e10vq
U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 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 April 1, 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: 000-49798
THORATEC CORPORATION
(Exact name of registrant as specified in its charter)
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California
(State or other jurisdiction of incorporation or
organization)
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94-2340464
(I.R.S. Employer Identification No.) |
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6035 Stoneridge Drive, Pleasanton, California
(Address of principal executive offices)
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94588
(Zip Code) |
Registrants telephone number, including area code: (925) 847-8600
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 (as defined in Rule 12b-2 of the Exchange Act):
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Large-accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o |
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 May 5, 2006, the registrant had 52,723,847 shares of common stock outstanding.
THORATEC CORPORATION AND SUBSIDIARIES
TABLE OF CONTENTS
2
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
THORATEC CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
(in thousands)
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April 1, |
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December 31, |
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2006 |
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2005 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
23,027 |
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$ |
35,109 |
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Short-term available-for-sale investments |
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178,028 |
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175,827 |
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Restricted short-term investments |
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3,361 |
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3,330 |
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Receivables, net of allowances of $533 and $634, respectively |
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35,490 |
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35,904 |
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Inventories |
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41,870 |
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41,671 |
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Deferred tax asset |
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5,461 |
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5,461 |
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Prepaid expenses and other assets |
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4,956 |
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3,582 |
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Total current assets |
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292,193 |
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300,884 |
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Property, plant and equipment, net |
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42,577 |
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28,906 |
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Restricted long-term investments |
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1,619 |
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1,610 |
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Goodwill |
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94,097 |
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94,097 |
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Purchased intangible assets, net |
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138,964 |
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141,938 |
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Other assets |
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6,486 |
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6,483 |
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Total Assets |
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$ |
575,936 |
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$ |
573,918 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
6,744 |
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$ |
8,421 |
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Accrued compensation |
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8,900 |
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15,707 |
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Accrued income taxes |
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2,063 |
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3,659 |
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Other accrued liabilities |
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4,676 |
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3,804 |
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Total current liabilities |
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22,383 |
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31,591 |
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Senior subordinated convertible notes |
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143,750 |
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143,750 |
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Long-term deferred tax liability and other |
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49,783 |
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50,430 |
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Total Liabilities |
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215,916 |
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225,771 |
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Shareholders equity: |
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Common shares: authorized 100,000; issued and outstanding 52,626 and 51,737, respectively |
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420,053 |
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407,531 |
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Deferred compensation |
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(184 |
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Accumulated deficit |
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(59,731 |
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(58,801 |
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Accumulated other comprehensive loss: |
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Unrealized loss on investments |
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(200 |
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(258 |
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Cumulative translation adjustments |
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(102 |
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(141 |
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Total accumulated other comprehensive loss |
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(302 |
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(399 |
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Total Shareholders Equity |
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360,020 |
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348,147 |
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Total Liabilities and Shareholders Equity |
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$ |
575,936 |
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$ |
573,918 |
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See notes to condensed consolidated financial statements.
3
THORATEC CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share data)
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Three Months Ended |
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April 1, |
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April 2, |
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2006 |
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2005 |
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Product sales |
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$ |
48,755 |
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$ |
50,488 |
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Cost of product sales |
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20,108 |
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20,048 |
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Gross profit |
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28,647 |
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30,440 |
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Operating expenses: |
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Selling, general and administrative |
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18,060 |
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14,817 |
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Research and development |
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9,585 |
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7,719 |
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Amortization of purchased intangible assets |
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2,974 |
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2,804 |
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Litigation |
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57 |
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178 |
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Total operating expenses |
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30,676 |
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25,518 |
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Income (loss) from operations |
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(2,029 |
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4,922 |
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Other income and (expense): |
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Interest expense |
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(1,103 |
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(1,008 |
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Interest income and other |
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1,701 |
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836 |
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Income (loss) before income tax benefit (expense) |
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(1,431 |
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4,750 |
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Income tax benefit (expense) |
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501 |
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(1,615 |
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Net income (loss) |
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$ |
(930 |
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$ |
3,135 |
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Net income (loss) per share: |
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Basic |
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$ |
(0.02 |
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$ |
0.07 |
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Diluted |
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$ |
(0.02 |
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$ |
0.06 |
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Shares used to compute net income per share: |
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Basic |
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52,218 |
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48,202 |
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Diluted |
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52,218 |
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49,009 |
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See notes to condensed consolidated financial statements.
4
THORATEC CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
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Three Months Ended |
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April 1, |
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April 2, |
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2006 |
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2005 |
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Cash flows from operating activities: |
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Net income (loss) |
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$ |
(930 |
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$ |
3,135 |
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Adjustments to reconcile net income to net cash provided (used) by operating activities: |
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Depreciation and amortization |
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4,875 |
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4,453 |
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Investment discount (premium) amortization |
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134 |
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132 |
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Non-cash interest and other expenses |
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1,103 |
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1,008 |
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Tax benefit related to stock options |
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1,896 |
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90 |
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Stock-based compensation expense |
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2,649 |
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232 |
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Excess tax benefits from stock-based compensation |
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(1,761 |
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Change in net deferred tax liability |
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(1,151 |
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(1,183 |
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Changes in assets and liabilities: |
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Receivables |
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414 |
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1,757 |
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Inventories |
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(358 |
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1,250 |
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Prepaid expenses and other assets |
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(1,374 |
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(690 |
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Accounts payable and other liabilities |
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(9,717 |
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(512 |
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Other |
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(126 |
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119 |
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Net cash provided (used) by operating activities |
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(4,346 |
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9,791 |
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Cash flows from investing activities: |
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Purchases of available-for-sale investments |
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(38,900 |
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(15,370 |
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Sales of available-for-sale investments |
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21,700 |
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8,900 |
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Maturities of available-for-sale investments and restricted investments |
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14,920 |
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3,070 |
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Purchases of property, plant and equipment, net |
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(15,329 |
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(1,104 |
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Net cash used in investing activities |
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(17,609 |
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(4,504 |
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Cash flows from financing activities: |
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Proceeds from stock option exercises, net |
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9,173 |
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541 |
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Restricted stock forfeiture |
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(1,100 |
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Excess tax benefits from stock-based compensation |
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1,761 |
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Repurchase of common stock |
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(2,238 |
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Net cash provided by financing activities |
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9,834 |
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(1,697 |
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Effect of exchange rate changes on cash and cash equivalents |
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39 |
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(108 |
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Net increase (decrease) in cash and cash equivalents |
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(12,082 |
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3,482 |
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Cash and cash equivalents at beginning of period |
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35,109 |
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16,017 |
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Cash and cash equivalents at end of period |
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$ |
23,027 |
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$ |
19,499 |
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Supplemental disclosure of cash flow information: |
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Cash paid for taxes |
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$ |
379 |
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$ |
427 |
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Supplemental disclosure of non-cash investing and financing activities: |
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Transfers of equipment from inventory |
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$ |
246 |
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$ |
502 |
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See notes to condensed consolidated financial statements.
5
THORATEC CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(unaudited)
(in thousands)
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Three Months Ended |
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April 1, |
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April 2, |
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2006 |
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2005 |
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Net income (loss) |
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$ |
(930 |
) |
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$ |
3,135 |
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Other net comprehensive income (loss): |
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Unrealized gain (loss) on
investments (net of taxes of $38
and $(108) for the three months
ended April 1, 2006 and April 2,
2005, respectively) |
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58 |
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(57 |
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Foreign currency translation
adjustments (net of taxes of $11
and $(33) for the three months
ended April 1, 2006 and April 2,
2005, respectively) |
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39 |
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(132 |
) |
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Comprehensive income (loss) |
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$ |
(833 |
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$ |
2,946 |
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See notes to condensed consolidated financial statements.
6
THORATEC CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
(in thousands, unless otherwise stated)
1. Basis of Presentation
The interim condensed consolidated financial statements of Thoratec Corporation, referred to
herein as we, our, Thoratec, or the Company, have been prepared and presented in accordance
with accounting principles generally accepted in the United States of America and the rules and
regulations of the Securities and Exchange Commission, referred to herein as the SEC, without
audit, and reflect all adjustments necessary (consisting only of normal recurring adjustments) to
present fairly our financial position, results of operations and cash flows. Certain information
and footnote disclosures normally included in our annual financial statements, prepared in
accordance with accounting principles generally accepted in the United States of America, have been
condensed or omitted. The accompanying financial statements should be read in conjunction with our
fiscal 2005 consolidated financial statements filed with the SEC in our Annual Report on Form 10-K.
The operating results for any interim period are not necessarily indicative of the results that may
be expected for any future period.
The preparation of our condensed consolidated financial statements necessarily requires us to
make estimates and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the condensed consolidated balance sheet dates
and the reported amounts of revenues and expenses for the periods presented.
2. Stock Based Compensation
Effective January 1, 2006 we adopted Statement of Financial Accounting Standards (SFAS)
No. 123(R), utilizing the modified prospective transition method. Prior to the adoption of SFAS No. 123(R), we accounted for stock-based compensation to employees using the intrinsic value method in
accordance with Accounting Principals Board Opinion (APB) No. 25, Accounting for Stock Issued to
Employees, and accordingly recognized no compensation expense for stock option grants or for our
employee stock purchase plan.
Under the modified prospective transition method, SFAS No. 123(R) applies to new awards and to
awards that were outstanding on January 1, 2006 that are subsequently modified, repurchased or
cancelled. Additionally, compensation cost recognized in the first quarter of 2006 includes
compensation cost for all share based payments granted prior to, but not yet vested as of January 1, 2006, based on the grant-date fair value estimated in accordance with the original provisions of
SFAS No. 123, and compensation cost for all share-based payments granted after January 1, 2006
based on the grant-date fair value estimated in accordance with the provisions of SFAS No. 123(R).
Prior periods were not restated.
As a result of adopting SFAS No. 123(R)
on January 1, 2006, our income before taxes, net
income, cash flow from operations, cash flow from financing activities and basic and diluted
earnings per share for the three months ended April 1, 2006,
were $2.3 million, $1.5 million,
$3.2 million, $1.8 million and $0.03 lower, respectively, than if we had continued to account for
stock-based compensation under APB No. 25 for our stock option grants.
We receive a tax deduction for certain stock option exercises during the period the options
are exercised, generally for the excess of the price at which the options are sold over the
exercise prices of the options. Prior to the adoption of SFAS No. 123(R), we reported all tax
benefits resulting from the exercise of stock options as operating cash flows in our condensed
consolidated statements of cash flows. In accordance with SFAS No. 123(R), for the three months
ended April 1, 2006, we revised our condensed consolidated statements of cash flows presentation to
report the tax benefits from the exercise of stock options as financing cash flows. For the three
months ended April 1, 2006, $1.7 million of tax benefits were reported as financing cash flows
rather than operating cash flows.
Net cash proceeds from the exercise of stock options were $8.6 million for the three months
ended April 1, 2006. The actual income tax benefit realized from stock option exercises was $1.9 million for the same period.
The following table illustrates the effect on operating results and per share information had
we accounted for our stock-
7
based compensation plans in accordance with SFAS No. 123(R), rather than using the intrinsic
value method in accordance with APB No. 25, for the three months ended April 2, 2005 (in thousands,
except per share amounts):
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Three Months Ended |
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April 2, 2005 |
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Net income: |
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As reported |
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$ |
3,135 |
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Add: Stock-based compensation expense included in
reported net income, net of related tax effects |
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153 |
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Deduct: Total stock-based compensation expense
determined under fair value based method for all
awards, net of related tax effects |
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(2,023 |
) |
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Pro forma net income |
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$ |
1,265 |
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Basic and Diluted earnings per share: |
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As reported |
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Basic |
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$ |
0.07 |
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Diluted |
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$ |
0.03 |
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Pro forma income |
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Basic |
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$ |
0.06 |
|
Diluted |
|
$ |
0.03 |
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Stock Option Plans
Pursuant to the terms of the Thoratec and Thermo Cardiosystems, Inc., or TCA, merger
agreement, all TCA stock-based compensation plans were assumed by Thoratec effective February 14,
2001. There have been no grants under any of TCAs plans since the merger. Moreover, all
outstanding options and restrictions on past TCA grants were accelerated and became fully vested as
of the merger date of February 14, 2001 and were converted to 971,222 shares of our common stock
options at the merger conversion ratio of 0.835 to 1. Although assumed by Thoratec, the TCA stock
options remain exercisable upon the same terms and conditions as under the TCA stock option plan
pursuant to which they were granted and the applicable option agreement.
In 1993, our Board of Directors approved the 1993 Stock Option Plan (1993 SOP), which
permits us to grant options to purchase up to 666,667 shares of our common stock. This plan expired
in 2003 and no options have been granted under the plan since its expiration.
In 1996, the Board of Directors adopted the 1996 Stock Option Plan (1996 SOP) and the 1996
Non-employee Directors Stock Option Plan (Directors Option Plan). The 1996 SOP consists of two
parts. Part One permits us to grant options to purchase up to 500,000 shares of common stock. This
plan expired in the first quarter of 2006. No options were granted during the quarter under Part
One of the 1996 SOP. Part Two related to the former Chief Executive Officer, Mr. Grossman, and
permitted us to grant non-qualified options to the former CEO to purchase up to 333,333 shares of
common stock, which were granted in 1996. The Directors Option Plan, as amended, permits us to
grant up to 550,000 shares and provides for an initial grant to a director to purchase 15,000
shares upon appointment to the Board, and annual grants thereafter to purchase 7,500 shares
(granted in four equal installments). Provisions also include immediate vesting of both initial and
annual grants and a five year life of the options. In addition, the plan administrator has been
provided with the discretion to impose any repurchase rights in our favor on any optionee. The
Directors Option Plan expired in February 2006 and during the quarter, no options were granted
under the Directors Option Plan.
In 1997, the Board of Directors adopted the 1997 Stock Option Plan (1997 SOP). The 1997 SOP
was amended by approval of a vote of our shareholders in February 2001, amended by the Board of
Directors in December 2001, and amended again by approval of a vote of our shareholders in May
2003. The 1997 SOP allows us to grant up to 13.7 million shares of stock in the form of stock
options, restricted stock awards, and stock bonuses. During the first quarter of 2006, 1.4 million
options were granted at fair market value under this plan and 0.3 million shares were granted as
restricted stock awards and restricted stock units under this plan.
We have four common stock option plans described above with options still outstanding at April
1, 2006, with only the 1997 SOP available for future grants. Options under the 1997 SOP may be
granted by the Board of Directors at the fair market value on the date of grant and generally
become fully exercisable within five years of grant and expire between five and ten years from the
date of grant. Options granted to officers contain a provision which provides for acceleration of
8
vesting upon a change of control. At the end of the first quarter of 2006, 0.4 million shares
remain available for grant under the 1997 SOP.
The fair value of each option granted is estimated at the date of grant using the
Black-Scholes option pricing model. The risk-free interest rate is based on the U.S. Treasury yield curve
in effect at the time of grant. Expected volatilities are based on the historical volatility of
our stock. The expected term of options represents the period of time that options are expected to
be outstanding. Beginning this quarter, groups of employees that have similar historical exercise
behavior are considered separately. The range below reflects the expected option impact of these
separate groups. The following assumptions were used for grants made in the first quarter of 2006 and
2005:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
April 1, 2006 |
|
April 2, 2005 |
Risk-free interest rate (weighted average) |
|
|
4.49 |
% |
|
|
4.22 |
% |
Expected volatility |
|
|
40 |
% |
|
|
50 |
% |
Expected option life (in years) |
|
|
3.88 5.25 |
|
|
|
3.67 |
|
Dividends |
|
None |
|
None |
At April 1, 2006, there was $10.6 million of unrecognized compensation cost related to
share-based payments which is expected to be recognized over a weighted average period of 1.45
years. The aggregate intrinsic value of in the money shares outstanding, based on a market price
of the Companys common stock on March 31, 2006 of $19.27, was $37.5 million, and the aggregate
intrinsic value of options exercisable was $23.0 million. The total intrinsic value of options
exercised was $4.9 million for the three months ended April 1, 2006.
Stock option activity is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
Weighted |
|
Weighted Average |
|
|
Options |
|
Average |
|
Remaining Contract |
|
|
(in thousands) |
|
Exercise Price |
|
Life |
Outstanding options at January 1, 2006 |
|
|
6,445 |
|
|
$ |
12.80 |
|
|
|
|
|
Granted |
|
|
1,392 |
|
|
|
21.51 |
|
|
|
|
|
Exercised |
|
|
(686 |
) |
|
|
12.89 |
|
|
|
|
|
Forfeited or expired |
|
|
(66 |
) |
|
|
14.02 |
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding options at April 1, 2006 |
|
|
7,085 |
|
|
$ |
14.49 |
|
|
7.33yrs. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding options exercisable at April 1, 2006 |
|
|
3,484 |
|
|
|
12.82 |
|
|
5.92yrs. |
|
|
|
Restricted Stock Units
In the first quarter of 2006, we granted restricted stock units to certain of our non-U.S.
employees under the 1997 SOP. At April 1, 2006, there was $0.1 million of unrecognized
compensation cost related to these restricted stock units which is expected to be recognized over a
weighted average period of 2.40 years. The aggregate intrinsic value of the units, based on the
Companys stock price on March 31, 2006, was
$0.2 million and the aggregate intrinsic value of units
vested during the three months ended April 1, 2006 was none as
no units vested during the quarter.
Restricted Stock unit activity is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
Weighted Average |
|
Weighted Average |
|
|
Units |
|
Grant Date Fair |
|
Remaining Contract |
|
|
(in thousands) |
|
Value |
|
Life |
Outstanding units at January 1, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
8 |
|
|
$ |
20.34 |
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding units at April 1, 2006 |
|
|
8 |
|
|
$ |
20.34 |
|
|
|
2.40 |
|
|
|
|
Outstanding units vested at April 1, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9
Employee Stock Purchase Plan
In May 2002, our shareholders approved the Companys Employee Stock Purchase Plan (ESPP)
under which 500,000 shares of common stock were reserved for issuance. In addition, the ESPP
provides for an annual increase of up to 250,000 shares in the total number of shares available for
issuance under the ESPP on March 1 of each year. Under this provision, on March 1, 2006, an
additional 250,000 shares were reserved for issuance under the ESPP. Eligible employees may
purchase a limited number of shares of the Companys stock at 85% of the lower of the market value
on the offering date or the market value on the purchase date. No shares of common stock were
issued under the ESPP during the first quarter of 2006. As of the end of the first quarter,
approximately 337,000 shares are available for issuance under this plan.
The estimated subscription date fair value of the current offering under the ESPP is
approximately $0.2 million using the Black-Scholes option pricing model and using the following
assumptions:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
April 1, 2006 |
|
April 2, 2005 |
Risk-free interest rate |
|
|
4.25 |
% |
|
|
2.20 |
% |
Expected volatility |
|
|
40 |
% |
|
|
50 |
% |
Expected option life |
|
0.5 yrs |
|
0.5yrs |
Dividends |
|
None |
|
None |
At April 1, 2006, there was approximately $40,000 of unrecognized compensation cost related to
subscriptions that began on November 1, 2005 which is expected to be recognized during the second
quarter of 2006.
Restricted Stock
The 1997 Stock Option Plan allows for the issuance of restricted stock awards and restricted
stock units which may not be sold or otherwise transferred until certain restrictions have lapsed.
The unearned stock-based compensation related to these awards is being amortized to compensation
expense over the period of the restrictions, generally four years. The expense for these awards
was determined based on the market price of our stock on the date of grant applied to the total
number of shares that were granted. Except for the restricted stock awards to executive officers
and a consultant described below, no such awards were issued prior to the first quarter of 2006.
In 2001, an award of 250,000 shares of restricted common stock was made to our then Chief
Executive Officer, Mr. Grossman, under our 1997 Stock Option Plan. This award was valued at $4.1
million, recorded as deferred compensation, and was being amortized over the restriction lapse
period prior to the acceleration described below. In 2002, a similar award of 50,000 shares was
made to another of our executive officers. This award was valued at $0.3 million, was recorded as
deferred compensation, and was being amortized over the restriction lapse period. The second award
was forfeited in December 2004 upon the resignation of the executive officer and the previously
recognized amortization of deferred compensation of $0.2 million was reversed. In addition, 25,000
shares of restricted stock were granted to a consultant in December 2004. This award is re-valued
each period at the current market rate and is accrued ratably over the restriction lapse period of
three years. In August 2005, Mr. Grossman announced his resignation and entered into an agreement
which amended his employment contract and provided that he would remain employed by the Company for
up to three months following the appointment of the replacement CEO in order to assist in the
transition. The transition period ended on February 2, 2006. Mr. Grossman remains a member of the
Companys Board of Directors and will provide consulting services to the Company pursuant to a
Consulting Services Agreement dated August 15, 2005 for a period of nine months. Pursuant to the
terms of the amended employment agreement with Mr. Grossman, the restriction on the remaining
125,000 shares of such restricted common stock was accelerated generating an additional $0.1
million in expense in the first quarter of 2006.
Share-based compensation expense related to these restricted stock grants was $ 0.2 million
for each of the three months ended April 1, 2006 and April 2, 2005. As of April 1, 2006, we had
$3.2 million of unrecognized compensation cost associated with these restricted stock awards which
is expected to be recognized over a weighted average period of 3.07 years. The total fair value of
the shares that vested during the quarter ended April 1, 2006 was $2.1 million.
The following table summarizes the restricted stock award activity in the first quarter of
2006:
10
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
Weighted Average |
|
|
|
Shares |
|
|
Grant Date Fair |
|
|
|
(in thousands) |
|
|
Value |
|
Outstanding non-vested restricted stock at January 1, 2006 |
|
|
150 |
|
|
$ |
14.89 |
|
Granted |
|
|
260 |
|
|
|
20.34 |
|
Vested |
|
|
(133 |
) |
|
|
15.94 |
|
Forfeited or expired |
|
|
|
|
|
|
|
|
|
|
|
Outstanding non-vested restricted stock at April 1, 2006 |
|
|
277 |
|
|
$ |
19.51 |
|
|
|
|
3. New Accounting Pronouncements
None.
4. Cash and cash equivalents
Cash and cash equivalents are defined as short-term, highly liquid investments with original
maturities of 90 days or less.
5. Investments
Investments classified as short-term available-for-sale are reported at fair value based upon
quoted market prices and consist primarily of auction rate securities, corporate and municipal
bonds, and U.S. government obligations. All investments mature within two years or less from the
date of purchase. Investments with maturities beyond one year may be classified as short-term, if
they are available and intended for use in current operations, based on their highly liquid nature
or due to the frequency with which the interest rate is reset, such as with auction rate
securities.
Investments classified as restricted are securities held in U.S. Treasuries as collateral for
future interest payments related to our convertible notes and are reported at fair value based upon
quoted market prices. The investments that relate to interest payments due within one year have
been classified as restricted short-term investments and the investments that relate to interest
payments due after one year have been classified as restricted long-term investments.
For all investments, temporary differences between cost and fair value are presented as a
separate component of accumulated other comprehensive income. We have determined that the
investments had no impairments that were other than temporary. The specific identification method
is used to determine realized gains and losses on investments.
6. Financial Instruments
We conduct business in foreign countries. Our international operations consist primarily of
sales and service personnel for our ventricular assist products who report to our U.S. sales and
marketing group and are internally reported as part of that group. All assets and liabilities of
our non-U.S. operations are translated into U.S. dollars at the period-end exchange rates and the
resulting translation adjustments are included in comprehensive income. The period-end translation
of the non-functional currency assets and liabilities (primarily assets and liabilities on our UK
subsidiarys consolidated balance sheet that are not denominated in UK pounds sterling) at the
period-end exchange rates result in foreign currency gains and losses, which are included in
Interest Income and Other.
We use forward foreign currency contracts to hedge the gains and losses generated by the
re-measurement of non-functional currency assets and liabilities (primarily assets and liabilities
on our UK subsidiarys condensed consolidated balance sheet that are not denominated in UK pounds
sterling). Changes in the fair value of the forward currency contracts are included in Interest
Income and Other, and typically offset the foreign currency exchange gains and losses. These
derivatives are not designated as cash flow or fair value hedges under SFAS No. 133 and typically
have maturities of three months or less. At April 1, 2006, we had forward foreign currency
contracts in euros with a notional value of $4.7 million, and at December 31, 2005, we had forward
foreign currency contracts in euros with a notional value at $4.4 million. These contracts had an
average exchange rate of euros to U.S. dollars of 0.8332 as of April 1, 2006. The impact of
foreign currency revaluation, net of forward foreign currency contracts, was a gain of $0.1 million
for the quarter ended April 1, 2006 and a loss of $0.2 million for the quarter ended April 2, 2005.
11
7. Inventories
Inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
April 1, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
|
(in thousands) |
|
Finished goods |
|
$ |
20,854 |
|
|
$ |
19,952 |
|
Work in process |
|
|
6,402 |
|
|
|
6,303 |
|
Raw materials |
|
|
14,614 |
|
|
|
15,416 |
|
|
|
|
|
|
|
|
Total |
|
$ |
41,870 |
|
|
$ |
41,671 |
|
|
|
|
|
|
|
|
8. Property, Plant and Equipment, net
Property, plant and equipment, net, consist of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
April 1, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
|
(in thousands) |
|
Land |
|
$ |
4,096 |
|
|
$ |
341 |
|
Building |
|
|
12,040 |
|
|
|
2,445 |
|
Building lease |
|
|
2,285 |
|
|
|
2,285 |
|
Equipment |
|
|
44,859 |
|
|
|
44,067 |
|
Rental equipment |
|
|
7,544 |
|
|
|
7,334 |
|
Improvements |
|
|
12,663 |
|
|
|
11,526 |
|
|
|
|
|
|
|
|
Total |
|
|
83,487 |
|
|
|
67,998 |
|
Accumulated depreciation and amortization |
|
|
(40,910 |
) |
|
|
(39,092 |
) |
|
|
|
|
|
|
|
|
|
$ |
42,577 |
|
|
$ |
28,906 |
|
|
|
|
|
|
|
|
9. Goodwill and Purchased Intangible Assets
The carrying amount of goodwill, which is attributable solely to our Cardiovascular segment,
for the three and twelve month periods ended April 1, 2006 and December 31, 2005 was $94.1 million.
The components of identifiable intangible assets, consisting primarily of patents and
trademarks, core technology (i.e., Thoralon, our patent protected bio-material that is present in
most products) and developed technology (i.e., patent technology, other than core technology,
acquired in our merger with TCA), which are included in purchased intangible assets on the
condensed consolidated balance sheets, are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of April 1, 2006 |
|
|
|
Gross Carrying |
|
|
Accumulated |
|
|
Net Carrying |
|
|
|
Amount |
|
|
Amortization |
|
|
Amount |
|
|
|
(in thousands) |
|
Patents and Trademarks |
|
$ |
37,815 |
|
|
$ |
(18,602 |
) |
|
$ |
19,213 |
|
Core Technology |
|
|
37,485 |
|
|
|
(9,143 |
) |
|
|
28,342 |
|
Developed Technology |
|
|
122,782 |
|
|
|
(31,430 |
) |
|
|
91,352 |
|
Non-compete Agreement |
|
|
90 |
|
|
|
(33 |
) |
|
|
57 |
|
|
|
|
|
|
|
|
|
|
|
Total Purchased Intangible Assets, net |
|
$ |
198,172 |
|
|
$ |
(59,208 |
) |
|
$ |
138,964 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2005 |
|
|
|
Gross Carrying |
|
|
Accumulated |
|
|
Net Carrying |
|
|
|
Amount |
|
|
Amortization |
|
|
Amount |
|
(in thousands) |
|
|
|
|
|
Patents and Trademarks |
|
$ |
37,815 |
|
|
$ |
(17,692 |
) |
|
$ |
20,123 |
|
Core Technology |
|
|
37,485 |
|
|
|
(8,762 |
) |
|
|
28,723 |
|
Developed Technology |
|
|
122,782 |
|
|
|
(29,750 |
) |
|
|
93,032 |
|
Non-compete Agreement |
|
|
90 |
|
|
|
(30 |
) |
|
|
60 |
|
|
|
|
|
|
|
|
|
|
|
Total Purchased Intangible Assets |
|
$ |
198,172 |
|
|
$ |
(56,234 |
) |
|
$ |
141,938 |
|
|
|
|
|
|
|
|
|
|
|
Effective January 1, 2006, the Company revised its estimate for the remaining useful lives for
certain of its developed technology intangible assets. The effect of the change was to increase
amortization expense by $0.2 million during the three
12
months ended April 1, 2006 and is expected to increase amortization by $0.7 million during
each of the next five years. Amortization expense related to purchased intangible assets, net, was
$3.0 million and $2.8 million for the three months ended April 1, 2006 and April 2, 2005,
respectively. Amortization expense is expected to be approximately $11.9 million for each of the
next five years. Patents and trademarks have useful lives of eight to twenty years, core and
developed technology assets have useful lives ranging from nine to twenty-four years and the useful
life of the non-compete agreement is approximately six years.
10. Long-Term Debt
In the second quarter of 2004, we sold $143.8 million in initial principal amount of senior
subordinated convertible notes due 2034. The convertible notes were sold to Qualified Institutional
Buyers pursuant to the exemption from the registration requirements of the Securities Act of 1933,
as amended, provided by Rule 144A thereunder. We used $9.8 million of the net proceeds to purchase
and pledge to the trustee under the indenture for the exclusive benefit of the holders of the
convertible notes, U.S. Treasury securities to provide for the payment, in full, of the first six
scheduled interest payments. These securities are reflected on our condensed consolidated balance
sheets as restricted short-term and long-term investments. Additional net proceeds were used to
repurchase 4.2 million shares of our outstanding common stock for $60 million. The remaining net
proceeds have been and will be used for general corporate purposes, which may include additional
stock repurchases, strategic investments or acquisitions. Total net proceeds to the Company from
the sale were $139.4 million, after debt issuance costs of $4.3 million.
The convertible notes were issued at an issue price of $580.98 per note, which is 58.098% of
the principal amount at maturity of the notes. The convertible notes bear interest at a rate of
1.3798% per year on the principal amount at maturity, payable semi-annually in arrears in cash on
May 16 and November 16 of each year, from November 16, 2004 until May 16, 2011. Beginning on May
16, 2011, the original issue discount will accrue daily at a rate of 2.375% per year on a
semi-annual bond equivalent basis and, on the maturity date, a holder will receive $1,000 per note.
As a result, the aggregate principal amount of the notes at maturity will be $247.4 million.
The deferred debt issuance costs of $3.2 million, net of $1.1 million in amortization, are included
in Other assets on the condensed consolidated balance sheet as of April 1, 2006. The deferred
debt issuance costs are amortized on a straight line basis until May 2011 at which point the
Company can redeem the debt. These charges are included in Interest expense in our condensed
consolidated statements of operations.
|
|
|
|
|
|
|
Fiscal Year |
|
|
|
2004 |
|
|
|
(in millions) |
|
Long Term Debt Offering Proceeds: |
|
|
|
|
Principal amount of convertible notes at maturity |
|
$ |
247.4 |
|
Original issue discount |
|
|
(103.7 |
) |
Debt issuance costs |
|
|
(4.3 |
) |
|
|
|
|
Net proceeds |
|
$ |
139.4 |
|
|
|
|
|
Holders of the convertible notes may convert their notes into shares of our common stock at a
conversion rate of 29.4652 shares per $1,000 principal amount of convertible notes, which
represents a conversion price of $19.72 per share, subject to adjustments upon the occurrence of
certain events. Holders may convert their convertible notes at any point after the close of
business on September 30, 2004 if, as of the last day preceding the calendar quarter, the closing
price of our common stock for at least 20 trading days in a period of 30 consecutive trading days
ending on the last trading day of such preceding calendar quarter is more than 120% of the accreted
conversion price per share of our common stock. Holders may surrender their convertible notes for
conversion on or before May 16, 2029 during the five business day period after any five consecutive
trading day period in which the trading price per note for each day of that period was less than
98% of the product of the closing sale price of our common stock and the conversion rate on each
such day. However, in such event, if on the day before any conversion the closing sale price of
our common stock is greater than the accreted conversion price (i.e., the issue price of the note
plus accrued original issue discount divided by the conversion rate) but less than or equal to 120%
of the accreted conversion price, instead of shares of our common stock based on the conversion
rate, holders will receive cash or common stock, or a combination of each at our option, with a
value equal to the accreted principal amount of the notes plus accrued but unpaid interest as of
the conversion date. Additionally, holders may convert their convertible notes if we call them for
redemption or if specified corporate transactions or significant distributions to holders of our
stock have occurred. As of April 1, 2006 no notes had been converted or called.
13
Holders may require us to repurchase all or a portion of their convertible notes on each of
May 16, 2011, 2014, 2019, 2024 and 2029 at a repurchase price equal to 100% of the issue price,
plus accrued original issue discount, if any. In addition, if we experience a change in control or
a termination of trading of our common stock each holder may require us to purchase all or a
portion of such holders notes at the same price, plus, in certain circumstances, a make whole
premium. This premium is considered an embedded derivative under SFAS No. 133 and has been
bifurcated from the convertible notes and recorded at its estimated fair value, $0.2 million at
April 1, 2006. There are significant variables and assumptions used in valuing the make-whole
provision including, but not limited to, the companys stock price, volatility of the companys
stock, the probability of acquisition and the probability of the type of consideration used by a
potential acquirer.
We may redeem any of the convertible notes, at any time beginning May 16, 2011, by giving the
holders at least 30 days notice, either in whole or in part at a redemption price equal to the sum
of the issue price and the accrued original issue discount, plus accrued and unpaid interest and
liquidation damages, if any for our failure to comply with our registration obligations regarding
the convertible notes.
The convertible notes are subordinated to all of our senior indebtedness and structurally
subordinated to all indebtedness of our subsidiaries. Therefore, in the event of a bankruptcy,
liquidation or dissolution of us or one or more of our subsidiaries and acceleration of or payment
default on our senior indebtedness, holders of the convertible notes will not receive any payment
until holders of any senior indebtedness we may have outstanding have been paid in full.
The aggregate fair value of the convertible notes at April 1, 2006, based on market quotes,
was $164.8 million.
11. Litigation
On August 3, 2004, a putative Federal securities law class action entitled Johnson v. Thoratec
Corporation, et al. was filed in the U.S. District Court for the Northern District of California on
behalf of purchasers of our publicly traded securities between April 28, 2004 and June 29, 2004.
Subsequent to the filing of the Johnson complaint, additional complaints were filed in the same
court alleging substantially similar claims. On November 24, 2004, the Court entered an order
consolidating the various putative class action complaints into a single action entitled In re
Thoratec Corp. Securities Litigation and thereafter entered an order appointing Craig Toby as
Lead Plaintiff pursuant to the Private Securities Litigation Reform Act of 1995. On or about
January 18, 2005, Lead Plaintiff filed a Consolidated Complaint. The Consolidated Complaint
generally alleges violations of the Securities Exchange Act of 1934 by Thoratec, its former Chief
Executive Officer, its former Chief Financial Officer, and its Cardiovascular Division President
based upon, among other things, alleged false statements about the Companys expected sales and the
market for HeartMate as a Destination Therapy treatment. The Consolidated Complaint seeks to
recover unspecified damages on behalf of all purchasers of the Companys publicly traded securities
during the putative class period. On March 4, 2005, defendants moved to dismiss the Consolidated
Complaint and that motion currently is pending.
On or about September 1, 2004, a shareholder derivative action entitled Wong v. Grossman was
filed in the California Superior Court for Alameda County based upon essentially the same facts as
the Federal securities class action suit referred to above. This action names the individual
members of our Board of Directors, including the former Chief Executive Officer and certain other
former and current executive officers of the Company, as defendants, and alleges that the
defendants breached their fiduciary duties and wasted corporate assets, and that certain of the
defendants traded in Thoratec securities while in possession of material nonpublic information.
Proceedings in Wong v. Grossman are currently stayed until June 7, 2006.
We believe that the claims asserted in both the Federal securities law putative class action
and the state shareholder derivative actions are without merit. We have moved to dismiss the
Federal action and will file a similar motion in the Wong action if necessary.
We are unable to predict at this time the final outcome of these actions.
We carry sufficient insurance to cover what management believes to be any reasonable potential
exposure on these actions; however, we cannot give assurance that our insurance will cover all
costs or other exposures we may incur with respect to these actions.
14
12. Income Taxes
Our effective income tax expense rates were 35% and 34%, respectively, for the three months
ended April 1, 2006 and April 2, 2005. The increase in our effective tax rate on a comparative
basis was due primarily to a combination of nondeductible compensatory costs under SFAS No. 123(R)
and reduced federal research credits, offset in part by increased interest income from tax
favorable investments and continuing benefits related to export of manufactured goods.
At April 1, 2006 and December 31, 2005, we reported a net deferred tax liability of
approximately $49.8 million and $50.4 million, respectively, comprised principally of temporary
differences between the financial statement and income tax bases of intangible assets.
13. Net Income (Loss) Per Share
Basic and diluted net income (loss) per share was calculated as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
April 1, |
|
|
April 2, |
|
|
|
2006 |
|
|
2005 |
|
Net income (loss) |
|
$ |
(930 |
) |
|
$ |
3,135 |
|
|
|
|
|
|
|
|
Weighted average number of common shares-basic |
|
|
52,218 |
|
|
|
48,202 |
|
Dilutive effect of stock options and Employee
Stock Purchase Plan shares |
|
|
|
|
|
|
807 |
|
|
|
|
|
|
|
|
Weighted average number of common shares-diluted |
|
|
52,218 |
|
|
|
49,009 |
|
|
|
|
|
|
|
|
Net income (loss) per common share
Basic |
|
$ |
(0.02 |
) |
|
$ |
0.07 |
|
|
|
|
|
|
|
|
Diluted |
|
$ |
(0.02 |
) |
|
$ |
0.06 |
|
|
|
|
|
|
|
|
Basic earnings (loss) per share are computed by dividing net income (loss) by the weighted
average number of common shares outstanding during the period. Diluted earnings per share reflect
the potential dilution that could occur if securities or other contracts to issue common stock were
exercised or converted into common stock. Options to purchase 3.4 and 5.9 million shares of common
stock were not included in the computation of diluted income and losses per share for the three
months ended April 1, 2006 and April 2, 2005, respectively, as their inclusion would be
antidilutive. In addition, the computation of diluted earnings per share for April 1, 2006 and
April 2, 2005, respectively, excludes the effect of assuming the conversion of our convertible
notes, which are convertible at $19.72 per share into 7.3 million shares of common stock, because
their effect would have been antidilutive for each of the three months ended April 1, 2006 and
April 2, 2005.
14. Business Segment and Geographical Data
We organize and manage our business by functional operating entities. Our functional entities
operate in two segments: Cardiovascular and ITC. The Cardiovascular segment develops, manufactures
and markets proprietary medical devices used for circulatory support and vascular graft
applications. The ITC segment designs, develops, manufactures and markets point-of-care diagnostic
test systems and incision devices.
Business Segments:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
April 1, |
|
|
April 2 |
|
|
|
2006 |
|
|
2005 |
|
Product sales: |
|
|
|
|
|
|
|
|
Cardiovascular |
|
$ |
29,816 |
|
|
$ |
32,066 |
|
ITC |
|
|
18,939 |
|
|
|
18,422 |
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
48,755 |
|
|
$ |
50,488 |
|
|
|
|
|
|
|
|
Income before income taxes: |
|
|
|
|
|
|
|
|
Cardiovascular (a)(d) |
|
$ |
2,257 |
|
|
$ |
6,128 |
|
ITC(a)(d) |
|
|
690 |
|
|
|
3,151 |
|
Corporate (b)(d) |
|
|
(4,919 |
) |
|
|
(4,179 |
) |
Litigation (c) |
|
|
(57 |
) |
|
|
(178 |
) |
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
(2,029 |
) |
|
|
4,922 |
|
15
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
April 1, |
|
|
April 2 |
|
|
|
2006 |
|
|
2005 |
|
Other income and (expense): |
|
|
|
|
|
|
|
|
Interest expense |
|
|
(1,103 |
) |
|
|
(1,008 |
) |
Interest income and other |
|
|
1,701 |
|
|
|
836 |
|
|
|
|
|
|
|
|
Income (loss) before income tax benefit (expense) |
|
$ |
(1,431 |
) |
|
$ |
4,750 |
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Includes amortization expense of $2.9 million and $2.8 million for the three months ended
April 1, 2006 and April 2, 2005, respectively, related to the Cardiovascular segment. The ITC
segment also includes amortization expense of $40,000 for each of the three months ended April
1, 2006 and April 2, 2005. |
|
(b) |
|
Represents primarily general and administrative items not specifically identified to a
particular business segment. |
|
(c) |
|
Relates to expenses not specifically identified to a particular business segment. |
|
(d) |
|
Includes additional SFAS No. 123(R) expense of $1.0 million, $0.7 million and $0.8 million
for Cardiovascular, ITC and Corporate, respectively, for the three months ended April 1, 2006. |
Geographic Areas:
The geographic composition of our product sales was as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
April 1, |
|
|
April 2, |
|
|
|
2006 |
|
|
2005 |
|
Domestic |
|
$ |
36,646 |
|
|
$ |
39,204 |
|
International |
|
|
12,109 |
|
|
|
11,284 |
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
48,755 |
|
|
$ |
50,488 |
|
|
|
|
|
|
|
|
15. Subsequent Events
In May 2006 we purchased approximately 0.3 million shares of our common stock for $5.0 million
completing the stock repurchase program authorized in July 2004 by our Board of Directors.
16
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Forward-Looking Statements
This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934,
as amended. These statements can be identified by the words expects, projects, hopes,
believes, intends, should, estimate, will, would, may, anticipates, plans,
could and other similar words. Actual results, events or performance could differ materially from
these forward-looking statements based on a variety of factors, many of which are beyond our
control. Therefore, readers are cautioned not to put undue reliance on these statements. Factors
that could cause actual results or conditions to differ from those anticipated by these and other
forward-looking statements include those more fully described in the Risk Factors section of our
2005 Annual Report on Form 10-K and in other documents we file with the Securities and Exchange
Commission. These forward-looking statements speak only as of the date hereof. We undertake no
obligation to publicly release the results of any revisions to these forward-looking statements
that may be made to reflect events or circumstances after the date hereof, or to reflect the
occurrence of unanticipated events.
The following presentation of managements discussion and analysis of our financial condition
and results of operations should be read together with our condensed consolidated financial
statements included in this Form 10-Q.
Overview
We are a leading manufacturer of circulatory support products for use by patients with heart
failure, or HF. Our Ventricular Assist Devices, or VADs, are used primarily by HF patients to
perform some or all of the pumping function of the heart. We currently offer the widest range of
products to serve this market. We believe that our long-standing reputation for quality and
innovation, and our excellent relationships with leading cardiovascular surgeons worldwide,
position us to capture growth opportunities in the expanding HF market. Through our wholly-owned
subsidiary International Techidyne Corporation, or ITC, we design, develop, manufacture and market
point-of-care diagnostic test systems and incision products that provide for fast, accurate blood
test results to improve patient management, reduce healthcare costs and improve patient outcomes.
Our Business Model
Our business is comprised of two segments: Cardiovascular and ITC.
The product line of our Cardiovascular segment is:
|
|
|
Circulatory Support Products. Our circulatory support products include VADs for the
short, intermediate and long-term treatment of advanced heart failure. In addition, we
have developed small diameter grafts using our proprietary materials to address the
vascular access market. Our grafts are used for hemodialysis. |
The product lines of our ITC segment are:
|
|
|
Point-of-Care Diagnostics. Our point-of-care products include coagulation diagnostic
test systems that monitor blood coagulation for a patient while being administered certain
anticoagulants, blood gas/electrolyte and chemistry status, or anemia. |
|
|
|
|
Incision. Our incision products include devices used to obtain a patients blood sample
for diagnostic testing and screening for platelet function. |
Cardiovascular segment
We offer the following broad product portfolio of implantable and external circulatory support
devices:
|
|
|
The Thoratec Ventricular Assist Device System is an external device for short to
mid-term cardiac support, which is sold worldwide. The device is approved to assist left,
right and biventricular support and is worn outside of the body. The Thoratec VAD is
approved for use in bridge-to-transplantation, or BTT, and for post-cardiotomy myocardial
recovery. |
17
|
|
|
The Thoratec IVAD is the only implantable blood pump approved for both BTT and
post-cardiotomy myocardial recovery. It can be used for left, right, or biventricular
support. The IVAD utilizes the same internal working components as the Thoratec VAD System,
but has an outer housing made of a titanium alloy that makes it more suitable for
implantation. |
|
|
|
|
The HeartMate XVE Left Ventricular Assist System, or LVAS, is an implantable device for
mid to long-term cardiac support and the only device approved in the U.S., Europe and
Canada for permanent support, or Destination Therapy, of those patients ineligible for
heart transplantation. The HeartMate XVE is also approved for use in BTT. |
|
|
|
|
The HeartMate II, which is currently in clinical trials for BTT and Destination
Therapy, is an implantable device consisting of a miniature rotary blood pump designed to
provide long-term cardiac support. Its design is intended to be not only smaller, but also
simpler, quieter, and longer lasting than the current generation of ventricular assist
devices. |
In addition to our cardiac assist products, we sell vascular access grafts, used in
hemodialysis for patients with late-stage renal disease.
We primarily market our VAD products to those patients suffering from heart failure and, in
particular, from late-stage HF. HF is a chronic disease that occurs when degeneration of the heart
muscle reduces the pumping power of the heart, causing the heart to become too weak to pump blood
at a level adequate to meet the bodys demands. HF can be caused by artery or valve diseases or a
general weakening of the heart muscle itself. Other conditions, such as high blood pressure or
diabetes, can also lead to HF.
In the United States, we currently have two FDA-approved indications for the use of VADs in
patients with HF: as a bridge to heart transplant and as Destination Therapy. We are currently
pursuing an additional indication for our Thoratec VAD products: therapeutic recovery of the heart.
Beyond the HF markets, VADs are also approved for use during recovery following cardiac surgery.
We currently market VADs that may be implanted or worn outside the body and that are suitable
for treatments for different durations for patients of varying sizes and ages. We estimate that
doctors have implanted more than 10,000 of our devices in patients suffering from heart failure. On
November 6, 2002, the United States Food and Drug Administration, or FDA, approved the HeartMate
VAD as the first heart assist device for Destination Therapy. On April 7, 2003, the FDA approved
the HeartMate XVE, an enhanced version of the HeartMate VAD, for Destination Therapy. Thoratec is
the only company to have a ventricular assist device approved for Destination Therapy in the United
States. In August 2004, we received FDA approval in the U.S. to market the IVAD for use in
bridge-to-transplantation and post-cardiotomy recovery patients who are unable to be weaned from
cardiopulmonary bypass. This makes the IVAD the only currently approved implantable cardiac assist
device that can provide left, right or biventricular support.
ITC Segment
Our major point-of-care, or POC, diagnostic test systems and incision device products are:
|
|
|
The Hemochron POC coagulation system, which is used to monitor a patients coagulation
while being administered anticoagulants in various settings, including in the
cardiovascular operating room and cardiac catheterization lab to monitor the drug Heparin
and in an anticoagulation clinic to monitor the drug Coumadin. Hemochron is considered a
moderately complex device and must be used by professionally trained personnel. The system
consists of a small, portable analytical instrument and disposable test cuvettes. |
|
|
|
|
The IRMA POC blood gas/electrolyte and chemistry system, which is used to monitor a
patients blood gas/electrolyte and chemistry status. It is considered moderately complex
and its use requires supervision by professionally trained personnel. The system consists
of a small, portable analytical instrument and disposable test cartridges. |
|
|
|
|
The ProTime coagulation monitoring system, which is used to monitor patients
coagulation while they are taking oral anticoagulants such as Warfarin, and can be
prescribed for use by patients at home or can be used in the physicians office or clinic.
The system consists of a small, portable, analytical instrument and disposable test
cuvettes. |
18
|
|
|
The Hemoglobin Pro, or Hgb Pro, which is used by professionals, mainly in the doctors
office to test for anemia. It provides quick results from a very small blood sample. The
system consists of a small, hand held test meter and disposable test strips. |
|
|
|
|
Tenderfoot, Tenderlett and Surgicutt incision products, which are used by professionals
to obtain a patients blood sample for diagnostic testing. The Tenderfoot is a heel stick
used for infant testing, the Tenderlett is used for finger incisions and the Surgicutt is
used to perform screening tests to determine platelet function. All products feature
permanently retracting blades for safe, virtually pain-free incision. |
The Hemochron and IRMA products are primarily sold into the hospital POC segment of the
market. The ProTime and Hemoglobin Pro products are sold into the alternate site (non-hospital) POC
market comprising physicians offices, long-term care facilities, clinics, visiting nurse
associations, and home healthcare companies.
Our incision products are sold to both the hospital POC and the alternate site POC markets.
Our most successful incision product is the Tenderfoot. Although we market this product based on
its high-end features, we believe that customers are increasingly making purchasing decisions on
these types of products based on price.
Critical Accounting Policies and Estimates
We have identified the policies below as critical to our business operations and the
understanding of our results of operations. The impact of, and any associated risks related to
these policies on our business operations are discussed below. For a more detailed discussion on
the application of these and other accounting policies, see the notes to the condensed consolidated
financial statements included in this Quarterly Report on Form 10-Q and our Annual Report on Form
10-K for fiscal 2005 filed with the SEC. Preparation of financial statements in accordance with
generally accepted accounting principles requires management to make estimates and assumptions that
affect the reported amount of assets, liabilities, revenue and expenses and the disclosure of
contingent assets and liabilities. There can be no assurance that actual results will not differ
from those estimates.
Make-Whole Premium
Under the terms of our senior subordinated convertible notes issued in 2004, if we experience
a change in control or a termination of trading of our common stock, each note holder may require
us to purchase all or a portion of their notes at a price equal to the issue price plus any
original issue discount. In addition, if the consideration for the change in control is all cash,
the company will pay a make-whole premium to the note holders. This premium is considered an
embedded derivative under SFAS No. 133 and has been bifurcated from the convertible notes and
recorded at its estimated fair value, $0.2 million and none at April 1, 2006 and April 2, 2005,
respectively.
There are significant variables and assumptions used in valuing the make-whole provision
including, but not limited to, the companys stock price, volatility of the companys stock, the
probability of acquisition and the probability of the type of consideration used by a potential
acquirer. If any of these variables change significantly or if managements assumptions prove
incorrect, our financial statements could be materially and adversely affected.
Revenue Recognition
We recognize revenue from product sales for our Cardiovascular and ITC business segments when
evidence of an arrangement exists, title has passed (generally upon shipment) or services have been
rendered, the selling price is fixed or determinable and collectibility is reasonably assured.
Sales to distributors are recorded when title transfers upon shipment. One of our distributors has
certain limited product return rights. Other distributors have certain rights of return upon
termination of their distribution agreement. A reserve for sales returns is recorded for these
customers applying reasonable estimates of product returns based upon historical experience. No
other direct sales customers or distributors have return rights or price protection.
We recognize sales of certain Cardiovascular segment products to first-time customers when we
have determined that the customer has the ability to use the products. These sales frequently
include the sale of products and training services under multiple element arrangements. Training is
not considered essential to the functionality of the products. The amount of revenue under these
arrangements allocated to training is based upon fair market value of the training, which is
typically
19
performed on behalf of the Company by third party providers. The amount of product sales
allocated to the Cardiovascular segment products is done on a fair value basis. Under this basis,
the total value of the arrangement is allocated to the training and the Cardiovascular segment
products based on the relative fair market value of the training and products.
In determining when to recognize revenue, management makes decisions on such matters as the
fair values of the product and training elements when sold together, customer credit worthiness and
warranty reserves. If these decisions prove incorrect, the carrying value of these assets and
liabilities on our condensed consolidated balance sheets could be significantly different and it
could have a material adverse effect on our results of operations for any fiscal period.
Reserves
We maintain allowances for doubtful accounts for estimated losses resulting from the inability
of our customers to make payments owed to us for product sales. If the financial condition of our
customers were to deteriorate, resulting in an impairment of their ability to make payments,
additional allowances may be required.
The majority of our products are covered by up to a two-year limited manufacturers warranty
from the date of shipment or installation. Estimated contractual warranty obligations are recorded
when related sales are recognized and any additional amounts are recorded when such costs are
probable and can be reasonably estimated, at which time they are included in Cost of product
sales in our condensed consolidated statements of operations.
We believe we have provided adequate reserves for anticipated tax audit adjustments in the
U.S., state and other foreign tax jurisdictions based on our estimate of whether, and the extent to
which, additional taxes, interest and penalties may be due. If events occur which indicate payment
of these amounts are unnecessary, the reversal of the liabilities would result in tax benefits
being recognized in the period when we determine the accrued liabilities are no longer warranted.
If our estimate of tax liabilities proves to be less than the ultimate assessment, a further charge
to expense would result.
Management must make judgments to determine the amount of reserves to accrue. If management
estimates prove incorrect, our financial statements could be materially and adversely affected.
Evaluation of Purchased Intangibles and Goodwill for Impairment
In accordance with SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived
Assets, we periodically evaluate the carrying value of long-lived assets to be held and used,
including intangible assets subject to amortization, when events or circumstances warrant such a
review. The carrying value of a long-lived asset to be held and used is considered impaired when
the anticipated separately identifiable undiscounted cash flows from such an asset are less than
the carrying value of the asset. In that event, a loss is recognized based on the amount by which
the carrying value exceeds the fair value of the long-lived asset. Fair value is determined
primarily using the anticipated cash flows discounted at a rate commensurate with the risk
involved. Management must make estimates of these future cash flows and the approximate discount
rate, and if any of these estimates proves incorrect, the carrying value of these assets on our
condensed consolidated balance sheet could become significantly impaired.
In accordance with SFAS No. 142, Goodwill and Other Intangible Assets, we no longer amortize
goodwill. We complete an impairment test of goodwill and other intangible assets subject to
amortization as required by SFAS No. 142 and SFAS No. 144. Upon completion of our impairment tests
as of the end of fiscal year 2005, we determined that neither goodwill nor intangible assets were
impaired.
Valuation of stock-based awards
We account for stock-based compensation in accordance with the fair value recognition
provisions of SFAS No. 123(R). Under SFAS No. 123(R), stock-based compensation cost is measured at
the grant date based on the value of the award and is recognized as expense over the vesting
period. Determining the fair value of stock-based awards at the grant date requires judgment,
including estimating the expected term of stock options, the expected volatility of our stock,
expected forfeitures and expected dividends. The computation of the expected volatility assumption
used in the Black-Scholes calculation for option grants is based on historical volatility When
establishing the expected life assumption, we review annual historical employee exercise behavior
of option grants with similar vesting periods. In addition, judgment is also required in
estimating the amount of stock-based awards that are expected to be forfeited. If actual results
differ significantly from these estimates, stock-based compensation expense and our results of
operations could be materially affected.
20
Results of Operations
The following table sets forth selected condensed consolidated statements of operations data
for the periods indicated as a percentage of total product sales:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
April 1, |
|
April 2, |
|
|
2006 |
|
2005 |
Product sales |
|
|
100 |
% |
|
|
100 |
% |
Cost of product sales |
|
|
41 |
|
|
|
40 |
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
59 |
|
|
|
60 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
37 |
|
|
|
30 |
|
Research and development |
|
|
20 |
|
|
|
15 |
|
Amortization of purchased intangible assets |
|
|
6 |
|
|
|
6 |
|
Litigation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
63 |
|
|
|
51 |
|
Income (loss) from operations |
|
|
(4 |
) |
|
|
9 |
|
Other income and (expense): |
|
|
|
|
|
|
|
|
Interest expense |
|
|
(2 |
) |
|
|
(2 |
) |
Interest income and other |
|
|
3 |
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
Income (loss) before income tax benefit (expense) |
|
|
(3 |
) |
|
|
9 |
|
Income tax benefit (expense) |
|
|
1 |
|
|
|
(3 |
) |
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
(2 |
)% |
|
|
6 |
% |
|
|
|
|
|
|
|
|
|
See Note 14 to our unaudited condensed consolidated financial statements in this quarterly report
for data presented by business segment.
See Note 2
to our unaudited condensed consolidated financial statements in this quarterly report for a
discussion of changes in the financial results due to the adoption of SFAS No. 123(R).
Three months ended April 1, 2006 and April 2, 2005
Product Sales
Product sales in the first quarter of 2006 were $48.8 million compared to $50.5 million in the
first quarter of 2005. Cardiovascular segment sales decreased $2.2 million and ITC segment sales
increased $0.5 million. Product sales changes are due to volume unless otherwise noted. The primary
components of the total $1.7 million decrease in product sales were the following:
|
|
|
VAD product sales decreased $1.0 million. The decrease came from lower sales of our
Thoratec product line, partially offset by an increase in sales of our HeartMate product
line. |
|
|
|
|
Other ancillary revenue (drivers, cannulae, service, rentals and spares) decreased $0.8
million, including decreases in cannulae and driver sales associated with the Thoratec
product line, partially offset by increased driver rental revenue. |
|
|
|
|
Graft product sales decreased by $0.4 million. |
|
|
|
|
Point-of-care diagnostic product sales increased $0.4 million, due primarily to
increases in our sales of Protime products, partially offset by decreases in IRMA,
Hemochron and Hgb Pro products quarter over quarter. |
|
|
|
|
Incision product sales increased by $0.1 million quarter over quarter. |
Sales originating outside of the United States and U.S. export sales accounted for approximately
25% and 22% of our total product sales in the first quarter ended April 1, 2006 and April 2, 2005,
respectively.
21
Gross Profit
Gross profit as a percentage of product sales in the first quarters of 2006 and 2005 was 59%
and 60%, respectively. The change in gross profit was due to the proportionate sales of ITC versus
Cardiovascular products in conjunction with the following:
|
|
|
Cardiovascular segment gross profit increased by 3.3% due to decreased manufacturing
costs related to favorable manufacturing variances. |
|
|
|
|
ITC segment gross profit decreased by 6.4%, due to higher manufacturing, shipping and
labor costs. |
Selling, General and Administrative
Selling, general and administrative expenses in the first quarter of 2006 were $18.1 million,
or 37% of product sales, compared to $14.8 million, or 30% of product sales, in the first quarter
of 2005. The $3.3 million increase in spending was primarily attributable to the following:
|
|
|
Costs related to stock based compensation of $1.4 million that were incurred in 2006
but not in 2005. |
|
|
|
|
Increased personnel costs of $0.6 million associated with CEO transition, CFO
recruitment, and other bonus and retention programs not specifically identified to any
particular business segment. |
|
|
|
|
Increased personnel costs associated with the addition of the Heart Failure Specialists
in our Cardiovascular segment of $0.3 million and a $0.4 million increase in personnel
costs in our ITC segment. |
|
|
|
|
Higher spending on marketing and training related activities primarily associated with
HeartMate II in the Cardiovascular segment totaling $0.5 million, in addition to a $0.1
million increase in spending by the ITC segment related to increased administrative fees
due to Group Purchasing Organizations. |
Research and Development
Research and development expenses in the first quarter of 2006 were $9.6 million, or 20% of
product sales, compared to $7.7 million, or 15% of product sales, in the first quarter of 2005. Of
the $1.9 million increase, our Cardiovascular and ITC segments incurred $1.6 million and $0.3
million, in additional expenses, respectively, quarter over quarter. Research and development
costs are largely project driven, and the level of spending depends on the level of project
activity planned and subsequently approved and conducted. The primary component of our research and
development costs is employee salaries, benefits and, for the first quarter of 2006, stock based
compensation expenses primarily related to our adoption of SFAS No. 123(R) on January 1, 2006.
Research and development costs also include regulatory and clinical costs associated with our
compliance with FDA regulations and clinical trials such as the Phase II HeartMate II pivotal
trial.
Amortization of Purchased Intangible Assets
Amortization of purchased intangible assets in the first quarter of 2006 was $3.0 million
compared to $2.8 million in the first quarter of 2005. The increase of $0.2 million resulted from
a change in business conditions that caused us to modify the remaining economic useful lives of
certain of our developed technology assets. These modifications were made in accordance with our
periodic valuation of the useful lives of our identifiable intangible assets under SFAS No. 144 as
of December 31, 2005.
Interest Expense
Interest expense in the first quarter of 2006 was $1.1 million compared to $1.0 million in the
first quarter of 2005. The expense for the three months ended April 1, 2006 and April 2, 2005,
respectively, includes $0.9 million and $0.8 million in interest payments, respectively, and $0.2
million for both periods in amortization of the debt issuance costs related to our convertible
notes.
Interest Income and Other
Interest income and other for the three months ended April 1, 2006 was $1.7 million compared
to $0.8 million in the
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three months ended April 2, 2005. The increase was primarily due to higher interest income
earned on our portfolio as a result of increased cash balances and higher short term interest rates
compared to the same quarter last year. In addition we received approximately $0.1 million in
lease revenue related to our acquisition of a new building in January of 2006.
Income Taxes
Our effective tax rates were 35% and 34% for the first quarters of 2006 and 2005. The increase
in our effective tax rate on a comparative basis was due primarily to a combination of
nondeductible stock based compensation costs under SFAS No. 123(R) and reduced federal research
credits, offset in part by increased interest income from tax favorable investments and continuing
benefits related to export of manufactured goods.
We continue to maintain adequate amounts for anticipated tax audit adjustments in the U.S.,
state and other foreign tax jurisdictions based on our estimate of whether, and the extent to
which, additional taxes and interest may be due. If events occur which indicate payment of these
amounts are unnecessary or the liability proves to be more than anticipated, the reversal of the
liabilities would result in tax benefits being recognized or a further charge to expense would
result in the period the event occurs.
Our effective tax rate is calculated based on the statutory tax rate imposed on projected annual
pre-tax income or loss in various jurisdictions. Since relatively small changes in our forecasted
profitability for 2006 can significantly affect our projected annual effective tax rate, we believe
our quarterly tax expense rate of 35% is the most reliable estimate of our effective tax expense
rate. Accordingly, our quarterly tax rate for the second quarter of 2006 and the remainder of 2006
will be largely dependent on our profitability and could fluctuate significantly.
Liquidity and Capital Resources
At April 1, 2006, we had net working capital of $269.8 million compared with $269.3 million at
December 31, 2005. Cash and cash equivalents at April 1,
2006 were $23.0 million compared to $35.1 million at December 31, 2005. The decrease is due
primarily to cash used in operations, net purchases of property, plant and equipment and purchases
of investment securities, offset in part by proceeds from stock option exercises.
Cash used in operating activities for the three months ended April 1, 2006 was $4.3 million.
This amount included a net loss of $0.9 million offset by positive non-cash adjustments to net
losses of $7.7 million primarily comprised of $4.9 million for depreciation and amortization, $2.6 million related to stock-based compensation expenses principally related to our adoption of SFAS
No. 123(R) and CEO transition costs, $1.9 million related to tax benefit related to stock options,
and $1.2 million for unrealized costs related to investments and interest and other, partially
offset by $1.8 million related to excess tax benefits from stock based compensation and a $1.1
million change in the deferred tax liability. Changes in assets and liabilities used additional
cash of $9.7 million due to the decrease in accounts payable and other liabilities, driven largely
by payments made in the first quarter of 2006 for bonus and accrued compensation, cash of $1.4 million used for prepaid and other expenses.
Investing activities used $17.6 million, with $2.3 million net purchases of investment
securities and $15.3 million used to acquire property, plant and equipment, net of $0.2 million in
transfers of product inventory of drivers and demonstration equipment into fixed assets. The
purchases of property, plant and equipment consisted of the January 2006 building purchase in
Pleasanton, California that used cash of $12.3 million, of which $8.6 million was allocated to the
building and $3.7 million to land. Additionally, $0.5 million of cash was used for improvements,
some of which for the new building purchase, and $1.3 million for equipment purchases relating to
our Cardiovascular segment, with an additional $0.6 million in improvements and $0.8 million in
equipment purchases relating to our ITC segment.
Cash provided by financing activities for the three months ended April 1, 2006 was $9.8 million, including $9.2 million from proceeds related to stock option exercises, $1.7 million
provided by excess tax benefits from stock based compensation, partially offset by $1.1 million
related to restricted stock forfeitures.
In March 2005, we agreed to purchase a new enterprise resource planning software system, or
ERP system, for ITC. The cost of the purchased software licenses, hardware, implementation costs
and consulting for the ERP system through April 1, 2006 was $1.4 million, with $1.3 million of this
amount capitalized.
We believe that cash and cash equivalents, short-term available-for-sale investments on hand
and expected cash flows from operations, will be sufficient to fund our operations, capital
requirements and stock repurchase programs for at least
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the next twelve months.
Contractual Obligations
During the quarter ended April 1, 2006 there were no material changes in contractual
obligations outside our normal course of business other than the payment in January 2006 of our
$12.4 million real estate obligation for the purchase of a 67,000-square foot office building in
Pleasanton, California.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE OF MARKET RISK
Interest Rate Risk
Our investment portfolio is comprised of marketable investments in money market funds, auction
rate securities, U.S. Treasury securities and debt instruments of government agencies, local
municipalities, and high quality corporate issuers. All investments are carried at market value and
are treated as available-for-sale. All investments mature within two years or less from the date of
purchase, except some of the investments in U.S. Treasuries that are held as restricted investments
as collateral for future interest payments related to our convertible debt, which mature within
three years from the original date of purchase. Our holdings of the securities of any one issuer,
except government agencies, do not exceed 10% of the portfolio. If interest rates rise, the market
value of our investments may decline, which could result in a loss if we are forced to sell an
investment before its scheduled maturity. If interest rates were to rise or fall from current
levels by 25 basis points, the change in our net unrealized loss on investments would be nominal.
We do not utilize derivative financial instruments to manage interest rate risks.
Our convertible notes do not bear interest rate risk as they were issued at a fixed rate of
interest.
Foreign Currency Rate Fluctuations
We conduct business in foreign countries. Our international operations consist primarily of
sales and service personnel for our ventricular assist products who report to our U.S. sales and
marketing group and are internally reported as part of that group. All assets and liabilities of
our non-U.S. operations are translated into U.S. dollars at the period-end exchange rates and the
resulting translation adjustments are included in comprehensive income. The period-end translation
of the non-functional currency assets and liabilities (primarily assets and liabilities on our U.K.
subsidiarys consolidated balance sheet that are not denominated in U.K. pounds sterling) at the
period-end exchange rates result in foreign currency gains and losses, which are included in
Interest Income and Other.
We use forward foreign currency contracts to hedge the gains and losses generated by the
revaluation of these non-functional currency assets and liabilities. These derivatives are not
designated as cash flow or fair value hedges under SFAS No. 133. As a result, changes in the fair
value of the forward foreign currency contracts are included in Interest Income and Other. The
change in the fair value of the forward foreign currency contracts typically offsets the change in
value from revaluation of the non-functional currency assets and liabilities. These contracts
typically have maturities of three months or less. At April 1, 2006, we had forward foreign
currency contracts in euros with a notional value of $4.7 million and, at December 31, 2005, we had
forward foreign currency contracts in euros with a notional value at $4.4 million. These contracts
had an average exchange rate of euros to U.S. dollars of 0.8332 as of April 1, 2006. The impact of
foreign currency revaluation, net of forward foreign currency contracts, was nominal for the three
months ended April 1, 2006 and April 2, 2005.
ITEM 4. CONTROLS AND PROCEDURES
Attached as exhibits to this Form 10-Q are certifications of our Chief Executive Officer and
Chief Financial Officer, which are required in accordance with Rule 13a-14 of the Securities
Exchange Act of 1934, as amended (the Exchange Act). This Controls and Procedures section
includes information concerning the controls and controls evaluation referred to in the
certifications. Item 8 of our 2005 Annual Report on Form 10-K sets forth managements report on
internal control over financial reporting as of December 31, 2005. This section should be read in
conjunction with managements report of internal control over financial reporting as of December
31,2005.
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Disclosure Controls and Procedures
An evaluation was performed under the supervision and with the participation of our
management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness
of the design and operation of our disclosure controls and procedures, as defined in Rule 13a-15(e)
under the Exchange Act, as of April 1, 2006. The evaluation of our disclosure controls and
procedures included a review of our processes and implementation and the effect on the information
generated for use in this Quarterly Report on Form 10-Q. In the course of this evaluation, we
sought to identify any significant deficiencies or material weaknesses in our disclosure controls
and procedures, to determine whether we had identified any acts of fraud involving personnel who
have a significant role in our disclosure controls and procedures, and to confirm that any
necessary corrective action, including process improvements, was taken. This type of evaluation is
done quarterly so that our conclusions concerning the effectiveness of these controls can be
reported in our periodic reports filed with the SEC. The overall goals of these evaluation
activities are to monitor our disclosure controls and procedures and to make modifications as
necessary. We intend to maintain these disclosure controls and procedures, modifying them as
circumstances warrant.
Based on that evaluation, our management, including the Chief Executive Officer and Chief
Financial Officer, concluded that as of April 1, 2006 the Companys disclosure controls and
procedures, as defined in Rule 13a-15(e) under the Exchange Act, were effective.
Changes to Internal Controls
As part of the implementation of section 404 of the Sarbanes Oxley Act of 2002, the Company
instituted internal controls that were designed to detect errors. There have been no changes in our
internal controls over financial reporting during the quarter ended April 1, 2006 that have
materially affected or are reasonably likely to materially affect our internal control over
financial reporting.
Inherent Limitations on Controls and Procedures
Our management, including the Chief Executive Officer and the Chief Financial Officer, does
not expect that internal controls will prevent all error and all fraud. A control system, no matter
how well designed and operated, can only provide reasonable assurances that the objectives of the
control system are met. The design of a control system reflects resource constraints; the benefits
of controls must be considered relative to their costs. Because there are inherent limitations in
all control systems, no evaluation of controls can provide absolute assurance that all control
issues and instances of fraud, if any, within the Company have been or will be detected. As these
inherent limitations are known features of the financial reporting process, it is possible to
design into the process safeguards to reduce, though not eliminate, these risks. These inherent
limitations include the realities that judgments in decision-making can be faulty and that
breakdowns occur because of simple error or mistake. Controls can be circumvented by the individual
acts of some persons, by collusion of two or more people, or by management override of the control.
The design of any system of controls is based in part upon certain assumptions about the likelihood
of future events. While our disclosure controls and procedures are designed to provide reasonable
assurance of achieving their objectives, there can be no assurance that any design will succeed in
achieving its stated goals under all future conditions. Over time, controls may become inadequate
because of changes in conditions or deterioration in the degree of compliance with the policies or
procedures. Because of the inherent limitations in a cost-effective control system, misstatements
due to error or fraud may occur and not be detected.
We intend to review and evaluate the design and effectiveness of our disclosure controls and
procedures on an ongoing basis and to improve our controls and procedures over time and to correct
any deficiencies that we may discover in the future. While our Chief Executive Officer and Chief
Financial Officer have concluded that, as of April 1, 2006, the design
of our disclosure controls and procedures, as defined in Rule 13a-15(e) under the Exchange
Act, was effective, future events affecting our business may cause us to significantly modify our
disclosure controls and procedures.
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PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
See Note 11 to our unaudited condensed consolidated interim financial statements in this Quarterly
Report on Form 10-Q.
ITEM 1A. RISK FACTORS
In addition to the other information set forth in this Quarterly Report, you should carefully
consider the factors discussed in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K
for the year ended December 31, 2005, which could materially affect our business, financial
condition or future results. The risks described in our Annual Report on Form 10-K are not the
only risks facing us. Additional risks and uncertainties not currently known to us or that we
currently deem to be immaterial also may materially adversely affect our business, financial
condition and/or operating results.
ITEM 6. EXHIBITS
(a) Exhibits:
10.30 |
|
Thoratec Corporation Corporate Executive Incentive Plan FY2006, effective for certain executive officers of
the Company. |
|
10.31 |
|
Thoratec Corporation Cardiovascular Business Executive Incentive Plan FY2006, effective for certain executive
officers
of the Company. |
|
10.32 |
|
International Technidyne Corporation Executive Incentive Plan FY2006, effective for certain executive officers of
the Company. |
|
31.1 |
|
Section 302 Certification of Chief Executive Officer. |
|
31.2 |
|
Section 302 Certification of Chief Financial Officer. |
|
32.1 |
|
Section 906 Certification of Chief Executive Officer. |
|
32.2 |
|
Section 906 Certification of Chief Financial Officer. |
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SIGNATURES
In accordance with the requirements of the 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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THORATEC CORPORATION |
|
|
|
Date: May 11, 2006
|
|
/s/ Gerhard F. Burbach |
|
|
|
|
|
Gerhard F. Burbach |
|
|
Chief Executive Officer |
|
|
|
Date: May 11, 2006
|
|
/s/ Cynthia Lucchese |
|
|
|
|
|
Cynthia Lucchese |
|
|
Chief Financial Officer |
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