e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
(Mark One)
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þ |
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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 December 31, 2006
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: 000-51323
Micrus Endovascular Corporation
(Exact name of registrant as specified in its charter)
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Delaware
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23-2853441 |
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer Identification No.) |
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821 Fox Lane
San Jose, California
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95131 |
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(Address of principal executive offices)
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(Zip Code) |
(408) 433-1400
(Registrants telephone number, including area code)
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 (Check one):
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
As of February 1, 2007, there were 15,003,607 shares of common stock, par value $0.01, of the
registrant outstanding.
MICRUS ENDOVASCULAR CORPORATION
INDEX TO FORM 10-Q
2
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
MICRUS ENDOVASCULAR CORPORATION
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands, except share and per share amounts)
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December 31, |
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March 31, |
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2006 |
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2006 |
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ASSETS |
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Current Assets: |
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Cash and cash equivalents |
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$ |
33,580 |
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$ |
36,104 |
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Short-term investments |
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984 |
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Accounts receivable, net of allowance for doubtful accounts
of $307 at December 31, 2006 and $317 at March 31, 2006 |
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9,003 |
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8,267 |
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Inventories, net |
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7,516 |
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4,479 |
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Prepaid expenses and other current assets |
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1,190 |
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766 |
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Total current assets |
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51,289 |
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50,600 |
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Property and equipment, net |
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4,561 |
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2,488 |
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Goodwill |
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3,320 |
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3,309 |
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Intangible assets, net |
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9,882 |
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5,417 |
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Other assets |
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282 |
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300 |
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Total assets |
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$ |
69,334 |
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$ |
62,114 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current Liabilities: |
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Accounts payable |
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$ |
1,697 |
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$ |
2,088 |
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Accrued payroll and other related expenses |
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4,373 |
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3,147 |
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Accrued liabilities |
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4,899 |
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4,308 |
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Total current liabilities |
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10,969 |
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9,543 |
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Other non-current liabilities |
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3,031 |
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1,255 |
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Total liabilities |
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14,000 |
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10,798 |
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Commitments and contingencies (Note 5)
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Stockholders equity: |
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Common stock, $0.01 par value; Authorized: 50,000,000 shares
Issued and outstanding:14,993,951 shares at December 31, 2006 and
14,190,287 shares at March 31, 2006 |
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150 |
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142 |
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Additional paid-in capital |
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109,692 |
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101,430 |
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Deferred stock-based compensation |
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(222 |
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(397 |
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Accumulated other comprehensive loss |
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(555 |
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(240 |
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Accumulated deficit |
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(53,731 |
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(49,619 |
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Total stockholders equity |
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55,334 |
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51,316 |
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Total liabilities and stockholders equity |
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$ |
69,334 |
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$ |
62,114 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
MICRUS ENDOVASCULAR CORPORATION
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except per share amounts)
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Three months ended |
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Nine months ended |
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December 31, |
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December 31, |
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2006 |
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2005 |
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2006 |
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2005 |
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Revenues |
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$ |
15,544 |
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$ |
8,092 |
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$ |
42,754 |
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$ |
21,334 |
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Cost of goods sold |
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4,192 |
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2,416 |
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11,348 |
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6,264 |
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Gross profit |
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11,352 |
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5,676 |
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31,406 |
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15,070 |
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Operating expenses: |
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Research and development |
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1,769 |
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834 |
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6,025 |
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4,072 |
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Sales and marketing |
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5,992 |
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4,049 |
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17,199 |
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9,767 |
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General and administrative |
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5,273 |
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2,638 |
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14,166 |
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7,098 |
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Total operating expenses |
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13,034 |
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7,521 |
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37,390 |
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20,937 |
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Loss from operations |
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(1,682 |
) |
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(1,845 |
) |
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(5,984 |
) |
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(5,867 |
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Interest and investment income |
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426 |
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389 |
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1,211 |
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900 |
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Interest expense |
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(5 |
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(2 |
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(5 |
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(11 |
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Other income (expense), net |
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221 |
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(132 |
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554 |
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(681 |
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Loss before income taxes |
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(1,040 |
) |
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(1,590 |
) |
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(4,224 |
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(5,659 |
) |
Income tax provision (benefit) |
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(38 |
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62 |
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(112 |
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62 |
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Net loss |
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(1,002 |
) |
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(1,652 |
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(4,112 |
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(5,721 |
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Accretion of redeemable convertible preferred stock to
redemption value including beneficial conversion feature |
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(659 |
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Net loss attributable to common stockholders |
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$ |
(1,002 |
) |
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$ |
(1,652 |
) |
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$ |
(4,112 |
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$ |
(6,380 |
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Net loss per share attributable to common stockholders: |
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Basic and diluted |
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$ |
(0.07 |
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$ |
(0.12 |
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$ |
(0.28 |
) |
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$ |
(0.62 |
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Weighted-average number of shares used in per share calculations: |
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Basic and diluted |
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14,766 |
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14,139 |
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14,466 |
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10,282 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
MICRUS ENDOVASCULAR CORPORATION
Condensed Consolidated Statement of Cash Flows
(unaudited)
(in thousands)
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Nine months ended |
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December 31, |
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2006 |
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2005 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(4,112 |
) |
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$ |
(5,721 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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1,364 |
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657 |
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Provision for doubtful accounts |
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(12 |
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1 |
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Loss on disposal of equipment |
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1 |
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Provision for impairment of inventory |
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191 |
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164 |
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Increase in fair value of 2005 common stock warrants |
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158 |
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Realized (gain) loss on investments |
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(4 |
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5 |
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Stock-based compensation expense |
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1,629 |
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180 |
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Changes in operating assets and liabilities net of effect of acquisitions: |
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Accounts receivable |
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(298 |
) |
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(605 |
) |
Inventories |
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(2,232 |
) |
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(149 |
) |
Prepaid expenses and other current assets |
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(391 |
) |
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(564 |
) |
Other assets |
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27 |
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(114 |
) |
Accounts payable |
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(399 |
) |
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(1,378 |
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Accrued payroll and other related expenses |
|
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1,179 |
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|
808 |
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Accrued liabilities |
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|
1,127 |
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|
873 |
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Other non-current liabilties |
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(139 |
) |
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512 |
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Net cash used in operating activities |
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(2,070 |
) |
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(5,172 |
) |
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Cash flows from investing activities: |
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Proceeds from sales of available-for-sale securities |
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1,000 |
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Purchase of VasCon, LLC, net of cash acquired |
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(2,736 |
) |
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Purchase of Neurologic UK Ltd., net of cash acquired |
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(11 |
) |
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(5,139 |
) |
Payment to Biotronik AG for developed technology |
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(835 |
) |
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Acquisition of property and equipment |
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(967 |
) |
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(1,458 |
) |
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Net cash used in investing activities |
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(3,549 |
) |
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(6,597 |
) |
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Cash flows from financing activities: |
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Proceeds from issuance of common stock, net of issuance costs |
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2,043 |
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33,871 |
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Proceeds from exercise of preferred and common stock warrants |
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1,007 |
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Proceeds from exercise of stock options |
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1,367 |
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434 |
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Proceeds from employee stock purchase plan |
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379 |
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126 |
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Payments of issuance costs for issuance of convertible preferred stock and warrants |
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(238 |
) |
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Net cash provided by financing activities |
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3,789 |
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35,200 |
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Effect of exchange rate changes on cash |
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(694 |
) |
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426 |
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Net increase (decrease) in cash and cash equivalents |
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(2,524 |
) |
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|
23,857 |
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Cash and cash equivalents at beginning of period |
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36,104 |
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|
15,017 |
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Cash and cash equivalents at end of period |
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$ |
33,580 |
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$ |
38,874 |
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Supplemental schedule of noncash investing and financing activities: |
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Issuance of common stock for purchase of VasCon, LLC |
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$ |
2,972 |
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$ |
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Conversion of preferred stock to common stock |
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$ |
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$ |
59,227 |
|
Accretion to redemption value of redeemable convertible preferred stock
including beneficial conversion feature |
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$ |
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$ |
659 |
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Reclassification of 2005 common stock warrants to equity |
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$ |
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$ |
3,358 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
5
MICRUS ENDOVASCULAR CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 1 Formation and Business of the Company
Micrus Endovascular Corporation (the Company), formerly Micrus Corporation, was incorporated
under the laws of the state of Delaware in June 1996. The Company develops, manufactures and
markets both implantable and disposable medical devices used in the treatment of cerebral vascular
diseases.
Interim unaudited financial information
The accompanying unaudited condensed consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the United States of America
(generally accepted accounting principles) for interim financial information and in accordance
with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not
include all of the information and footnotes required by generally accepted accounting principles
for complete financial statements. The unaudited interim condensed consolidated financial
statements have been prepared on the same basis as the annual financial statements, except for the
adoption of SFAS 123R on April 1, 2006 (see Note 2). In the opinion of management, the accompanying
unaudited condensed consolidated financial statements reflect all adjustments (consisting only of
normal recurring adjustments) considered necessary for a fair presentation. These financial
statements should be read in conjunction with the audited financial statements and notes thereto
for the preceding fiscal year included in the Companys Annual Report on Form 10-K filed with the
Securities and Exchange Commission (SEC) on June 16, 2006.
The results of operations for the interim periods ended December 31, 2006 may not necessarily
be indicative of the results that may be expected for the fiscal year ended March 31, 2007, or any
future period.
Note 2 Summary of Significant Accounting Policies
Principles of consolidation
The consolidated financial statements include the accounts of the Company and its wholly-owned
subsidiaries. All significant intercompany balances and transactions have been eliminated in
consolidation.
The Companys international subsidiaries use their local currency as the functional currency.
Assets and liabilities are translated at exchange rates in effect at the balance sheet date.
Revenue, expense, gain and loss accounts are translated at average exchange rates during the
period. Resulting translation adjustments are recorded directly to accumulated other comprehensive
income (loss).
Use of estimates
The preparation of consolidated financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the dates of the consolidated financial statements and the reported
amounts of revenues and expenses during the reporting periods. Actual results could differ from
these estimates. These estimates and assumptions include reserves and write-downs related to
accounts receivable and inventories, the recoverability of long-term assets, deferred tax assets
and related valuation allowances and valuation of stock-based compensation and equity instruments.
Comprehensive income ( loss)
Total comprehensive loss for the nine months ended December 31, 2006 and 2005 was $4.4 million
and $6.2 million, respectively. This included other comprehensive income (loss) of ($315,000) and
$165,000, respectively related to the Companys unrealized gains and losses on its
available-for-sale securities and foreign currency translation.
6
Cost of goods sold
The Companys cost of goods sold includes the cost of products sold to customers including
materials, direct labor, depreciation, overhead costs associated with manufacturing, impairments of
inventory and warranty expenses. Also, beginning with the quarter ended December 31, 2006, cost of
goods sold includes amortization of capitalized license technology in connection with the Biotronik
agreement and acquired intangible assets in connection with the acquisition of VasCon, LLC
(VasCon).
Net loss per common share
Basic net loss per share is computed by dividing net loss attributable to common stockholders
by the weighted average number of common shares outstanding during the period. Diluted net loss per
share is computed by giving effect to all potential dilutive common
shares, including options, restricted stock units,
warrants and redeemable convertible preferred shares. There is no difference between basic and
diluted net loss per share for all periods presented due to the Companys net losses. A
reconciliation of the numerator and denominator used in the calculation of basic and diluted net
loss per share follows (in thousands):
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|
Three months ended |
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Nine months ended |
|
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|
December 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Numerator: |
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|
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|
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|
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|
|
|
|
|
|
Net loss |
|
$ |
(1,002 |
) |
|
$ |
(1,652 |
) |
|
$ |
(4,112 |
) |
|
$ |
(5,721 |
) |
Beneficial conversion feature of preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(383 |
) |
Accretion of redeemable convertible preferred stock to
redemption value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(276 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders |
|
$ |
(1,002 |
) |
|
$ |
(1,652 |
) |
|
$ |
(4,112 |
) |
|
$ |
(6,380 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares outstanding used in
computing basic and diluted net loss per share |
|
|
14,766 |
|
|
|
14,139 |
|
|
|
14,466 |
|
|
|
10,282 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share basic and diluted |
|
$ |
(0.07 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.62 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Anti-dilutive securities
The following outstanding stock options and restricted stock units were excluded from the
computation of diluted net loss per common share for the periods presented because their impact
would have been anti-dilutive (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Periods ended |
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Shares issuable upon exercise of common stock options |
|
|
3,204 |
|
|
|
2,559 |
|
Shares issuable upon settlement of restricted stock units |
|
|
10 |
|
|
|
|
|
Shares issuable under employee stock purchase plan |
|
|
20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,234 |
|
|
|
2,559 |
|
|
|
|
|
|
|
|
Stock-based compensation
The Company has adopted various stock plans that provide for the grant of stock awards to
employees, non-employee directors and consultants. The Company also has an employee stock purchase
plan, which enables employees to purchase the Companys common stock.
On April 1, 2006, the Company adopted the provisions of, and accounts for stock-based
compensation in accordance with, the Financial Accounting Standards Boards (FASB) Statement of
Financial Accounting Standards No. 123 revised 2004 (SFAS 123R), Share-Based Payment which
replaced Statement of Financial Accounting Standards No. 123 (SFAS 123), Accounting for
Stock-Based Compensation and supersedes APB Opinion No. 25 (APB 25), Accounting for Stock
Issued to Employees.
7
Under the fair value recognition provisions of SFAS 123R, stock-based
compensation cost is measured at the grant date based on the fair value of the award and is
recognized as expense on a straight-line basis over the requisite service period, which is
generally the vesting period. The Company elected the modified-prospective method, under which
prior periods are not revised for comparative purposes. The valuation provisions of SFAS 123R apply
to new grants and to grants that were outstanding prior to the effective date and are subsequently
modified. Estimated compensation for grants that were outstanding as of the effective date will be
recognized over the remaining service period using the compensation cost estimated for the SFAS 123
pro forma disclosures, excluding pre-IPO options for which the fair value was determined using the
minimum value method. For these grants, any remaining unamortized deferred compensation expenses
will continue to be accounted for under the intrinsic value method of APB 25.
The adoption of SFAS 123R had and will have a material impact on our consolidated financial
position and results of operations. See Note 6 for further information regarding stock-based
compensation assumptions and expenses, including pro forma disclosures for prior periods as if
stock-based compensation expense had been recorded.
Recent accounting pronouncements
In July 2006, the FASB issued FASB Interpretation No. 48 (FIN 48), Accounting for
Uncertainty in Income Taxes an interpretation of FASB Statement No. 109, which clarifies the
accounting for uncertainty in tax positions. FIN 48 requires that the Company recognize in its
financial statements, the impact of a tax position, if that position is more likely than not of
being sustained on audit, based on the technical merits of the position. The provisions of FIN 48
are effective as of the beginning of the Companys 2008 fiscal year, with the cumulative effect, if
any, of the change in accounting principle recorded as an adjustment to opening retained earnings.
The Company is currently evaluating the impact of adopting FIN 48 on its financial statements.
In September 2006, the FASB issued FASB Statement No. 157 (SFAS 157), Fair Value
Measurements. SFAS 157 defines fair value, establishes a framework for measuring fair value in
generally accepted accounting principles, and expands disclosures about fair value measurements.
SFAS 157 applies to other accounting pronouncements that require or permit fair value measurements,
the FASB having previously concluded in those accounting pronouncements that fair value is the
relevant measurement attribute. Accordingly, SFAS 157 does not require any new fair value
measurements. However, for some entities, the application of this Statement will change current
practice. The provisions of SFAS 157 are effective as of the beginning of the Companys 2008 fiscal
year. The Company is currently evaluating the impact of SFAS 157, but does not expect the adoption
of SFAS 157 to have a material impact on its consolidated financial position, results of operations
or cash flows.
In September 2006, the Securities and Exchange Commission issued Staff Accounting Bulletin No.
108, (SAB 108), which provides guidance on quantifying and evaluating the materiality of
unrecorded misstatements. SAB 108 is effective for annual financial statements covering the first
fiscal year ending after November 15, 2006, with earlier application encouraged for any interim
period of the first fiscal year ending after November 15, 2006, filed after the publication of SAB
108 (September 13, 2006). The Company is currently evaluating the impact of SAB 108, but does not
expect the adoption of SAB 108 to have a material impact on its consolidated financial position,
results of operations or cash flows.
Note 3 Business Combination
On November 30, 2006, the Company completed the acquisition of VasCon, a privately held
company engaged in the development and manufacture of vascular access and delivery devices. The acquisition of VasCon is intended to add expertise in developing clinically advanced
access and catheter systems to the Companys core competencies and provide the
Company with manufacturing capabilities that are expected to lead to significant cost
reductions for a wide range of the Companys products.
Micrus
Design Technology Inc., a newly formed subsidiary of the Company, will develop and manufacture
neurovascular access and delivery products for the Company, including the Companys steerable
catheter. VasCons existing cardio and peripheral vascular products will continue to be sold
through non-Micrus distribution channels.
The acquisition consideration consisted of an up-front payment and additional contingent
earn-out payments as described below. The up-front payment consisted of the payment of
approximately $2.5 million in cash, the issuance of 156,666 shares of the Companys common stock
having an aggregate value of approximately $3.0 million calculated based on the average closing
price two days before and the day of the acquisition, and $329,000 in acquisition-related closing
costs. The final purchase price is subject to
certain post-closing working capital adjustments. Additionally, VasCon may receive certain
earn-out payments in an amount not to exceed $10 million based on sales and manufacturing
performance as set forth in the asset purchase agreement entered into by the parties. The common
stock portion of the up-front payment was placed in escrow to satisfy certain indemnification
obligations of VasCon and its members as described in such asset purchase agreement.
8
The preliminary consideration paid was comprised of (in thousands):
|
|
|
|
|
Initial cash payment |
|
$ |
2,500 |
|
Common stock |
|
|
2,972 |
|
Acquistion-related closing costs |
|
|
329 |
|
|
|
|
|
Total preliminary purchase price |
|
$ |
5,801 |
|
|
|
|
|
The acquisition of VasCon was accounted for using the purchase method of accounting and,
accordingly, the results of operations are included in the accompanying consolidated statements of
operations for all periods or partial periods subsequent to the acquisition date. The purchase
price was allocated to the net tangible and identifiable intangible assets acquired and the
liabilities assumed based on their estimated fair values at the date of acquisition as determined
by management. The fair value of the net assets acquired exceeded the up-front purchase
consideration resulting in negative goodwill in the amount of $1.8 million. Because the acquisition
involves contingent consideration, the negative goodwill has been recorded as a deferred credit
(non-current liability) in the consolidated balance sheet and will be reduced by the contingent
consideration of up to $10 million that will be paid over the next three years, with any additional
contingent consideration being recorded as goodwill. The preliminary consideration paid was
allocated as follows (in thousands):
|
|
|
|
|
Inventories |
|
$ |
769 |
|
Fixed assets |
|
|
1,654 |
|
Other acquired net assets |
|
|
76 |
|
Intangible assets |
|
|
5,150 |
|
Contingent purchase price |
|
|
(1,848 |
) |
|
|
|
|
Total preliminary purchase price |
|
$ |
5,801 |
|
|
|
|
|
The Company acquired certain intangibles assets in the amount of $5.2 million in connection
with the acquisition of VasCon. These intangible assets are comprised of existing process
technology of $4.6 million, existing product technology of $260,000 and patents of $300,000.
Purchased intangible assets are being amortized on a straight-line basis over a weighted-average
period of approximately seven years.
The following
unaudited pro forma information presents a summary of consolidated results of
operations of the Company and VasCon as if the acquisition had occurred April 1, 2004. The
unaudited pro forma information was derived from the historical financial statements of Micrus
Endovascular and VasCon.
The following table presents
pro forma financial information for the combined entity of Micrus Endovascular and VasCon for the three and nine
months ended December 31, 2006 and 2005, as if the acquisition had occurred at the beginning of each of the periods
presented after giving effect to certain pro forma adjustments (in thousands except for per share data).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Revenues |
|
$ |
15,713 |
|
|
$ |
8,218 |
|
|
$ |
43,546 |
|
|
$ |
25,146 |
|
Net loss |
|
$ |
(1,380 |
) |
|
$ |
(2,563 |
) |
|
$ |
(5,850 |
) |
|
$ |
(5,824 |
) |
Net loss per share basic and diluted |
|
$ |
(0.09 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.40 |
) |
|
$ |
(0.56 |
) |
9
Note 4 Balance Sheet Components
Inventories
Inventories consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
|
|
2006 |
|
|
2006 |
|
Raw materials |
|
$ |
2,334 |
|
|
$ |
507 |
|
Work-in-progress |
|
|
639 |
|
|
|
504 |
|
Finished goods |
|
|
1,685 |
|
|
|
1,294 |
|
Consigned inventory |
|
|
3,709 |
|
|
|
2,874 |
|
Inventory held by Latin American distributors |
|
|
232 |
|
|
|
230 |
|
|
|
|
|
|
|
|
Gross inventory |
|
|
8,599 |
|
|
|
5,409 |
|
Less inventory allowances |
|
|
(1,083 |
) |
|
|
(930 |
) |
|
|
|
|
|
|
|
|
|
$ |
7,516 |
|
|
$ |
4,479 |
|
|
|
|
|
|
|
|
Consigned inventory is held at customer locations, primarily hospitals, and is under the
physical control of the customer. The Company retains title to the inventory until used and
purchased by the customer, generally when used in a medical procedure
Intangible assets
Intangible assets consisted of the following as of December 31, 2006 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Useful |
|
|
Gross CarryingAmount |
|
|
Accumulated Amortization |
|
|
Net |
|
|
|
Life |
|
|
March 31, |
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
March 31, |
|
|
|
(years) |
|
|
2006 |
|
|
Additions |
|
|
2006 |
|
|
2006 |
|
|
Additions |
|
|
2006 |
|
|
2006 |
|
|
2006 |
|
Existing process technology |
|
|
7 |
|
|
$ |
|
|
|
$ |
4,590 |
|
|
$ |
4,590 |
|
|
$ |
|
|
|
$ |
(54 |
) |
|
$ |
(54 |
) |
|
$ |
4,536 |
|
|
$ |
|
|
Distribution agreements |
|
|
5 |
|
|
|
2,300 |
|
|
|
|
|
|
|
2,300 |
|
|
|
(234 |
) |
|
|
(355 |
) |
|
|
(589 |
) |
|
|
1,711 |
|
|
|
2,066 |
|
Capitalized license fee |
|
|
7 |
|
|
|
1,462 |
|
|
|
103 |
|
|
|
1,565 |
|
|
|
|
|
|
|
(56 |
) |
|
|
(56 |
) |
|
|
1,509 |
|
|
|
1,462 |
|
Patents -
microcoil |
|
|
10 |
|
|
|
1,100 |
|
|
|
|
|
|
|
1,100 |
|
|
|
(660 |
) |
|
|
(83 |
) |
|
|
(743 |
) |
|
|
357 |
|
|
|
440 |
|
Non-compete agreements |
|
|
6 |
|
|
|
700 |
|
|
|
|
|
|
|
700 |
|
|
|
(59 |
) |
|
|
(89 |
) |
|
|
(148 |
) |
|
|
552 |
|
|
|
641 |
|
Customer relationships |
|
|
5 |
|
|
|
900 |
|
|
|
|
|
|
|
900 |
|
|
|
(92 |
) |
|
|
(137 |
) |
|
|
(229 |
) |
|
|
671 |
|
|
|
808 |
|
Patents -
catheter |
|
|
7 |
|
|
|
|
|
|
|
300 |
|
|
|
300 |
|
|
|
|
|
|
|
(4 |
) |
|
|
(4 |
) |
|
|
296 |
|
|
|
|
|
Existing product technology |
|
|
2 |
|
|
|
|
|
|
|
260 |
|
|
|
260 |
|
|
|
|
|
|
|
(10 |
) |
|
|
(10 |
) |
|
|
250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
6,462 |
|
|
$ |
5,253 |
|
|
$ |
11,715 |
|
|
$ |
(1,045 |
) |
|
$ |
(788 |
) |
|
$ |
(1,833 |
) |
|
$ |
9,882 |
|
|
$ |
5,417 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangible assets included in the results of operations is as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Cost of goods sold |
|
$ |
124 |
|
|
$ |
|
|
|
$ |
124 |
|
|
$ |
|
|
Operating expenses |
|
|
217 |
|
|
|
210 |
|
|
|
664 |
|
|
|
285 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
341 |
|
|
$ |
210 |
|
|
$ |
788 |
|
|
$ |
285 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
The amortization expense of the intangible assets related to existing technology in the
manufacturing process and design of products resulting from the acquisition of VasCon in the amount
of $68,000 is included in cost of goods sold for the three and nine months ended December 31, 2006.
The Company started generating revenue from the stent product associated with the capitalized
license technology in the third quarter of fiscal 2007. The amortization expense related to the
capitalized license technology in the amount of $56,000 is included in cost of goods sold for the
three and nine months ended December 31, 2006.
The expected future amortization of intangible assets is as follows (in thousands):
|
|
|
|
|
For Years Ended March 31, |
|
Amortization |
|
2007 (remaining 3 months) |
|
$ |
477 |
|
2008 |
|
|
1,908 |
|
2009 |
|
|
1,870 |
|
2010 |
|
|
1,793 |
|
2011 |
|
|
1,345 |
|
2012 and beyond |
|
|
2,489 |
|
|
|
|
|
Total |
|
$ |
9,882 |
|
|
|
|
|
Accruals
Accrued payroll and other related expenses consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
|
|
2006 |
|
|
2006 |
|
Accrued bonuses |
|
$ |
1,772 |
|
|
$ |
1,157 |
|
Accrued salaries |
|
|
299 |
|
|
|
478 |
|
Accrued vacation |
|
|
1,109 |
|
|
|
804 |
|
Accrued commissions |
|
|
668 |
|
|
|
392 |
|
Accrued payroll taxes |
|
|
525 |
|
|
|
316 |
|
|
|
|
|
|
|
|
|
|
$ |
4,373 |
|
|
$ |
3,147 |
|
|
|
|
|
|
|
|
Accrued liabilities consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
|
|
2006 |
|
|
2006 |
|
Accrued professional fees |
|
$ |
1,377 |
|
|
$ |
709 |
|
Development costs |
|
|
551 |
|
|
|
|
|
Earn-out payment in connection with Neurologic acquistion |
|
|
|
|
|
|
1,403 |
|
Biotronik milestone payment |
|
|
|
|
|
|
732 |
|
Other |
|
|
2,971 |
|
|
|
1,464 |
|
|
|
|
|
|
|
|
|
|
$ |
4,899 |
|
|
$ |
4,308 |
|
|
|
|
|
|
|
|
11
Other non-current liabilities
Other non-current liabilities consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
|
|
2006 |
|
|
2006 |
|
Contingent purchase price (Note 3) |
|
$ |
1,848 |
|
|
$ |
|
|
Deferred tax liability |
|
|
613 |
|
|
|
641 |
|
Deferred revenue from Japan distribution agreement |
|
|
413 |
|
|
|
525 |
|
Other non-current liabilities |
|
|
157 |
|
|
|
89 |
|
|
|
|
|
|
|
|
|
|
$ |
3,031 |
|
|
$ |
1,255 |
|
|
|
|
|
|
|
|
On September 30, 2005, the Company entered into a five-year, exclusive distribution
agreement with Goodman, CO., LTD (Goodman). Under the terms of the distribution agreement,
Goodman will promote and market the Companys products in Japan. In connection with the
distribution agreement, Goodman paid the Company an up-front cash payment of $750,000 which has
been recorded as deferred revenue. The Company is recognizing the deferred revenue on a
straight-line basis over the five year term of the agreement.
Note 5 Commitments and Contingencies
Indemnification
In the normal course of business, the Company enters into contracts and agreements that
contain a variety of representations and warranties and provide for general indemnification. The
Companys exposure under these agreements is unknown because it involves claims that may be made
against the Company in the future, but have not yet been made. To date, the Company has not paid
any claims or been required to defend any action related to its indemnification obligations, and
accordingly, the Company has not accrued any amounts for such indemnification obligations. However,
the Company may record charges in the future as a result of these indemnification obligations.
Litigation
The Company is from time to time subject to various lawsuits. The Company does not believe
that it is probable that resolution of pending litigation will have a material adverse effect on
the Companys consolidated financial statements; however the outcome of litigation is inherently
uncertain.
FCPA investigation
In August 2004, the Company identified certain payments made to physicians located in France,
Germany, Spain and Turkey that may likely have violated the Foreign Corrupt Practices Act (FCPA)
and the laws of certain foreign countries. In September 2004, the Company voluntarily disclosed to
the United States Department of Justice (DOJ) factual information obtained in the Companys
internal investigation of potential violations of the FCPA. In February 2005, the DOJ and the
Company entered into an agreement pursuant to which the DOJ agreed not to prosecute the Company for
conduct disclosed to the DOJ, provided that the Company accepted responsibility for the actions of
its employees and officers, paid a monetary penalty of $450,000, continues to cooperate with the
DOJ in its investigation, including the waiver of legal privileges, establishes policies and
procedures to assure compliance with the FCPA and other relevant bribery laws, retains and pays for
an independent monitor, which shall report to the DOJ for a period of three years to assure
compliance with the agreement with the DOJ and the Companys implementation and adherence to FCPA
compliance policies and procedures, and cooperates fully with the DOJ, the independent monitor and
the Securities and Exchange Commission
(SEC). The Company must remain in compliance with these conditions for a period of two years
following February 28, 2005 or face the filing of a criminal complaint by the DOJ. The monetary
penalty was accrued in fiscal 2005 and was paid in April 2005. The ongoing cost of compliance with
the DOJ agreement is being recorded as expenses are incurred.
The payments made to physicians in France, Germany, Spain and Turkey also may likely have
violated the applicable laws in those foreign jurisdictions and may possibly have violated laws in
Switzerland, where our Swiss subsidiary is located. The Company is not able to determine at this
time what penalties or other actions, if any, authorities in France, Germany, Spain, or Turkey may
impose as a result of such violations. Such amounts could be material to the financial position,
results of operations or cash flows of the Company. The Company has been notified by the Swiss
Federal Prosecutor that it does not intend to bring any action or impose any penalties on the
Company.
12
Patent litigation
In September 2004, Boston Scientific Corporation and Target Therapeutics, Inc., a subsidiary
of Boston Scientific Corporation (collectively Boston Scientific), filed a patent infringement
suit in the United States District Court for the Northern District of California, alleging that the
Companys embolic coil products infringe two patents held by Boston Scientific and that this
infringement is willful. In November 2004, the Company answered Boston Scientifics complaint and
counterclaimed, alleging that Boston Scientifics embolic coil products, and their use, infringed
three of the Companys patents. On November 10, 2006, the Company withdrew one of its three
asserted patents from the litigation to pursue a reissue application filed with the United States
Trademark and Patent Office. Each party is seeking an injunction preventing manufacture, sale,
offer for sale, use and importation of the others embolic coil products in the United States,
damages for past infringement, which may be trebled, and its legal fees and costs. In addition,
each party seeks a declaration that the patents of the other are invalid and not infringed and has
alleged that certain of the asserted patents of the other are unenforceable due to inequitable
conduct.
Boston Scientific is also a party in two other lawsuits against Cordis Corporation and
ev3/Micro Therapeutics, Inc. in which the Boston Scientific patents which are the basis of Boston
Scientifics suit against Micrus are also at issue. In October 2004, Cordis requested ex parte
reexamination of certain claims in those patents. The Company and Boston Scientific have negotiated
a schedule that permits discovery and claim construction proceedings to proceed for the both
patents while still undergoing reexamination and reissue proceedings. Discovery is ongoing in the
case and a claim construction hearing is scheduled to occur in March 2007.
The Company is unable at this time to determine the outcome of any such litigation. If the
litigation is protracted or results in an unfavorable outcome to the Company, the impact to the
financial position, results of operations or cash flows of the Company could be material.
Note 6 Stock-based Compensation
Stock options
The Companys stock option program is a long-term retention program that is intended to
attract, retain and provide incentives for talented employees, officers and directors, and to align
stockholder and employee interests. The Company considers the option program critical to its
operations and productivity. Currently, the Company grants options from the 2005 Equity Incentive
Plan (the 2005 Plan), under which options could be granted to all employees, including executive
officers, and outside consultants. In addition, the Companys stock option program includes 1)
shares under the 1996 Stock Option Plan that became available for grant under the 2005 Plan and 2)
shares under the 1998 Stock Plan that became available for grant under the 2005 Plan. Stock
options issued under the above plans generally vest based on 4 years of continuous service and have
10-year contractual terms.
1996 Stock Option Plan
Upon the effectiveness of the Companys initial public offering in June 2005 (IPO), 14,633
shares available for grant under the 1996 Stock Option Plan (the 1996 Plan) became available for
grant under the 2005 Plan. There were no options outstanding under the 1996 Plan as of the
Companys IPO.
1998 Stock Plan
Upon the effectiveness of the Companys IPO, 158,167 shares available for grant under the 1998
Stock Option Plan (the 1998 Plan) became available for grant under the 2005 Plan. All options
previously granted under the 1998 Plan continue to be administered under the 1998 Plan. As of
December 31, 2006, options to purchase 1,438,739 shares of common stock were outstanding under the
1998 Plan.
2005 Equity Incentive Plan
The 2005 Equity Incentive Plan (the 2005 Plan) became effective upon the Companys IPO. The
2005 Plan provides for the issuance of nonstatutory stock options, stock appreciation rights, stock
awards and cash awards. The Company initially reserved a total of 2,222,220 shares of its common
stock for issuance under the 2005 Plan. In addition, the 2005 Plan provides for an automatic
13
annual
increase in the number of shares reserved for issuance thereunder by an amount equal to the lesser
of (i) 5% of the Companys total number of outstanding shares; (ii) 666,666 shares, or (iii) a
number of shares determined by the Companys Board of Directors. The shares reserved under the 2005
Plan will also be increased as a result of the cancellation of unexercised options under the 1998
Plan. As of December 31, 2006, there were 3,131,385 shares reserved for issuance under the 2005
Plan, of which 1,340,058 were available for grant, 1,766,092 shares were subject to outstanding
options and 10,000 shares were subject to outstanding restricted stock units.
Employee stock purchase plan
The 2005 Employee Stock Purchase Plan (the Purchase Plan) became effective upon the
Companys IPO. The Purchase Plan provides employees with an opportunity to purchase the Companys
common stock through accumulated payroll deductions.
The Company initially reserved a total of 222,222 shares of common stock for issuance under
the Purchase Plan. The Purchase Plan provides for annual increases in the total number of shares
available for issuance under this plan on April 1 of each year beginning on April 1, 2006, by a
number of shares that is equal to the lesser of: (1) 2% of the outstanding shares of the Companys
common stock on the immediately preceding March 31; (2) 222,222 shares; or (3) a lesser number
determined by the Companys Board of Directors. As of December 31, 2006, there were 444,444 shares
reserved for issuance under the Purchase Plan of which 83,287 shares were issued and outstanding.
The Purchase Plan permits participants to purchase the Companys common stock through payroll
deductions of up to 15% of the participants compensation, up to a maximum of $25,000 per year, and
up to a maximum of 1,111 shares per purchase period. Amounts deducted and accumulated for the
participants account are used to purchase shares of the Companys common stock on the last trading
day of each purchase period at a price of at least 85% of the lesser of the fair market values of
the common stock at the beginning of the offering period or at the end of the purchase period.
The Purchase Plan provides for offering periods of 12 months and purchase periods of 6 months
or such shorter period as may be established by the Companys Board of Directors. The offering
periods start on April 1 and October 1 of each year.
Stock-based compensation
On April 1, 2006, the Company adopted the provisions of SFAS 123R. Under the fair value
recognition provisions of this statement, stock-based compensation cost is measured at the grant
date based on the fair value of the award and is recognized as expense on a straight-line basis
over the requisite service period, which is generally the vesting period. The Company transitioned
to SFAS 123R using the modified-prospective method, under which prior periods have not been revised
for comparative purposes. The Companys financial statements as of and for the nine months ended
December 31, 2006 reflect the impact of SFAS 123R. The valuation provisions of SFAS 123R apply to
new grants and to grants that were outstanding as of the effective date and are subsequently
modified. Estimated compensation for grants that were outstanding as of the effective date will be
recognized over the remaining service period using the compensation cost previously estimated for
the Companys SFAS 123 pro forma disclosures, excluding pre-IPO options, for which the fair value
was determined using the minimum value method. For these grants, any remaining unamortized deferred
compensation expenses will continue to be accounted for under the intrinsic value method of APB 25.
Stock-based compensation expense recognized during the period is based on the value of the
portion of share-based payment awards that is ultimately expected to vest. Recognized stock-based
compensation expense includes compensation expense for share-based payment awards granted prior to,
but not yet vested as of April 1, 2006, based on the grant date fair value estimated in
accordance with the pro forma provisions of SFAS 123 for options granted after the Companys
IPO. Compensation expense for the share-based payment awards granted subsequent to April 1, 2006 is
based on the grant date fair value estimated in accordance with the provisions of SFAS 123R.
Stock-based compensation charges also include the amortization of unrecognized deferred
compensation charges as deferred under APB 25 for all options granted prior to the Companys IPO.
The estimated fair value of the Companys equity-based awards, less expected forfeitures, is
amortized over the awards vesting periods on a straight-line basis. In the Companys pro forma
information required to be disclosed under SFAS 123 for the periods prior to April 1, 2006, the
Company accounted for forfeitures as they occurred.
The Company currently uses the Black-Scholes option pricing model to determine the fair value
of employee stock options and employee stock purchase plan shares. The determination of the fair
value of stock-based payment awards on the date of grant using an
14
option pricing model is affected
by the Companys stock price as well as by assumptions regarding a number of complex and subjective
variables. These variables include the Companys expected stock price volatility over the term of
the awards, actual and projected employee stock option exercise behaviors, risk-free interest rate
and expected dividends.
Because there is insufficient historical information available to estimate the expected term
of the stock-based awards, the Company adopted the simplified method for estimating the expected
term pursuant to Staff Accounting Bulletin No. 107 (SAB 107). On this basis, the Company
estimated the expected term of options granted by taking the average of the vesting term and the
contractual term of the option.
The expected volatility used in the valuation model is based on the Companys peer group in
the industry in which it does business and the Companys historical volatility since its IPO.
The risk-free interest rate is based on the yield on zero-coupon U.S. Treasury securities with
remaining terms similar to the expected term on the employee stock option and employee stock
purchase plan awards.
The Company does not anticipate paying any cash dividends in the foreseeable future and
therefore uses an expected dividend yield of zero in the option valuation model.
The Company is required to estimate forfeitures at the time of grant and revise those
estimates in subsequent periods if actual forfeitures differ from those estimates. The Company uses
historical data to estimate pre-vesting option forfeitures and record stock-based compensation
expense only for those awards that are expected to vest. All stock-based payment awards are
amortized on a straight-line basis over the requisite service periods of the awards, which are
generally the vesting periods.
The determination of the fair value of employee stock options and employee stock purchase plan
shares has been estimated using the following weighted-average assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
December 31, |
|
December 31, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Employee Stock Option Plans |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected term (in years) |
|
|
6.0 |
|
|
|
4.0 |
|
|
|
6.0 |
|
|
|
4.0 |
|
Volatility |
|
|
45 |
% |
|
|
43 |
% |
|
|
45 |
% |
|
|
43 |
% |
Risk-free interest rate |
|
|
4.55 |
% |
|
|
4.36 |
% |
|
|
4.74 |
% |
|
|
4.32 |
% |
Dividend yield |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
Weighted average fair value at date of grant |
|
$ |
8.54 |
|
|
$ |
7.18 |
|
|
$ |
7.69 |
|
|
$ |
7.18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee Stock Purchase Plan |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected term (in years) |
|
|
0.5 |
|
|
|
|
|
|
|
0.5 |
|
|
|
|
|
Volatility |
|
|
49 |
% |
|
|
|
|
|
|
42 |
% |
|
|
|
|
Risk-free interest rate |
|
|
5.11 |
% |
|
|
|
|
|
|
5.11 |
% |
|
|
|
|
Dividend yield |
|
|
0 |
% |
|
|
|
|
|
|
0 |
% |
|
|
|
|
The fair value of each purchase right granted under the Companys Employee Stock Purchase Plan
during the nine months ended December 31, 2006 and 2005 was estimated at the date of grant using
the Black-Scholes option pricing model, and is not subject to revaluation as a result of subsequent
stock price fluctuations.
15
Stock-based compensation expense included in results of operations is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Cost of goods sold |
|
$ |
64 |
|
|
$ |
6 |
|
|
$ |
145 |
|
|
$ |
19 |
|
Research and development |
|
|
55 |
|
|
|
(2 |
) |
|
|
135 |
|
|
|
7 |
|
Sales and marketing |
|
|
190 |
|
|
|
2 |
|
|
|
578 |
|
|
|
22 |
|
General and administrative |
|
|
418 |
|
|
|
50 |
|
|
|
771 |
|
|
|
132 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
727 |
|
|
$ |
56 |
|
|
$ |
1,629 |
|
|
$ |
180 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2006, there was approximately $5.7 million of total stock-based
compensation expense, after estimated forfeitures, related to unvested employee stock options and
restricted stock units, which is expected to be recognized over an estimated weighted average
amortization period of 2.9 years.
The table below summarizes the effect of recording share-based compensation expense under SFAS
123R included charges related to option modifications for the three and nine months ended December
31, 2006 which is allocated as follows:
|
|
|
|
|
|
|
|
|
|
|
Three months |
|
|
Nine months |
|
|
|
ended |
|
|
ended |
|
|
|
December 31, 2006 |
|
|
December 31, 2006 |
|
Cost of goods sold |
|
$ |
58 |
|
|
$ |
126 |
|
Research and development |
|
|
55 |
|
|
|
117 |
|
Sales and marketing |
|
|
178 |
|
|
|
467 |
|
General and administrative |
|
|
366 |
|
|
|
628 |
|
|
|
|
|
|
|
|
Total |
|
$ |
657 |
|
|
$ |
1,338 |
|
|
|
|
|
|
|
|
Additionally, approximately $61,000 in stock-based compensation expense related to SFAS 123R
has been capitalized in inventory as of December 31, 2006. The tax benefit, and the resulting
effect on cash flows from operations and financial activities, related to stock-based compensation
expense was not recognized as the Company currently provides a full valuation allowance for all of
its deferred tax assets.
Stock-based compensation expense recognized for the three months ended December 31, 2006 and
2005 related to the amortization of deferred stock-based compensation was $56,000 and $57,000,
respectively. For the nine months ended December 31, 2006 and 2005, the amortization of deferred
stock based compensation expense was $168,000 and $172,000, respectively.
Additionally, the expected future amortization of deferred compensation is as follows (in
thousands):
|
|
|
|
|
Fiscal Year 2007 (remaining 3 months) |
|
$ |
56 |
|
Fiscal Year 2008 |
|
|
166 |
|
|
|
|
|
|
|
$ |
222 |
|
|
|
|
|
The stock-based compensation expense will be reduced in the period of forfeiture for any
accrued but unvested compensation arising from early termination of an option holders services.
16
In previous years, certain stock options were issued to non-employees, generally in exchange
for consulting services related to patient studies or marketing analysis. The stock options are
recorded at their fair value on the date of vesting and recognized over the respective service or
vesting period. The fair value of the stock options granted was calculated at each reporting date
using the Black-Scholes option pricing model using the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
December 31, |
|
December 31, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Expected lives (in years) |
|
|
5.0 |
|
|
|
6.0 |
|
|
|
5.0 |
|
|
|
6.0 |
|
Volatility |
|
|
43 |
% |
|
|
48 |
% |
|
|
43 |
% |
|
|
48 |
% |
Risk-free interest rate |
|
|
4.71 |
% |
|
|
4.39 |
% |
|
|
4.71 |
% |
|
|
4.39 |
% |
Dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
Stock-based compensation expense (income) recognized for the three months ended December 31,
2006 and 2005 related to non-employee options was $14,000 and ($1,000), respectively. For the nine
months ended December 31, 2006 and 2005, stock-based compensation expense related to non-employee
options was $123,000 and $8,000, respectively. The non-employee stock-based compensation expense
will fluctuate as the fair market value of the common stock fluctuates.
Periods prior to the adoption of SFAS 123R
SFAS 123R requires the Company to present pro forma information for the comparative period
prior to the adoption as if it had accounted for all of its stock options under the fair value
method of SFAS 123.
The following table sets forth the pro forma amounts regarding the effect on net loss and net
loss per share for the three and nine months ended December 31, 2005 that would have resulted if
the Company had accounted for its employee stock plans under the fair value provisions of SFAS 123:
|
|
|
|
|
|
|
|
|
|
|
Three months |
|
|
Nine months |
|
|
|
ended |
|
|
ended |
|
|
|
December 31, 2005 |
|
|
December 31, 2005 |
|
Net loss attributable to common stockholders (as reported) |
|
$ |
(1,652 |
) |
|
$ |
(6,380 |
) |
Add: Stock-based employee compensation expenses
included in reported net loss |
|
|
57 |
|
|
|
172 |
|
Deduct: Total stock-based employee compensation expenses
determined under fair value based method for all awards |
|
|
(100 |
) |
|
|
(389 |
) |
|
|
|
|
|
|
|
Adjusted net loss attributable to common stockholders |
|
$ |
(1,695 |
) |
|
$ |
(6,597 |
) |
|
|
|
|
|
|
|
Net loss per common share attributable to common stockholders,
basic and diluted: |
|
|
|
|
|
|
|
|
As reported |
|
$ |
(0.12 |
) |
|
$ |
(0.62 |
) |
Adjusted |
|
$ |
(0.12 |
) |
|
$ |
(0.63 |
) |
17
General stock option information
The following table sets forth the summary of option and restricted stock unit activity for
the nine months ended December 31, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Contractual |
|
|
Aggregate |
|
|
|
|
|
|
|
Exercise |
|
|
Term |
|
|
Intrinsic Value |
|
|
|
Shares |
|
|
Price |
|
|
(in years) |
|
|
(in thousands) |
|
Options outstanding at March 31, 2006 |
|
|
2,804 |
|
|
$ |
6.54 |
|
|
|
|
|
|
|
|
|
Options granted |
|
|
1,015 |
|
|
$ |
15.25 |
|
|
|
|
|
|
|
|
|
Restricted stock units issued |
|
|
10 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
(398 |
) |
|
$ |
3.44 |
|
|
|
|
|
|
|
|
|
Options forfeited |
|
|
(211 |
) |
|
$ |
9.56 |
|
|
|
|
|
|
|
|
|
Options expired |
|
|
(6 |
) |
|
$ |
11.78 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options and restricted stock units
outstanding at December 31, 2006 |
|
|
3,214 |
|
|
$ |
9.47 |
|
|
|
8.4 |
|
|
$ |
30,822 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at December 31, 2006 |
|
|
1,165 |
|
|
$ |
5.82 |
|
|
|
7.2 |
|
|
$ |
15,448 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average per share fair value of options granted during the nine months ended
December 31, 2006 was $8.54 per share. The total intrinsic value of options exercised during the
three and nine months ended December 31, 2006 was $4.0 million and $5.2 million, respectively. The
intrinsic value as of December 31, 2006 is calculated as the difference between the market value as
of December 31, 2006 of the shares of common stock to be issued upon exercise of the stock option
and the exercise price of the options. The market value of a share of the Companys common stock as
of December 31, 2006 was $19.08 per share as reported by the National Stock Market.
The cash proceeds from the exercise of stock options were $1.1 million and $1.4 million in the
three and nine months ended December 31, 2006, respectively.
The following table sets forth the summary of the Companys nonvested shares activity for the
nine months ended December 31, 2006:
|
|
|
|
|
|
|
Shares |
|
Nonvested at March 31, 2006 |
|
|
1,646 |
|
Options granted |
|
|
1,015 |
|
Restricted stock units awarded |
|
|
10 |
|
Options vested |
|
|
(405 |
) |
Options forfeited and expired |
|
|
(217 |
) |
|
|
|
|
Nonvested at December 31, 2006 |
|
|
2,049 |
|
|
|
|
|
18
Information regarding stock option awards outstanding at December 31, 2006 is summarized
below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding |
|
Options exercisable |
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
average |
|
Weighted |
|
|
|
|
|
Weighted |
|
|
|
|
|
|
remaining |
|
average |
|
|
|
|
|
average |
Range of |
|
Number |
|
contractual life |
|
exercise |
|
Number |
|
exercise |
exercise prices |
|
outstanding |
|
(years) |
|
price |
|
exercisable |
|
price |
$ 0.68 - $ 1.15 |
|
|
405 |
|
|
|
5.3 |
|
|
$ |
0.91 |
|
|
|
371 |
|
|
$ |
0.89 |
|
$ 5.63 |
|
|
767 |
|
|
|
8.0 |
|
|
$ |
5.63 |
|
|
|
444 |
|
|
$ |
5.63 |
|
$ 6.51 - $ 9.44 |
|
|
479 |
|
|
|
9.0 |
|
|
$ |
8.64 |
|
|
|
92 |
|
|
$ |
8.45 |
|
$ 9.50 - $12.38 |
|
|
472 |
|
|
|
9.0 |
|
|
$ |
10.74 |
|
|
|
92 |
|
|
$ |
10.61 |
|
$12.48 - $13.73 |
|
|
500 |
|
|
|
8.7 |
|
|
$ |
13.10 |
|
|
|
160 |
|
|
$ |
13.10 |
|
$13.75 - $19.03 |
|
|
510 |
|
|
|
9.7 |
|
|
$ |
16.73 |
|
|
|
6 |
|
|
$ |
17.68 |
|
$19.40 - $19.94 |
|
|
71 |
|
|
|
9.9 |
|
|
$ |
19.62 |
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 0.68 - $19.94 |
|
|
3,204 |
|
|
|
8.4 |
|
|
$ |
9.47 |
|
|
|
1,165 |
|
|
$ |
5.82 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 7 Common Stock
On July 19, 2006, Micrus completed a secondary public offering in which certain stockholders
sold 1,270,211 shares of common stock at the public offering price of $11.89 per share. On July 19,
2006, the underwriters purchased 190,531 shares of common stock from the Company pursuant to the
exercise of their over-allotment option. The Company did not receive any proceeds from the sale of
common stock by the selling stockholders. The total cash proceeds from the exercise of the
over-allotment option were approximately $2.0 million, net of the underwriting discount and
offering expenses. Common stock offering expenses of $0.6 million were incurred by the Company on
behalf of the selling stockholders and were expensed to general and administrative expense in the
second quarter of fiscal 2007.
2005 Common Stock Warrants
In conjunction with the Series E preferred stock financing in February and March of 2005, the
Company issued warrants to purchase common stock of the Company (the 2005 common stock warrants).
The 2005 common stock warrants were not initially exercisable, but were to become exercisable for
an aggregate of 671,614 shares of common stock at $9.00 per share if the Company had not closed the
IPO prior to December 31, 2005, or for an adjusted number of shares (calculated based on the IPO
price) with an exercise price of $0.000225 if the IPO closed prior to December 31, 2005 at a price
less than $13.50 per share. Based on the closing of the IPO at a price of $11.00 per share in June
2005, the 2005 common stock warrants became exercisable for an aggregate of 305,272 shares of
common stock at an exercise price of $0.000225 per share.
As of December 31, 2006, all of these warrants have been exercised. Warrants covering an
aggregate of 281,013 shares of common stock were exercised without cash. In most cases the
aggregate purchase price was offset by the value of fractional shares payable upon exercise of such
warrants; however an aggregate of 2 shares were withheld in payment of the aggregate exercise price
of one warrant resulting in a net issue of 281,011 shares. Warrants covering an additional 24,259
shares of common stock were exercised for cash. There were no warrants to purchase common stock
outstanding at December 31, 2006.
19
Note 8 Segment and Geographic Information
The Companys significant operations outside the United States include two sales subsidiaries
in Europe (located in Switzerland and the United Kingdom). Revenues from unaffiliated customers by
geographic area, based on the customers shipment locations were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
December 31 |
|
|
December 31 |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
United States |
|
$ |
7,824 |
|
|
$ |
4,107 |
|
|
$ |
20,743 |
|
|
$ |
10,449 |
|
Japan |
|
|
2,420 |
|
|
|
|
|
|
|
7,479 |
|
|
|
|
|
United Kingdom |
|
|
1,508 |
|
|
|
1,307 |
|
|
|
4,464 |
|
|
|
2,625 |
|
Rest of the world |
|
|
3,792 |
|
|
|
2,678 |
|
|
|
10,068 |
|
|
|
8,260 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
15,544 |
|
|
$ |
8,092 |
|
|
$ |
42,754 |
|
|
$ |
21,334 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company identifies its operating segments based on how management views and evaluates
the Companys operations, which is primarily based on geographic location. For all periods
presented, the Company operated in the following three business segments: the Americas, Europe and
Asia Pacific. The products sold by each segment are substantially the same and the Company
evaluates performance and allocates resources primarily based on revenues and gross profit.
Revenues and gross profit for these segments were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
December 31 |
|
|
December 31 |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Americas |
|
$ |
8,457 |
|
|
$ |
4,644 |
|
|
$ |
22,554 |
|
|
$ |
12,021 |
|
Europe |
|
|
4,423 |
|
|
|
3,291 |
|
|
|
12,115 |
|
|
|
8,836 |
|
Asia Pacific |
|
|
2,664 |
|
|
|
157 |
|
|
|
8,085 |
|
|
|
477 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
15,544 |
|
|
$ |
8,092 |
|
|
$ |
42,754 |
|
|
$ |
21,334 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Americas |
|
$ |
6,596 |
|
|
$ |
3,419 |
|
|
$ |
18,211 |
|
|
$ |
9,178 |
|
Europe |
|
|
3,089 |
|
|
|
2,182 |
|
|
|
8,085 |
|
|
|
5,672 |
|
Asia Pacific |
|
|
1,667 |
|
|
|
75 |
|
|
|
5,110 |
|
|
|
220 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
11,352 |
|
|
$ |
5,676 |
|
|
$ |
31,406 |
|
|
$ |
15,070 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The gross profit amounts by geographic segments for the three and nine months ended
December 31, 2005 have been revised from that previously reported to correct a misallocation among
the three segments as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
December 31, 2005 |
|
|
December 31, 2005 |
|
|
|
|
|
|
|
As previously |
|
|
|
|
|
|
As previously |
|
|
|
As revised |
|
|
reported |
|
|
As revised |
|
|
reported |
|
Gross Profit: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Americas |
|
$ |
3,419 |
|
|
$ |
3,826 |
|
|
$ |
9,178 |
|
|
$ |
10,739 |
|
Europe |
|
|
2,182 |
|
|
|
1,850 |
|
|
|
5,672 |
|
|
|
4,331 |
|
Asia Pacific |
|
|
75 |
|
|
|
|
|
|
|
220 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
5,676 |
|
|
$ |
5,676 |
|
|
$ |
15,070 |
|
|
$ |
15,070 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The above revisions had no impact on the consolidated results of operations, cash flows,
or the financial position of the Company.
20
The Companys long lived assets by segment were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
|
|
2006 |
|
|
2006 |
|
Americas |
|
$ |
11,206 |
|
|
$ |
4,147 |
|
Europe |
|
|
6,557 |
|
|
|
7,067 |
|
Asia Pacific |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
17,763 |
|
|
$ |
11,214 |
|
|
|
|
|
|
|
|
Item 2. Managements Discussion and Analysis of Financial Conditions and Results of Operations.
The following discussion and analysis of the financial condition and results of operations of
the Company should be read in conjunction with the condensed consolidated financial statements and
the related notes included elsewhere in this report, and with other factors described from time to
time in our other filings with the Securities and Exchange Commission. This Quarterly Report on
Form 10-Q contains forward-looking statements that involve risks and uncertainties. Actual results
and the timing of events may differ materially from those contained in the forward-looking
statements due to a number of factors, including those discussed in Part II, Item 1A Risk Factors
in this Quarterly Report on Form 10-Q.
Overview
We develop, manufacture and market both implantable and disposable medical devices used in the
treatment of cerebral vascular diseases. We also are developing products for the treatment of
ischemic disease and have recently launched our first product in this market. Our products are used
by interventional neuroradiologists and neurosurgeons to treat cerebral aneurysms responsible for
hemorrhagic stroke. Both hemorrhagic and ischemic stroke are significant causes of death worldwide.
Our product lines consist of endovascular systems that enable a physician to gain access to the
brain in a minimally invasive manner through the vessels of the arterial system. We believe our
products provide a safe and reliable alternative to more invasive neurosurgical procedures for
treating aneurysms. Our proprietary three-dimensional, embolic coils are unique in that they
automatically and rapidly deploy within an aneurysm, forming a scaffold that conforms to a wide
diversity of aneurysm shapes and sizes. We also supply access devices and products including
microcatheters and guidewires used to deliver microcoils and stents for the treatment of cerebral
vascular disease. We plan on growing our business by continuing to penetrate our existing markets,
bringing new products and technologies to interventional neuroradiologists and neurosurgeons, and
by entering new geographic territories such as Asia where we introduced our products in Japan
through a distributor. We commenced selling our products in Japan in March 2006.
Our revenues are derived primarily from sales of our microcoils. We also sell access devices,
which currently do not account for a significant portion of our revenues. Geographically, our
revenues are generally from sales to customers in the Americas, Europe and Asia. Our products are
shipped from our facilities in the United States, Switzerland, United Kingdom, and a logistics
facility in the Netherlands, to either hospitals or distributors. We invoice our customers upon
shipment. In select hospitals, our products are held on consignment, and remain on site, free of
charge until used.
We anticipate that our cost of goods sold will generally increase in absolute dollars during
those quarters in which our sales increase or we incur additional manufacturing costs in
anticipation of the commercial introduction of new products. Furthermore, our gross margin
percentage may decrease in those quarters in which we initiate sales of new products or product
lines, or enter new geographic territories.
Our product development efforts are primarily focused on expanding our current line of
microcoils and broadening our product offerings. In August 2004, we introduced our Cerecyte
microcoil product line and since June 2005 we have launched seven new products, including
microcoils, stents, microcatheters and guidewires. We intend to continue this product line
expansion with the goal of continuing to increase our per-procedure revenue.
We also intend to continue to expand our direct sales force in the United States and Europe as
necessary and enter the Asian markets through distributors. In March 2006, we launched our sales
and marketing efforts in Japan through our distribution partner,
Goodman. We recorded product sales of $2.2 million to Goodman in March 2006 and $7.5 million
in the first nine months of fiscal 2007.
21
We currently anticipate that the broadening of our product line, the worldwide expansion of
our direct sales force and our entry into the Asian market will be primarily funded with our
currently available cash.
We introduced our first proprietary, three-dimensional microcoil in May 2000. Our revenues
have grown from $1.8 million in fiscal 2001 to $32.8 million in fiscal 2006. Our revenues were
$42.8 million in the first nine months of fiscal 2007.
Since inception, we have been unprofitable. We incurred net losses of $2.0 million in fiscal
2004, $6.7 million in fiscal 2005, $8.3 million in fiscal 2006 and $4.1 million in the first nine
months of fiscal 2007. As of December 31, 2006, we had cash and marketable securities of $33.6
million. We believe that our current cash position and the cash expected to be generated from
product sales will be sufficient to meet our working capital and capital expenditure requirements
for at least the next twelve months. We expect to incur net losses for the foreseeable future as we
expand our manufacturing and sales activities and expand geographically. As of December 31, 2006,
we had an accumulated deficit of $53.7 million.
Recent Developments
On April 1, 2006, we adopted the provisions of Statement of Financial Accounting Standards No.
123 revised 2004 (SFAS 123R). Under the fair value recognition provisions of this Statement,
stock-based compensation cost is measured at the grant date based on the fair value of the award
and is recognized as expense on a straight-line basis over the requisite service period, which is
generally the vesting period. We transitioned to SFAS 123R using the modified-prospective method,
under which prior periods are not revised for comparative purposes. The valuation provisions of
SFAS 123R apply to new grants and to grants that were outstanding prior to the effective date and
are subsequently modified. Estimated compensation for grants that were outstanding as of the
effective date will be recognized over the remaining service period using the compensation cost
estimated for the SFAS 123 pro forma disclosures, excluding pre-IPO options for which the fair
value was determined using the minimum value method. For these grants, any remaining unamortized
deferred compensation expenses will continue to be accounted for under the intrinsic value method
of APB 25.
The adoption of SFAS 123R had and will have a material impact on our consolidated financial
position and results of operations. See Note 6 to the condensed consolidated financial statements
for further discussion regarding the SFAS 123R disclosures.
On November 30, 2006, we completed the acquisition of VasCon, LLC (VasCon), a privately held
company engaged in the development and manufacture of vascular access and delivery devices. The acquisition of VasCon is intended to add expertise in developing clinically advanced access and catheter systems to our core competencies and provide us with manufacturing capabilities that are expected to lead to significant cost reductions for a wide range of our products. Micrus
Design Technology Inc., a newly formed subsidiary, will develop and manufacture neurovascular
access and delivery products for us, including our steerable catheter. VasCons existing cardio and
peripheral vascular products will continue to be sold through non-Micrus distribution channels.
The acquisition consideration consisted of an up-front payment and additional contingent
earn-out payments as described below. The up-front payment consisted of the payment of
approximately $2.5 million in cash, the issuance of 156,666 shares of our common stock having an
aggregate value of approximately $3.0 million, and $329,000 in acquisition-related closing costs.
The final purchase price is subject to certain post-closing working capital adjustments.
Additionally, VasCon may receive certain earn-out payments in an amount not to exceed $10 million
based on sales and manufacturing performance as set forth in the asset purchase agreement entered
into by the parties. The common stock portion of the up-front payment was placed in escrow to
satisfy certain indemnification obligations of VasCon and its members as described in the asset
purchase agreement.
On July 19, 2006 we completed a secondary public offering in which certain stockholders sold
1,270,211 shares of common stock at the public offering price of $11.89 per share. On July 19,
2006, the underwriters purchased 190,531 shares of common stock from us pursuant to the exercise of
their over-allotment option. We did not receive any proceeds from the sale of common stock by the
selling stockholders. The total cash proceeds from the exercise of the over-allotment option were
approximately $2.0 million, net of the underwriting discount and offering expenses. Common stock
offering expenses of $0.6 million were incurred by us on behalf of the selling stockholders and
were expensed to general and administrative expense in the second quarter of fiscal 2007.
22
Results of Operations
The following table sets forth the results of our operations, expressed as percentages of
revenues, for the three and nine months ended December 31, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
December 31, |
|
December 31, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
|
|
% |
|
|
|
% |
|
|
|
% |
|
|
|
% |
|
Consolidated Statement of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
Cost of goods sold |
|
|
27 |
% |
|
|
30 |
% |
|
|
27 |
% |
|
|
29 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
73 |
% |
|
|
70 |
% |
|
|
73 |
% |
|
|
71 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
11 |
% |
|
|
10 |
% |
|
|
14 |
% |
|
|
19 |
% |
Sales and marketing |
|
|
39 |
% |
|
|
50 |
% |
|
|
40 |
% |
|
|
46 |
% |
General and administrative |
|
|
34 |
% |
|
|
33 |
% |
|
|
33 |
% |
|
|
33 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
84 |
% |
|
|
93 |
% |
|
|
87 |
% |
|
|
98 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(11 |
%) |
|
|
(23 |
%) |
|
|
(14 |
%) |
|
|
(27 |
%) |
Interest and investment income |
|
|
3 |
% |
|
|
5 |
% |
|
|
3 |
% |
|
|
4 |
% |
Interest expense |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
Other income (expense), net |
|
|
2 |
% |
|
|
(2 |
%) |
|
|
1 |
% |
|
|
(3 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(6 |
%) |
|
|
(20 |
%) |
|
|
(10 |
%) |
|
|
(26 |
%) |
Income tax provision (benefit) |
|
|
0 |
% |
|
|
1 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(6 |
%) |
|
|
(21 |
%) |
|
|
(10 |
%) |
|
|
(26 |
%) |
Accretion of redeemable convertible preferred stock to
redemption value including beneficial conversion
feature
|
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
(3 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders |
|
|
(6 |
%) |
|
|
(21 |
%) |
|
|
(10 |
%) |
|
|
(29 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, 2006 and 2005
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
December 31, |
|
|
Change |
|
(Dollars in thousands) |
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
Americas |
|
$ |
8,457 |
|
|
$ |
4,644 |
|
|
$ |
3,813 |
|
|
|
82 |
% |
Europe |
|
|
4,423 |
|
|
|
3,291 |
|
|
|
1,132 |
|
|
|
34 |
% |
Asia Pacific |
|
|
2,664 |
|
|
|
157 |
|
|
|
2,507 |
|
|
|
1597 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Revenues |
|
$ |
15,544 |
|
|
$ |
8,092 |
|
|
$ |
7,452 |
|
|
|
92 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our revenues are derived primarily from sales of our microcoils and to a lesser extent
sales of accessory devices used in the treatment of cerebral vascular diseases. The increase in
total revenues in the third quarter of fiscal 2007 compared to the third quarter of fiscal 2006 was
primarily due to an increase in the number of microcoil products sold during this period. Factors
driving the increase included growth in the overall market for embolic coils, an increase in our
share of both the domestic and foreign markets in which we participate, expansion of our direct and
distributor sales force and the introduction of new products. Additionally, the increase in
revenues was partially due to higher average selling prices as a result of increased Cerecyte
product sales in the third quarter of fiscal 2007 as a percentage of our overall product sales. The
increase in revenues from Asia Pacific in the third quarter of
23
fiscal 2007 compared to the third quarter of fiscal 2006 was primarily due to product sales of $2.4
million during the quarter to our distributor in Japan. In February 2006, we received regulatory
clearance to sell our products in Japan through our distributor, and the sale of our products in
Japan commenced in March 2006.
Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
December 31, |
|
Change |
(Dollars in thousands) |
|
2006 |
|
2005 |
|
$ |
|
% |
Cost of goods sold |
|
$ |
4,192 |
|
|
$ |
2,416 |
|
|
$ |
1,776 |
|
|
|
74 |
% |
Gross profit |
|
|
11,352 |
|
|
|
5,676 |
|
|
|
5,676 |
|
|
|
100 |
% |
Cost of goods sold consists primarily of materials, direct labor, depreciation, overhead
costs associated with manufacturing, impairments of inventory and warranty expenses. Also, for the
three months ended December 31, 2006, cost of goods sold includes amortization of intangible assets
that were acquired by us as part of the acquisition of VasCon. The increase in cost of goods sold
during the third quarter of fiscal 2007 as compared to the third quarter of fiscal 2006 was
primarily due to an increase in personnel and manufacturing costs associated with increased sales
of our products as well as increased costs attributable to a general increase in salaries, benefits
and overhead costs resulting from increased production (partially offset by increased manufacturing
efficiencies) and the amortization of intangibles acquired from the acquisition of VasCon.
Gross margin was 73% in the third quarter of fiscal 2007 and 70% in the third quarter of
fiscal 2006. The increase was primarily due to an increase in revenue from sales of higher margin
products and manufacturing efficiencies, partially offset by higher levels of distributor sales of
lower margin products primarily due to our entry into the Japanese market in the fourth quarter of
fiscal 2006. We expect our gross margin to fluctuate in future periods based on the mix of our
product sales.
Operating Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
December 31, |
|
Change |
(Dollars in thousands) |
|
2006 |
|
2005 |
|
$ |
|
% |
Research and development |
|
$ |
1,769 |
|
|
$ |
834 |
|
|
$ |
935 |
|
|
|
112 |
% |
Research and development expenses consist primarily of costs associated with the design,
development, and testing of products. Such costs are expensed as they are incurred and include
salaries and related personnel costs, fees paid to outside consultants, and other direct and
indirect costs related to research and product development. Research and development expenses
increased in the third quarter of fiscal 2007 compared to the third quarter of fiscal 2006
primarily due to an increase of $247,000 related to increased headcount and an increase of $443,000
in outside services related to new product development. As a percentage of revenues, research and
development expenses were 11% in the third quarter of fiscal 2007 and 10% in the third quarter of
fiscal 2006. We expect our research and development expenses to increase in absolute dollars in
future periods as we hire additional development personnel, continue work on product developments,
and expand our existing product line.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
December 31, |
|
Change |
(Dollars in thousands) |
|
2006 |
|
2005 |
|
$ |
|
% |
Sales and marketing |
|
$ |
5,992 |
|
|
$ |
4,049 |
|
|
$ |
1,943 |
|
|
|
48 |
% |
Sales and marketing expenses consist primarily of compensation costs of our direct sales force
and marketing personnel, as well as overhead costs related to these activities. Also included are
costs associated with promotional literature and videos, trade show participation, and education
and training of physicians. Sales and marketing expenses increased in the third quarter of fiscal
2007 compared to the third quarter of fiscal 2006 primarily due to an increase of $537,000
associated with additional sales and marketing personnel in the United States and Europe, higher
sales incentive and commission costs of $455,000 associated with increased sales in the United
States and Europe, an increase of $234,000 related to outsourced consulting expenses incurred
primarily due to product
24
marketing, an increase of $216,000 in travel expenses, an increase of $188,000 in stock-based
compensation expense due primarily to the impact of the adoption of SFAS 123R, and an increase of
$163,000 in market research associated with the randomized trial of our cerecyte product. As a
percentage of revenues, sales and marketing expenses decreased to 39% in the third quarter of
fiscal 2007 from 50% in the third quarter of fiscal 2006. The decrease was due to a faster growth
rate of revenue compared to the growth rate of sales and marketing expenses. We anticipate that
sales and marketing expenses will increase in absolute dollars in future periods as we continue to
increase the size of our direct sales force and clinical support group, increase spending on
additional sales and marketing programs and expand into additional geographic territories.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
December 31, |
|
Change |
(Dollars in thousands) |
|
2006 |
|
2005 |
|
$ |
|
% |
General and administrative |
|
$ |
5,273 |
|
|
$ |
2,638 |
|
|
$ |
2,635 |
|
|
|
100 |
% |
General and administrative expenses consist primarily of compensation and related costs
for finance, human resources, facilities, information technology, insurance, and professional
services. Professional services are principally comprised of outside legal, audit and information
technology consulting. General and administrative expenses increased in the third quarter of fiscal
2007 compared to the third quarter of fiscal 2006 primarily due to an increase of $0.9 million in
legal fees incurred primarily in connection with the patent litigation with Boston Scientific, an
increase of $0.7 million related to higher finance and administrative personnel costs due to
increased headcount, an increase of $368,000 in stock-based compensation expense due primarily to
the impact of the adoption of SFAS 123R, and an increase of $304,000 in consulting fees due to
compliance with Sarbanes-Oxley regulations. As a percentage of revenues, general and administrative
expenses were 34% in the third quarter of fiscal 2007 and 33% in the third quarter of fiscal 2006.
As we incur additional expenses associated with being a public company and to the extent our
business expands, we expect that general and administrative expenses will increase in absolute
dollars in future periods.
Other Income, Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
December 31, |
|
|
Change |
|
(Dollars in thousands) |
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
Interest and investment income |
|
$ |
426 |
|
|
$ |
389 |
|
|
$ |
37 |
|
|
|
10 |
% |
Interest expense |
|
|
(5 |
) |
|
|
(2 |
) |
|
|
(3 |
) |
|
|
150 |
% |
Other income (expense), net |
|
|
221 |
|
|
|
(132 |
) |
|
|
353 |
|
|
|
-267 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense), net |
|
$ |
642 |
|
|
$ |
255 |
|
|
$ |
387 |
|
|
|
152 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net consists primarily of investment income, interest expense, and foreign
currency gains and losses. Total other income, net increased in the third quarter of fiscal 2007
compared to the third quarter of fiscal 2006 primarily due to foreign exchange gains resulting from
differences in exchange rates
between the time of the recording of the transaction and settlement of foreign currency
denominated receivables and payables.
Income Taxes
We have incurred net operating losses for both federal and state purposes since inception and,
as a result, we have paid no federal or state income taxes. In the third quarter of fiscal 2007, we
recorded a noncurrent tax benefit of approximately $38,000 for the tax effect of the current
quarter amortization related to the intangible assets acquired in the Neurologic transaction which
is not deductible. As of March 31, 2006, we had federal, state and foreign net operating loss
carryforwards (NOLs) that are available to reduce future taxable income of approximately $27.8
million, $20.1 million and $2.1 million, respectively. The federal NOLs will expire at various
dates beginning in 2012, state NOLs will expire beginning in 2007 and the foreign NOLs will expire
beginning in 2009. As of March 31, 2006 we also had federal and state tax research and development
credit carryforwards of approximately $0.9 million and $0.8 million, respectively. The federal tax
credit carryforwards will expire beginning in 2012. The state tax credit carryforwards do not
expire. Due to the uncertainty of our ability to generate sufficient taxable income to realize the
carryforwards prior to their expiration, we have established a valuation allowance at December 31,
2006 to fully offset the deferred tax assets.
25
Nine Months Ended December 31, 2006 and 2005
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
December 31, |
|
|
Change |
|
(Dollars in thousands) |
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
Americas |
|
$ |
22,554 |
|
|
$ |
12,021 |
|
|
$ |
10,533 |
|
|
|
88 |
% |
Europe |
|
|
12,115 |
|
|
|
8,836 |
|
|
|
3,279 |
|
|
|
37 |
% |
Asia Pacific |
|
|
8,085 |
|
|
|
477 |
|
|
|
7,608 |
|
|
|
1595 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Revenues |
|
$ |
42,754 |
|
|
$ |
21,334 |
|
|
$ |
21,420 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in total revenues during the first nine months of fiscal 2007 compared to
the first nine months of fiscal 2006 was primarily due to an increase in the number of microcoil
products sold during this period. Factors driving the increase included growth in the overall
market for embolic coils, an increase in our share of both the domestic and foreign markets in
which we participate, expansion of our direct and distributor sales force and the introduction of
new products. Additionally, the increase in revenues was partially due to higher average selling
prices as a result of increased Cerecyte product sales in the first nine months of fiscal 2007. The
increase in revenues from Asia Pacific during the first nine months of fiscal 2007 compared to the
first nine months of fiscal 2006 was primarily due to product sales of $7.5 million during the
first nine months of fiscal 2007 to our distributor in Japan. In February 2006, we received
regulatory clearance to sell our products in Japan through our distributor, and the sale of our
products in Japan commenced in March 2006.
Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
|
December 31, |
|
Change |
(Dollars in thousands) |
|
2006 |
|
2005 |
|
$ |
|
% |
Cost of goods sold |
|
$ |
11,348 |
|
|
$ |
6,264 |
|
|
$ |
5,084 |
|
|
|
81 |
% |
Gross profit |
|
|
31,406 |
|
|
|
15,070 |
|
|
|
16,336 |
|
|
|
108 |
% |
The increase in cost of goods sold during the first nine months of fiscal 2007 as
compared to the first nine months of fiscal 2006 was primarily due to an increase in personnel and
manufacturing costs associated with increased sales of our products as well as increased costs
attributable to a general increase in salaries, benefits and overhead costs resulting from
increased production, partially offset by increased manufacturing efficiencies.
Gross margin was 73% in the first nine months of fiscal 2007 and 71% in the first nine months
of fiscal 2006. Also, for the three months ended December 31, 2006, cost of goods sold includes
amortization of intangible assets that were acquired by us as part of the acquisition of VasCon.
The increase was primarily due to an increase in revenue from sales of higher margin products and
manufacturing efficiencies, partially offset by higher levels of distributor sales of lower margin
products primarily due to our entry into the Japanese market in the fourth quarter of fiscal 2006,
and the amortization of intangibles acquired from the acquisition of VasCon.
26
Operating Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
|
December 31, |
|
Change |
(Dollars in thousands) |
|
2006 |
|
2005 |
|
$ |
|
% |
Research and development |
|
$ |
6,025 |
|
|
$ |
4,072 |
|
|
$ |
1,953 |
|
|
|
48 |
% |
Research and development expenses increased in the first nine months of fiscal 2007
compared to the first nine months of fiscal 2006 due to an increase of $1.1 million related to
outside services associated with new product development, and an increase of $0.6 million related
to increased headcount. As a percentage of revenues, research and development expenses were 14% in
the first nine months of fiscal 2007 and 19% in the first nine months of fiscal 2006. The decrease
was due to a faster growth rate of revenue compared to the growth rate of research and development
expenses.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
|
December 31, |
|
Change |
(Dollars in thousands) |
|
2006 |
|
2005 |
|
$ |
|
% |
Sales and marketing |
|
$ |
17,199 |
|
|
$ |
9,767 |
|
|
$ |
7,432 |
|
|
|
76 |
% |
Sales and marketing expenses increased in the first nine months of fiscal 2007 compared
to the first nine months of fiscal 2006 due to an increase $2.3 million associated with additional
sales and marketing personnel in the United States and Europe, higher sales incentive and
commissions costs of $1.9 million associated with increased sales, higher travel expenses of $0.7
million, an increase of $0.7 million related to outsourced consulting expenses incurred primarily
due to product marketing, an increase of $0.6 million in stock-based compensation expense due
primarily to the impact of the adoption of SFAS 123R, and an increase of $395,000 related to
graphic design, promotional and printing costs. As a percentage of revenues, sales and marketing
expenses were 40% in the first nine months of fiscal 2007 and 46% in the first nine months of
fiscal 2006. The decrease was due to a faster growth rate of revenue compared to the growth rate of
sales and marketing expenses.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
|
December 31, |
|
Change |
(Dollars in thousands) |
|
2006 |
|
2005 |
|
$ |
|
% |
General and administrative |
|
$ |
14,166 |
|
|
$ |
7,098 |
|
|
$ |
7,068 |
|
|
|
100 |
% |
General and administrative expenses increased in the first nine months of fiscal 2007
compared to the first nine months of fiscal 2006 due to an increase of $2.2 million in legal fees
incurred primarily in connection with the patent litigation with Boston Scientific, an increase of
$1.5 million related to higher finance and administrative personnel costs due to increased
headcount, common stock offering expenses of $0.6 million we incurred on behalf of the selling
stockholders in connection with our secondary offering, an increase of $388,000 primarily related
to the amortization of identifiable intangible assets in connection with the purchase of
Neurologic, an increase of $0.6 million in consulting fees due to compliance with Sarbanes-Oxley
regulations, an increase of $0.6 million in stock-based compensation expense due primarily to the
impact of the adoption of SFAS 123R, an increase of $0.6 million in outside services primarily
related to compensation analysis and benchmarking, printer costs associated with our SEC filings,
and regulatory filings associated with our microcoils and microcatheters, and an increase in audit
fees of $159,000 related primarily to the year end audit, compliance with Sarbanes-Oxley
regulations and the adoption of SFAS 123R partially offset by a decrease of $100,000 primarily
related to management bonuses in connection with our IPO incurred in the first quarter of fiscal
2006. As a percentage of revenues, general and administrative expenses were 33% in the first nine
months of fiscal 2007 and 33% in the first nine months of fiscal 2006. As we incur additional
expenses associated with being a public company and to the extent our business expands, we expect
that general and administrative expenses will increase in absolute dollars in future periods.
27
Other Income, Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
December 31, |
|
|
Change |
|
(Dollars in thousands) |
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
Interest and investment income |
|
$ |
1,211 |
|
|
$ |
900 |
|
|
$ |
311 |
|
|
|
35 |
% |
Interest expense |
|
|
(5 |
) |
|
|
(11 |
) |
|
|
6 |
|
|
|
-55 |
% |
Other income (expense), net |
|
|
554 |
|
|
|
(681 |
) |
|
|
1,235 |
|
|
|
-181 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense), net |
|
$ |
1,760 |
|
|
$ |
208 |
|
|
$ |
1,552 |
|
|
|
746 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income, net increased in the first nine months of fiscal 2007 compared to the same
period in fiscal 2006 primarily due to foreign exchange gains resulting from differences in
exchange rates between the time of the recording of the transaction and settlement of foreign
currency denominated receivables and payables, and an increase in interest and investment income as
a result of higher interest rates and higher average cash and investment balances due primarily
from proceeds from our IPO and secondary offering. During the first quarter of fiscal 2006, a
non-operating charge of $158,000 was recorded upon the completion of the IPO for the change in fair
value of the 2005 common stock warrants.
Income Taxes
We have incurred net operating losses for both federal and state purposes since inception and,
as a result, we have paid no federal or state income taxes. In the first nine months of fiscal
2007, we recorded a noncurrent tax benefit of approximately $112,000 for the tax effect of the
current quarter amortization related to the intangible assets acquired in the Neurologic
transaction which is not deductible.
Accretion of Redeemable Convertible Preferred Stock to Redemption Value
Our convertible preferred stock that was outstanding prior to the closing of our initial
public offering in June 2005 was redeemable at the request of the holder on or after the sixth
anniversary of the original issuance date based upon certain circumstances. This right expired upon
the automatic conversion of all of our preferred stock into common stock upon the closing of the
IPO. Prior to the closing of the IPO, we were accreting the carrying value of the preferred stock
to the mandatory redemption amount on the sixth anniversary using the effective interest method
through periodic charges to additional paid-in capital. We recorded a non-cash charge of $276,000
for the accretion on our redeemable convertible preferred stock in the first six months of fiscal
2006.
Beneficial Conversion Feature
The difference between the proceeds allocated to the Series E preferred stock and the
estimated fair value of the common stock issuable upon conversion resulted in a beneficial
conversion feature on the Series E preferred stock which was recorded as a reduction to the Series
E preferred stock and an increase to additional paid-in-capital. The total beneficial conversion
feature was $383,000 which, prior to the completion of the IPO, was being amortized as a reduction
of net income available to common stockholders over the period of redemption of the Series E
preferred stock. Upon completion of the IPO, we recorded a non-cash charge of $383,000 for the
beneficial conversion feature on our Series E preferred stock in the first nine months of fiscal
2006.
28
Liquidity and Capital Resources
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
December 31, |
|
|
2006 |
|
2005 |
Cash flow activities: |
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
$ |
(2,070 |
) |
|
$ |
(5,172 |
) |
Net cash used in investing activities |
|
$ |
(3,549 |
) |
|
$ |
(6,597 |
) |
Net cash provided by financing activities |
|
$ |
3,789 |
|
|
$ |
35,200 |
|
Since our inception, we have funded our operations primarily through issuances of stock and
related warrants. From November 1996 to March 2005, issuances of convertible preferred stock and
related warrants provided us with aggregate proceeds of $59.9 million, net of issuance costs. On
June 21, 2005, we completed an IPO in which we sold 3,250,000 shares of our common stock at $11.00
per share for net cash proceeds to us of approximately $33.2 million, net of underwriting discounts
and commissions. On July 6, 2005, we sold an additional 250,000 shares of common stock at $11.00
per share pursuant to the over-allotment option granted to the underwriters. Together with the
over-allotment shares sold by us, cash proceeds to us in the offering were approximately $33.0
million, net of underwriting discounts and offering expenses. On July 19, 2006 we completed a
secondary public offering in which certain stockholders sold 1,270,211 shares of common stock at
the public offering price of $11.89 per share. On July 19, 2006, the underwriters purchased 190,531
shares of common stock from us pursuant their over-allotment option. We did not receive any
proceeds from the sale of common stock by the selling stockholders. The total cash proceeds from
the over-allotment were approximately $2.0 million, net of the underwriting discount and offering
expenses. Common stock offering expenses of $0.6 million were incurred by us on behalf of the
selling stockholders and were expensed to general and administrative expense in the second quarter
of fiscal 2007.
As of December 31, 2006, we had cash and marketable securities of $33.6 million, compared to
$37.1 million at March 31, 2006. We believe that our current cash position and the cash expected to
be generated from product sales will be sufficient to meet our working capital and capital
expenditure requirements for at least the next twelve months.
Net cash used in operating activities was $2.1 million during the first nine months of fiscal
2007, compared to $5.2 million during the first nine months of fiscal 2006. Net cash used in
operating activities during the first nine months of fiscal 2007 resulted primarily from operating
losses, an increase in accounts receivable due to an increase in number of microcoil products sold,
an increase in inventory primarily due to an increase in the number of consignment locations, an
increase in prepaid expenses and other current assets primarily related to the payment of directors
and officers insurance premiums, and a decrease in accounts payable due to timing of payments made
to our vendors. These factors were partially offset by an increase in accrued payroll and related
expenses attributable to increased headcount and the timing of payroll payments, an increase in
accrued liabilities due to higher accrued professional fees associated with legal fees and SOX
compliance and higher VAT payables, and noncash items such as stock-based compensation expense
primarily due to the adoption of SFAS 123R, depreciation and amortization, and provision for
impairment of inventory. Net cash used in operating activities during the first nine months of
fiscal 2006 resulted primarily from operating losses, and increases in accounts receivable due to
an increase in the number of microcoil products sold, and an increase in prepaid expenses and other
assets primarily related to the payment of directors and officers insurance premiums, a decrease in
accounts payable primarily related to (i) payment of a monetary penalty to the Department of
Justice; (ii) payments of audit fees in connection with our preparation for the IPO; (iii) payments
of legal costs related to FCPA compliance and patent litigation matters; and (iv) payments of
international tax restructuring and planning fees, partially offset by an increase in other accrued
liabilities primarily related to the upfront payment in connection with the Japan distribution
agreement, an increase in accrual payroll and related expenses primarily related to higher accrued
bonuses and commissions and noncash items such as depreciation and amortization, charges related to
certain stock warrants and stock-based compensation.
Net cash used in investing activities was $3.5 million during the first nine months of fiscal
2007, compared to $6.6 million during the first nine months of fiscal 2006. Net cash used in
investing activities during the first nine months of fiscal 2007 was primarily related to the
acquisition of VasCon, the milestone payment to Biotronik which has been capitalized as licensed
technology and the
purchase of capital equipment offset by proceeds from sale of marketable securities. Net cash
used in investing activities during the first nine months of fiscal 2006 was primarily related to
the acquisition of Neurologic and the purchase of capital equipment.
29
Net cash provided by financing activities was $3.8 million during the first nine months of
fiscal 2007, compared to $35.2 million during the first nine months of fiscal 2006. Net cash
provided by financing activities during the first nine months of fiscal 2007 consisted of net
proceeds of $2.0 million from the exercise of the over-allotment option by the underwriters in
connection with our secondary offering, and proceeds of $1.7 million from the exercise of stock
options and purchase common stock under an employee stock purchase plan. Net cash provided by
financing activities was $35.2 million during the first nine months of fiscal 2006, primarily
consisting of net proceeds of $33.2 million from the sale of common stock in our IPO, partially
offset by the expenditure of $1.9 million incurred in preparation for the IPO, net proceeds of $2.6
million from the over-allotment option exercise by the underwriters, proceeds of $1.0 million from
the exercise of preferred and common stock warrants, and proceeds from the exercise of stock
options and purchase common stock under an employee stock purchase plan, partially offset by
payments related to issuance costs for issuance of convertible preferred stock and related
warrants.
To the extent that existing cash and marketable securities and cash from operations are
insufficient to fund our future activities, we may need to raise additional funds through public or
private equity or debt financing. Although we are currently not a party to any definitive agreement
with respect to potential investments in, or acquisitions of, complementary businesses, services or
technologies, we may enter into such agreements in the future, which could require us to seek
additional funds through public or private equity or debt financing. Additional funds may not be
available on terms favorable to us or at all.
Critical Accounting Policies and Estimates
We prepare our consolidated financial statements in accordance with accounting principles
generally accepted in the United States (GAAP). In doing so, we have to make estimates and
assumptions that affect our reported amounts of assets, liabilities, revenues and expenses, as well
as related disclosure of contingent assets and liabilities. In many cases, we could reasonably have
used different accounting policies and estimates. In some cases, changes in the accounting
estimates are reasonably likely to occur from period to period. Accordingly, actual results could
differ materially from our estimates. To the extent that there are material differences between
these estimates and actual results, our financial condition or results of operations will be
affected. We base our estimates on past experience and other assumptions that we believe are
reasonable under the circumstances, and we evaluate these estimates on an ongoing basis. We refer
to accounting estimates of this type as critical accounting policies and estimates, which we
discuss below. Our management has reviewed our critical accounting policies and estimates with our
accounting advisors, audit committee and board of directors.
Our significant accounting policies are fully described in Note 2 to our Consolidated
Financial Statements included in our annual report filed on Form 10-K for the fiscal year ended
March 31, 2006, that was filed with the SEC on June 16, 2006 except for a description of our
stock-based compensation critical accounting policy, set forth below, which was implemented upon
our adoption of SFAS 123R on April 1, 2006, the beginning of our 2007 fiscal year.
Stock-based Compensation
We adopted the provisions of, and account for stock-based compensation in accordance with,
SFAS 123R on April 1, 2006. We elected the modified-prospective method, under which prior periods
are not revised for comparative purposes. Under the fair value recognition provisions of this
statement, stock-based compensation cost is measured at the grant date based on the fair value of
the award and is recognized as expense on a straight-line basis over the requisite service period,
which is the vesting period.
We currently use the Black-Scholes option pricing model to determine the fair value of stock
options and employee stock purchase plan shares. The determination of the fair value of stock-based
payment awards on the date of grant using an option-pricing model is affected by our stock price as
well as assumptions regarding a number of complex and subjective variables. These variables include
our expected stock price volatility over the term of the awards, actual and projected employee
stock option exercise behaviors, risk-free interest rate and expected dividends.
Because there is insufficient historical information available to estimate the expected term
of the stock-based awards, we adopted the simplified method for estimating the expected term
pursuant to SAB 107. On this basis, we estimated the expected term of options
granted by taking the average of the vesting term and the contractual term of the option. The
expected volatility used in the valuation model is based our peer group in the industry in which we
do business and our historical volatility since our IPO.
30
If factors change and we employ different assumptions for estimating stock-based compensation
expense in future periods or if we decide to use a different valuation model, the future periods
may differ significantly from what we have recorded in the current period and could materially
affect our operating income, net income and net income per share.
The Black-Scholes option-pricing model was developed for use in estimating the fair value of
traded options that have no vesting restrictions and are fully transferable, characteristics not
present in our option grants and employee stock purchase plan shares. Existing valuation models,
including the Black-Scholes and lattice binomial models, may not provide reliable measures of the
fair values of our stock-based compensation. Consequently, there is a risk that our estimates of
the fair values of our stock-based compensation awards on the grant dates may bear little
resemblance to the actual values realized upon the exercise, expiration, early termination or
forfeiture of those stock-based payments in the future. Certain stock-based payments, such as
employee stock options, may expire worthless or otherwise result in zero intrinsic value as
compared to the fair values originally estimated on the grant date and reported in our financial
statements. Alternatively, value may be realized from these instruments that are significantly
higher than the fair values originally estimated on the grant date and reported in our financial
statements. There currently is no market-based mechanism or other practical application to verify
the reliability and accuracy of the estimates stemming from these valuation models, nor is there a
means to compare and adjust the estimates to actual values.
The guidance in SFAS 123R and SAB 107 is relatively new. The application of these principles may be
subject to further interpretation and refinement over time. There are significant differences among
valuation models, and there is a possibility that we will adopt different valuation models in the
future. This may result in a lack of consistency in future periods and materially affect the fair
value estimate of stock-based payments. It may also result in a lack of comparability with other
companies that use different models, methods and assumptions. See Note 6 to our condensed
consolidated financial statements for further information regarding the SFAS 123R disclosures.
Recent Accounting Pronouncements
In July 2006, the FASB issued FASB Interpretation No. 48 (FIN 48), Accounting for
Uncertainty in Income Taxes an interpretation of FASB Statement No. 109, which clarifies the
accounting for uncertainty in tax positions. FIN 48 requires that we recognize in its financial
statements, the impact of a tax position, if that position is more likely than not of being
sustained on audit, based on the technical merits of the position. The provisions of FIN 48 are
effective as of the beginning of our 2008 fiscal year, with the cumulative effect, if any, of the
change in accounting principle recorded as an adjustment to opening retained earnings. We are
currently evaluating the impact of adopting FIN 48 on our financial statements.
In September 2006, the FASB issued FASB Statement No. 157 (SFAS 157), Fair Value
Measurements. SFAS 157 defines fair value, establishes a framework for measuring fair value in
generally accepted accounting principles, and expands disclosures about fair value measurements.
SFAS 157 applies to other accounting pronouncements that require or permit fair value measurements,
the FASB having previously concluded in those accounting pronouncements that fair value is the
relevant measurement attribute. Accordingly, this Statement does not require any new fair value
measurements. However, for some entities, the application of SFAS 157 will change current practice.
The provisions of SFAS 157 are effective as of the beginning of our fiscal year. We are currently
evaluating the impact of SFAS 157, but do not expect the adoption of SFAS 157 to have a material
impact on our consolidated financial position, results of operations or cash flows.
In September 2006, the Securities and Exchange Commission issued Staff Accounting Bulletin No.
108, (SAB 108), which provides guidance on quantifying and evaluating the materiality of
unrecorded misstatements. SAB 108 is effective for annual financial statements covering the first
fiscal year ending after November 15, 2006, with earlier application encouraged for any interim
period of the first fiscal year ending after November 15, 2006, filed after the publication of SAB
108 (September 13, 2006). We are currently evaluating the impact of SAB 108, but do not expect the
adoption of SAB 108 to have a material impact on our consolidated financial position, results of
operations or cash flows.
Contractual Obligations
We have obligations under non-cancelable operating leases with various expiration dates
through 2012 and purchase commitments for inventory, capital equipment and operating expenses, such
as materials for research and development and consulting.
31
As of December 31, 2006, our contractual commitments were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
|
|
|
Less than |
|
1-3 |
|
3-5 |
|
Beyond |
Contractual obligations: |
|
Total |
|
1 year |
|
years |
|
years |
|
5 years |
Non-cancelable operating lease obligations |
|
$ |
3,721 |
|
|
$ |
748 |
|
|
$ |
1,883 |
|
|
$ |
1,049 |
|
|
$ |
41 |
|
Purchase commitments |
|
|
2,935 |
|
|
|
2,935 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
6,656 |
|
|
$ |
3,683 |
|
|
$ |
1,883 |
|
|
$ |
1,049 |
|
|
$ |
41 |
|
|
|
|
We are required to pay future earn-out amounts associated with the purchase of Neurologic. The
future earn-out payments will be one-third of Neurologics product sales during specified periods.
We are required to pay future earn-out amounts associated with the purchase of VasCon. The future
earn-out payments will be an amount not to exceed $10 million based on the sales and manufacturing
performance of Micrus Design Technology as set forth in the asset purchase agreement.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Foreign Currency Market Risks. Historically, we have been exposed to risks from fluctuations
in currency exchange rates due to intercompany loans made to Micrus SA, our Swiss subsidiary, in
2001 in connection with its incorporation. These loans are denominated in Swiss francs and will
fluctuate in value against the U.S. dollar, causing us to recognize foreign exchange gains and
losses. The functional currency of our Swiss subsidiary is the Swiss franc. The functional currency
of our UK subsidiary is the pound sterling. In Europe, our revenues are denominated in Swiss
francs, euros, pounds sterling and other currencies. Accordingly, we are exposed to market risk
related to changes between the Swiss franc and these other currencies. If the Swiss franc
appreciates against the currencies in which our receivables are denominated, we will recognize
foreign currency losses. For the preparation of our consolidated financial statements, the
financial results of our Swiss subsidiary are translated into U.S. dollars based on average
exchange rates during the applicable period. A hypothetical 10% decline in the value of the Swiss
franc versus the U.S. dollar would cause us to recognize a loss of $167,000 related to our loan
with Micrus SA and a $92,000 decrease in our comprehensive loss from our investment in Micrus SA. A
hypothetical 10% decline in the value of the pound sterling versus the U.S. dollar would cause us
to recognize a $182,000 decrease in our comprehensive loss from our investment in Micrus UK. A
hypothetical 10% decline in the value of the Euro versus the Swiss franc would cause us to
recognize a loss of $192,000 based on our foreign denominated receivables as of December 31, 2006.
For the nine months ended December 31, 2006, approximately 30% of our revenues were denominated in
currencies other than the U.S. dollar. In future periods, we believe a greater portion of our
revenues could be denominated in currencies other than the U.S. dollar, thereby increasing our
exposure to exchange rate gains and losses on non-U.S. currency transactions. We do not currently
enter into forward exchange contracts to hedge exposure denominated in foreign currencies or any
other derivative financial instruments for trading or speculative purposes. In the future, if we
believe our currency exposure merits, we may consider entering into transactions to help mitigate
that risk.
Interest Rate Market Risk. Our cash is invested in bank deposits and money market funds
denominated in U.S. dollars. The carrying value of these cash equivalents approximates fair market
value. Our investments in marketable securities are subject to interest rate risk, which is the
risk that our financial condition and results of operations could be adversely affected due to
movements in interest rates.
Item 4. Controls and Procedures
(1) Disclosure controls and procedures
Our management, with the participation of our President and Chief Executive Officer, John T.
Kilcoyne, and our Executive Vice President, Chief Financial Officer and Secretary, Robert A. Stern, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules
13a-15(e) and 15d-15(e) under the Exchange Act). Based on their evaluation, they concluded that our
disclosure controls and procedures as of December 31, 2006 were effective in providing reasonable
assurance that material information relating to our company is made known to management on a timely
basis during the period when our periodic reports are being prepared.
32
(2) Changes in internal controls
There were no changes in our internal control over financial reporting (as defined in Rules
13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended December 31, 2006 that
have materially affected, or are reasonably likely to materially affect, our internal control over
financial reporting.
Part II OTHER INFORMATION
Item 1. Legal Proceedings.
FCPA Investigation
See the
risk factor regarding international operations on page 37 below for a discussion of the
FCPA investigation we carried out in 2004 and our resulting agreement with the Department of
Justice.
Since the date of our last report on Form 10-Q, we have been notified by the Swiss government that
they do not intend to bring any action or impose any charges on us.
Patent Litigation
See the
risk factor regarding patent litigation below on page 34 for a detailed discussion of our
patent litigation with Boston Scientific Corporation.
Discovery is ongoing in the patent litigation with Boston Scientific Corporation, and a claim
construction hearing is scheduled to occur in March 2007, although Micrus and Boston Scientific
have jointly requested a continuance of the hearing to March 26, 2007 and are awaiting a response
from the Court on that request.
Item 1A. Risk Factors.
Certain Factors that May Affect Our Business and Future Results
Some of the information included herein contains forward-looking statements as defined in
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended. Such forward-looking statements are based on the beliefs of, estimates
made by and information currently available to our management and are subject to certain risks,
uncertainties and assumptions. Any statements contained herein (including, without limitation,
statements to the effect that the Company, we, or management may, will, expects,
anticipates, estimates, continues, plans, believes, or projects, or statements
concerning potential or opportunity, and any variations thereof, comparable terminology or the
negative thereof) that are not statements of historical fact should be construed as forward-looking
statements. Our actual results may vary materially from those expected in these forward-looking
statements. The realization of such forward-looking statements may be impaired by risks
including, but not limited to the following:
Our future success is dependent on the continued growth in embolic coiling procedures and our
ability to convince a concentrated customer base of neurointerventionalists to use our products as
an alternative to other available products.
Our future success and revenue growth are significantly dependent upon an increase in the use
of embolic coiling as a procedure to treat cerebral aneurysms. If the number of embolic coiling
procedures does not increase or if a new procedure that does not employ our products becomes a more
acceptable alternative among neurointerventionalists, our business would be seriously harmed.
The number of interventional neuroradiologists and neurosurgeons trained to conduct embolic
coiling procedures is relatively small, both in the United States and abroad. There are currently
approximately 300 neurointerventionalists in the United States who perform embolic coiling
procedures. We believe less than one-third of these physicians perform a substantial majority of
the total
33
number of embolic coiling procedures per year. In the first nine months ended December 31,
2006, a substantial portion of our product sales were to approximately 74 hospitals in the United
States. The growth in the number of interventional neuroradiologists and neurosurgeons in the
United States is constrained by the lengthy training programs required to educate these physicians.
Accordingly, our revenue growth will be primarily dependent on our ability to increase sales of our
products to our existing customers and to increase sales of products to trained
neurointerventionalists that currently use products offered by our competitors. We believe that
neurointerventionalists who do not currently use our products will not widely adopt our products
unless they determine, based on experience, clinical data and published peer reviewed journal
articles, that our products provide benefits or an attractive alternative to the clipping of
aneurysms or the use of competitors products. We believe neurointerventionalists base their
decision to use an alternative procedure or product on the following criteria, among others:
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|
extent of clinical evidence supporting patient benefits; |
|
|
|
|
their level of experience with the alternative product; |
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|
perceived liability risks generally associated with the use of new products and procedures; |
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|
availability of reimbursement within healthcare payment systems; and |
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|
costs associated with the purchase of new products and equipment. |
In addition, we believe that recommendations and support of our products by influential
physicians are essential for market acceptance and adoption. If we do not receive continued support
from such influential physicians, neurointerventionalists and hospitals may not use our products.
In such circumstances, we may not achieve expected revenue levels and our business will suffer.
We are currently involved in a patent litigation action involving Boston Scientific Corporation
and, if we do not prevail in this action, we could be liable for past damages and be prevented from
making, using, selling, offering to sell, importing into the U.S. or exporting from the U.S., our
microcoils, our primary product line.
In September 2004, Boston Scientific Corporation and Target Therapeutics, Inc., a subsidiary
of Boston Scientific Corporation, (collectively Boston Scientific), filed a patent infringement
suit in the United States District Court for the Northern District of California, alleging that our
embolic coil products infringe two patents held by Boston Scientific and that this infringement is
willful. Sales of our embolic coil products currently represent virtually all of our revenues.
Boston Scientific is a large, publicly-traded corporation with significantly greater financial
resources than us. In November 2004, we answered Boston Scientifics complaint and counterclaimed,
alleging that Boston Scientifics embolic coil products, and their use, infringe three of our
patents. On November 10, 2006, we withdrew one of its three asserted patents from the litigation
to pursue a reissue application filed with the United States Trademark and Patent Office (USPTO).
Each party seeks an injunction preventing the making, using, selling, offering to sell, importing
into the U.S. or exporting from the U.S., of the others embolic coil products in the United
States, damages for past infringement, which may be trebled, and payment of its legal fees and
costs. In addition, each party seeks a declaration that the patents of the other are invalid and
not infringed and has alleged that certain of the asserted patents of the other are unenforceable
due to inequitable conduct.
Boston Scientific is also a party in two other lawsuits against Cordis, a division of Johnson
& Johnson (Cordis) and ev3/Micro Therapeutics, Inc. in which the Boston Scientific patents, which
are the basis of Boston Scientifics suit against us, are also at issue. An outcome of either of
these lawsuits adverse to Cordis or ev3/Micro Therapeutics, Inc., and related to the same patent
claims Boston Scientific asserts against us, could have an adverse impact on certain of our
defenses in our litigation with Boston Scientific.
In October 2004, Cordis requested ex parte reexamination of certain claims in those patents.
In February 2005, the court granted a stay of the Boston Scientific lawsuit against Micrus until
the earlier of 12 months or the outcome of the reexamination by the USPTO in the Cordis case. In
February 2006, the USPTO issued a Notice of Intent to Issue Ex Parte Reexamination Certificate for
one of the two patents, apparently confirming all of the claims of that patent. In February 2006,
the USPTO also issued an Office Action in which it apparently confirmed the patentability of
certain of the claims in the second patent, but rejected the remainder. Boston Scientific has
stated to the USPTO and to the court that the rejected claims from the second patent can be
reissued and certified as patentable upon reexamination if a correction is made to the priority
chain for the second patent. In March 2006, the court lifted the stay with respect to any claims
that were confirmed as patentable in the reexamination proceedings and has permitted discovery in
the
34
case to commence with respect to those claims. Boston Scientific and us subsequently
negotiated, and the Court entered, a schedule that would permit discovery and claim construction
proceedings to proceed for the second patent while it is still undergoing reexamination and reissue
proceedings. In the period from April through September 2006, Boston Scientific and us exchanged
preliminary infringement and invalidity contentions concerning each of the four patents-in-suit. In
September 2006, the USPTO granted Cordis second requested ex parte reexamination of all the
asserted claims in one of Boston Scientifics asserted patents. Discovery is ongoing in the case
and a claim construction hearing is scheduled to occur in March 2007, although Micrus and Boston
Scientific have jointly requested a continuance of the hearing to March 26, 2007 and are awaiting a
response from the Court on that request.
We are unable at this time to determine the likely outcome of the patent litigation. Patent
lawsuits involve complex legal and factual issues which can take a number of years and a great deal
of expense and management attention to resolve. We may also be subject to negative publicity due to
the litigation. In the event it is determined that we infringe patent claims asserted by Boston
Scientific and that those claims are not invalid and not unenforceable we may, among other things,
be required to do one or more of the following:
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|
|
pay damages, including up to treble damages and Boston Scientifics attorneys fees and
costs, which may be substantial; |
|
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|
|
cease, because of an injunction, the making, using, selling, offering to sell, importing
into the U.S. or exporting from the U.S. of our embolic coil products, which currently
represent virtually all of our revenues, found to infringe the patent claims asserted by
Boston Scientific; |
|
|
|
|
expend significant resources to redesign our technology so that it does not infringe the
patent claims asserted by Boston Scientific, which may not be possible; |
|
|
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|
discontinue manufacturing or other processes that incorporate technology that infringes
the patent claims asserted by Boston Scientific; |
|
|
|
|
become subject to a compulsory license order under which we would be required to pay
Boston Scientific a royalty on future sales of our products; and/or |
|
|
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|
obtain a license from Boston Scientific to use the relevant patents, which may not be
available to us on acceptable terms, or at all. |
If our embolic coil products were found to infringe, any development or acquisition of
products or technologies that do not infringe the patent claims asserted by Boston Scientific could
require the expenditure of substantial time and other resources and could have a material adverse
effect on our business and financial results. If we were required to but could not obtain a license
under the patent claims asserted by Boston Scientific, we would likely be prevented from
commercializing or further commercializing the relevant products. We believe that it is unlikely
that we would be able to obtain a license under the patent claims being asserted by Boston
Scientific. If we need to redesign our products to avoid the patent claims being asserted by Boston
Scientific, we may suffer significant regulatory delays associated with conducting additional
studies or submitting technical, manufacturing or other information related to the redesigned
product and, ultimately, in obtaining approval.
As a result of Boston Scientifics answer to our counterclaim that Boston Scientific infringes
our two remaining patents-in-suit, the validity of those patents is now at issue in the lawsuit.
The court could find that those patents are invalid, which would prevent us from asserting those
patents against third parties.
An unfavorable outcome for us in this patent litigation would significantly harm our business
and may cause us to materially change our business model.
We have a limited operating history, have incurred significant operating losses since inception,
and expect to continue to incur losses, and we cannot assure you that we will achieve
profitability.
We were incorporated in the State of Delaware in 1996, and began commercial sales of our
microcoil products in 2000. We have yet to demonstrate that we can generate sufficient sales of our
products to become profitable. The extent of our future operating losses
35
and the timing of profitability are highly uncertain, and we may never achieve profitability.
We have incurred significant net losses since our inception, including losses of approximately $8.3
million in fiscal 2006, $6.7 million in fiscal 2005, $2.0 million in fiscal 2004 and $4.1 million
in the first nine months of fiscal 2007. At December 31, 2006, we had an accumulated deficit of
$53.7 million. It is possible that we will never generate sufficient revenues from product sales to
achieve profitability. Even if we do achieve significant revenues from our product sales, we expect
that increased operating expenses will result in significant operating losses in the near term as
we, among other things:
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|
grow our internal and third-party sales and marketing forces to expand the sales of our
products in the United States and internationally; |
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|
increase our research and development efforts to improve upon our existing products and develop new products; |
|
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|
perform clinical research and trials on our existing products and product candidates; |
|
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|
expand our regulatory resources in order to obtain governmental approvals for our
existing product enhancements and new products; |
|
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|
acquire and/or license new technologies; and |
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expand manufacturing. |
As a result of these activities, we may never become profitable. Even if we do achieve
profitability, we may not be able to sustain or increase profitability on an ongoing basis.
Our quarterly operating and financial results and our gross margins are likely to fluctuate
significantly in future periods.
Our quarterly operating and financial results are difficult to predict and may fluctuate
significantly from period to period. The level of our revenues, gross margins and results of
operations at any given time will be based primarily on the following factors:
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neurointerventionalist and patient acceptance of our products; |
|
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|
changes in the number of embolic coiling procedures performed to treat cerebral aneurysms; |
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|
the seasonality of our product sales; |
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the mix of our products sold; |
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stocking patterns for distributors; |
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the development of new procedures to treat cerebral aneurysms; |
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results of clinical research and trials on our existing products and products in development; |
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|
demand for, and pricing of, our products; |
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levels of third-party reimbursement for our products; |
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timing of new product offerings, acquisitions, licenses or other significant events involving us or our competitors; |
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increases in the costs of manufacturing and selling our products; |
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the amount and timing of our operating expenses; |
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litigation expenses; |
36
|
|
|
fluctuations in foreign currency exchange rates; |
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|
regulatory approvals and legislative changes affecting the products we may offer or those of our competitors; |
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the effect of competing technological and market developments; |
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changes in our ability to obtain and maintain FDA approval or clearance for our products; |
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inventory adjustments we may have to make in any quarter; |
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|
interruption in the manufacturing or distribution of our products; |
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our ability to maintain and expand our sales force and operational personnel; |
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|
the ability of our suppliers to timely provide us with an adequate supply of materials and components; and |
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|
amount and timing of capital expenditures and other costs relating to any potential expansion of our operations. |
Many of the products we may seek to develop and introduce in the future will require FDA
approval or clearance and meet similar regulatory requirements in other countries where we seek to
market our products, without which we cannot begin to commercialize them. Forecasting the timing of
sales of our products is difficult due to the delay inherent in seeking FDA and other clearance or
approval, or the failure to obtain such clearance or approval. In addition, we will be increasing
our operating expenses as we build our commercial capabilities. Accordingly, we may experience
significant, unanticipated quarterly losses. Because of these factors, our operating results in one
or more future quarters may fail to meet the expectations of securities analysts or investors,
which could cause our stock price to decline significantly.
We may not be able to develop new products or product enhancements that will be accepted by the
market.
Our success will depend in part on our ability to develop and introduce new products and
enhancements to our existing products. We cannot assure you that we will be able to successfully
develop or market new products or that any of our future products will be accepted by the
neurointerventionalists who use our products or the payors who reimburse for many of the procedures
performed with our products. The success of any new product offering or enhancement to an existing
product will depend on several factors, including our ability to:
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|
properly identify and anticipate interventionalist and patient needs; |
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|
develop new products or enhancements in a timely manner; |
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|
obtain the necessary regulatory approvals for new products or product enhancements; |
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|
provide adequate training to potential users of our products; |
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receive adequate reimbursement for our procedures; and |
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develop an effective marketing and distribution network. |
If we do not develop new products or product enhancements in time to meet market demand or if
there is insufficient demand for our products or enhancements, we may not achieve expected revenue
levels and our business will suffer.
Our international operations and our relationships with physicians and other consultants require us
to comply with a number of U.S. and international regulations.
We are required to comply with a number of international regulations related to sales of
medical devices and contractual relationships with physicians in countries outside of the United
States. In addition, we must comply with the Foreign Corrupt Practices
37
Act (FCPA) which prohibits U.S. companies or their agents and employees from providing
anything of value to a foreign official for the purposes of influencing him or her to help obtain
or retain business, direct business to any person or corporate entity, or obtain any unfair
advantage.
In August 2004 while reviewing our sales and payment procedures, we identified certain
payments we made to physicians outside the United States that may have violated the FCPA and the
laws of certain foreign countries. Following an internal investigation, we voluntarily disclosed to
the United States Department of Justice (DOJ) the factual information obtained in our internal
investigation of potential violations of the FCPA.
After reviewing the results of the internal investigation and the compliance procedures
implemented by us, the DOJ entered into an agreement (the DOJ Agreement) with us in February
2005. Pursuant to that agreement, the DOJ will not prosecute us for the conduct disclosed to the
DOJ, and we agreed to various conditions, including establishing policies and procedures to assure
compliance with the FCPA and other relevant anti-bribery laws, retaining an independent law firm to
act as a monitor for purposes of reporting to the DOJ for a period of three years as to our
compliance with the DOJ Agreement and to monitor our implementation of and adherence to FCPA
compliance policies and procedures, and fully cooperating with the DOJ, the independent monitor,
and the SEC. We must remain in complete compliance with these conditions for a period of two years,
or face the filing of a criminal complaint against us. The terms of the DOJ Agreement will bind our
successors, or any merger partners, as long as the DOJ Agreement is in effect.
The payments we made to physicians in France, Germany, Spain and Turkey also may have likely
violated the applicable laws in those foreign jurisdictions and may possibly have violated laws in
Switzerland, where our Swiss subsidiary is located. We are not able to determine at this time what
penalties or other sanctions, if any, authorities in France, Germany, Spain, or Turkey may impose
on us as a result of such violations. We have been notified by the Swiss Federal Prosecutor that it
does not intend to bring any action or impose any penalties on us.
Though we have adopted a number of compliance procedures, including adoption of a Foreign
Corrupt Practices Act Policy and related procedures, and appointed a Compliance Officer, we cannot
assure you that we will be able to comply with the various regulations in foreign jurisdictions,
which vary from country to country. Implementing and monitoring such compliance procedures in a
number of foreign jurisdictions can be very expensive and time-consuming. Any failure by us to
adopt appropriate compliance procedures and ensure that our employees and agents comply with
applicable laws and regulations in foreign jurisdictions could result in substantial penalties
and/or restrictions in our ability to sell products in certain foreign jurisdictions.
We are in a highly competitive market segment, face competition from large, well-established
medical device manufacturers with significant resources, and may not be able to increase
penetration in our markets or otherwise compete effectively.
The market for medical devices for treatment of cerebral vascular diseases is intensely
competitive, subject to rapid change and significantly affected by new product introductions and
other market activities of industry participants. We compete primarily with the Target Therapeutics
division of Boston Scientific Corporation, the market leader, as well as the Cordis division of
Johnson & Johnson, ev3/Micro Therapeutics and Terumo/MicroVention. At any time, other companies may
develop alternative treatments, products or procedures for the treatment of cerebral aneurysms that
compete directly or indirectly with our products. If alternative treatments prove to be superior to
our microcoil or other products, continued use or adoption of our products could be negatively
affected and our future revenues could suffer.
In addition, most of our current and potential competitors are either large publicly traded or
divisions or subsidiaries of large publicly traded companies, and enjoy several competitive
advantages over us, including:
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greater financial and personnel resources; |
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significantly greater name recognition; |
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established relationships with neurointerventionalists; |
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established distribution networks; |
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greater experience in obtaining and maintaining FDA, and other regulatory approvals for
products and product enhancements, and greater experience in developing compliance programs
for compliance with numerous federal, state, local and similar laws in non-U.S.
jurisdictions; |
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greater resources for product research and development; |
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greater experience in, and resources for, launching, marketing, distributing and selling products; and |
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broader product lines. |
Except for our distribution agreement with Goodman, none of our customers has long-term
purchase agreements with us and may at any time switch to the use of our competitors products.
For these reasons, we may not be able to compete successfully against our current or potential
future competitors and sales of our products and our revenues may decline.
Our sales in international markets subject us to foreign currency exchange and other risks and
costs that could harm our business.
A substantial portion of
our revenues are derived from outside the U.S. For the fiscal years
ended March 31, 2004, 2005 and 2006, revenues from customers outside the U.S. represented
approximately 50%, 48% and 53% respectively, of our revenues. For the nine months ended December
31, 2006, revenues from customers outside the United States represented 51% or our revenues. We
anticipate that revenues from international customers will continue to represent a substantial
portion of our revenues as we expand in new international markets including China and Japan.
Because we generate revenues in foreign currencies, we are subject to the effects of exchange rate
fluctuations. For the nine months ended December 31, 2006, approximately 30% of our revenues were
denominated in currencies other than the U.S. dollar. The functional currency of our Swiss
subsidiary is the Swiss franc. In Europe, our revenues are denominated in Swiss francs, euros,
pounds sterling and U.S. dollars. Accordingly, we are exposed to market risk related to changes
between the Swiss franc and these other currencies in which we conduct business. If the Swiss franc
appreciates against the currencies in which our receivables are denominated, we will recognize
foreign currency losses. For the preparation of our consolidated financial statements, the
financial results of our Swiss and UK subsidiaries are translated into U.S. dollars based on
average exchange rates during the applicable period. If the U.S. dollar appreciates against the
Swiss franc and pounds sterling, the revenues we recognize from sales by our European subsidiaries
will be adversely impacted. Historically, we have also been exposed to risks from fluctuations in
currency exchange rates due to intercompany loans made to Micrus SA, our Swiss subsidiary, in 2001
in connection with its incorporation. These loans are denominated in Swiss francs and will
fluctuate in value against the U.S. dollar, causing us to recognize foreign exchange gains and
losses. Foreign exchange gains or losses as a result of exchange rate fluctuations in any given
period could harm our operating results and negatively impact our revenues. Additionally, if the
effective price of our products were to increase as a result of fluctuations in foreign currency
exchange rates, demand for our products could decline and adversely affect our results of
operations and financial condition.
We are subject to various
additional risks as a consequence of doing business internationally,
and, in particular in Argentina, Brazil, Chile, Columbia, Costa Rica, Mexico, Peru, Venezuela,
Greece and Turkey, each of which could harm our business, including the following:
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local economic and political instability or other potentially adverse conditions; |
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lack of experience in certain geographical markets; |
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unexpected delays or changes in regulatory requirements; |
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increased difficulty in collecting accounts receivables in certain foreign countries; |
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delays and expenses associated with tariffs and other trade barriers; |
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difficulties and costs associated with attracting and maintaining third party distributors; |
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compliance with foreign laws and regulations; and |
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adverse tax consequences or overlapping tax structures. |
If we fail to increase our direct sales force in a timely manner, our business could suffer.
We have a limited domestic and international direct sales force. We also have a distribution
network for sales in the major markets in Europe, Latin America, Asia and the Middle East. As we
launch new products and increase our marketing efforts with respect to existing products, we will
need to significantly expand the number of our direct sales personnel on a worldwide basis. The
establishment and development of a more extensive sales force will be expensive and time consuming.
There is significant competition for sales personnel experienced in interventional medical device
sales. If we are unable to attract, motivate and retain qualified sales personnel and thereby
increase our sales force, we may not be able to increase our revenues.
If we fail to properly manage our anticipated growth, our business could suffer.
We have experienced, and may continue to experience, periods of rapid growth and expansion,
which have placed, and will likely continue to place, a significant strain on our limited personnel
and other resources. In particular, the expansion of our fabrication facility and the continuing
expansion of our direct sales force will require significant management, technical and
administrative resources. Any failure by us to manage our growth effectively, could have an adverse
effect on our ability to achieve our development and commercialization goals.
To achieve our revenue goals, we must successfully increase production in our fabrication
facility as required by customer demand. We may in the future experience difficulties in increasing
production, including problems with production yields and quality control and assurance and in
satisfying and maintaining compliance with regulatory requirements. These problems could result in
delays in product availability and increases in expenses. Any such delay or increased expense could
adversely affect our ability to generate revenues.
Future growth will also impose significant added responsibilities on management, including the
need to identify, recruit, train and integrate additional employees. In addition, rapid and
significant growth will place a strain on our administrative and operational infrastructure. In
order to manage our operations and growth we will need to continue to improve our operational,
financial and management controls, reporting systems and procedures. If we are unable to manage our
growth effectively, it may be difficult for us to execute our business strategy and our operating
results and business could suffer.
We can provide no assurance regarding our, or our independent registered public accounting firms,
conclusions at March 31, 2007 with respect to the effectiveness of our internal controls over
financial reporting.
Section 404 of the Sarbanes-Oxley Act of 2002 (the Act) will require us to include an
internal controls report from management in our Annual Report on Form 10-K for the fiscal year
ended March 31, 2007 and in subsequent Annual Reports. The internal control report must include a
statement:
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about managements responsibility for establishing and maintaining adequate internal
controls over financial reporting; |
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identifying the framework used by management to conduct the required evaluation of the
effectiveness of our internal control over financial reporting; |
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concerning managements assessment of the effectiveness of our internal control over
financial reporting as of March 31, 2007, including a statement as to whether or not
internal control over financial reporting is effective; and |
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that our independent registered public accounting firm has issued an attestation report
on managements assessment and the effectiveness of internal control over financial
reporting. |
We have and will be required to continue to expend significant resources in developing the
necessary documentation and testing procedures required by Section 404. We have not completed our
assessment as required by Section 404, and our independent
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registered accounting firm has not been engaged to express and has not expressed, an opinion
on our internal controls over financial reporting. However, in connection with its audit of our
2006 fiscal year our independent registered accounting firm identified significant deficiencies in
our internal controls. A significant deficiency is a control deficiency, or a combination of
control deficiencies, that results in more than a remote likelihood that a misstatement of our
financial statements that is more than inconsequential will not be prevented or detected. We are in
the process of hiring additional accounting personnel, and management believes that the identified
significant deficiencies will be remedied by the hiring of such personnel.
Through fiscal 2007 we anticipate significant growth in our business, including international
expansion. As a result, given the risks inherent in the design and operation of internal controls
over financial reporting, we can provide no assurance as to our, or our independent registered
public accounting firms, conclusions at March 31, 2007 with respect to the effectiveness of our
internal controls over financial reporting. If our internal controls are not designed or operating
effectively, we would be required to disclose at such time that our internal control over financial
reporting is not effective. In addition, our registered public accounting firm may either disclaim
an opinion as it relates to managements assessment of the effectiveness of our internal controls
or may issue an adverse opinion on the effectiveness of our internal controls over financial
reporting. Investors may lose confidence in the reliability of our financial statements, which
could cause the market price of our common stock to decline and which could affect our ability to
run our business as we otherwise would like to.
Our future capital needs are uncertain and we may need to raise additional funds in the future, and
such funds may not be available on acceptable terms or at all.
We believe that our current cash position, together with the cash to be generated from
expected product sales will be sufficient to meet our projected operating requirements for at least
the next 12 months. However, after such period we may be required to seek additional funds from
public and private stock offerings, borrowings under lease lines or other sources. Our capital
requirements will depend on many factors, including:
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the revenues generated by sales of our products; |
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the costs associated with expanding our sales and marketing efforts; |
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the expenses we incur in manufacturing and selling our products; |
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the costs of developing and or acquiring new products or technologies; |
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the cost of obtaining and maintaining U.S Food and Drug Administration (FDA) approval
or clearance of our products and products in development; |
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costs associated with our litigation with Boston Scientific; |
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the expenses we incur related to compliance with the U.S. Foreign Corrupt Practices Act
(FCPA) and laws and regulations in non-U.S. jurisdictions; |
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costs associated with compliance with the Sarbanes-Oxley Act of 2002 and rules and
regulations affecting public companies recently promulgated by the Securities and Exchange
Commission and the Nasdaq National Market; |
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the costs associated with our facilities expansion, if any; and |
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the costs associated with increased capital expenditures. |
As a result of these factors, we may need to raise additional funds, and such funds may not be
available on favorable terms, or at all. Furthermore, if we issue equity or debt securities to
raise additional funds, our existing stockholders may experience dilution, and the new equity or
debt securities may have rights, preferences and privileges senior to those of our existing
stockholders. In addition, if we raise additional funds through collaboration, licensing or other
similar arrangements, it may be necessary to relinquish valuable rights to our potential products
or proprietary technologies, or grant licenses on terms that are not favorable to us. If we cannot
raise funds on acceptable terms, we may not be able to develop or enhance our products, execute our
business plan, take advantage of future
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opportunities, or respond to competitive pressures or unanticipated customer requirements. In
these events, our ability to achieve our development and commercialization goals would be adversely
affected.
If we choose to acquire new and complementary businesses, products or technologies instead of
developing them ourselves, we may be unable to complete these acquisitions or to successfully
integrate them in a cost effective and non-disruptive manner.
Our success depends on our ability to continually enhance and broaden our product offerings in
response to changing customer demands, competitive pressures and technologies. We may in the future
pursue the acquisition of additional complementary businesses, products or technologies instead of
developing them ourselves. We do not know if we will be able to successfully complete any such
acquisitions, or whether we will be able to successfully integrate any acquired business, product
or technology or retain any key employees. Integrating any business, product or technology we
acquire could be expensive and time consuming, disrupt our ongoing business and distract our
management. If we are unable to integrate any acquired businesses, products or technologies
effectively, our business will suffer. In addition, any amortization or charges resulting from the
costs of acquisitions could harm our business and operating results.
We are dependent on single source suppliers for components and materials used in our devices, and
the loss of any of these suppliers, or their inability to supply us with an adequate supply of
materials, could harm our business.
We rely on third-party suppliers for components and materials used in our products and rely on
single sources for many of the microcoil and delivery system components, including tubing,
connectors and sterilization services. Our dependence on third-party suppliers involves several
risks, including limited control over pricing, availability, quality, delivery schedules and
supplier compliance with regulatory requirements. Any delays in delivery of such components or
provision of such services or shortages of such components could cause delays in the shipment of
our products, which could significantly harm our business. We generally acquire our single source
components pursuant to purchase orders placed in the ordinary course of business, and we have no
guaranteed supply arrangements with any of our single source suppliers. Because of our reliance on
these vendors, we may also be subject to increases in component costs. These increases could
significantly harm our business. For us to be successful, our third-party suppliers must also be
able to provide us with the materials and components of our products in substantial quantities, in
compliance with regulatory requirements, in accordance with agreed upon specifications, at
acceptable cost and on a timely basis. Our anticipated growth may strain the ability of suppliers
to deliver an increasingly large supply of materials and components. If we are unable to obtain
sufficient quantities of high quality components and materials to meet customer demand on a timely
basis, we could lose customers, our reputation may be harmed and our business could suffer. If any
one or more of our third-party suppliers cease to provide us with sufficient quantities of our
materials or components in a timely manner or on terms acceptable to us, we would have to seek
alternative sources of supply. We could incur delays while we locate and engage alternative
qualified suppliers and we might be unable to engage alternative suppliers on favorable terms. Any
such disruption or increased expenses could harm our commercialization efforts and adversely affect
our ability to generate revenues.
We rely on independent contract manufacturers for the manufacture and assembly of certain of
our products and components. Reliance on independent contract manufacturers involves several risks,
including the potential inadequacy of capacity, the unavailability of or interruptions in access to
certain process technologies and reduced control over product quality, compliance with regulatory
requirements, delivery schedules, manufacturing yields and costs. Such manufacturers have
possession of and at times title to molds for certain manufactured components of our products.
Shortages of raw materials, production capacity constraints or delays by our contract manufacturers
could negatively affect our ability to meet our production obligations and result in increased
prices for affected parts. Any such reduction, constraint or delay may result in delays in
shipments of our products or increases in the prices of components, either of which could have a
material adverse effect on our business, operating results and financial condition. We have no
supply agreements with our current contract manufacturers and utilize purchase orders which are
subject to supplier acceptance. The unanticipated loss of any of our contract manufacturers could
cause delays in our ability to deliver product while we identify and qualify a replacement
manufacturer. If our current or future independent contract manufacturers are unable to meet our
requirements for manufactured components, our business could suffer.
Our operations are currently conducted at several locations that may be at risk from earthquakes or
other natural disasters.
We currently conduct all of our manufacturing, development and management activities at two
locations in Silicon Valley, California, near known earthquake fault zones and in Doral, Florida,
where there is a risk of hurricanes. We have taken precautions to safeguard our facilities,
including insurance, health and safety protocols, and off-site storage of computer data. However,
any future
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natural disaster, such as an earthquake or hurricane, could cause substantial delays in our
operations, damage or destroy our equipment or inventory, and cause us to incur additional
expenses. A disaster could seriously harm our business and results of operations.
If we are unable to effectively manage our inventory held on consignment by our intended customers,
we will not achieve our expected results.
A significant portion of our inventory is held on consignment by hospitals that purchase the
inventory as they use it. In these consignment locations, we do not have physical possession of the
consigned inventory. We therefore have to rely on information from our customers as well as
periodic inspections by our sales personnel to determine when our products have been used. We have
in the past experienced problems managing appropriate consigned inventory levels and as a result we
recorded an impairment of inventory for anticipated obsolescence in fiscal 2004 and an impairment
of excess inventory in both fiscal 2004 and 2005. If we are not able to effectively manage
appropriate consigned inventory levels, we may suffer inventory losses that will reduce our gross
profit levels. There can be no assurance that any efforts to strengthen our monitoring and
management of consigned inventory will be adequate to meaningfully reduce the risk of inventory
loss.
We are dependent on our senior management team, key clinical advisors and scientific personnel, and
the loss of any of them could harm our business.
Our continued success depends in part upon the continued availability and contributions of our
senior management team and the continued participation of our key clinical advisors. We have
entered into letter agreements with certain members of our senior management team, but none of
these agreements guaranty the services of the individual for a specified period of time. We also
rely on the skills and talents of our scientific personnel because of the complexity of our
products. The loss of members of our senior management, key clinical advisors or scientific
personnel, or our inability to attract or retain other qualified personnel or advisors could have a
material adverse effect on our results of operations and financial condition.
The medical device industry is characterized by patent litigation, which could be costly, result in
the diversion of managements time and efforts and require us to pay damages.
The medical device industry is characterized by extensive litigation and administrative
proceedings over patent and other intellectual property rights. Accordingly, we may in the future
be subject to further litigation and administrative proceedings over such rights with other
companies in our industry. As we have discussed above with respect to our current litigation with
Boston Scientific, whether a product or method infringes a patent involves complex legal and
factual issues rendering the outcome of any patent dispute largely unpredictable. In the future,
other competitors may assert that at least one of our products, its components, or the methods we
employ in the use or manufacture of our products are covered by and infringe the competitors U.S.
or foreign patents held by them. In addition, should our patents or applications have claims that
encompass the same scope as claims pending or issued to a third party competitor, that third party
may claim that its claims have priority over ours because they invented the claimed subject matter
first. Because patent applications generally take many years to issue, there may be third party
applications presently pending of which we are unaware, that may in the future result in issued
patents that at least one of our products, its components, or the methods we employ in the use or
manufacture of our product(s) may infringe. There could also be issued patents that one or more
components of our products may inadvertently be infringing, of which we are unaware. As the number
of participants in the market for cerebral vascular treatments and the number of issued patents in
this technology area grows, the possibility of being charged with patent infringement increases.
As we have discussed above with respect to our litigation with Boston Scientific, any
infringement claims against us may cause us to incur substantial costs, could place a significant
strain on our financial resources, divert the attention of management from our core business and
harm our reputation. If the relevant patent claims are upheld as valid and enforceable and we are
found to infringe, we could be required to pay substantial damages and/or royalties and could be
prevented from selling our products unless we could obtain a license or were able to redesign our
products to avoid infringement. Any such license may not be available on reasonable terms, if at
all. If we fail to obtain any required licenses or make any necessary changes to our products or
technologies, we may be unable to commercialize one or more of our products or practice the methods
we employ in the use or manufacture of our products.
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Our ability to protect our intellectual property and proprietary technology through patents and
other means is uncertain.
Our success depends significantly on our ability to procure proprietary rights to the
technologies used in our products. We rely on patent protection, as well as a combination of
copyright, trade secret and trademark laws, and nondisclosure, confidentiality and other
contractual restrictions to protect our proprietary technology. However, these legal means afford
only limited protection and may not be sufficient to adequately protect our intellectual property
or permit us to gain or keep any competitive advantage. For example, any of our pending U.S. or
foreign patent applications may ultimately not issue as a patent or, alternatively, may issue with
claims that are of little or no value to us. In addition, once issued, a valuable patent may be
challenged successfully by third parties and invalidated, such as is being attempted by Boston
Scientific in our presently ongoing litigation. In addition, our patent protection for material
aspects of our products and methods is presently being pursued with applications that have been
filed but not issued, such that these material aspects are not presently protected by patents.
Competitors may further be able to get around having to license our technology in order to avoid
infringement by designing around our issued and published patent claims, thereby staying clear of
our proprietary rights. Similarly, competitors may develop products and methods that are equivalent
or superior to ours. Our confidentiality agreements and intellectual property assignment agreements
with our employees, consultants and advisors may not be enforceable or may not provide meaningful
protection for our trade secrets or other proprietary information in the event of unauthorized use
or disclosure or other breaches of the agreements. Furthermore, the laws of some foreign countries
may not protect our intellectual property rights to the same extent as do the laws of the United
States. Both the process of procuring patent rights and the process of managing patent disputes can
be time consuming and expensive.
In the event a competitor infringes upon our patent or other intellectual property rights,
enforcing those rights may be difficult and time consuming. Even if successful, litigation to
enforce our intellectual property rights or to defend our patents against challenge could be
prolonged, costly and could divert our managements attention. We may not have sufficient resources
to enforce our intellectual property rights or to defend our patents against a challenge.
If we fail to obtain, or experience significant delays in obtaining, FDA clearances or approvals
for our future products or product enhancements, or to comply with similar regulatory requirements
in other countries where we market our products, our ability to commercially distribute and market
our products could suffer.
Our medical devices are subject to rigorous regulation by the FDA and numerous other federal,
state and foreign governmental authorities. Our failure to comply with such regulations could lead
to the imposition of injunctions, suspensions or loss of regulatory clearances or approvals,
product recalls, termination of distribution or product seizures or the need to invest substantial
resources to comply with various existing or new requirements. In the more egregious cases,
criminal sanctions, civil penalties, disgorgement of profits or closure of our manufacturing
facilities are possible. The process of obtaining regulatory clearances or approvals to market a
medical device, particularly from the FDA, can be costly and time consuming, and there can be no
assurance that such clearances or approvals will be granted on a timely basis, if at all. In
particular, the FDA permits commercial distribution of most new medical devices only after the
device has received 510(k) clearance or is the subject of an approved pre-market approval
application, or PMA. The FDA will clear marketing of a medical device through the 510(k) process if
it is demonstrated that the new product has the same intended use, is substantially equivalent to
another legally marketed device, including a 510(k)-cleared product, and otherwise meets the FDAs
requirements. The PMA approval process is more costly, lengthy and uncertain than the 510(k)
clearance process and requires the development and submission of clinical studies supporting the
safety and effectiveness of the device. Product modifications may also require the submission of a
new 510(k) clearance, or the approval of a PMA before the modified product can be marketed. Changes
in labeling and manufacturing site for a PMA approved device may require the submission and
approval of a PMA supplement. Any products we develop that require regulatory clearance or approval
may be delayed, if approved at all. In addition, we believe that some of our new products will
require an approved PMA before we can commercially distribute the device and we cannot assure you
that any new products or any product enhancements we develop will be subject to the shorter 510(k)
clearance process instead of the more lengthy PMA requirements. Additionally, certain of our
products under development may involve both device and drug or biologic regulation and we will need
to comply with drug and biologic regulations in addition to medical device requirements.
Accordingly, we anticipate that the regulatory review and approval process for some of our future
products or product enhancements may take significantly longer than anticipated or that we have
experienced in the past. We will also be required to pay a medical device user fee and may also be
required to pay a drug or biologic user fee. There is no assurance that the FDA will not require
that a certain new product or product enhancement go through the lengthy and expensive PMA approval
process. We have no experience in obtaining PMA approval. We also have no experience in obtaining
drug or biologic approval, and will need to rely on third party assistance in navigating the
regulatory approval pathway for future combination products.
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Further, pursuant to FDA regulations, we can only market our products for cleared or approved
uses. Certain of our products may be used by physicians for indications other than those cleared or
approved by the FDA, but we cannot promote the products for such off-label uses.
Modifications to our marketed products may require new 510(k) clearances or pre-market approvals,
or may require us to cease marketing or recall the modified products until clearances are obtained.
Any modification to a 510(k)-cleared device that could significantly affect its safety or
effectiveness, or that would constitute a change in its intended use, requires a new 510(k)
clearance or, possibly, PMA approval. The FDA requires every manufacturer to make this
determination in the first instance, but the FDA may review a manufacturers decision. The FDA may
not agree with any of our past or future decisions regarding whether new clearances or approvals
are necessary. If the FDA requires us to seek 510(k) clearance or PMA approval for any modification
to a previously cleared product, we may be required to cease marketing and/or to recall the
modified product until we obtain clearance or approval, and we may be subject to significant
regulatory fines or penalties. Further, our products could be subject to recall if the FDA
determines, for any reason, that our products are not safe, including but not limited to new safety
data from use of the product, or manufacturing defects. Any recall or FDA requirement that we seek
additional approvals or clearances could result in delays, fines, costs associated with
modification of a product, loss of revenue and potential operating restrictions imposed by the FDA.
If we or our suppliers fail to comply with the FDAs quality system regulations, the manufacture of
our products could be delayed.
We and our suppliers are required to comply with the FDAs quality system regulations, which
cover the methods and documentation of the design, testing, production, control, quality assurance,
labeling, packaging, storage and shipping of our products. The FDA enforces these quality system
regulations through unannounced inspections. If we or one of our suppliers fail a quality system
regulations inspection or if any corrective action plan is not sufficient, or is very expensive or
time consuming to implement, the manufacture of our products could be delayed until satisfactory
corrections are made, or in the event we are unable to correct the problems we may not be able to
continue manufacturing and distributing the particular device or devices. Such a delay potentially
could disrupt our business, harm our reputation and adversely affect our sales and revenues.
If interventionalists are unable to obtain sufficient reimbursement for procedures performed with
our products, it is unlikely that our products will be widely used.
Successful sales of our products will depend on the availability of adequate reimbursement
from third-party payors. Healthcare providers that purchase medical devices for treatment of their
patients, generally rely on third-party payors to cover the use of the product for the particular
procedure and reimburse all or part of the costs and fees associated with the procedures performed
with these devices. Currently, the costs of our products distributed domestically are being
reimbursed by third party payors. There is no guarantee that coverage and adequate reimbursement
will be available in the future for our existing and/or new products. Both public and private
insurance reimbursement plans are central to new product acceptance. Neurointerventionalists are
unlikely to use our products if they do not receive reimbursement adequate to cover the cost of our
products and related procedures.
In international markets, market acceptance may depend, in part, upon the availability of
reimbursement within prevailing healthcare payment systems. Reimbursement and healthcare payment
systems in international markets vary significantly by country, and include both government
sponsored healthcare and private insurance. Currently, the costs of our products distributed
internationally, other than in some Latin American countries, are being reimbursed by public and
private healthcare insurers. We may not obtain international reimbursement approvals in a timely
manner, if at all, our failure to receive international reimbursement approvals would negatively
impact market acceptance of our products in the international markets in which those approvals are
sought. In addition, in certain countries, such as France, Germany and Japan, we are required to
obtain regulatory clearance for our products to be eligible for reimbursements by third party
payors, even though reimbursement for embolic coiling procedures is already in place.
Future reimbursement may be subject to increased restrictions both in the United States and in
international markets. Third-party reimbursement and coverage may not be available or adequate in
either the United States or international markets. Future legislation,
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regulation or reimbursement policies of third-party payors may adversely affect the demand for
our existing products or our products currently under development and limit our ability to sell our
products on a profitable basis.
The adoption of Statement of Financial Accounting Standard No. 123R and changes to existing
accounting pronouncements or taxation rules or practices may affect how we conduct our business and
affect our reported results of operations.
On April 1, 2006, we adopted the provisions of, and account for stock-based compensation in
accordance with, the Financial Accounting Standards Boards (FASB) Statement of Financial
Accounting Standards No. 123-revised 2004 (SFAS 123R), Share-Based Payment, which replaced
Statement of Financial Accounting Standards No. 123 (SFAS 123), Accounting for Stock-Based
Compensation and supersedes APB Opinion No. 25 (APB 25), Accounting for Stock Issued to
Employees. Under the fair value recognition provisions of this statement, stock-based compensation
cost is measured at the grant date based on the fair value of the award and is recognized as
expense on a straight-line basis over the requisite service period, which is generally the vesting
period. The effective date of this new standard under these new rules for our financial statements
was April 1, 2006. Adoption of this statement has had a significant impact on our consolidated
financial statements, as we are now required to expense the fair value of our stock option grants
and stock purchases under our employee stock purchase plan rather than disclose the impact on our
net loss within our footnotes. The impact of SFAS 123R on our consolidated financial statements and
related disclosures is, and is expected to continue to be, material to our results of operations.
Our actual stock-based compensation expense in fiscal 2007 will be dependent on a number of
factors, including the amount of awards granted and the fair value of those awards at the time of
grant, as well as any changes in variables or underlying assumptions used to determine fair value
under our pricing model. In addition, a change in accounting pronouncements or taxation rules or
practices can have a significant effect on our reported results and may even affect our reporting
of transactions completed before the change is effective. Other new accounting pronouncements or
taxation rules and varying interpretations of accounting pronouncements or taxation practice have
occurred and may occur in the future. Changes to existing rules, future changes, if any, or the
questioning of current practices may adversely affect our reported financial results or the way we
conduct our business.
We may become subject to product liability claims which could require us to pay damages that exceed
our insurance coverage.
Our business exposes us to potential product liability claims that are inherent in the
testing, manufacture and sale of medical devices for neurointerventional procedures. These
procedures involve significant risk of serious complications, including intracranial bleeding,
brain injury, paralysis and even death. Any product liability claim brought against us, with or
without merit, could result in the increase of our product liability insurance rates or the
inability to secure coverage in the future. In addition, we could have to pay an amount in excess
of policy limits, which would have to be paid out of cash reserves. If longer-term patient results
and experience indicate that our products or any component cause tissue damage, motor impairment or
other adverse effects, we could be subject to significant liability. Finally, even a meritless or
unsuccessful product liability claim could harm our reputation in the industry, lead to significant
legal fees and could result in the diversion of managements attention from managing our business.
We may be subject to damages resulting from claims that we or our employees have wrongfully used or
disclosed alleged trade secrets of their former employers.
Many of our employees were previously employed at other medical device companies, including
our competitors or potential competitors. Although no claims against us are currently pending, we
may be subject to claims that these employees or we have inadvertently or otherwise used or
disclosed trade secrets or other proprietary information of their former employers. Litigation may
be necessary to defend against these claims. Even if we are successful in defending against these
claims, litigation could result in substantial costs and be a distraction to management. If we fail
in defending such claims, in addition to paying monetary damages, we may lose valuable intellectual
property rights or personnel. A loss of key research personnel or their work product could hamper
or prevent our ability to commercialize product candidates, which could severely harm our business.
The price of our common stock has fluctuated and we expect will continue to fluctuate substantially
and you may not be able to sell your shares at or above your purchase price.
The market price of our common stock has been and we expect will continue to be highly
volatile and may fluctuate substantially due to many factors, including:
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volume and timing of orders for our products;
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the introduction of new products or product enhancements by us or our competitors; |
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disputes or other developments with respect to intellectual property rights; |
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our ability to develop, obtain regulatory clearance for, and market, new and enhanced products on a timely basis; |
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product liability claims or other litigation; |
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quarterly variations in our or our competitors results of operations; |
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sales of large blocks of our common stock, including sales by our executive officers and directors; |
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changes in governmental regulations or in the status of our regulatory approvals or applications; |
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changes in the availability of third-party reimbursement in the United States or other countries; |
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changes in earnings estimates or recommendations by securities analysts; and |
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general market conditions and other factors, including factors unrelated to our operating
performance or the operating performance of our competitors. |
Furthermore, to the extent there is an inactive market for our common stock, the value of your
shares and your ability to sell your shares at the time you wish to sell them may be impaired. An
inactive market may also impair our ability to raise capital by selling shares and may impair our
ability to acquire other companies, products or technologies by using our shares as consideration.
Because of their significant stock ownership, our executive officers, directors and principal
stockholders will be able to exert control over us and our significant corporate decisions.
Based on shares outstanding at February 1, 2007, our executive officers, directors, and
stockholders holding more than 5% of our outstanding common stock and their affiliates will, in the
aggregate, beneficially own approximately 32% of our outstanding common stock. As a result, these
persons, acting together, may have the ability to determine the outcome of all matters submitted to
our stockholders for approval, including the election and removal of directors and any merger,
consolidation, or sale of all or substantially all of our assets. This concentration of ownership
may harm the market price of our common stock by, among other things:
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delaying, deferring or preventing a change in control of our company; |
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impeding a merger, consolidation, takeover or other business combination involving our company; or |
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causing us to enter into transactions or agreements that are not in the best interests of all stockholders. |
Further, three of our eight current directors were designated by our principal stockholders
which may increase such stockholders influence relating to matters submitted to the Board of
Directors.
Future sales of our common stock may depress our stock price.
Our current stockholders hold a substantial number of shares of our common stock that they are
able to sell in the public market A significant portion of these shares are held by a small number
of stockholders. Sales by our current stockholders of a substantial number of shares could
significantly reduce the market price of our common stock. Moreover certain holders of our common
stock have the right to require us to file registration statements covering their shares or to
include their shares in registration statements that we may file for ourselves or other
stockholders.
We have registered 4,972,187 shares of common stock that we may issue under our 1998 Stock
Plan, 2005 Equity Incentive Plan and 2005 Employee Stock Purchase Plan. These shares can be freely
sold in the public market upon issuance. The sale by any of these
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holders of a large number of securities in the public market could reduce the trading price of
our common stock and impede our ability to raise future capital.
We may incur increased costs as a result of recently enacted and proposed changes in laws and
regulations.
Recently enacted and proposed changes in the laws and regulations affecting public companies,
including the provisions of the Sarbanes-Oxley Act of 2002 and rules proposed by the Securities and
Exchange Commission (SEC) and by the Nasdaq National Market, could result in increased costs to us.
The new rules could make it more difficult or more costly for us to obtain certain types of
insurance, including directors and officers liability insurance, and we may be forced to accept
reduced policy limits and coverage or incur substantially higher costs to obtain the same or
similar coverage. The impact of these events could also make it more difficult for us to attract
and retain qualified persons to serve on our board of directors, our board committees or as
executive officers. We are presently evaluating and monitoring developments with respect to new and
proposed rules and cannot predict or estimate the amount of the additional costs we may incur or
the timing of such costs.
We may become involved in securities class action litigation that could divert managements
attention and harm our business.
The stock market in general, the Nasdaq National Market and the market for medical device
companies in particular, has experienced extreme price and volume fluctuations that have often been
unrelated or disproportionate to the operating performance of those companies. Further, the market
prices of securities of medical device companies have been particularly volatile. These broad
market and industry factors may materially harm the market price of our common stock, regardless of
our operating performance. In the past, following periods of volatility in the market price of a
particular companys securities, securities class action litigation has often been brought against
that company. We may become involved in this type of litigation in the future. Litigation often is
expensive and diverts managements attention and resources, which could materially harm our
financial condition and results of operations.
We do not intend to pay cash dividends.
We have never declared or paid cash dividends on our capital stock. We currently intend to
retain all available funds and any future earnings for use in the operation and expansion of our
business and do not anticipate paying any cash dividends in the foreseeable future. In addition,
the terms of any future debt or credit facility may preclude us from paying any dividends. As a
result, capital appreciation, if any, of our common stock will be your sole source of potential
gain for the foreseeable future.
Anti-takeover provisions in our organizational documents and Delaware law may discourage or prevent
a change of control, even an acquisition which would be beneficial to our stockholders, and thereby
affect our stock price adversely and prevent attempts by our stockholders to replace or remove our
current management.
Our amended and restated certificate of incorporation and amended bylaws contain provisions
that could delay or prevent a change of control of our company or changes in our board of directors
that our stockholders might consider favorable. Some of these provisions:
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authorize the issuance of preferred stock which can be created and issued by the board of
directors without prior stockholder approval, with rights senior to those of the common
stock; |
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provide for a classified board of directors, with each director serving a staggered
three-year term; |
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prohibit our stockholders from filling board vacancies, calling special stockholder
meetings, or taking action by written consent; |
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prohibit our stockholders from making certain changes to our amended and restated
certificate of incorporation or bylaws except with 66 2/3% stockholder approval; and |
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require advance written notice of stockholder proposals and director nominations. In
addition, we are subject to the provisions of Section 203 of the Delaware General
Corporation Law, which may prohibit certain business combinations with stockholders owning
15% or more of our outstanding voting stock. These and other provisions in our amended and
restated certificate of incorporation, restated bylaws and Delaware law could make it more
difficult for stockholders or potential acquirers to obtain control of our board of
directors or initiate actions that are opposed by our then-current board of directors,
including delaying or impeding a merger, tender offer, or proxy contest involving our
company. Any delay or prevention of a change of control transaction or changes in our board
of directors could cause the market price of our common stock to decline. |
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
On November 30, 2006, we issued 156,666 unregistered shares of our common stock to VasCon
pursuant to Regulation D under the Securities Act of 1933. The shares were issued in partial
consideration of the assets that we acquired pursuant to the Asset Purchase Agreement. We did not
sell any other unregistered shares of our common stock during the third quarter of fiscal 2007.
Use of Proceeds
Our Registration Statement on Form S-1 (File No. 333-123154) related to our IPO was declared
effective by the SEC on June 16, 2005. The public offering commenced on June 17, 2005. All
3,250,000 shares of common stock offered in the final prospectus were sold at the initial closing
on June 21, 2005, and an additional 250,000 shares of common stock subject to the underwriters
over-allotment option, were sold at a second closing on July 6, 2005, in each case at a price to
public of $11.00 per share (before deducting underwriting discounts and commissions) through a
syndicate of underwriters managed by A.G. Edwards and Needham & Company, LLC. The aggregate gross
proceeds of the shares offered and sold was $38.5 million, out of which we paid an aggregate of
$2.7 million in underwriting discounts and commissions to the underwriters. In addition, as of
March 31, 2006, we incurred additional expenses of approximately $2.8 million in connection with
the offering, which when added to the underwriting discounts and commissions paid by us, amounts to
total expenses of approximately $5.5 million.
We have used and intend to continue to use the net proceeds of the public offering primarily
for general corporate purposes, including costs associated with our entry into the Japanese and
Chinese markets, expansion of our sales force, research and development activities, technology and
asset acquisitions facilities expansion and other working capital and capital expenditures. The
amounts and timing of our actual expenditures will depend upon numerous factors, including the
growth of our sales and marketing activities, status of our research and development efforts and
the amount of cash generated by our operations, if any. We have used and may in the future also use
a portion of the proceeds for the acquisition of, or investment in, companies, technologies,
products or assets that complement our business.
We have not determined the amount of net proceeds to be used specifically for the foregoing
purposes. As a result, management will have broad discretion over the proceeds from the IPO.
Pending these uses, we intend to invest the net proceeds of the IPO in United States government and
short-term investment grade securities.
Issuer Purchases of Equity Securities
We do not have a stock repurchase program and did not repurchase any of our equity securities
during the quarter ended December 31, 2006.
Item 3. Defaults Upon Senior Securities.
None
Item 4. Submission of Matters to a Vote of Security Holders.
None
Item 5. Other Information.
None
Item 6. Exhibits.
See
the Index to Exhibits on Page 51 of this report
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Date: February 14, 2007 |
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By:
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/s/ John T. Kilcoyne
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John T. Kilcoyne |
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President and Chief Executive Officer |
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By:
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/s/ Robert A. Stern |
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Robert A. Stern |
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Executive Vice President, Chief Financial Officer |
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and Secretary |
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50
INDEX TO EXHIBITS
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Exhibit |
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Number |
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Description |
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3.1
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Certificate of Incorporation (incorporated by reference to Exhibit 3.2 of Amendment No. 3 to the
Registrants Registration Statement on Form S-1 filed on May 17, 2005 Registration No.
333-123154) (Amendment No. 3) |
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3.2
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Bylaws (incorporated by reference to Exhibit 3.4 of Amendment No. 3) |
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4.1
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Specimen Stock Certificate (incorporated by reference to Exhibit 4.1 of the Registrants
Registration Statement on Form S-1 filed on March 4, 2005 (Registration No. 333-123154) (Form
S-1) |
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4.2
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Warrant dated as of December 11, 2000 among the Registrant and Roberts Mitani Capital, LLC
(incorporated by reference to Exhibit 4.2 of Form S-1) |
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4.3
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Amended and Restated Stockholders Rights Agreement dated as of February 21, 2005 among the
Registrant and the parties listed therein (incorporated by reference to Exhibit 4.3 of Form S-1) |
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4.4
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Form of Common Stock Warrant issued in connection with the Series E Preferred Stock and Warrant
Purchase Agreement dated February 21, 2005, among the Registrant and the purchasers of the
Registrants Series E Preferred Stock (incorporated by reference to Exhibit 4.4 of Form 10-Q
filed on February 14, 2006) |
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10.1*
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Asset Purchase Agreement, dated November 30, 2006, by and among the Registrant, Micrus Design
Technology, Inc., VasCon, LLC and the members of VasCon, LLC |
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10.2
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Form of Director and Executive Officer Indemnification Agreement |
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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 Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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Certifications 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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* |
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Seeking confidential treatment as to portions of this agreement. |
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