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 September 29, 2007
or
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o |
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Transition report pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934 |
For the transition period from to
COMMISSION FILE NUMBER: 000-49798
THORATEC CORPORATION
(Exact name of registrant as specified in its charter)
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California
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94-2340464 |
(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.) |
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6035 Stoneridge Drive, Pleasanton, California
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94588 |
(Address of principal executive offices)
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(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 October 27, 2007, the registrant had 54,014,105 shares of common stock outstanding.
THORATEC CORPORATION
TABLE OF CONTENTS
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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. |
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CentriMag is a registered trademark of Levitronix LLC. |
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ITC, A-VOX Systems, AVOXimeter, 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
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
(in thousands)
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September 29, |
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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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$ |
14,499 |
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$ |
67,453 |
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Short-term available-for-sale investments |
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196,419 |
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127,025 |
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Restricted short-term investments |
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1,681 |
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Receivables, net of allowances of $1,010 and $491, respectively |
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39,963 |
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43,718 |
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Inventories |
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58,857 |
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49,666 |
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Deferred tax assets |
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5,965 |
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6,623 |
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Prepaid expenses and other assets |
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13,549 |
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2,986 |
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Total current assets |
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329,252 |
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299,152 |
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Property, plant and equipment, net |
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46,480 |
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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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124,910 |
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134,349 |
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Deferred tax assets |
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1,006 |
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Other assets |
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15,417 |
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12,326 |
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Total Assets |
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$ |
614,553 |
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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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$ |
11,106 |
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$ |
13,591 |
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Accrued compensation |
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13,166 |
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12,043 |
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Accrued income taxes |
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1,063 |
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3,691 |
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Other accrued liabilities |
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5,608 |
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4,136 |
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Total current liabilities |
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30,943 |
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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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43,395 |
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46,421 |
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Other |
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6,966 |
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2,430 |
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Total Liabilities |
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225,054 |
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226,062 |
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Shareholders equity: |
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Common shares: authorized 100,000; issued and outstanding 53,988 and 52,329, respectively |
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453,326 |
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427,941 |
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Accumulated deficit |
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(65,165 |
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(63,675 |
) |
Accumulated other comprehensive income (loss): |
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Unrealized gain (loss) on investments |
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113 |
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(16 |
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Cumulative translation adjustments |
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1,225 |
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823 |
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Total accumulated other comprehensive income |
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1,338 |
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807 |
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Total Shareholders Equity |
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389,499 |
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365,073 |
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Total Liabilities and Shareholders Equity |
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$ |
614,553 |
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$ |
591,135 |
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See notes to condensed consolidated financial statements.
3
THORATEC CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share data)
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Three Months Ended |
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Nine Months Ended |
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September 29, |
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September 30, |
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September 29, |
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September 30, |
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2007 |
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2006 |
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2007 |
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2006 |
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Product sales |
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$ |
56,055 |
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$ |
51,747 |
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$ |
170,698 |
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$ |
155,285 |
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Cost of product sales |
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23,707 |
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22,078 |
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70,152 |
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64,840 |
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Gross profit |
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32,348 |
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29,669 |
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100,546 |
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90,445 |
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Operating expenses: |
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Selling, general and administrative |
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20,873 |
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17,977 |
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61,952 |
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55,228 |
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Research and development |
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10,712 |
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8,766 |
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32,372 |
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28,108 |
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Amortization of purchased intangible assets |
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3,143 |
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2,974 |
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9,439 |
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8,921 |
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Litigation |
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447 |
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Total operating expenses |
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34,728 |
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29,717 |
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103,763 |
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92,704 |
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Loss from operations |
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(2,380 |
) |
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(48 |
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(3,217 |
) |
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(2,259 |
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Other income and (expense): |
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Interest expense |
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(1,016 |
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(1,051 |
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(3,158 |
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(3,159 |
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Interest income and other |
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2,261 |
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2,186 |
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6,214 |
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5,678 |
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Income (loss) before income taxes |
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(1,135 |
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1,087 |
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(161 |
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260 |
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Income tax benefit (expense) |
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(273 |
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403 |
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(269 |
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637 |
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Net income (loss) |
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$ |
(1,408 |
) |
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$ |
1,490 |
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$ |
(430 |
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$ |
897 |
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Net income (loss) per share, basic and diluted |
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$ |
(0.03 |
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$ |
0.03 |
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$ |
(0.01 |
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$ |
0.02 |
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Shares used to compute net income (loss) per share: |
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Basic |
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53,808 |
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51,955 |
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53,303 |
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52,154 |
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Diluted |
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53,808 |
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52,755 |
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53,303 |
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53,510 |
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See notes to condensed consolidated financial statements.
4
THORATEC CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
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Nine Months Ended |
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September 29, |
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September 30, |
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2007 |
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2006 |
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Cash flows from operating activities: |
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Net income (loss) |
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$ |
(430 |
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$ |
897 |
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Adjustments to reconcile net income to net cash provided by operating activities: |
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Depreciation and amortization |
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16,183 |
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15,016 |
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Investment discount amortization |
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664 |
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88 |
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Write-down of investment |
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215 |
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Non-cash interest and other expenses |
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1,523 |
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1,483 |
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Tax benefit related to stock options |
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3,131 |
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2,418 |
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Share-based compensation expense |
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8,132 |
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7,644 |
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Excess tax benefits from share-based compensation |
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(1,861 |
) |
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(2,283 |
) |
Loss on disposal of assets |
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74 |
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9 |
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Change in net deferred tax liability |
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(1,890 |
) |
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(5,234 |
) |
Changes in assets and liabilities: |
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Receivables |
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2,201 |
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(2,466 |
) |
Inventories |
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(11,846 |
) |
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(2,734 |
) |
Prepaid expenses and other assets |
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(1,774 |
) |
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(464 |
) |
Accounts payable and other liabilities |
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(688 |
) |
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|
1,038 |
|
Accrued income taxes |
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(8,646 |
) |
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(637 |
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Other |
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(405 |
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(258 |
) |
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Net cash provided by operating activities |
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4,583 |
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14,517 |
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Cash flows from investing activities: |
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Purchases of investments |
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(247,363 |
) |
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(255,300 |
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Sales of investments |
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177,475 |
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245,359 |
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Maturities of investments and restricted investments |
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1,712 |
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53,795 |
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Investment in convertible debenture |
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(5,027 |
) |
Purchases of property, plant and equipment, net |
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(4,867 |
) |
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(22,547 |
) |
Other |
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(214 |
) |
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Net cash provided by (used in) investing activities |
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(73,043 |
) |
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|
16,066 |
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Cash flows from financing activities: |
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Proceeds from stock option exercises |
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13,311 |
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10,447 |
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Proceeds from stock issued under employee stock purchase plan |
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1,084 |
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|
860 |
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Excess tax benefits from share-based compensation |
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1,861 |
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|
2,283 |
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Repurchase and retirement of common shares |
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(878 |
) |
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(16,201 |
) |
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Net cash provided by (used in) financing activities |
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15,378 |
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(2,611 |
) |
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Effect of exchange rate changes on cash and cash equivalents |
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128 |
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250 |
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Net increase (decrease) in cash and cash equivalents |
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(52,954 |
) |
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|
28,222 |
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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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$ |
14,499 |
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$ |
63,331 |
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Supplemental disclosure of cash flow information: |
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Cash paid for taxes |
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$ |
8,642 |
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$ |
1,496 |
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Cash paid for interest |
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$ |
1,707 |
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$ |
1,707 |
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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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$ |
2,820 |
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$ |
1,260 |
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See notes to condensed consolidated financial statements.
5
THORATEC CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(unaudited)
(in thousands)
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Three Months Ended |
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Nine Months Ended |
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|
|
September 29, |
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September 30, |
|
|
September 29, |
|
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September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Net income (loss) |
|
$ |
(1,408 |
) |
|
$ |
1,490 |
|
|
$ |
(430 |
) |
|
$ |
897 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other net comprehensive income (loss): |
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|
|
|
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Unrealized gain on investments
(net of taxes of $141 and $59 for
the three months ended and $86 and
$146 for the nine months ended
September 29, 2007 and September
30, 2006, respectively) |
|
|
211 |
|
|
|
89 |
|
|
|
129 |
|
|
|
220 |
|
Foreign currency translation
adjustments (net of taxes of none
and $43 for the three months ended
and none and $167 for the nine
months ended September 29, 2007
and September 30, 2006,
respectively) |
|
|
162 |
|
|
|
(64 |
) |
|
|
402 |
|
|
|
251 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss) |
|
$ |
(1,035 |
) |
|
$ |
1,515 |
|
|
$ |
101 |
|
|
$ |
1,368 |
|
|
|
|
|
|
|
|
|
|
|
|
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|
See notes to condensed consolidated financial statements.
6
THORATEC CORPORATION
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) 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 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 the effective 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 decreased by approximately
the $0.5 million in the first nine months of 2007 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. On September
29, 2007, we had $7.3 million of unrecognized tax benefits, of which $2.5 million would impact our
effective tax rate, if recognized. In addition, during the third quarter of 2007 we filed tax
returns in certain jurisdictions further decreasing our liability for unrecognized tax benefits by
approximately $1.5 million. It is reasonably possible that we will file or amend our tax returns
in other jurisdictions within twelve months after the date of adoption of FIN 48 which will further
decrease our liability for unrecognized tax benefits by approximately $0.8 million.
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 was approximately $0.8 million and the
corresponding benefit for the interest deduction was approximately $0.3 million resulting in a net
balance of approximately $0.5 million. On September 29, 2007, gross interest accrued associated
with unrecognized income tax benefits was approximately $0.6 million and the benefit of the
interest deduction was approximately $0.3 million resulting in a net balance of approximately $0.3
million because interest payments were made during the nine month period ending September 29, 2007.
The amount of penalties accrued on unrecognized income tax benefits included in our condensed
consolidated balance sheet was $0.1 million at September 29, 2007.
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, made to the State of New
Jersey in respect of those years, 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.
7
The provision for income taxes in the accompanying condensed consolidated statements of
operations differs from the provision calculated by applying the U.S. federal statutory income tax
rate of 35% to income (loss) before taxes due to the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 29, 2007 |
|
|
September 30, 2006 |
|
|
September 29, 2007 |
|
|
September 30, 2006 |
|
|
|
(in thousands, except percentages) |
|
U.S. federal statutory income tax
benefit (expense) |
|
$ |
398 |
|
|
|
35.0 |
% |
|
$ |
(381 |
) |
|
|
35.0 |
% |
|
$ |
56 |
|
|
|
35.0 |
% |
|
$ |
(91 |
) |
|
|
35.0 |
% |
State income tax benefit, net of
federal tax expense |
|
|
15 |
|
|
|
1.3 |
|
|
|
(66 |
) |
|
|
6.0 |
|
|
|
2 |
|
|
|
1.8 |
|
|
|
(16 |
) |
|
|
6.0 |
|
Non-deductible expenses |
|
|
441 |
|
|
|
38.8 |
|
|
|
(349 |
) |
|
|
32.1 |
|
|
|
305 |
|
|
|
189.9 |
|
|
|
(84 |
) |
|
|
32.1 |
|
Foreign earnings permanently
reinvested |
|
|
(7 |
) |
|
|
(0.6 |
) |
|
|
5 |
|
|
|
(0.5 |
) |
|
|
(1 |
) |
|
|
(0.9 |
) |
|
|
1 |
|
|
|
(0.5 |
) |
Tax advantaged investment income |
|
|
(594 |
) |
|
|
(52.3 |
) |
|
|
338 |
|
|
|
(31.0 |
) |
|
|
(100 |
) |
|
|
(62.6 |
) |
|
|
81 |
|
|
|
(31.0 |
) |
Return to provision true-up and other |
|
|
(526 |
) |
|
|
(46.2 |
) |
|
|
856 |
|
|
|
(78.6 |
) |
|
|
(531 |
) |
|
|
(330.3 |
) |
|
|
746 |
|
|
|
(286.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit (expense) |
|
$ |
(273 |
) |
|
|
(24.0 |
)% |
|
$ |
403 |
|
|
|
(37.0 |
)% |
|
$ |
(269 |
) |
|
|
(167.1 |
)% |
|
$ |
637 |
|
|
|
(244.6 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At September 29, 2007 and December 30, 2006, we reported a net deferred tax liability of
approximately $37.4 million and $38.8 million, respectively, comprised principally of temporary
differences between the financial statement and income tax basis of intangible assets.
3. Recently Issued Accounting Pronouncements
In June 2007, the Emerging Issues Task Force (EITF) reached a final consensus on Issue No.
07-3 (EITF 07-3), Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used
in Future Research and Development Activities, which requires that non-refundable advance payments
for future research and development activities be capitalized until the goods have been delivered
or related services have been performed. Adoption is on a prospective basis and could impact the
timing of expense recognition for agreements entered into after December 31, 2007. We have not
determined whether the adoption of EITF 07-3 will have a significant impact on our consolidated
financial position or operating results.
In May 2007, the FASB issued FASB Staff Position No. FIN 48-1, Definition of Settlement in
FASB Interpretation No. 48, (FSP FIN 48-1) which amends FIN 48 to provide guidance on how we
should determine whether a tax position is effectively settled for the purpose of recognizing
previously unrecognized tax benefits. FSP FIN 48-1, a tax position is considered to be effectively
settled if the taxing authority completed its examination, we do not plan to appeal, and it is
remote that the taxing authority would re-examine the tax position in the future. FSP FIN 48-1 did
not have a material impact on our application of FIN 48, which we adopted as of December 31, 2006.
See further discussion regarding our implementation of FIN 48 in Note 2.
In February 2007, the FASB issued 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. 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.
8
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.
For all investments, temporary differences between cost and fair value are presented as a
separate component of accumulated other comprehensive income (loss). Unrealized gain on investments
was $0.1 million and none as of September 29, 2007 and December 30, 2006, respectively. We have
determined that our investments had no impairments that were other than temporary. The specific
identification method is used to determine realized gains and losses on investments.
9
6. Financial Instruments
We conduct business in foreign countries. Our international operations consist primarily of
sales and service personnel for our mechanical circulatory support 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 stated in UK pounds are translated into U.S.
dollars at the period-end exchange rates and the resulting translation adjustments are included in
comprehensive income (loss). 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). These
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 valued these contracts at the estimated fair
value at September 29, 2007. The change in 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 impacts of these foreign currency contracts
are:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 29, 2007 |
|
September 30, 2006 |
|
September 29, 2007 |
|
September 30, 2006 |
|
|
( in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency
exchange gains
(losses) on foreign
currency contracts |
|
$ |
(346 |
) |
|
$ |
59 |
|
|
$ |
(388 |
) |
|
$ |
(214 |
) |
Foreign currency
exchange gains
(losses) on foreign
translation
adjustments |
|
|
431 |
|
|
|
(43 |
) |
|
|
433 |
|
|
|
278 |
|
As of September 29, 2007, we had forward contracts to sell euros with a notional value of 6.8
million and purchase UK pounds with a notional value of £4.0 million, and as of September 30, 2006
we had forward contracts to sell euros with a notional value of 3.3 million and purchase UK pounds
with a notional value of £1.5 million. As of September 29, 2007, our forward contracts had an
average exchange rate of one U.S. dollar to 0.7094 euros and one U.S. dollar to 0.4962 UK pounds.
It is highly uncertain how currency exchange rates will fluctuate in the future.
7. Inventories
Inventories consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
September 29, |
|
|
December 30, |
|
|
|
2007 |
|
|
2006 |
|
|
|
(in thousands) |
|
Finished goods |
|
$ |
24,164 |
|
|
$ |
22,527 |
|
Work in process |
|
|
10,294 |
|
|
|
7,008 |
|
Raw materials |
|
|
24,399 |
|
|
|
20,131 |
|
|
|
|
|
|
|
|
Total |
|
$ |
58,857 |
|
|
$ |
49,666 |
|
|
|
|
|
|
|
|
Inventories include an increase of HeartMate II of approximately $4 million in preparation for the U.S. launch upon possible Food and Drug Administration ("FDA") approval for commercial distribution.
10
8. Property, Plant and Equipment, net
Property, plant and equipment, net, consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
September 29, |
|
|
December 30, |
|
|
|
2007 |
|
|
2006 |
|
|
|
(in thousands) |
|
Land |
|
$ |
4,096 |
|
|
$ |
4,096 |
|
Building |
|
|
12,038 |
|
|
|
12,038 |
|
Building lease |
|
|
2,285 |
|
|
|
2,285 |
|
Equipment |
|
|
52,205 |
|
|
|
47,904 |
|
Rental equipment |
|
|
10,926 |
|
|
|
8,612 |
|
Building and leasehold improvements |
|
|
17,104 |
|
|
|
16,258 |
|
|
|
|
|
|
|
|
Total |
|
|
98,654 |
|
|
|
91,193 |
|
Accumulated depreciation and amortization |
|
|
(52,174 |
) |
|
|
(45,385 |
) |
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
$ |
46,480 |
|
|
$ |
45,808 |
|
|
|
|
|
|
|
|
Depreciation expense was $2.3 million and $2.1 million for the three months ended September
29, 2007 and September 30, 2006, respectively, and $6.8 million and $6.1 million for the nine
months ended September 29, 2007 and September 30, 2006, respectively.
9. Goodwill and Purchased Intangible Assets
The carrying amount of goodwill was $98.5 million as of September 29, 2007 and December 30,
2006, $94.1 million of which amount is attributable to our Cardiovascular division and $4.4 million
of which amount 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 included in purchased
intangibles on the condensed consolidated balance sheets are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of September 29, 2007 |
|
|
|
Gross Carrying |
|
|
Accumulated |
|
|
Net Carrying |
|
|
|
Amount |
|
|
Amortization |
|
|
Amount |
|
|
|
(in thousands) |
|
Patents and trademarks |
|
$ |
38,515 |
|
|
$ |
(24,156 |
) |
|
$ |
14,359 |
|
Core technology |
|
|
37,485 |
|
|
|
(11,414 |
) |
|
|
26,071 |
|
Developed technology |
|
|
125,742 |
|
|
|
(41,950 |
) |
|
|
83,792 |
|
Customer and distributor relationships and other |
|
|
897 |
|
|
|
(209 |
) |
|
|
688 |
|
|
|
|
|
|
|
|
|
|
|
Total purchased intangible assets |
|
$ |
202,639 |
|
|
$ |
(77,729 |
) |
|
$ |
124,910 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, was $3.1 million and $3.0 million
for the three months ended September 29, 2007 and September 30, 2006, respectively, and $9.4
million and $8.9 million for the nine months ended September 29, 2007 and September 30, 2006,
respectively. The acquisition of Avox, during the fourth quarter of 2006, increased amortization
expense by approximately $0.7 million for the year. We determined the fair value of the Avox
acquisition based upon the estimated
11
fair value of assets and liabilities by using an income approach for valuation of intangibles,
which projects the associated revenues, expenses and cash flows attributable to the customer base,
and the market value approach for valuation of other assets and liabilities, which considers the
price at which 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. Other Assets
On August 23, 2006, we purchased a $5.0 million convertible debenture from 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 each 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 September 29, 2007, our ownership
interest in Levitronix would have been less than 5%.
The $5.3 million outstanding principal amount of the Levitronix convertible debenture,
including accrued but unpaid interest thereon, is included in Other assets on our condensed
consolidated balance sheet.
11. Contingencies
From time to time we are involved in litigation arising out of claims in the normal course of
business. Based on the information presently available, management believes that there are no
claims or actions pending or threatened against us, the ultimate resolution of which will have a
material adverse effect on our financial position, liquidity or results of operations, although the
results of litigation are inherently uncertain and adverse outcomes are possible.
12. 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. Net proceeds were used to repurchase 4.2
million shares of our outstanding common stock for $60.0 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 $2.3 million, net of $2.0 million in amortization, are
included in Other assets on the condensed consolidated balance sheet as of September 29, 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 costs are included in Interest expense in our
condensed consolidated statements of operations.
12
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
the 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 September 29, 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 September 29, 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.
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 September 29, 2007,
based on market quotes, was $174.4 million.
13. 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 Principles 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 including 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, as adjusted for
estimated forfeitures 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).
Share-based compensation expense is measured based on the grant-date fair value of the
share-based awards. We recognize share-based compensation expense for the portion of the award that
will ultimately be expected to vest over the requisite service period for those awards with graded
vesting and service conditions. We develop an estimate of the number of share-based awards, which
will ultimately vest primarily based on historical experience. The estimated forfeiture rate is
re-assessed periodically throughout the
requisite service period. Such estimates are revised if they differ materially from actual
forfeitures. As required, the forfeiture estimates will be adjusted to reflect actual forfeitures
when an award vests.
13
Share-based compensation has been classified in the income statement or capitalized on the
balance sheet in the same manner as compensation that is paid to our employees. Share-based
compensation expense for the three and nine months ended September 29, 2007 were $1.9 million and
$8.1 million, respectively, and for the three and nine months ended September 30, 2006 were $2.2
million and $7.2 million, respectively. As of September 29, 2007, share-based compensation expense
of $1.2 million was capitalized to inventory.
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 excess 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 excess tax
benefits from the exercise of stock options as financing cash flows. For the nine months ended
September 29, 2007 and September 30, 2006, $1.9 million and $2.3 million, respectively, of tax
benefits were reported as financing cash flows rather than operating cash flows.
Cash proceeds from the exercise of stock options were $13.3 million and the cash proceeds from
our employee stock purchase plan were $1.1 million for the nine months ended September 29, 2007.
The actual income tax deduction realized from stock options exercised and awards released was $3.1
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 after 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). 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 and nine months ended September 29, 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 and no options were granted under the 1997 SOP in the three and nine
months ended September 29, 2007.
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 common 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 nine months ended September 29, 2007, 582,683 options were granted under
the 2006 Plan at fair market value and 560,020 shares of restricted
stock and restricted stock units were granted under this plan. At September 29, 2007, 0.8
million shares remained available for grant under the 2006 Plan.
14
Stock Options
Five of the common stock option plans or equity incentive plans described above had options
outstanding at September 29, 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 of 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 life 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 |
|
Nine Months Ended |
|
|
September 29, 2007 |
|
September 30, 2006 |
|
September 29, 2007 |
|
September 30, 2006 |
Risk-free interest rate (weighted average) |
|
|
4.45 |
% |
|
|
4.87 |
% |
|
|
4.79 |
% |
|
|
4.53 |
% |
Expected volatility |
|
|
40 |
% |
|
|
40 |
% |
|
|
40 |
% |
|
|
40 |
% |
Expected option life (years) |
|
|
5.06 to 5.92 |
|
|
|
3.90 |
|
|
|
5.08 to 6.05 |
|
|
|
3.84 to 5.22 |
|
Dividends |
|
None |
|
|
None |
|
|
None |
|
|
None |
|
The weighted average fair value of the stock options granted during the nine months ended
September 29, 2007 was $8.12 per share.
At September 29, 2007, there was $5.5 million of unrecognized compensation expense related to
stock options, which expense we expect to recognize over a weighted average period of 1.49 years.
The aggregate intrinsic value of in-the-money options outstanding, based on the closing price of
the Companys common stock on September 28, 2007, the last trading day in the nine months ended
September 29, 2007, of $20.69 per share, was $32.3 million, and the aggregate intrinsic value of
options exercisable was $28.2 million. The total intrinsic value of options exercised was $8.7
million for the nine months ended September 29, 2007.
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 |
|
|
583 |
|
|
|
18.32 |
|
|
|
|
|
Exercised |
|
|
(1,122 |
) |
|
|
11.86 |
|
|
|
|
|
Forfeited or expired |
|
|
(223 |
) |
|
|
17.65 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding options at September 29, 2007 |
|
|
5,823 |
|
|
$ |
15.44 |
|
|
|
6.44 |
|
|
|
|
|
|
|
|
|
|
|
Outstanding options exercisable at September 29, 2007 |
|
|
3,937 |
|
|
$ |
13.71 |
|
|
|
5.42 |
|
|
|
|
|
|
|
|
|
|
|
Outstanding options exercisable and expected to become exercisable
at September 29, 2007 |
|
|
5,235 |
|
|
$ |
14.99 |
|
|
|
6.20 |
|
|
|
|
|
|
|
|
|
|
|
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.
15
In the first nine months of 2007, we issued restricted stock under the 2006 Plan to employees
and directors. As of September 29, 2007, we had $8.5 million of unrecognized compensation expense
associated with these restricted stock awards, which amount we expect to recognize over a
weighted-average period of 3.15 years. The total fair value of the shares for which the restriction
period lapsed during the nine months ended September 29, 2007 was $2.4 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 |
|
|
545 |
|
|
|
18.34 |
|
Vested |
|
|
(146 |
) |
|
|
16.72 |
|
Forfeited or expired |
|
|
(52 |
) |
|
|
18.33 |
|
|
|
|
|
|
|
|
Outstanding unvested restricted stock at September 29, 2007 |
|
|
769 |
|
|
$ |
18.26 |
|
|
|
|
|
|
|
|
Restricted Stock Units
In the first nine months of 2007, we granted restricted stock units with no exercise price to
certain of our non-U.S. employees under the 2006 Plan. At September 29, 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 3.1 years. The aggregate intrinsic value
of the units outstanding, based on the Companys stock price on September 29, 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 |
|
|
Life (in years) |
|
Outstanding units at December 30, 2006 |
|
|
10 |
|
|
$ |
19.08 |
|
|
|
1.74 |
|
Granted |
|
|
14 |
|
|
|
18.28 |
|
|
|
|
|
Released |
|
|
(3 |
) |
|
|
19.49 |
|
|
|
|
|
Forfeited or Expired |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding units at September 29, 2007 |
|
|
21 |
|
|
$ |
18.55 |
|
|
|
1.73 |
|
|
|
|
|
|
|
|
|
|
|
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 nine months ended September 29, 2007, 84,752 shares were
purchased under the ESPP. As of September 29, 2007, 134,336 shares remained available for issuance
under this plan.
The estimated subscription date fair value of the offering under the ESPP is approximately
$0.5 million using the Black-Scholes option pricing model and the following assumptions:
|
|
|
|
|
Risk-free interest rate |
|
|
5.04 |
% |
Expected volatility |
|
|
40 |
% |
Expected option life |
|
0.50 years |
Dividends |
|
None |
16
At September 29, 2007, there was approximately $0.1 million of unrecognized compensation
expense related to ESPP subscriptions that began on May 1, 2007, which amount we expect to
recognize during the fourth quarter of 2007.
14. Net Income (Loss) Per Share
Basic and diluted net income (loss) per share were calculated as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 29, |
|
|
September 30, |
|
|
September 29, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
(in thousands, except per share data) |
|
Net income (loss) |
|
$ |
(1,408 |
) |
|
$ |
1,490 |
|
|
$ |
(430 |
) |
|
$ |
897 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares-basic |
|
|
53,808 |
|
|
|
51,955 |
|
|
|
53,303 |
|
|
|
52,154 |
|
Dilutive effect of stock-based compensation plans |
|
|
|
|
|
|
800 |
|
|
|
|
|
|
|
1,356 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares-diluted |
|
|
53,808 |
|
|
|
52,755 |
|
|
|
53,303 |
|
|
|
53,510 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common share, basic and diluted |
|
$ |
(0.03 |
) |
|
$ |
0.03 |
|
|
$ |
(0.01 |
) |
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per share is computed by dividing net income (loss) by the
weighted-average number of common shares outstanding during the period. Diluted net income (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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 29, |
|
September 30, |
|
September 29, |
|
September 30, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
|
|
(in thousands) |
Options to purchase
shares not included
in the computation
of diluted income
(loss) per share
because their
inclusion would be
antidilutive |
|
|
1,911 |
|
|
|
3,583 |
|
|
|
1,907 |
|
|
|
1,819 |
|
The computation of diluted net income (loss) per share for the three and nine months ended
September 29, 2007 and September 30, 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. None and 1.0 million shares of our common stock were repurchased
under our publicly announced repurchase programs during the nine months ended September 29, 2007
and September 30, 2006, respectively. All repurchased shares have been retired and are not included
in the net income (loss) per common share computation.
17
15. 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 mechanical 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 |
|
|
Nine Months Ended |
|
|
|
September 29, |
|
|
September 30, |
|
|
September 29, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
(in thousands) |
|
Product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular |
|
$ |
34,016 |
|
|
$ |
31,612 |
|
|
$ |
103,707 |
|
|
$ |
97,224 |
|
ITC |
|
|
22,039 |
|
|
|
20,135 |
|
|
|
66,991 |
|
|
|
58,061 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
56,055 |
|
|
$ |
51,747 |
|
|
$ |
170,698 |
|
|
$ |
155,285 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes and other: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular (a)(d) |
|
$ |
(426 |
) |
|
$ |
493 |
|
|
$ |
1,969 |
|
|
$ |
3,873 |
|
ITC(a)(d) |
|
|
2,203 |
|
|
|
2,194 |
|
|
|
5,462 |
|
|
|
3,636 |
|
Corporate (b)(d) |
|
|
(4,157 |
) |
|
|
(2,735 |
) |
|
|
(10,648 |
) |
|
|
(9,321 |
) |
Litigation (c) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(447 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
(2,380 |
) |
|
|
(48 |
) |
|
|
(3,217 |
) |
|
|
(2,259 |
) |
Other income and (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense (b) |
|
|
(1,016 |
) |
|
|
(1,051 |
) |
|
|
(3,158 |
) |
|
|
(3,159 |
) |
Interest income and other (b) |
|
|
2,261 |
|
|
|
2,186 |
|
|
|
6,214 |
|
|
|
5,678 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income tax benefit (expense) |
|
$ |
(1,135 |
) |
|
$ |
1,087 |
|
|
$ |
(161 |
) |
|
$ |
260 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
September 29, |
|
|
December 30, |
|
|
|
2007 |
|
|
2006 |
|
|
|
(in thousands) |
|
Total assets: |
|
|
|
|
|
|
|
|
Cardiovascular |
|
$ |
316,378 |
|
|
$ |
319,604 |
|
ITC |
|
|
62,993 |
|
|
|
58,030 |
|
Corporate (b) |
|
|
235,182 |
|
|
|
213,501 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
614,553 |
|
|
$ |
591,135 |
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Includes amortization expense on purchased intangible assets of $2.9 million and $0.2 million
for Cardiovascular and ITC, respectively, for the three months ended September 29, 2007, and
$8.8 million and $0.6 million for Cardiovascular and ITC, respectively, for the nine months
ended September 29, 2007. Includes amortization expense of $2.9 million and $0.1 million for
Cardiovascular and ITC, respectively for the three months ended September 30, 2006 and $8.8
million and $0.1 million for Cardiovascular and ITC respectively, for the nine months ended
September 30, 2006. |
|
(b) |
|
Represents unallocated costs and assets 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 $1.2 million, $0.6 million and $0.1 million for
Cardiovascular, ITC and Corporate, respectively, for the three months ended September 29, 2007
and $4.6 million, $2.2 million and $1.3 million for Cardiovascular, ITC and Corporate,
respectively, for the nine months ended September 29, 2007. Includes SFAS No. 123(R) expense
of $1.2 million, $0.8 million and $0.2 million for Cardiovascular, ITC and Corporate,
respectively, for the three months ended September 30, 2006 and $4.0 million, $2.2 million and
$1.0 million for Cardiovascular, ITC and Corporate, respectively, for the nine months ended
September 30, 2006. |
18
Geographic Areas:
The geographic composition of our product sales was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 29, |
|
|
September 30, |
|
|
September 29, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
(in thousands) |
|
Domestic |
|
$ |
40,956 |
|
|
$ |
39,942 |
|
|
$ |
125,856 |
|
|
$ |
118,653 |
|
International |
|
|
15,099 |
|
|
|
11,805 |
|
|
|
44,842 |
|
|
|
36,632 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
56,055 |
|
|
$ |
51,747 |
|
|
$ |
170,698 |
|
|
$ |
155,285 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16. Subsequent Event
On November 1, 2007, our ITC division received a warning letter from the New Jersey district
office of the FDA, regarding the ProTime Microcoagulation System (ProTime). As a result of the
matters addressed in the FDA warning letter, ITC intends to institute a recall of certain ProTime
instruments manufactured prior to February 2007.
We estimate the cost of this product recall to be within the range of $0.5 million and $1.0
million. The recall will result in higher cost of product sales in the condensed consolidated
statements of operations during the fourth quarter of 2007.
19
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, or 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
mechanical circulatory support. Our primary product lines are our ventricular assist devices
(VADs): the Thoratec Paracorporeal Ventricular Assist Device (PVAD), the Thoratec Implantable
Ventricular Assist Device (IVAD), the HeartMate Left Ventricular Assist System (HeartMate XVE),
and the HeartMate II Left Ventricular Assist System (HeartMate II). We refer to the PVAD and the
IVAD collectively as the Thoratec product line. The PVAD, IVAD 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 alternate site point-of-care
markets, as well as 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 mechanical circulatory support products include the
PVAD, IVAD, HeartMate XVE, HeartMate II and CentriMag for acute, intermediate and long-term
mechanical circulatory support for patients with advanced HF. 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 anticoagulants,
as well as monitor blood gas/electrolytes, oxygenation and chemistry status. |
20
|
|
|
Incision. Our incision products include devices used to obtain a patients blood sample
for diagnostic testing and screening for platelet function. |
Cardiovascular Division
Our product portfolio of implantable and external mechanical circulatory support devices
includes the following:
|
|
|
The PVAD is an external, pulsatile, ventricular assist device for short to
intermediate-term mechanical circulatory support. This device provides left, right and
biventricular mechanical circulatory support. The PVAD is approved by the FDA for use as a
bridge-to-transplantation (BTT), including home discharge, and post-cardiotomy myocardial
recovery. |
|
|
|
|
The IVAD is an implantable, pulsatile, ventricular assist device approved for BTT,
including home discharge, and post-cardiotomy myocardial recovery and provides left, right,
or biventricular mechanical circulatory 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, pulsatile, left ventricular assist device for
intermediate and longer-term mechanical circulatory support and is the only device approved
in the U.S., Europe and Canada for permanent support of patients ineligible for heart
transplantation. The unique, textured, blood-contacting surface of this device eliminates
the need for systemic anticoagulation. The system is comprised of the blood pump and a
wearable controller and batteries providing a high degree of patient freedom and mobility. |
|
|
|
|
The HeartMate II is an implantable, continuous flow, left ventricular assist device
consisting of a miniature rotary blood pump designed to provide intermediate and long-term
mechanical circulatory support. Its design is intended to be not only smaller, but also
simpler, quieter, and longer lasting than other commercially available ventricular assist
devices. The HeartMate II is CE Mark approved for distribution in Europe, and is in Phase II
pivotal trial in the U.S. |
|
|
|
|
CentriMag is an external device for short-term mechanical 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 extracorporeal circulatory support during cardiac surgery. |
We market a portfolio of VAD products to provide mechanical circulatory support for a range of
needs for patients suffering from HF. The primary market of our VAD products is for those patients
suffering from late stage advanced HF. This type of 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 late stage HF: BTT and permanent support, known as Destination Therapy (DT). In
addition to the chronic HF markets, VADs are also used to treat acute HF.
On April 7, 2003, the FDA approved the HeartMate XVE, an enhanced version of the HeartMate VE,
for DT. We are the only company to offer a VAD approved by the FDA for DT and this approval 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 prospective randomized multi-center clinical trial
called Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure
(also known as REMATCH), which showed our HeartMate device nearly doubled and tripled patient
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 mechanical circulatory support for a broad range of advanced HF patients. The
HeartMate II is a small, implantable, continuous flow ventricular assist device. 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. More than 1,000 patients
worldwide have been implanted with the HeartMate II. The Investigational Device Exemption (IDE)
for our pivotal trial in the U.S. for both BTT and DT indications was fully approved by the FDA in
May 2005. Enrollment in the BTT arm of the trial was completed in May 2006 and the Pre-Market
Approval (PMA) application was submitted to the FDA in December 2006 with additional enrollment
ongoing under an approved continued access protocol (CAP). The DT arm of the trial has been completely enrolled with two year follow-up
ongoing. Additional patients are being enrolled in the DT arm under an approved CAP. We sell the
HeartMate II in Europe under CE Mark approval received in November 2005.
21
In August 2006, we entered into a distribution agreement under which we distribute the
CentriMag blood pump in the U.S. The initial term of the agreement expires in 2011. This device is
510(k) approved by the FDA for patients requiring short-term extracorporeal circulatory support.
In addition to our cardiac assist products, we sell vascular access graft products used in
hemodialysis for patients with late-stage renal disease.
ITC Division
The following are our major point-of-care diagnostic test systems and incision products:
|
|
|
The HEMOCHRON Whole Blood Coagulation System (HEMOCHRON) is used to quantitatively
monitor a patients coagulation while being administered anticoagulants at various settings.
For instance, it is used in the cardiovascular operating room and cardiac catheterization
lab to monitor the drug Heparin, and in an anticoagulation clinic to monitor the drug
warfarin. This system consists of a small portable instrument and disposable test cuvettes
or tubes and delivers results in minutes. |
|
|
|
|
The IRMA TRUpoint Blood Analysis System (IRMA) is used to quantitatively monitor a
patients blood gas, electrolyte and chemistry status. This instrument is a self-contained,
portable system which uses disposable test cartridges and delivers results in minutes. |
|
|
|
|
The AVOXimeter Whole Blood Co-Oximeter/Oximeter System (AVOXimeter) 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. This portable instrument uses small, single-use test cuvettes and delivers
results in less than ten seconds. |
|
|
|
|
The ProTime Microcoagulation System (ProTime) is designed to safely monitor the
clotting activity in blood in patients on anticoagulant therapy, specifically warfarin. The
system can be prescribed for use by patients at home or can be used in the physicians
office or clinic. The system consists of a portable, quantitative instrument and disposable
test cuvettes and delivers results in minutes. |
|
|
|
|
The Hgb Pro Professional Hemoglobin Testing System (Hgb Pro) is used by professionals,
mainly in the doctors office, to test for anemia. Hgb Pro delivers quick results from a
small blood sample placed on a disposable test strip inserted into a hand-held test meter. |
|
|
|
|
The Tenderfoot Heel Incision Device (Tenderfoot), the Tenderlett Finger Incision Device
(Tenderlett) and the Surgicutt Bleeding Time Device (Surgicutt) are used by medical
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. These devices
feature permanently retracting blades for safe incision with minimal pain, as compared to
traditional lancets, which puncture the skin. |
The HEMOCHRON, IRMA and AVOXimeter systems are primarily sold to the hospital point-of-care
segment of the market and our integrated data management system connects all of these systems. The
ProTime and Hgb Pro products are sold to the alternate site (non-hospital) point-of-care segment of
the 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 segment of the market.
In October 2006, we acquired A-VOX Systems, Inc. (Avox), a point-of-care company that
develops and manufactures portable, bedside AVOXimeter systems to assist clinicians in assessing a
patients oxygenation status.
22
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
accounting principles generally accepted in the United States of America 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.
Revenue Recognition
We recognize revenue from product sales for our Cardiovascular and ITC 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 collection is reasonably assured. Sales to
distributors are recorded when title transfers upon shipment. In addition, one of ITCs largest
distributors has certain limited product return rights and we record a reserve for these returns by
applying reasonable estimates based upon historical experience.
We recognize revenue from 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 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 the fair market value of the training,
which is typically performed on behalf of the Company by third party providers. The amount of
revenue allocated to Cardiovascular products is made using the fair value method. Under this
method, the total value of the arrangement is allocated to the training and the products based on
the relative fair market values 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.
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.
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 the effective 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.
23
We record a valuation allowance to reduce our deferred income tax assets to the amount that is
more-likely-than-not to be realized. In evaluating our ability to recover our deferred income tax
assets we consider all available positive and negative evidence, including our operating results,
on-going tax planning and forecasts of future taxable income on a jurisdiction by jurisdiction
basis. In the event we were to determine that we would be able to realize our deferred income tax
assets in the future in excess of their net recorded amount, we would make an adjustment to the
valuation allowance which would reduce the provision for income taxes. Conversely, in the event
that all or part of the net deferred tax assets are determined not to be realizable in the future,
an adjustment to the valuation allowance would be charged to earnings in the period such
determination is made.
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 more-likely-than-not to meet the threshold. 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.
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. Our liability for unrecognized tax benefits was reduced by approximately $0.5
million in the first nine months of 2007 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,
during the third quarter of 2007, we filed tax returns in certain jurisdictions further decreasing
our liability for unrecognized tax benefit by approximately $1.5 million. It is reasonably possible
that we will file or amend our tax returns in other jurisdictions, within twelve months after the
date of adoption of FIN 48 which will further decrease our liability for unrecognized tax benefits
by approximately $0.8 million.
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 annually complete an 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 not subject to
amortization 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 fair 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.
24
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 |
|
Nine Months Ended |
|
|
September 29, |
|
September 30, |
|
September 29, |
|
September 30, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
Product sales |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
Cost of product sales |
|
|
42 |
|
|
|
43 |
|
|
|
41 |
|
|
|
42 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
58 |
|
|
|
57 |
|
|
|
59 |
|
|
|
58 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
37 |
|
|
|
35 |
|
|
|
36 |
|
|
|
36 |
|
Research and development |
|
|
19 |
|
|
|
17 |
|
|
|
19 |
|
|
|
18 |
|
Amortization of purchased intangible assets |
|
|
6 |
|
|
|
5 |
|
|
|
6 |
|
|
|
6 |
|
Litigation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
62 |
|
|
|
57 |
|
|
|
61 |
|
|
|
60 |
|
Income (loss) from operations |
|
|
(4 |
) |
|
|
|
|
|
|
(2 |
) |
|
|
(2 |
) |
Interest expense |
|
|
(2 |
) |
|
|
(2 |
) |
|
|
(2 |
) |
|
|
(2 |
) |
Interest income and other |
|
|
4 |
|
|
|
4 |
|
|
|
4 |
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income tax benefit (expense) |
|
|
(2 |
) |
|
|
2 |
|
|
|
|
|
|
|
|
|
Income tax benefit (expense) |
|
|
(1 |
) |
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
(3 |
)% |
|
|
3 |
% |
|
|
|
% |
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See Note 15 to our condensed consolidated financial statements in this Quarterly Report for data
presented by business segment.
Three months ended September 29, 2007 and September 30, 2006
Product Sales
Product sales in the third quarter of 2007 were $56.1 million compared to $51.7 million in the
third quarter of 2006. Cardiovascular sales increased $2.5 million and ITC sales increased $1.9
million. Product sales changes are due to volume unless otherwise noted. The primary components of
the total $4.4 million increase in product sales were the following:
|
|
|
Cardiovascular product sales increased by $2.5 million, primarily due to increased
international sales of HeartMate II, partially offset by lower sales in our Thoratec product
line as a result of variability in the BTT market. In addition, product sales of CentriMag
contributed to increased sales in the third quarter of 2007 with no comparative sales in the
third quarter of 2006. |
|
|
|
|
Point-of-care diagnostic product sales increased by $1.9 million, due primarily to
increases in sales of our international alternate site and hospital point-of-care products
resulting from market growth and greater market penetration. In addition, sales of
AVOXimeters contributed to the increase in sales in the third quarter of 2007, with no
comparative sales in the third quarter of 2006. |
Sales originating outside of the U.S. and U.S. export sales accounted for approximately 27%
and 23% of our total product sales in the third quarters of 2007 and 2006, respectively.
Gross Profit
Gross profit was $32.3 million in the third quarter of 2007 compared to $29.7 million in the
third quarter of 2006. As a percentage of product sales, gross profit in the third quarter of 2007
was 58% as compared to 57% in the third quarter of 2006. Gross profit percentage included the
following fluctuations:
|
|
|
Cardiovascular gross profit percentage increased by 0.4%, as a result of improved foreign
currency exchange rates and favorable manufacturing variances, partially offset by
unfavorable product mix. |
|
|
|
|
ITC gross profit percentage increased by 0.5% due to improved manufacturing variances
partially offset by unfavorable product/customer mix. |
25
Selling, General and Administrative
Selling, general and administrative expenses in the third quarter of 2007 were $20.9 million,
or 37% of product sales, compared to $18.0 million, or 35% of product sales, in the third quarter
of 2006. The $2.9 million increase in expenses was primarily attributable to the following:
|
|
|
Cardiovascular costs decreased by $0.4 million, primarily due to a decrease in
share-based compensation costs. |
|
|
|
|
ITC costs increased by $0.8 million, primarily due to higher personnel costs and reserves
for overdue accounts receivable. In addition, there was an increase in costs related to
AVOXimeter products with no comparative costs in the third quarter of 2006. |
|
|
|
|
Corporate costs increased by $2.5 million because of market research and compliance
consulting. |
Research and Development
Research and development expenses in the third quarter of 2007 were $10.7 million, or 19% of
product sales, compared to $8.8 million, or 17% of product sales, in the third quarter of 2006. The
total increase of $1.9 million was comprised of a $1.4 million increase at our Cardiovascular
division and a $0.5 million increase at our ITC division. Research and development costs are
largely project driven, and the level of spending depends on the level of project activity planned.
The increase in research and development costs at our Cardiovascular division was due to
development costs associated with HeartMate II product enhancements. The increase in research and
development costs at our ITC division was primarily due to personnel and consulting costs related
to product development.
Amortization of Purchased Intangible Assets
Amortization of purchased intangible assets in the third quarter of 2007 was $3.1 million as
compared to $3.0 million in the third quarter of 2006. The $0.1 million increase in our 2007
expense resulted from intangible assets acquired through our acquisition of Avox in the fourth
quarter of 2006.
Interest Expense
Interest expense was $1.0 million in the third quarter of 2007 as compared to $1.1 million in
the third quarter of 2006. Interest expense in the third quarter of 2007 was comprised of $0.9
million in interest costs, and $0.1 million of amortization of the debt issuance costs related to
our senior subordinated convertible notes. Interest expense in the third quarter of 2006 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.
Interest Income and Other
Interest income and other was $2.3 million for the third quarter of 2007 as compared to $2.2
million in the third quarter of 2006. Interest income and other included $2.0 million of interest
income for both of the third quarters of 2007 and 2006. In addition, we received a royalty payment
of approximately $0.1 million and realized exchange gains of approximately $0.1 million during the
third quarter of 2007, and we received approximately $0.1 million in lease revenue during the third
quarter of 2006.
Income Taxes
Our effective income tax rates were an expense of 24% and a benefit of 37% for the three
months ended September 29, 2007 and September 30, 2006, respectively. This increase in our
effective tax rate of 61% on a comparative basis was primarily due to tax expenses that resulted
from filing our 2006 U.S. tax returns provision true-up in 2007 as compared to a tax benefit from
filing our 2005 U.S. tax returns provision true-up in 2006.
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 depend on our profitability and could fluctuate
significantly.
26
Nine months ended September 29, 2007 and September 30, 2006
Product Sales
Product sales in the first nine months of 2007 were $170.7 million compared to $155.3 million
in the first nine months of 2006. Cardiovascular sales increased $6.5 million and ITC sales
increased $8.9 million. Product sales changes are due to volume unless otherwise noted. The primary
components of the total $15.4 million increase in product sales were the following:
|
|
|
Cardiovascular product sales increased $6.5 million, primarily due to increased
international sales of HeartMate II, partially offset by lower sales in our Thoratec product
line as a result of variability in the BTT market and increased usage of short term
devices. In addition, total product sales from CentriMag contributed to the increase in
sales in the first nine months of 2007, with no comparative sales in the first nine months
of 2006. |
|
|
|
|
Point-of-care diagnostic product sales increased by $8.9 million, primarily due to an
increase in sales of our hospital point-of-care along with an increase in alternate site and
incision products resulting from market expansion and competitor product recalls. In
addition, product sales of AVOXimeters also contributed to the increase in sales in the
first nine months of 2007, with no comparative sales in the first nine months of 2006. |
Sales originating outside of the U.S. and U.S. export sales accounted for approximately 26%
and 24% of our total product sales in the first nine months of 2007 and 2006, respectively.
Gross Profit
Gross profit in the first nine months of 2007 was $100.5 million compared to $90.4 million in
the first nine months of 2006. As a percentage of product sales, gross profit was 59% and 58% for
the first nine months of 2007 and 2006, respectively. Gross profit percentage included the
following fluctuations:
|
|
|
Cardiovascular gross profit percentage increased 0.3% due to improved foreign currency
exchange rates partially offset by unfavorable product mix. |
|
|
|
|
ITC gross profit percentage increased by 2.1% due to improved manufacturing variances
partially offset by product/customer mix. |
Selling, General and Administrative
Selling, general and administrative expenses in the first nine months of 2007 were $62.0
million, or 36% of product sales, compared to $55.2 million, or 36% of product sales, in the first
nine months of 2006. The $6.8 million increase in spending was due to the following:
|
|
|
Cardiovascular costs increased by $0.4 million, primarily due to an increase in personnel
costs related to our preparation for the launch of HeartMate II and related increase in
share-based compensation costs. |
|
|
|
|
ITC costs increased by $1.9 million, primarily due to higher personnel costs, consulting
fees and reserves for overdue accounts receivable. The 2007 period also includes costs
related to the AVOXimeter products with no comparative costs in the first nine months of
2006. |
|
|
|
|
Corporate costs increased by $4.5 million because of higher consulting and legal expenses
related to the review we conducted of our stock option granting practices, market research
and compliance consulting during the first nine months of 2007 as compared to the first nine
months of 2006. |
27
Research and Development
Research and development expenses in the first nine months of 2007 were $32.4 million, or 19%
of product sales, compared to $28.1 million, or 18% of product sales, in the first nine months of
2006. The $4.3 million increase was comprised of $2.9 million at our Cardiovascular division and
$1.4 million at our ITC division. 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 increase in costs at our Cardiovascular division was primarily due to regulatory
and clinical costs associated with our compliance with FDA regulations, clinical trial expenses for
Phase II of the HeartMate II pivotal trial, and HeartMate II product development. The increase in
costs at our ITC division was primarily due to higher personnel and consulting costs related to
product development.
Amortization of Purchased Intangible Assets
Amortization of purchased intangible assets in the first nine months of 2007 was $9.4 million
compared to $8.9 million for the first nine months of 2006. The $0.5 million increase resulted from
intangible assets acquired through our acquisition of Avox in the fourth quarter of 2006.
Interest Expense
Interest expense was $3.2 million for both of the first nine months of 2007 and 2006, which
was comprised of interest expense of $2.7 million for both of the first nine months of 2007 and
2006 and $0.5 million in amortization of the debt issuance costs related to our senior subordinated
convertible notes.
Interest Income and Other
Interest income and other for the first nine months of 2007 was $6.2 million compared to $5.7
million for the first nine months of 2006. Interest income and other included $5.9 million of
interest income in 2007 and $5.1 million of interest income in 2006. The increase in interest
income was primarily due to higher short-term interest rates compared to the same period last year.
In addition, we received a royalty payment of approximately $0.1 million during the first nine
months of 2007 and we received approximately $0.4 million in lease revenue during the third quarter
of 2006.
Income Taxes
Our effective tax rates were an expense of 167% and a benefit of 245% for the nine months
ended September 29, 2007 and September 30, 2006, respectively. This increase in our effective tax
rate of 412% on a comparative basis was primarily due to tax expenses that resulted from filing our
2006 U.S. tax returns provision true-up in 2007 as compared to a tax benefit from filing our 2005
U.S. tax returns provision true-up in 2006.
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 depend on our profitability and could fluctuate
significantly.
Liquidity and Capital Resources
At September 29, 2007, we had net working capital of $298.3 million compared with $265.7
million at December 30, 2006. Cash and cash equivalents at September 29, 2007 were $14.5 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, repurchased restricted shares for payment of
income withholding taxes due upon vesting and paid corporate taxes, which payments were partially
offset by cash provided by operations and proceeds from exercises of stock options and ESPP
exercises.
Cash provided by operating activities was $4.6 million for the nine months ended September 29,
2007. Cash provided by operations includes positive non-cash adjustments primarily comprised of
$16.2 million for depreciation and amortization, $8.1 million related to share-based compensation
expense and $3.1 million of excess tax benefit related to stock option exercises. The uses of cash
comprised of a net loss for the period of $0.4 million, $1.9 million related to tax benefits from
share-based compensation, $11.8 million increase in inventories, $1.8 million increase in prepaid
expenses and other, $2.2 million decrease in receivables and $8.6 million decrease in income taxes.
28
Investing
activities for the nine months ended September 29, 2007 used $73.0 million,
comprised primarily of $68.2 million net purchases of available-for-sale investments and $4.9
million for purchases of property, plant and equipment, net of $2.8 million in transfers of drivers
and demonstration equipment from inventory to fixed assets. The cash used by the Cardiovascular
division for purchases of property, plant and equipment includes $2.3 million for management
information systems equipment, production equipment and leasehold improvements, and cash used by
the ITC division includes $2.4 million for facility expansion costs.
Financing activities for the nine months ended September 29, 2007 provided $15.4 million,
comprised primarily of $14.4 million from proceeds from stock option exercises and employee stock
plan purchases and $1.9 million from excess tax benefits from share-based compensation, partially
offset by $0.9 million from repurchases of restricted stock for payment of income withholding taxes
due upon vesting.
We believe that cash and cash equivalents, short-term available-for-sale investments on hand
together with 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 September 29th of each year, unless terminated by one of the parties. At September 29,
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. Our liability for unrecognized tax benefits was
reduced by approximately $0.5 million in the first nine months of 2007 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, during the third quarter of 2007, we filed tax returns in certain
jurisdictions further decreasing our liability for unrecognized tax benefit by approximately $1.5
million. It is reasonably possible that we will file or amend our tax returns in other
jurisdictions within twelve months after the date of adoption of FIN 48 which will further decrease
our liability for unrecognized tax benefits by approximately $0.8 million.
During the second quarter of 2007, we entered into a lease agreement for office space in the
U.K. under which we are obligated to pay approximately $0.2 million per year for the next ten
years, with the option to renew the lease for a five-year period.
There were no other material changes in contractual obligations outside our normal course of
business.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT 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. 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 or gain on investments would be approximately $0.3 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.
29
Foreign Currency Rate Fluctuations
We conduct business in foreign countries. Our international operations consist primarily of
sales and service personnel for our mechanical circulatory support 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 stated in UK pounds are translated into U.S.
dollars at the period-end exchange rates and the resulting translation adjustments are included in
comprehensive income (loss). 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). These
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 their estimated fair
value at September 29, 2007. The change in 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 are:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 29, 2007 |
|
September 30, 2006 |
|
September 29, 2007 |
|
September 30, 2006 |
|
|
|
|
|
|
( in thousands) |
|
|
|
|
Foreign currency
exchange gains
(losses) on foreign
currency contracts |
|
$ |
(346 |
) |
|
$ |
59 |
|
|
$ |
(387 |
) |
|
$ |
(214 |
) |
Foreign currency
exchange gains
(losses) on foreign
translation
adjustments |
|
|
431 |
|
|
|
(43 |
) |
|
|
433 |
|
|
|
278 |
|
As of September 29, 2007, we had forward contracts to sell euros with a notional value of 6.8
million and purchase UK pounds with a notional value of £4.0 million, and as of September 30, 2006
we had forward contracts to sell euros with a notional value of 3.3 million and purchase UK pounds
with a notional value of £1.5 million. As of September 29, 2007, our forward contracts had an
average exchange rate of one U.S. dollar to 0.7094 euros and one U.S. dollar to 0.4962 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
September 29, 2007 would be approximately $1.8 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 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 on 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 September 29, 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 September 29, 2007 the Companys disclosure controls and
procedures, as defined in Rule 13a-15(e) under the Exchange Act, were
30
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 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 September 29, 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.
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 September 29, 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 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. Additionally, please
see Note 16 to our condensed consolidated financial statements in this Quarterly Report related to
a subsequent event that represents a specific example of the risk entitled If we fail to obtain
approval from the FDA and from foreign regulatory authorities, we cannot market and sell our
products under development in the U.S. and in other countries, and if we fail to adhere to ongoing
FDA Quality System Regulations, the FDA may withdraw our market clearance or take other action,
included in our 2006 Annual Report. 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.
31
ITEM 2: UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
There were no unregistered sales of our equity securities during the three months ended
September 29, 2007.
The following table sets forth certain information about our common stock repurchased during
the three months ended September 29, 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 (1) |
|
|
paid per share |
|
|
programs (2) |
|
|
programs |
|
|
|
(in thousands, except per share data) |
|
July 1, 2007 through July 28, 2007 |
|
|
0.1 |
|
|
$ |
19.72 |
|
|
|
|
|
|
$ |
|
|
July 29, 2007 through August 25, 2007 |
|
|
1.5 |
|
|
|
20.08 |
|
|
|
|
|
|
|
|
|
August 26, 2007 through September 29, 2007 |
|
|
2.7 |
|
|
|
20.05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
5.2 |
|
|
$ |
20.00 |
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
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. |
|
(2) |
|
Our share repurchase programs, which authorized us to repurchase up to a total of $130
million of the Companys common shares, were publicly 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
September 29, 2007. |
32
ITEM 6. EXHIBITS
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. |
33
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: November 8, 2007 |
/s/ Gerhard F. Burbach
|
|
|
Gerhard F. Burbach |
|
|
Chief Executive Officer |
|
|
|
|
|
Date: November 8, 2007 |
/s/ David V. Smith
|
|
|
David V. Smith |
|
|
Chief Financial Officer |
|
|
34