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 March 31, 2007
or
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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) |
(925) 847-8600
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by
Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is, a large accelerated filer, an accelerated filer
or a non-accelerated filer (as defined in Rule 12b-2 of the Exchange Act):
Large-accelerated filer þ Accelerated filer o 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 April 28, 2007, the registrant had 53,203,260 shares of common stock outstanding.
THORATEC CORPORATION AND SUBSIDIARIES
TABLE OF CONTENTS
Thoratec, the Thoratec logo, Thoralon, TLC-II, HeartMate, and HeartMate II are registered trademarks of Thoratec
Corporation, and IVAD is a trademark of Thoratec Corporation.
CentriMag is a registered trademark of Levitronix LLC.
ITC, A-VOX Systems, HEMOCHRON, ProTime, Surgicutt, Tenderlett, Tenderfoot, and IRMA are registered trademarks of
International Technidyne Corporation (ITC), our wholly-owned subsidiary.
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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March 31, |
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December 30, |
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2007 |
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2006 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
13,356 |
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$ |
67,453 |
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Short-term available-for-sale investments |
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180,330 |
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127,025 |
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Restricted short-term investments |
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1,703 |
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1,681 |
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Receivables, net of allowances of $596 and $491, respectively |
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43,581 |
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43,718 |
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Inventories |
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56,594 |
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49,666 |
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Deferred tax asset |
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5,932 |
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6,623 |
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Prepaid expenses and other assets |
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5,152 |
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2,986 |
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Total current assets |
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306,648 |
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299,152 |
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Property, plant and equipment, net |
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46,806 |
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45,808 |
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Goodwill |
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98,494 |
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98,494 |
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Purchased intangible assets, net |
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131,196 |
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134,349 |
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Other assets |
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16,649 |
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13,332 |
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Total Assets |
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$ |
599,793 |
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$ |
591,135 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
12,823 |
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$ |
13,591 |
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Accrued compensation |
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10,186 |
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12,043 |
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Accrued income taxes |
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327 |
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3,691 |
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Other accrued liabilities |
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5,416 |
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4,136 |
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Total current liabilities |
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28,752 |
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33,461 |
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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 |
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45,714 |
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46,421 |
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Other |
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7,727 |
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2,430 |
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Total Liabilities |
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225,943 |
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226,062 |
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Shareholders equity: |
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Common shares: authorized 100,000; issued and outstanding 53,159 and 52,329, respectively |
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437,917 |
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427,941 |
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Accumulated deficit |
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(64,890 |
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(63,675 |
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Accumulated other comprehensive income (loss): |
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Unrealized loss on investments |
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(15 |
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(16 |
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Cumulative translation adjustments |
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838 |
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823 |
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Total accumulated other comprehensive income |
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823 |
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807 |
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Total Shareholders Equity |
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373,850 |
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365,073 |
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Total Liabilities and Shareholders Equity |
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$ |
599,793 |
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$ |
591,135 |
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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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March 31, |
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April 1, |
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2007 |
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2006 |
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Product sales |
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$ |
57,310 |
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$ |
48,755 |
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Cost of product sales |
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22,797 |
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20,108 |
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Gross profit |
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34,513 |
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28,647 |
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Operating expenses: |
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Selling, general and administrative |
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21,945 |
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18,060 |
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Research and development |
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10,893 |
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9,585 |
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Amortization of purchased intangible assets |
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3,153 |
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2,974 |
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Litigation |
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57 |
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Total operating expenses |
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35,991 |
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30,676 |
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Loss from operations |
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(1,478 |
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(2,029 |
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Other income and (expense): |
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Interest expense |
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(1,068 |
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(1,103 |
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Interest income and other |
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2,187 |
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1,701 |
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Loss before income tax benefit |
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(359 |
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(1,431 |
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Income tax benefit |
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84 |
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501 |
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Net loss |
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$ |
(275 |
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$ |
(930 |
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Net loss per share: |
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Basic and diluted |
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$ |
(0.01 |
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$ |
(0.02 |
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Shares used to compute net loss per share: |
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Basic and diluted |
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52,736 |
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52,218 |
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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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March 31, |
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April 1, |
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2007 |
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2006 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(275 |
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$ |
(930 |
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Adjustments to reconcile net income to net cash used in operating activities: |
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Depreciation and amortization |
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5,337 |
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4,875 |
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Investment premium amortization (net) |
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92 |
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134 |
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Non-cash interest and other expenses |
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359 |
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1,103 |
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Tax benefit related to stock options |
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1,210 |
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1,896 |
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Share-based compensation expense |
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3,503 |
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2,649 |
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Excess tax benefits from share-based compensation |
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(653 |
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(1,761 |
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Change in net deferred tax liability |
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302 |
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(1,151 |
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Changes in assets and liabilities: |
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Receivables |
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187 |
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414 |
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Inventories |
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(8,079 |
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(358 |
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Prepaid expenses and other assets |
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(1,258 |
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(1,374 |
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Accounts payable and other liabilities |
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(1,352 |
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(8,117 |
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Accrued income taxes |
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(3,372 |
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(1,600 |
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Other |
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(126 |
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Net cash used in operating activities |
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(3,999 |
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(4,346 |
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Cash flows from investing activities: |
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Purchases of available-for-sale investments |
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(149,793 |
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(38,900 |
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Sales of available-for-sale investments |
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96,335 |
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21,700 |
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Maturities of available-for-sale investments and restricted investments |
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14,920 |
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Purchases of property, plant and equipment |
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(2,018 |
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(15,329 |
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Net cash used in investing activities |
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(55,476 |
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(17,609 |
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Cash flows from financing activities: |
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Proceeds from stock option exercises |
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5,400 |
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9,173 |
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Excess tax benefits from share-based compensation |
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653 |
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1,761 |
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Repurchase and retirement of common shares |
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(671 |
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(1,100 |
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Net cash provided by financing activities |
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5,382 |
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9,834 |
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Effect of exchange rate changes on cash and cash equivalents |
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(4 |
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39 |
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Net decrease in cash and cash equivalents |
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(54,097 |
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(12,082 |
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Cash and cash equivalents at beginning of period |
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67,453 |
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35,109 |
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Cash and cash equivalents at end of period |
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$ |
13,356 |
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$ |
23,027 |
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Supplemental disclosure of cash flow information: |
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Cash paid for taxes |
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$ |
2,609 |
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$ |
379 |
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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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$ |
1,286 |
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$ |
246 |
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See notes to condensed consolidated financial statements.
5
THORATEC CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(unaudited)
(in thousands)
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Three Months Ended |
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March 31, |
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April 1, |
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2007 |
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2006 |
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Net loss |
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$ |
(275 |
) |
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$ |
(930 |
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Other net comprehensive income (loss): |
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Unrealized gain (loss) on investments (net of taxes of ($1) and $38 for the three months
ended March 31, 2007 and April 1, 2006, respectively) |
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(1 |
) |
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58 |
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Foreign currency translation adjustments (net of taxes of none and $11 for the three months
ended March 31, 2007 and April 1, 2006, respectively) |
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(15 |
) |
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39 |
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Comprehensive loss |
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$ |
(291 |
) |
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$ |
(833 |
) |
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See notes to condensed consolidated financial statements.
6
THORATEC CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. Basis of Presentation
The interim condensed consolidated financial statements of Thoratec Corporation (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 (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 2006 consolidated financial statements,
and the accompanying notes thereto, filed with the SEC in our Annual Report on Form 10-K (the 2006
Annual Report). 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. Income Taxes
We adopted the provisions of Financial Accounting Standards Board (FASB) issued FASB
Interpretation No. (FIN) 48, Accounting for Uncertainty in Income Taxes, an interpretation of
SFAS No. 109 on December 31, 2006. Under FIN 48, tax positions are evaluated for recognition
using a more-likely-than-not recognition threshhold, and those tax positions eligible for
recognition are measured as the largest amount of tax benefit that is greater than fifty percent
likely of being realized upon ultimate settlement with a taxing authority that has full knowledge
of all relevant information. As a result of adopting FIN 48, we reported a cumulative-effect
adjustment of $0.5 million which increased our accumulated deficit as of December 31, 2006.
On December 31, 2006, we had $9.3 million of unrecognized tax benefits, of which $3.9 million
would impact our effective tax rate if recognized. An unrecognized tax benefit under FIN 48 is the
difference between a tax position taken (or expected to be taken) in a tax return and the benefit
measured and recognized in a companys financial statements in accordance with the guidelines set
forth in FIN 48. The Companys liability for unrecognized tax benefits was reduced by approximately
$0.5 million in the first quarter to reflect the impact of a payment to the State of New Jersey in
settlement of a tax audit with respect to years 1997 through 2000. In addition, in 2007, the
Company intends to file or amend its tax returns in certain jurisdictions which will further
decrease the liability for unrecognized tax benefits by approximately $2.4 million as a result of the payment of
additional tax expected to be due.
Our policy for classifying interest and penalties associated with unrecognized income tax
benefits is to include such items in income tax expense. On December 31, 2006, gross interest accrued associated
with unrecognized income tax benefits, is approximately $0.8 million and the benefit of the interest deductible is approximately $0.3 million of
deductions for such interest resulting in a net balance of approximately $0.5 million. The amount
of penalties accrued on unrecognized income tax benefits included in our condensed consolidated
balance sheet was $0.2 million
We are currently under income tax audit in the State of California for 2003 and 2004,
Massachusetts for 2003 and 2004, and Pennsylvania for an unspecified number of years. In February
2007, we concluded our audit with the State of New Jersey for the years 1997 through 2000. A
payment of approximately $1.0 million, including penalties and interest, was made to the State of
New Jersey in respect of those years, which resulted in a decrease to our reserves for unrecognized
tax benefits. In addition, to the extent we are deemed to have sufficient connection to a
particular jurisdiction to enable that jurisdiction to tax us, but we have not filed an income tax
return in that jurisdiction for the year(s) at issue, the jurisdiction would be able to assert a
tax liability for such years without limitation on the number of years it may examine.
The tax years 2003 through 2006 remain subject to audit by certain jurisdictions in which we
are subject to taxation with the exception of California and New Jersey, which remain subject to
audit from 2002 to 2006, and the UK which remains subject to audit from 2005. However, as we had
net operating losses and credits carried forward in several
jurisdictions including federal and California, certain items attributed to closed years remain subject to adjustment by the relevant
tax authority through an adjustment to tax attributes carried forward to open years.
7
Our effective income tax rates were a benefit of 23% and 35%, for the three months ended March
31, 2007 and April 1, 2006, respectively. The 12% decrease in our effective tax rate was primarily
due to increased tax-exempt interest income, a reduction in expenses related to incentive stock
options and ESPP stock purchases, and higher research and development tax credits.
At March 31, 2007 and December 30, 2006, we reported a net deferred tax liability of
approximately $39.6 million and $38.8 million, respectively, comprised principally of temporary
differences between the financial statement and income tax bases of intangible assets.
3. Recently Issued Accounting Pronouncements
In February 2007, the FASB issued Statement of Financial Accounting Standards
(SFAS) No. 159, The Fair Value Option for Financial Assets and Financial Liabilities. SFAS No.
159 permits us to choose, at specified election dates, eligible instruments to measure at fair
value ( Fair Value Option). Unrealized gains and losses on instruments for which the Fair Value
Option has been elected are reported in earnings. The Fair Value Option is applied
instrument-by-instrument (with certain exceptions), is irrevocable (unless a new election date
occurs) and is applied only to an entire instrument. Under SFAS No. 159, the decision to measure
instruments at fair value is made at specified election dates on an irrevocable
instrument-by-instrument basis. If we elect to adopt the Fair Value Option we would be required to
recognize changes in fair value in earnings and to expense upfront cost and fees associated with
the instrument for which the Fair Value Option is elected from and after January 1, 2008. We have
not yet determined whether we will elect to apply the Fair Value Option or the impact that such
election may have on our consolidated financial position, operating results or cash flows.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements which defines fair
value, establishes a framework for measuring fair value, and expands disclosures about fair value
measurements effective for financial statements issued for fiscal years beginning after November
15, 2007 and interim periods within those fiscal years. SFAS No. 157 does not require any new fair
value measurements, but rather eliminates inconsistencies in guidance found in various prior
accounting pronouncements. We are currently evaluating the accounting and disclosure requirements
that this guidance will have on our results of operations or financial condition when we adopt SFAS
No. 157 at the beginning of our 2008 fiscal year.
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 United States 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 U.S. Treasury securities held as collateral for
future interest payments on 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.
For all investments, temporary differences between cost and fair value are presented as a
separate component of accumulated other comprehensive income. There were no unrealized gains or
losses on investments for the three months ended March 31, 2007. The unrealized gain on
investments, net of taxes, was approximately $0.1 million for the three months ended April 1, 2006.
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.
8
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 our Cardiovascular division. 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) at the period-end exchange rates result in foreign currency gains and losses, which are
included in our condensed consolidated statements of operations 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 consolidated balance sheet that are not denominated in UK pounds). Our
contracts typically have maturities of three months or less.
Our financial instrument contracts qualify as derivatives under SFAS No. 133 Accounting for
Derivative Instrument and Hedging Activities and we value these contracts at the estimated fair
value at March 31, 2007. The fair value of the forward currency contracts is included in Interest
income and other, and offsets the foreign currency exchange
gains and losses in the condensed consolidated statement of
operations. The impact of these foreign currency contracts was a loss of $0.1 million for both of
the three months ended March 31, 2007 and April 1, 2006. The impact of the foreign currency
translation adjustments from conducting our foreign operations was a gain of $0.1 million for both
of the three months ended March 31, 2007 and April 1, 2006.
At March 31, 2007, we had forward contracts to sell euros with a notional value of $5.0
million and purchase UK pounds with a notional value of $2.3 million and at April 1, 2006, we had
forward contracts to purchase euros with a notional value of $4.7 million. As of March 31, 2007,
our forward contracts had an average exchange rate of one U.S. dollar to 0.7509 euros and one U.S.
dollar to 0.5101 UK pounds. It is highly uncertain how currency exchange rates will fluctuate in
the future.
7. Inventories
Inventories consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
March 31, |
|
|
December 30, |
|
|
|
2007 |
|
|
2006 |
|
|
|
(in thousands) |
|
Finished goods |
|
$ |
21,687 |
|
|
$ |
22,527 |
|
Work in process |
|
|
9,913 |
|
|
|
7,008 |
|
Raw materials |
|
|
24,994 |
|
|
|
20,131 |
|
|
|
|
|
|
|
|
Total |
|
$ |
56,594 |
|
|
$ |
49,666 |
|
|
|
|
|
|
|
|
8. Property, Plant and Equipment, net
Property, plant and equipment, net, consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
March 31, |
|
|
December 30, |
|
|
|
2007 |
|
|
2006 |
|
|
|
(in thousands) |
|
Land |
|
$ |
4,096 |
|
|
$ |
4,096 |
|
Building |
|
|
12,040 |
|
|
|
12,038 |
|
Building lease |
|
|
2,285 |
|
|
|
2,285 |
|
Equipment |
|
|
50,127 |
|
|
|
47,904 |
|
Rental equipment |
|
|
9,410 |
|
|
|
8,612 |
|
Improvements |
|
|
16,398 |
|
|
|
16,258 |
|
|
|
|
|
|
|
|
Total |
|
|
94,356 |
|
|
|
91,193 |
|
Accumulated depreciation and amortization |
|
|
(47,550 |
) |
|
|
(45,385 |
) |
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
$ |
46,806 |
|
|
$ |
45,808 |
|
|
|
|
|
|
|
|
9
Depreciation expense for the three months ended March 31, 2007 and April 1, 2006 was $2.1
million and $1.9 million, respectively.
9. Other Assets
On August 23, 2006, we purchased a $5 million convertible debenture from Levitronix, LLC
(Levitronix), a company with which we have a distribution arrangement to sell Levitronix
products. The convertible debenture is a long-term note receivable with an annual interest rate of
5.7%, to be accrued monthly and at the option of Levitronix, paid in cash or in-kind semi-annually
on February 23rd and August 23rd until its maturity on August 23, 2013. We
may convert the debenture at any time at our option into membership interests of Levitronix at a
conversion price of $4.2857, which may be adjusted as a result of certain corporate events. This
conversion feature is not an embedded derivative under SFAS No. 133 because the membership
interests of the issuer are not readily convertible to cash. If we had converted the debenture at
March 31, 2007, our ownership in Levitronix would have been less than 5%.
The $5 million outstanding principal amount of the Levitronix convertible debenture plus
accrued but unpaid interest thereon, is included in Other assets on our condensed consolidated
balance sheet.
10. Goodwill and Purchased Intangible Assets
The carrying amount of goodwill was $98.5 million as of March 31, 2007 and December 30, 2006,
$94.1 million of which is attributable to our Cardiovascular division and $4.4 million of which is
attributable to International Technidyne Corporations (ITC) acquisition of the outstanding
common shares of privately held A-VOX Systems, Inc. (Avox).
In February 2001, we merged with Thermo Cardiosystems, Inc. (TCA). Prior to the merger with
TCA (the Merger), TCA was a subsidiary of Thermo Electron Corporation (TCI). The components of
identifiable intangible assets related to the Merger include: patents and trademarks, core
technology (Thoralon, our patent protected bio-material), and developed technology (patent
technology, other than core technology, acquired in the Merger). The components of intangible
assets related to the Avox acquisition include: patents and trademarks, developed technology and
customer and distributor relationships and other. The combined components are included in purchased
intangibles on the condensed consolidated balance sheets are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2007 |
|
|
|
Gross Carrying |
|
|
Accumulated |
|
|
Net Carrying |
|
|
|
Amount |
|
|
Amortization |
|
|
Amount |
|
|
|
( in thousands) |
|
Patents and trademarks |
|
$ |
38,515 |
|
|
$ |
(22,298 |
) |
|
$ |
16,217 |
|
Core technology |
|
|
37,485 |
|
|
|
(10,655 |
) |
|
|
26,830 |
|
Developed technology |
|
|
125,742 |
|
|
|
(38,352 |
) |
|
|
87,390 |
|
Customer and distributor relationships and other |
|
|
897 |
|
|
|
(138 |
) |
|
|
759 |
|
|
|
|
|
|
|
|
|
|
|
Total purchased intangible assets |
|
$ |
202,639 |
|
|
$ |
(71,443 |
) |
|
$ |
131,196 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 30, 2006 |
|
|
|
Gross Carrying |
|
|
Accumulated |
|
|
Net Carrying |
|
|
|
Amount |
|
|
Amortization |
|
|
Amount |
|
|
|
(in thousands) |
|
Patents and trademarks |
|
$ |
38,515 |
|
|
$ |
(21,350 |
) |
|
$ |
17,165 |
|
Core technology |
|
|
37,485 |
|
|
|
(10,275 |
) |
|
|
27,210 |
|
Developed technology |
|
|
125,742 |
|
|
|
(36,564 |
) |
|
|
89,178 |
|
Customer and distributor relationships and other |
|
|
897 |
|
|
|
(101 |
) |
|
|
796 |
|
|
|
|
|
|
|
|
|
|
|
Total purchased intangible assets |
|
$ |
202,639 |
|
|
$ |
(68,290 |
) |
|
$ |
134,349 |
|
|
|
|
|
|
|
|
|
|
|
Amortization expense related to purchased intangible assets, net, was $3.2 million and $3.0
million for the three months ended March 31, 2007 and April 1, 2006. The Company acquired Avox
during the fourth quarter of 2006, which will increase amortization expense for 2007 by
approximately $0.7 million. The Avox acquisition was based upon
the estimated fair value of assets and liabilities as determined by us using an income approach for valuation of intangibles which projects the associated revenues, expenses and cash flows attributable to the custmomer base and the market value approach for valuation of other assets and liabilities, which considers the price comparable assets have been or
are being purchased. Assuming no further acquisitions by Thoratec, amortization expense is
expected to be approximately $12.6 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 six to twenty-four years and customer and distributor relationships and other have
useful lives ranging from six to eleven years.
10
11. Long-Term Debt
In 2004, we completed the sale of $143.8 million initial principal amount of senior
subordinated convertible notes due in 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 senior subordinated 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
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 senior subordinated convertible notes were issued at a price of $580.98 per note, which is
58.098% of the principal amount at maturity of the notes. The senior subordinated 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 16th and November 16th 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.
|
|
|
|
|
|
|
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 |
|
|
|
|
|
The deferred debt issuance costs of $2.5 million, net of $1.8 million in amortization, are
included in Other assets on the condensed consolidated balance sheet as of March 31, 2007. The
deferred debt issuance costs are amortized on a straight line basis until May 16, 2011 at which
time the Company can redeem the notes.
These charges are included in Interest expense in our condensed consolidated statements of
operations.
Holders of the senior subordinated 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 at maturity of
senior subordinated convertible notes, which represents a conversion price of $19.72 per share,
subject to adjustments upon the occurrence of certain events. Holders have been and are able to
convert their convertible notes at any point after the close of business on September 30, 2004 if,
as of the last day of the 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 senior subordinated 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 senior subordinated 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 March 31, 2007, no notes had been converted or called.
Holders may require us to repurchase all or a portion of their senior subordinated 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 senior subordinated convertible notes and
recorded at its estimated fair value of $0.1 million at March 31, 2007. There are significant variables
and assumptions used in valuing the make-whole provision including, but not limited to, our stock
price, the volatility of our stock, the probability of our being acquired and the probability of
the type of consideration used by a potential acquirer.
11
We may redeem, in whole or in part, any of the senior subordinated convertible notes, at any
time beginning May 16, 2011, by giving the holders at least 30 days notice, at a redemption price
equal to the sum of the issue price and the accrued original issue discount.
The senior subordinated 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 senior subordinated convertible notes at March 31, 2007, based
on market quotes, was $180.2 million.
12. Share-Based Compensation
Effective January 1, 2006, we adopted SFAS No. 123(R), Share-Based Payment utilizing the
modified prospective transition method. Prior to the adoption of SFAS No. 123(R), we accounted for
share-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 three months 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, Accounting for Stock-Based Compensation, 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).
We receive a tax deduction for certain stock option exercises during the period the options
are exercised, generally for the excess of the fair market value of the options at the date of
exercise 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), beginning
in 2006 our condensed consolidated statements of cash flows present the tax benefits from the
exercise of stock options as financing cash flows. For the three months ended March 31, 2007, $0.7
million of tax benefits were reported as financing cash flows rather than operating cash flows.
Cash proceeds from the exercise of stock options were $5.4 million for the three months ended
March 31, 2007. The income tax deduction realized from stock option exercises was $1.2 million for
the same period.
Equity Plans
In 1993, our Board of Directors approved the 1993 Stock Option Plan (1993 SOP), which
permitted us to grant options to purchase up to 666,667 shares of our common stock. This plan
expired in 2003 and no options were granted since its expiration. Prior to its expiration, all
available options under the plan were granted.
In 1996, the Board of Directors and our shareholders approved the 1996 Stock Option Plan
(1996 SOP) and the 1996 Non-employee Directors Stock Option Plan (Directors Option Plan). The
Directors Option Plan was amended by the Board of Directors in November 1996, amended again by
approval of our shareholders in May 1997, amended again by approval of our shareholders in May
1999, amended again by the Board of Directors in February 2003, amended again by approval of our
shareholders in May 2003, and amended again by the Board of Directors in October 2003. The 1996 SOP
consists of two parts. Part One permitted us to grant options to purchase up to 500,000 shares of
common stock. This plan expired in February 2006. Part Two related to the former Chief Executive
Officer, D. Keith Grossman, and permitted us to grant non-qualified options to Mr. Grossman to
purchase up to 333,333 shares of common stock, all of which were granted in 1996. The Directors
Option Plan, as amended, permitted us to grant options for a total of up to 550,000 shares of our
common stock and provided for an initial grant to a director of an option to purchase 15,000 shares
upon appointment to the Board, and annual grants thereafter to purchase 7,500 shares (granted in
four equal installments).
12
Provisions also include immediate vesting of both the initial and annual grants and a five
year term 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 no options were granted under the Directors Option Plan in the three months ended
March 31, 2007.
In 1997, the Board of Directors adopted the 1997 Stock Option Plan (1997 SOP). The 1997 SOP
was amended by approval of our shareholders in February 2001, amended by the Board of Directors in
December 2001, amended again by approval of our shareholders in May 2003, and amended again by the
Board of Directors in March 2006. The 1997 SOP allowed us to grant up to a total of 13.7 million
shares of common stock in the form of stock options, restricted stock awards, and stock bonuses.
This plan expired in May 2006.
In April 2006, the Board of Directors approved the 2006 Incentive Stock Plan (2006 Plan),
and in May 2006 the 2006 Plan was amended by the Board of Directors and approved by our
shareholders. The 2006 Plan allows us to grant to employees and directors of, and consultants to,
the Company up to a total of 2.2 million shares of stock in the form of options, restricted stock
bonuses, restricted stock purchases, restricted stock units, stock appreciation rights, phantom
stock units, performance share bonuses, and performance share units. The 2006 Plan stipulates that
no more than 50% of the authorized shares may be issued as restricted stock bonuses, restricted
stock units, phantom stock units, performance share bonuses or performance share units. During the
three months ended March 31, 2007, 498,883 options were granted under the 2006 Plan at fair market
value and 435,633 shares of restricted stock and restricted stock units were granted under this
plan. At March 31, 2007, 1.0 million shares remained available for grant under the 2006 Plan.
Stock Options
Five of the common stock option plans or equity incentive plans described above had options
outstanding at March 31, 2007, with only the 2006 Plan available for future grants. Options under
the 2006 Plan may be granted by the Board of Directors at the fair market value on the date of
grant and generally become fully exercisable within four years after the grant date and expire
between five and ten years from the date of grant. Vesting on options granted to officers will be
accelerated in certain circumstances following a change in control of the Company.
The fair value of each option is estimated at the date of grant using the Black-Scholes option
pricing model. The risk-free interest rate is based on the United States 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 in 2006, we have used separate assumptions for groups of employees (for
example, officers) that have similar historical exercise behavior. The range below reflects the
expected option impact of these separate groups.
The fair value of each option is estimated at the date of grant using the Black-Scholes option
pricing model with the following assumptions used:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, 2007 |
|
April 1, 2006 |
Risk-free interest rate |
|
|
4.82 |
% |
|
|
4.49 |
% |
Expected volatility |
|
|
40 |
% |
|
|
40 |
% |
Expected option life |
|
|
5.10 to 6.06 years |
|
|
|
3.88 to 5.25 years |
|
Dividends |
|
None |
|
None |
At March 31, 2007, there was $7.5 million of unrecognized compensation expense related to
stock options, which expense we expect to recognize over a weighted average period of 1.53 years.
The aggregate intrinsic value of in-the-money options outstanding, based on the closing price of
the Companys common stock on March 30, 2007, the last trading day in the three months ended March
31, 2007, of $20.90, was $39.8 million, and the aggregate intrinsic value of options exercisable
was $30.9 million. The total intrinsic value of options exercised was $3.3 million for the three
months ended March 31, 2007.
13
Stock option activity is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
Weighted |
|
|
Weighted Average |
|
|
|
Options |
|
|
Average Exercise |
|
|
Remaining Contract |
|
|
|
(in thousands) |
|
|
Price Per Share |
|
|
Life (years) |
|
Outstanding options at December 30, 2006 |
|
|
6,585 |
|
|
$ |
14.65 |
|
|
|
6.74 |
|
Granted |
|
|
499 |
|
|
|
18.00 |
|
|
|
|
|
Exercised |
|
|
(449 |
) |
|
|
12.04 |
|
|
|
|
|
Forfeited or expired |
|
|
(118 |
) |
|
|
16.73 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding options at March 31, 2007 |
|
|
6,517 |
|
|
$ |
15.05 |
|
|
|
6.77 |
|
|
|
|
|
|
|
|
|
|
|
Outstanding options exercisable at March 31, 2007 |
|
|
4,057 |
|
|
$ |
13.45 |
|
|
|
5.70 |
|
|
|
|
|
|
|
|
|
|
|
Restricted Stock
The 1997 SOP allowed and the 2006 Plan allows for the issuance of restricted stock awards and
restricted stock units, which awards or units may not be sold or otherwise transferred until
certain restrictions have lapsed. The unearned share-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 shares on the date of
grant applied to the total number of shares that were granted.
In the first three months of 2007, we issued restricted stock to employees and directors under
the 2006 Plan. Share-based compensation expense related to these restricted stock grants was $2.7
million for the three months ended March 31, 2007. As of March 31, 2007, we had $9.0 million of
unrecognized compensation expense associated with these restricted stock awards, which amount we
expect to recognize over a weighted-average period of 3.55 years. The total fair value of the
shares for which the restriction period lapsed during the three months ended March 31, 2007 was
$1.9 million.
Restricted stock activity is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
Weighted Average |
|
|
|
Shares |
|
|
Grant Date Fair |
|
|
|
(in thousands) |
|
|
Value |
|
Outstanding unvested restricted stock at December 30, 2006 |
|
|
422 |
|
|
$ |
17.63 |
|
Granted |
|
|
424 |
|
|
|
18.04 |
|
Vested |
|
|
(112 |
) |
|
|
16.80 |
|
Forfeited or expired |
|
|
(12 |
) |
|
|
18.83 |
|
|
|
|
|
|
|
|
Outstanding unvested restricted stock at March 31, 2007 |
|
|
722 |
|
|
$ |
17.98 |
|
|
|
|
|
|
|
|
Restricted Stock Units
In the first three months of 2007, we granted restricted stock units to certain of our
non-U.S. employees under the 2006 Plan. At March 31, 2007, there was $0.2 million of unrecognized
compensation expense related to these restricted stock units, which amount we expect to recognize
over a weighted-average period of 3.50 years. The aggregate intrinsic value of the units
outstanding, based on the Companys stock price on March 30, 2007, was $0.4 million.
Restricted stock unit activity is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
Weighted Average |
|
|
Weighted Average |
|
|
|
Units |
|
|
Grant Date Fair |
|
|
Remaining Contract |
|
|
|
(in thousands) |
|
|
Value |
|
|
(in years) |
|
Outstanding units at December 30, 2006 |
|
|
10 |
|
|
$ |
19.08 |
|
|
|
1.74 |
|
Granted |
|
|
11 |
|
|
|
18.05 |
|
|
|
|
|
Released |
|
|
(2 |
) |
|
|
20.94 |
|
|
|
|
|
Forfeited or expired |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding units at March 31, 2007 |
|
|
19 |
|
|
$ |
20.90 |
|
|
|
2.15 |
|
|
|
|
|
|
|
|
|
|
|
14
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, automatic increase of up to 250,000 shares in the total number of shares
available for issuance thereunder on March 1st of each year, unless our Board of Directors
specifies a smaller increase or no increase. Under this provision, an additional 250,000 shares
were reserved for issuance under the ESPP on March 1, 2006 and our Board of Directors specified no
increase as of March 1, 2007. Eligible employees may purchase a limited number of shares of the
Companys common stock at 85% of the lower of the market value on the offering date or the market
value on the purchase date. During the three months ended March 31, 2007, no shares of common stock
were issued under the ESPP. As of March 31, 2007, approximately 219,000 shares remained available
for issuance under this plan.
The estimated subscription date fair value of the current offering under the ESPP is
approximately $1.5 million using the Black-Scholes option pricing model and the following
assumptions:
|
|
|
|
|
Risk-free interest rate |
|
|
5.10 |
% |
Expected volatility |
|
|
40 |
% |
Expected option life |
|
0.50 years |
Dividends |
|
None |
At March 31, 2007, there was approximately $0.1 million of unrecognized compensation expense
related to ESPP subscriptions that began on November 1, 2006, which amount we expect to recognize
during the second quarter of 2007.
13. Net Loss Per Share
Basic and diluted net loss per share were calculated as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
April 1, |
|
|
|
2007 |
|
|
2006 |
|
|
|
(in thousands, except per share data) |
|
Net loss |
|
$ |
(275 |
) |
|
$ |
(930 |
) |
|
|
|
|
|
|
|
Weighted average number of common shares-basic |
|
|
52,736 |
|
|
|
52,218 |
|
Dilutive effect of stock options and Employee Stock Purchase Plan shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares-diluted |
|
|
52,736 |
|
|
|
52,218 |
|
|
|
|
|
|
|
|
Net loss per common share basic and diluted |
|
$ |
(0.01 |
) |
|
$ |
(0.02 |
) |
|
|
|
|
|
|
|
Basic net loss per share is computed by dividing net loss by the weighted-average number of
common shares outstanding during the period. Diluted net loss per share reflects 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 3.2 million shares and 3.4 million shares of
common stock were not included in the computation of diluted net loss per share for the three
months ended March 31, 2007 and April 1, 2006, respectively, as their inclusion would be
antidilutive. In addition, the computation of diluted net loss per share for the three months ended
March 31, 2007 and April 1, 2006, excludes the effect of assuming the conversion of our senior
subordinated convertible notes, which are convertible at $19.72 per share into 7.3 million shares
of common stock, because the effect would have been antidilutive for those periods.
Our share repurchase programs, which authorized us to repurchase up to a total of $130 million
of the Companys common stock, were announced on February 11, 2004 as a $25 million program, on May
12, 2004 as a $60 million program, on July 29, 2004 as a $25 million program and on February 2,
2006 as a $20 million program. No shares of our common stock were repurchased under our publicly
announced repurchase programs during the three months ended March 31, 2007 and April 1, 2006. All
repurchased shares have been retired and are not included in net loss per common share.
15
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 designs, develops,
manufactures and markets proprietary medical devices used for circulatory support and vascular
graft applications. The ITC segment designs, develops, manufactures and markets proprietary
point-of-care diagnostic test systems and incision devices.
Business Segments:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
April 1, |
|
|
|
2007 |
|
|
2006 |
|
|
|
( in thousands) |
|
|
|
|
|
|
|
Restated (e) |
|
Product sales: |
|
|
|
|
|
|
|
|
Cardiovascular |
|
$ |
35,538 |
|
|
$ |
29,816 |
|
ITC |
|
|
21,772 |
|
|
|
18,939 |
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
57,310 |
|
|
$ |
48,755 |
|
|
|
|
|
|
|
|
Income(loss) before income taxes: |
|
|
|
|
|
|
|
|
Cardiovascular (a)(d) |
|
$ |
1,127 |
|
|
$ |
636 |
|
ITC(a)(d) |
|
|
1,398 |
|
|
|
690 |
|
Corporate (b)(d) |
|
|
(4,003 |
) |
|
|
(3,298 |
) |
Litigation (c) |
|
|
|
|
|
|
(57 |
) |
|
|
|
|
|
|
|
Total operating loss |
|
|
(1,478 |
) |
|
|
(2,029 |
) |
Other income and (expense): |
|
|
|
|
|
|
|
|
Interest expense |
|
|
(1,068 |
) |
|
|
(1,103 |
) |
Interest income and other |
|
|
2,187 |
|
|
|
1,701 |
|
|
|
|
|
|
|
|
Loss before income tax benefit |
|
$ |
(359 |
) |
|
$ |
(1,431 |
) |
|
|
|
|
|
|
|
|
|
|
(a) |
|
Includes amortization expense of $2.9 million for each of the three months ended March 31,
2007 and April 1, 2006, related to the Cardiovascular segment. The ITC segment also includes
amortization expense of $0.2 million and $0.04 million for the three months ended March 31,
2007 and April 1, 2006, respectively. |
|
(b) |
|
Represents unallocated costs, not specifically identified to any particular business segment. |
|
(c) |
|
Relates to litigation expenses not specifically identified to a particular business segment. |
|
(d) |
|
Includes SFAS No. 123(R) expense of $1.3 million, $0.8 million and $1.3 million for
Cardiovascular, ITC and Corporate, respectively, for the three months ended March 31, 2007 and
$1.4 million, $0.7 million and $0.3 million for Cardiovascular, ITC and Corporate,
respectively, for the three months ended April 1, 2006. |
|
(e) |
|
The restatement is to reclassify general and administration expenses from the Corporate to
the Cardiovascular segment on a consistent basis to the 2005 Annual Report on Form 10K. As a
result of the restatement, for the three months ended April 1, 2006, income before taxes from
the Cardiovascular segment decreased by $1.6 million and the loss before taxes from Corporate
decreased by $1.6 million. |
Geographic Areas:
The geographic composition of our product sales was as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
April 1, |
|
|
|
2007 |
|
|
2006 |
|
|
|
(in thousands) |
|
Domestic |
|
$ |
43,678 |
|
|
$ |
36,646 |
|
International |
|
|
13,632 |
|
|
|
12,109 |
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
57,310 |
|
|
$ |
48,755 |
|
|
|
|
|
|
|
|
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, as amended, 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 2006 Annual Report on Form 10-K (the 2006 Annual Report) and in other documents we file
with the Securities and Exchange Commission (SEC). These forward-looking statements speak only as
of the date hereof. We are not under any obligation, and we expressly disclaim any 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 Quarterly Report on Form 10-Q.
Overview
Thoratec Corporation (we, our, us, the Company) is a world leader in therapies to
address advanced heart failure (HF) and point-of-care diagnostics.
For advanced HF we develop, manufacture and market proprietary medical devices used for
circulatory support. Our primary product lines are our ventricular assist devices (VADs): the
Paracorporeal Ventricular Assist Device (PVAD), the Implantable Ventricular Assist Device
(IVAD), the HeartMate Left Ventricular Assist System (HeartMate XVE), and the HeartMate II Left
Ventricular Assist System (HeartMate II). The IVAD, PVAD and the HeartMate XVE are approved by
the U.S. Food and Drug Administration (FDA) and CE Mark approved in Europe. The HeartMate II is
CE Mark approved in Europe and is in a Phase II pivotal trial in the U.S. We also manufacture a
vascular access graft for renal dialysis.
In August 2006, we began marketing the CentriMag Blood Pumping System (CentriMag) for acute
HF. CentriMag is manufactured by Levitronix LLC (Levitronix) and distributed by us in the U.S.
under a distribution agreement with Levitronix.
In addition to our circulatory support products, we also develop, manufacture and market
point-of-care diagnostic test systems for hospital point-of-care and alternative site point-of-care
and incision products.
Our Business Model
Our business is comprised of two operating divisions: Cardiovascular and ITC.
The product line of our Cardiovascular division is:
|
|
|
Circulatory Support Products. Our circulatory support products include the PVAD, IVAD,
HeartMate XVE and HeartMate II for short, intermediate and long-term treatment of advanced
HF. In addition, we market and sell the CentriMag for extra corporeal circulatory support
during cardiac surgery. We also manufacture and sell small diameter grafts using our
proprietary materials to address the vascular access market for hemodialysis. |
The product lines of our ITC division are:
|
|
|
Point-of-Care Diagnostics. Our point-of-care products include diagnostic test systems
that monitor blood coagulation while a patient is being administered certain anticogulants,
as well as monitor blood gas/electrolytes, oxygenation and chemistry status. |
|
|
|
|
Incision. Our incision products include devices used to obtain a patients blood sample
for diagnostic testing and screening for platelet function. |
17
Cardiovascular Division
Our product portfolio of implantable and external circulatory support product devices includes
the following:
|
|
|
The PVAD is an external device for short to mid-term cardiac support. This device, which
is sold worldwide, is approved to assist left, right and biventricular support and is worn
outside of the body. The PVAD is approved by the FDA for use as a bridge to transplantation
and for post-cardiotomy myocardial recovery. |
|
|
|
|
The IVAD is the only implantable blood pump approved for both bridge-to-transplantation
(BTT) and post-cardiotomy myocardial recovery that can be used for left, right, or
biventricular support. The IVAD utilizes the same internal working components as the PVAD,
but has an outer housing made of a titanium alloy that makes it more suitable for
implantation. |
|
|
|
|
The HeartMate XVE is an implantable device for mid to longer-term cardiac support and is
the only device approved in the U.S., Europe and Canada for permanent support for those
patients ineligible for heart transplantation. This device is designed to assist the pumping
function of the hearts left ventricle and features a unique, textured blood-contacting
surface that eliminates the need for systemic anticoagulation. |
|
|
|
|
The HeartMate II is an implantable device consisting of a miniature rotary blood pump
designed to provide long-term support. Its design is intended to be not only smaller, but
also simpler, quieter, and longer lasting than the current generation of ventricular assist
device. The HeartMate II is CE Mark approved for distribution in Europe, and is in a Phase
II pivotal trial in the U.S. |
|
|
|
|
CentriMag is an external device for short-term circulatory support consisting of a
single-use blood pump, a motor and a device console. This device is 510(k) approved by the
FDA for patients requiring extra corporeal circulatory support during cardiac surgery. |
In addition to our cardiac assist products, we sell vascular access graft products used in
hemodialysis for patients with late-stage renal disease.
We primarily market our VAD products for those patients suffering from HF 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 U.S., there are currently two FDA-approved indications for the long-term use of VADs in
patients with HF: as a bridge to heart transplantation and as Destination Therapy (DT). We are
currently pursuing an additional indication for our VAD products: therapeutic recovery of the
heart. In addition to the chronic HF markets, VADs are also approved for use for acute heart
failure following cardiac surgery and the CentriMag is approved for use during cardiac surgery.
We currently market VADs that may be implanted or worn outside the body, can be used for left,
right or biventricular support and that are suitable for treatments for different durations for
patients of varying sizes and ages. We estimate that doctors have implanted more than 11,000 of our
devices, primarily for patients awaiting a heart transplant or those who require permanent support.
On November 6, 2002, the FDA approved the HeartMate VE as the first heart assist device for DT. On
April 7, 2003, the FDA approved the HeartMate XVE, an enhanced version of the HeartMate VE, for DT.
Thoratec is the only company to offer a VAD approved by the FDA for DT and marks the first time a
VAD has been approved as a permanent treatment for late-stage HF patients who do not qualify for
heart transplants because of age or extenuating health circumstances, and who otherwise have a life
expectancy of less than two years. The FDAs decision to approve the HeartMate VAD for DT was based
on data from a clinical trial called Randomized Evaluation of Mechanical Assistance for the
Treatment of Congestive HF, which showed our HeartMate device nearly doubled and tripled survival
over the drug therapy group at one and two years, respectively.
The HeartMate II is designed to improve survival and quality of life and to provide five to
ten years of circulatory support for a broad range of advanced heart failure patients. The
HeartMate II is a small, implantable, electrically powered device that weighs about 12 ounces and
is approximately 1.7 inches in diameter and 3.2 inches in length. In addition to being
significantly smaller than the HeartMate XVE, with only one moving part the HeartMate II is simpler
and designed to operate more quietly than pulsatile devices. The HeartMate II is designed to
provide blood flow through the circulatory system on a continual basis. As of April 27, 2007, we
had enrolled 616 patients in the HeartMate II pivotal trial. The IDE for the pivotal trial in the
U.S. for both BTT and DT indications for use was fully approved by the FDA in May 2005. The device
received CE Mark approval in November 2005, allowing for its commercial sale in Europe.
18
In August 2006, we announced a distribution agreement under which we are distributing the
CentriMag in the U.S. The initial term of the agreement expires in 2011. This device is 510(k), is
approved and cleared by the FDA for patients requiring extracorporeal circulatory support during
cardiac surgery.
ITC Division
The following are our major point-of-care diagnostic test systems and incision products:
|
|
|
The Hemochron point-of-care coagulation system 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 warfarin. The system consists of a
small, portable analytical instrument and disposable test cuvettes. |
|
|
|
|
The IRMA point-of-care blood gas/electrolyte and chemistry system is used to monitor a
patients blood gas/electrolyte and chemistry status. The system consists of a small,
portable analytical instrument and disposable test cartridges. |
|
|
|
|
Avox CO-oximetry system is used to assess a patients oxygenation status and is
commonly used in the cardiac catherization lab, the intensive care unit (ICU), the
neonatal intensive care unit (NICU) and the emergency department. The system consists of
a small battery operated instrument and disposable test cuvettes. |
|
|
|
|
The ProTime coagulation monitoring system 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. |
|
|
|
|
The Hemoglobin Pro 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 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 as compared to
traditional lancets, which puncture the skin. |
The Hemochron, IRMA and Avox CO-oximetry systems are primarily sold into the hospital
point-of-care division of the market. The ProTime and Hemoglobin Pro products are sold into the
alternate site (non-hospital) point-of-care market, comprised of physicians offices, long-term
care facilities, clinics, visiting nurse associations, and home healthcare companies.
Our incision products are sold to both the hospital point-of-care and the alternate site
point-of-care markets. Our highest revenue-generating incision product is the Tenderfoot.
In October 2006, we acquired A-VOX Systems, Inc. (Avox), a point-of-care company that
develops and manufactures portable, bedside CO-oximetry systems to assist clinicians in assessing a
patients oxygenation status. These systems are used in hospitals in the cardiac catherization lab,
the ICU and NICU and the emergency department. We are selling these systems along with our
Hemochron and IRMA point-of-care products as well as our data management system which connects all
of these systems.
Critical Accounting Policies and Estimates
We have identified the policies and estimates 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 and estimates on our business operations are discussed below. For a more detailed
discussion on the application of these and other accounting policies and estimates, see the notes
to the consolidated financial statements included in this Quarterly Report on Form 10-Q and our
2006 Annual Report 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 and assumptions.
19
Revenue Recognition
We recognize revenue from product sales for our Cardiovascular and ITC business divisions 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. A reserve for sales returns
is recorded for sales through this distributor applying reasonable estimates of product returns
based upon historical experience.
We recognize sales of certain Cardiovascular division 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 performed on behalf of the Company by third party providers. The amount of product sales
allocated to the Cardiovascular division products is made using the fair value method. Under this
method, the total value of the arrangement is allocated to the training and the Cardiovascular
division 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 any of these decisions proves incorrect, the carrying value of these assets
and liabilities on our condensed consolidated balance sheets could be significantly different,
which 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 and training services. 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 by United
States, federal, state and local, as well as foreign, tax authorities 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 is 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 any of these
management estimates proves incorrect, our financial statements could be materially and adversely
affected.
Income Taxes
We make certain estimates and judgments in determining income tax expense for financial
statement purposes. These estimates and judgments occur in the calculation of tax credits,
benefits, and deductions, such as tax benefits from our non-U.S. operations and in the calculation
of certain tax assets and liabilities, which arise from differences in the timing of revenue and
expense for tax and financial statement purposes.
Determining our deferred tax liabilities involves uncertainties in the assessment of our
domestic and foreign operations. We recognize liabilities for anticipated tax liabilities in the
U.S. and other tax jurisdictions based on our estimate of whether, and the extent to which,
additional tax payments are probable. If we determine that payment of these amounts is not likely,
we will reverse the liability and recognize a tax benefit during the period in which we determine
that the liability is no longer necessary.
20
We assess the likelihood that we will be able to recover our deferred tax assets. If recovery
is not likely, we must increase our provision for taxes by recording a valuation allowance against
deferred tax assets that we estimate will ultimately not be recoverable. We believe that our
deferred tax assets recorded on our condensed consolidated balance sheets will ultimately be
recovered. However, should there occur a change in our ability to recover our deferred tax assets,
our tax provision would increase in the period in which we determine that recovery is not likely.
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 sheets could become significantly impaired.
In accordance with SFAS No. 142, Goodwill and Other Intangible Assets, we no longer amortize
goodwill. We complete an annual impairment test of goodwill and other intangible assets subject to
amortization as required by SFAS No. 142. Upon completion of our impairment tests as of the end of
fiscal year 2006, we determined that neither goodwill nor intangible assets were impaired.
Valuation of Share-Based Awards
We account for share-based compensation in accordance with the fair value recognition
provisions of SFAS No. 123(R). Under SFAS No. 123(R), share-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 option 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 option pricing model 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 share-based awards that are expected to be forfeited. If actual results differ
significantly from these estimates, share-based compensation expense and our results of operations
could be materially affected.
21
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 |
|
|
March 31, |
|
April 1, |
|
|
2007 |
|
2006 |
Product sales |
|
|
100 |
% |
|
|
100 |
% |
Cost of product sales |
|
|
40 |
|
|
|
41 |
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
60 |
|
|
|
59 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
38 |
|
|
|
37 |
|
Research and development |
|
|
19 |
|
|
|
20 |
|
Amortization of purchased intangible assets |
|
|
6 |
|
|
|
6 |
|
Litigation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
63 |
|
|
|
63 |
|
Loss from operations |
|
|
(3 |
) |
|
|
(4 |
) |
Other income and (expense): |
|
|
|
|
|
|
|
|
Interest expense |
|
|
(2 |
) |
|
|
(2 |
) |
Interest income and other |
|
|
4 |
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
loss before income tax benefit (expense) |
|
|
(1 |
) |
|
|
(3 |
) |
Income tax benefit (expense) |
|
|
|
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(1 |
)% |
|
|
(2 |
)% |
|
|
|
|
|
|
|
|
|
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 Financial Accounting
Standards Board (FASB) Interpretation No. 48 (FIN 48) , Accounting for Uncertainty in Income
Taxes, an interpretation of SFAS No. 109 on December 31, 2006.
Three months ended March 31, 2007 and April 1, 2006
Product Sales
Product sales in the first quarter of 2007 were $57.3 million compared to $48.8 million in the
first quarter of 2006. Cardiovascular sales increased $5.7 million and ITC sales increased $2.8
million. Product sales changes are due to volume unless otherwise noted. The primary components of
the total $8.5 million increase in product sales were the following:
|
|
|
Cardiovascular product sales increased by $5.7 million. This increase primarily
resulted from higher sales of our HeartMate II product line in the first quarter of 2007 as
compared to the first quarter of 2006. In addition, total product sales increased due to
sales of CentriMag, with no comparative sales in the first quarter of 2006. |
|
|
|
|
Point-of-care diagnostic product sales increased by $2.8 million, due primarily to
increases in sales of our ProTime and Signature Elite products, partially offset by a
decrease in incision and IRMA product sales in the first quarter of 2007 as compared to the
first quarter of 2006. In addition, product sales from the Avox CO-oximetry system also
contributed to the increase in sales in the first quarter of 2007, with no comparative
sales in the first quarter of 2006. |
Sales originating outside of the U.S. and U.S. export sales accounted for approximately 23% and 25%
of our total product sales in the first quarters of 2007 and 2006, respectively.
22
Gross Profit
Gross profit in the first quarter of 2007 was $34.5 million compared to $28.6 million in the
first quarter of 2006. As a percentage of product sales, gross profit in the first quarters of 2007
and 2006 was 60% and 59%, respectively. The increase in gross profit percentage was primarily due
to the following:
|
|
|
Cardiovascular gross profit percentage increased by 0.2% partly due improved
manufacturing variances offset by unfavorable product mix. |
|
|
|
|
ITC division gross profit percentage increased by 3.0% due to improved manufacturing
variances and increased instrument upgrade activity coupled with lower average selling
price in incision products. |
Selling, General and Administrative
Selling, general and administrative expenses in the first quarter of 2007 were $21.9 million,
or 38% of product sales, compared to $18.1 million, or 37% of product sales, in the first quarter
of 2006. The $3.9 million increase in expenses was primarily attributable to the following:
|
|
|
Cardiovascular costs increased by $1.3 million in the first quarter of 2007 as compared
to the first quarter of 2006, primarily due to an increase in personnel costs related to
the expansion of our sales force and marketing development initiatives as we prepare to
launch our HeartMate II product line and related increase in share-based compensation
costs. |
|
|
|
|
ITC costs increased by $0.7 million in the first quarter of 2007 as compared to the
first quarter of 2006, primarily due to higher personnel costs and continued development in
product lines. In addition, the first quarter of 2007 included costs related to the Avox
CO-oximetry product, which were not included in the first quarter of 2006. |
|
|
|
|
Corporate costs increased by $1.9 million because of higher consulting and legal
expenses related to the stock option review we conducted of our stock option granting
practices and higher share-based compensation costs in the first quarter of 2007 as
compared to the first quarter of 2006. |
Research and Development
Research and development expenses in the first quarter of 2007 were $10.9 million, or 19% of
product sales, compared to $9.6 million, or 20% of product sales, in the first quarter of 2006. Of
the $1.3 million increase, our Cardiovascular and ITC division incurred $1.1 million and $0.2
million, respectively, in additional expenses, 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 components of our research and
development costs are employee salaries and benefits. Research and development costs also include
regulatory and clinical costs associated with our compliance with FDA regulations and clinical
trials such as Phase II of the HeartMate II pivotal trial.
Amortization of Purchased Intangible Assets
Amortization of purchased intangible assets in the first quarter of 2007 was $3.2 million as
compared to $3.0 million in the first quarter of 2006. The $0.2 million increase resulted from
intangible assets acquired through our acquisition of Avox in the fourth quarter of 2006.
Interest Expense
Interest expense was $1.1 million for both of the first quarters of 2007 and 2006. In each
quarter, interest expense was comprised of $0.9 million in interest costs, and $0.2 million of
amortization of the debt issuance costs related to our senior subordinated convertible notes.
23
Interest Income and Other
Interest income and other for the first quarter of 2007 was $2.2 million compared to $1.7
million in the first quarter of 2006. The increase was primarily due to higher interest income
earned on our portfolio resulting from higher short-term interest rates in the first quarter of
2007 compared to the same quarter last year.
Income Taxes
Our effective income tax rates were a benefit of 23% and 35%, for the three months ended March
31, 2007 and April 1, 2006, respectively. The 12% decrease in our effective tax rate was primarily
due to increased tax-exempt interest income, a reduction in expenses related to incentive stock
options and ESPP stock purchases, and higher research and development tax credits.
We adopted FIN 48 on December 31, 2006, as a result of which our tax positions are evaluated
for recognition using a more-likely-than-not threshold, and those tax positions eligible for
recognition are measured as the largest amount of tax benefit that is greater than fifty percent
likely of being realized upon ultimate settlement with a taxing authority that has full knowledge
of all relevant information. As a result of adopting FIN 48, we reported a cumulative-effect
adjustment of $0.5 million which increased our December 31,
2006 accumulated deficit balance.
On December 31, 2006, we had $9.3 million of unrecognized tax benefits, of which $3.9 million
would impact our effective tax rate if recognized. An unrecognized tax benefit under FIN 48 is the
difference between a tax position taken (or expected to be taken) in a tax return and the benefit
measured and recognized in a companys financial statements in accordance with the guidelines set
forth in FIN 48. The Companys liability for unrecognized tax benefits was reduced by approximately
$0.5 million in the first quarter to reflect the FIN 48 impact of a payment to the State of New
Jersey in settlement of a tax audit with respect to years 1997 through 2000. In addition, in 2007,
the Company intends to file or amend its tax returns in certain jurisdictions and as a result of
the liability for additional tax due expects to further decrease unrecognized tax benefits by
approximately $2.4 million.
We believe we have provided adequate reserves for anticipated tax audit adjustments by United
States federal, state and local, as well as foreign, tax authorities, 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 is 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 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 2007 can significantly affect our projected annual effective tax rate,
we believe our quarterly tax rate will be dependent on our profitability and could fluctuate
significantly.
Liquidity and Capital Resources
At March 31, 2007, we had net working capital of $277.9 million compared with $265.7 million
at December 30, 2006. Cash and cash equivalents at March 31, 2007 were $13.4 million compared to
$67.5 million at December 30, 2006. The decrease in cash and cash equivalents was mainly due to an
increase in net purchases of short-term available-for-sale investments. In addition, we acquired
property, plant and equipment and used cash in operations, partially offset by proceeds from
exercises of stock options.
Cash used in operating activities for the three months ended March 31, 2007 was $4.0 million.
This amount included the net loss for the period of $0.3 million increased by positive non-cash
adjustments to net income of approximately $10.8 million and partially offset by decreases of
approximately $13.9 million from changes in assets and liabilities and $0.7 million related to
excess tax benefits from share-based compensation. The positive non-cash adjustments to net income
were primarily comprised of $5.3 million for depreciation and amortization, $3.5 million related to
share-based compensation expense and $1.2 million of tax benefit
related to stock option exercises. The changes in assets and liabilities were primarily due to $8.1 million increase in inventory and
$1.3 million in prepaid expenses and other assets, partially
offset by decreases of $1.4 million
in accounts payable and $3.4 million in accrued income taxes.
24
Investing activities for the three months ended March 31, 2007 used $55.5 million, comprised
primarily of $53.5 million net purchases of available-for-sale investments and $2.0 million for
purchases of property, plant and equipment, net of $1.3 million in transfers of drivers and
demonstration equipment from inventory into fixed assets. The purchased property, plant and
equipment included $0.9 million for leasehold improvements and purchases of management information
systems equipment. ITC used $1.1 million of cash primarily for facility expansion costs.
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 the next twelve months.
Off Balance Sheet Arrangements
We maintain an Irrevocable Standby Letter of Credit as part of our workers compensation
insurance program. The Letter of Credit is not collateralized. The Letter of Credit automatically
renews on June 30th of each year, unless terminated by one of the parties. At March 31, 2007, our
Letter of Credit balance was $460,000.
Contractual Obligations
Upon
adoption of FIN 48 on December 31, 2006, we decreased our
current taxes payable by approximately $2.5 million and
increased our long-term taxes payable by approximately
$5.2 million as FIN 48 specifies that tax positions for
which the timing of the ultimate resolution is uncertain should be
recognized as long-term liabilities. In addition, we made a payment of
approximately $1.0 million during the three months ended
March 31, 2007 and recognized additional long-term taxes payable
of approximately $0.1 million. At this time, we are unable to
make a reasonably reliable estimate of the timing of payments in
individual years beyond twelve months due to uncertainties in the
timing of tax audit outcomes.
During
the three months ended March 31, 2007 there were no other material changes in contractual
obligations outside our normal course of business.
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. Treasury securities that are restricted investments and
held as collateral for future interest payments on our senior subordinated convertible notes, 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
approximately $0.2 million. We do not utilize derivative financial instruments to manage interest
rate risk.
Our senior subordinated convertible notes and the Levitronix convertible debenture 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 UK
subsidiarys consolidated balance sheet that are not denominated in UK pounds) at the period-end
exchange rates result in foreign currency gains and losses, which are included in our condensed
consolidated statements of operations 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 consolidated balance sheet that are not denominated in UK pounds). Our
contracts typically have maturities of three months or less.
Our financial instrument contracts qualify as derivatives under SFAS No. 133 Accounting for
Derivative Instrument and Hedging Activities and we value these contracts at the estimated fair
value at March 31, 2007. The fair value of the forward currency contracts is included in Interest
income and other, and typically offsets the foreign currency exchange gains and losses in the
condensed consolidated statement of operations. The impact of these foreign currency contracts was
a loss of $0.1 million for both of the three months ended March 31, 2007 and April 1, 2006. The
impact of the foreign currency translation adjustments from conducting our foreign operations was a
gain of $0.1 million for both of the three months ended March 31, 2007 and April 1, 2006.
25
At March 31, 2007, we had forward contracts to sell euros with a notional value of $5.0
million and purchase UK pounds with a notional value of $2.3 million and, at April 1, 2006, we had
forward contracts to purchase euros with a notional value of $4.7 million. As of March 31, 2007,
our forward contracts had an average exchange rate of one U.S. dollar to 0.7509 euros and one U.S.
dollar to 0.5101 UK pounds. It is highly uncertain how currency exchange rates will fluctuate in
the future. The potential fair value loss for a hypothetical 10% adverse change in foreign currency
exchange rates at March 31, 2007 would be approximately $1.2 million.
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 9A of our 2006 Annual Report on Form 10-K sets forth managements report on
internal control over financial reporting as of December 30, 2006. This section should be read in
conjunction with managements report of internal control over financial reporting as of December
30, 2006.
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 March 31, 2007. 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
made 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 March 31, 2007 the Companys disclosure controls and
procedures, as defined in Rule 13a-15(e) under the Exchange Act, were effective to provide
reasonable assurance that information required to be disclosed by us in the reports that we file or
submit under the Exchange Act is recorded, processed, summarized, and then reported within the time
periods specified in the SECs rules and forms and to provide reasonable assurance that such
information is accumulated and communicated to our management, including our principal executive
officer, as appropriate to allow timely decisions regarding required disclosures.
Changes to Internal Controls
As part of our 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 March 31, 2007 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.
26
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 March 31, 2007, 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.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None
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 2006 Annual Report, which
could materially affect our business, financial condition or future results. The risks described in
our 2006 Annual Report 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 2: UNREGISTERED SALE OF EQUITY SECURITIES AND USE OF PROCEEDS
There were no unregistered sales of our equity securities during the three months ended March
31, 2007.
The following table sets forth certain information about our common stock repurchased during
the three months ended March 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total number |
|
|
Approximate |
|
|
|
|
|
|
|
|
|
|
|
of shares |
|
|
value of shares |
|
|
|
|
|
|
|
|
|
|
|
purchased |
|
|
authorized to be |
|
|
|
|
|
|
|
|
|
|
|
under |
|
|
purchased under |
|
|
|
Total number |
|
|
|
|
|
|
publicly |
|
|
publicly |
|
|
|
of shares |
|
|
Average price |
|
|
announced |
|
|
announced |
|
|
|
purchased (2) |
|
|
paid per share |
|
|
programs (1) |
|
|
programs |
|
|
|
(in thousands, except per share data) |
|
December 31, 2006 through January 27, 2007 |
|
|
0.7 |
|
|
$ |
17.92 |
|
|
|
|
|
|
$ |
|
|
January 28, 2007 through February 24, 2007 |
|
|
0.3 |
|
|
|
18.47 |
|
|
|
|
|
|
|
|
|
February 25, 2007 through March 31, 2007 |
|
|
31.6 |
|
|
|
20.70 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
32.6 |
|
|
$ |
20.62 |
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Our share repurchase programs, which authorized us to repurchase up to a total of $130
million of the Companys common shares, were announced on February 11, 2004 as a $25 million
program, on May 12, 2004 as a $60 million program, on July 29, 2004 as a $25 million program
and on February 2, 2006 as a $20 million program. These programs authorize us to acquire
shares in the open market or in privately negotiated transactions and do not have an
expiration date. No shares were repurchased under these programs during the three months ended
March 31, 2007. |
|
(2) |
|
Shares purchased that were not part of our publicly announced repurchase programs represent
the surrender value of shares of restricted stock used to pay income taxes due upon vesting,
and do not reduce the dollar value that may yet be purchased under our publicly announced
repurchase programs. |
27
ITEM 6. EXHIBITS
|
10.34 |
|
Thoratec Corporation Corporate Executive Incentive Plan FY 2007, effective for certain
executive officer of the Company. |
|
|
10.35 |
|
Thoratec Corporation Cardiovascular Business Executive Incentive Plan FY 2007,
effective for certain executive officers of the Company. |
|
|
10.36 |
|
International Technidyne Corporation Executive Incentive Plan FY 2007, 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. |
28
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.
|
|
|
|
|
|
THORATEC CORPORATION
|
|
Date: May 10, 2007 |
/s/ Gerhard F. Burbach
|
|
|
Gerhard F. Burbach |
|
|
Chief Executive Officer |
|
|
|
|
|
Date: May 10, 2007 |
/s/ David V. Smith
|
|
|
David V. Smith |
|
|
Chief Financial Officer |
|
29