign currency translation adjustments |
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(9 |
) |
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Comprehensive loss |
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$ |
(4,929 |
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$ |
(294 |
) |
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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
1. Basis of Presentation
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 month period ended March 31, 2007 are not necessarily indicative of the results for
the year ending December 29, 2007 or any future interim period.
The Company does not expect that current cash and cash equivalents, revenue expected to be
generated from operations and available credit facilities, if any, will be sufficient to meet the
Companys planned operating requirements for the next 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 expected 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
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 quarter ended March 31, 2007 the Company has implemented an accounting
policy for the valuation of goodwill and intangible assets.
-5-
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 over 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 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.
-6-
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).
Changes in the estimated fair values of these assets in the future could result in significant
impairment charges or changes to our expected amortization.
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 three months ending March 31, 2007 and April 1,
2006 follows:
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Three Months Ended |
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March 31, |
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April 1, |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
Balance, beginning of period |
|
$ |
1,415 |
|
|
$ |
1,072 |
|
Additions to deferral through acquisition |
|
|
1,870 |
|
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|
Additions to deferral |
|
|
1,976 |
|
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|
281 |
|
Revenue recognized |
|
|
(1,576 |
) |
|
|
(340 |
) |
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Balance, end of period |
|
$ |
3,685 |
|
|
$ |
1,013 |
|
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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 three months
ending March 31, 2007 and April 1, 2006 follows:
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Three Months Ended |
|
|
|
March 31, |
|
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April 1, |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
Balance, beginning of period |
|
$ |
866 |
|
|
$ |
1,128 |
|
Warranty accrual acquired through acquisition |
|
|
1,771 |
|
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Accruals for warranties issued during the period |
|
|
356 |
|
|
|
222 |
|
Settlements made in kind during the period |
|
|
(657 |
) |
|
|
(344 |
) |
|
|
|
|
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|
Balance, end of period |
|
$ |
2,336 |
|
|
$ |
1,006 |
|
|
|
|
|
|
|
|
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
-7-
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.
3. Business Combination
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:
|
|
|
|
|
Cash paid on closing |
|
$ |
26,000 |
|
Issuance of common stock |
|
|
2,014 |
|
Post Closing adjustment to purchase price |
|
|
(675 |
) |
Acquisition costs |
|
|
2,976 |
|
|
|
|
|
Total preliminary purchase price |
|
$ |
30,315 |
|
|
|
|
|
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.
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 preliminary purchase price has been 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 |
|
$ |
11,751 |
|
|
|
|
|
Total preliminary purchase price |
|
$ |
30,315 |
|
|
|
|
|
-8-
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 $675,000 as due from AMS as an adjustment to the purchase price as determined
under the terms of the asset purchase agreement. The Company has not reached an agreement with AMS
regarding this post close adjustment, therefore, we expect there to be future adjustments to the
balance sheet primarily associated with the amount owed to AMS and the amount of residual goodwill
recorded related to this transaction. Included in our cash balance at March 31, 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 paid to
Laserscope or netted against payments owed to the Company upon settlement of the post close balance
sheet adjustment.
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 |
|
|
$ |
61 |
|
|
$ |
2,934 |
|
Gemini Current Technology |
|
4 Years |
|
|
1,282 |
|
|
|
5,129 |
|
|
|
260 |
|
|
|
4,869 |
|
Other Products Current Technology |
|
1 Year |
|
|
341 |
|
|
|
341 |
|
|
|
69 |
|
|
|
272 |
|
Accessories Current Technology |
|
4 Years |
|
|
15 |
|
|
|
62 |
|
|
|
3 |
|
|
|
59 |
|
Services Contractual Customer
Relationships |
|
10 Years |
|
|
532 |
|
|
|
5,318 |
|
|
|
108 |
|
|
|
5,210 |
|
Contractual Distribution Agreement |
|
5 Years |
|
|
370 |
|
|
|
1,848 |
|
|
|
75 |
|
|
|
1,773 |
|
Trade Name |
|
5 Years |
|
|
151 |
|
|
|
754 |
|
|
|
30 |
|
|
|
724 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,990 |
|
|
$ |
16,447 |
|
|
$ |
606 |
|
|
$ |
15,841 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 $11.8 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:
|
|
|
|
|
2007 |
|
$ |
2,849 |
|
2008 |
|
$ |
2,666 |
|
2009 |
|
$ |
2,649 |
|
2010 |
|
$ |
2,649 |
|
2011 |
|
$ |
1,413 |
|
Thereafter |
|
$ |
4,221 |
|
|
|
|
|
Total |
|
$ |
16,447 |
|
|
|
|
|
-9-
The Company has agreed under a Product Supply Agreement with Laserscope 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 determined in accordance with GAAP not to
exceed $9.0 million. Pursuant to the Product Supply Agreement this ending inventory will be
non-obsolete at the time of purchase and of a quality useable in manufacturing. 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. (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.
4. Bank Borrowings
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-based revolving line of credit of up to $6 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 $5.9 million and $5.2
million respectively at March 31, 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, 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, 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. The
Company does not expect to be 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 is 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 our 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
expected on June 30, 2007 and does not cover any subsequent breach, should one occur, of the
financial covenants contained within the loan agreements.
-10-
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.
5. Inventories
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.
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:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 30, |
|
|
|
2007 |
|
|
2006 |
|
Raw materials and work in progress |
|
$ |
5,455 |
|
|
$ |
4,000 |
|
Finished goods |
|
|
7,789 |
|
|
|
5,499 |
|
|
|
|
|
|
|
|
Total inventories |
|
$ |
13,244 |
|
|
$ |
9,499 |
|
|
|
|
|
|
|
|
6. Contingencies
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 US 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,
followed with annual payments of $0.8 million on each April 16th until 2012.
-11-
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.
During the three months ended March 31, 2007 and April 1, 2006 options to purchase 2,306,529
and 2,131,304 shares of common stock at weighted average exercise prices of $6.55 and $5.70 per
share, respectively, were not included in the computations of diluted net loss per common share
because their effect was antidilutive. Additionally, for the three months ended March 31, 2007 and
April 1, 2006 warrants to purchase 25,000 shares of common stock at an average exercise price of
$6.07 were outstanding. These options and the warrants 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 months ended March 31, 2007 and April 1, 2006
is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, 2007 |
|
|
Three Months Ended April 1, 2006 |
|
|
|
Ophthalmology |
|
|
Aesthetics |
|
|
|
|
|
|
Ophthalmology |
|
|
Aesthetics |
|
|
|
|
|
|
Medical |
|
|
Medical |
|
|
|
|
|
|
Medical |
|
|
Medical |
|
|
|
|
|
|
Devices |
|
|
Devices |
|
|
Total |
|
|
Devices |
|
|
Devices |
|
|
Total |
|
Sales |
|
$ |
7,189 |
|
|
$ |
5,377 |
|
|
$ |
12,566 |
|
|
$ |
7,540 |
|
|
$ |
1,303 |
|
|
$ |
8,843 |
|
Direct cost of goods sold |
|
|
2,144 |
|
|
|
2,835 |
|
|
|
4,979 |
|
|
|
2,529 |
|
|
|
683 |
|
|
|
3,212 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Direct gross margin |
|
|
5,045 |
|
|
|
2,542 |
|
|
|
7,587 |
|
|
|
5,011 |
|
|
|
620 |
|
|
|
5,631 |
|
Total unallocated indirect costs |
|
|
|
|
|
|
|
|
|
|
(12,507 |
) |
|
|
|
|
|
|
|
|
|
|
(6,243 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre-tax income (loss) |
|
|
|
|
|
|
|
|
|
$ |
(4,920 |
) |
|
|
|
|
|
|
|
|
|
$ |
(612 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
-12-
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 month periods
ended March 31, 2007 and April 1, 2006 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Quarter Ended |
|
|
|
March 31, |
|
|
December 30, |
|
|
|
2007 |
|
|
2006 |
|
Cost of sales |
|
$ |
26 |
|
|
$ |
36 |
|
Research and development |
|
|
62 |
|
|
|
48 |
|
Sales, general and administrative |
|
|
268 |
|
|
|
373 |
|
|
|
|
|
|
|
|
|
|
$ |
356 |
|
|
$ |
457 |
|
|
|
|
|
|
|
|
10. Subsequent Events
On April 6, 2007, the Company reached settlement on the claims against Synergetics under a
patent infringement action. This settlement resulted in the Company receiving payment from
Synergetics of $2.5 million in April 2007 and subsequent annual payments of $0.8 million per year
for the next five years.
On May 23, 2007 Laserscope provided the Company with notice of material breach of the Product
Supply Agreement as a result of the Companys failure to timely pay invoices of approximately $2.7
million for finished goods inventory delivered by Laserscope to the Company under the Product
Supply Agreement. As of June 27, 2007 the unpaid amount was equal to approximately $3.5 million,
which consisted of amounts due under outstanding invoices plus accrued interest. As a result of
this nonpayment, Laserscope is currently only selling product to the Company on a prepaid basis.
Until the Company is able to bring Laserscope current on its payments under this Product Supply
Agreement, Laserscope has the right to terminate the agreement which would result in all payments
immediately becoming due and payable.
On June 27, 2007, the Company entered into a letter agreement (the Letter Agreement) with
Laserscope pursuant to which the parties agreed that beginning with the week of July 2, 2007, the
Company will pay $400,000 per week to Laserscope against invoices outstanding under the Product
Supply Agreement, plus accrued interest thereon and that the Company will pay all outstanding
invoices in full, plus accrued interest, upon the earlier of (a) two (2) business days following
the closing of an equity financing or (b) July 31, 2007. The parties further agreed that upon
payment in full of all outstanding invoices, plus accrued interest in accordance with the Letter
Agreement the Company will have cured the breach under the Product Supply Agreement. As long as
the Company complies with its obligation to make payments to Laserscope in accordance with the
Letter Agreement, Laserscope will ship service parts and products to the Company on a cash in
advance or confirmed letter of credit basis. In exchange for the payment schedule outlined above,
Laserscope has agreed that it will not exercise its right to terminate the Product Supply Agreement
as a result of the material breach described in the May 23, 2007 letter from Laserscope to the
Company. If the Company fails to comply in any respect with its obligation to make timely payments
to
-13-
Laserscope in accordance with the Letter Agreement, Laserscope has the right to terminate the
Product Supply Agreement immediately upon written notice to the Company with no additional notice
period or opportunity to cure.
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.
-14-
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; 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 and a reduction in legal fees; expectations of revenue from the
settlement of litigation; 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 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.
Lasersopes delivery devices VersaStat i SmartScan Plus, SmartScan , CoolSpot , Dermastats
and MicronSpot Dermastats.
-15-
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.
Results of Operations
The following table sets forth certain operating data as a percentage of sales for the periods
included.
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
April 1, |
|
|
|
2007 |
|
|
2006 |
|
Sales |
|
|
100.0 |
% |
|
|
100.0 |
% |
Cost of Sales |
|
|
58.5 |
% |
|
|
51.8 |
% |
|
|
|
|
|
|
|
Gross Profit |
|
|
41.5 |
% |
|
|
48.2 |
% |
|
|
|
|
|
|
|
Operating Expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
13.8 |
% |
|
|
12.7 |
% |
Sales, general and administrative |
|
|
65.8 |
% |
|
|
44.4 |
% |
|
|
|
|
|
|
|
Total operating expenses |
|
|
79.6 |
% |
|
|
57.1 |
% |
|
|
|
|
|
|
|
Loss from operations |
|
|
(38.1 |
)% |
|
|
(8.9 |
)% |
Interest and other expense, net |
|
|
(1.0 |
)% |
|
|
2.0 |
% |
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(39.1 |
)% |
|
|
(6.9 |
)% |
Benefit from income taxes |
|
|
0.0 |
% |
|
|
3.5 |
% |
|
|
|
|
|
|
|
Net loss |
|
|
(39.1 |
)% |
|
|
(3.4 |
)% |
|
|
|
|
|
|
|
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 |
|
|
|
March 31, 2007 |
|
|
April 1, 2006 |
|
|
|
|
|
|
|
Percentage of |
|
|
|
|
|
|
Percentage of |
|
|
|
Amount |
|
|
total sales |
|
|
Amount |
|
|
total sales |
|
Domestic |
|
$ |
6,675 |
|
|
|
53.1 |
% |
|
$ |
5,130 |
|
|
|
58.0 |
% |
International |
|
|
5,891 |
|
|
|
46.9 |
% |
|
|
3,713 |
|
|
|
42.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
12,566 |
|
|
|
100.0 |
% |
|
|
8,843 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Ophthalmology: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic |
|
|
4,007 |
|
|
|
31.9 |
% |
|
|
4,094 |
|
|
|
46.3 |
% |
International |
|
|
3,182 |
|
|
|
25.3 |
% |
|
|
3,446 |
|
|
|
39.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
7,189 |
|
|
|
57.2 |
% |
|
|
7,540 |
|
|
|
85.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Aesthetics: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic |
|
|
2,668 |
|
|
|
21.2 |
% |
|
|
1,036 |
|
|
|
11.7 |
% |
International |
|
|
2,709 |
|
|
|
21.6 |
% |
|
|
267 |
|
|
|
3.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
5,377 |
|
|
|
42.8 |
% |
|
$ |
1,303 |
|
|
|
14.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
-16-
Total sales increased by 42.1% to $12.6 million for the three months ended March 31, 2007 from
$8.8 million for the three months ended April 1, 2006. Domestic sales, which represented 53.1% of
total sales, increased 30.1% to $6.7 million for the three month period ended March 31, 2007 from
$5.1 million for the three months ended April 1, 2006. The increase in domestic sales was the
result of a $0.7 million increase in domestic aesthetic revenue and a $1.1 million increase in
domestic service revenue largely attributable to the newly acquired Laserscope business offset by a
$0.2 million decrease in domestic ophthalmology revenue. International sales, which represented
46.9% of total sales, increased 58.7% to $5.9 million for the three month period ended March 31,
2007 from $3.7 million for the three months ended April 1, 2006. The increase in international
sales was the result of a $2.4 million increase in international aesthetic revenue and a $0.1
million increase in international service revenue largely attributable to the newly acquired
Laserscope aesthetics business offset by a $0.3 million decrease in international ophthalmology
revenue.
Ophthalmology Sales
Ophthalmology sales decreased 4.6% to $7.2 million for the three month period ended March 31,
2007 from $7.5 million for the three months ended April 1, 2006. For the three month period ended
March 31, 2007, domestic ophthalmology sales decreased 2.1% to $4.0 million from $4.1 million for
the three months ended April 1, 2006, primarily as a result of a $0.3 million decrease in OEM
business. International ophthalmology sales for the three month period ended March 31, 2007
decreased 7.7% to $3.2 million, from $3.4 million for the three months ended April 1, 2006. The
decrease in international ophthalmology sales during the period was due to a $0.3 million decrease
in laser console sales offset by a $0.1 million increase in sales of recurring disposable probes.
Aesthetic Sales
Aesthetic sales increased $4.1 million from $1.3 million for the three month period ended
April 1, 2006 to $5.4 million for the three month period ended March 31, 2007. Domestic aesthetic
sales increased to $2.7 million for the three month period ended March 31, 2007 from $1.0 million
for the three month period ended April 1, 2006. International aesthetic sales increased $2.4
million from $0.3 million for the three month period ended April 1, 2006 to $2.8 million for the
three month period ended March 31, 2007. The increase in aesthetic revenue was due to the addition
of the newly acquired Laserscope business.
Gross Margin
Gross profit increased by $0.9 million to $5.2 million for the three months ended March 31,
2007 compared to $4.3 million for the three months ended April 1, 2006. Gross profit as a
percentage of sales for the three months ended March 31, 2007 decreased to 41.5% from 48.2% for the
comparable prior year three month period. The total 6.7% decrease in gross profit as a percentage
of sales during this period resulted from a 3.3% increase in overhead spending combined with a 3.7%
increase in direct costs which included amortization expense of recently acquired intangible assets
related to product technology. 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.
Margins for our ophthalmic Iridex products improved slightly compared to prior year levels.
Our immediate margin improvement efforts are focused on achieving planned manufacturing cost
efficiencies from integration of the Laserscope products with existing manufacturing capacity.
Integration is
-17-
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.
Research and Development
Research and development includes the cost of research and product innovation efforts.
Research and product innovation expenses increased by 54.2% to $1.7 million, or 13.7% of net sales,
in the first quarter of 2007 from $1.1 million, or 12.7% of net sales, in the first quarter of
2006. The increase in spending in the first quarter of 2007 in comparison to the first quarter of
2006 related to $0.4 million in increased salary expense associated with increased headcount and
increased consultant and project spending of $0.2 million associated with increased development
efforts. R&D spending is targeted to approximate 9.0% of net sales in our planned business model.
Selling, General and Administrative
Selling, general and administrative expense increased in the first quarter of 2007 by $4.3
million to $8.3 million or 65.8% of net sales from $3.9 million or 44.4% of net sales in the first
quarter of 2006. The increase related primarily to higher salary due to increased headcount and
associated selling expenses of $0.8 million, $0.7 million for increased marketing headcount and
aesthetics related marketing programs and $0.8 million of expense incurred in the two acquired
Laserscope entities in the France and the United Kingdom. In addition general and administrative
expense increased $1.6 million due to an increase in legal fees of $0.8 million in support of
litigation, increased accounting fees of $0.3 million and increased spending on consultants and
contractors of $0.3 million hired in support of the Laserscope integration activities, and $0.2
million of amortization expense associated with marketing intangibles. We are planning to reduce
the overall level of selling, general and administrative spending in future quarters through
reduced spending programs, a reduction in the use of consultants and contractors and a reduction in
legal expense due to the settlement of the Synergetics litigation.
Amortization of purchased intangibles
In the first quarter of 2007, we completed the acquisition of the aesthetics business from
Laserscope. Amortization of intangible assets acquired from Laserscope was $0.6 million recorded
in the first quarter of 2007. $0.4 million of this total was allocated to cost of goods sold since
it relates to product technology intangibles. The remaining $0.2 million of marketing amortization
expense is recorded in selling, general and administrative expenses. We expect quarterly
amortization expense of $0.5 million to be recorded in cost of goods sold and $0.3 million of
amortization expense to be recorded in selling, general and administrative expenses for each of the
remaining three quarters in 2007.
Interest and Other (expense) income, net.
For the three months ended March 30, 2007 amounts included in Interest and Other Expense, net
consisted of interest expense of $0.1 million on newly acquired debt. For the three months ended
April 1, 2006 other income was $0.2 million 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 new credit facility.
-18-
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 month period ending April 1, 2006
was 50.5%. 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 does not expect that 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 planned operating requirements for the next twelve months.
Generally, the Companys principal sources of liquidity are cash from operations and
borrowings under our credit facility. As of March 31, 2007 we had $9.5 million of cash and cash
equivalents. Our cash and cash equivalents decreased by $11.5 million during the three months
ended March 31, 2007. This decrease is due to acquisition related payments, partially offset by
financing activities. In the first three months of 2007, cash
provided by operations was $1.2
million. Significant changes in working capital accounts, net of
amounts related to the acquisition were:
|
|
|
a $1.7 million decrease in accounts receivable; |
|
|
|
|
a $1.3 million increase in inventory; |
|
|
|
|
a $3.6 million increase in accounts payable, and |
|
|
|
|
a $0.9 million increase in accrued expenses. |
The
Company generated positive cash flow from operations despite the
$4.9 million loss for the quarter due to non-cash charges of
approximately $1.15 million and increases in accounts payable
and accruals of $4.9 million. In future periods as accounts
payable and accruals are reduced, cash flow from operations will be
reduced.
In
the first three months of 2007, cash flow used in investing activities was $24.4 million
primarily related to the acquisition of the aesthetics business of Laserscope. In the first three
months of 2007, cash flows from financing activities included proceeds from the issuance of common
stock under our equity based stock compensation plans of
$0.7 million and $11.9 million of cash
from the draw-down of our current credit facility. Included in our cash balance at March 31, 2007
is $4.0 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 paid to
Laserscope or netted against payments owed to the Company upon settlement of the post close balance
sheet adjustment.
The Company has agreed under a product supply agreement (the Product Supply Agreement) with
Laserscope 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 determined in
accordance with GAAP not to exceed $9.0 million. Pursuant to the Product Supply Agreement this
ending inventory will be non-obsolete and of a quality useable in manufacturing. 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.
We are currently not able to make payments on all of our outstanding obligations as they come
due, including obligations of approximately $3.5 million, which consists of amounts due under
outstanding invoices plus accrued interest owed to Laserscope pursuant to the Product Supply
Agreement. On June 27, 2007, the Company entered into a letter agreement (the Letter Agreement)
with Laserscope pursuant to
-19-
which the parties agreed that beginning with the week of July 2, 2007, the Company will pay
$400,000 per week to Laserscope against invoices outstanding under the Product Supply Agreement,
plus accrued interest thereon and that the Company will pay all outstanding invoices in full, plus
accrued interest, upon the earlier of (a) two business days following the close of a equity
financing or (b) July 31, 2007. The parties further agreed that upon payment in full of all
outstanding invoices, plus accrued interest in accordance with the Letter Agreement, the Company
will have cured the breach under the Product Supply Agreement. As long as the Company complies
with its obligation to make payments to Laserscope in accordance with the Letter Agreement,
Laserscope will ship service parts and products to the Company on a cash in advance or confirmed
letter of credit basis. In exchange for the payment schedule outlined above Laserscope has agreed
it will not exercise its right to terminate the Product Supply Agreement as a result of the
material breach described in the May 23, 2007 letter from Laserscope to the Company. If the
Company fails to comply in any respect with its obligation to make timely payments to Laserscope in
accordance with the Letter Agreement, Laserscope has the right to terminate the Product Supply
Agreement immediately upon written notice to the Company with no additional notice period or
opportunity to cure.
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.
The Company expects that for the second fiscal quarter ending June 30, 2007 the Company will
not be able to satisfy certain restrictive financial covenants contained in its credit facilities
with Mid-Peninsula Bank and Exim Bank. In anticipation of this violation Mid-Peninsula Bank and
Export-Import Bank on June 19, 2007 waived the default from our 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 relates only to the breach of financial covenants expected on June 30, 2007
and does not cover any subsequent breach, should one occur, of the financial covenants contained
within the loan agreements. 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.
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.
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.
-20-
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 March 31, 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 4. Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures
Our management evaluated, with the participation of our Chief Executive Officer (CEO) and its
Chief Financial Officer (CFO), 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 and CFO 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 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 March 31, 2007.
-21-
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. The remediation plan addresses the following corrective actions:
|
|
|
implementation of additional controls over the preparation and review of key
spreadsheets; |
|
|
|
|
implementation of automated general ledger reports to replace existing key
spreadsheets where possible; |
|
|
|
|
implementation of additional review procedures; and |
|
|
|
|
enhancement of the current capabilities of the finance function. |
We began implementing certain corrective actions relating to our period-end review procedures
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 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 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. These
changes relate to the acquisition of two foreign subsidiaries operating in the countries of France
and the United Kingdom. We are in the process of integrating these foreign subsidiaries which have
internal control and disclosure procedures that were not
designed or maintained for public company reporting. We will focus our efforts on improving
their internal control over financial reporting during the remainder of this year.
During February 2007, the Company enhanced the current capabilities of the Companys finance
function by adding a new Chief Financial Officer.
-22-
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 US 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 for the next 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 liquidity and capital resources, cash expected to be
generated from operations and our ability to draw-down on our credit facilities, if at all, will be
sufficient to meet our currently planned operating requirements for the next 12 months. Our
concerns about our ability to satisfy our liquidity requirements over the next 12 months 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 Laserscope under the Product Supply Agreement
-24-
including currently
outstanding invoices of approximately $3.5 million and up to $9.0 million for raw material and work in process inventory payable upon termination of the 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. This one-time waiver does 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 liquidity requirements over
the next 12 months. Our obligations under these credit facilities are secured by a lien on
substantially all of the Companys assets. We currently have drawn down $11.1 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 June 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 quarter ending June 30, 2007. In
anticipation of this violation Mid-Peninsula Bank and Export-Import Bank on June 19, 2007 waived
the default from our 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 expected on June 30, 2007 and does not cover any subsequent breach
should one occur, of the financial covenants contained within the loan agreements. 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.
-25-
We are not currently able to make payments on all of our outstanding obligations as they come
due, including obligations of approximately $3.5 million currently owed to Laserscope as of June
27, 2007 pursuant to the Product Supply Agreement we entered into with Laserscope in connection
with the acquisition of the aesthetics business of Laserscope. On May 23, 2007 Laserscope provided
the Company with notice of material breach of the Product Supply Agreement as a result of the
Companys failure to timely pay invoices of approximately $2.7 million for finished goods inventory
delivered to the company under the agreement. On June 27, 2007, the Company entered into a letter
agreement (the Letter Agreement) with Laserscope pursuant to which the parties agreed that
beginning with the week of July 2, 2007, the Company will pay $400,000 per week to Laserscope
against invoices outstanding under the Product Supply Agreement, plus accrued interest thereon and
that the Company will pay all outstanding invoices in full, plus accrued interest, upon the earlier
of (a) two (2) business days following the closing of an equity financing or (b) July 31, 2007.
The parties further agreed that (i) upon payment in full of all outstanding invoices, plus accrued
interest in accordance with the Letter Agreement the Company will have cured the breach under the
Product Supply Agreement, (ii) for so long as the Company complies with its obligation to make
payments to Laserscope in accordance with the Letter Agreement, Laserscope will ship service parts
and products to the Company only on a cash in advance or confirmed letter of credit basis, and
(iii) after the Company has paid in full all outstanding invoices, plus accrued interest, in
accordance with the Letter Agreement, Laserscope will ship service parts and products to the
Company under the Product Supply Agreement only on a cash in advance or confirmed letter of credit
basis for the remaining term of the Product Supply Agreement. In exchange for the Companys
agreements under the Letter Agreement, Laserscope agreed that for so long as the Company complies
with its obligation to make payments to Laserscope in accordance with the Letter Agreement,
Laserscope will not exercise its right to terminate the Product Supply Agreement as a result of the
material breach described in the May 23, 2007 letter from Laserscope to the Company. If the
Company fails to comply in any respect with its obligation to make timely payments to Laserscope in
accordance with the Letter Agreement, Laserscope has the right to terminate the Product Supply
Agreement immediately upon written notice to the Company with no additional notice period or
opportunity to cure.
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 $12 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. Upon the transfer
of the manufacturing of the Laserscope products from Laserscope to us, we are required to purchase
up to $9 million of raw materials
-26-
inventory from 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. |
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.
-27-
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.
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.
Integration efforts often take a significant amount of time, place a significant strain on
managerial, operational and financial resources and can prove to be more difficult or expensive
than predicted. The diversion of our managements attention and any delay or difficulties
encountered in connection with the pending acquisition of 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.
-28-
As discussed above, we are currently in breach of our Product Supply Agreement with Laserscope
and on June 27, 2007 we entered into a letter agreement with Laserscope relating to this breach.
Pursuant to this letter agreement, Laserscope agreed to not terminated the Product Supply Agreement
so long as we pay $400,000 per week to Laserscope against invoices outstanding under the Product
Supply Agreement, plus accrued interest thereon and pay all outstanding invoices in full, plus
accrued interest, upon the earlier of (a) two (2) business days following the closing of an equity
financing or (b) July 31, 2007. If we fail to make these scheduled payments and are unable to
bring Laserscope current on the payments we owe to them under the Product Supply Agreement,
Laserscope has the right to terminate the agreement which would result in all payments immediately
becoming due and payable, including the final payment for raw material and work in process
inventory, which could require us to pay up to $9.0 million for such raw materials and work in
process inventory in addition to any other outstanding amounts we owe to Laserscope.
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 4 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 Sarbanes-Oxley Act which will require management to perform an assessment of
internal control over financial reporting. These requirements might place a strain on our systems
and resources. 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.
-29-
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.
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; |
-30-
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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.
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.
-31-
The Clinical Trial Process Required to Obtain Regulatory Approvals is Costly and Uncertain,
and Could Result in Delays in New Product Introductions or Even an Inability to Release a Product.
The clinical trials required to obtain regulatory approvals for our products are complex and
expensive and their outcomes are uncertain. We incur expense for, and devote time to, clinical
trials but cannot be certain that the trials will ever result in the commercial sale of a product.
We may suffer significant setbacks in clinical trials, even after earlier clinical trials showed
promising results. Any of our products may produce undesirable side effects that could cause us or
regulatory authorities to interrupt, delay or halt clinical trials of a product candidate. We, the
FDA, or another regulatory authority may suspend or terminate clinical trials at any time if they
or we believe the trial participants face unacceptable health risks.
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.
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 March 31, 2007, our
ophthalmology sales were
$7.2 million or 57.2% 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.
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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 March 31, 2007, our international sales were $5.9 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 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.
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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. Key personnel, including certain members of
our aesthetics sales force who joined the company in connection with the acquisition of 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
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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
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regulatory agency guidelines, which may delay sales and increase product costs. Any failures
by our vendors to adequately 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. Our business, results of operations and
financial condition would be adversely affected if we are unable to continue to obtain components
in the quantity and quality desired and at the prices we have budgeted.
Pursuant to our Product Supply Agreement, we rely on AMS, through its Laserscope subsidiary to
manufacture significant portions of our aesthetics products. On May 23, 2007 Laserscope provided
us with notice of material breach of the Product Supply Agreement as a result of our failure to
timely pay invoices of approximately $2.7 million for finished goods inventory delivered by
Laserscope to us under the Product Supply Agreement. As a result of this nonpayment, Laserscope is
currently only selling product to us on a prepaid basis. On June 27, 2007 we entered into a letter
agreement with Laserscope relating to this breach. Pursuant to this letter agreement, Laserscope
agreed to not terminated the Product Supply Agreement so long as we pay $400,000 per week to
Laserscope against invoices outstanding under the Product Supply Agreement, plus accrued interest
thereon and pay all outstanding invoices in full, plus accrued interest, upon the earlier of (a)
two (2) business days following the closing of a $5 million equity financing or (b) July 31, 2007.
If we fail to make these scheduled payments and are unable to bring Laserscope current on the
payments we owe to them under the Product Supply Agreement, Laserscope has the right to terminate
the agreement which would result in all payments immediately becoming due and payable, including
the final payment for raw material and work in process inventory, which could require us to pay up
to $9.0 million for such raw materials and work in process inventory in addition to any other
outstanding amounts we owe to Laserscope.
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
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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 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. 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 ability of
our sole or limited source suppliers to 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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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. 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.
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. From time to time, we meet with investors and potential investors. In
addition, we receive attention by securities analysts
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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) premarket notification process
or the lengthier premarket 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 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.
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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 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
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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 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.
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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.
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.
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If We Fail to Manage Growth Effectively, Our Business Could Be Disrupted Which Could Harm Our
Operating Results.
We have experienced and may continue to 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, 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
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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 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
-44-
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.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
-45-
Item 5. Other Information
None.
Item 6. Exhibits
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10.1
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Amended and Restated 1998 Stock Plan |
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31.1
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Certification of Chief Financial Officer pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002. |
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31.2
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Certification of Chief Executive Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. |
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32.1
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Certification of Chief Financial Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. |
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.
-46-
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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IRIDEX Corporation (Registrant) |
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Date:
July 6, 2007
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By:
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/s/ MERYL RAINS |
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Meryl Rains |
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Chief Financial Officer and Vice President, Administration |
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(Principal Financial Officer, |
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Chief Accounting Officer and Authorized Signatory) |
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-47-
Index
10.1 |
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Amended and Restated 1998 Stock Plan |
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31.1 |
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Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act
of 2002. |
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31.2 |
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Certification of Chief Financial pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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32.1 |
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Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
exv10w1
Exhibit 10.1
IRIDEX CORPORATION
1998 STOCK PLAN
(As amended June 19, 2007)
1. Purposes of the Plan. The purposes of this Stock Plan are:
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to attract and retain the best available personnel for positions of
substantial responsibility, |
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to provide additional incentive to Employees, Directors and Consultants, and |
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to promote the success of the Companys business. |
The Plan permits the grant of Incentive Stock Options, Nonstatutory Stock Options, Stock
Appreciation Rights, Restricted Stock, Restricted Stock Units, Performance Shares and Performance
Units, as the Administrator may determine.
2. Definitions. As used herein, the following definitions shall apply:
(a) Administrator means the Board or any of its Committees as shall be administering
the Plan, in accordance with Section 4 of the Plan.
(b) Affiliate means any corporation or any other entity (including, but not limited
to, partnerships and joint ventures) controlling, controlled by, or under common control with the
Company.
(c) Applicable Laws means the requirements relating to the administration of
equity-based awards under U.S. state corporate laws, U.S. federal and state securities laws, the
Code, any stock exchange or quotation system on which the Common Stock is listed or quoted and the
applicable laws of any foreign country or jurisdiction where Awards are, or will be, granted under
the Plan.
(d) Award means, individually or collectively, a grant under the Plan of Options,
Stock Appreciation Rights, Restricted Stock, Restricted Stock Units, Performance Units and
Performance Shares as the Administrator may determine.
(e) Award Agreement means the written or electronic agreement setting forth the
terms and provisions applicable to each Award granted under the Plan, which shall include an Option
Agreement. The Award Agreement is subject to the terms and conditions of the Plan.
(f) Board means the Board of Directors of the Company.
(g) Cash Position means as to any Performance Period, the Companys level of cash,
cash equivalents, available-for-sales securities, and the long term portion of available-for-sales
securities.
(h) Code means the Internal Revenue Code of 1986, as amended. Any reference to a
section of the Code herein will be a reference to any successor or amended section of the Code.
(i) Committee means a committee of Directors or of other individuals satisfying
Applicable Laws appointed by the Board in accordance with Section 4 hereof.
(j) Common Stock means the common stock of the Company.
(k) Company means IRIDEX Corporation, a Delaware corporation, or any successor
thereto.
(l) Consultant means any person, including an advisor, engaged by the Company or its
Affiliate to render services to such entity.
(m) Determination Date means the latest possible date that will not jeopardize the
qualification of an Award granted under the Plan as performance-based compensation under Section
162(m) of the Code.
(n) Director means a member of the Board.
(o) Disability means total and permanent disability as defined in Section 22(e)(3)
of the Code, provided that in the case of Awards other than Incentive Stock Options, the
Administrator in its discretion may determine whether a permanent and total disability exists in
accordance with uniform and non-discriminatory standards adopted by the Administrator from time to
time.
(p) Earnings Per Share means as to any Performance Period, the Companys or a
business units Net Income, divided by a weighted average number of Common Stock outstanding and
dilutive common equivalent Shares deemed outstanding.
(q) Employee means any person, including Officers and Directors, employed by the
Company or its Affiliates. Neither service as a Director nor payment of a directors fee by the
Company will be sufficient to constitute employment by the Company.
(r) Exchange Act means the Securities Exchange Act of 1934, as amended.
(s) Fair Market Value means, as of any date, the value of Common Stock as the
Administrator may determine in good faith by reference to the price of such stock on any
established stock exchange or a national market system on the day of determination if the Common
Stock is so listed on any established stock exchange or a national market system. If the Common
Stock is not listed on any established stock exchange or a national market system, the value of the
Common Stock as the Administrator may determine in good faith.
(t) Fiscal Year means the fiscal year of the Company.
(u) Incentive Stock Option means an Option that by its terms qualifies and is
otherwise intended to qualify as an incentive stock option within the meaning of Section 422 of the
Code and the regulations promulgated thereunder.
2
(v) Individual Objectives means as to a Participant for any Performance Period, the
objective and measurable goals set by a management by objectives process and approved by the
Administrator (in its discretion).
(w) Net Income means as to any Performance Period, the Companys or a business
units income after taxes.
(x) Nonstatutory Stock Option means an Option that by its terms does not qualify or
is not intended to qualify as an Incentive Stock Option.
(y) Officer means a person who is an officer of the Company within the meaning of
Section 16 of the Exchange Act and the rules and regulations promulgated thereunder.
(z) Operating Cash Flow means as to any Performance Period, the Companys or a
business units sum of Net Income plus depreciation and amortization plus changes in working
capital comprised of accounts receivable, inventories, other current assets, trade accounts
payable, accrued expenses, product warranty, advance payments from customers and long-term accrued
expenses.
(aa) Operating Income means as to any Performance Period, the Companys or a
business units income from operations but excluding any unusual items or non-operating or non-cash
related expenses.
(bb) Option means a stock option granted pursuant to the Plan.
(cc) Option Agreement means an agreement between the Company and a Participant
evidencing the terms and conditions of an individual Option grant. The Option Agreement is subject
to the terms and conditions of the Plan.
(dd) Optioned Stock means the Common Stock subject to an Award
(ee) Parent means a parent corporation, whether now or hereafter existing, as
defined in Section 424(e) of the Code.
(ff) Participant means the holder of an outstanding Award, which shall include an
Optionee.
(gg) Performance Goals means the goal(s) (or combined goal(s)) determined by the
Administrator (in its discretion) to be applicable to a Participant with respect to an Award. As
determined by the Administrator, the Performance Goals applicable to an Award may provide for a
targeted level or levels of achievement using one or more of the following measures: (a) Cash
Position, (b) Earnings Per Share, (c) Individual Objectives, (d) Net Income, (e) Operating Cash
Flow, (f) Operating Income, (g) Return on Assets, (h) Return on Equity, (i) Return on Sales, (j)
Revenue, and (k) Total Stockholder Return. The Performance Goals may differ from Participant to
Participant and from Award to Award. Prior to the Determination Date, the Administrator shall
determine whether any significant element(s) shall be included in or excluded from the calculation
of any Performance Goal with respect to any Participant. For example (but not by way of
limitation), the Administrator may determine that the measures for one or more Performance Goals
shall be based upon the Companys pro-forma results and/or results in accordance with generally
accepted accounting principles.
3
(hh) Performance Period means any Fiscal Year or such other period as determined by
the Administrator in its sole discretion.
(ii) Performance Share means an Award denominated in Shares which may be earned in
whole or in part upon attainment of Performance Goals or other vesting criteria as the
Administrator may determine pursuant to Section 10.
(jj) Performance Unit means an Award which may be earned in whole or in part upon
attainment of Performance Goals or other vesting criteria as the Administrator may determine and
which may be settled for cash, Shares or other securities or a combination of the foregoing
pursuant to Section 10.
(kk) Plan means this 1998 Stock Plan, as amended and restated.
(ll) Restricted Stock means Shares issued pursuant to a Restricted Stock award under
Section 8 of the Plan, or issued pursuant to the early exercise of an Option.
(mm) Restricted Stock Unit means a bookkeeping entry representing an amount equal to
the Fair Market Value of one Share, granted pursuant to Section 9. Each Restricted Stock Unit
represents an unfunded and unsecured obligation of the Company.
(nn) Return on Assets means as to any Performance Period, the percentage equal to
the Companys or a business units Operating Income, divided by average net Company or business
unit, as applicable, assets.
(oo) Return on Equity means as to any Performance Period, the percentage equal to
the Companys Net Income divided by average stockholders equity.
(pp) Return on Sales means as to any Performance Period, the percentage equal to the
Companys or a business units Operating Income, divided by the Companys or the business units,
as applicable, revenue.
(qq) Revenue means as to any Performance Period, the Companys or business units
net sales.
(rr) Rule 16b-3 means Rule 16b-3 of the Exchange Act or any successor to Rule 16b-3,
as in effect when discretion is being exercised with respect to the Plan.
(ss) Section 16(b) means Section 16(b) of the Exchange Act.
(tt) Service Provider means an Employee, Director or Consultant.
(uu) Share means a share of the Common Stock, as adjusted in accordance with Section
13 of the Plan.
(vv) Stock Appreciation Right means an Award, granted alone or in connection with an
Option, that pursuant to Section 7 is designated as a Stock Appreciation Right.
(ww) Subsidiary means a subsidiary corporation, whether now
or hereafter existing, as defined in Section 424(f) of the Code.
4
(xx) Total Stockholder Return means as to any Performance Period, the total return
(change in Share price plus reinvestment of any dividends) of a Share.
3. Stock Subject to the Plan.
(a) Stock Subject to the Plan. Subject to the provisions of Section 13 of the Plan,
the maximum aggregate number of Shares which may be optioned and sold under the Plan is two million
one hundred and fifty thousand (2,150,000) Shares. The Shares may be authorized, but unissued, or
reacquired Common Stock.
(b) Full Value Awards. Any Shares subject to Options or Stock Appreciation Rights
will be counted against the numerical limits of this Section 3 as one Share for every Share subject
thereto. Any Shares subject to Awards of Restricted Stock, Restricted Stock Units, Performance
Shares or Performance Units with a per share or unit purchase price lower than 100% of Fair Market
Value on the date of grant will be counted against the numerical limits of this Section 3 as two
(2) Shares for every one Share subject thereto. To the extent that a Share that was subject to an
Award that counted as two (2) Shares against the Plan reserve pursuant to the preceding sentence is
recycled back into the Plan under the next paragraph of this Section 3, the Plan will be credited
with two (2) Shares.
(c) Lapsed Awards. If an Award expires or becomes unexercisable without having been
exercised in full, or, with respect to Restricted Stock, Restricted Stock Units, Performance Shares
or Performance Units, is forfeited to or repurchased by the Company, the unpurchased Shares (or for
Awards other than Options and Stock Appreciation Rights, the forfeited or repurchased shares) which
were subject thereto will become available for future grant or sale under the Plan (unless the Plan
has terminated). With respect to Stock Appreciation Rights, Shares actually issued pursuant to a
Stock Appreciation Right as well as the Shares that represent payment of the exercise price will
cease to be available under the Plan. Shares that have actually been issued under the Plan under
any Award will not be returned to the Plan and will not become available for future distribution
under the Plan; provided, however, that if Shares subject to Awards of Restricted Stock, Restricted
Stock Units, Performance Shares or Performance Units are repurchased by the Company or are
forfeited to the Company, such Shares will become available for future grant under the Plan.
Shares used to pay the exercise price of an Option will not become available for future grant or
sale under the Plan. Shares used to satisfy tax withholding obligations will not become available
for future grant or sale under the Plan. To the extent an Award under the Plan is paid out in cash
rather than Shares, such cash payment will not reduce the number of Shares available for issuance
under the Plan. Notwithstanding the foregoing and, subject to adjustment provided in Section 13,
the maximum number of Shares that may be issued upon the exercise of Incentive Stock Options will
equal the aggregate Share number stated in Section 3(a), plus, to the extent allowable under
Section 422 of the Code, any Shares that become available for issuance under the Plan under this
Section 3(c).
(d) Share Reserve. The Company, during the term of this Plan, will at all times
reserve and keep available such number of Shares as will be sufficient to satisfy the requirements
of the Plan.
4. Administration of the Plan.
(a) Procedure.
5
(i) Multiple Administrative Bodies. The Plan may be administered by different
Committees with respect to different groups of Service Providers.
(ii) Section 162(m). To the extent that the Administrator determines it to be
desirable to qualify Options granted hereunder as performance-based compensation within the
meaning of Section 162(m) of the Code, the Plan shall be administered by a Committee of two or more
outside directors within the meaning of Section 162(m) of the Code.
(iii) Rule 16b-3. To the extent desirable to qualify transactions hereunder as exempt
under Rule 16b-3, the transactions contemplated hereunder shall be structured to satisfy the
requirements for exemption under Rule 16b-3.
(iv) Other Administration. Other than as provided above, the Plan shall be
administered by (A) the Board or (B) a Committee, which committee shall be constituted to satisfy
Applicable Laws.
(b) Powers of the Administrator. Subject to the provisions of the Plan, and in the
case of a Committee, subject to the specific duties delegated by the Board to such Committee, the
Administrator shall have the authority, in its discretion:
(i) to select the Service Providers to whom Awards may be granted hereunder;
(ii) to determine the terms and conditions, not inconsistent with the terms of the Plan, of
any Award granted hereunder;
(iii) to construe and interpret the terms of the Plan and Awards granted pursuant to the Plan;
(iv) to prescribe, amend and rescind rules and regulations relating to the Plan, including
rules and regulations relating to sub-plans established for the purpose of satisfying applicable
foreign laws;
(v) to modify or amend each Award (subject to Section 21(c) of the Plan) including, without
limitation, the discretionary authority to extend the post-termination exercisability period of
Awards longer than is otherwise provided for in the Plan. Notwithstanding the previous sentence,
the Administrator may not modify or amend an Option or Stock Appreciation Right to reduce the
exercise price of such Option or Stock Appreciation Right after it has been granted (except for
adjustments made pursuant to Section 16) nor may the Administrator cancel any outstanding Option or
Stock Appreciation Right and replace it with a new Option or Stock Appreciation Right with a lower
exercise price, unless, in either case, such action is approved by the Companys stockholders;
(vi) to authorize any person to execute on behalf of the Company any instrument required to
effect the grant of an Award previously granted by the Administrator;
(vii) to allow a Participant to defer the receipt of the payment of cash or the delivery of
Shares that would otherwise be due to such Participant under an Award pursuant to such procedures
as the Administrator may determine; and
6
(viii) to make all other determinations deemed necessary or advisable for administering the
Plan.
(c) Effect of Administrators Decision. The Administrators decisions, determinations
and interpretations shall be final and binding on all Participants and any other holders of Awards.
5. Eligibility. Nonstatutory Stock Options, Stock Appreciation Rights, Restricted
Stock, Restricted Stock Units, Performance Shares and Performance Units as the Administrator
determines may be granted to Service Providers. Incentive Stock Options may be granted only to
Employees of the Company or any Parent or Subsidiary of the Company.
6. Options.
(a) Limitations.
(i) Each Option shall be designated in the Award Agreement as either an Incentive Stock Option
or a Nonstatutory Stock Option. However, notwithstanding such designation, to the extent that the
aggregate Fair Market Value of the Shares with respect to which Incentive Stock Options are
exercisable for the first time by the Participant during any calendar year (under all plans of the
Company and any Parent or Subsidiary) exceeds $100,000, such Options shall be treated as
Nonstatutory Stock Options. For purposes of this Section 6(a), Incentive Stock Options shall be
taken into account in the order in which they were granted. The Fair Market Value of the Shares
shall be determined as of the time the Option with respect to such Shares is granted.
(ii) The following limitations shall apply to grants of Options:
(1) No Service Provider shall be granted, in any Fiscal Year, Options to purchase more than
200,000 Shares.
(2) In connection with his or her initial service, a Service Provider may be granted Options
to purchase up to an additional 400,000 Shares which shall not count against the limit set forth in
subsection (1) above.
(3) The foregoing limitations shall be adjusted proportionately in connection with any change
in the Companys capitalization as described in Section 13.
(4) If an Option is cancelled in the same fiscal year of the Company in which it was granted
(other than in connection with a transaction described in Section 13), the cancelled Option will be
counted against the limits set forth in subsections (1) and (2) above. For this purpose, if the
exercise price of an Option is reduced, the transaction will be treated as a cancellation of the
Option and the grant of a new Option.
(b) Term of Option. The term of each Option shall be stated in the Award Agreement and
shall be seven (7) years from the date of grant or such shorter term as may be provided by the
Administrator; provided, however, that in the case of an Incentive Stock Option granted to a
Participant who, at the time the Incentive Stock Option is granted, owns stock representing more
than ten percent (10%) of the total combined voting power of all classes of stock of the Company or
any Parent or Subsidiary, the term of the Incentive Stock Option shall be five (5) years from the
date of grant or such shorter term as may be provided by the Administrator.
7
(c) Option Exercise Price and Consideration.
(i) Exercise Price. The per share exercise price for the Shares to be issued pursuant
to exercise of an Option shall be determined by the Administrator, subject to the following:
(1) In the case of an Incentive Stock Option
a) granted to an Employee who, at the time the Incentive Stock Option is granted, owns stock
representing more than ten percent (10%) of the voting power of all classes of stock of the Company
or any Parent or Subsidiary, the per Share exercise price shall be no less than 110% of the Fair
Market Value per Share on the date of grant.
b) granted to any Employee other than an Employee described in paragraph (A) immediately
above, the per Share exercise price shall be no less than 100% of the Fair Market Value per Share
on the date of grant.
(2) In the case of a Nonstatutory Stock Option, the per Share exercise price will be
determined by the Administrator, but will be no less than 100% of the Fair Market Value per Share
on the date of grant.
(3) Notwithstanding the foregoing, Options may be granted with a per Share exercise price of
less than 100% of the Fair Market Value per Share on the date of grant pursuant to a transaction
described in, and in a manner consistent with, Section 424(a) of the Code.
(ii) Waiting Period and Exercise Dates. At the time an Option is granted, the Administrator
shall fix the period within which the Option may be exercised and shall determine any conditions
which must be satisfied before the Option may be exercised.
(iii) Form of Consideration. The Administrator will determine the acceptable form(s) of
consideration for exercising an Option, including the method of payment, to the extent permitted by
Applicable Laws.
(d) Exercise of Option.
(i) Procedure for Exercise; Rights as a Stockholder. Any Option granted hereunder
shall be exercisable according to the terms of the Plan and at such times and under such conditions
as determined by the Administrator and set forth in the Award Agreement. An Option may not be
exercised for a fraction of a Share.
An Option shall be deemed exercised when the Company receives: (i) written or electronic
notice of exercise (in accordance with the Award Agreement) from the person entitled to exercise
the Option, and (ii) full payment for the Shares with respect to which the Option is exercised
together with any applicable withholding taxes. Full payment may consist of any consideration and
method of payment authorized by the Administrator and permitted by the Award Agreement and the
Plan. Shares issued upon exercise of an Option shall be issued in the name of the Participant or,
if requested by the Participant, in the name of the Participant and his or her spouse. Until the
Shares are issued (as evidenced by the appropriate entry on the books of the Company or of a duly
authorized transfer agent of the Company), no right to vote or receive dividends or any other
rights as a stockholder shall exist with respect to the Optioned Stock, notwithstanding the
exercise of the Option. The Company shall issue (or cause to be issued) such Shares promptly after
the Option
8
is exercised. No adjustment will be made for a dividend or other right for which the record
date is prior to the date the Shares are issued, except as provided in Section 13 of the Plan.
Exercising an Option in any manner shall decrease the number of Shares thereafter available,
both for purposes of the Plan and for sale under the Option, by the number of Shares as to which
the Option is exercised.
(ii) Termination of Relationship as a Service Provider. If an Participant ceases to be
a Service Provider, other than upon the Participants death or Disability, the Participant may
exercise his or her Option within such period of time as is specified in the Award Agreement to the
extent that the Option is vested on the date of termination (but in no event later than the
expiration of the term of such Option as set forth in the Award Agreement). In the absence of a
specified time in the Award Agreement, the Option shall remain exercisable for three (3) months
following the Participants termination. If, on the date of termination, the Participant is not
vested as to his or her entire Option, the Shares covered by the unvested portion of the Option
shall revert to the Plan. If, after termination, the Participant does not exercise his or her
Option within the time specified by the Administrator, the Option shall terminate, and the Shares
covered by such Option shall revert to the Plan.
(iii) Disability of Participant. If an Participant ceases to be a Service Provider as
a result of the Participants Disability, the Participant may exercise his or her Option within
such period of time as is specified in the Award Agreement to the extent the Option is vested on
the date of termination (but in no event later than the expiration of the term of such Option as
set forth in the Award Agreement). In the absence of a specified time in the Award Agreement, the
Option shall remain exercisable for twelve (12) months following the Participants termination. If,
on the date of termination, the Participant is not vested as to his or her entire Option, the
Shares covered by the unvested portion of the Option shall revert to the Plan. If, after
termination, the Participant does not exercise his or her Option within the time specified herein,
the Option shall terminate, and the Shares covered by such Option shall revert to the Plan.
(iv) Death of Participant. If an Participant dies while a Service Provider, the Option
may be exercised within such period of time as is specified in the Award Agreement (but in no event
later than the expiration of the term of such Option as set forth in the Award Agreement), by the
Participants estate or by a person who acquires the right to exercise the Option by bequest or
inheritance, but only to the extent that the Option is vested on the date of death. In the absence
of a specified time in the Award Agreement, the Option shall remain exercisable for twelve (12)
months following the Participants termination. If, at the time of death, the Participant is not
vested as to his or her entire Option, the Shares covered by the unvested portion of the Option
shall immediately revert to the Plan. The Option may be exercised by the executor or administrator
of the Participants estate or, if none, by the person(s) entitled to exercise the Option under the
Participants will or the laws of descent or distribution. If the Option is not so exercised within
the time specified herein, the Option shall terminate, and the Shares covered by such Option shall
revert to the Plan.
9
7. Stock Appreciation Rights.
(a) Grant of Stock Appreciation Rights. Subject to the terms and conditions of the
Plan, a Stock Appreciation Right may be granted to Service Providers at any time and from time to
time as will be determined by the Administrator, in its sole discretion.
(b) Number of Shares. The Administrator will have complete discretion to determine
the number of Stock Appreciation Rights granted to any Participant, provided that during any Fiscal
Year, no Participant will be granted Stock Appreciation Rights covering more than 200,000 Shares.
Notwithstanding the foregoing limitation, in connection with a Participants initial service as an
Employee, an Employee may be granted Stock Appreciation Rights covering up to an additional 400,000
Shares.
(c) Exercise Price and Other Terms. The Administrator, subject to the provisions of
the Plan, will have complete discretion to determine the terms and conditions of Stock Appreciation
Rights granted under the Plan, provided, however, that the exercise price will be not less than one
hundred percent (100%) of the Fair Market Value of a Share on the date of grant.
(d) Stock Appreciation Right Agreement. Each Stock Appreciation Right grant will be
evidenced by an Award Agreement that will specify the exercise price, the term of the Stock
Appreciation Right, the conditions of exercise, and such other terms and conditions as the
Administrator, in its sole discretion, will determine.
(e) Expiration of Stock Appreciation Rights. A Stock Appreciation Right granted under
the Plan will expire upon the date determined by the Administrator, in its sole discretion, and set
forth in the Award Agreement. Notwithstanding the foregoing, the rules of Section 6(d) also will
apply to Stock Appreciation Rights.
(f) Payment of Stock Appreciation Right Amount. Upon exercise of a Stock Appreciation
Right, a Participant will be entitled to receive payment from the Company in an amount determined
by multiplying:
(i) The difference between the Fair Market Value of a Share on the date of exercise over the
exercise price; times
(ii) The number of Shares with respect to which the Stock Appreciation Right is exercised.
At the discretion of the Administrator, the payment upon Stock Appreciation Right exercise may be
in cash, in Shares of equivalent value, or in some combination thereof.
8. Restricted Stock.
(a) Grant of Restricted Stock. Subject to the terms and provisions of the Plan, the
Administrator, at any time and from time to time, may grant Shares of Restricted Stock to Service
Providers in such amounts as the Administrator, in its sole discretion, will determine.
(b) Restricted Stock Agreement. Each Award of Restricted Stock will be evidenced by
an Award Agreement that will specify the number of Shares granted, and such other
10
terms and conditions as the Administrator, in its sole discretion, will determine.
Notwithstanding the foregoing, during any Fiscal Year no Participant will receive more than an
aggregate of 150,000 Shares of Restricted Stock; provided, however, that in connection with a
Participants initial service as an Employee, an Employee may be granted an aggregate of up to an
additional 150,000 Shares of Restricted Stock. Unless the Administrator determines otherwise,
Shares of Restricted Stock will be held by the Company as escrow agent until the restrictions on
such Shares have lapsed.
(c) Transferability. Except as provided in this Section 8, Shares of Restricted Stock
may not be sold, transferred, pledged, assigned, or otherwise alienated or hypothecated until the
Shares have vested and are no longer subject to a substantial risk of forfeiture.
(d) Other Restrictions. The Administrator, in its sole discretion, may impose such
other restrictions on Shares of Restricted Stock as it may deem advisable or appropriate.
(e) Removal of Restrictions. Except as otherwise provided in this Section 8, Shares
of Restricted Stock covered by each Restricted Stock grant made under the Plan will be released
from escrow as soon as practicable after the last day the Shares have vested and are no longer
subject to a substantial risk of forfeiture. The restrictions will lapse at a rate determined by
the Administrator. The Administrator, in its discretion, may accelerate the time at which any
restrictions will lapse or be removed.
(f) Voting Rights. During the period during which Shares of Restricted Stock are
unvested and subject to a substantial risk of forfeiture, Service Providers holding such Shares may
exercise full voting rights with respect to those Shares, unless the Administrator determines
otherwise.
(g) Dividends and Other Distributions. During the period during which Shares of
Restricted Stock are unvested and subject to substantial risk of forfeiture, Service Providers
holding such Shares will be entitled to receive all dividends and other distributions paid with
respect to such Shares unless otherwise Administrator provides otherwise. If any such dividends or
distributions are paid in Shares, the Shares will be subject to the same restrictions on
transferability and forfeitability as the Shares of Restricted Stock with respect to which they
were paid.
(h) Return of Restricted Stock to Company. On the date set forth in the Award
Agreement, the Restricted Stock for which restrictions have not lapsed will revert to the Company
and again will become available for grant under the Plan.
9. Restricted Stock Units.
(a) Grant. Restricted Stock Units may be granted at any time and from time to time as
determined by the Administrator. Each Restricted Stock Unit grant shall be evidenced by an Award
Agreement that shall specify such other terms and conditions as the Administrator, in its sole
discretion, shall determine, including all terms, conditions, and restrictions related to the
grant, the number of Restricted Stock Units and the form of payout, which, subject to Section 9(d),
may be left to the discretion of the Administrator. Notwithstanding the anything to the contrary
in this subsection (a), during any Fiscal Year, no Participant will receive more than an aggregate
of 150,000 Restricted Stock Units; provided, however, that in connection with a Participants
initial service as an Employee, an Employee may be granted an aggregate of up to an additional
150,000 Restricted Stock Units.
11
(b) Vesting Criteria and Other Terms. The Administrator shall set vesting criteria in
its discretion, which, depending on the extent to which the criteria are met, will determine the
number of Restricted Stock Units that will be paid out to the Participant. The Administrator may
set vesting criteria based upon the achievement of Company-wide, business unit, or individual goals
(including, but not limited to, continued employment or service), or any other basis determined by
the Administrator in its discretion.
(c) Earning Restricted Stock Units. Upon meeting the applicable vesting criteria, the
Participant shall be entitled to receive a payout as specified in the Restricted Stock Unit Award
Agreement. Notwithstanding the foregoing, at any time after the grant of Restricted Stock Units,
the Administrator, in its sole discretion, may reduce or waive any vesting criteria that must be
met to receive a payout.
(d) Form and Timing of Payment. Payment of earned Restricted Stock Units shall be
made as soon as practicable after the date(s) set forth in the Award Agreement. The Administrator,
in its sole discretion, may pay earned Restricted Stock Units in cash, Shares, or a combination
thereof. Shares represented by Restricted Stock Units that are fully paid in cash again shall be
available for grant under the Plan.
(e) Cancellation. On the date set forth in the Award Agreement, all unearned
Restricted Stock Units shall be forfeited to the Company.
10. Performance Units and Performance Shares.
(a) Grant of Performance Units/Shares. Performance Units and Performance Shares may
be granted to Service Providers at any time and from time to time, as will be determined by the
Administrator, in its sole discretion. The Administrator will have complete discretion in
determining the number of Performance Units/Shares granted to each Participant provided that during
any Fiscal Year, (a) no Participant will receive Performance Units having an initial value greater
than $1,000,000, and (b) no Participant will receive more than 150,000 Performance Shares.
Notwithstanding the foregoing limitation, in connection with a Participants initial service as an
Employee, an Employee may be granted up to an additional 150,000 Performance Shares.
(b) Value of Performance Units/Shares. Each Performance Unit will have an initial
value that is established by the Administrator on or before the date of grant. Each Performance
Share will have an initial value equal to the Fair Market Value of a Share on the date of grant.
(c) Performance Objectives and Other Terms. The Administrator will set performance
objectives or other vesting provisions (including, without limitation, continued status as a
Service Provider) in its discretion which, depending on the extent to which they are met, will
determine the number or value of Performance Units/Shares that will be paid out to the Participant.
Each Award of Performance Units/Shares will be evidenced by an Award Agreement that will specify
the Performance Period, and such other terms and conditions as the Administrator, in its sole
discretion, will determine.
(d) Earning of Performance Units/Shares. After the applicable Performance Period has
ended, the holder of Performance Units/Shares will be entitled to receive a payout of the number of
Performance Units/Shares earned by the Participant over the Performance Period, to be
12
determined as a function of the extent to which the corresponding performance objectives or
other vesting provisions have been achieved. After the grant of a Performance Unit/Share, the
Administrator, in its sole discretion, may reduce or waive any performance objectives or other
vesting provisions for such Performance Unit/Share.
(e) Form and Timing of Payment of Performance Units/Shares. Payment of earned
Performance Units/Shares will be made as soon as practicable after the expiration of the applicable
Performance Period. The Administrator, in its sole discretion, may pay earned Performance
Units/Shares in the form of cash, in Shares (which have an aggregate Fair Market Value equal to the
value of the earned Performance Units/Shares at the close of the applicable Performance Period) or
in a combination thereof.
(f) Cancellation of Performance Units/Shares. On the date set forth in the Award
Agreement, all unearned or unvested Performance Units/Shares will be forfeited to the Company, and
again will be available for grant under the Plan.
11. Leaves of Absence. Unless the Administrator provides otherwise, vesting of Awards
granted hereunder will be suspended during any unpaid leave of absence. A Service Provider will
not cease to be an Employee in the case of (i) any leave of absence approved by the Company or (ii)
transfers between locations of the Company or between the Company, its Parent, or any Subsidiary.
For purposes of Incentive Stock Options, no such leave may exceed ninety (90) days, unless
reemployment upon expiration of such leave is guaranteed by statute or contract. If reemployment
upon expiration of a leave of absence approved by the Company is not so guaranteed, then three (3)
months following the 91st day of such leave any Incentive Stock Option held by the Participant will
cease to be treated as an Incentive Stock Option and will be treated for tax purposes as a
Nonstatutory Stock Option.
12. Transferability of Awards. Unless determined otherwise by the Administrator, an
Award may not be sold, pledged, assigned, hypothecated, transferred, or disposed of in any manner
other than by will or by the laws of descent or distribution and may be exercised, during the
lifetime of the Participant, only by the Participant. If the Administrator makes an Award
transferable, such Award will contain such additional terms and conditions as the Administrator
deems appropriate.
13. Adjustments Upon Changes in Capitalization, Dissolution, Merger or Asset Sale.
(a) Changes in Capitalization. Subject to any required action by the stockholders of
the Company, the number of shares of Common Stock that have been authorized for issuance under the
Plan but as to which no Awards have yet been granted or which have been returned to the Plan upon
cancellation or expiration of an Award, the number of shares of Common Stock as well as the price
per share of Common Stock covered by each such outstanding Award, and the numerical Share limits in
Sections 6, 7, 8, 9 and 10, shall be proportionately adjusted for any change in, or increase or
decrease in the number of issued shares of Common Stock resulting from a stock split, reverse stock
split, stock dividend, spin-off, combination or reclassification of the Common Stock, or any other
change in, or increase or decrease in the number of issued shares of Common Stock effected without
receipt of consideration by the Company; provided, however, that conversion of any convertible
securities of the Company shall not be deemed to have been effected without receipt of
consideration. Such adjustment shall be made by the Board, whose determination in that respect
shall be final, binding and conclusive. Except as expressly provided herein, no issuance by the
Company of shares of stock of any class, or securities convertible into shares of stock of any
13
class, shall affect, and no adjustment by reason thereof shall be made with respect to, the
number or price of shares of Common Stock subject to an Award.
(b) Dissolution or Liquidation. In the event of the proposed dissolution or
liquidation of the Company, the Administrator shall notify each Participant as soon as practicable
prior to the effective date of such proposed transaction. The Administrator in its discretion may
provide for a Participant to have the right to exercise his or her Award until ten (10) days prior
to such transaction as to all of the Optioned Stock covered thereby, including Shares as to which
the Award would not otherwise be exercisable. In addition, the Administrator may provide that any
Company repurchase option or reacquisition right applicable to any Restricted Stock shall lapse as
to all such Shares, provided the proposed dissolution or liquidation takes place at the time and in
the manner contemplated. To the extent it has not been previously exercised, an Award will
terminate immediately prior to the consummation of such proposed action.
(c) Merger or Asset Sale. In the event of a merger of the Company with or into another
corporation or the sale of all or substantially all of the Companys assets, each outstanding Award
will be assumed or an equivalent award substituted by the successor corporation or a Parent or
Subsidiary of the successor corporation. In the event that the successor corporation refuses to
assume or substitute for the Award, the Participant will fully vest in and have the right to
exercise all of his or her outstanding Options and Stock Appreciation Rights, including Shares as
to which such Awards would not otherwise be vested or exercisable, all restrictions on Restricted
Stock and Restricted Stock Units will lapse, and, with respect to Performance Shares and
Performance Units, all Performance Goals or other vesting criteria will be deemed achieved at
target levels and all other terms and conditions met. In addition, if an Option or Stock
Appreciation Right becomes fully vested and exercisable in lieu of assumption or substitution in
the event of a merger or sale of assets, the Administrator will notify the Participant in writing
or electronically that the Option or Stock Appreciation Right will be fully vested and exercisable
for a period of time determined by the Administrator in its sole discretion, and the Option or
Stock Appreciation Right will terminate upon the expiration of such period.
For the purposes of this subsection (c), an Award will be considered assumed if, following the
merger or sale of assets, the Award confers the right to purchase or receive, for each Share
subject to the Award immediately prior to the merger or sale of assets, the consideration (whether
stock, cash, or other securities or property) or, in the case of a Stock Appreciation Right upon
the exercise of which the Administrator determines to pay cash or a Restricted Stock Unit,
Performance Share or Performance Unit which the Administrator can determine to pay in cash, the
fair market value of the consideration received in the merger or merger or sale of assets by
holders of Common Stock for each Share held on the effective date of the transaction (and if
holders were offered a choice of consideration, the type of consideration chosen by the holders of
a majority of the outstanding Shares); provided, however, that if such consideration received in
the merger or sale of assets is not solely common stock of the successor corporation or its Parent,
the Administrator may, with the consent of the successor corporation, provide for the consideration
to be received upon the exercise of an Option or Stock Appreciation Right or upon the payout of a
Restricted Stock Unit, Performance Share or Performance Unit, for each Share subject to such Award
(or in the case of Restricted Stock Units or Performance Units, the number of implied shares
determined by dividing the value of the Restricted Stock Units or Performance Units, as applicable,
by the per share consideration received by holders of Common Stock in the merger or sale of
assets), to be solely common stock of the successor corporation or its Parent equal in fair market
value to the per share consideration received by holders of Common Stock in the merger or sale of
assets.
14
Notwithstanding anything in this Section 13(c) to the contrary, an Award that vests, is earned
or paid-out upon the satisfaction of one or more Performance Goals will not be considered assumed
if the Company or its successor modifies any of such Performance Goals without the Participants
consent; provided, however, a modification to such Performance Goals only to reflect the successor
corporations post-transaction corporate structure will not be deemed to invalidate an otherwise
valid Award assumption.
14. Tax Withholding
(a) Withholding Requirements. Prior to the delivery of any Shares or cash pursuant to
an Award (or exercise thereof), the Company will have the power and the right to deduct or
withhold, or require a Participant to remit to the Company, an amount sufficient to satisfy
federal, state, local, foreign or other taxes (including the Participants FICA obligation)
required to be withheld with respect to such Award (or exercise thereof).
(b) Withholding Arrangements. The Administrator, in its sole discretion and pursuant
to such procedures as it may specify from time to time, may permit a Participant to satisfy such
tax withholding obligation, in whole or in part by (without limitation) (a) paying cash, (b)
electing to have the Company withhold otherwise deliverable cash or Shares having a Fair Market
Value equal to the amount required to be withheld, (c) delivering to the Company already-owned
Shares having a Fair Market Value equal to the amount required to be withheld, or (d) selling a
sufficient number of Shares otherwise deliverable to the Participant through such means as the
Administrator may determine in its sole discretion (whether through a broker or otherwise) equal to
the amount required to be withheld. The amount of the withholding requirement will be deemed to
include any amount which the Administrator agrees may be withheld at the time the election is made,
not to exceed the amount determined by using the maximum federal, state or local marginal income
tax rates applicable to the Participant with respect to the Award on the date that the amount of
tax to be withheld is to be determined. The Fair Market Value of the Shares to be withheld or
delivered will be determined as of the date that the taxes are required to be withheld.
15. No Effect on Employment or Service. Neither the Plan nor any Award will confer
upon a Participant any right with respect to continuing the Participants relationship as a Service
Provider with the Company, nor will they interfere in any way with the Participants right or the
Companys right to terminate such relationship at any time, with or without cause, to the extent
permitted by Applicable Laws.
16. Date of Grant. The date of grant of an Award will be, for all purposes, the date
on which the Administrator makes the determination granting such Award, or such other later date as
is determined by the Administrator. Notice of the determination will be provided to each
Participant within a reasonable time after the date of such grant.
17. Term of Plan. Subject to Section 21 of the Plan, the Plan shall become effective
upon its original adoption by the Board. It shall continue in effect for a term of ten (10) years
unless terminated earlier under Section 18 of the Plan.
18. Amendment and Termination of the Plan.
(a) Amendment and Termination. The Administrator may at any time amend, alter,
suspend or terminate the Plan.
15
(b) Stockholder Approval. The Company will obtain stockholder approval of any Plan
amendment to the extent necessary and desirable to comply with Applicable Laws.
(c) Effect of Amendment or Termination. No amendment, alteration, suspension or
termination of the Plan will impair the rights of any Participant, unless mutually agreed otherwise
between the Participant and the Administrator, which agreement must be in writing and signed by the
Participant and the Company. Termination of the Plan will not affect the Administrators ability
to exercise the powers granted to it hereunder with respect to Awards granted under the Plan prior
to the date of such termination.
19. Conditions Upon Issuance of Shares.
(a) Legal Compliance. Shares will not be issued pursuant to the exercise of an Award
unless the exercise of such Award and the issuance and delivery of such Shares will comply with
Applicable Laws and will be further subject to the approval of counsel for the Company with respect
to such compliance.
(b) Investment Representations. As a condition to the exercise of an Award, the
Company may require the person exercising such Award to represent and warrant at the time of any
such exercise that the Shares are being purchased only for investment and without any present
intention to sell or distribute such Shares if, in the opinion of counsel for the Company, such a
representation is required.
20. Inability to Obtain Authority. The inability of the Company to obtain authority
from any regulatory body having jurisdiction, which authority is deemed by the Companys counsel to
be necessary to the lawful issuance and sale of any Shares hereunder, shall relieve the Company of
any liability in respect of the failure to issue or sell such Shares as to which such requisite
authority shall not have been obtained.
21. Stockholder Approval. The Plan shall be subject to approval by the stockholders of
the Company within twelve (12) months after the date the Plan is adopted. Such stockholder
approval shall be obtained in the manner and to the degree required under Applicable Laws.
16
exv31w1
EXHIBIT 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO
SECTION 13(a) OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 AS
ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF
I, Barry G. Caldwell, certify that:
1. I have reviewed this quarterly report on Form 10-Q of IRIDEX Corporation;
2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this quarterly report;
3. Based on my knowledge, the financial statements, and other financial information included in
this quarterly report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this quarterly
report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for
the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material information relating to
the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this quarterly report is being prepared;
b) Evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls and
procedures, as of the end of the period covered by this report based on such evaluation; and
c) Disclosed in this report any changes in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth
fiscal quarter in the case of the annual report) that has materially affected, or is reasonably
likely to materially affect the registrants internal control over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of registrants board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal
control over financial reporting which are reasonably likely to adversely affect the registrants
ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a
significant role in the registrants internal control over financial reporting.
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Date:
July 6, 2007 |
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By:
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/s/ BARRY G. CALDWELL |
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Name: Barry G. Caldwell |
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Title: President and Chief Executive Officer
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(Principal Executive Officer) |
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exv31w2
EXHIBIT 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO
SECTION 13(a) OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 AS
ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Meryl Rains, certify that:
1. I have reviewed this quarterly report on Form 10-Q of IRIDEX Corporation;
2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this quarterly report;
3. Based on my knowledge, the financial statements, and other financial information included in
this quarterly report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this quarterly
report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for
the registrant and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material information relating to
the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this quarterly report is being prepared;
b. Evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls and
procedures, as of the end of the period covered by this report based on such evaluation; and
c. Disclosed in this report any changes in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth
fiscal quarter in the case of the annual report) that has materially affected, or is reasonably
likely to materially affect the registrants internal control over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of registrants board of directors (or persons performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal
control over financial reporting which are reasonably likely to adversely affect the registrants
ability to record, process, summarize and report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a
significant role in the registrants internal control over financial reporting.
Date:
July 6, 2007
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By:
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/s/ MERYL RAINS |
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Name: Meryl Rains |
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Title: Chief Financial Officer and Vice President, |
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Administration |
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(Principal Financial and Accounting Officer) |
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exv32w1
EXHIBIT 32.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER
PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of IRIDEX Corporation (the Company) on Form 10-Q for
the quarter ending March 31, 2007, as filed with the Securities and Exchange Commission on the date
hereof (the Report), Barry G. Caldwell, Chief Executive Officer, and Meryl Rains, Chief Financial
Officer, of the Company, each certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the
Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
Date:
July 6, 2007
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By:
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/s/ BARRY G. CALDWELL |
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Name: Barry G. Caldwell |
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Title: President and Chief Executive Officer |
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(Principal Executive Officer) |
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Date: July 6, 2007 |
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By:
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/s/ MERYL RAINS |
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Name: Meryl Rains |
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Title: Chief Financial Officer and Vice President, |
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Administration |
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(Principal Financial and Accounting Officer) |
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